76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... intended for non-invasive aesthetic use will need to address the issues covered in the special controls... intended for non-invasive aesthetic use. (b) Classification. Class II (special controls). The special... into class II (special controls). The special control that will apply to the device is the guidance...

21 CFR 878.4480 - Absorbable powder for lubricating a surgeon's glove.

Code of Federal Regulations, 2010 CFR

2010-04-01

... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878... degradation. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. As of...

75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... Suction Apparatus Device Intended for Negative Pressure Wound Therapy AGENCY: Food and Drug Administration...- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II... ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative...

21 CFR 878.4010 - Tissue adhesive.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., is a device used for adhesion of internal tissues and vessels. (2) Classification. Class III... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tissue adhesive. 878.4010 Section 878.4010 Food... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue...

21 CFR 878.4010 - Tissue adhesive.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., is a device used for adhesion of internal tissues and vessels. (2) Classification. Class III... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Tissue adhesive. 878.4010 Section 878.4010 Food... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue...

21 CFR 874.4780 - Intranasal splint.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...

21 CFR 874.4780 - Intranasal splint.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...

21 CFR 874.4780 - Intranasal splint.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...

21 CFR 874.4780 - Intranasal splint.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...

21 CFR 874.4780 - Intranasal splint.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...

21 CFR 888.4600 - Protractor for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery. (b) Classification. Class I (general controls). The device is exempt from...

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety...

76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... and it is identified as a device using focused ultrasound to produce localized, mechanical motion... labeling includes warnings related to patient reaction in terms of pain and information to user in terms of observable skin reactions that are known to be precursors to the potential thermal adverse effects...

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... running to unintended areas, etc. Wound dehiscence Bench Testing, Shelf Life Testing, Animal Testing, Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing, Clinical Studies. Infection Bench Testing, Biocompatibility Animal Testing, Clinical Studies, Sterility...

Correlation-based pattern recognition for implantable defibrillators.

PubMed Central

Wilkins, J.

1996-01-01

An estimated 300,000 Americans die each year from cardiac arrhythmias. Historically, drug therapy or surgery were the only treatment options available for patients suffering from arrhythmias. Recently, implantable arrhythmia management devices have been developed. These devices allow abnormal cardiac rhythms to be sensed and corrected in vivo. Proper arrhythmia classification is critical to selecting the appropriate therapeutic intervention. The classification problem is made more challenging by the power/computation constraints imposed by the short battery life of implantable devices. Current devices utilize heart rate-based classification algorithms. Although easy to implement, rate-based approaches have unacceptably high error rates in distinguishing supraventricular tachycardia (SVT) from ventricular tachycardia (VT). Conventional morphology assessment techniques used in ECG analysis often require too much computation to be practical for implantable devices. In this paper, a computationally-efficient, arrhythmia classification architecture using correlation-based morphology assessment is presented. The architecture classifies individuals heart beats by assessing similarity between an incoming cardiac signal vector and a series of prestored class templates. A series of these beat classifications are used to make an overall rhythm assessment. The system makes use of several new results in the field of pattern recognition. The resulting system achieved excellent accuracy in discriminating SVT and VT. PMID:8947674

21 CFR 878.4440 - Eye pad.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Eye pad. 878.4440 Section 878.4440 Food and Drugs... GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4440 Eye pad. (a) Identification. An eye pad is... use as a bandage over the eye for protection or absorption of secretions. (b) Classification. Class I...

21 CFR 878.4440 - Eye pad.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Eye pad. 878.4440 Section 878.4440 Food and Drugs... GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4440 Eye pad. (a) Identification. An eye pad is... use as a bandage over the eye for protection or absorption of secretions. (b) Classification. Class I...

21 CFR 884.3900 - Vaginal stent.

Code of Federal Regulations, 2013 CFR

2013-04-01

... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II...

21 CFR 884.3900 - Vaginal stent.

Code of Federal Regulations, 2012 CFR

2012-04-01

... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II...

21 CFR 884.3900 - Vaginal stent.

Code of Federal Regulations, 2011 CFR

2011-04-01

... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II...

21 CFR 884.3900 - Vaginal stent.

Code of Federal Regulations, 2014 CFR

2014-04-01

... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II...

Orthopedic devices; classification for the resorbable calcium salt bone void filler device. Final rule.

PubMed

2003-06-02

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

Balance System

NASA Technical Reports Server (NTRS)

1988-01-01

TherEx Inc.'s AT-1 Computerized Ataxiameter precisely evaluates posture and balance disturbances that commonly accompany neurological and musculoskeletal disorders. Complete system includes two-strain gauged footplates, signal conditioning circuitry, a computer monitor, printer and a stand-alone tiltable balance platform. AT-1 serves as assessment tool, treatment monitor, and rehabilitation training device. It allows clinician to document quantitatively the outcome of treatment and analyze data over time to develop outcome standards for several classifications of patients. It can evaluate specifically the effects of surgery, drug treatment, physical therapy or prosthetic devices.

Clinical efficacy and effectiveness of 3D printing: a systematic review

PubMed Central

Diment, Laura E; Thompson, Mark S; Bergmann, Jeroen H M

2017-01-01

Objective To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields. Design Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Data sources PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar. Methods A double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study. Results Of the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy. Conclusions All medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before they become part of standard clinical practice. PMID:29273650

Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database.

PubMed

Naumann, R Wendel; Brown, Jubilee

2015-01-01

To evaluate adverse events associated with electromechanical morcellation as reported to the Manufacturer and User Facility Device Experience (MAUDE) database. Retrospective analysis of an established database (Canadian Task Force classification III). A search of the MAUDE database for terms associated with commercially available electromechanical morcellation devices was undertaken for events leading to injury or death between 2004 and 2014. Data, including the types of injury, need for conversion to open surgery, type of open surgery, and clinical outcomes, were extracted from the records. Over a 10-year period, 9 events associated with death and 215 events associated with patient injury or significant delay of the surgical procedure were recorded. These involved 137 device failures, 51 organ injuries, and the morcellation of 27 previously undiagnosed malignancies. Of the 9 deaths, 1 was associated with organ injury, and the other 8 were associated with morcellation of cancer. Of the 27 undiagnosed cancers, 5 were reported by the manufacturer, 8 were reported by the patient or family, 9 were reported by medical or news reports, 2 were reported by medical professionals, and 3 were due to litigation. Morcellation of an undiagnosed malignancy was first reported to the database in December 2013. The MAUDE database appears to detect perioperative events, such as device failures and organ injury at the time of surgery, but appears to be poor at detecting late events after surgery, such as the potential spread of cancer. Outcome registries are likely a more efficient means of tracking potential long-term adverse events associated with surgical devices. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

A New Classification System to Report Complications in Growing Spine Surgery: A Multicenter Consensus Study.

PubMed

Smith, John T; Johnston, Charles; Skaggs, David; Flynn, John; Vitale, Michael

2015-12-01

The use of growth-sparing instrumentation in pediatric spinal deformity is associated with a significant incidence of adverse events. However, there is no consistent way to report these complications, allowing for meaningful comparison of different growth-sparing techniques and strategies. The purpose of this study is to develop consensus for a new classification system to report these complications. The authors, who represent lead surgeons from 5 major pediatric spine centers, collaborated to develop a classification system to report complications associated with growing spine surgery. Following IRB approval, this system was then tested using a minimum of 10 patients from each center with at least 2-year follow-up after initial implantation of growing instrumentation to assess ease of use and consistency in reporting complications. Inclusion criteria were only patients who had surgical treatment of early onset scoliosis and did not include casting or bracing.Complications are defined as an unplanned medical event in the course of treatment that may or may not affect final outcome. Severity refers to the level of care and urgency required to treat the complication, and can be classified as device related or disease related. Severity grade (SV) I is a complication that does not require unplanned surgery, and can be corrected at the next scheduled surgery. SVII requires an unplanned surgery, with SVIIA requiring a single trip and SVIIB needing multiple trips for resolution. SVIII is a complication that substantially alters the planned course of treatment. Disease-related complications are classified as grade SVI if no hospitalization is required and grade SVII if hospitalization is required. SVIV was defined as death, either disease or device related. A total of 65 patients from 5 institutions met enrollment criteria for the study; 56 patients had at least 1 complication and 9 had no complications. There were 14 growing rods, 47 VEPTRs, ,and 4 hybrid constructs. The average age at implant was 4.7 years. There were an average of 5.4 expansions, 1.6 revisions, and 0.8 exchanges per patient. The minimum follow-up was 2 years. The most common complications were migration (60), infection (31), pneumonia (21), and instrumentation failure (23). When classified, the complications were grade I (57), grade IIA (79), grade IIB (10), and grade III (6). Well-documented uncertainty in clinical decision making in this area highlights the need for more rigorous clinical research. Reporting complications standardized for severity and impact on the course of treatment in growing spine surgery is a necessary prerequisite for meaningful comparative evaluation of different treatment options. This study shows that although complications were common, only 9% (SVIII) were severe enough to change the planned course of treatment. We propose that future studies reporting complications of different methods of growth-sparing spine surgery use this classification moving forward so that meaningful comparisons can be made between different treatment techniques.

Reliability and Usefulness of Intraoperative 3-Dimensional Imaging by Mobile C-Arm With Flat-Panel Detector.

PubMed

Fujimori, Takahito; Iwasaki, Motoki; Nagamoto, Yukitaka; Kashii, Masafumi; Takao, Masaki; Sugiura, Tsuyoshi; Yoshikawa, Hideki

2017-02-01

Reliability and agreement study. To assess the reliability of intraoperative 3-dimensional imaging with a mobile C-arm (3D C-arm) equipped with a flat-panel detector. Pedicle screws are widely used in spinal surgery. Postoperative computed tomography (CT) is the most reliable method to detect screw misplacement. Recent advances in imaging devices have enabled surgeons to acquire 3D images of the spine during surgery. However, the reliability of these imaging devices is not known. A total of 203 screws were used in 22 consecutive patients who underwent surgery for scoliosis. Screw position was read twice with a 3D C-arm and twice with CT in a blinded manner by 2 independent observers. Screw positions were classified into 4 categories at every 2 mm and then into 2 simpler categories of acceptable or unacceptable. The degree of agreement with respect to screw positions between the double readings was evaluated by κ value. With unanimous agreement between 2 observers regarding postoperative CT readings considered the gold standard, the sensitivity of the 3D C-arm for determining screw misplacement was calculated. A total 804 readings were performed. For the 4-category classification, the mean κ value for the 2 interobserver readings was 0.52 for the 3D C-arm and 0.46 for CT. For the 2-category classification, the mean κ value for the 2 interobserver readings was 0.80 for the 3D C-arm and 0.66 for CT. The sensitivity, specificity, positive predictive value, and negative predictive value of intraoperative imaging with the 3D C-arm were 70%, 95%, 44%, and 98%, respectively. With respect to screws with perforation ≥4 mm, the sensitivity was 83%. No revision surgery was performed. Intraoperative imaging with a 3D C-arm was reliable for detecting screw misplacement and helpful in decreasing the rate of revision surgery for screw misplacement.

Clinical efficacy and effectiveness of 3D printing: a systematic review.

PubMed

Diment, Laura E; Thompson, Mark S; Bergmann, Jeroen H M

2017-12-21

To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields. Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses. PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar. A double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study. Of the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy. All medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before they become part of standard clinical practice. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Behavioral state classification in epileptic brain using intracranial electrophysiology

NASA Astrophysics Data System (ADS)

Kremen, Vaclav; Duque, Juliano J.; Brinkmann, Benjamin H.; Berry, Brent M.; Kucewicz, Michal T.; Khadjevand, Fatemeh; Van Gompel, Jamie; Stead, Matt; St. Louis, Erik K.; Worrell, Gregory A.

2017-04-01

Objective. Automated behavioral state classification can benefit next generation implantable epilepsy devices. In this study we explored the feasibility of automated awake (AW) and slow wave sleep (SWS) classification using wide bandwidth intracranial EEG (iEEG) in patients undergoing evaluation for epilepsy surgery. Approach. Data from seven patients (age 34+/- 12 , 4 women) who underwent intracranial depth electrode implantation for iEEG monitoring were included. Spectral power features (0.1-600 Hz) spanning several frequency bands from a single electrode were used to train and test a support vector machine classifier. Main results. Classification accuracy of 97.8  ±  0.3% (normal tissue) and 89.4  ±  0.8% (epileptic tissue) across seven subjects using multiple spectral power features from a single electrode was achieved. Spectral power features from electrodes placed in normal temporal neocortex were found to be more useful (accuracy 90.8  ±  0.8%) for sleep-wake state classification than electrodes located in normal hippocampus (87.1  ±  1.6%). Spectral power in high frequency band features (Ripple (80-250 Hz), Fast Ripple (250-600 Hz)) showed comparable performance for AW and SWS classification as the best performing Berger bands (Alpha, Beta, low Gamma) with accuracy  ⩾90% using a single electrode contact and single spectral feature. Significance. Automated classification of wake and SWS should prove useful for future implantable epilepsy devices with limited computational power, memory, and number of electrodes. Applications include quantifying patient sleep patterns and behavioral state dependent detection, prediction, and electrical stimulation therapies.

Initial experience with the new da Vinci single-port robot-assisted platform.

PubMed

Ballestero Diego, R; Zubillaga Guerrero, S; Truan Cacho, D; Carrion Ballardo, C; Velilla Diez, G; Calleja Hermosa, P; Gutiérrez Baños, J L

2017-06-01

To describe our experience in the first cases of urological surgeries performed with the da Vinci single-port robot-assisted platform. We performed 5 single-port robot-assisted surgeries (R-LESS) between May and October 2014. We performed 3 ureteral reimplant surgeries, one ureteropyeloplasty in an inverted kidney and 1 partial nephrectomy. The perioperative and postoperative results were collected, as well as a report of the complications according to the Clavien classification system. Of the 5 procedures, 4 were performed completely by LESS, while 1 procedure was reconverted to multiport robot-assisted surgery. There were no intraoperative complications. We observed perioperative complications in 4 patients, all of which were grade 1 or 2. The mean surgical time was 262minutes (range, 230-300). In our initial experience with the da Vinci device, R-LESS surgery was feasible and safe. There are still a number of limitations in its use, which require new and improved R-LESS platforms. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Impact of automobile restraint device utilization on facial fractures and fiscal implications for plastic surgeons.

PubMed

Adkinson, Joshua M; Murphy, Robert X

2011-05-01

In 2009, the National Highway Traffic Safety Administration projected that 33,963 people would die and millions would be injured in motor vehicle collisions (MVC). Multiple studies have evaluated the impact of restraint devices in MVCs. This study examines longitudinal changes in facial fractures after MVC as result of utilization of restraint devices. The Pennsylvania Trauma Systems Foundation-Pennsylvania Trauma Outcomes Study database was queried for MVCs from 1989 to 2009. Restraint device use was noted, and facial fractures were identified by International Classification of Diseases-ninth revision codes. Surgeon cost data were extrapolated. More than 15,000 patients sustained ≥1 facial fracture. Only orbital blowout fractures increased over 20 years. Patients were 2.1% less likely every year to have ≥1 facial fracture, which translated into decreased estimated surgeon charges. Increased use of protective devices by patients involved in MVCs resulted in a change in incidence of different facial fractures with reduced need for reconstructive surgery.

21 CFR 886.4360 - Ocular surgery irrigation device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

21 CFR 886.4360 - Ocular surgery irrigation device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

21 CFR 886.4360 - Ocular surgery irrigation device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

21 CFR 886.4360 - Ocular surgery irrigation device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

21 CFR 886.4360 - Ocular surgery irrigation device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ocular surgery irrigation device. 886.4360 Section... (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4360 Ocular surgery irrigation device. (a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the...

Heterotopic ossification and clinical outcome in nonconstrained cervical arthroplasty 2 years after surgery: the Norwegian Cervical Arthroplasty Trial (NORCAT).

PubMed

Sundseth, Jarle; Jacobsen, Eva Astrid; Kolstad, Frode; Sletteberg, Ruth O; Nygaard, Oystein P; Johnsen, Lars Gunnar; Pripp, Are Hugo; Andresen, Hege; Fredriksli, Oddrun Anita; Myrseth, Erling; Zwart, John A

2016-07-01

Heterotopic ossification is a phenomenon in cervical arthroplasty. Previous reports have mainly focused on various semiconstrained devices and only a few publications have focused on ossification around devices that are nonconstrained. The purpose of this study was to assess the occurrence of heterotopic ossification around a nonconstrained cervical device and how it affects clinical outcome 2 years after surgery. Thirty-seven patients were included from a larger cohort of a randomized controlled trial (NORCAT) which compared single-level cervical arthroplasty with fusion. The occurrence of heterotopic ossification was assessed with a CT scan and two neuroradiologists determined its degree. For grading, we used the Mehren/Suchomel classification system (grade 0-4). The patients were divided by level of ossification, low grade (0-2) or high grade (3-4), and clinical outcomes were compared. Self-rated disability for neck and arm pain (Neck Disability Index), health-related quality of life (the Short Form-36 and EuroQol-5D), and pain (the Numeric Rating Scale 11) were used as clinical outcome measures. Heterotopic ossification was encountered in all patients 2 years after surgery. Complete fusion (grade 4) was found in 16 % of participants, and high-grade ossification (grade 3-4) occurred in 62 %. The remaining patients were classified as having low-grade ossification (grade 2). There were no differences in the clinical outcomes of patients with low- and high-grade ossification. High-grade heterotopic ossification and spontaneous fusion 2 years after surgery were seen in a significant number of patients. However, the degree of ossification did not influence the clinical outcome.

Cochlear implant outcomes in children with motor developmental delay.

PubMed

Amirsalari, Susan; Yousefi, Jaleh; Radfar, Shokofeh; Saburi, Amin; Tavallaie, Seyed Abbas; Hosseini, Mohammad Javad; Noohi, Sima; Hassan Alifard, Mahdieh; Ajallouyean, Mohammad

2012-01-01

Multiple handicapped children and children with syndromes and conditions resulting additional disabilities such as cerebral palsy, global developmental delay and autistic spectrum disorder, are now not routinely precluded from receiving a cochlear implant. The primary focus of this study was to determine the effect of cochlear implants on the speech perception and intelligibility of deaf children with and without motor development delay. In a cohort study, we compared cochlear implant outcomes in two groups of deaf children with or without motor developmental delay (MDD). Among 262 children with pre-lingual profound hearing loss, 28 (10%) had a motor delay based on Gross Motor Function Classification (GMFC). Children with severe motor delays (classification scale levels 4 and 5) and cognitive delays were excluded. All children completed the Categories of Auditory Perception Scales (CAP) and Speech Intelligibility Rating (SIR) prior to surgery and 24 months after the device was activated. The mean age for the study population was 4.09 ± 1.86 years. In all 262 patients the mean CAP score after surgery (5.38 ± 0.043) had a marked difference in comparison with the mean score before surgery (0.482 ± 0.018) (P=0.001). The mean CAP score after surgery for MDD children was 5.03, and was 5.77 for normal motor development children (NMD). The mean SIR score after surgery for MDD children was 2.53, and was 2.66 for NMD children. The final results of CAP and SIR did not have significant difference between NMD children versus MDD children (P>0.05). Regarding to the result, we concluded that children with hearing loss and concomitant MDD as an additional disabilities can benefit from cochlear implantation similar to those of NMD. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

76 FR 69034 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

21 CFR 878.3925 - Plastic surgery kit and accessories.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

Use of Vagus Nerve Stimulator on Children With Primary Generalized Epilepsy.

PubMed

Welch, William P; Sitwat, Bilal; Sogawa, Yoshimi

2018-06-01

To describe the response to vagus nerve stimulator (VNS) in otherwise neurotypical children with medically intractable primary generalized epilepsy. Retrospective chart review of patients who underwent vagus nerve stimulator surgery between January 2011 and December 2015. Eleven patients were identified. Median follow-up duration was 2.5 years (1.2-8.4 years). Prior to vagus nerve stimulator surgery, all patients had at least 1 seizure per week, and 7/11 (64%) had daily seizures. At 1-year follow-up after vagus nerve stimulator, 7/11 (64%) reported improved seizure frequency and 6/11 (55%) reported fewer than 1 seizure per month. Three patients (27%) reported complications related to vagus nerve stimulator surgery, and no patients required device removal. In children with medically intractable primary generalized epilepsy, vagus nerve stimulator is well tolerated and appears to lead to improvement in seizure frequency. Improvement was not attributable to epilepsy classification, age at vagus nerve stimulator implantation, output current, duty cycle, or follow-up duration.

Plastic bag clip discovered in partial colectomy accompanying proposal for phylogenic plastic bag clip classification

PubMed Central

Lehmer, Larisa M; Ragsdale, Bruce D; Daniel, John; Hayashi, Edwin; Kvalstad, Robert

2011-01-01

A plastic bag clip was incidentally found anchored in the mucosa of a partial colectomy specimen 2.6 cm proximal to a ruptured diverticulum for which the patient, a mentally retarded, diabetic, 58-year-old man, underwent surgery. Over 20 cases of accidental ingestion of plastic bag clips have been published. Known complications include small bowel perforation, obstruction, dysphagia, gastrointestinal bleeding and colonic impaction. Preoperative diagnosis of plastic clips lodged in the gastrointestinal tract is frustrated due to radiographic translucency. This occult threat could likely be prevented by the design of gastrointestinally safe, plastic-bag-sealing devices. Presented here is a morphologically based classification of bag clips as a possible guide for determining the most hazardous varieties and to aid further discussions of their impact on health. PMID:22679182

Changes in Crohn's disease phenotype over time in the Chinese population: validation of the Montreal classification system.

PubMed

Chow, Dorothy K L; Leong, Rupert W L; Lai, Larry H; Wong, Grace L H; Leung, Wai-Keung; Chan, Francis K L; Sung, Joseph J Y

2008-04-01

Phenotypic evolution of Crohn's disease occurs in whites but has never been described in other populations. The Montreal classification may describe phenotypes more precisely. The aim of this study was to validate the Montreal classification through a longitudinal sensitivity analysis in detecting phenotypic variation compared to the Vienna classification. This was a retrospective longitudinal study of consecutive Chinese Crohn's disease patients. All cases were classified by the Montreal classification and the Vienna classification for behavior and location. The evolution of these characteristics and the need for surgery were evaluated. A total of 109 patients were recruited (median follow-up: 4 years, range: 6 months-18 years). Crohn's disease behavior changed 3 years after diagnosis (P = 0.025), with an increase in stricturing and penetrating phenotypes, as determined by the Montreal classification, but was only detected by the Vienna classification after 5 years (P = 0.015). Disease location remained stable on follow-up in both classifications. Thirty-four patients (31%) underwent major surgery during the follow-up period with the stricturing [P = 0.002; hazard ratio (HR): 3.3; 95% CI: 1.5-7.0] and penetrating (P = 0.03; HR: 5.8; 95% CI: 1.2-28.2) phenotypes according to the Montreal classification associated with the need for major surgery. In contrast, colonic disease was protective against a major operation (P = 0.02; HR: 0.3; 95% CI: 0.08-0.8). This is the first study demonstrating phenotypic evolution of Crohn's disease in a nonwhite population. The Montreal classification is more sensitive to behavior phenotypic changes than is the Vienna classification after excluding perianal disease from the penetrating disease category and was useful in predicting course and the need for surgery.

Lenke and King classification systems for adolescent idiopathic scoliosis: interobserver agreement and postoperative results.

PubMed

Hosseinpour-Feizi, Hojjat; Soleimanpour, Jafar; Sales, Jafar Ganjpour; Arzroumchilar, Ali

2011-01-01

The aim of this study was to investigate the interobserver agreement of the Lenke and King classifications for adolescent idiopathic scoliosis, and to compare the results of surgery performed based on classification of the scoliosis according to each of these classification systems. The study was conducted in Shohada Hospital in Tabriz, Iran, between 2009 and 2010. First, a reliability assessment was undertaken to assess interobserver agreement of the Lenke and King classifications for adolescent idiopathic scoliosis. Second, postoperative efficacy and safety of surgery performed based on the Lenke and King classifications were compared. Kappa coefficients of agreement were calculated to assess the agreement. Outcomes were compared using bivariate tests and repeated measures analysis of variance. A low to moderate interobserver agreement was observed for the King classification; the Lenke classification yielded mostly high agreement coefficients. The outcome of surgery was not found to be substantially different between the two systems. Based on the results, the Lenke classification method seems advantageous. This takes into consideration the Lenke classification's priority in providing details of curvatures in different anatomical surfaces to explain precise intensity of scoliosis, that it has higher interobserver agreement scores, and also that it leads to noninferior postoperative results compared with the King classification method.

Major and Minor Classifications for Surgery in People With Hemophilia: A Literature Review.

PubMed

Solimeno, Luigi Piero; Escobar, Miguel A; Krassova, Snejana; Seremetis, Stephanie

2018-05-01

Agents that control bleeding and the usage of bypassing agents have made surgery an option to consider in people with hemophilia. However, the lack of consistent definitions for major or minor surgery may lead to inconsistencies in patient management. This literature review has evaluated how surgical procedures in people with hemophilia were categorized as major or minor surgery and assessed the consistency across publications. After screening 926 potentially relevant articles, 547 were excluded and 379 full-text articles were reviewed. Ninety-five articles categorized major or minor surgical procedures; of these, 35 publications categorized three or more major or minor surgical procedures and were included for analysis. Seven (20%) publications provided varying criteria for defining major or minor surgery, five of which defined surgery according to the level of surgical invasiveness. Across all 35 publications, there was considerable variance in the categorization of major and minor surgical procedures and some overlap in surgical nomenclature (eg, type of synovectomy, arthroscopy, and central venous access device insertion/removals). The lack of consistent guidance when referring to major or minor surgery in people with hemophilia needs to be addressed. Clear and consistent definitions, achieved by consensus and promoted by relevant international hemophilia committees, are desirable, to provide guidance on appropriate treatment, to increase the accuracy of trial data and may confound the interpretation of surgical outcomes.

21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...

21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...

21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...

21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...

21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...

National Trends in Surgery for Rotator Cuff Disease in Korea

PubMed Central

2017-01-01

The objective of this study was to investigate the national trends in rotator cuff surgery in Korea and analyze hospital type-specific trends. We analyzed a nationwide database acquired from the Korean Health Insurance Review and Assessment Service (HIRA) from 2007 to 2015. International Classification of Diseases, 10th revision (ICD-10) codes, procedure codes, and arthroscopic device code were used to identify patients who underwent surgical treatment for rotator cuff disease. A total of 383,719 cases of rotator cuff surgeries were performed from 2007 to 2015. The mean annual percentage change in the age-adjusted rate of rotator cuff surgery per population of 100,000 persons rapidly increased from 2007 to 2012 (53.3%, P < 0.001), while that between 2012 to 2015 remained steady (2.3%, P = 0.34). The proportion of arthroscopic surgery among all rotator cuff surgeries steadily rose from 89.9% in 2007 to 96.8% in 2015 (P < 0.001). In terms of hospital types, the rate of rotator cuff surgery increased to the greatest degree in hospitals with 30–100 inpatient beds, and isolated acromioplasty procedure accounted for a larger proportion of the rotator cuff surgeries in small hospitals and clinics compared to large hospitals. Overall, our findings indicate that cases of rotator cuff surgery have increased rapidly recently in Korea, of which arthroscopic surgeries account for the greatest proportion. While rotator cuff surgery is a popular procedure that is commonly performed even in small hospitals, there was a difference in the component ratio of the procedure code in accordance with hospital type. PMID:28049250

Maxillary-driven simultaneous maxillo-mandibular distraction for hemifacial microsomia.

PubMed

Nakajima, Hideo; Sakamoto, Yoshiaki; Tamada, Ikkei; Ogata, Hisao; Kishi, Kazuo; Sakamoto, Teruo

2011-12-01

We treat hemifacial microsomia with a combination of surgery and orthodontic treatment during the growth period, resulting in early improvement in facial asymmetry and the induction of normal growth. We previously used gradual distraction of the mandibular ramus for Pruzansky's type II classification (Pruzansky, 1969). In type II cases, the maxilla should also be treated actively as, using this technique, improvement of the occlusal plane is difficult to achieve, resulting in a cross bite and difficulties in post-operative orthodontic treatment-especially in older patients. Morphologically, the mandibular angle region of the operative side is flat, and the angle of the mouth remains elevated. We performed mandibular-driven simultaneous maxillo-mandibular distraction while the occlusion was maintained using intermaxillary anchorage. However, mandibular-driven distraction tended to elongate the face because the mandible only elongated downwards and the mandibular ramus did not reach the glenoid. Furthermore, external distraction devices produce significant distress for patients until removal of the device and cause scars on the face. We developed a new internal distraction device with a variable angle and performed maxillary-driven simultaneous maxillo-mandibular distraction using this device. The result was morphologically satisfactory and solved the above problems. Because the patient was in the growth period, careful follow-up and induction to normal growth were important while the inferior growth of the affected side was monitored. Copyright © 2010 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Lenke and King classification systems for adolescent idiopathic scoliosis: interobserver agreement and postoperative results

PubMed Central

Hosseinpour-Feizi, Hojjat; Soleimanpour, Jafar; Sales, Jafar Ganjpour; Arzroumchilar, Ali

2011-01-01

Purpose The aim of this study was to investigate the interobserver agreement of the Lenke and King classifications for adolescent idiopathic scoliosis, and to compare the results of surgery performed based on classification of the scoliosis according to each of these classification systems. Methods The study was conducted in Shohada Hospital in Tabriz, Iran, between 2009 and 2010. First, a reliability assessment was undertaken to assess interobserver agreement of the Lenke and King classifications for adolescent idiopathic scoliosis. Second, postoperative efficacy and safety of surgery performed based on the Lenke and King classifications were compared. Kappa coefficients of agreement were calculated to assess the agreement. Outcomes were compared using bivariate tests and repeated measures analysis of variance. Results A low to moderate interobserver agreement was observed for the King classification; the Lenke classification yielded mostly high agreement coefficients. The outcome of surgery was not found to be substantially different between the two systems. Conclusion Based on the results, the Lenke classification method seems advantageous. This takes into consideration the Lenke classification’s priority in providing details of curvatures in different anatomical surfaces to explain precise intensity of scoliosis, that it has higher interobserver agreement scores, and also that it leads to noninferior postoperative results compared with the King classification method. PMID:22267934

Proposal for a histopathological consensus classification of the periprosthetic interface membrane

PubMed Central

Morawietz, L; Classen, R‐A; Schröder, J H; Dynybil, C; Perka, C; Skwara, A; Neidel, J; Gehrke, T; Frommelt, L; Hansen, T; Otto, M; Barden, B; Aigner, T; Stiehl, P; Schubert, T; Meyer‐Scholten, C; König, A; Ströbel, P; Rader, C P; Kirschner, S; Lintner, F; Rüther, W; Bos, I; Hendrich, C; Kriegsmann, J; Krenn, V

2006-01-01

Aims The introduction of clearly defined histopathological criteria for a standardised evaluation of the periprosthetic membrane, which can appear in cases of total joint arthroplasty revision surgery. Methods Based on histomorphological criteria, four types of periprosthetic membrane were defined: wear particle induced type (detection of foreign body particles; macrophages and multinucleated giant cells occupy at least 20% of the area; type I); infectious type (granulation tissue with neutrophilic granulocytes, plasma cells and few, if any, wear particles; type II); combined type (aspects of type I and type II occur simultaneously; type III); and indeterminate type (neither criteria for type I nor type II are fulfilled; type IV). The periprosthetic membranes of 370 patients (217 women, 153 men; mean age 67.6 years, mean period until revision surgery 7.4 years) were analysed according to the defined criteria. Results Frequency of histopathological membrane types was: type I 54.3%, type II 19.7%, type III 5.4%, type IV 15.4%, and not assessable 5.1%. The mean period between primary arthroplasty and revision surgery was 10.1 years for type I, 3.2 years for type II, 4.5 years for type III and 5.4 years for type IV. The correlation between histopathological and microbiological diagnosis was high (89.7%), and the inter‐observer reproducibility sufficient (85%). Conclusion The classification proposed enables standardised typing of periprosthetic membranes and may serve as a tool for further research on the pathogenesis of the loosening of total joint replacement. The study highlights the importance of non‐infectious, non‐particle induced loosening of prosthetic devices in orthopaedic surgery (membrane type IV), which was observed in 15.4% of patients. PMID:16731601

Proposal for a histopathological consensus classification of the periprosthetic interface membrane.

PubMed

Morawietz, L; Classen, R-A; Schröder, J H; Dynybil, C; Perka, C; Skwara, A; Neidel, J; Gehrke, T; Frommelt, L; Hansen, T; Otto, M; Barden, B; Aigner, T; Stiehl, P; Schubert, T; Meyer-Scholten, C; König, A; Ströbel, P; Rader, C P; Kirschner, S; Lintner, F; Rüther, W; Bos, I; Hendrich, C; Kriegsmann, J; Krenn, V

2006-06-01

The introduction of clearly defined histopathological criteria for a standardised evaluation of the periprosthetic membrane, which can appear in cases of total joint arthroplasty revision surgery. Based on histomorphological criteria, four types of periprosthetic membrane were defined: wear particle induced type (detection of foreign body particles; macrophages and multinucleated giant cells occupy at least 20% of the area; type I); infectious type (granulation tissue with neutrophilic granulocytes, plasma cells and few, if any, wear particles; type II); combined type (aspects of type I and type II occur simultaneously; type III); and indeterminate type (neither criteria for type I nor type II are fulfilled; type IV). The periprosthetic membranes of 370 patients (217 women, 153 men; mean age 67.6 years, mean period until revision surgery 7.4 years) were analysed according to the defined criteria. Frequency of histopathological membrane types was: type I 54.3%, type II 19.7%, type III 5.4%, type IV 15.4%, and not assessable 5.1%. The mean period between primary arthroplasty and revision surgery was 10.1 years for type I, 3.2 years for type II, 4.5 years for type III and 5.4 years for type IV. The correlation between histopathological and microbiological diagnosis was high (89.7%), and the inter-observer reproducibility sufficient (85%). The classification proposed enables standardised typing of periprosthetic membranes and may serve as a tool for further research on the pathogenesis of the loosening of total joint replacement. The study highlights the importance of non-infectious, non-particle induced loosening of prosthetic devices in orthopaedic surgery (membrane type IV), which was observed in 15.4% of patients.

External Validation of the European Hernia Society Classification for Postoperative Complications after Incisional Hernia Repair: A Cohort Study of 2,191 Patients.

PubMed

Kroese, Leonard F; Kleinrensink, Gert-Jan; Lange, Johan F; Gillion, Jean-Francois

2018-03-01

Incisional hernia is a frequent complication after midline laparotomy. Surgical hernia repair is associated with complications, but no clear predictive risk factors have been identified. The European Hernia Society (EHS) classification offers a structured framework to describe hernias and to analyze postoperative complications. Because of its structured nature, it might prove to be useful for preoperative patient or treatment classification. The objective of this study was to investigate the EHS classification as a predictor for postoperative complications after incisional hernia surgery. An analysis was performed using a registry-based, large-scale, prospective cohort study, including all patients undergoing incisional hernia surgery between September 1, 2011 and February 29, 2016. Univariate analyses and multivariable logistic regression analysis were performed to identify risk factors for postoperative complications. A total of 2,191 patients were included, of whom 323 (15%) had 1 or more complications. Factors associated with complications in univariate analyses (p < 0.20) and clinically relevant factors were included in the multivariable analysis. In the multivariable analysis, EHS width class, incarceration, open surgery, duration of surgery, Altemeier wound class, and therapeutic antibiotic treatment were independent risk factors for postoperative complications. Third recurrence and emergency surgery were associated with fewer complications. Incisional hernia repair is associated with a 15% complication rate. The EHS width classification is associated with postoperative complications. To identify patients at risk for complications, the EHS classification is useful. Copyright © 2017. Published by Elsevier Inc.

21 CFR 860.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...) of the act with respect to the classification and reclassification of devices intended for human use... information submitted to classification panels or to the Commissioner in connection with classification and...

21 CFR 860.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...) of the act with respect to the classification and reclassification of devices intended for human use... information submitted to classification panels or to the Commissioner in connection with classification and...

75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

...; Clarification of Classification for Human Dura Mater; Technical Amendment AGENCY: Food and Drug Administration... amending the device regulations to clarify the applicability of the device classification for human dura..., human dura mater is now defined under 21 CFR 1271.3(d) as a HCT/P. As such, it is regulated under...

Epilepsy surgery in children and adolescents with malformations of cortical development--outcome and impact of the new ILAE classification on focal cortical dysplasia.

PubMed

Mühlebner, Angelika; Gröppel, Gudrun; Dressler, Anastasia; Reiter-Fink, Edith; Kasprian, Gregor; Prayer, Daniela; Dorfer, Christian; Czech, Thomas; Hainfellner, Johannes A; Coras, Roland; Blümcke, Ingmar; Feucht, Martha

2014-11-01

To determine long-term efficacy and safety of epilepsy surgery in children and adolescents with malformations of cortical development (MCD) and to identify differences in seizure outcome of the various MCD subgroups. Special focus was set on the newly introduced International League Against Epilepsy (ILAE) classification of focal cortical dysplasia (FCD). This is a single center retrospective cross-sectional analysis of prospectively collected data. age at surgery <18 years, pre-surgical evaluation and epilepsy surgery performed at the Vienna pediatric epilepsy center, histologically proven MCD, complete follow-up data for at least 12 months. Clinical variables evaluated: type and localization of MCD, type of surgery and a variety of clinical characteristics reported to be associated with (un-)favorable outcomes. MCD were classified following the existing classification schemes (Barkovich et al., 2012. Brain. 135, 1348-1369; Palmini et al., 2004. Neurology. 62, S2-S8) and the ILAE classification for FCD recently proposed by Blümcke in 2011. Seizure outcome was classified using the ILAE classification proposed by Wieser in 2001. 60 Patients (51.7% male) were included. Follow up was up to 14 (mean 4.4 ± 3.2) years. Mean age at surgery was 8.0 ± 6.0 (median 6.0) years; mean age at epilepsy onset was 2.9 ± 3.2 (median 2.0) years; duration of epilepsy before surgery was 4.8 ± 4.4 (median 3.0) years. 80% of the patients were seizure free at last follow-up. AEDs were successfully withdrawn in 56.7% of all patients. Extended surgery, lesion localization in the temporal lobes and absence of inter-ictal spikes in postsurgical EEG recordings were predictive of favorable seizure outcomes after surgery. However, no association was found between outcome and MCD sub-types. Epilepsy surgery is highly effective in carefully selected drug-resistant children with MCD. Surrogate markers for complete resection of the epileptogenic zone remain the only significant predictors for seizure freedom after surgery. Copyright © 2014 Elsevier B.V. All rights reserved.

76 FR 28689 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

.... FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus... of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would... in the Federal Register. 1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002...

75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-19

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...

Use of fused deposit modeling for additive manufacturing in hospital facilities: European certification directives.

PubMed

Otero, Joel J; Vijverman, An; Mommaerts, Maurice Y

2017-09-01

The goal of this study was to identify current European Union regulations governing hospital-based use of fused deposit modeling (FDM), as implemented via desktop three-dimensional (3D) printers. Literature and Internet sources were screened, searching for official documents, regulations/legislation, and views of specialized attorneys or consultants regarding European regulations for 3D printing or additive manufacturing (AM) in a healthcare facility. A detailed review of the latest amendment (2016) of the European Parliament and Council legislation for medical devices and its classification was performed, which has regularly updated published guidelines for medical devices, that are classified by type and duration of patient contact. As expected, regulations increase in accordance with the level (I-III) of classification. Custom-made medical devices are subject to different regulations than those controlling serially mass-produced items, as originally specified in 98/79/EC European Parliament and Council legislation (1993) and again recently amended (2016). Healthcare facilities undertaking in-house custom production are not obliged to fully follow the directives as stipulated, given an exception for this scenario (Article 4.4a, 98/79/EC). Patient treatment and diagnosis with the aid of customized 3D printing in a healthcare facility can be performed without fully meeting the European Parliament and Council legislation if the materials used are ISO 10993 certified and article 4.4a applies. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Methodological Issues in Predicting Pediatric Epilepsy Surgery Candidates Through Natural Language Processing and Machine Learning

PubMed Central

Cohen, Kevin Bretonnel; Glass, Benjamin; Greiner, Hansel M.; Holland-Bouley, Katherine; Standridge, Shannon; Arya, Ravindra; Faist, Robert; Morita, Diego; Mangano, Francesco; Connolly, Brian; Glauser, Tracy; Pestian, John

2016-01-01

Objective: We describe the development and evaluation of a system that uses machine learning and natural language processing techniques to identify potential candidates for surgical intervention for drug-resistant pediatric epilepsy. The data are comprised of free-text clinical notes extracted from the electronic health record (EHR). Both known clinical outcomes from the EHR and manual chart annotations provide gold standards for the patient’s status. The following hypotheses are then tested: 1) machine learning methods can identify epilepsy surgery candidates as well as physicians do and 2) machine learning methods can identify candidates earlier than physicians do. These hypotheses are tested by systematically evaluating the effects of the data source, amount of training data, class balance, classification algorithm, and feature set on classifier performance. The results support both hypotheses, with F-measures ranging from 0.71 to 0.82. The feature set, classification algorithm, amount of training data, class balance, and gold standard all significantly affected classification performance. It was further observed that classification performance was better than the highest agreement between two annotators, even at one year before documented surgery referral. The results demonstrate that such machine learning methods can contribute to predicting pediatric epilepsy surgery candidates and reducing lag time to surgery referral. PMID:27257386

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2013 CFR

2013-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2012 CFR

2012-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2014 CFR

2014-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2011 CFR

2011-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

Code of Federal Regulations, 2010 CFR

2010-04-01

... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4810 Laser surgical instrument for use in general and plastic surgery and in...

Novel Sternal Protection Device for Cardiac Surgery Via Median Sternotomy Incision

PubMed Central

Marasco, Silvana F.; McGiffin, David C.; Zimmet, Adam D.; Solis, Pablo C.; Bingham, Judy M.; Moshinsky, Randall A.

2017-01-01

Objective Sternal bleeding during cardiac surgery is currently controlled using bone wax or other chemical substances that may result in adverse effects and affect wound healing and recovery. The purpose of this study was to identify a safe, cost-effective, and easy-to-use technique to reduce sternal bleeding and sternal trauma during cardiac surgery. Methods After sternotomy, a sternal protection device was placed over each hemisternal section before insertion of the retractor and remained in situ until the end of surgery. Sternal bleeding and ease of use were assessed and recorded during surgery. Sternal trauma was assessed and recorded within 5 minutes of removal of the device, and overall satisfaction (Global Impression) and any intraoperative adverse events or device malfunction were reported at surgery completion. Patients were followed up 24 hours and 4 weeks after surgery. Results Twelve patients completed the study. Adverse events reported were not considered related to the device. No sternal trauma was identified in any patient. In 9 of 11 patients, sternal bleeding was reduced after insertion of the device. The device was generally considered easy to use, although some difficulty was encountered when used with the Internal Mammary Artery retractor. Conclusions Our data suggest that the device is safe and able to reduce sternal bleeding during surgery using sternal retractors. We recommend further studies in a larger population of patients with a control group to evaluate the device's ability to reduce the morbidity associated with sternal bleeding and sternal trauma. PMID:29023352

Novel Sternal Protection Device for Cardiac Surgery Via Median Sternotomy Incision.

PubMed

Marasco, Silvana F; McGiffin, David C; Zimmet, Adam D; Solis, Pablo C; Bingham, Judy M; Moshinsky, Randall A

Sternal bleeding during cardiac surgery is currently controlled using bone wax or other chemical substances that may result in adverse effects and affect wound healing and recovery. The purpose of this study was to identify a safe, cost-effective, and easy-to-use technique to reduce sternal bleeding and sternal trauma during cardiac surgery. After sternotomy, a sternal protection device was placed over each hemisternal section before insertion of the retractor and remained in situ until the end of surgery. Sternal bleeding and ease of use were assessed and recorded during surgery. Sternal trauma was assessed and recorded within 5 minutes of removal of the device, and overall satisfaction (Global Impression) and any intraoperative adverse events or device malfunction were reported at surgery completion. Patients were followed up 24 hours and 4 weeks after surgery. Twelve patients completed the study. Adverse events reported were not considered related to the device. No sternal trauma was identified in any patient. In 9 of 11 patients, sternal bleeding was reduced after insertion of the device. The device was generally considered easy to use, although some difficulty was encountered when used with the Internal Mammary Artery retractor. Our data suggest that the device is safe and able to reduce sternal bleeding during surgery using sternal retractors. We recommend further studies in a larger population of patients with a control group to evaluate the device's ability to reduce the morbidity associated with sternal bleeding and sternal trauma.

Management of severe ischemic cardiomyopathy: left ventricular assist device as destination therapy versus conventional bypass and mitral valve surgery.

PubMed

Maltais, Simon; Tchantchaleishvili, Vahtang; Schaff, Hartzell V; Daly, Richard C; Suri, Rakesh M; Dearani, Joseph A; Topilsky, Yan; Stulak, John M; Joyce, Lyle D; Park, Soon J

2014-04-01

Patients with severe ischemic cardiomyopathy (left ventricular ejection fraction <25%) and severe ischemic mitral regurgitation have a poor survival with medical therapy alone. Left ventricular assist device as destination therapy is reserved for patients who are too high risk for conventional surgery. We evaluated our outcomes with conventional surgery within this population and the comparative effectiveness of these 2 therapies. We identified patients who underwent conventional surgery or left ventricular assist device as destination therapy for severe ischemic cardiomyopathy (left ventricular ejection fraction <25%) and severe mitral regurgitation. The era for conventional surgery spanned from 1993 to 2009 and from 2007 to 2011 for left ventricular assist device as destination therapy. We compared baseline patient characteristics and outcomes in terms of end-organ function and survival. A total of 88 patients were identified; 55 patients underwent conventional surgery (63%), and 33 patients (37%) received a left ventricular assist device as destination therapy. Patients who received left ventricular assist device as destination therapy had the increased prevalence of renal failure, inotrope dependency, and intra-aortic balloon support. Patients undergoing conventional surgery required longer ventilatory support, and patients receiving a left ventricular assist device required more reoperation for bleeding. Mortality rates were similar between the 2 groups at 30 days (7% in the conventional surgery group vs 3% in the left ventricular assist device as destination therapy group, P = .65) and at 1 year (22% in the conventional surgery group vs 15% in the left ventricular assist device as destination therapy group, P = .58). There was a trend toward improved survival in patients receiving a left ventricular assist device compared with the propensity-matched groups at 1 year (94% vs 71%, P = .171). The operative mortality and early survival after conventional surgery seem to be acceptable. For inoperable or prohibitive-risk patients, left ventricular assist device as destination therapy can be offered with similar outcomes. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Do we need a new classification of parotid gland surgery?

PubMed

Wierzbicka, Małgorzata; Piwowarczyk, Krzysztof; Nogala, Hanna; Błaszczyńska, Marzena; Kosiedrowski, Michał; Mazurek, Cezary

2016-06-30

In February 2016 the European Salivary Gland Society (ESGS) presented and recommended classification of parotidectomies based on the anatomical I-V level division of parotid gland. The main goal of this paper is to present the new classification, and to answer the question if it is more precise compared to classic one. 607 patients (315 man, 292 women) operated on for parotid tumours in a tertiary referral centre, Department of Otolaryngology, Head and Neck Surgery, Medical University of Poznań (502 benign and 105 malignant tumours). Parotid surgery descriptions provided by retrospective analysis of all operating protocols covering the years 2006-2015 were "translated" into the new classification proposed by the ESGS. Analysis of operating protocols and fitting them into the new classification proposed by the ESGS show some discrepancies, in both benign and malignant tumours. Based on the re-evaluation of 607 cases, in 94 procedures for benign tumors the only information available was that "surgery was performed within the superficial lobe". Thus, the new classification forces the surgeon to be much more precise than previously. In 3 cases the whole superficial lobe was removed, together with the upper part of the deep lobe. Because the classification lacked parotidectomy I-II-IV, it indicated that the new classification was insufficient in the aforementioned three cases. In 6 cases of ECD more than one parotid gland tumour was removed. Among malignant tumours, total parotidectomy was the predominant procedure. In 3/13 cases of expanded parotidectomy the temporomandibular joint (TMJ) was additionally removed and it seems that the acronym TMJ should be included among the additional resected structures. It is also necessary to supplement the description of the treatment with casuistically resected anatomical structures for oncological purposes (RT planning) and follow-up imaging. Currently, since 2015 in Poland there has been the National Cancer Registry of benign salivary gland tumours (https://guzyslinianek.pcss.pl). New surgical anatomy and classification based on it will be very helpful in unequivocal, albeit brief and not laborious, reporting of procedures. To summarize, the classification is: easy to use, precise, and forced the surgeon to make a detailed description saving time at the same time. Although it is broad and accurate, it did not cover all clinically rare cases, multiple foci and it does not contain key information about the rupture of the tumour's capsule, so it is necessary to complement the type of surgery by this annotations. The simple, clear and comprehensive classification is especially valuable for centres that lead registration. Thus, we are personally grateful for this new classification, which facilitates multicentre communication.

Can K-Line Predict the Clinical Outcome of Anterior Controllable Antedisplacement and Fusion Surgery for Cervical Myelopathy Caused by Multisegmental Ossification of the Posterior Longitudinal Ligament?

PubMed

Sun, Jing Chuan; Zhang, Bin; Shi, Jiangang; Sun, Kai Qiang; Huan, Le; Sun, Xiao Fei; Liu, Ning; Zheng, Bing; Wang, Hai Bo

2018-04-27

To analyze the correlation between the K-line-based classification of patients with ossification of the posterior longitudinal ligament (OPLL) and their outcome after anterior controllable antedisplacement and fusion (ACAF) surgery. A series of 24 patients with multisegmental OPLL were enrolled. All patients underwent ACAF surgery. First, the patients were classified into 2 groups according to their K-line classification. Then, we separated the patients into subgroups according to their OPLL thickness. The Japanese Orthopaedic Association scores before and 6 months after surgery were studied, and the recovery rate (RR) was calculated. The preoperative and postoperative radiologic parameters were also investigated. Clinical and radiographic assessments showed no significant correlation between the K-line-based classification of patients with OPLL and their outcome of ACAF surgery (P > 0.05). When the OPLL was ≤6 mm thick, K-line-based classification groups had a similar change of occupation ratio and RR (P > 0.05). However, when the OPLL was >6 mm thick, the mean RR was 61.8% ± 14.0% in the K-line (+) group and 78.3% ± 9.7% in the K-line (-) group (P < 0.05), and the mean was 16.0% ± 4.2% in the K-line (+) group and 28.0% ± 7.1% in the K-line (-) group (P < 0.05). This study shows that K-line can predict the clinical outcome of ACAF surgery for multisegmental OPLL in a different way from posterior decompression surgery. When the OPLL was thin, the outcome was satisfactory and there was no correlation with K-line-based classification of patients with OPLL. When the OPLL was >6 mm thick, the K-line (-) group patients had a better outcome than did K-line (+) group patients. Copyright © 2018 Elsevier Inc. All rights reserved.

77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...

Comparing performance of mothers using simplified mid-upper arm circumference (MUAC) classification devices with an improved MUAC insertion tape in Isiolo County, Kenya.

PubMed

Grant, Angeline; Njiru, James; Okoth, Edgar; Awino, Imelda; Briend, André; Murage, Samuel; Abdirahman, Saida; Myatt, Mark

2018-01-01

A novel approach for improving community case-detection of acute malnutrition involves mothers/caregivers screening their children for acute malnutrition using a mid-upper arm circumference (MUAC) insertion tape. The objective of this study was to test three simple MUAC classification devices to determine whether they improved the sensitivity of mothers/caregivers at detecting acute malnutrition. Prospective, non-randomised, partially-blinded, clinical diagnostic trial describing and comparing the performance of three "Click-MUAC" devices and a MUAC insertion tape. The study took place in twenty-one health facilities providing integrated management of acute malnutrition (IMAM) services in Isiolo County, Kenya. Mothers/caregivers classified their child ( n =1040), aged 6-59 months, using the "Click-MUAC" devices and a MUAC insertion tape. These classifications were compared to a "gold standard" classification (the mean of three measurements taken by a research assistant using the MUAC insertion tape). The sensitivity of mother/caregiver classifications was high for all devices (>93% for severe acute malnutrition (SAM), defined by MUAC < 115 mm, and > 90% for global acute malnutrition (GAM), defined by MUAC < 125 mm). Mother/caregiver sensitivity for SAM and GAM classification was higher using the MUAC insertion tape (100% sensitivity for SAM and 99% sensitivity for GAM) than using "Click-MUAC" devices. Younden's J for SAM classification, and sensitivity for GAM classification, were significantly higher for the MUAC insertion tape (99% and 99% respectively). Specificity was high for all devices (>96%) with no significant difference between the "Click-MUAC" devices and the MUAC insertion tape. The results of this study indicate that, although the "Click-MUAC" devices performed well, the MUAC insertion tape performed best. The results for sensitivity are higher than found in previous studies. The high sensitivity for both SAM and GAM classification by mothers/caregivers with the MUAC insertion tape could be due to the use of an improved MUAC tape design which has a number of new design features. The one-on-one demonstration provided to mothers/caregivers on the use of the devices may also have helped improve sensitivity. The results of this study provide evidence that mothers/caregivers can perform sensitive and specific classifications of their child's nutritional status using MUAC. Clinical trials registration number: NCT02833740.

What Should I Expect Before, During, and After Surgery?

MedlinePlus

... Medical Devices Products and Medical Procedures Surgery Devices LASIK What should I expect before, during, and after ... Surgery If you decide to go ahead with LASIK surgery, you will need an initial or baseline ...

Preoperative classification assessment reliability and influence on the length of intertrochanteric fracture operations.

PubMed

Shen, Jing; Hu, FangKe; Zhang, LiHai; Tang, PeiFu; Bi, ZhengGang

2013-04-01

The accuracy of intertrochanteric fracture classification is important; indeed, the patient outcomes are dependent on their classification. The aim of this study was to use the AO classification system to evaluate the variation in classification between X-ray and computed tomography (CT)/3D CT images. Then, differences in the length of surgery were evaluated based on two examinations. Intertrochanteric fractures were reviewed and surgeons were interviewed. The rates of correct discrimination and misclassification (overestimates and underestimates) probabilities were determined. The impact of misclassification on length of surgery was also evaluated. In total, 370 patents and four surgeons were included in the study. All patients had X-ray images and 210 patients had CT/3D CT images. Of them, 214 and 156 patients were treated by intramedullary and extramedullary fixation systems, respectively. The mean length of surgery was 62.1 ± 17.7 min. The overall rate of correct discrimination was 83.8 % and in the classification of A1, A2 and A3 were 80.0, 85.7 and 82.4 %, respectively. The rate of misclassification showed no significant difference between stable and unstable fractures (21.3 vs 13.1 %, P = 0.173). The overall rates of overestimates and underestimates were significantly different (5 vs 11.25 %, P = 0.041). Subtracting the rate of overestimates from underestimates had a positive correlation with prolonged surgery and showed a significant difference with intramedullary fixation (P < 0.001). Classification based on the AO system was good in terms of consistency. CT/3D CT examination was more reliable and more helpful for preoperative assessment, especially for performance of an intramedullary fixation.

Proposal of a new classification of postoperative ileus based on its clinical impact-results of a global survey and preliminary evaluation in colorectal surgery.

PubMed

Venara, Aurélien; Slim, Karem; Regimbeau, Jean-Marc; Ortega-Deballon, Pablo; Vielle, Bruno; Lermite, Emilie; Meurette, Guillaume; Hamy, Antoine

2017-06-01

There is no consensual definition of postoperative ileus (POI), which leads to a lack of reproducibility. The aims of this study were (i) to propose and evaluate a classification of postoperative ileus based on its consequences and (ii) to assess the reproducibility of the classification. A national global survey was carried out according to the DELPHI method in order to create a classification of primary POI. The classification was subsequently tested on a cohort of patients who underwent colorectal surgery. Finally, a reproducibility test was performed in five teaching hospitals with junior and senior surgeons. A five-stage classification was proposed: grade A (least) to grade E (worst). For better differentiation, subcategories (D1/D2) were included. Overall, 173 patients were included who underwent colorectal surgery. Forty of them experienced primary postoperative ileus (23.1%). Grade A occurred in 10 cases, grade B in 10 cases, grade C in 14 cases, grade D1 in 2 cases, and grade D2 in 2 cases. POI-related death (grade E) occurred in 2 cases. Patients with grade A POI recovered their gastrointestinal function significantly faster than those with higher grades (p = 0.01), and were more likely to undergo laparoscopic surgery (p = 0.04). The Intraclass Correlation Coefficient (ICC) was 0.83 in the overall population, and 0.83 and 0.82 respectively in the junior and senior surgeon populations. This classification is easy to both use and reproduce. It will improve the reproducibility, evaluation, and assessment of POI. These preliminary results should be confirmed in a multi-centric international study.

76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...

Multidisciplinary care in severe pediatric electrical oral burn.

PubMed

Pontini, A; Reho, F; Giatsidis, G; Bacci, C; Azzena, B; Tiengo, C

2015-05-01

Oral burns in pediatric patient are commonly due to electrical injuries, representing an important reconstructive issue even for functional than esthetic reason. Different classification, surgical management and even oral device were described to allow the best long-term result. In most case a multidisciplinary approach is necessary to achieve a satisfactory outcome. A severe case of pediatric oral burn with germinative teeth damage is presented, describing a multispecialist team approach that guarantee a satisfactory outcome by reconstructive surgery, careful progressive evaluation of dental and soft tissue healing and speech recovery. The use of acellular dermal substitute template within traditional reconstructive surgery had provided a good functional and esthetic result joint to valid preservation of germinative dental element as shown at long-term X-ray evaluation. Intensive rehabilitation speech program has also avoided phonetic impairment in an important speech develop period. It was so evident that the necessity of a multispecialist care in such difficult injury to achieve the best long-term result. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

Novel use of an ultrasonic bone-cutting device for endoscopic-assisted craniosynostosis surgery.

PubMed

Chaichana, Kaisorn L; Jallo, George I; Dorafshar, Amir H; Ahn, Edward S

2013-07-01

Endoscopic-assisted craniosynostosis surgery is associated with less blood loss and shorter operative times as compared to open surgery. However, in infants who have low circulating blood volumes, the endoscopic approach is still associated with significant blood loss. A major source of blood loss is the bone that is cut during surgery. We discuss the novel use of an ultrasonic bone-cutting device for craniosynostosis surgery, which decreases bone bleeding. This device, which has primarily only been used for spine and skull base surgery, may help reduce blood loss in these infants. All patients with single suture craniosynostosis who were operated on with the use of an ultrasonic bone-cutting device were identified. The information retrospectively recorded from patient charts included patient age, suture involved, blood loss, operative times, complications, preoperative hemoglobin, postoperative hemoglobin, length of hospital stay, and follow-up times. Thirteen patients (12 males, 1 female) underwent surgery with an ultrasonic bone-cutting device during the reviewed period. The average age (±standard deviation) of the patients was 11.8 (±1.6) weeks. Four patients had metopic synostosis and nine patients had sagittal synostosis. The average surgery time was 84 (±13) min. The median (interquartile range) blood loss was 20 (10-70) cc. No patients required blood transfusions. Three patients had dural tears. We demonstrate the novel use of an ultrasonic bone-cutting device for endoscopic-assisted craniosynostosis surgery. This device limited blood loss while maintaining short operative times for infants with low circulating blood volumes.

Innovations in Bariatric Surgery.

PubMed

Zhu, Catherine; Pryor, Aurora D

2015-11-01

Surgery has consistently been demonstrated to be the most effective long-term therapy for the treatment of obesity. However, despite excellent outcomes with current procedures, most patients with obesity- and weight-related comorbidities who meet criteria for surgical treatment choose not to pursue surgery out of fear of operative risks and complications or concerns about high costs. Novel minimally invasive procedures and devices may offer alternative solutions for patients who are hesitant to pursue standard surgical approaches. These procedures may be used for primary treatment of obesity, early intervention for patients approaching morbid obesity, temporary management prior to bariatric surgery, or revision of bypass surgery associated with weight regain. Novel bariatric procedures can in general be divided into four categories: endoluminal space-occupying devices, gastric suturing and restrictive devices, absorption-limiting devices, and neural-hormonal modulating devices. Many of these are only approved as short-term interventions, but these devices may be effective for patients desiring low-risk procedures or a transient effect. We will see the expansion of indications and alternatives for metabolic surgery as these techniques gain approval.

Challenging Residual Contamination of Instruments for Robotic Surgery in Japan.

PubMed

Saito, Yuhei; Yasuhara, Hiroshi; Murakoshi, Satoshi; Komatsu, Takami; Fukatsu, Kazuhiko; Uetera, Yushi

2017-02-01

BACKGROUND Recently, robotic surgery has been introduced in many hospitals. The structure of robotic instruments is so complex that updating their cleaning methods is a challenge for healthcare professionals. However, there is limited information on the effectiveness of cleaning for instruments for robotic surgery. OBJECTIVE To determine the level of residual contamination of instruments for robotic surgery and to develop a method to evaluate the cleaning efficacy for complex surgical devices. METHODS Surgical instruments were collected immediately after operations and/or after in-house cleaning, and the level of residual protein was measured. Three serial measurements were performed on instruments after cleaning to determine the changes in the level of contamination and the total amount of residual protein. The study took place from September 1, 2013, through June 30, 2015, in Japan. RESULTS The amount of protein released from robotic instruments declined exponentially. The amount after in-house cleaning was 650, 550, and 530 µg/instrument in the 3 serial measurements. The overall level of residual protein in each measurement was much higher for robotic instruments than for ordinary instruments (P<.0001). CONCLUSIONS Our data demonstrated that complete removal of residual protein from surgical instruments is virtually impossible. The pattern of decline differed depending on the instrument type, which reflected the complex structure of the instruments. It might be necessary to establish a new standard for cleaning using a novel classification according to the structural complexity of instruments, especially for those for robotic surgery. Infect Control Hosp Epidemiol 2017;38:143-146.

21 CFR 878.4010 - Tissue adhesive.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue... intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery...

21 CFR 878.4010 - Tissue adhesive.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue... intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery...

21 CFR 878.4010 - Tissue adhesive.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue... intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery...

Hysteroscopic sterilization success in outpatient vs office setting is not affected by patient or procedural characteristics.

PubMed

Anderson, Ted L; Yunker, Amanda C; Scheib, Stacey A; Callahan, Tamara L

2013-01-01

To determine factors associated with hysteroscopic sterilization success and whether it differs between the operating room and office settings. Retrospective cohort analysis (Canadian Task Force classification II-2). Major university medical center. Six hundred thirty-eight women who underwent hysteroscopic sterilization between July 1, 2005, and June 30, 2011. Data collected included age, body mass index, previous office procedures, previous cesarean section, and presence of myomas or retroverted uterus. Place of surgery, experience of surgeon, insurance type, bilateral device placement, compliance with hysterosalpingography, and confirmation of occlusion were also recorded. Bivariate analysis of patient characteristics between groups was performed using χ(2) and independent t tests, and identified confounders and associated variables. Multivariate analysis was performed using logistic regression to assess for association and to adjust for confounders. Procedures were performed in the operating room (57%) or in the office (43%). There was no association between success in bilateral device placement or occlusion and any patient characteristic, regardless of surgery setting. Private insurance, patient age, and performance of procedures in the office setting were positively associated with likelihood of compliance with hysterosalpingography. Successful device placement and tubal occlusion are independent of patient age, body mass index, or setting of the procedure. Association between insurance type and completing hysterosalpingography illustrates an important public health problem. Patients who fail to undergo hysterosalpingography to confirm tubal occlusion may unknowingly be at risk of pregnancy and increased risk of ectopic pregnancy. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

PubMed

2015-11-20

The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

21 CFR 878.4840 - Absorbable polydioxanone surgical suture.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4840 Absorbable... expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or...

21 CFR 878.4840 - Absorbable polydioxanone surgical suture.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4840 Absorbable... expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or...

21 CFR 878.4840 - Absorbable polydioxanone surgical suture.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4840 Absorbable... expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or...

21 CFR 878.4840 - Absorbable polydioxanone surgical suture.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4840 Absorbable... expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or...

21 CFR 860.84 - Classification procedures for “old devices.”

Code of Federal Regulations, 2010 CFR

2010-04-01

... Classification procedures for “old devices.” (a) This subpart sets forth the procedures for the original... the appropriate classification panel organized and operated in accordance with section 513 (b) and (c... set forth in § 860.7 relating to the determination of safety and effectiveness; (2) Determines the...

Views on the Oberg-Manske-Tonkin Classification System for Congenital Anomalies of the Hand and Upper Limb.

PubMed

Lowry, R Brian; Bedard, Tanya; Kiefer, Gerhard N; Sass, Kimberly R

2017-05-01

A new classification system was proposed by Tonkin et al as a replacement for the Swanson/International Federation of Societies for Surgery of the Hand system. We have reviewed their aims and have pointed out a number of problems that will make it difficult to be universally accepted. Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

[Preoperative risk assessment with the ASA classification. A prospective study of morbidity and mortality in various ASA classes in 2,937 patients in general surgery].

PubMed

Menke, H; John, K D; Klein, A; Lorenz, W; Junginger, T

1992-12-01

The value of ASA classification in assessment of perioperative risk, i.e. especially postoperative morbidity, was analyzed prospectively using the data of 2937 patients. The analysis took into account the criteria validity, reliability, and sensitivity. The incidence of post-operative morbidity after elective surgery rose from 3.9% in ASA class I to 36% in ASA class IV. Mortality was 0.6% in ASA class II, whereas 9.3% died in ASA class IV. Morbidity, mortality respectively, after emergency surgery was 10.2% in ASA class II compared to 69% in class IV, mortality 1.4% compared to 21.5%. Differences between the ASA classes were confirmed (p-value < 0.05) considering separate kinds of complications and different periods. Furthermore, ASA classification was a valuable reference to length of stay and severity of necessary therapy at the ICU.

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Henschke, Cornelia; Panteli, Dimitra; Perleth, Matthias; Busse, Reinhard

2015-01-01

The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

Development of a novel disposable lid speculum with a drape.

PubMed

Urano, Toru; Kasaoka, Masataka; Yamakawa, Ryoji; Yukihikotamai; Nakamura, Shoichiro

2013-01-01

To evaluate the clinical use of a newly-developed disposable lid speculum with a drape. LiDrape® is a cylindrical device that consists of two flexible rings of polyacetal resin with a transparent elastic silicone sheet attached to the rings. The novel device holds the eyelids between the rings, and a hole in the center of the device provides a surgical field. We used the novel device in cataract surgery (75 eyes), glaucoma surgery (eleven eyes), vitrectomy (ten eyes), and intravitreal injection (six eyes) and evaluated its clinical efficacy. The LiDrape was easy to attach and detach. The novel device was not detached from the eye during surgery. No eyelashes or secretions from the meibomian glands were seen in the surgical field, and the drape provided a sufficient surgical field. The LiDrape functions as a lid speculum as well as a drape. Our results showed that the novel device is useful for ocular surgeries.

Classifying breast cancer surgery: a novel, complexity-based system for oncological, oncoplastic and reconstructive procedures, and proof of principle by analysis of 1225 operations in 1166 patients.

PubMed

Hoffmann, Jürgen; Wallwiener, Diethelm

2009-04-08

One of the basic prerequisites for generating evidence-based data is the availability of classification systems. Attempts to date to classify breast cancer operations have focussed on specific problems, e.g. the avoidance of secondary corrective surgery for surgical defects, rather than taking a generic approach. Starting from an existing, simpler empirical scheme based on the complexity of breast surgical procedures, which was used in-house primarily in operative report-writing, a novel classification of ablative and breast-conserving procedures initially needed to be developed and elaborated systematically. To obtain proof of principle, a prospectively planned analysis of patient records for all major breast cancer-related operations performed at our breast centre in 2005 and 2006 was conducted using the new classification. Data were analysed using basic descriptive statistics such as frequency tables. A novel two-type, six-tier classification system comprising 12 main categories, 13 subcategories and 39 sub-subcategories of oncological, oncoplastic and reconstructive breast cancer-related surgery was successfully developed. Our system permitted unequivocal classification, without exception, of all 1225 procedures performed in 1166 breast cancer patients in 2005 and 2006. Breast cancer-related surgical procedures can be generically classified according to their surgical complexity. Analysis of all major procedures performed at our breast centre during the study period provides proof of principle for this novel classification system. We envisage various applications for this classification, including uses in randomised clinical trials, guideline development, specialist surgical training, continuing professional development as well as quality of care and public health research.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures. Final order.

PubMed

2016-07-13

The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

76 FR 43582 - Cardiovascular Devices; Classification of Electrocardiograph Electrodes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2007-N-0092] (Formerly Docket No. 2007N-0308) Cardiovascular Devices; Classification of... amended as follows: [[Page 43585

77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-03

... medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for... assist that office in processing your request, or fax your request to CDRH at (301) 847-8149. The draft... parts 862 through 892)) have been the basis for the CDRH's Classification Product Code structure and...

Comparison of cost-effectiveness and postoperative outcome of device closure and open surgery closure techniques for treatment of patent ductus arteriosus.

PubMed

Ahmadi, Alireza; Sabri, Mohammadreza; Bigdelian, Hamid; Dehghan, Bahar; Gharipour, Mojgan

2014-01-01

Various devices have been recently employed for percutaneous closure of the patent ductus arteriosus (PDA). Although the high effectiveness of device closure techniques has been clearly determined, a few studies have focused on the cost-effectiveness and also postoperative complications of these procedures in comparison with open surgery. The present study aimed to evaluate the clinical outcome and cost-effectiveness of PDA occlusion by Amplatzer and coil device in comparisong with open surgery. In this cross-sectional study, a randomized sample of 201 patients aged 1 month to 16 years (105 patients with device closure and 96 patients with surgical closure) was selected. The ratio of total pulmonary blood flow to total systemic blood flow, the Qp/Qs ratio, was measured using a pulmonary artery catheter. The cost analysis included direct medical care costs associated with device implantation and open surgery, as well as professional fees. All costs were calculated in Iranian Rials and then converted to US dollars. There was no statistical difference in mean Qp/Qs ratio before the procedure between the device closure group and the open surgery group (2.1 ± 0.7 versus 1.7 ± 0.6, P = 0.090). The mean measured costs were overall higher in the device closure group than in open closure group (948.87 ± 548.76 US$ versus 743.70 ± 696.91 US$, P < 0.001). This difference remained significant after adjustment for age and gender (Standardized Beta = 0.160, P = 0.031). PDA closure with the Amplatzer ductal occluder (1053.05 ± 525.73 US$) or with Nit-Occlud coils (PFM) (912.73 ± 565.94 US$, P < 0.001) was more expensive than that via open surgery. However, the Cook detachable spring coils device closure (605.65 ± 194.62 US$, P = 0.650) had a non-significant cost difference with open surgery. No event was observed in the device closure group regarding in-hospital mortality or morbidity; however, in another group, 2 in-hospital deaths occurred, two patients experienced pneumonia and seizure, and one suffered electrolyte abnormalities including hyponatremia and hypocalcemia. Although open surgery seems to be less expensive than device closure technique, because of lower mortality and morbidity, the latter group is more preferable.

Endoscopic Devices for Obesity.

PubMed

Sampath, Kartik; Dinani, Amreen M; Rothstein, Richard I

2016-06-01

The obesity epidemic, recognized by the World Health Organization in 1997, refers to the rising incidence of obesity worldwide. Lifestyle modification and pharmacotherapy are often ineffective long-term solutions; bariatric surgery remains the gold standard for long-term obesity weight loss. Despite the reported benefits, it has been estimated that only 1% of obese patients will undergo surgery. Endoscopic treatment for obesity represents a potential cost-effective, accessible, minimally invasive procedure that can function as a bridge or alternative intervention to bariatric surgery. We review the current endoscopic bariatric devices including space occupying devices, endoscopic gastroplasty, aspiration technology, post-bariatric surgery endoscopic revision, and obesity-related NOTES procedures. Given the diverse devices already FDA approved and in development, we discuss the future directions of endoscopic therapies for obesity.

A survey of healthcare industry representatives' participation in surgery: some new ethical concerns.

PubMed

Bedard, Jeffrey; Moore, Crystal Dea; Shelton, Wayne

2014-01-01

To provide preliminary evidence of the types and amount of involvement by healthcare industry representatives (HCIRs) in surgery, as well as the ethical concerns of those representatives. A link to an anonymous, web-based survey was posted on several medical device boards of the website http://www. cafepharma.com. Additionally, members of two different medical device groups on LinkedIn were asked to participate. Respondents were self-identified HCIRs in the fields of orthopedics, cardiology, endoscopic devices, lasers, general surgery, ophthalmic surgery, oral surgery, anesthesia products, and urologic surgery. A total of 43 HCIRs replied to the survey over a period of one year: 35 men and eight women. Respondents reported attending an average of 184 surgeries in the prior year and had an average of 17 years as an HCIR and six years with their current employer. Of the respondents, 21 percent (nine of 43) had direct physical contact with a surgical team or patient during a surgery, and 88 percent (38 of 43) provided verbal instruction to a surgical team during a surgery. Additionally, 37 percent (16 of 43) had participated in a surgery in which they felt that their involvement was excessive, and 40 percent (17 of 43) had attended a surgery in which they questioned the competence of the surgeon. HCIRs play a significant role in surgery. Involvement that exceeds their defined role, however, can raise serious ethical and legal questions for surgeons and surgical teams. Surgical teams may at times be substituting the knowledge of the HCIR for their own competence with a medical device or instrument. In some cases, contact with the surgical team or patient may violate the guidelines not only of hospitals and medical device companies, but the law as well. Further study is required to determine if the patients involved have any knowledge or understanding of the role that an HCIR played in their surgery. Copyright 2014 The Journal of Clinical Ethics. All rights reserved.

The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI).

PubMed

Mills, Joseph L; Conte, Michael S; Armstrong, David G; Pomposelli, Frank B; Schanzer, Andres; Sidawy, Anton N; Andros, George

2014-01-01

Critical limb ischemia, first defined in 1982, was intended to delineate a subgroup of patients with a threatened lower extremity primarily because of chronic ischemia. It was the intent of the original authors that patients with diabetes be excluded or analyzed separately. The Fontaine and Rutherford Systems have been used to classify risk of amputation and likelihood of benefit from revascularization by subcategorizing patients into two groups: ischemic rest pain and tissue loss. Due to demographic shifts over the last 40 years, especially a dramatic rise in the incidence of diabetes mellitus and rapidly expanding techniques of revascularization, it has become increasingly difficult to perform meaningful outcomes analysis for patients with threatened limbs using these existing classification systems. Particularly in patients with diabetes, limb threat is part of a broad disease spectrum. Perfusion is only one determinant of outcome; wound extent and the presence and severity of infection also greatly impact the threat to a limb. Therefore, the Society for Vascular Surgery Lower Extremity Guidelines Committee undertook the task of creating a new classification of the threatened lower extremity that reflects these important considerations. We term this new framework, the Society for Vascular Surgery Lower Extremity Threatened Limb Classification System. Risk stratification is based on three major factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). The implementation of this classification system is intended to permit more meaningful analysis of outcomes for various forms of therapy in this challenging, but heterogeneous population. Copyright © 2014 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

A Raman spectroscopy bio-sensor for tissue discrimination in surgical robotics.

PubMed

Ashok, Praveen C; Giardini, Mario E; Dholakia, Kishan; Sibbett, Wilson

2014-01-01

We report the development of a fiber-based Raman sensor to be used in tumour margin identification during endoluminal robotic surgery. Although this is a generic platform, the sensor we describe was adapted for the ARAKNES (Array of Robots Augmenting the KiNematics of Endoluminal Surgery) robotic platform. On such a platform, the Raman sensor is intended to identify ambiguous tissue margins during robot-assisted surgeries. To maintain sterility of the probe during surgical intervention, a disposable sleeve was specially designed. A straightforward user-compatible interface was implemented where a supervised multivariate classification algorithm was used to classify different tissue types based on specific Raman fingerprints so that it could be used without prior knowledge of spectroscopic data analysis. The protocol avoids inter-patient variability in data and the sensor system is not restricted for use in the classification of a particular tissue type. Representative tissue classification assessments were performed using this system on excised tissue. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Classification of instability after reverse shoulder arthroplasty guides surgical management and outcomes.

PubMed

Abdelfattah, Adham; Otto, Randall J; Simon, Peter; Christmas, Kaitlyn N; Tanner, Gregory; LaMartina, Joey; Levy, Jonathan C; Cuff, Derek J; Mighell, Mark A; Frankle, Mark A

2018-04-01

Revision of unstable reverse shoulder arthroplasty (RSA) remains a significant challenge. The purpose of this study was to determine the reliability of a new treatment-guiding classification for instability after RSA, to describe the clinical outcomes of patients stabilized operatively, and to identify those with higher risk of recurrence. All patients undergoing revision for instability after RSA were identified at our institution. Demographic, clinical, radiographic, and intraoperative data were collected. A classification was developed using all identified causes of instability after RSA and allocating them to 1 of 3 defined treatment-guiding categories. Eight surgeons reviewed all data and applied the classification scheme to each case. Interobserver and intraobserver reliability was used to evaluate the classification scheme. Preoperative clinical outcomes were compared with final follow-up in stabilized shoulders. Forty-three revision cases in 34 patients met the inclusion for study. Five patients remained unstable after revision. Persistent instability most commonly occurred in persistent deltoid dysfunction and postoperative acromial fractures but also in 1 case of soft tissue impingement. Twenty-one patients remained stable at minimum 2 years of follow-up and had significant improvement of clinical outcome scores and range of motion. Reliability of the classification scheme showed substantial and almost perfect interobserver and intraobserver agreement among all the participants (κ = 0.699 and κ = 0.851, respectively). Instability after RSA can be successfully treated with revision surgery using the reliable treatment-guiding classification scheme presented herein. However, more understanding is needed for patients with greater risk of recurrent instability after revision surgery. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

PubMed

2017-07-27

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

The Classification of Swanson for Congenital Anomalies of Upper Limb Modified by the Japanese Society for Surgery of the Hand (JSSH).

PubMed

Iba, Kousuke; Horii, Emiko; Ogino, Toshihiko; Kazuki, Kenichi; Kashiwa, Katsuhiko

2015-01-01

The aim of this study is to introduce the classification of Swanson for congenital anomalies of upper limb modified by the Japanese Society for Surgery of the Hand (the JSSH modification) in English. The Swanson classification has been widely accepted by most hand surgeons. However, several authors have suggested that complex cases, particularly those involving the complex spectrum of cleft hand and symbrachydactyly, are difficult to classify into the classification schemes. In the JSSH modification, brachysyndactyly, so-called atypical cleft hand and transverse deficiency are included under the same concept of transverse deficiency. Cleft hand, central polydactyly, and syndactyly are included in the same category of abnormal induction of digital rays. We believe that the JSSH modification system is effective in providing hand surgeons with the clinical features and conditions for congenital anomalies.

Diabetic foot surgery: classifying patients to predict complications.

PubMed

Bevilacqua, Nicholas J; Rogers, Lee C; Armstrong, David G

2008-01-01

The purpose of this article is to describe a classification of diabetic foot surgery performed in the absence of critical limb ischaemia. The basis of this classification is centred on three fundamental variables that are present in the assessment of risk and indication: (1) presence or absence of neuropathy (the loss of protective sensation); (2) presence or absence of an open wound; (3) presence or absence of acute limb-threatening infection. The conceptual framework for this classification is to define distinct classes of surgery in an order of theoretically increasing risk for high-level amputation. These include: Class I: elective diabetic foot surgery (procedures performed to treat a painful deformity in a patient without the loss of protective sensation); Class II: prophylactic (procedure performed to reduce the risk of ulceration or reulceration in a person with the loss of protective sensation but without an open wound); Class III: curative (procedure performed to assist in healing an open wound); and Class IV: emergency (procedure performed to limit the progression of acute infection). The presence of critical ischaemia in any of these classes of surgery should prompt a vascular evaluation to consider (1) the urgency of the procedure being considered and (2) possible revascularization prior to or temporally concomitant with the procedure. It is our hope that this system begins a dialogue amongst physicians and surgeons which can ultimately facilitate communication, enhance perspective, and improve care.

Clinically Significant Pocket Hematoma Increases Long-Term Risk of Device Infection: BRUISE CONTROL INFECTION Study.

PubMed

Essebag, Vidal; Verma, Atul; Healey, Jeff S; Krahn, Andrew D; Kalfon, Eli; Coutu, Benoit; Ayala-Paredes, Felix; Tang, Anthony S; Sapp, John; Sturmer, Marcio; Keren, Arieh; Wells, George A; Birnie, David H

2016-03-22

The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma. The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection. The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection. The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p < 0.0001). Empiric antibiotics upon development of hematoma did not reduce long-term infection risk. CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Submerged Object Detection and Classification System

DTIC Science & Technology

1993-04-16

example of this type of system is a conventional sonar device wherein a highly directional beam of sonic energy periodically radiates from a...scanning transducer which in turn operates as a receiver to detect echoes reflected from any object within the path of 15 propagation. Sonar devices...classification, which requires relatively high frequency signals. Sonar devices also have the shortcoming of sensing background noise generated by

Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss. Final order.

PubMed

2017-12-20

The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Vascular connector devices increase the availability of minimally invasive cardiac surgery to ischemic heart patients.

PubMed

Ramchandani, M; Bedeir, K

2011-01-01

The revival of off-pump cardiac surgery and the exploration of less invasive techniques for coronary artery bypass grafting, have lead to an increasing technical difficulty, as compared to conventional surgery using cardiopulmonary bypass. The moving target vessel in off-pump coronary artery bypass surgery, as well as the increasingly limited space in minimally invasive cardiac surgery were not convenient to many surgeons, a fact that lead many surgeons to deprive their patients the potential benefits of these techniques. Since the 1950's, surgeons have attempted to make the anastomotic procedure less cumbersome and less time consuming. Many creative ideas and devices were made, but for many different reasons, they eventually faded away. Since then, hand-sewn anastomoses have been the standard of care in coronary artery bypass grafting. Today, with the obvious need for a facilitated and fast coronary anastomosis, interest in these anastomotic devices has been re-awakened. The exact geometry, physiology and dynamics of the perfect anastomosis have thus been studied, in an attempt to provide an understanding of reasons behind anastomosis and graft failure after coronary artery bypass surgery, and eventually design the best performing device. These devices would allow for a faster, more accurate and a more reproducible coronary anastomosis using minimally invasive techniques. Also, due to a short learning curve, the standardization of percutaneous devices would allow much more surgeons to more widely adopt less invasive techniques. In summary, we see anastomotic devices as a solution to the technical challenges surgeons encounter with minimally invasive coronary artery bypass grafting.

Policy Analysis of Surgical Utilization at Blanchfield Army Community Hospital

DTIC Science & Technology

2009-04-09

orthopedics/podiatry, eyes/ears/nose/throat (EENT), general surgery , and specialized clinics in optical refractory care and bariatric surgery . Patients that...numbers of surgeries , and the access to care. The first three courses of action show improvement with these projected outcomes, however, the... surgery , surgical, utilization, in room time, resource sharing, swing shift 16. SECURITY CLASSIFICATION OF: a. REPORT U b. ABSTRACT U c. THIS PAGE U

American Epilepsy Society

MedlinePlus

... Epilepsy Society CLINICAL RESOURCES FAQs GUIDELINES IOM EPILEPSY MEDICAL MARIJUANA SUDEP SURGERY DEVICES GENETICS TREATMENTS Drug Alerts and ... RESOURCES Navigation CLINICAL RESOURCES FAQs GUIDELINES IOM EPILEPSY MEDICAL MARIJUANA SUDEP SURGERY DEVICES GENETICS TREATMENTS Drug Alerts and ...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

21 CFR 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical..., including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be...

Bioactive titan cage Implaspin in treatment of degenerative disease of the cervcal spine--the results from 2007 till 2008.

PubMed

Filip, Michal; Linzer, Petr; Sámal, Filip; Jurek, Patrik; Strnad, Zdenek; Strnad, Jakub

2010-01-01

The authors present results of surgical treatment of cervical spine degenerative disease via Implaspin biotitanium replacement. Surgery was indicated for a group of 24 patients with symptoms of cervical spondylogenic myelopathy or the irritation decay root syndrome non-reacting to conservative treatment. Pre-surgery X-ray and MRI examinations showed spinal canal stenosis caused by the intervertebral disk osteochondrosis combined with prolapse or dorsal osteophytes. Clinical problems of the group of patients were evaluated through the JOA classification before surgery and during the 2nd, the 6th and month 12th after surgery. The surgery rate of success was evaluated in percentages during post-surgery examinations that took place in the 12th month. Based on the JOA classification, that rate of success falls into the good surgery results zone. The post-surgery X-ray examinations showed two sank replacements by 1/3 of its height into the surrounding vertebral bodies. In these cases we performed the control MRI. No signs of the new spinal compression were found and the spinal canal was free in the operated site. Based on our short-term experiences, the Implaspin bioactive replacement seems to be a suitable alternative to the other types of replacements designed for intervertebral fusion in the lower cervical spine area.

Controlling a human-computer interface system with a novel classification method that uses electrooculography signals.

PubMed

Wu, Shang-Lin; Liao, Lun-De; Lu, Shao-Wei; Jiang, Wei-Ling; Chen, Shi-An; Lin, Chin-Teng

2013-08-01

Electrooculography (EOG) signals can be used to control human-computer interface (HCI) systems, if properly classified. The ability to measure and process these signals may help HCI users to overcome many of the physical limitations and inconveniences in daily life. However, there are currently no effective multidirectional classification methods for monitoring eye movements. Here, we describe a classification method used in a wireless EOG-based HCI device for detecting eye movements in eight directions. This device includes wireless EOG signal acquisition components, wet electrodes and an EOG signal classification algorithm. The EOG classification algorithm is based on extracting features from the electrical signals corresponding to eight directions of eye movement (up, down, left, right, up-left, down-left, up-right, and down-right) and blinking. The recognition and processing of these eight different features were achieved in real-life conditions, demonstrating that this device can reliably measure the features of EOG signals. This system and its classification procedure provide an effective method for identifying eye movements. Additionally, it may be applied to study eye functions in real-life conditions in the near future.

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

21 CFR 874.3540 - Prosthesis modification instrument for ossicular replacement surgery.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Prosthesis modification instrument for ossicular replacement surgery. 874.3540 Section 874.3540 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Prosthetic Devices § 874.3540 Prosthesis modification...

Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System. Final order.

PubMed

2018-01-02

The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

PubMed

2017-10-18

The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

PubMed

2018-01-03

The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Common uses and cited complications of energy in surgery.

PubMed

Sankaranarayanan, Ganesh; Resapu, Rajeswara R; Jones, Daniel B; Schwaitzberg, Steven; De, Suvranu

2013-09-01

Instruments that apply energy to cut, coagulate, and dissect tissue with minimal bleeding facilitate surgery. The improper use of energy devices may increase patient morbidity and mortality. The current article reviews various energy sources in terms of their common uses and safe practices. For the purpose of this review, a general search was conducted through NCBI, SpringerLink, and Google. Articles describing laparoscopic or minimally invasive surgeries using single or multiple energy sources are considered, as are articles comparing various commercial energy devices in laboratory settings. Keywords, such as laparoscopy, energy, laser, electrosurgery, monopolar, bipolar, harmonic, ultrasonic, cryosurgery, argon beam, laser, complications, and death were used in the search. A review of the literature shows that the performance of the energy devices depends upon the type of procedure. There is no consensus as to which device is optimal for a given procedure. The technical skill level of the surgeon and the knowledge about the devices are both important factors in deciding safe outcomes. As new energy devices enter the market increases, surgeons should be aware of their indicated use in laparoscopic, endoscopic, and open surgery.

Morbidity Assessment in Surgery: Refinement Proposal Based on a Concept of Perioperative Adverse Events

PubMed Central

Kazaryan, Airazat M.; Røsok, Bård I.; Edwin, Bjørn

2013-01-01

Background. Morbidity is a cornerstone assessing surgical treatment; nevertheless surgeons have not reached extensive consensus on this problem. Methods and Findings. Clavien, Dindo, and Strasberg with coauthors (1992, 2004, 2009, and 2010) made significant efforts to the standardization of surgical morbidity (Clavien-Dindo-Strasberg classification, last revision, the Accordion classification). However, this classification includes only postoperative complications and has two principal shortcomings: disregard of intraoperative events and confusing terminology. Postoperative events have a major impact on patient well-being. However, intraoperative events should also be recorded and reported even if they do not evidently affect the patient's postoperative well-being. The term surgical complication applied in the Clavien-Dindo-Strasberg classification may be regarded as an incident resulting in a complication caused by technical failure of surgery, in contrast to the so-called medical complications. Therefore, the term surgical complication contributes to misinterpretation of perioperative morbidity. The term perioperative adverse events comprising both intraoperative unfavourable incidents and postoperative complications could be regarded as better alternative. In 2005, Satava suggested a simple grading to evaluate intraoperative surgical errors. Based on that approach, we have elaborated a 3-grade classification of intraoperative incidents so that it can be used to grade intraoperative events of any type of surgery. Refinements have been made to the Accordion classification of postoperative complications. Interpretation. The proposed systematization of perioperative adverse events utilizing the combined application of two appraisal tools, that is, the elaborated classification of intraoperative incidents on the basis of the Satava approach to surgical error evaluation together with the modified Accordion classification of postoperative complication, appears to be an effective tool for comprehensive assessment of surgical outcomes. This concept was validated in regard to various surgical procedures. Broad implementation of this approach will promote the development of surgical science and practice. PMID:23762627

Specifying Skill-Based Training Strategies and Devices: A Model Description

DTIC Science & Technology

1990-06-01

Technical Report 897 Specifying Skill-Based Training N Strategies and Devices: A Model Description I Paui J. Sticha and Mark Schlager Human Resources...unlimied 90 ’ Technical Report 897 Specifying Skill-Based Training Strategies and Devices: A Model Description Paul J. Sticha and Mark Schlager Human...SECURITY CLASSIFICATION OF THIS PAGE Form Approved REPORT DOCUMENTATION PAGE FMNo o7 ote la. REPORT SECURITY CLASSIFICATION lb. RESTRICTWE MARKINGS

Thoracic surgery in patients with an implanted neurostimulator device.

PubMed

Meyring, Kristina; Zehnder, Adrian; Schmid, Ralph A; Kocher, Gregor J

2017-10-01

Movement disorders such as Parkinson's disease are increasingly treated with deep brain stimulators. Being implanted in a subcutaneous pocket in the chest region, thoracic surgical procedures can interfere with such devices, as they are sensible to external electromagnetic forces. Monopolar electrocautery can lead to dysfunction of the device or damage of the brain tissue caused by heat. We report a series of 3 patients with deep brain stimulators who underwent thoracic surgery. By turning off the deep brain stimulators before surgery and avoiding the use of monopolar cautery, electromagnetic interactions were avoided in all patients. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

A novel risk classification system for 30-day mortality in children undergoing surgery

PubMed Central

Walter, Arianne I.; Jones, Tamekia L.; Huang, Eunice Y.; Davis, Robert L.

2018-01-01

A simple, objective and accurate way of grouping children undergoing surgery into clinically relevant risk groups is needed. The purpose of this study, is to develop and validate a preoperative risk classification system for postsurgical 30-day mortality for children undergoing a wide variety of operations. The National Surgical Quality Improvement Project-Pediatric participant use file data for calendar years 2012–2014 was analyzed to determine preoperative variables most associated with death within 30 days of operation (D30). Risk groups were created using classification tree analysis based on these preoperative variables. The resulting risk groups were validated using 2015 data, and applied to neonates and higher risk CPT codes to determine validity in high-risk subpopulations. A five-level risk classification was found to be most accurate. The preoperative need for ventilation, oxygen support, inotropic support, sepsis, the need for emergent surgery and a do not resuscitate order defined non-overlapping groups with observed rates of D30 that vary from 0.075% (Very Low Risk) to 38.6% (Very High Risk). When CPT codes where death was never observed are eliminated or when the system is applied to neonates, the groupings remained predictive of death in an ordinal manner. PMID:29351327

Applications of 3D printing in the management of severe spinal conditions.

PubMed

Provaggi, Elena; Leong, Julian J H; Kalaskar, Deepak M

2017-06-01

The latest and fastest-growing innovation in the medical field has been the advent of three-dimensional printing technologies, which have recently seen applications in the production of low-cost, patient-specific medical implants. While a wide range of three-dimensional printing systems has been explored in manufacturing anatomical models and devices for the medical setting, their applications are cutting-edge in the field of spinal surgery. This review aims to provide a comprehensive overview and classification of the current applications of three-dimensional printing technologies in spine care. Although three-dimensional printing technology has been widely used for the construction of patient-specific anatomical models of the spine and intraoperative guide templates to provide personalized surgical planning and increase pedicle screw placement accuracy, only few studies have been focused on the manufacturing of spinal implants. Therefore, three-dimensional printed custom-designed intervertebral fusion devices, artificial vertebral bodies and disc substitutes for total disc replacement, along with tissue engineering strategies focused on scaffold constructs for bone and cartilage regeneration, represent a set of promising applications towards the trend of individualized patient care.

Low-back electromyography (EMG) data-driven load classification for dynamic lifting tasks.

PubMed

Totah, Deema; Ojeda, Lauro; Johnson, Daniel D; Gates, Deanna; Mower Provost, Emily; Barton, Kira

2018-01-01

Numerous devices have been designed to support the back during lifting tasks. To improve the utility of such devices, this research explores the use of preparatory muscle activity to classify muscle loading and initiate appropriate device activation. The goal of this study was to determine the earliest time window that enabled accurate load classification during a dynamic lifting task. Nine subjects performed thirty symmetrical lifts, split evenly across three weight conditions (no-weight, 10-lbs and 24-lbs), while low-back muscle activity data was collected. Seven descriptive statistics features were extracted from 100 ms windows of data. A multinomial logistic regression (MLR) classifier was trained and tested, employing leave-one subject out cross-validation, to classify lifted load values. Dimensionality reduction was achieved through feature cross-correlation analysis and greedy feedforward selection. The time of full load support by the subject was defined as load-onset. Regions of highest average classification accuracy started at 200 ms before until 200 ms after load-onset with average accuracies ranging from 80% (±10%) to 81% (±7%). The average recall for each class ranged from 69-92%. These inter-subject classification results indicate that preparatory muscle activity can be leveraged to identify the intent to lift a weight up to 100 ms prior to load-onset. The high accuracies shown indicate the potential to utilize intent classification for assistive device applications. Active assistive devices, e.g. exoskeletons, could prevent back injury by off-loading low-back muscles. Early intent classification allows more time for actuators to respond and integrate seamlessly with the user.

Effects of peritoneal ropivacaine nebulization for pain control after laparoscopic gynecologic surgery.

PubMed

Somaini, Marta; Brambillasca, Pietro; Ingelmo, Pablo Mauricio; Lovisari, Federica; Catenacci, Stefano Scalia; Rossini, Valeria; Bucciero, Mario; Sahillioglu, Emre; Buda, Alessandro; Signorelli, Mauro; Gili, Mauro; Joshi, Girish; Fumagalli, Roberto; Ferland, Catherine E; Diemunsch, Pierre

2014-01-01

To evaluate the effects of peritoneal cold nebulization of ropivacaine on pain control after gynecologic laparoscopy. Evidence obtained from a properly designed, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). Tertiary care center. One hundred thirty-five women with American Society of Anesthesiologists disease classified as ASA I-III who were scheduled to undergo operative laparoscopy. Patients were randomized to receive either nebulization of 30 mg ropivacaine before surgery (preoperative group), nebulization of 30 mg ropivacaine after surgery (postoperative group), instillation of 100 mg ropivacaine before surgery (instillation group), or instillation of saline solution (control group). Nebulization was performed using the Aeroneb Pro device. Pain scores, morphine consumption, and ambulation time were collected in the post-anesthesia care unit and at 4, 6, and 24 hours postoperatively. One hundred eighteen patients completed the study. Patients in the preoperative group reported lower pain Numeric Ranking Scale values compared with those in the control group (net difference 2 points; 95% confidence interval [CI], 0.3-3.1 at 4 hours, 1-3 at 6 hours, and 0.7-3 at 24 hours; p = .01) Patients in the preoperative group consumed significantly less morphine than did those in the control group (net difference 7 mg; 95% CI, 0.7-13; p = .02). More patients who received nebulization walked without assistance within 12 hours after awakening than did those in the instillation and control groups (net difference 15%; 95% CI, 6%-24%; p = .001). Cold nebulization of ropivacaine before surgery reduced postoperative pain and morphine consumption and was associated with earlier walking without assistance. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

PubMed

2017-10-20

The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

A Novel Classification System for Injuries After Electronic Cigarette Explosions.

PubMed

Patterson, Scott B; Beckett, Allison R; Lintner, Alicia; Leahey, Carly; Greer, Ashley; Brevard, Sidney B; Simmons, Jon D; Kahn, Steven A

Electronic cigarettes (e-cigarettes) contain lithium batteries that have been known to explode and/or cause fires that have resulted in burn injury. The purpose of this article is to present a case study, review injuries caused by e-cigarettes, and present a novel classification system from the newly emerging patterns of burns. A case study was presented and online media reports for e-cigarette burns were queried with search terms "e-cigarette burns" and "electronic cigarette burns." The reports and injury patterns were tabulated. Analysis was then performed to create a novel classification system based on the distinct injury patterns seen in the study. Two patients were seen at our regional burn center after e-cigarette burns. One had an injury to his thigh and penis that required operative intervention after ignition of this device in his pocket. The second had a facial burn and corneal abrasions when the device exploded while he was inhaling vapor. The Internet search and case studies resulted in 26 cases for evaluation. The burn patterns were divided in direct injury from the device igniting and indirect injury when the device caused a house or car fire. A numerical classification was created: direct injury: type 1 (hand injury) 7 cases, type 2 (face injury) 8 cases, type 3 (waist/groin injury) 11 cases, and type 5a (inhalation injury from using device) 2 cases; indirect injury: type 4 (house fire injury) 7 cases and type 5b (inhalation injury from fire started by the device) 4 cases. Multiple e-cigarette injuries are occurring in the United States and distinct patterns of burns are emerging. The classification system developed in this article will aid in further study and future regulation of these dangerous devices.

Urogenital tuberculosis: definition and classification.

PubMed

Kulchavenya, Ekaterina

2014-10-01

To improve the approach to the diagnosis and management of urogenital tuberculosis (UGTB), we need clear and unique classification. UGTB remains an important problem, especially in developing countries, but it is often an overlooked disease. As with any other infection, UGTB should be cured by antibacterial therapy, but because of late diagnosis it may often require surgery. Scientific literature dedicated to this problem was critically analyzed and juxtaposed with the author's own more than 30 years' experience in tuberculosis urology. The conception, terms and definition were consolidated into one system; classification stage by stage as well as complications are presented. Classification of any disease includes dispersion on forms and stages and exact definitions for each stage. Clinical features and symptoms significantly vary between different forms and stages of UGTB. A simple diagnostic algorithm was constructed. UGTB is multivariant disease and a standard unified approach to it is impossible. Clear definition as well as unique classification are necessary for real estimation of epidemiology and the optimization of therapy. The term 'UGTB' has insufficient information in order to estimate therapy, surgery and prognosis, or to evaluate the epidemiology.

Mycobacterium chimaera left ventricular assist device infections.

PubMed

Balsam, Leora B; Louie, Eddie; Hill, Fred; Levine, Jamie; Phillips, Michael S

2017-06-01

A global outbreak of invasive Mycobacterium chimaera infections after cardiac surgery has recently been linked to bioaerosols from contaminated heater-cooler units. The majority of cases have occurred after valvular surgery or aortic graft surgery and nearly half have resulted in death. To date, infections in patients with left ventricular assist devices (LVADs) have not been characterized in the literature. We report two cases of device-associated M. chimaera infection in patients with continuous-flow LVADs and describe challenges related to diagnosis and management in this population. © 2017 Wiley Periodicals, Inc.

Development of a Classification Scheme for Examining Adverse Events Associated with Medical Devices, Specifically the DaVinci Surgical System as Reported in the FDA MAUDE Database.

PubMed

Gupta, Priyanka; Schomburg, John; Krishna, Suprita; Adejoro, Oluwakayode; Wang, Qi; Marsh, Benjamin; Nguyen, Andrew; Genere, Juan Reyes; Self, Patrick; Lund, Erik; Konety, Badrinath R

2017-01-01

To examine the Manufacturer and User Facility Device Experience Database (MAUDE) database to capture adverse events experienced with the Da Vinci Surgical System. In addition, to design a standardized classification system to categorize the complications and machine failures associated with the device. Overall, 1,057,000 DaVinci procedures were performed in the United States between 2009 and 2012. Currently, no system exists for classifying and comparing device-related errors and complications with which to evaluate adverse events associated with the Da Vinci Surgical System. The MAUDE database was queried for events reports related to the DaVinci Surgical System between the years 2009 and 2012. A classification system was developed and tested among 14 robotic surgeons to associate a level of severity with each event and its relationship to the DaVinci Surgical System. Events were then classified according to this system and examined by using Chi-square analysis. Two thousand eight hundred thirty-seven events were identified, of which 34% were obstetrics and gynecology (Ob/Gyn); 19%, urology; 11%, other; and 36%, not specified. Our classification system had moderate agreement with a Kappa score of 0.52. Using our classification system, we identified 75% of the events as mild, 18% as moderate, 4% as severe, and 3% as life threatening or resulting in death. Seventy-seven percent were classified as definitely related to the device, 15% as possibly related, and 8% as not related. Urology procedures compared with Ob/Gyn were associated with more severe events (38% vs 26%, p < 0.0001). Energy instruments were associated with less severe events compared with the surgical system (8% vs 87%, p < 0.0001). Events that were definitely associated with the device tended to be less severe (81% vs 19%, p < 0.0001). Our classification system is a valid tool with moderate inter-rater agreement that can be used to better understand device-related adverse events. The majority of robotic related events were mild but associated with the device.

Crohn's disease in a southern European country: Montreal classification and clinical activity.

PubMed

Magro, Fernando; Portela, Francisco; Lago, Paula; Ramos de Deus, João; Vieira, Ana; Peixe, Paula; Cremers, Isabelle; Cotter, José; Cravo, Marília; Tavares, Lourdes; Reis, Jorge; Gonçalves, Raquel; Lopes, Horácio; Caldeira, Paulo; Ministro, Paula; Carvalho, Laura; Azevedo, Luis; da Costa-Pereira, Altamiro

2009-09-01

Given the heterogeneous nature of Crohn's disease (CD), our aim was to apply the Montreal Classification to a large cohort of Portuguese patients with CD in order to identify potential predictive regarding the need for medical and/or surgical treatment. A cross-sectional study was used based on data from an on-line registry of patients with CD. Of the 1692 patients with 5 or more years of disease, 747 (44%) were male and 945 (56%) female. On multivariate analysis the A2 group was an independent risk factor of the need for steroids (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.1-2.3) and the A1 and A2 groups for immunosuppressants (OR 2.2; CI 1.2-3.8; OR 1.4; CI 1.0-2.0, respectively). An L3+L3(4) and L(4) location were risk factors for immunosuppression (OR 1.9; CI 1.5-2.4), whereas an L1 location was significantly associated with the need for abdominal surgery (P < 0.001). After 20 years of disease, less than 10% of patients persisted without steroids, immunosuppression, or surgery. The Montreal Classification allowed us to identify different groups of disease severity: A1 were more immunosuppressed without surgery, most of A2 patients were submitted to surgery, and 52% of L1+L1(4) patients were operated without immunosuppressants. Stratifying patients according to the Montreal Classification may prove useful in identifying different phenotypes with different therapies and severity. Most of our patients have severe disease.

Reduction of the Dimensionality of the EEG Channels during Scoliosis Correction Surgeries Using a Wavelet Decomposition Technique

PubMed Central

Al-Kadi, Mahmoud I.; Reaz, Mamun Bin Ibne; Ali, Mohd Alauddin Mohd; Liu, Chian Yong

2014-01-01

This paper presents a comparison between the electroencephalogram (EEG) channels during scoliosis correction surgeries. Surgeons use many hand tools and electronic devices that directly affect the EEG channels. These noises do not affect the EEG channels uniformly. This research provides a complete system to find the least affected channel by the noise. The presented system consists of five stages: filtering, wavelet decomposing (Level 4), processing the signal bands using four different criteria (mean, energy, entropy and standard deviation), finding the useful channel according to the criteria's value and, finally, generating a combinational signal from Channels 1 and 2. Experimentally, two channels of EEG data were recorded from six patients who underwent scoliosis correction surgeries in the Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM) (the Medical center of National University of Malaysia). The combinational signal was tested by power spectral density, cross-correlation function and wavelet coherence. The experimental results show that the system-outputted EEG signals are neatly switched without any substantial changes in the consistency of EEG components. This paper provides an efficient procedure for analyzing EEG signals in order to avoid averaging the channels that lead to redistribution of the noise on both channels, reducing the dimensionality of the EEG features and preparing the best EEG stream for the classification and monitoring stage. PMID:25051031

[Classification and treatment of symbrachydactyly. A series of 117 cases].

PubMed

Foucher, G; Medina, J; Pajardi, G; Navarro, R

2000-07-01

In the present study, a modification has been proposed of the Blauth and Gekeler classification, aimed at a more accurate definition of appropriate surgical treatment. An analysis was made of a series of 120 cases of symbrachydactyly (117 patients); however, surgery was only performed in 86 cases (51 toe transfers in 49 patients; mean age at surgery 12 months). Type I included the separation of short and sometimes stiff fingers; type II, the 'pseudo-cleft', could be subdivided into three groups. Type IIA included those hands with more than two long and frequently hypoplastic digits, regarding which a decision had to be made between removal of rudimentary fingers or their stabilization. In type IIB, hand function was good and surgery was rarely needed. Type III (monodactylous) could also be subdivided into two categories, i.e., normal thumb in type IIIA and hypoplasia in IIIB. Finally, in type IVA, toe transfer surgery was performed on condition that wrist mobility was sufficient to compensate for the insufficient mobility of the artificial thumb on the anterior aspect of the radius. In all cases, a weak but useful pincer movement was obtained, with poor cosmetic results. In the case of toe transfers, surgery was advocated before the age of one year; and although mobility was disappointing (35 degrees active motion), good growth and excellent discrimination (5 mm on average) was observed. Symbrachydactyly is a fairly frequent congenital malformation; its diverse clinical features require a precise classification to better determine adequate treatment management.

21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES... material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or...

21 CFR 878.4011 - Tissue adhesive with adjunct wound closure device for topical approximation of skin.

Code of Federal Regulations, 2014 CFR

2014-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery...

21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES... material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or...

21 CFR 878.4011 - Tissue adhesive with adjunct wound closure device for topical approximation of skin.

Code of Federal Regulations, 2012 CFR

2012-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery...

21 CFR 878.4011 - Tissue adhesive with adjunct wound closure device for topical approximation of skin.

Code of Federal Regulations, 2013 CFR

2013-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery...

21 CFR 878.3500 - Polytetrafluoroethylene with carbon fibers composite implant material.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES... material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or...

Guidelines for innovation in pediatric surgery.

PubMed

Kastenberg, Zachary; Dutta, Sanjeev

2011-05-01

Surgical innovation involves the conceptualization, research, and translation of a novel idea into a viable procedure or device. The technological advancements made within the field of pediatric surgery over the last century have led to major improvements in patient care and outcomes. There has, however, been a parallel increase in the complexity of the regulatory bodies governing research and device implementation. This article briefly outlines the history of innovation in pediatric surgery, describes the existing regulatory bodies governing surgical research and device development (i.e., Department of Health and Human Services, Food and Drug Administration), and offers a set of guidelines for the pediatric surgeon planning to incorporate a new procedure or device into clinical practice.

Pattern classification using charge transfer devices

NASA Technical Reports Server (NTRS)

1980-01-01

The feasibility of using charge transfer devices in the classification of multispectral imagery was investigated by evaluating particular devices to determine their suitability in matrix multiplication subsystem of a pattern classifier and by designing a protype of such a system. Particular attention was given to analog-analog correlator devices which consist of two tapped delay lines, chip multipliers, and a summed output. The design for the classifier and a printed circuit layout for the analog boards were completed and the boards were fabricated. A test j:g for the board was built and checkout was begun.

Effects of Lumbar Fusion Surgery with ISOBAR Devices Versus Posterior Lumbar Interbody Fusion Surgery on Pain and Disability in Patients with Lumbar Degenerative Diseases: A Meta-Analysis.

PubMed

Su, Shu-Fen; Wu, Meng-Shan; Yeh, Wen-Ting; Liao, Ying-Chin

2018-06-01

Purpose/Aim: Lumbar degenerative diseases (LDDs) cause pain and disability and are treated with lumbar fusion surgery. The aim of this study was to evaluate the efficacy of lumbar fusion surgery with ISOBAR devices versus posterior lumbar interbody fusion (PLIF) surgery for alleviating LDD-associated pain and disability. We performed a literature review and meta-analysis conducted in accordance with Cochrane methodology. The analysis included Group Reading Assessment and Diagnostic Evaluation assessments, Jadad Quality Score evaluations, and Risk of Bias in Non-randomized Studies of Interventions assessments. We searched PubMed, MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, ProQuest, the Airiti Library, and the China Academic Journals Full-text Database for relevant randomized controlled trials and cohort studies published in English or Chinese between 1997 and 2017. Outcome measures of interest included general pain, lower back pain, and disability. Of the 18 studies that met the inclusion criteria, 16 examined general pain (802 patients), 5 examined lower back pain (274 patients), and 15 examined disability (734 patients). General pain, lower back pain, and disability scores were significantly lower after lumbar fusion surgery with ISOBAR devices compared to presurgery. Moreover, lumbar fusion surgery with ISOBAR devices was more effective than PLIF for decreasing postoperative disability, although it did not provide any benefit in terms of general pain or lower back pain. Lumbar fusion surgery with ISOBAR devices alleviates general pain, lower back pain, and disability in LDD patients and is superior to PLIF for reducing postoperative disability. Given possible publication bias, we recommend further large-scale studies.

Laparoscopy vs robotics in surgical management of endometrial cancer: comparison of intraoperative and postoperative complications.

PubMed

Seror, Julien; Bats, Anne-Sophie; Huchon, Cyrille; Bensaïd, Chérazade; Douay-Hauser, Nathalie; Lécuru, Fabrice

2014-01-01

To compare the rates of intraoperative and postoperative complications of robotic surgery and laparoscopy in the surgical treatment of endometrial cancer. Unicentric retrospective study (Canadian Task Force classification II-2). Tertiary teaching hospital. The study was performed from January 2002 to December 2011 and included patients with endometrial cancer who underwent laparoscopic or robotically assisted laparoscopic surgical treatment. Data collected included preoperative data, tumor characteristics, intraoperative data (route of surgery, surgical procedures, and complications), and postoperative data (early and late complications according to the Clavien-Dindo classification, and length of hospital stay). Morbidity was compared between the 2 groups. The study included 146 patients, of whom 106 underwent laparoscopy and 40 underwent robotically assisted surgery. The 2 groups were comparable in terms of demographic and preoperative data. Intraoperative complications occurred in 9.4% of patients who underwent laparoscopy and in none who underwent robotically assisted surgery (p = .06). There was no difference between the 2 groups in terms of postoperative events. Robotically assisted surgery is not associated with a significant difference in intraoperative and postoperative complications, even when there were no intraoperative complications of robotically assisted surgery. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.

Safety and Efficacy of Microinvasive Glaucoma Surgery

PubMed Central

Chen, David Z.

2017-01-01

Microinvasive glaucoma surgery (MIGS) is emerging as a new therapeutic option for glaucoma patients who wish to reduce their medication burden and avoid the postoperative complications of conventional glaucoma filtration surgery. These devices differ in terms of their efficacy and safety profile. Schlemm's canal devices have the most favorable safety profile at the compromise of modest efficacy, while subconjunctival and suprachoroidal devices are potentially more effective at lowering the intraocular pressure at the expense of a higher rate of complications. This review consolidates the latest evidence on the efficacy and safety of the MIGS devices in clinical use and provides an overview on upcoming devices which would likely also become viable treatment options in the near future. These clinical data would assist a glaucoma surgeon in selecting the most appropriate MIGS device for each patient based on the glaucoma severity and patient expectations. PMID:28512578

Congenital portosystemic shunts in children: a new anatomical classification correlated with surgical strategy.

PubMed

Blanc, Thomas; Guerin, Florent; Franchi-Abella, Stéphanie; Jacquemin, Emmanuel; Pariente, Danièle; Soubrane, Olivier; Branchereau, Sophie; Gauthier, Frédéric

2014-07-01

To propose an anatomical classification of congenital portosystemic shunts (CPSs) correlating with conservative surgery. CPSs entail a risk of life-threatening complications because of poor portal inflow, which may be prevented or cured by their closure. Current classifications based on portal origin of the shunt are not helpful for planning conservative surgery. Twenty-three patients who underwent at least 1 surgical procedure to close the CPSs were included in this retrospective study (1997-2012). We designed a classification according to the ending of the shunt in the caval system. We analyzed the results and outcomes of surgery according to this classification. Two patients had an extrahepatic portosystemic shunt, 17 had a portacaval shunt [subdivided in 5 end-to-side-like portal-caval, 7 side-to-side-like portal-caval, and 5 H-shaped (H-type portal-caval)], 2 had portal-to-hepatic vein shunts (portohepatic), and 2 had a persistent ductus venosus. All extrahepatic portosystemic shunts, H-type portal-caval, portohepatic, and patent ductus venosus patients had a successful 1-stage ligation. All 5 end-to-side-like portal-caval patients had a threadlike intrahepatic portal venous system; a 2-stage complete closure was successfully achieved for 4 and a partial closure for 1. The first 2 side-to-side-like portal-caval patients had a successful 2-stage closure whereas the 5 others had a 1-stage longitudinal caval partition. All patients are alive and none needed a liver transplantation. Our classification correlates the anatomy of CPSs and the surgical strategy: outcomes are good provided end-to-side-like portal-caval shunts patients have a 2-stage closure, side-to-side portal-caval shunts patients have a 1-stage caval partition, and the others have a 1-stage ligation.

Screening and classification of ceramic powders

NASA Technical Reports Server (NTRS)

Miwa, S.

1983-01-01

A summary is given of the classification technology of ceramic powders. Advantages and disadvantages of the wet and dry screening and classification methods are discussed. Improvements of wind force screening devices are described.

Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms. Final order.

PubMed

2017-12-27

The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the flow cytometric test system for hematopoietic neoplasms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

Code of Federal Regulations, 2014 CFR

2014-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...

21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

Code of Federal Regulations, 2012 CFR

2012-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...

21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

Code of Federal Regulations, 2013 CFR

2013-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...

Contour classification in thermographic images for detection of breast cancer

NASA Astrophysics Data System (ADS)

Okuniewski, Rafał; Nowak, Robert M.; Cichosz, Paweł; Jagodziński, Dariusz; Matysiewicz, Mateusz; Neumann, Łukasz; Oleszkiewicz, Witold

2016-09-01

Thermographic images of breast taken by the Braster device are uploaded into web application which uses different classification algorithms to automatically decide whether a patient should be more thoroughly examined. This article presents the approach to the task of classifying contours visible on thermographic images of breast taken by the Braster device in order to make the decision about the existence of cancerous tumors in breast. It presents the results of the researches conducted on the different classification algorithms.

Single-incision laparoscopic distal gastrectomy for early gastric cancer through a homemade single port access device.

PubMed

Jiang, Zhi-Wei; Zhang, Shu; Wang, Gang; Zhao, Kun; Liu, Jiang; Ning, Li; Li, Jieshou

2015-01-01

We presented a series of single-incision laparoscopic distal gastrectomies for early gastric cancer patients through a type of homemade single port access device and some other conventional laparoscopic instruments. A single-incision laparoscopic distal gastrectomy with D1 + α lymph node dissection was performed on a 46 years old male patient who had an early gastric cancer. This single port access device has facilitated the conventional laparoscopic instruments to accomplish the surgery and we made in only 6 minutes. Total operating time for this surgery was 240 minutes. During the operation, there were about 100 milliliters of blood loss, and 17 lymph-nodes were retrieved. This homemade single port access device shows its superiority in economy and convenience for complex single-incision surgeries. Single-incision laparoscopic distal gastrectomy for early gastric cancer can be conducted by experienced laparoscopic surgeons. Fully take advantage of both SILS and fast track surgery plan can bring to successful surgeries with minimal postoperative pain, quicker mobilization, early recovery of intestinal function, and better cosmesis effect for the patients.

Certain aspects on medical devices software law regulation.

PubMed

Pashkov, Vitalii; Harkusha, Andrii

some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.

75 FR 33169 - Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-11

.... FDA-2008-N-0163] (formerly Docket No. 2001N-0067) RIN 0910-AG21 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam... the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II...

Classification and discrimination of pediatric patients undergoing open heart surgery with and without methylprednisolone treatment by cytomics

NASA Astrophysics Data System (ADS)

Bocsi, Jozsef; Mittag, Anja; Pierzchalski, Arkadiusz; Osmancik, Pavel; Dähnert, Ingo; Tárnok, Attila

2011-02-01

Introduction: Methylprednisolone (MP) is frequently preoperatively administered in children undergoing open heart surgery. The aim of this medication is to inhibit overshooting immune responses. Earlier studies demonstrated cellular and humoral immunological changes in pediatric patients undergoing heart surgeries with and without MP administration. Here in a retrospective study we investigated the modulation of the cellular immune response by MP. The aim was to identify suitable parameters characterizing MP effects by cluster analysis. Methods: Blood samples were analysed from two aged matched groups with surgical correction of septum defects. Group without MP treatment consisted of 10 patients; MP was administered on 21 patients (median dose: 11mg/kg) before cardiopulmonary bypass (CPB). EDTA anticoagulated blood was obtained 24 h preoperatively, after anesthesia, at CPB begin and end (CPB2), 4h, 24h, 48h after surgery, at discharge and at out-patient followup (8.2; 3.3-12.2 month after surgery; median and IQR). Flow cytometry showed the biggest MP relevant changes at CPB2 and 4h postoperatively. They were used for clustering analysis. Classification was made by discriminant analysis and cluster analysis by means of Genes@work software. Results & conclusion: 146 parameters were obtained from analysis. Cross-validation revealed several parameters being able to discriminate between MP groups and to identify immune modulation. MP administration resulted in a delayed activation of monocytes, increased ratio of neutrophils, reduced T-lymphocytes counts. Cluster analysis demonstrated that classification of patients is possible based on the identified cytomics parameters. Further investigation of these parameters might help to understand the MP effects in pediatric open heart surgery.

21 CFR 868.1800 - Rhinoanemometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1800 Rhinoanemometer. (a) Identification. A... differential pressure across, a patient's nasal passages. (b) Classification. Class II (performance standards). ...

Low-back electromyography (EMG) data-driven load classification for dynamic lifting tasks

PubMed Central

Ojeda, Lauro; Johnson, Daniel D.; Gates, Deanna; Mower Provost, Emily; Barton, Kira

2018-01-01

Objective Numerous devices have been designed to support the back during lifting tasks. To improve the utility of such devices, this research explores the use of preparatory muscle activity to classify muscle loading and initiate appropriate device activation. The goal of this study was to determine the earliest time window that enabled accurate load classification during a dynamic lifting task. Methods Nine subjects performed thirty symmetrical lifts, split evenly across three weight conditions (no-weight, 10-lbs and 24-lbs), while low-back muscle activity data was collected. Seven descriptive statistics features were extracted from 100 ms windows of data. A multinomial logistic regression (MLR) classifier was trained and tested, employing leave-one subject out cross-validation, to classify lifted load values. Dimensionality reduction was achieved through feature cross-correlation analysis and greedy feedforward selection. The time of full load support by the subject was defined as load-onset. Results Regions of highest average classification accuracy started at 200 ms before until 200 ms after load-onset with average accuracies ranging from 80% (±10%) to 81% (±7%). The average recall for each class ranged from 69–92%. Conclusion These inter-subject classification results indicate that preparatory muscle activity can be leveraged to identify the intent to lift a weight up to 100 ms prior to load-onset. The high accuracies shown indicate the potential to utilize intent classification for assistive device applications. Significance Active assistive devices, e.g. exoskeletons, could prevent back injury by off-loading low-back muscles. Early intent classification allows more time for actuators to respond and integrate seamlessly with the user. PMID:29447252

Does semi-automatic bone-fragment segmentation improve the reproducibility of the Letournel acetabular fracture classification?

PubMed

Boudissa, M; Orfeuvre, B; Chabanas, M; Tonetti, J

2017-09-01

The Letournel classification of acetabular fracture shows poor reproducibility in inexperienced observers, despite the introduction of 3D imaging. We therefore developed a method of semi-automatic segmentation based on CT data. The present prospective study aimed to assess: (1) whether semi-automatic bone-fragment segmentation increased the rate of correct classification; (2) if so, in which fracture types; and (3) feasibility using the open-source itksnap 3.0 software package without incurring extra cost for users. Semi-automatic segmentation of acetabular fractures significantly increases the rate of correct classification by orthopedic surgery residents. Twelve orthopedic surgery residents classified 23 acetabular fractures. Six used conventional 3D reconstructions provided by the center's radiology department (conventional group) and 6 others used reconstructions obtained by semi-automatic segmentation using the open-source itksnap 3.0 software package (segmentation group). Bone fragments were identified by specific colors. Correct classification rates were compared between groups on Chi 2 test. Assessment was repeated 2 weeks later, to determine intra-observer reproducibility. Correct classification rates were significantly higher in the "segmentation" group: 114/138 (83%) versus 71/138 (52%); P<0.0001. The difference was greater for simple (36/36 (100%) versus 17/36 (47%); P<0.0001) than complex fractures (79/102 (77%) versus 54/102 (53%); P=0.0004). Mean segmentation time per fracture was 27±3min [range, 21-35min]. The segmentation group showed excellent intra-observer correlation coefficients, overall (ICC=0.88), and for simple (ICC=0.92) and complex fractures (ICC=0.84). Semi-automatic segmentation, identifying the various bone fragments, was effective in increasing the rate of correct acetabular fracture classification on the Letournel system by orthopedic surgery residents. It may be considered for routine use in education and training. III: prospective case-control study of a diagnostic procedure. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Medical Adhesive-Related Skin Injury Following Emergent Appendectomy: A Case Study of MARSI and Missed Opportunities in Nursing Care.

PubMed

Britt, Sylvia E; Coles, Karen M; Polson, Shannon S

The potential for skin damage from adhesive products is documented in the literature. Nevertheless, health care providers continue to lack understanding of the impact and seriousness of skin injury associated with use of tapes or other adhesive devices when applied to a patient with a history or hypersensitivity or allergy to adhesives. A 67-year-old woman with a history of tape allergy underwent emergency appendectomy. Initial removal of an adhesive bandage placed over the surgical incision revealed medical adhesive-related skin injury (MARSI). The largest of the 3 wounds was a Class III skin tear based on the Payne-Martin Classification System. It measured (L) 4.4 cm × (W) 1.8 cm × (D) 0.3 cm and required 3 months to heal. Experiences with this case revealed the need for evidence-based practice innovations to prevent physical, emotional, and economic cost resulting from MARSI. We recommend early identification and careful documentation of susceptibility to MARSI prior to surgery and implementation of consensus-based recommendations for prevention of MARSI as advocated by the MARSI consensus group when preparing patients for surgery and treating wounds.

Breast cancer surgery and diagnosis-related groups (DRGs): patient classification and hospital reimbursement in 11 European countries.

PubMed

Scheller-Kreinsen, David; Quentin, Wilm; Geissler, Alexander; Busse, Reinhard

2013-10-01

Researchers from eleven countries (i.e. Austria, England, Estonia, Finland, France, Germany, Ireland, Netherlands, Poland, Spain, and Sweden) compared how their DRG systems deal with breast cancer surgery patients. DRG algorithms and indicators of resource consumption were assessed for those DRGs that individually contain at least 1% of all breast cancer surgery patients. Six standardised case vignettes were defined and quasi prices according to national DRG-based hospital payment systems were ascertained. European DRG systems classify breast cancer surgery patients according to different sets of classification variables into three to seven DRGs. Quasi prices for an index case treated with partial mastectomy range from €577 in Poland to €5780 in the Netherlands. Countries award their highest payments for very different kinds of patients. Breast cancer specialists and national DRG authorities should consider how other countries' DRG systems classify breast cancer patients in order to identify potential scope for improvement and to ensure fair and appropriate reimbursement. Copyright © 2012 Elsevier Ltd. All rights reserved.

Characterizing the Utility and Limitations of Repurposing an Open-Field Optical Imaging Device for Fluorescence-Guided Surgery in Head and Neck Cancer Patients.

PubMed

Moore, Lindsay S; Rosenthal, Eben L; Chung, Thomas K; de Boer, Esther; Patel, Neel; Prince, Andrew C; Korb, Melissa L; Walsh, Erika M; Young, E Scott; Stevens, Todd M; Withrow, Kirk P; Morlandt, Anthony B; Richman, Joshua S; Carroll, William R; Zinn, Kurt R; Warram, Jason M

2017-02-01

The purpose of this study was to assess the potential of U.S. Food and Drug Administration-cleared devices designed for indocyanine green-based perfusion imaging to identify cancer-specific bioconjugates with overlapping excitation and emission wavelengths. Recent clinical trials have demonstrated potential for fluorescence-guided surgery, but the time and cost of the approval process may impede clinical translation. To expedite this translation, we explored the feasibility of repurposing existing optical imaging devices for fluorescence-guided surgery. Consenting patients (n = 15) scheduled for curative resection were enrolled in a clinical trial evaluating the safety and specificity of cetuximab-IRDye800 (NCT01987375). Open-field fluorescence imaging was performed preoperatively and during the surgical resection. Fluorescence intensity was quantified using integrated instrument software, and the tumor-to-background ratio characterized fluorescence contrast. In the preoperative clinic, the open-field device demonstrated potential to guide preoperative mapping of tumor borders, optimize the day of surgery, and identify occult lesions. Intraoperatively, the device demonstrated robust potential to guide surgical resections, as all peak tumor-to-background ratios were greater than 2 (range, 2.2-14.1). Postresection wound bed fluorescence was significantly less than preresection tumor fluorescence (P < 0.001). The repurposed device also successfully identified positive margins. The open-field imaging device was successfully repurposed to distinguish cancer from normal tissue in the preoperative clinic and throughout surgical resection. This study illuminated the potential for existing open-field optical imaging devices with overlapping excitation and emission spectra to be used for fluorescence-guided surgery. © 2017 by the Society of Nuclear Medicine and Molecular Imaging.

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

... the device materials must be performed; (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device; (v...

Comparison of corneal power, astigmatism, and wavefront aberration measurements obtained by a point-source color light-emitting diode-based topographer, a Placido-disk topographer, and a combined Placido and dual Scheimpflug device.

PubMed

Ventura, Bruna V; Wang, Li; Ali, Shazia F; Koch, Douglas D; Weikert, Mitchell P

2015-08-01

To evaluate and compare the performance of a point-source color light-emitting diode (LED)-based topographer (color-LED) in measuring anterior corneal power and aberrations with that of a Placido-disk topographer and a combined Placido and dual Scheimpflug device. Cullen Eye Institute, Baylor College of Medicine, Houston, Texas USA. Retrospective observational case series. Normal eyes and post-refractive-surgery eyes were consecutively measured using color-LED, Placido, and dual-Scheimpflug devices. The main outcome measures were anterior corneal power, astigmatism, and higher-order aberrations (HOAs) (6.0 mm pupil), which were compared using the t test. There were no statistically significant differences in corneal power measurements in normal and post-refractive surgery eyes and in astigmatism magnitude in post-refractive surgery eyes between the color-LED device and Placido or dual Scheimpflug devices (all P > .05). In normal eyes, there were no statistically significant differences in 3rd-order coma and 4th-order spherical aberration between the color-LED and Placido devices and in HOA root mean square, 3rd-order coma, 3rd-order trefoil, 4th-order spherical aberration, and 4th-order secondary astigmatism between the color-LED and dual Scheimpflug devices (all P > .05). In post-refractive surgery eyes, the color-LED device agreed with the Placido and dual-Scheimpflug devices regarding 3rd-order coma and 4th-order spherical aberration (all P > .05). In normal and post-refractive surgery eyes, all 3 devices were comparable with respect to corneal power. The agreement in corneal aberrations varied. Drs. Wang, Koch, and Weikert are consultants to Ziemer Ophthalmic Systems AG. Dr. Koch is a consultant to Abbott Medical Optics, Inc., Alcon Surgical, Inc., and i-Optics Corp. Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

New stapling devices in robotic surgery

PubMed Central

Casiraghi, Monica; Pardolesi, Alessandro; Borri, Alessandro; Spaggiari, Lorenzo

2017-01-01

Minimally invasive thoracic surgery is rapidly diffusing worldwide. Robotic anatomic pulmonary resection is gaining popularity and acceptance in the thoracic community for the reported feasibility, safety, and good outcomes. The last available robotic system, da Vinci Xi System, added new technical improvements on robotic device allowing best performances in robotic lung resection. We report our initial experience in the use of EndoWrist Stapler during robotic anatomic surgery for lung cancer. PMID:29078608

Mobile locally operated detachable end-effector manipulator for endoscopic surgery.

PubMed

Kawai, Toshikazu; Shin, Myongyu; Nishizawa, Yuji; Horise, Yuki; Nishikawa, Atsushi; Nakamura, Tatsuo

2015-02-01

Local surgery is safer than remote surgery because emergencies can be more easily addressed. Although many locally operated surgical robots and devices have been developed, none can safely grasp organs and provide traction. A new manipulator with a detachable commercial forceps was developed that can act as a third arm for a surgeon situated in a sterile area near the patient. This mechanism can be disassembled into compact parts that enable mobile use. A mobile locally operated detachable end-effector manipulator (LODEM) was developed and tested. This device uses crank-slider and cable-rod mechanisms to achieve 5 degrees of freedom and an acting force of more than 5 N. The total mass is less than 15 kg. The positional accuracy and speed of the prototype device were evaluated while performing simulated in vivo surgery. The accuracy of the mobile LODEM was 0.4 mm, sufficient for handling organs. The manipulator could be assembled and disassembled in 8 min, making it highly mobile. The manipulator could successfully handle the target organs with the required level of dexterity during an in vivo laparoscopic surgical procedure. A mobile LODEM was designed that allows minimally invasive robotically assisted endoscopic surgery by a surgeon working near the patient. This device is highly promising for robotic surgery applications.

A review of robotics in surgery.

PubMed

Davies, B

2000-01-01

A brief introduction is given to the definitions and history of surgical robotics. The capabilities and merits of surgical robots are then contrasted with the related field of computer assisted surgery. A classification is then given of the various types of robot system currently being investigated internationally, together with a number of examples of different applications in both soft-tissue and orthopaedic surgery. The paper finishes with a discussion of the main difficulties facing robotic surgery and a prediction of future progress.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis. Final order.

PubMed

2017-10-24

The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Classification for animal vocal fold surgery: resection margins impact histological outcomes of vocal fold injury.

PubMed

Imaizumi, Mitsuyoshi; Thibeault, Susan L; Leydon, Ciara

2014-11-01

Extent of vocal fold injury impacts the nature and timing of wound healing and voice outcomes. However, depth and extent of the lesion created to study wound healing in animal models vary across studies, likely contributing to different outcomes. Our goal was to create a surgery classification system to enable comparison of postoperative outcomes across animal vocal fold wound-healing studies. Prospective, controlled animal study. Rats underwent one of three types of unilateral vocal fold surgeries classified by depth and length of resection. The surgeries were: for subepithelial injury, resection of epithelium and superficial layer of the lamina propria at the midmembranous portion of the vocal fold; for transmucosal injury, resection of epithelium and lamina propria; and for transmuscular injury, resection of epithelium, lamina propria, and superficial portion of the vocalis muscle. Wound healing was evaluated histologically at various time points up to 35 days postinjury. Complete healing occurred by 14 days postsurgery for subepithelial injury, and by day 35 for transmucosal injury. Injury remained present at day 35 for transmuscular injury. Timing and completeness of healing varied by extent and depth of resection. Scarless healing occurred rapidly following subepithelial injury, whereas scarring was observed at 5 weeks after transmuscular injury. The proposed classification system may facilitate comparison of surgical outcomes across vocal fold wound-healing studies. N/A. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Risk Factors for Failure of Male Slings and Artificial Urinary Sphincters: Results from a Large Middle European Cohort Study.

PubMed

Hüsch, Tanja; Kretschmer, Alexander; Thomsen, Frauke; Kronlachner, Dominik; Kurosch, Martin; Obaje, Alice; Anding, Ralf; Pottek, Tobias; Rose, Achim; Olianas, Roberto; Friedl, Alexander; Hübner, Wilhelm; Homberg, Roland; Pfitzenmaier, Jesco; Grein, Ulrich; Queissert, Fabian; Naumann, Carsten Maik; Schweiger, Josef; Wotzka, Carola; Nyarangi-Dix, Joanne; Hofmann, Torben; Ulm, Kurt; Bauer, Ricarda M; Haferkamp, Axel

2017-01-01

We analysed the impact of predefined risk factors: age, diabetes, history of pelvic irradiation, prior surgery for stress urinary incontinence (SUI), prior urethral stricture, additional procedure during SUI surgery, duration of incontinence, ASA-classification and cause for incontinence on failure and complications in male SUI surgery. We retrospectively identified 506 patients with an artificial urinary sphincter (AUS) and 513 patients with a male sling (MS) in a multicenter cohort study. Complication rates were correlated to the risk factors in univariate analysis. Subsequently, a multivariate logistic regression adjusted to the risk factors was performed. A p value <0.05 was considered statistically significant. A history of pelvic irradiation was an independent risk factor for explantation in AUS (p < 0.001) and MS (p = 0.018). Moreover, prior urethral stricture (p = 0.036) and higher ASA-classification (p = 0.039) were positively correlated with explantation in univariate analysis for AUS. Urethral erosion was correlated with prior urethral stricture (p < 0.001) and a history of pelvic irradiation (p < 0.001) in AUS. Furthermore, infection was correlated with additional procedures during SUI surgery in univariate analysis (p = 0.037) in MS. We first identified the correlation of higher ASA-classification and explantation in AUS. Nevertheless, only a few novel risk factors had a significant influence on the failure of MS or AUS. © 2016 S. Karger AG, Basel.

Intraoperative cochlear nerve mapping with the mobile cochlear nerve compound action potential tracer in vestibular schwannoma surgery.

PubMed

Watanabe, Nobuyuki; Ishii, Takuya; Fujitsu, Kazuhiko; Kaku, Shogo; Ichikawa, Teruo; Miyahara, Kosuke; Okada, Tomu; Tanino, Shin; Uriu, Yasuhiro; Murayama, Yuichi

2018-05-18

OBJECTIVE The authors describe the usefulness and limitations of the cochlear nerve compound action potential (CNAP) mobile tracer (MCT) that they developed to aid in cochlear nerve mapping during vestibular schwannoma surgery (VSS) for hearing preservation. METHODS This MCT device requires no more than 2 seconds for stable placement on the nerve to obtain the CNAP and thus is able to trace the cochlear nerve instantaneously. Simultaneous bipolar and monopolar recording is possible. The authors present the outcomes of 18 consecutive patients who underwent preoperative useful hearing (defined as class I or II of the Gardner-Robertson classification system) and underwent hearing-preservation VSS with the use of the MCT. Mapping was considered successful when it was possible to detect and trace the cochlear nerve. RESULTS Mapping of the cochlear nerve was successful in 13 of 18 patients (72.2%), and useful hearing was preserved in 11 patients (61.1%). Among 8 patients with large tumors (Koos grade 3 or 4), the rate of successful mapping was 62.5% (5 patients). The rate of hearing preservation in patients with large tumors was 50% (4 patients). CONCLUSIONS In addition to microsurgical presumption of the arrangement of each nerve, frequent probing on and around an unidentified nerve and comparison of each waveform are advisable with the use of both more sensitive monopolar and more location-specific bipolar MCT. MCT proved to be useful in cochlear nerve mapping and may consequently be helpful in hearing preservation. The authors discuss some limitations and problems with this device.

Using Electronic Health Records to Build an Ophthalmologic Data Warehouse and Visualize Patients' Data.

PubMed

Kortüm, Karsten U; Müller, Michael; Kern, Christoph; Babenko, Alexander; Mayer, Wolfgang J; Kampik, Anselm; Kreutzer, Thomas C; Priglinger, Siegfried; Hirneiss, Christoph

2017-06-01

To develop a near-real-time data warehouse (DW) in an academic ophthalmologic center to gain scientific use of increasing digital data from electronic medical records (EMR) and diagnostic devices. Database development. Specific macular clinic user interfaces within the institutional hospital information system were created. Orders for imaging modalities were sent by an EMR-linked picture-archiving and communications system to the respective devices. All data of 325 767 patients since 2002 were gathered in a DW running on an SQL database. A data discovery tool was developed. An exemplary search for patients with age-related macular degeneration, performed cataract surgery, and at least 10 intravitreal (excluding bevacizumab) injections was conducted. Data related to those patients (3 142 204 diagnoses [including diagnoses from other fields of medicine], 720 721 procedures [eg, surgery], and 45 416 intravitreal injections) were stored, including 81 274 optical coherence tomography measurements. A web-based browsing tool was successfully developed for data visualization and filtering data by several linked criteria, for example, minimum number of intravitreal injections of a specific drug and visual acuity interval. The exemplary search identified 450 patients with 516 eyes meeting all criteria. A DW was successfully implemented in an ophthalmologic academic environment to support and facilitate research by using increasing EMR and measurement data. The identification of eligible patients for studies was simplified. In future, software for decision support can be developed based on the DW and its structured data. The improved classification of diseases and semiautomatic validation of data via machine learning are warranted. Copyright © 2017 Elsevier Inc. All rights reserved.

Identifying Adverse Events Using International Classification of Diseases, Tenth Revision Y Codes in Korea: A Cross-sectional Study.

PubMed

Ock, Minsu; Kim, Hwa Jung; Jeon, Bomin; Kim, Ye-Jee; Ryu, Hyun Mi; Lee, Moo-Song

2018-01-01

The use of administrative data is an affordable alternative to conducting a difficult large-scale medical-record review to estimate the scale of adverse events. We identified adverse events from 2002 to 2013 on the national level in Korea, using International Classification of Diseases, tenth revision (ICD-10) Y codes. We used data from the National Health Insurance Service-National Sample Cohort (NHIS-NSC). We relied on medical treatment databases to extract information on ICD-10 Y codes from each participant in the NHIS-NSC. We classified adverse events in the ICD-10 Y codes into 6 types: those related to drugs, transfusions, and fluids; those related to vaccines and immunoglobulin; those related to surgery and procedures; those related to infections; those related to devices; and others. Over 12 years, a total of 20 817 adverse events were identified using ICD-10 Y codes, and the estimated total adverse event rate was 0.20%. Between 2002 and 2013, the total number of such events increased by 131.3%, from 1366 in 2002 to 3159 in 2013. The total rate increased by 103.9%, from 0.17% in 2002 to 0.35% in 2013. Events related to drugs, transfusions, and fluids were the most common (19 446, 93.4%), followed by those related to surgery and procedures (1209, 5.8%) and those related to vaccines and immunoglobulin (72, 0.3%). Based on a comparison with the results of other studies, the total adverse event rate in this study was significantly underestimated. Improving coding practices for ICD-10 Y codes is necessary to precisely monitor the scale of adverse events in Korea.

21 CFR 876.4400 - Hemorrhoidal ligator.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Surgical Devices § 876.4400 Hemorrhoidal ligator. (a... of a ligature or band placed around the hemorrhoid. (b) Classification. Class II (performance...

Validity: Applying Current Concepts and Standards to Gynecologic Surgery Performance Assessments

ERIC Educational Resources Information Center

LeClaire, Edgar L.; Nihira, Mikio A.; Hardré, Patricia L.

2015-01-01

Validity is critical for meaningful assessment of surgical competency. According to the Standards for Educational and Psychological Testing, validation involves the integration of data from well-defined classifications of evidence. In the authoritative framework, data from all classifications support construct validity claims. The two aims of this…

Cochlear implant revision surgeries in children.

PubMed

Amaral, Maria Stella Arantes do; Reis, Ana Cláudia Mirândola B; Massuda, Eduardo T; Hyppolito, Miguel Angelo

2018-02-16

The surgery during which the cochlear implant internal device is implanted is not entirely free of risks and may produce problems that will require revision surgeries. To verify the indications for cochlear implantation revision surgery for the cochlear implant internal device, its effectiveness and its correlation with certain variables related to language and hearing. A retrospective study of patients under 18 years submitted to cochlear implant Surgery from 2004 to 2015 in a public hospital in Brazil. Data collected were: age at the time of implantation, gender, etiology of the hearing loss, audiological and oral language characteristics of each patient before and after Cochlear Implant surgery and any need for surgical revision and the reason for it. Two hundred and sixty-five surgeries were performed in 236 patients. Eight patients received a bilateral cochlear implant and 10 patients required revision surgery. Thirty-two surgeries were necessary for these 10 children (1 bilateral cochlear implant), of which 21 were revision surgeries. In 2 children, cochlear implant removal was necessary, without reimplantation, one with cochlear malformation due to incomplete partition type I and another due to trauma. With respect to the cause for revision surgery, of the 8 children who were successfully reimplanted, four had cochlear calcification following meningitis, one followed trauma, one exhibited a facial nerve malformation, one experienced a failure of the cochlear implant internal device and one revision surgery was necessary because the electrode was twisted. The incidence of the cochlear implant revision surgery was 4.23%. The period following the revision surgeries revealed an improvement in the subject's hearing and language performance, indicating that these surgeries are valid in most cases. Copyright © 2018 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Medical devices; hematology and pathology devices; classification of early growth response 1 gene fluorescence in-situ hybridization test system for specimen characterization. Final order.

PubMed

2014-09-03

The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Predictive Factors for Patients Undergoing ASD Device Occlusion Who "Crossover" to Surgery.

PubMed

Mulukutla, Venkatachalam; Qureshi, Athar M; Pignatelli, Ricardo; Ing, Frank F

2018-03-01

The aim of this study was to define characteristics of those patients who are referred for device closure of an Atrial septal defect (ASD), but identified to "crossover" surgery. All patients who underwent surgical and device (Amplatzer or Helex occluder) closures of secundum ASDs from 2001 to 2010 were reviewed and organized into three groups: surgical closure, device closure, and "crossover" group. 369 patients underwent ASD closure (265 device, 104 surgical). 42 of the 265 patients referred for device closure "crossed over" to the surgical group at various stages of the catheterization procedure. The device group had defect size measuring 14.2 mm (mean) and an ASD index (Defect Size (mm)/BSA) of 14.0 compared to the corresponding values in the surgical group (20.1 mm, ASD index 25.9) (P < 0.001) and in the "crossover" group (20.7 mm, 22.6 ASD index) (P < 0.001). 79 patients in the device group had a deficient rim, and 86% were located in the retroaortic region. 33 patients in the "crossover" group had deficient rims with 70% deficiency in the posterior/inferior rim. The device group with deficient rims had an ASD index of 14.7 compared with the crossover group ASD index of 23.8 (P < 0.001). Comparing the device and "crossover" groups, an ASD index greater than 23.7 had a 90% specificity in "crossing over" to surgery. The crossover and surgical groups had statistically larger ASD defect size indexes compared with the device group. Deficient rim in the posterior/inferior rim is associated with a large ASD size index which is a predictive factor for crossing over to surgery. Catheterization did not negatively impact surgical results in the "crossover" group.

Osteochondritis dissecans of the humeral capitellum: reliability of four classification systems using radiographs and computed tomography.

PubMed

Claessen, Femke M A P; van den Ende, Kimberly I M; Doornberg, Job N; Guitton, Thierry G; Eygendaal, Denise; van den Bekerom, Michel P J

2015-10-01

The radiographic appearance of osteochondritis dissecans (OCD) of the humeral capitellum varies according to the stage of the lesion. It is important to evaluate the stage of OCD lesion carefully to guide treatment. We compared the interobserver reliability of currently used classification systems for OCD of the humeral capitellum to identify the most reliable classification system. Thirty-two musculoskeletal radiologists and orthopaedic surgeons specialized in elbow surgery from several countries evaluated anteroposterior and lateral radiographs and corresponding computed tomography (CT) scans of 22 patients to classify the stage of OCD of the humeral capitellum according to the classification systems developed by (1) Minami, (2) Berndt and Harty, (3) Ferkel and Sgaglione, and (4) Anderson on a Web-based study platform including a Digital Imaging and Communications in Medicine viewer. Magnetic resonance imaging was not evaluated as part of this study. We measured agreement among observers using the Siegel and Castellan multirater κ. All OCD classification systems, except for Berndt and Harty, which had poor agreement among observers (κ = 0.20), had fair interobserver agreement: κ was 0.27 for the Minami, 0.23 for Anderson, and 0.22 for Ferkel and Sgaglione classifications. The Minami Classification was significantly more reliable than the other classifications (P < .001). The Minami Classification was the most reliable for classifying different stages of OCD of the humeral capitellum. However, it is unclear whether radiographic evidence of OCD of the humeral capitellum, as categorized by the Minami Classification, guides treatment in clinical practice as a result of this fair agreement. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

21 CFR 862.1795 - Vanilmandelic acid test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... certain hypertensive conditions. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 862.1335 - Glucagon test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... mellitus, hypoglycemia, and hyperglycemia. (b) Classification. Class I (general controls). The device is...

Bariatric Outcomes and Obesity Modeling: Study Meeting

DTIC Science & Technology

2010-09-17

to obesity. 15. SUBJECT TERMS Bariatric Surgery , Cost Effectiveness, Surgical Outcome 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF a. REPORT...EFFECTIVENESS MODEL OVERVIEW  Two parts: 1) Decision Tree and 2) Natural History Model  Results: Bariatric Surgery is cost-effective compared to no...9,300 for AGB $10,600 for LRYGB AGB: Adjustable gastric banding LRYGB: laparoscopic Roux-en-Y gastric bypass A Financial Model of Bariatric Surgery for

Review of Pure Endoscopic Full-Thickness Resection of the Upper Gastrointestinal Tract

PubMed Central

Mori, Hirohito; Kobara, Hideki; Nishiyama, Noriko; Fujihara, Shintaro; Masaki, Tsutomu

2015-01-01

Natural-orifice transluminal endoscopic surgery (NOTES) using flexible endoscopy has attracted attention as a minimally invasive surgical method that does not cause an operative wound on the body surface. However, minimizing the number of devices involved in endoscopic, compared to laparoscopic, surgeries has remained a challenge, causing endoscopic surgeries to gradually be phased out of use. If a flexible endoscopic full-thickness suturing device and a counter-traction device were developed to expand the surgical field for gastrointestinal-tract collapse, then endoscopic full-thickness resection using NOTES, which is seen as an extension of endoscopic submucosal dissection for full-thickness excision of tumors involving the gastrointestinal-tract wall, might become an extremely minimally invasive surgical method that could be used to resect only full-thickness lesions approached by the shortest distance via the mouth. It is expected that gastroenterological endoscopists will use this surgery if device development is advanced. This extremely minimally invasive surgery would have an immeasurable impact with regard to mitigating the burden on patients and reducing healthcare costs. Development of a new surgical method using a multipurpose flexible endoscope is therefore considered a socially urgent issue. PMID:26343069

Common Uses and Cited Complications of Energy in Surgery

PubMed Central

Sankaranarayanan, Ganesh; Resapu, Rajeswara R.; Jones, Daniel B.; Schwaitzberg, Steven; De, Suvranu

2013-01-01

Background Instruments that apply energy to cut, coagulate and dissect tissue with minimal bleeding facilitate surgery. The improper use of energy devices may increase patient morbidity and mortality. The current article reviews various energy sources in terms of their common uses and safe practices. Methods For the purpose of this review, a general search was conducted through NCBI, SpringerLink and Google. Articles describing laparoscopic or minimally invasive surgeries using a single or multiple energy sources are considered, as are the articles comparing various commercial energy devices in laboratory settings. Keywords such as ‘laparoscopy’, ‘energy’, ‘laser’, ‘electrosurgery’, ‘monopolar’, ‘bipolar’, ‘harmonic’, ‘ultrasonic’, ‘cryosurgery’, ‘argon beam’, ‘laser’, ‘complications’, and ‘death’ were used in the search. Results and Conclusion A review of the literature shows that the performance of the energy devices depends upon the type of procedure. There is no consensus as to which device is optimal for a given procedure. The technical skill level of the surgeon and the knowledge about the devices are both important factors in deciding safe outcomes. As new energy devices enter the market increases, surgeons should be aware of their indicated use in laparoscopic, endoscopic and open surgery. PMID:23609857

21 CFR 860.5 - Confidentiality and use of data and information submitted in connection with classification and...

Code of Federal Regulations, 2013 CFR

2013-04-01

... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...

21 CFR 860.5 - Confidentiality and use of data and information submitted in connection with classification and...

Code of Federal Regulations, 2012 CFR

2012-04-01

... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...

21 CFR 860.5 - Confidentiality and use of data and information submitted in connection with classification and...

Code of Federal Regulations, 2014 CFR

2014-04-01

... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...

21 CFR 860.5 - Confidentiality and use of data and information submitted in connection with classification and...

Code of Federal Regulations, 2011 CFR

2011-04-01

... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...

21 CFR 860.5 - Confidentiality and use of data and information submitted in connection with classification and...

Code of Federal Regulations, 2010 CFR

2010-04-01

... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...

21 CFR 862.1490 - Lysozyme (muramidase) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... monocytic leukemia and kidney disease. (b) Classification. Class I (general controls). The device is exempt...

21 CFR 862.1430 - 17-Ketosteroids test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... hypertension, diabetes, and hypothyroidism. (b) Classification. Class I (general controls). The device is...

21 CFR 862.1500 - Malic dehydrogenase test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... marrow) leukemia. (b) Classification. Class I (general controls). The device is exempt from the premarket...

21 CFR 886.1700 - Pupillometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... eye. (b) Classification. Class I (general controls). The AC-powered device and the manual device are... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1700 Pupillometer. (a) Identification. A pupillometer is an AC...

[Analysis of the factors contributing to diabetes insipidus after surgeries for craniopharyngiomas].

PubMed

Luo, Shi; Pan, Jun; Qi, Song-Tao; Fang, Lu-Xiong; Fan, Jun; Liu, Bao-Guo

2009-03-01

To analyze the factors contributing to the occurrence of diabetes insipidus after operations for craniopharyngiomas. A total of 121 cases of diabetes insipidus following surgeries for craniopharyngiomas were retrospectively analyzed and the factors associated with postoperative diabetes insipidus were analyzed. The incidence of diabetes insipidus was 27.3% (33/121 cases) before the operation, 89.9% (107/1119) early after the operation and 39.8%(37/93) in later stages after the operation. The occurrence of early postoperative diabetes insipidus showed a significant relation to the classification and calcification of the craniopharyngioma. Patients with supradiaphragmatic and extraventricular tumors had the lowest incidence of postoperative diabetes insipidus. Late postoperative diabetes insipidus was closely correlated to such factors as age, classification of craniopharyngioma, and intraoperative treatment of the pituitary stalk, but not to the scope of tumor resection or tumor calcification. Late diabetes insipidus was more frequent in children and patients with severed pituitary stalk. The incidence of late postoperative diabetes insipidus was significantly higher in patients with supradiaphragmatic and extra-intraventricular tumors than in those with tumors beneath the diaphragma sellae and extraventricular tumors. Postoperative diabetes insipidus following surgeries for craniopharyngiomas is closely related to the tumor classification, calcification and pituitary stalk protection.

Understanding nonlinear vibration behaviours in high-power ultrasonic surgical devices

PubMed Central

Mathieson, Andrew; Cardoni, Andrea; Cerisola, Niccolò; Lucas, Margaret

2015-01-01

Ultrasonic surgical devices are increasingly used in oral, craniofacial and maxillofacial surgery to cut mineralized tissue, offering the surgeon high accuracy with minimal risk to nerve and vessel tissue. Power ultrasonic devices operate in resonance, requiring their length to be a half-wavelength or multiple-half-wavelength. For bone surgery, devices based on a half-wavelength have seen considerable success, but longer multiple-half-wavelength endoscopic devices have recently been proposed to widen the range of surgeries. To provide context for these developments, some examples of surgical procedures and the associated designs of ultrasonic cutting tips are presented. However, multiple-half-wavelength components, typical of endoscopic devices, have greater potential to exhibit nonlinear dynamic behaviours that have a highly detrimental effect on device performance. Through experimental characterization of the dynamic behaviour of endoscopic devices, it is demonstrated how geometrical features influence nonlinear dynamic responses. Period doubling, a known route to chaotic behaviour, is shown to be significantly influenced by the cutting tip shape, whereas the cutting tip has only a limited effect on Duffing-like responses, particularly the shape of the hysteresis curve, which is important for device stability. These findings underpin design, aiming to pave the way for a new generation of ultrasonic endoscopic surgical devices. PMID:27547081

21 CFR 862.1330 - Globulin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... other disorders of blood globulins. (b) Classification. Class I (general controls). The device is exempt...

21 CFR 862.1470 - Lipid (total) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

21 CFR 862.1805 - Vitamin A test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

21 CFR 862.1605 - Pregnanediol test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 862.1610 - Pregnanetriol test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (congenital enlargement of the adrenal gland). (b) Classification. Class I (general controls). The device is...

21 CFR 862.1395 - 17-Hydroxyprogesterone test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... adrenal glands or the ovaries. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 864.2360 - Mycoplasma detection media and components.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Cell And Tissue Culture Products... microbial contaminant in cell cultures. (b) Classification. Class I (general controls). These devices are...

Tissue classification for laparoscopic image understanding based on multispectral texture analysis

NASA Astrophysics Data System (ADS)

Zhang, Yan; Wirkert, Sebastian J.; Iszatt, Justin; Kenngott, Hannes; Wagner, Martin; Mayer, Benjamin; Stock, Christian; Clancy, Neil T.; Elson, Daniel S.; Maier-Hein, Lena

2016-03-01

Intra-operative tissue classification is one of the prerequisites for providing context-aware visualization in computer-assisted minimally invasive surgeries. As many anatomical structures are difficult to differentiate in conventional RGB medical images, we propose a classification method based on multispectral image patches. In a comprehensive ex vivo study we show (1) that multispectral imaging data is superior to RGB data for organ tissue classification when used in conjunction with widely applied feature descriptors and (2) that combining the tissue texture with the reflectance spectrum improves the classification performance. Multispectral tissue analysis could thus evolve as a key enabling technique in computer-assisted laparoscopy.

21 CFR 878.4011 - Tissue adhesive with adjunct wound closure device for topical approximation of skin.

Code of Federal Regulations, 2011 CFR

2011-04-01

... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but...

Deep learning application: rubbish classification with aid of an android device

NASA Astrophysics Data System (ADS)

Liu, Sijiang; Jiang, Bo; Zhan, Jie

2017-06-01

Deep learning is a very hot topic currently in pattern recognition and artificial intelligence researches. Aiming at the practical problem that people usually don't know correct classifications some rubbish should belong to, based on the powerful image classification ability of the deep learning method, we have designed a prototype system to help users to classify kinds of rubbish. Firstly the CaffeNet Model was adopted for our classification network training on the ImageNet dataset, and the trained network was deployed on a web server. Secondly an android app was developed for users to capture images of unclassified rubbish, upload images to the web server for analyzing backstage and retrieve the feedback, so that users can obtain the classification guide by an android device conveniently. Tests on our prototype system of rubbish classification show that: an image of one single type of rubbish with origin shape can be better used to judge its classification, while an image containing kinds of rubbish or rubbish with changed shape may fail to help users to decide rubbish's classification. However, the system still shows promising auxiliary function for rubbish classification if the network training strategy can be optimized further.

21 CFR 886.3100 - Ophthalmic tantalum clip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...

21 CFR 886.1380 - Diagnostic condensing lens.

Code of Federal Regulations, 2010 CFR

2010-04-01

... light from the fundus of the eye. (b) Classification. Class I (general controls). The device is exempt...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure...

21 CFR 892.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.1 Scope. (a) This part sets forth the classification of radiology devices... devices, as required by § 807.87. (c) To avoid duplicative listings, a radiology device that has two or...

21 CFR 872.6865 - Powered toothbrush.

Code of Federal Regulations, 2010 CFR

2010-04-01

... remove adherent plaque and food debris from the teeth to reduce tooth decay. (b) Classification. Class I... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6865 Powered toothbrush. (a) Identification. A powered...

21 CFR 862.1325 - Gastrin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...-secreting tumor of the pancreas). (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.

Code of Federal Regulations, 2011 CFR

2011-04-01

... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882... the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class...

Towards automated spectroscopic tissue classification in thyroid and parathyroid surgery.

PubMed

Schols, Rutger M; Alic, Lejla; Wieringa, Fokko P; Bouvy, Nicole D; Stassen, Laurents P S

2017-03-01

In (para-)thyroid surgery iatrogenic parathyroid injury should be prevented. To aid the surgeons' eye, a camera system enabling parathyroid-specific image enhancement would be useful. Hyperspectral camera technology might work, provided that the spectral signature of parathyroid tissue offers enough specific features to be reliably and automatically distinguished from surrounding tissues. As a first step to investigate this, we examined the feasibility of wide band diffuse reflectance spectroscopy (DRS) for automated spectroscopic tissue classification, using silicon (Si) and indium-gallium-arsenide (InGaAs) sensors. DRS (350-1830 nm) was performed during (para-)thyroid resections. From the acquired spectra 36 features at predefined wavelengths were extracted. The best features for classification of parathyroid from adipose or thyroid were assessed by binary logistic regression for Si- and InGaAs-sensor ranges. Classification performance was evaluated by leave-one-out cross-validation. In 19 patients 299 spectra were recorded (62 tissue sites: thyroid = 23, parathyroid = 21, adipose = 18). Classification accuracy of parathyroid-adipose was, respectively, 79% (Si), 82% (InGaAs) and 97% (Si/InGaAs combined). Parathyroid-thyroid classification accuracies were 80% (Si), 75% (InGaAs), 82% (Si/InGaAs combined). Si and InGaAs sensors are fairly accurate for automated spectroscopic classification of parathyroid, adipose and thyroid tissues. Combination of both sensor technologies improves accuracy. Follow-up research, aimed towards hyperspectral imaging seems justified. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Pancreatic neuroendocrine tumour: Correlation of apparent diffusion coefficient or WHO classification with recurrence-free survival.

PubMed

Kim, Mimi; Kang, Tae Wook; Kim, Young Kon; Kim, Seong Hyun; Kwon, Wooil; Ha, Sang Yun; Ji, Sang A

2016-03-01

To evaluate the correlation between grade of pancreatic neuroendocrine tumours (pNETs) based on the 2010 World Health Organization (WHO) classification and the apparent diffusion coefficient (ADC), and to assess whether the ADC value and WHO classification can predict recurrence-free survival (RFS) after surgery for pNETs. This retrospective study was approved by the Institutional Review Board. The requirement for informed consent was waived. Between March 2009 and November 2014, forty-nine patients who underwent magnetic resonance (MR) imaging with diffusion-weighted image and subsequent surgery for single pNETs were included. Correlations among qualitative MR imaging findings, quantitative ADC values, and WHO classifications were assessed. An ordered logistic regression test was used to control for tumour size as a confounding factor. The association between ADC value (or WHO classification) and RFS was analysed. All tumors (n=49) were classified as low- (n=29, grade 1), intermediate- (n=17, grade 2), and high-grade (n=3, grade 3), respectively. The mean ADC of pNETs was moderately negatively correlated with WHO classification before and after adjustment for tumour size (ρ=-0.64, p<0.001 and ρ=-0.55, p=0.001 respectively). RFS was significantly associated with WHO classification (p=0.007), but not with the ADC value (p=0.569). The ADC value of pNETs is moderately correlated with WHO tumour grade, regardless of tumour size. However, the WHO tumour classification of pNET may be more suitable for predicting RFS than the ADC value. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

42 CFR 84.52 - Respiratory hazards; classification.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...

Current state of medical device nomenclature and taxonomy systems in the UK: spotlight on GMDN and SNOMED CT

PubMed Central

White, Judith; Carolan-Rees, Grace

2013-01-01

A standardised terminology for describing medical devices can enable safe and unambiguous exchange of information. Proposed changes to EU-wide medical devices regulations mandate the use of such a system. This article reviews two important classification systems for medical devices in the UK. The Global Medical Device Nomenclature (GMDN) provides a classification system specifically for medical devices and diagnostics, and facilitates data exchange between manufacturers and regulators. SNOMED CT is the terminology of choice in the NHS for communicating, sharing and storing information about patients’ healthcare episodes. Harmonisation of GMDN and SNOMED CT will encourage use of single terminology throughout the lifetime of a device; from regulatory approval through clinical use and post-marketing surveillance. Manufacturers will be required to register medical devices with a European device database (Eudamed) and to fit certain devices with a Unique Device Identifier; both are efforts to improve transparency and traceability of medical devices. Successful implementation of these elements depends on having a consistent nomenclature for medical devices. PMID:23885299

Spatio-spectral classification of hyperspectral images for brain cancer detection during surgical operations.

PubMed

Fabelo, Himar; Ortega, Samuel; Ravi, Daniele; Kiran, B Ravi; Sosa, Coralia; Bulters, Diederik; Callicó, Gustavo M; Bulstrode, Harry; Szolna, Adam; Piñeiro, Juan F; Kabwama, Silvester; Madroñal, Daniel; Lazcano, Raquel; J-O'Shanahan, Aruma; Bisshopp, Sara; Hernández, María; Báez, Abelardo; Yang, Guang-Zhong; Stanciulescu, Bogdan; Salvador, Rubén; Juárez, Eduardo; Sarmiento, Roberto

2018-01-01

Surgery for brain cancer is a major problem in neurosurgery. The diffuse infiltration into the surrounding normal brain by these tumors makes their accurate identification by the naked eye difficult. Since surgery is the common treatment for brain cancer, an accurate radical resection of the tumor leads to improved survival rates for patients. However, the identification of the tumor boundaries during surgery is challenging. Hyperspectral imaging is a non-contact, non-ionizing and non-invasive technique suitable for medical diagnosis. This study presents the development of a novel classification method taking into account the spatial and spectral characteristics of the hyperspectral images to help neurosurgeons to accurately determine the tumor boundaries in surgical-time during the resection, avoiding excessive excision of normal tissue or unintentionally leaving residual tumor. The algorithm proposed in this study to approach an efficient solution consists of a hybrid framework that combines both supervised and unsupervised machine learning methods. Firstly, a supervised pixel-wise classification using a Support Vector Machine classifier is performed. The generated classification map is spatially homogenized using a one-band representation of the HS cube, employing the Fixed Reference t-Stochastic Neighbors Embedding dimensional reduction algorithm, and performing a K-Nearest Neighbors filtering. The information generated by the supervised stage is combined with a segmentation map obtained via unsupervised clustering employing a Hierarchical K-Means algorithm. The fusion is performed using a majority voting approach that associates each cluster with a certain class. To evaluate the proposed approach, five hyperspectral images of surface of the brain affected by glioblastoma tumor in vivo from five different patients have been used. The final classification maps obtained have been analyzed and validated by specialists. These preliminary results are promising, obtaining an accurate delineation of the tumor area.

Spatio-spectral classification of hyperspectral images for brain cancer detection during surgical operations

PubMed Central

Kabwama, Silvester; Madroñal, Daniel; Lazcano, Raquel; J-O’Shanahan, Aruma; Bisshopp, Sara; Hernández, María; Báez, Abelardo; Yang, Guang-Zhong; Stanciulescu, Bogdan; Salvador, Rubén; Juárez, Eduardo; Sarmiento, Roberto

2018-01-01

Surgery for brain cancer is a major problem in neurosurgery. The diffuse infiltration into the surrounding normal brain by these tumors makes their accurate identification by the naked eye difficult. Since surgery is the common treatment for brain cancer, an accurate radical resection of the tumor leads to improved survival rates for patients. However, the identification of the tumor boundaries during surgery is challenging. Hyperspectral imaging is a non-contact, non-ionizing and non-invasive technique suitable for medical diagnosis. This study presents the development of a novel classification method taking into account the spatial and spectral characteristics of the hyperspectral images to help neurosurgeons to accurately determine the tumor boundaries in surgical-time during the resection, avoiding excessive excision of normal tissue or unintentionally leaving residual tumor. The algorithm proposed in this study to approach an efficient solution consists of a hybrid framework that combines both supervised and unsupervised machine learning methods. Firstly, a supervised pixel-wise classification using a Support Vector Machine classifier is performed. The generated classification map is spatially homogenized using a one-band representation of the HS cube, employing the Fixed Reference t-Stochastic Neighbors Embedding dimensional reduction algorithm, and performing a K-Nearest Neighbors filtering. The information generated by the supervised stage is combined with a segmentation map obtained via unsupervised clustering employing a Hierarchical K-Means algorithm. The fusion is performed using a majority voting approach that associates each cluster with a certain class. To evaluate the proposed approach, five hyperspectral images of surface of the brain affected by glioblastoma tumor in vivo from five different patients have been used. The final classification maps obtained have been analyzed and validated by specialists. These preliminary results are promising, obtaining an accurate delineation of the tumor area. PMID:29554126

21 CFR 862.1615 - Pregnenolone test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... diseases of the adrenal cortex or the gonads. (b) Classification. Class I (general controls). The device is...

Failed epilepsy surgery deserves a second chance.

PubMed

Reed, Chrystal M; Dewar, Sandra; Fried, Itzhak; Engel, Jerome; Eliashiv, Dawn

2017-12-01

Resective epilepsy surgery has been shown to have up to 70-80% success rates in patients with intractable seizure disorder. Around 20-30% of patients with Engel Classification III and IV will require reevaluation for further surgery. Common reasons for first surgery failures include incomplete resection of seizure focus, incorrect identification of seizure focus and recurrence of tumor. Clinical chart review of seventeen patients from a single adult comprehensive epilepsy program who underwent reoperation from 2007 to 2014 was performed. High resolution Brain MRI, FDG-PET, Neuropsychometric testing were completed in all cases in both the original surgery and the second procedure. Postoperative outcomes were confirmed by prospective telephone follow up and verified by review of the patient's electronic medical records. Outcomes were classified according to the modified Engel classification system: Engel classes I and II are considered good outcomes. A total of seventeen patients (involving 10 females) were included in the study. The average age of patients at second surgery was 42 (range 23-64 years). Reasons for reoperation included: incomplete first resection (n=13) and recurrence of tumor (n=4). Median time between the first and second surgery was 60 months. After the second surgery, ten of the seventeen patients (58.8%) achieved seizure freedom (Engel Class I), in agreement with other published reports. Of the ten patients who were Engel Class I, seven required extension of the previous resection margins, while three had surgery for recurrence of previously partially resected tumor. We conclude that since the risk of complications from reoperation is low and the outcome, for some, is excellent, consideration of repeat surgery is justified. Copyright © 2017 Elsevier B.V. All rights reserved.

Pre- and post-operative risk factors associated with cerebrovascular accidents in patients supported by left ventricular assist device. -Single center's experience in japan-.

PubMed

Nakajima, Ikutaro; Kato, Tomoko S; Komamura, Kazuo; Takahashi, Ayako; Oda, Noboru; Sasaoka, Taro; Asakura, Masanori; Hashimura, Kazuhiko; Kitakaze, Masafumi

2011-01-01

Cerebrovascular accident (CVA) is a major adverse event following left ventricular assist device (LVAD) surgery. This study investigates pre- and post-operative factors associated with CVA in this population. A total of 118 consecutive patients who underwent LVAD surgery at our institution between April 1994 and April 2009 were retrospectively reviewed. Clinical characteristics, hemodynamic data, and laboratory indexes associated with CVA after LVAD surgery were analyzed. In total, 57 (48.3%) patients developed CVA 133.5 ± 184.7 days after surgery. The combination of baseline heart disease, type of LVAD surgery, mean right atrial pressure (mRA), serum total bilirubin and total protein concentration, and right ventricular end-diastolic dimension (RVEDd) was associated with CVA at any time after LVAD surgery, with a discriminant probability of 718%. With regard to CVA development later than 3 months after surgery, the combination of mRA and RVEDd before surgery [odds ratio (OR), 1.24, 1.20; 95% confidential interval (CI), 1.07-1.42, 1.06-1.34; P = 0.004, P = 0.006, respectively], positive blood culture, and C-reactive protein after surgery (OR, 7.66, 2.19; 95%CI, 1.50-39.0, 1.47-3.25; P = 0.015, P < 0.0001, respectively) was associated with CVA with a discriminant probability of 85.9%. Patients' general condition including malnutrition, in addition to device selection, contributed to overall CVA development after surgery. In the chronic phase after surgery, pre-LVAD right heart failure and post-LVAD systemic infection were highly associated with CVA development.

21 CFR 872.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended... devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more...

21 CFR 872.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended... devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more...

21 CFR 872.6570 - Impression tube.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

21 CFR 886.1770 - Manual refractor.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1770 Manual refractor. (a) Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

Elimination of Mycobacterium chimaera in a heater cooler device used during on-pump cardiothoracic surgery.

PubMed

Nielsen, Conny; Winther, Conni L; Thomsen, Philip K; Andreasen, Jan J

2017-09-01

Since 2014, several infections with non-tuberculous mycobacteria (NTM) belonging to the species Mycobacterium ( M.) chimaera have been associated with the use of heater-cooler devices during on-pump cardiothoracic surgery both in European countries and the United States of America. Infections have been detected after surgery, with a delay of a few months and up to five years. Bacterial contamination of heater-cooler devices has also been described without any associated infections. In many centres, it has been a challenging task to eliminate NTM from the heater-cooler devices in order to reduce the risk to patients. In this case-report, we describe how we managed to achieve negative cultures for M. chimaera by changing the cleaning procedure of the Sorin Group Heater-Cooler System with three tanks.

Endoscopic Management of Peri-Pancreatic Fluid Collections.

PubMed

Yip, Hon Chi; Teoh, Anthony Yuen Bun

2017-09-15

In the past decade, there has been a progressive paradigm shift in the management of peri-pancreatic fluid collections after acute pancreatitis. Refinements in the definitions of fluid collections from the updated Atlanta classification have enabled better communication amongst physicians in an effort to formulate optimal treatments. Endoscopic ultrasound (EUS)-guided drainage of pancreatic pseudocysts has emerged as the procedure of choice over surgical cystogastrostomy. The approach provides similar success rates with low complications and better quality of life compared with surgery. However, an endoscopic "step up" approach in the management of pancreatic walled-off necrosis has also been advocated. Both endoscopic and percutaneous drainage routes may be used depending on the anatomical location of the collections. New-generation large diameter EUS-specific stent systems have also recently been described. The device allows precise and effective drainage of the collections and permits endoscopic necrosectomy through the stents.

Robot-assisted laparoscopic ultrasonography for hepatic surgery.

PubMed

Schneider, Caitlin M; Peng, Peter D; Taylor, Russell H; Dachs, Gregory W; Hasser, Christopher J; DiMaio, Simon P; Choti, Michael A

2012-05-01

This study describes and evaluates a novel, robot-assisted laparoscopic ultrasonographic device for hepatic surgery. Laparoscopic liver surgery is being performed with increasing frequency. One major drawback of this approach is the limited capability of intraoperative ultrasonography (IOUS) using standard laparoscopic devices. Robotic surgery systems offer the opportunity to develop new tools to improve techniques in minimally invasive surgery. This study evaluates a new integrated ultrasonography (US) device with the da Vinci Surgical System for laparoscopic visualization, comparing it with conventional handheld laparoscopic IOUS for performing key tasks in hepatic surgery. A prototype laparoscopic IOUS instrument was developed for the da Vinci Surgical System and compared with a conventional laparoscopic US device in simulation tasks: (1) In vivo porcine hepatic visualization and probe manipulation, (2) lesion detection accuracy, and (3) biopsy precision. Usability was queried by poststudy questionnaire. The robotic US proved better than conventional laparoscopic US in liver surface exploration (85% success vs 73%; P = .030) and tool manipulation (79% vs 57%; P = .028), whereas no difference was detected in lesion identification (63 vs 58; P = .41) and needle biopsy tasks (57 vs 48; P = .11). Subjects found the robotic US to facilitate better probe positioning (80%), decrease fatigue (90%), and be more useful overall (90%) on the post-task questionnaire. We found this robot-assisted IOUS system to be practical and useful in the performance of important tasks required for hepatic surgery, outperforming free-hand laparoscopic IOUS for certain tasks, and was more subjectively usable to the surgeon. Systems such as this may expand the use of robotic surgery for complex operative procedures requiring IOUS. Copyright © 2012 Mosby, Inc. All rights reserved.

The Society for Vascular Surgery lower extremity threatened limb classification system based on Wound, Ischemia, and foot Infection (WIfI) correlates with risk of major amputation and time to wound healing.

PubMed

Zhan, Luke X; Branco, Bernardino C; Armstrong, David G; Mills, Joseph L

2015-04-01

The purpose of this study was to evaluate whether the new Society for Vascular Surgery (SVS) Wound, Ischemia, and foot Infection (WIfI) classification system correlates with important clinical outcomes for limb salvage and wound healing. A total of 201 consecutive patients with threatened limbs treated from 2010 to 2011 in an academic medical center were analyzed. These patients were stratified into clinical stages 1 to 4 on the basis of the SVS WIfI classification. The SVS objective performance goals of major amputation, 1-year amputation-free survival (AFS) rate, and wound healing time (WHT) according to WIfI clinical stages were compared. The mean age was 58 years (79% male, 93% with diabetes). Forty-two patients required major amputation (21%); 159 (78%) had limb salvage. The amputation group had a significantly higher prevalence of advanced stage 4 patients (P < .001), whereas the limb salvage group presented predominantly as stages 1 to 3. Patients in clinical stages 3 and 4 had a significantly higher incidence of amputation (P < .001), decreased AFS (P < .001), and delayed WHT (P < .002) compared with those in stages 1 and 2. Among patients presenting with stage 3, primarily as a result of wound and ischemia grades, revascularization resulted in accelerated WHT (P = .008). These data support the underlying concept of the SVS WIfI, that an appropriate classification system correlates with important clinical outcomes for limb salvage and wound healing. As the clinical stage progresses, the risk of major amputation increases, 1-year AFS declines, and WHT is prolonged. We further demonstrated benefit of revascularization to improve WHT in selected patients, especially those in stage 3. Future efforts are warranted to incorporate the SVS WIfI classification into clinical decision-making algorithms in conjunction with a comorbidity index and anatomic classification. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

The Variability in Surgical Margin Reporting in Limb Salvage Surgery for Sarcoma

PubMed Central

Hoang, Kevin; Gao, Yubo; Miller, Benjamin J.

2015-01-01

Background Surgical margins are a standard reported measurement in tumor surgery that has implications for functional outcome, local control, and overall survival. There is no single accepted classification, and it is unclear what form or margin reporting predominates in the sarcoma literature. Methods We performed a PubMed literature search to identify articles that reported surgical margins and oncologic outcomes in limb salvage surgery for sarcoma from 1980 to 2013. We recorded the margin classification, specialty of the journal, specialty of the author, and location of the authors' institution. Results We found that 159/448 (35%) of articles included in the study did not report surgical margins. Of the 289 papers that did include data on margins, 160 (55%) of articles used Enneking's classification. There has been an increase over time in the proportion of articles reporting surgical margins by the residual tumor (R) classification and the proportion of articles reporting margins dichotomously as “positive” or “negative.” Conclusions We did not find a common method for reporting margins in the limb salvage sarcoma literature. Of most concern was over 1/3 of clinical reports of oncologic outcomes did not include margin status, which substantially compromises any conclusions that readers may infer about treatment success, local recurrence, or survival. We believe there should be renewed efforts to encourage use of a common surgical margin reporting system that is simple, reproducible, and prognostic. PMID:26361463

Definition and classification of chyle leak after pancreatic operation: A consensus statement by the International Study Group on Pancreatic Surgery.

PubMed

Besselink, Marc G; van Rijssen, L Bengt; Bassi, Claudio; Dervenis, Christos; Montorsi, Marco; Adham, Mustapha; Asbun, Horacio J; Bockhorn, Maximillian; Strobel, Oliver; Büchler, Markus W; Busch, Olivier R; Charnley, Richard M; Conlon, Kevin C; Fernández-Cruz, Laureano; Fingerhut, Abe; Friess, Helmut; Izbicki, Jakob R; Lillemoe, Keith D; Neoptolemos, John P; Sarr, Michael G; Shrikhande, Shailesh V; Sitarz, Robert; Vollmer, Charles M; Yeo, Charles J; Hartwig, Werner; Wolfgang, Christopher L; Gouma, Dirk J

2017-02-01

Recent literature suggests that chyle leak may complicate up to 10% of pancreatic resections. Treatment depends on its severity, which may include chylous ascites. No international consensus definition or grading system of chyle leak currently is available. The International Study Group on Pancreatic Surgery, an international panel of pancreatic surgeons working in well-known, high-volume centers, reviewed the literature and worked together to establish a consensus on the definition and classification of chyle leak after pancreatic operation. Chyle leak was defined as output of milky-colored fluid from a drain, drain site, or wound on or after postoperative day 3, with a triglyceride content ≥110 mg/dL (≥1.2 mmol/L). Three different grades of severity were defined according to the management needed: grade A, no specific intervention other than oral dietary restrictions; grade B, prolongation of hospital stay, nasoenteral nutrition with dietary restriction, total parenteral nutrition, octreotide, maintenance of surgical drains, or placement of new percutaneous drains; and grade C, need for other more invasive in-hospital treatment, intensive care unit admission, or mortality. This classification and grading system for chyle leak after pancreatic resection allows for comparison of outcomes between series. As with the other the International Study Group on Pancreatic Surgery consensus statements, this classification should facilitate communication and evaluation of different approaches to the prevention and treatment of this complication. Copyright © 2016 Elsevier Inc. All rights reserved.

A new oscillating saw for robotic aided surgery.

PubMed

Moctezuma, J L; Schuster, D; Gossé, F; Schulz, H J

1997-01-01

In this paper a brief description of a computer and robotic aided surgery system is given with a detailed overview of the necessity to develop special tools for robotic surgery. The application range of this robotic system has been specially focused on the orthopaedics field and, more particularly, on the execution of osteotomies. It was therefore necessary to develop a new saw device which would meet medical and--from the robot system point of view--mechanical as well as functional requirements. After describing the device which was developed on the basis of these requirements, a detailed comparative study of off-the-shelf oscillating saws and the new device is given at the end of the paper.

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery

PubMed Central

2010-01-01

Background Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures. Methods/Design Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study: Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included. Ethics - beneficence, non-maleficence, autonomy, justice. Economics - scarcity of resources, choices, opportunity costs. For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material. Discussion The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy. PMID:20738887

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery.

PubMed

Ross, Sue; Weijer, Charles; Gafni, Amiram; Ducey, Ariel; Thompson, Carmen; Lafreniere, Rene

2010-08-26

Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures. Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study: Stakeholders--federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included. Ethics--beneficence, non-maleficence, autonomy, justice. Economics--scarcity of resources, choices, opportunity costs.For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material. The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.

21 CFR 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices..., pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. (b) Classification. Class II...

21 CFR 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices..., pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. (b) Classification. Class II...

21 CFR 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices..., pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. (b) Classification. Class II...

Localized primary gastrointestinal diffuse large B cell lymphoma received a surgical approach: an analysis of prognostic factors and comparison of staging systems in 101 patients from a single institution.

PubMed

Zhang, Shengting; Wang, Li; Yu, Dong; Shen, Yang; Cheng, Shu; Zhang, Li; Qian, Ying; Shen, Zhixiang; Li, Qinyu; Zhao, Weili

2015-08-15

Diffuse large B cell lymphoma (DLBCL) represents the most common histological subtype of primary gastrointestinal lymphoma and is a heterogeneous group of disease. Prognostic characterization of individual patients is an essential prerequisite for a proper risk-based therapeutic choice. Clinical and pathological prognostic factors were identified, and predictive value of four previously described prognostic systems were assessed in 101 primary gastrointestinal DLBCL (PG-DLBCL) patients with localized disease, including Ann Arbor staging with Musshoff modification, International Prognostic Index (IPI), Lugano classification, and Paris staging system. Univariate factors correlated with inferior survival time were clinical parameters [age>60 years old, multiple extranodal/gastrointestinal involvement, elevated serum lactate dehydrogenase and β2-microglobulin, and decreased serum albumin], as well as pathological parameters (invasion depth beyond serosa, involvement of regional lymph node or adjacent tissue, Ki-67 index, and Bcl-2 expression). Major independent variables of adverse outcome indicated by multivariate analysis were multiple gastrointestinal involvement. In patients unfit for Rituximab but received surgery, radical surgery significantly prolonged the survival time, comparing with alleviative surgery. Addition of Rituximab could overcome the negative prognostic effect of alleviative surgery. Among the four prognostic systems, IPI and Lugano classification clearly separated patients into different risk groups. IPI was able to further stratify the early-stage patients of Lugano classification into groups with distinct prognosis. Radical surgery might be proposed for the patients unfit for Rituximab treatment, and a combination of clinical and pathological staging systems was more helpful to predict the disease outcome of PG-DLBCL patients.

The definition of chronic lung disease in patients undergoing cardiac surgery: a comparison between the Society of Thoracic Surgeons and the American Thoracic Society/European Respiratory Society Classifications.

PubMed

Henry, L; Holmes, S D; Lamberti, J; Halpin, L; Hunt, S; Ad, N

2012-12-01

Early and late outcomes following cardiac surgery may be adversely affected in patients with chronic lung disease (CLD) and the presence of CLD is definition dependent. The purpose of this study was to compare the Society of Thoracic Surgeons (STS) definitions for CLD to the modified American Thoracic Society (ATS)/European Respiratory Society (ERS) definitions in diagnosing and classifying CLD among a cohort of cardiac surgery patients. A prospectively-designed study whereby high risk patients for CLD presenting for non-emergent cardiac surgery and had a history of asthma, a 10 or more pack year history of smoking or a persistent cough were included. All patients underwent spirometry testing within two weeks of surgery. The presence and severity of CLD was coded two times: 1) STS definitions with spirometry; 2) ATS/ERS guidelines. The rate of misclassification was determined using concordance and discordance rates. Sensitivity analysis of the STS spirometry definitions was calculated against the ATS/ERS definitions and respective classifications. The discordant rate for the STS spirometry driven definitions versus the ATS/ERS definitions was 21%. Forty patients (21%) classified as no CLD by the STS spirometry definition were found to have CLD by the ATS/ERS definition. The STS classification had 68% sensitivity (84/124) when identifying any CLD and only 26% sensitivity (14/54) when identifying moderate CLD. The current STS spirometry driven definitions for CLD did not perform as well as the ATS/ERS definitions in diagnosing and classifying the degree of CLD. Consideration should be given to using the ATS/ERS definitions.

Framework for hyperspectral image processing and quantification for cancer detection during animal tumor surgery.

PubMed

Lu, Guolan; Wang, Dongsheng; Qin, Xulei; Halig, Luma; Muller, Susan; Zhang, Hongzheng; Chen, Amy; Pogue, Brian W; Chen, Zhuo Georgia; Fei, Baowei

2015-01-01

Hyperspectral imaging (HSI) is an imaging modality that holds strong potential for rapid cancer detection during image-guided surgery. But the data from HSI often needs to be processed appropriately in order to extract the maximum useful information that differentiates cancer from normal tissue. We proposed a framework for hyperspectral image processing and quantification, which includes a set of steps including image preprocessing, glare removal, feature extraction, and ultimately image classification. The framework has been tested on images from mice with head and neck cancer, using spectra from 450- to 900-nm wavelength. The image analysis computed Fourier coefficients, normalized reflectance, mean, and spectral derivatives for improved accuracy. The experimental results demonstrated the feasibility of the hyperspectral image processing and quantification framework for cancer detection during animal tumor surgery, in a challenging setting where sensitivity can be low due to a modest number of features present, but potential for fast image classification can be high. This HSI approach may have potential application in tumor margin assessment during image-guided surgery, where speed of assessment may be the dominant factor.

Framework for hyperspectral image processing and quantification for cancer detection during animal tumor surgery

NASA Astrophysics Data System (ADS)

Lu, Guolan; Wang, Dongsheng; Qin, Xulei; Halig, Luma; Muller, Susan; Zhang, Hongzheng; Chen, Amy; Pogue, Brian W.; Chen, Zhuo Georgia; Fei, Baowei

2015-12-01

Hyperspectral imaging (HSI) is an imaging modality that holds strong potential for rapid cancer detection during image-guided surgery. But the data from HSI often needs to be processed appropriately in order to extract the maximum useful information that differentiates cancer from normal tissue. We proposed a framework for hyperspectral image processing and quantification, which includes a set of steps including image preprocessing, glare removal, feature extraction, and ultimately image classification. The framework has been tested on images from mice with head and neck cancer, using spectra from 450- to 900-nm wavelength. The image analysis computed Fourier coefficients, normalized reflectance, mean, and spectral derivatives for improved accuracy. The experimental results demonstrated the feasibility of the hyperspectral image processing and quantification framework for cancer detection during animal tumor surgery, in a challenging setting where sensitivity can be low due to a modest number of features present, but potential for fast image classification can be high. This HSI approach may have potential application in tumor margin assessment during image-guided surgery, where speed of assessment may be the dominant factor.

42 CFR 84.53 - Service time; classification.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...

42 CFR 84.53 - Service time; classification.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...

42 CFR 84.53 - Service time; classification.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...

42 CFR 84.53 - Service time; classification.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...

42 CFR 84.53 - Service time; classification.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...

Benign paroxysmal positional vertigo secondary to laparoscopic surgery

PubMed Central

Shan, Xizheng; Wang, Amy; Wang, Entong

2017-01-01

Objectives: Benign paroxysmal positional vertigo is a common vestibular disorder and it may be idiopathic or secondary to some conditions such as surgery, but rare following laparoscopic surgery. Methods: We report two cases of benign paroxysmal positional vertigo secondary to laparoscopic surgery, one after laparoscopic cholecystectomy in a 51-year-old man and another following laparoscopic hysterectomy in a 60-year-old woman. Results: Both patients were treated successfully with manual or device-assisted canalith repositioning maneuvers, with no recurrence on the follow-up of 6 -18 months. Conclusions: Benign paroxysmal positional vertigo is a rare but possible complication of laparoscopic surgery. Both manual and device-assisted repositioning maneuvers are effective treatments for this condition, with good efficacy and prognosis. PMID:28255446

21 CFR 872.3765 - Pit and fissure sealant and conditioner.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3765 Pit and fissure sealant and... depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities. (b) Classification...

21 CFR 872.3765 - Pit and fissure sealant and conditioner.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3765 Pit and fissure sealant and... depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities. (b) Classification...

Healthcare-Associated Mycobacterium chimaera Infection Subsequent to Heater-Cooler Device Exposure During Cardiac Surgery.

PubMed

Ninh, Allen; Weiner, Menachem; Goldberg, Andrew

2017-10-01

A SERIES of reports in the United States and Europe have linked Mycobacterium chimaera infections to contaminated heater-cooler devices used during cardiac surgery. Heater-cooler devices commonly are used for cardiopulmonary bypass during cardiac surgery. M. chimaera is a slow-growing nontuberculous mycobacterium that has been shown to cause cardiac complications that can lead to fatal disease following cardiac surgery. Given that more than 250,000 cardiothoracic surgical procedures requiring cardiopulmonary bypass take place each year in the United States, the estimated number of patient exposures to M. chimaera has prompted a public health crisis. The goal of this review is to summarize the present status of the M. chimaera outbreak and provide cardiothoracic surgeons, cardiac anesthesiologists, and other clinicians with current approaches to patient management and to discuss risk mitigation. Copyright © 2017 Elsevier Inc. All rights reserved.

21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic contact lens radius measuring device... lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device is... lens. (b) Classification. Class I (general controls). The device is exempt from the premarket...

21 CFR 886.1500 - Headband mirror.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1500 Headband mirror. (a) Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

A Dimensionally Aligned Signal Projection for Classification of Unintended Radiated Emissions

DOE PAGES

Vann, Jason Michael; Karnowski, Thomas P.; Kerekes, Ryan; ...

2017-04-24

Characterization of unintended radiated emissions (URE) from electronic devices plays an important role in many research areas from electromagnetic interference to nonintrusive load monitoring to information system security. URE can provide insights for applications ranging from load disaggregation and energy efficiency to condition-based maintenance of equipment-based upon detected fault conditions. URE characterization often requires subject matter expertise to tailor transforms and feature extractors for the specific electrical devices of interest. We present a novel approach, named dimensionally aligned signal projection (DASP), for projecting aligned signal characteristics that are inherent to the physical implementation of many commercial electronic devices. These projectionsmore » minimize the need for an intimate understanding of the underlying physical circuitry and significantly reduce the number of features required for signal classification. We present three possible DASP algorithms that leverage frequency harmonics, modulation alignments, and frequency peak spacings, along with a two-dimensional image manipulation method for statistical feature extraction. To demonstrate the ability of DASP to generate relevant features from URE, we measured the conducted URE from 14 residential electronic devices using a 2 MS/s collection system. Furthermore, a linear discriminant analysis classifier was trained using DASP generated features and was blind tested resulting in a greater than 90% classification accuracy for each of the DASP algorithms and an accuracy of 99.1% when DASP features are used in combination. Furthermore, we show that a rank reduced feature set of the combined DASP algorithms provides a 98.9% classification accuracy with only three features and outperforms a set of spectral features in terms of general classification as well as applicability across a broad number of devices.« less

A Dimensionally Aligned Signal Projection for Classification of Unintended Radiated Emissions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vann, Jason Michael; Karnowski, Thomas P.; Kerekes, Ryan

Characterization of unintended radiated emissions (URE) from electronic devices plays an important role in many research areas from electromagnetic interference to nonintrusive load monitoring to information system security. URE can provide insights for applications ranging from load disaggregation and energy efficiency to condition-based maintenance of equipment-based upon detected fault conditions. URE characterization often requires subject matter expertise to tailor transforms and feature extractors for the specific electrical devices of interest. We present a novel approach, named dimensionally aligned signal projection (DASP), for projecting aligned signal characteristics that are inherent to the physical implementation of many commercial electronic devices. These projectionsmore » minimize the need for an intimate understanding of the underlying physical circuitry and significantly reduce the number of features required for signal classification. We present three possible DASP algorithms that leverage frequency harmonics, modulation alignments, and frequency peak spacings, along with a two-dimensional image manipulation method for statistical feature extraction. To demonstrate the ability of DASP to generate relevant features from URE, we measured the conducted URE from 14 residential electronic devices using a 2 MS/s collection system. Furthermore, a linear discriminant analysis classifier was trained using DASP generated features and was blind tested resulting in a greater than 90% classification accuracy for each of the DASP algorithms and an accuracy of 99.1% when DASP features are used in combination. Furthermore, we show that a rank reduced feature set of the combined DASP algorithms provides a 98.9% classification accuracy with only three features and outperforms a set of spectral features in terms of general classification as well as applicability across a broad number of devices.« less

Proposal for a bariatric mortality risk classification system for patients undergoing bariatric surgery.

PubMed

Nguyen, Ninh T; Nguyen, Brian; Smith, Brian; Reavis, Kevin M; Elliott, Christian; Hohmann, Samuel

2013-01-01

An obesity surgery mortality risk score derived from a single clinical series can be used to stratify the mortality risk of patients undergoing gastric bypass. However, such a scoring system does not take into account 2 important factors in contemporary bariatric surgery--increased use of the laparoscopic approach and laparoscopic adjustable gastric banding. The present study analyzed the preoperative factors that might predict in-hospital mortality after bariatric surgery using data from academic medical centers and proposes a classification system for predicting mortality. Using the "International Classification of Diseases, 9th revision," diagnosis and procedural codes, the data for all patients who underwent bariatric surgery for the treatment of morbid obesity from 2002 to 2009 were obtained from the University HealthSystem Consortium database. The limitations of this database included the lack of the body mass index and the underestimation of some co-morbidities, such as sleep apnea. Multiple regression analyses were performed to determine the factors predictive of greater in-hospital mortality. The factors examined included race, gender, age, co-morbidities, surgical technique (laparoscopic versus open), bariatric operation (gastric bypass versus nongastric bypass), and payer type. A scoring system was devised by assigning 1 point for each major factor (those with an adjusted odds ratio [AOR] of ≥2.0) and .5 point for each minor factor (those with an AOR <2.0). Using contemporary data from 2007 to 2009, the in-hospital mortality was analyzed according to the classification: class I, 0-0.5 point; class II, 1.0-1.5 points; class III, 2.0-3.0 points; and class IV, ≥3.5 points. During the 8-year period, 105,287 patients underwent bariatric surgery. The operations included laparoscopic gastric bypass (45%), open gastric bypass (41%), and laparoscopic gastric banding or gastroplasty (14%). The overall in-hospital mortality rate was .17%. The number of deaths per 1000 bariatric operations decreased from 4.0 in 2002 to .6 in 2009. Using regression analyses, the factors predictive of greater in-hospital mortality were male gender (AOR 3.2), gastric bypass procedure (AOR 5.8), open surgical technique (AOR 4.8), Medicare payer (AOR 3.0), diabetes (AOR 1.6), and age >60 years (AOR 1.9). The mortality rate was .10% for class I patients, .15% for class II, .33% for class III, and .70% for class IV (P < .05 among all classes). Within the context of academic centers, the mortality after bariatric surgery has decreased substantially since 2002, with an increase in the use of the laparoscopic technique and laparoscopic gastric banding. A bariatric mortality risk classification system was developed to stratify mortality, given the limits of this database, which does not include the body mass index and underestimates the incidence of sleep apnea. It might be useful to aid surgeons in surgical decision-making, to inform patients of their risks, and for quality improvement reporting purposes. Copyright © 2013 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Long-term Results for the BacJac Interspinous Device in Lumbar Spine Degenerative Disease.

PubMed

Spallone, Aldo; Lavorato, Luigi; Belvisi, Daniele

2018-05-14

 To evaluate the long-term results of using the BacJac interspinous device (Pioneer Surgical Technology Inc.) in a series of patients with degenerative lumbar spine disease.  Forty-one patients undergoing lumbar surgery with implantation of a BacJac device from 2009 to 2012 were enrolled in the present study. Patients were evaluated using the Oswestry Disability Scale (ODI).  Although all patients showed a significant improvement of the ODI score immediately after surgery, only 41% of patients showed a satisfactory outcome. We observed worse results in the patients operated on at the L3-L4 level and in whom the device was implanted in a segment different from the one where surgical decompression had been performed. Weight gain in the months after surgery was also a poor outcome-influencing factor.  This study confirms what is already suggested in the relevant literature regarding the long-term inefficacy of the so-called dynamic stabilization devices. Georg Thieme Verlag KG Stuttgart · New York.

High Resolution Microendoscopy for Quantitative Diagnosis of Esophageal Neoplasia

NASA Astrophysics Data System (ADS)

Shin, Dongsuk

Esophageal cancer is the eighth most common cancer in the world. Cancers of the esophagus account for 3.8% of all cases of cancers, with approximately 482,300 new cases reported in 2008 worldwide. In the United States alone, it is estimated that approximately 18,000 new cases will be diagnosed in 2013, and 15,210 deaths are expected. Despite advances in surgery and chemoradiation therapy, these advances have not led to a significant increase in survival rates, primarily because diagnosis often at an advanced and incurable stage when treatment is more difficult and less successful. Accurate, objective methods for early detection of esophageal neoplasia are needed. Here, quantitative classification algorithms for high resolution miscroendoscopic images were developed to distinguish between esophageal neoplastic and non-neoplastic tissue. A clinical study in 177 patients with esophageal squamous cell carcinoma (ESCC) was performed to evaluate the diagnostic performance of the classification algorithm in collaboration with the Mount Sinai Medical Center in the United States, the First Hospital of Jilin University in China, and the Cancer Institute and Hospital, the Chinese Academy of Medical Science in China. The study reported a sensitivity and specificity of 93% and 92%, respectively, in the training set, 87% and 97%, respectively, in the test set, and 84% and 95%, respectively, in an independent validation set. Another clinical study in 31 patients with Barrett's esophagus resulted in a sensitivity of 84% and a specificity of 85%. Finally, a compact, portable version of the high resolution microendoscopy (HRME) device using a consumer-grade camera was developed and a series of biomedical experimental studies were carried out to assess the capability of the device.

Harmonic scalpel versus electrocautery in breast reduction surgery: a randomized controlled trial.

PubMed

Burdette, Todd E; Kerrigan, Carolyn L; Homa, Karen; Homa, Karen A

2011-10-01

The authors hypothesized that the Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, Ohio) might outperform electrocautery in bilateral breast reduction surgery, possibly resulting in (1) shorter operative times, (2) lower postoperative fluid drainage rates, and (3) reduced postoperative pain scores. Thirty-one patients were evaluated in a matched-pair design, with random (blinded) assignment of one side to the Harmonic Scalpel, with the other side defaulting to electrocautery. Main outcome measures were: (1) resection/hemostasis time, (2) drainage volume, and (3) postoperative pain. The authors also compared the learning curves, operative time versus specimen weights, complications, and costs for the devices. There was a statistically significant (but not clinically significant) difference between the median times for the Harmonic Scalpel (33 minutes) and electrocautery (31 minutes) (p=0.02). There was no statistical difference in drainage scores, and pain scores were equivalent. The analysis of specimen weight versus resection/hemostasis time showed no correlation. There were more complications on the breasts reduced with the Harmonic device, but due to the small sample size, the complication results were not statistically significant. Start-up costs for the devices were comparable, but the per-procedure cost for the Harmonic device was considerably higher. The Harmonic Scalpel is roughly equivalent to electrocautery in breast reduction surgery in terms of resection/hemostasis time, serous drainage, and postoperative pain. Though the Harmonic device may be excellent for other surgical procedures, its high cost suggests that surgeons and institutions can confidently forgo its use in breast reduction surgery. Therapeutic, II.

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...

21 CFR 886.1760 - Ophthalmic refractometer.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1760 Ophthalmic refractometer. (a) Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system... of the eye by measuring light reflexes from the retina. (b) Classification. Class I (general controls...

A randomised controlled trial comparing incentive spirometry with the Acapella® device for physiotherapy after thoracoscopic lung resection surgery.

PubMed

Cho, Y J; Ryu, H; Lee, J; Park, I K; Kim, Y T; Lee, Y H; Lee, H; Hong, D M; Seo, J H; Bahk, J H; Jeon, Y

2014-08-01

Lung resection surgery has been associated with numerous postoperative complications. Seventy-eight patients scheduled for elective video-assisted thoracoscopic lung resection were randomly assigned to receive standard postoperative care with incentive spirometry or standard care plus positive vibratory expiratory pressure treatment using the Acapella(®) device. There was no significant difference between incentive spirometry and the Acapella device in the primary outcome, forced expiratory volume in 1 s, on the third postoperative day, mean (SD) 53% (16%) vs 59% (18%) respectively, p = 0.113. Patients treated with both devices simultaneously found incentive spirometry to be less comfortable compared with the Acapella device, using a numeric rating scale from 1 to 5 with lower scores indicating higher comfort, median (IQR [range]) 3 (2-3 [2-4]) vs 1 (1-2 [1-3]) respectively, p < 0.001. In addition, 37/39 patients (95%) stated a clear preference for the Acapella device. Postoperative treatment with the Acapella device did not improve pulmonary function after thoracoscopic lung resection surgery compared with incentive spirometry, but it may be more comfortable to use. © 2014 The Association of Anaesthetists of Great Britain and Ireland.

The Unified Classification System (UCS): improving our understanding of periprosthetic fractures.

PubMed

Duncan, C P; Haddad, F S

2014-06-01

Periprosthetic fractures are an increasingly common complication following joint replacement. The principles which underpin their evaluation and treatment are common across the musculoskeletal system. The Unified Classification System proposes a rational approach to treatment, regardless of the bone that is broken or the joint involved. ©2014 The British Editorial Society of Bone & Joint Surgery.

The Evolution of Complex Microsurgical Midface Reconstruction: A Classification Scheme and Reconstructive Algorithm.

PubMed

Alam, Daniel; Ali, Yaseen; Klem, Christopher; Coventry, Daniel

2016-11-01

Orbito-malar reconstruction after oncological resection represents one of the most challenging facial reconstructive procedures. Until the last few decades, rehabilitation was typically prosthesis based with a limited role for surgery. The advent of microsurgical techniques allowed large-volume tissue reconstitution from a distant donor site, revolutionizing the potential approaches to these defects. The authors report a novel surgery-based algorithm and a classification scheme for complete midface reconstruction with a foundation in the Gillies principles of like-to-like reconstruction and with a significant role of computer-aided virtual planning. With this approach, the authors have been able to achieve significantly better patient outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

A simple working classification proposed for the latrogenic lesions of teeth and associated structures in the oral cavity.

PubMed

Shamim, Thorakkal

2013-09-01

Iatrogenic lesions can affect both hard and soft tissues in the oral cavity, induced by the dentist's activity, manner or therapy. There is no approved simple working classification for the iatrogenic lesions of teeth and associated structures in the oral cavity in the literature. A simple working classification is proposed here for iatrogenic lesions of teeth and associated structures in the oral cavity based on its relation with dental specialities. The dental specialities considered in this classification are conservative dentistry and endodontics, orthodontics, oral and maxillofacial surgery and prosthodontics. This classification will be useful for the dental clinician who is dealing with diseases of oral cavity.

Designing Tracking Software for Image-Guided Surgery Applications: IGSTK Experience

PubMed Central

Enquobahrie, Andinet; Gobbi, David; Turek, Matt; Cheng, Patrick; Yaniv, Ziv; Lindseth, Frank; Cleary, Kevin

2009-01-01

Objective Many image-guided surgery applications require tracking devices as part of their core functionality. The Image-Guided Surgery Toolkit (IGSTK) was designed and developed to interface tracking devices with software applications incorporating medical images. Methods IGSTK was designed as an open source C++ library that provides the basic components needed for fast prototyping and development of image-guided surgery applications. This library follows a component-based architecture with several components designed for specific sets of image-guided surgery functions. At the core of the toolkit is the tracker component that handles communication between a control computer and navigation device to gather pose measurements of surgical instruments present in the surgical scene. The representations of the tracked instruments are superimposed on anatomical images to provide visual feedback to the clinician during surgical procedures. Results The initial version of the IGSTK toolkit has been released in the public domain and several trackers are supported. The toolkit and related information are available at www.igstk.org. Conclusion With the increased popularity of minimally invasive procedures in health care, several tracking devices have been developed for medical applications. Designing and implementing high-quality and safe software to handle these different types of trackers in a common framework is a challenging task. It requires establishing key software design principles that emphasize abstraction, extensibility, reusability, fault-tolerance, and portability. IGSTK is an open source library that satisfies these needs for the image-guided surgery community. PMID:20037671

Usefulness of a Flexible Port for Natural Orifice Transluminal Endoscopic Surgery by the Transrectal and Transvaginal Routes

PubMed Central

Ohdaira, Takeshi; Ikeda, Keiichi; Tajiri, Hisao; Yasuda, Yoshikazu; Hashizume, Makoto

2010-01-01

We developed a flexible port for NOTES which allows the use of conventional forceps for laparoscope-assisted surgery without change. The port is not affected by the location of the through hole in the gastrointestinal tract or vagina which elicits a problem in conventional NOTES, and its length can be adjusted during surgery by cutting the port itself. The port is made of polymer resin with a low friction coefficient. Furthermore, the port walls have a square wave structure which contributes to (1) the prevention of devices, for example, endoscope, from getting stuck at the time of insertion and retrieval, (2) the prevention of port slippage in the surgical opening for port insertion, (3) the prevention of unexpected port removal, (4) the prevention of port bore deformation, and (5) the improvement of port flexibility in the longitudinal direction. We validated the insertion and retrieval capacities of commercially available forceps for laparoscope-assisted surgery and power devices. Furthermore, we used the flexible port to conduct cholecystectomy and partial gastrectomy. We could confirm that the selection of the flexible port diameter according to the device type allowed the smooth insertion and retrieval of the device and that the port produced no air leakage. We affirmed that it is possible to conduct surgery by the cross or parallel method similarly to single port surgery. We considered that the flexible port has a potential of becoming a revolutionary port in NOTES. PMID:20508827

A new palatal distractor device for bodily movement of maxillary bones by rigid self-locking miniplates and screws system.

PubMed

Cortese, Antonio; Savastano, Mauro; Cantone, Antonio; Claudio, Pier Paolo

2013-07-01

A new palatal distractor device for bodily movement of the maxillary bones after complete segmented Le Fort I osteotomy for 1-stage transversal distraction and tridimensional repositioning on 1 patient is presented. The new distractor has an intrinsic tridimensional rigidity also in the fixation system by self-locking miniplates and screws for better control of the 2 maxillary fragments during distraction. Le Fort I distraction and repositioning procedure in association with a bilateral sagittal split osteotomy were performed on 1 patient with complete solution of the cross-bite and class III malocclusion. Results of dental and cephalometric analysis performed before surgery (T1), after surgery and distraction time (T2), and 18 months after surgery and orthodontic appliance removal (T3) are reported. No complications were encountered using the new distractor device. Advantages of this device and technique are presented including improved rigidity of both distraction (jackscrew) and fixation (4 self-locking miniplates and screws) systems resulting in complete control of the position of the 2 maxillary fragments during distraction and surgery. In addition, this new device allows resuming palatal distraction in the event of cross-bite relapse without causing dental-related problems or the risks of screw slackening.

Malfunctions of robotic system in surgery: role and responsibility of surgeon in legal point of view.

PubMed

Ferrarese, Alessia; Pozzi, Giada; Borghi, Felice; Marano, Alessandra; Delbon, Paola; Amato, Bruno; Santangelo, Michele; Buccelli, Claudio; Niola, Massimo; Martino, Valter; Capasso, Emanuele

2016-01-01

Robotic surgery (RS) technology has undergone rapid growth in the surgical field since its approval. In clinical practice, failure of robotic procedures mainly results from a surgeon's inability or to a device malfunction. We reviewed the literature to estimate the impact of this second circumstance in RS and its consequent legal implications. According to data from the literature, device malfunction is rare. We believe it is necessary to complement surgical training with a technical understanding of RS devices.

Delirium, Frailty, and Fast-Track Surgery in Oncogeriatrics: Is There a Link?

PubMed Central

Monacelli, Fiammetta; Signori, Alessio; Prefumo, Matteo; Giannotti, Chiara; Nencioni, Alessio; Romairone, Emanuele; Scabini, Stefano; Odetti, Patrizio

2018-01-01

Background/Aims Postoperative delirium (POD) is more frequent in elderly patients undergoing major cancer surgery. The interplay between individual clinical vulnerability and a series of perioperative factors seems to play a relevant role. Surgery is the first-line treatment option for cancer, and fast-track surgery (FTS) has been documented to decrease postoperative complications. The study sought to assess, after comprehensive geriatric assessment (CGA) and frailty stratification (Rockwood 40 items index), which perioperative parameters were predictive of POD development in elderly patients undergoing FTS for colorectal cancer. Methods A total of 107 consecutive subjects admitted for elective colorectal FTS were enrolled. All patients underwent CGA, frailly stratification, Timed up & go (TUG) test, 4AT test for delirium screening, anesthesiologists physical status classification, and Dindo-Clavien classification. Results The incidence of POD was 12.3%. Patients’ prevalent clinical phenotype was pre-frail. The multivariate analysis indicated physical performance (TUG in seconds) as the most significant predictor of POD for each second of increase. Conclusions Only few procedure-specific studies have examined the impact of FTS for colorectal cancer on POD. This is the first study to investigate the risk factors for POD, in a vulnerable octogenarian oncogeriatric population submitted to FTS surgery and frailty stratification. PMID:29515621

Cost Analysis of Adult Male Circumcision with the PrePex Device versus Surgery in Rwanda.

PubMed

Mutabazi, Vincent; Bitega, Jean Paul; Muyenzi Ngeruka, Leon; Nyemazi, Jean Pierre; Dain, Mary; Kaplan, Steven A; Karema, Corine; Binagwaho, Agnes

2014-01-01

In this study from Rwanda, voluntary adult male circumcision costs 33% less with trained nurses using the PrePex device compared with physician-nurse teams performing dorsal-slit surgery. These cost savings and the documented safety, speed, and efficacy of the PrePex procedure, serve Rwanda's HIV prevention program.

Weight-elimination neural networks applied to coronary surgery mortality prediction.

PubMed

Ennett, Colleen M; Frize, Monique

2003-06-01

The objective was to assess the effectiveness of the weight-elimination cost function in improving classification performance of artificial neural networks (ANNs) and to observe how changing the a priori distribution of the training set affects network performance. Backpropagation feedforward ANNs with and without weight-elimination estimated mortality for coronary artery surgery patients. The ANNs were trained and tested on cases with 32 input variables describing the patient's medical history; the output variable was in-hospital mortality (mortality rates: training 3.7%, test 3.8%). Artificial training sets with mortality rates of 20%, 50%, and 80% were created to observe the impact of training with a higher-than-normal prevalence. When the results were averaged, weight-elimination networks achieved higher sensitivity rates than those without weight-elimination. Networks trained on higher-than-normal prevalence achieved higher sensitivity rates at the cost of lower specificity and correct classification. The weight-elimination cost function can improve the classification performance when the network is trained with a higher-than-normal prevalence. A network trained with a moderately high artificial mortality rate (artificial mortality rate of 20%) can improve the sensitivity of the model without significantly affecting other aspects of the model's performance. The ANN mortality model achieved comparable performance as additive and statistical models for coronary surgery mortality estimation in the literature.

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual blood cell counting device. 864.6160...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual blood cell counting device. 864.6160...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual blood cell counting device. 864.6160...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual blood cell counting device. 864.6160...

21 CFR 864.6160 - Manual blood cell counting device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual blood cell counting device. 864.6160... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general...

Classifier dependent feature preprocessing methods

NASA Astrophysics Data System (ADS)

Rodriguez, Benjamin M., II; Peterson, Gilbert L.

2008-04-01

In mobile applications, computational complexity is an issue that limits sophisticated algorithms from being implemented on these devices. This paper provides an initial solution to applying pattern recognition systems on mobile devices by combining existing preprocessing algorithms for recognition. In pattern recognition systems, it is essential to properly apply feature preprocessing tools prior to training classification models in an attempt to reduce computational complexity and improve the overall classification accuracy. The feature preprocessing tools extended for the mobile environment are feature ranking, feature extraction, data preparation and outlier removal. Most desktop systems today are capable of processing a majority of the available classification algorithms without concern of processing while the same is not true on mobile platforms. As an application of pattern recognition for mobile devices, the recognition system targets the problem of steganalysis, determining if an image contains hidden information. The measure of performance shows that feature preprocessing increases the overall steganalysis classification accuracy by an average of 22%. The methods in this paper are tested on a workstation and a Nokia 6620 (Symbian operating system) camera phone with similar results.

The M6-C Cervical Disk Prosthesis: First Clinical Experience in 33 Patients.

PubMed

Thomas, Sam; Willems, Karel; Van den Daelen, Luc; Linden, Patrick; Ciocci, Maria-Cristina; Bocher, Philippe

2016-05-01

Retrospective study. To determine the short-term clinical succesrate of the M6-C cervical disk prosthesis in primary and secondary surgery. Cervical disk arthroplasty (CDA) provides an alternative to anterior cervical decompression and fusion for the treatment of spondylotic radiculopathy or myelopathy. The prevention of adjacent segment disease (ASD), a possible complication of anterior cervical decompression and fusion, is its most cited--although unproven--benefit. Unlike older arthroplasty devices that rely on a ball-and-socket-type design, the M6-C cervical disk prosthesis represents a new generation of unconstrained implants, developed to achieve better restoration of natural segmental biomechanics. This device should therefore optimize clinical performance of CDA and reduce ASD. All patients had preoperative computed tomography or magnetic resonance imaging and postoperative x-rays. Clinical outcome was assessed using the Neck Disability Index, a Visual Analog Scale, and the SF-36 questionnaire. Patients were asked about overall satisfaction and whether they would have the surgery again. Thirty-three patients were evaluated 17.1 months after surgery, on average. Nine patients had a history of cervical interventions. Results for Neck Disability Index, Visual Analog Scale, and SF-36 were significantly better among patients who had undergone primary surgery. In this group, 87.5% of patients reported a good or excellent result and 91.7% would have the procedure again. In contrast, all 4 device-related complications occurred in the small group of patients who had secondary surgery. The M6-C prosthesis appears to be a valuable addition to the CDA armatorium. It generates very good results in patients undergoing primary surgery, although its use in secondary surgery should be avoided. Longer follow-up is needed to determine to what measure this device can prevent ASD.

21 CFR 862.3350 - Diphenylhydantoin test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test... monitoring levels of diphenylhydantoin to ensure appropriate therapy. (b) Classification. Class II. ...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

21 CFR 878.4930 - Suture retention device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Suture retention device. 878.4930 Section 878.4930 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4930 Suture retention device...

Cold atmospheric pressure plasma for treatment of chronic wounds: drug or medical device?

PubMed

Kramer, A; Conway, B R; Meissner, K; Scholz, F; Rauch, B H; Moroder, A; Ehlers, A; Meixner, A J; Heidecke, C-D; Partecke, L I; Kietzmann, M; Assadian, O

2017-08-02

The use of cold atmospheric pressure plasma (CAPP) as a new therapeutic option to aid the healing of chronic wounds appears promising. Currently, uncertainty exists regarding their classification as medical device or medical drug. Because the classification of CAPP has medical, legal, and economic consequences as well as implications for the level of preclinical and clinical testing, the correct classification is not an academic exercise, but an ethical need. A multidisciplinary team of physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP. It was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature. Depending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application.

Glaucoma Drainage Device Erosion Following Ptosis Surgery.

PubMed

Bae, Steven S; Campbell, Robert J

2017-09-01

To highlight the potential risk of glaucoma drainage device erosion following ptosis surgery. Case report. A 71-year-old man underwent uncomplicated superotemporal Ahmed glaucoma valve implantation in the left eye in 2008. Approximately 8 years later, the patient underwent bilateral ptosis repair, which successfully raised the upper eyelid position. Three months postoperatively, the patient's glaucoma drainage implant tube eroded through the corneal graft tissue and overlying conjunctiva to become exposed. A graft revision surgery was successfully performed with no further complications. Caution and conservative lid elevation may be warranted when performing ptosis repair in patients with a glaucoma drainage implant, and patients with a glaucoma implant undergoing ptosis surgery should be followed closely for signs of tube erosion.

Mastectomy or breast conserving surgery? Factors affecting type of surgical treatment for breast cancer--a classification tree approach.

PubMed

Martin, Michael A; Meyricke, Ramona; O'Neill, Terry; Roberts, Steven

2006-04-20

A critical choice facing breast cancer patients is which surgical treatment--mastectomy or breast conserving surgery (BCS)--is most appropriate. Several studies have investigated factors that impact the type of surgery chosen, identifying features such as place of residence, age at diagnosis, tumor size, socio-economic and racial/ethnic elements as relevant. Such assessment of "propensity" is important in understanding issues such as a reported under-utilisation of BCS among women for whom such treatment was not contraindicated. Using Western Australian (WA) data, we further examine the factors associated with the type of surgical treatment for breast cancer using a classification tree approach. This approach deals naturally with complicated interactions between factors, and so allows flexible and interpretable models for treatment choice to be built that add to the current understanding of this complex decision process. Data was extracted from the WA Cancer Registry on women diagnosed with breast cancer in WA from 1990 to 2000. Subjects' treatment preferences were predicted from covariates using both classification trees and logistic regression. Tumor size was the primary determinant of patient choice, subjects with tumors smaller than 20 mm in diameter preferring BCS. For subjects with tumors greater than 20 mm in diameter factors such as patient age, nodal status, and tumor histology become relevant as predictors of patient choice. Classification trees perform as well as logistic regression for predicting patient choice, but are much easier to interpret for clinical use. The selected tree can inform clinicians' advice to patients.

Transoral oropharyngeal resection classification: Proposal of the SCORL working group.

PubMed

Virós Porcuna, David; Avilés Jurado, Francisco; Pollán Guisasola, Carlos; Ramírez Ruiz, Rosa Delia; García Lorenzo, Jacinto; Tobed Secall, Marc; Vilaseca González, Isabel; Costa González, José Miguel; Soteras Olle, Josep; Casamitjana Claramunt, Francesc; Sumarroca Trouboul, Anna; Hijano Esqué, Rafael; Viscasillas Pallàs, Guillem; Mañós Pujol, Manel; Quer Agustí, Miquel

There has been a very significant increase in the use of minimally invasive surgery has in the last decade. In order to provide a common language after transoral surgery of the oropharynx, a system for classifying resections has been created in this area, regardless of the instrumentation used. From the Oncology Working Group of the Catalan Society of Otorhinolaryngology, a proposal for classification based on a topographical division of the different areas of the oropharynx is presented, as also based on the invasion of the related structures according to the anatomical routes of extension of these tumours. The classification starts using the letter D or I according to laterality either right (D) or left (I). The number of the resected area is then placed. This numbering defines the zones beginning at the cranial level where area I would be the soft palate, lateral area II in the tonsillar area, area III in the tongue base, area IV in the glossoepiglottic folds, epiglottis and pharyngoepiglottic folds, area V posterior oropharyngeal wall and VI the retromolar trigone. The suffix p is added if the resection deeply affects the submucosal plane of the compromised area. The different proposed areas would, in theory, have different functional implications. Proposal for a system of classification by area to definedifferent types of transoral surgery of the oropharynx, and enable as sharing of results and helps in teaching this type of technique. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.

Computed tomography vs. digital radiography assessment for detection of osteolysis in asymptomatic patients with uncemented cups: a proposal for a new classification system based on computer tomography.

PubMed

Sandgren, Buster; Crafoord, Joakim; Garellick, Göran; Carlsson, Lars; Weidenhielm, Lars; Olivecrona, Henrik

2013-10-01

Digital radiographic images in the anterior-posterior and lateral view have been gold standard for evaluation of peri-acetabular osteolysis for patients with an uncemented hip replacement. We compared digital radiographic images and computer tomography in detection of peri-acetabular osteolysis and devised a classification system based on computer tomography. Digital radiographs were compared with computer tomography on 206 hips, with a mean follow up 10 years after surgery. The patients had no clinical signs of osteolysis and none were planned for revision surgery. On digital radiographs, 192 cases had no osteolysis and only 14 cases had osteolysis. When using computer tomography there were 184 cases showing small or large osteolysis and only 22 patients had no osteolysis. A classification system for peri-acetabular osteolysis is proposed based on computer tomography that is easy to use on standard follow up evaluation. Copyright © 2013 Elsevier Inc. All rights reserved.

Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

PubMed

2014-01-23

The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

... reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge... provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 866.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...

21 CFR 860.130 - General procedures under section 513(e) of the act.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE CLASSIFICATION PROCEDURES Reclassification § 860.130... reclassification proceedings under the act based upon new information. (b) A proceeding to reclassify a device... would provide reasonable assurance of the safety and effectiveness of the device and there is sufficient...

Piezoelectric osteotomy in hand surgery: first experiences with a new technique

PubMed Central

Hoigne, Dominik J; Stübinger, Stefan; Kaenel, Oliver Von; Shamdasani, Sonia; Hasenboehler, Paula

2006-01-01

Background In hand and spinal surgery nerve lesions are feared complications with the use of standard oscillating saws. Oral surgeons have started using a newly developed ultrasound bone scalpel when performing precise osteotomies. By using a frequency of 25–29 kHz only mineralized tissue is cut, sparing the soft tissue. This reduces the risk of nerve lesions. As there is a lack of experience with this technique in the field of orthopaedic bone surgery, we performed the first ultrasound osteotomy in hand surgery. Method While performing a correctional osteotomy of the 5th metacarpal bone we used the Piezosurgery® Device from Mectron [Italy] instead of the usual oscillating saw. We will report on our experience with one case, with a follow up time of one year. Results The cut was highly precise and there were no vibrations of the bone. The time needed for the operation was slightly longer than the time needed while using the usual saw. Bone healing was good and at no point were there any neurovascular disturbances. Conclusion The Piezosurgery® Device is useful for small long bone osteotomies. Using the fine tip enables curved cutting and provides an opportunity for new osteotomy techniques. As the device selectively cuts bone we feel that this device has great potential in the field of hand- and spinal surgery. PMID:16611362

Accuracy of the All Patient Refined Diagnosis Related Groups Classification System in Congenital Heart Surgery

PubMed Central

Parnell, Aimee S.; Shults, Justine; Gaynor, J. William; Leonard, Mary B.; Dai, Dingwei; Feudtner, Chris

2015-01-01

Background Administrative data is increasingly used to evaluate clinical outcomes and quality of care in pediatric congenital heart surgery (CHS) programs. Several published analyses of large pediatric administrative datasets have relied on the All Patient Refined Diagnosis Related Groups (APR-DRG, version 24) diagnostic classification system. The accuracy of this classification system for patients undergoing CHS is unclear. Methods We performed a retrospective cohort study of all 14,098 patients 0-5 years of age undergoing any of six selected congenital heart operations, ranging in complexity from isolated closure of a ventricular septal defect to single ventricle palliation, at 40 tertiary care pediatric centers in the Pediatric Health Information Systems database between 2007 and 2010. Assigned APR-DRGs (cardiac versus non-cardiac) were compared using chi-squared or Fisher's exact tests between those patients admitted during the first day of life versus later and between those receiving extracorporeal membrane oxygenation support versus not. Recursive partitioning was used to assess the greatest determinants of APR-DRG type in the model. Results Every patient admitted on day of life 1 was assigned to a non-cardiac APR-DRG (p < 0.001 for each procedure). Similarly, use of extracorporeal membrane oxygenation was highly associated with misclassification of congenital heart surgery patients into a non-cardiac APR-DRG (p < 0.001 for each procedure). Cases misclassified into a non-cardiac APR-DRG experienced a significantly increased mortality (p < 0.001). Conclusions In classifying patients undergoing congenital heart surgery, APR-DRG coding has systematic misclassifications, which may result in inaccurate reporting of CHS case volumes and mortality. PMID:24200398

Adaptive sleep-wake discrimination for wearable devices.

PubMed

Karlen, Walter; Floreano, Dario

2011-04-01

Sleep/wake classification systems that rely on physiological signals suffer from intersubject differences that make accurate classification with a single, subject-independent model difficult. To overcome the limitations of intersubject variability, we suggest a novel online adaptation technique that updates the sleep/wake classifier in real time. The objective of the present study was to evaluate the performance of a newly developed adaptive classification algorithm that was embedded on a wearable sleep/wake classification system called SleePic. The algorithm processed ECG and respiratory effort signals for the classification task and applied behavioral measurements (obtained from accelerometer and press-button data) for the automatic adaptation task. When trained as a subject-independent classifier algorithm, the SleePic device was only able to correctly classify 74.94 ± 6.76% of the human-rated sleep/wake data. By using the suggested automatic adaptation method, the mean classification accuracy could be significantly improved to 92.98 ± 3.19%. A subject-independent classifier based on activity data only showed a comparable accuracy of 90.44 ± 3.57%. We demonstrated that subject-independent models used for online sleep-wake classification can successfully be adapted to previously unseen subjects without the intervention of human experts or off-line calibration.

Comparative Analysis of RF Emission Based Fingerprinting Techniques for ZigBee Device Classification

DTIC Science & Technology

quantify the differences invarious RF fingerprinting techniques via comparative analysis of MDA/ML classification results. The findings herein demonstrate...correct classification rates followed by COR-DNA and then RF-DNA in most test cases and especially in low Eb/N0 ranges, where ZigBee is designed to operate.

Seizures and Teens: When Medicines Don't Work--Devices & Diet

ERIC Educational Resources Information Center

Dean, Patricia

2007-01-01

When medicines do not work, the search for seizure control should not stop. Special diets or medical devices may be recommended to help control seizures. While not a cure for epilepsy, they may be able to help, especially for those who are not candidates for surgery or when surgery does not work. This article provides an overview of the devices…

Global Health Estimate of Invasive Mycobacterium chimaera Infections Associated with Heater-Cooler Devices in Cardiac Surgery.

PubMed

Sommerstein, Rami; Hasse, Barbara; Marschall, Jonas; Sax, Hugo; Genoni, Michele; Schlegel, Matthias; Widmer, Andreas F

2018-03-01

Investigations of a worldwide epidemic of invasive Mycobacterium chimaera associated with heater-cooler devices in cardiac surgery have been hampered by low clinical awareness and challenging diagnoses. Using data from Switzerland, we estimated the burden of invasive M. chimaera to be 156-282 cases/year in 10 major cardiac valve replacement market countries.

Improvement of surgical margin with a coupled saline-radio-frequency device for multiple colorectal liver metastases.

PubMed

Ogata, Satoshi; Kianmanesh, Reza; Varma, Deepak; Belghiti, Jacques

2005-01-01

Complete resection of colorectal liver metastases (LM) has been the only curative treatment. However, when LM are multiple and bilobar, only a few patients are candidates for curative surgery. We report on a 53-year-old woman with synchronous multiple and bilobar LM from sigmoidal cancer who became resectable after a multimodal strategy including preoperative systemic chemotherapy and two-step surgery. The spectacular decrease in tumor size after systemic chemotherapy led us to perform two-step surgery, including right portal-vein ligation and left liver metastasectomies, with a coupled saline-radiofrequency device, in order to improve the surgical margin. An extended right hepatectomy was performed later to remove the remaining right liver lesions. The patient was discharged after 28 days without major complication and was recurrence-free 14 months later. We conclude that improving the surgical margin with a coupled saline-radiofrequency device is feasible and effective, avoiding small remnant liver even after multiple tumorectomies. The multimodal strategy, including preoperative chemotherapy, two-step surgery, and tumorectomies, using a coupled saline-radiofrequency device, could increase the number of patients with diffuse bilobar liver metastases who can benefit from liver resection.

Prevention, identification, and management of post-operative penile implant complications of infection, hematoma, and device malfunction

PubMed Central

O’Rourke, Timothy K.; Erbella, Alexander; Zhang, Yu

2017-01-01

Penile prosthesis implant surgery is an effective management approach for a number of urological conditions, including medication refractory erectile dysfunction (ED). Complications encountered post-operatively include infection, bleeding/hematoma, and device malfunction. Since the 1970s, modifications to these devices have reduced complication rates through improvement in antisepsis and design using antibiotic coatings, kink-resistant tubing, lock-out valves to prevent autoinflation, and modified reservoir shapes. Device survival and complication rates have been investigated predominately by retrospective database-derived studies. This review article focuses on the identification and management of post-operative complications following penile prosthetic and implant surgery. Etiology for ED, surgical technique, and prosthesis type are variable among studies. The most common post-operative complications of infection, bleeding, and device malfunction may be minimized by adherence to consistent technique and standard protocol. Novel antibiotic coatings and standard antibiotic regimen may reduce infection rates. Meticulous hemostasis and intraoperative testing of devices may further reduce need for revision surgery. Additional prospective studies with consistent reporting of outcomes and comparison of surgical approach and prosthesis type in patients with variable ED etiology would be beneficial. PMID:29238663

Chemical action: what is it, and why does it really matter?

NASA Astrophysics Data System (ADS)

Koolage, W. John; Hall, Ralph

2011-04-01

Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration's (FDA) classification structure for "drugs" and "devices." The last major modification to these terms was in 1976, with the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by "chemical action." We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies.

[Erectile function and ablative surgery of penile tumors].

PubMed

Pisani, E; Austoni, E; Trinchieri, A; Ceresoli, A; Mantovani, F; Colombo, F; Mastromarino, G; Vecchio, D; Canclini, L; Fenice, O

1994-02-01

The Authors try to show the possibility to combine radical excision with minimal invasiveness in the surgery of penile cancer. The focal point of every therapeutic decision is correct clinical staging. Unfortunately there's some confusion in the two international staging systems (TNM and Jackson's classification). In fact it's not clear the anatomical difference between epithelioma of the glans infiltrating corpus spongiosum and subcoronary epithelioma of the shaft infiltrating the corpora cavernosa. It's obvious that the infiltration of the corpora cavernosa is a far more aggressive oncological manifestation than that of tumour infiltrating the corpus spongiosum. So we consider Jackson's classification more congenial. In terms of surgery this anatomical independence makes it easy to consider the corpora cavernosa as a distinct entity, so they remain perfectly functional when separated from the glandulo-spongio-urethral unit with its vasculo-nervous bundle. This makes conservation of the erectile function, when clinical staging show us that the tumour is not infiltrating the corpora cavernosa. The Authors show their results, which seem to be rather good.

21 CFR 862.1505 - Mucopolysaccharides (nonquantitative) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry..., Scheie's Morquio's and Maroteaux-Lamy syndromes. (b) Classification. Class I (general controls). The...

Review of emerging surgical robotic technology.

PubMed

Peters, Brian S; Armijo, Priscila R; Krause, Crystal; Choudhury, Songita A; Oleynikov, Dmitry

2018-04-01

The use of laparoscopic and robotic procedures has increased in general surgery. Minimally invasive robotic surgery has made tremendous progress in a relatively short period of time, realizing improvements for both the patient and surgeon. This has led to an increase in the use and development of robotic devices and platforms for general surgery. The purpose of this review is to explore current and emerging surgical robotic technologies in a growing and dynamic environment of research and development. This review explores medical and surgical robotic endoscopic surgery and peripheral technologies currently available or in development. The devices discussed here are specific to general surgery, including laparoscopy, colonoscopy, esophagogastroduodenoscopy, and thoracoscopy. Benefits and limitations of each technology were identified and applicable future directions were described. A number of FDA-approved devices and platforms for robotic surgery were reviewed, including the da Vinci Surgical System, Sensei X Robotic Catheter System, FreeHand 1.2, invendoscopy E200 system, Flex® Robotic System, Senhance, ARES, the Single-Port Instrument Delivery Extended Research (SPIDER), and the NeoGuide Colonoscope. Additionally, platforms were reviewed which have not yet obtained FDA approval including MiroSurge, ViaCath System, SPORT™ Surgical System, SurgiBot, Versius Robotic System, Master and Slave Transluminal Endoscopic Robot, Verb Surgical, Miniature In Vivo Robot, and the Einstein Surgical Robot. The use and demand for robotic medical and surgical platforms is increasing and new technologies are continually being developed. New technologies are increasingly implemented to improve on the capabilities of previously established systems. Future studies are needed to further evaluate the strengths and weaknesses of each robotic surgical device and platform in the operating suite.

The use of piezosurgery as an alternative method of minimally invasive surgery in the authors’ experience

PubMed Central

Rahnama, Mansur; Czajkowski, Leszek; Grasza, Joanna; Wallner, Jan

2013-01-01

Piezosurgery is a relatively new technique of bone surgery that is recently gaining popularity in implantology, periodontics and oral surgery. The piezosurgery device produces specific ultrasound frequency modulation (22 000–35 000 Hz). The unit provides extreme precision and safety as well as micrometric cutting, thus allowing one to selectively section the mineralized bone structures. Moreover, the device causes less bleeding during and after the operation and the healing process is shorter. Due to the aforementioned advantages, an ultrasound device could be utilized in a wide range of surgical procedures, e.g. impacted tooth extraction, elevation of the Schneiderian membrane, bone splitting or expansion of the ridge, preparing bone bed and bone sampling, and corticotomy, not to menton cystectomy. PMID:24501602

21 CFR 872.4840 - Rotary scaler.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

21 CFR 872.4840 - Rotary scaler.

Code of Federal Regulations, 2012 CFR

2012-04-01

... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

21 CFR 872.4840 - Rotary scaler.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

21 CFR 872.4840 - Rotary scaler.

Code of Federal Regulations, 2013 CFR

2013-04-01

... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

21 CFR 872.4840 - Rotary scaler.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

21 CFR 868.1760 - Volume plethysmograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the patient's lung volume changes. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Volume plethysmograph. 868.1760 Section 868.1760...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1760 Volume plethysmograph. (a...

21 CFR 866.4100 - Complement reagent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and Reagents § 866.4100... a component part of serological test kits used in the diagnosis of disease. (b) Classification...

21 CFR 862.3150 - Barbiturate test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862... in monitoring levels of barbiturate to ensure appropriate therapy. (b) Classification. Class II. ...

21 CFR 862.3830 - Salicylate test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862... salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy. (b) Classification...

AANA Journal Course: update for nurse anesthetists. Arrhythmia management devices and electromagnetic interference.

PubMed

Mattingly, Emily

2005-04-01

The technological complexity of implantable arrhythmia management devices, specifically pacemakers and defibrillators, has increased dramatically since their introduction only a few decades ago. Patients with such devices are encountered much more frequently in hospitals and surgery centers, yet anesthesia provider knowledge of safe and proper management is often incomplete. Anesthesia textbooks and references may provide only short paragraphs on arrhythmia management devices that do not address important perioperative management strategies for this ever-growing patient population. It is no longer satisfactory to simply place a magnet over an implanted device during surgery and assume that this action protects the patient from harm due to electromagnetic interference from inappropriate device function. This AANA Journal course serves as a concise review of basic device function, the sources and effects of electromagnetic interference in the operative setting, and patient management recommendations from current literature.

21 CFR 886.4300 - Intraocular lens guide.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct... lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this...

21 CFR 880.6890 - General purpose disinfectants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. (b) Classification. Class I (general controls). The device is exempt...

21 CFR 862.1510 - Nitrite (nonquantitative) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... diagnosis and treatment of uninary tract infection of bacterial origin. (b) Classification. Class I (general...

21 CFR 862.1575 - Phospholipid test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... treatment of disorders involving lipid (fat) metabolism. (b) Classification. Class I (general controls). The...

21 CFR 862.1542 - Oxalate test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... treatment of urinary stones or certain other metabolic disorders. (b) Classification. Class I (general...

76 FR 44489 - Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-26

...; Hazards caused by electromagnetic interference and electrostatic discharge hazards; and Hearing loss. FDA... electromagnetic Electromagnetic compatibility. interference and electrostatic discharge hazards. Labeling. Hearing...

Post-thyroidectomy complications. The role of the device: bipolar vs ultrasonic device: Collection of data from 1,846 consecutive patients undergoing thyroidectomy.

PubMed

De Palma, Maurizio; Rosato, Ludovico; Zingone, Fabiana; Orlando, Giulio; Antonino, Antonio; Vitale, Mario; Puzziello, Alessandro

2016-07-01

Specific complications after thyroid surgery, such as recurrent laryngeal nerve injury (RLN) or hypoparathyroidism, are feared because they may give rise to a lifelong disability for the patient. The aim of this study was to evaluate the possible association between the types of device used (bipolar vs ultrasound-based harmonic scalpel defined Harmonic Focus) and major postoperative complications. During a 1-year period, between October 2010 and October 2011, Italian Endocrine Surgery Units affiliated with the Italian Endocrine Surgery Units Association collected data on all consecutive patients older than 18 years who had undergone primary total thyroidectomy, near total thyroidectomy, and completion thyroidectomy. The data were included in a dataset, listing demographic variables, details on the surgical procedure, and 2 major complications of the thyroid surgery: postoperative RLN palsy/hypomobility and hypocalcemia. Our population comprised 1,846 subjects (78.6% women, median age 52 years). Six hundred four (32.7%) subjects underwent thyroidectomy by bipolar forceps and 1,242 (67.3%) by ultrasonic device. The risk of hypocalcemia in subjects undergoing thyroidectomy by ultrasonic device was similar to those undergoing thyroidectomy by bipolar after adjusting for sex, type of thyroidectomy, and central lymphadenectomy (odds ratio .94, 95% confidence interval .76 to 1.17). Subjects who underwent thyroidectomy by ultrasonic device had a lower risk of RLN paralysis compared with those undergoing thyroidectomy by bipolar forceps also after adjusting for central lymphadenectomy (odds ratio .39, 95% confidence interval .2 to .7). This multicenter study acknowledges the value of the ultrasonic device as a protective factor only for RLN palsy, confirming nodal dissection as a risk factor for postoperative hypocalcemia and vocal folds disorders. Copyright © 2015 Elsevier Inc. All rights reserved.

Systematic Review of Retraction Devices for Laparoscopic Surgery.

PubMed

Vargas-Palacios, Armando; Hulme, Claire; Veale, Thomas; Downey, Candice L

2016-02-01

Retraction plays a vital role in optimizing the field of vision in minimal-access surgery. As such, a number of devices have been marketed to aid the surgeon in laparoscopic retraction. This systematic review explores the advantages and disadvantages of the different instruments in order to aid surgeons and their institutions in selecting the appropriate device. Primary outcome measures include operation time, length of stay, use of staff, patient morbidity, ease of use, conversion rates to open surgery, and cost. Systematic literature searches were performed in MEDLINE, EMBASE, The Cochrane Library, Current Controlled Trials, and ClinicalTrials.gov. The search strategy focused on studies testing a retraction device. The selection process was based on a predefined set of inclusion and exclusion criteria. Data were then extracted and analyzed. Out of 1360 papers initially retrieved, 12 articles were selected for data extraction and analysis. A total of 10 instruments or techniques were tested. Devices included the Nathanson's liver retractor, liver suspension tape, the V-List technique, a silicone disk with or without a snake retractor, the Endoloop, the Endograb, a magnetic retractor, the VaroLift, a laparoscope holder, and a retraction sponge. None of the instruments reported were associated with increased morbidity. No studies found increased rates of conversion to open surgery. All articles reported that the tested instruments might spare the use of an assistant during the procedure. It was not possible to determine the impact on length of stay or operation time. Each analyzed device facilitates retraction, providing a good field of view while allowing reduced staff numbers and minimal patient morbidity. Due to economic and environmental advantages, reusable devices may be preferable to disposable instruments, although the choice must be primarily based on clinical judgement. © The Author(s) 2015.

78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...

76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable...

77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... Administration (FDA) is classifying the endovascular suturing system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance..., or FDA issues an order finding the device to be substantially equivalent, in accordance with section...

Global Health Estimate of Invasive Mycobacterium chimaera Infections Associated with Heater–Cooler Devices in Cardiac Surgery

PubMed Central

Hasse, Barbara; Marschall, Jonas; Sax, Hugo; Genoni, Michele; Schlegel, Matthias; Widmer, Andreas F.

2018-01-01

Investigations of a worldwide epidemic of invasive Mycobacterium chimaera associated with heater–cooler devices in cardiac surgery have been hampered by low clinical awareness and challenging diagnoses. Using data from Switzerland, we estimated the burden of invasive M. chimaera to be 156–282 cases/year in 10 major cardiac valve replacement market countries. PMID:29460746

21 CFR 868.1690 - Nitrogen gas analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... gas chromatography or mass spectrometry. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a...

21 CFR 868.1690 - Nitrogen gas analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... gas chromatography or mass spectrometry. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2011 CFR

2011-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2010 CFR

2010-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2014 CFR

2014-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2012 CFR

2012-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

21 CFR 868.6175 - Cardiopulmonary emergency cart.

Code of Federal Regulations, 2013 CFR

2013-04-01

... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

Technology Readiness Assessment (TRA) Deskbook

DTIC Science & Technology

2009-07-01

Document CDER Center for Drug Evaluation and Research CDR Critical Design Review CDRH Center for Devices and Radiologic Health CFD computational fluid...gational Device Exemption (IDE) meeting is held with Center for Devices and Radiological Health ( CDRH ) for proposed Class III devices, and the IDE...is prepared and submitted to CDRH . For a 510(k), determine substantially equivalent devices and their classification, validate func- tioning model

No-go decision: A newly identified adverse event in orthopaedic surgery - causes and medico-legal implications.

PubMed

Coudane, H; Benfrech, E; Lecoq, C; Zabee, L; Tracol, P; Danan, J L; Bruno, P Y; Lighezzolo Alnot, J

2018-06-01

No-go designates a decision not to perform surgery when it becomes apparent that safety and/or feasibility requirements are not met. No-go decisions can occur at any time between patient admission to a hospital department and immediately before the first incision. The primary objective of this study was to assess the causes of no-go decisions reported as healthcare-associated adverse events (HAAEs). Most no-go decisions in orthopaedic surgery are related to problems with medical devices. A preliminary retrospective study assessed HAAEs reported over the 1-year period from 1st October 2014 to 30th September 2015, using the risk-management tool ALARM. A prospective survey was then performed by emailing a 15-item questionnaire to the 1828 members of Orthorisq (the French orthopaedic surgeon accreditation agency). Responses were either yes/no or open. Statistical comparisons were performed, using the paired Wilcoxon signed-rank test to estimate p values. Among reported HAAEs, 5.6% were no-go decisions. Of the 101 reported no-go decisions, 43.5% and 45.2% were due to problems with managing implantable medical devices in the retrospective and prospective assessments, respectively. In over 85% of cases, surgery was cancelled or postponed. Over half the no-go decisions were associated with unnecessary anaesthesia. Checklist completion was performed in only half the cases and was not associated with no-go decisions (p>0.8). This study provides descriptive data on no-go decisions in orthopaedic surgery. Healthcare professionals use many methods to enhance patient safety by preventing adverse events or diminishing their impact. Errors in managing implantable medical devices are the leading cause of no-go decisions. The current checklist is not appropriate for managing implantable medical devices in orthopaedic surgery, in part because it does not include checking devices upon receipt. Before surgery, patients should be informed of the risk of a no-go decision, since unnecessary anaesthesia occurs in over half the cases. IV, prospective study. Copyright © 2018. Published by Elsevier Masson SAS.

21 CFR 862.1550 - Urinary pH (nonquantitative) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... the monitoring of patients with certain diets. (b) Classification. Class I (general controls). The...

21 CFR 862.1625 - Prolactin (lactogen) test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... anterior pituitary gland or of the hypothalamus portion of the brain. (b) Classification. Class I (general...

21 CFR 862.1320 - Gastric acidity test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...-secreting tumor of the pancreas), and related gastric disorders. (b) Classification. Class I (general...

21 CFR 862.3640 - Morphine test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862... monitoring levels of morphine and its analogs to ensure appropriate therapy. (b) Classification. Class II. ...

21 CFR 864.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...

21 CFR 864.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...

21 CFR 864.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...

21 CFR 864.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...

21 CFR 864.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...

Plastic Surgery Management of Victims of Terrorist Violence in Ankara, Turkey.

PubMed

İğde, Murat; Kaplan, Ahmet

2017-12-01

Terror attacks have been progressively increasing worldwide through the present era. The management of the consequences of terrorism events is under debate in almost every scientific area. The organization and advancement of health services constitute important components of the crisis management. Similar to other specialty areas in medicine, the medical management of terrorist attacks is becoming important in terms of plastic and reconstructive surgery.Ankara, the capital of Turkey, has been subject to 2 terrorist events in public places within a year. The total number of patients involved in both cases was 434. Ankara Numune Training and Research Hospital is a tertiary health care institution and one of the most important trauma centers in the region. A total of 178 Patients exposed to these events referred to our hospital. Of the total, 34 patients were completely or partially treated in the plastic and reconstructive surgery clinic. In this study, we tried to discuss the difficulties encountered in the classification of patients and plastic surgery during the treatment period of patients who experienced these attacks.Data were obtained from The National News Agency, hospital, and our own clinic registries. Patient classification was based on the injured parts of the body. Statistical analysis was performed for all data. In conclusion, the role and the importance of plastic surgery department especially in trauma management have been emphasized in the light of our findings.

Comparative Cost Analysis of Surgical and PrePex Device Male Circumcision in Zimbabwe and Mozambique.

PubMed

Schutte, Carl; Tshimanga, M; Mugurungi, Owen; Come, Iotamo; Necochea, Edgar; Mahomed, Mehebub; Xaba, Sinokuthemba; Bossemeyer, Debora; Ferreira, Thais; Macaringue, Lucinda; Chatikobo, Pessanai; Gundididza, Patricia; Hatzold, Karin

2016-06-01

The PrePex device has proven to be safe for voluntary medical male circumcision (VMMC) in adults in several African countries. Costing studies were conducted as part of a PrePex/Surgery comparison study in Zimbabwe and a pilot implementation study in Mozambique. The studies calculated per male circumcision unit costs using a cost-analysis approach. Both direct costs (consumable and nonconsumable supplies, device, personnel, associated staff training) and selected indirect costs (capital and support personnel costs) were calculated. The cost comparison in Zimbabwe showed a unit cost per VMMC of $45.50 for PrePex and $53.08 for surgery. The unit cost difference was based on higher personnel and consumable supplies costs for the surgical procedure, which used disposable instrument kits. In Mozambique, the costing analysis estimated a higher unit cost for PrePex circumcision ($40.66) than for surgery ($20.85) because of higher consumable costs, particularly the PrePex device and lower consumable supplies costs for the surgical procedure using reusable instruments. Supplies and direct staff costs contributed 87.2% for PrePex and 65.8% for surgical unit costs in Mozambique. PrePex device male circumcision could potentially be cheaper than surgery in Zimbabwe, especially in settings that lack the infrastructure and personnel required for surgical VMMC, and this might result in programmatic cost savings. In Mozambique, the surgical procedure seems to be less costly compared with PrePex mainly because of higher consumable supplies costs. With reduced device unit costs, PrePex VMMC could become more cost-efficient and considered as complementary for Mozambique's VMMC scale-up program.

Comparison Study of Percutaneous Osseointegrated Bone Conduction Device Complications When Using the 9 mm Abutment Versus 6 mm Abutment at Initial Implantation.

PubMed

Wise, Sean R; LaRouere, Jacqueline S; Bojrab, Dennis I; LaRouere, Michael J

2018-04-01

To assess differences in the incidence, type, and management of complications encountered with implantation of percutaneous osseointegrated bone conduction devices when using a 9 mm abutment versus 6 mm abutment at initial implantation. Retrospective cohort study. One hundred thirty consecutive patients between January 2010 and December 2011 underwent single-stage percutaneous osseointegrated bone conduction device implantation using a 9 or 6 mm abutment. Clinical outcomes assessed for the two groups included the incidence, type, and management of postoperative complications. Abutment size, age, sex, indication for surgery, implant device type, duration of follow-up, and patient comorbidities were evaluated as potential factors affecting outcomes. Average duration of follow-up was 16 months (range 6-29 mo). Postoperative complications occurred in 38 (29.2%) patients. Twenty-four (18.4%) patients experienced minor complications requiring simple, local care; eight (6.1%) patients required in-office procedural intervention; and six (4.6%) patients required revision surgery in the operating room. Implant extrusion occurred in three (2.3%) patients. Eleven (8.5%) patients required placement of a longer abutment. Patients receiving the 6 mm abutment at initial surgery were significantly more likely to encounter a complication requiring in-office procedural intervention or revision surgery (p = 0.001). Minor complications after implantation of percutaneous osseointegrated bone conduction devices are common. The vast majority of these complications are due to localized skin reactions, most of which are readily addressed through local care. Patients receiving the 9 mm abutment during initial implantation are significantly less likely to require in-office procedural intervention or revision surgery postoperatively as compared with those receiving the shorter, 6 mm abutment.

76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov/MedicalDevices... ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' from CDRH you may...

American Society of Anesthesiologists classification in cataract surgery: Results from the Ophthalmic Surgery Outcomes Data Project.

PubMed

Payal, Abhishek R; Sola-Del Valle, David; Gonzalez-Gonzalez, Luis A; Cakiner-Egilmez, Tulay; Chomsky, Amy S; Vollman, David E; Baze, Elizabeth F; Lawrence, Mary; Daly, Mary K

2016-07-01

To explore the association of American Society of Anesthesiologists (ASA) classification with cataract surgery outcomes. Five Veterans Affairs Medical Centers, United States. Retrospective observational cohort study. The study analyzed the outcomes of cataract surgery cases. Corrected distance visual acuity (CDVA), unanticipated events, and vision-related quality of life (VRQL) were assessed using the National Eye Institute Visual Function Questionnaire (NEI-VFQ), comparing ASA classes I through IV. For some analyses, ASA classes I and II were designated as Group A and ASA classes III and IV were designated Group B. Of the 4923 cases, 875 (17.8%) were in Group A, 4032 (81.9%) were in Group B, and 16 (0.3%) had missing data. The mean CDVA and mean composite NEI-VFQ score improved after cataract surgery in both groups (P < .0001); however, Group A had a better mean postoperative CDVA and postoperative VFQ composite scores than Group B (P < .0001, both outcomes). A higher ASA class was associated with an increased risk for 2 unanticipated events; that is, clinically significant macular edema (CSME) (Group A: 4 [0.47%] versus Group B: 50 [1.28%]; adjusted odds ratio [OR], 3.02; 95% confidence interval [CI], 1.02-13.05; P = 0.04) and readmission to the hospital within 30 days (2 [0.23%] versus 56 [1.41%]; OR, 8.26; 95% CI, 1.71-148.62; P = .004) CONCLUSIONS: Among United States veterans, the ASA classification could be an important predictor of VRQL and visual outcomes. In this cohort, it was associated with an increased risk for 2 serious unanticipated events-CSME and readmission to the hospital-both costly, unwanted outcomes. Dr. Vollman is a consultant to Forsight Vision5. None of the authors has a financial or proprietary interest in any material or method mentioned. Copyright © 2016 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Prognostic value of somatosensory-evoked potentials in the surgical management of cervical spondylotic myelopathy.

PubMed

Hu, Yong; Ding, Yu; Ruan, Dike; Wong, Y W; Cheung, Kenneth M C; Luk, Keith D K

2008-05-01

Preoperative somatosensory-evoked potentials (SEPs) were retrospectively analyzed and classified, and compared with surgical outcome. To evaluate the value of the preoperative SEP waveform in predicting the clinical outcome after surgical management of cervical spondylotic myelopathy (CSM). SEPs have played an important role in spinal surgery. However, the value of SEPs in predicting the outcome of surgery for CSM remains controversial. This study enrolled 76 CSM patients who underwent surgical intervention. Median nerve SEPs were recorded before surgery. The Japanese Orthopedic Association (JOA) scoring system was used to evaluate the neurologic function before surgery and at postoperative follow-up at 1, 3, 6, 12, and 24 months. Patients were divided into 5 groups according to the classification of their preoperative SEP waveforms. Group I patients had normal SEPs, group IIa had normal latency and abnormal amplitude, group IIb had abnormal latency and normal amplitude, group III had abnormal latency and amplitude, and group IV had immeasurable waveforms. The myelopathic disability scores and surgical outcomes in different groups were compared by the Kruskal-Wallis test. The SEP classification was found to be significantly associated with the JOA score (Pearson's chi test, chi = 53.9, P < 0.05). There were no significant differences in JOA score recovery at different follow-up times within any SEP group. At 24 months after surgery, there was no significant difference in the recovery ratio between groups I and IIa, or between groups IIb and III (Kruskal-Wallis test, P > 0.05). However, the recovery ratio was significantly higher in groups I and IIa than in all the other groups (Kruskal-Wallis test, P < 0.05), and in groups IIb and III than in group IV (Kruskal-Wallis test, P < 0.05). SEP classification correlates well with CSM disability and postoperative recovery ratio. Median nerve SEP recordings would be a valuable and practical tool for the diagnosis and prognosis of myelopathy.

[Bile leakage after liver resection: A retrospective cohort study].

PubMed

Menclová, K; Bělina, F; Pudil, J; Langer, D; Ryska, M

2015-12-01

Many previous reports have focused on bile leakage after liver resection. Despite the improvements in surgical techniques and perioperative care the incidence of this complication rather keeps increasing. A number of predictive factors have been analyzed. There is still no consensus regarding their influence on the formation of bile leakage. The objective of our analysis was to evaluate the incidence of bile leakage, its impact on mortality and duration of hospitalization at our department. At the same time, we conducted an analysis of known predictive factors. The authors present a retrospective review of the set of 146 patients who underwent liver resection at the Department of Surgery of the 2nd Faculty of Medicine of the Charles University and Central Military Hospital Prague, performed between 20102013. We used the current ISGLS (International Study Group of Liver Surgery) classification to evaluate the bile leakage. The severity of this complication was determined according to the Clavien-Dindo classification system. Statistical significance of the predictive factors was determined using Fishers exact test and Students t-test. The incidence of bile leakage was 21%. According to ISGLS classification the A, B, and C rates were 6.5%, 61.2%, and 32.3%, respectively. The severity of bile leakage according to the Clavien-Dindo classification system - I-II, IIIa, IIIb, IV and V rates were 19.3%, 42%, 9.7%, 9.7%, and 19.3%, respectively. We determined the following predictive factors as statistically significant: surgery for malignancy (p<0.001), major hepatic resection (p=0.001), operative time (p<0.001), high intraoperative blood loss (p=0.02), construction of HJA (p=0.005), portal venous embolization/two-stage surgery (p=0.009) and ASA score (p=0.02). Bile leakage significantly prolonged hospitalization time (p<0.001). In the group of patients with bile leakage the perioperative mortality was 23 times higher (p<0.001) than in the group with no leakage. Bile leakage is one of the most serious complications of liver surgery. Most of the risk factors are not easily controllable and there is no clear consensus on their influence. Intraoperative leak tests could probably reduce the incidence of bile leakage. In the future, further studies will be required to improve the perioperative management and techniques to prevent such serious complications. Multidisciplinary approach is essential in the treatment.

Levels of Evidence in Cosmetic Surgery: Analysis and Recommendations Using a New CLEAR Classification

PubMed Central

2013-01-01

Background: The Level of Evidence rating was introduced in 2011 to grade the quality of publications. This system evaluates study design but does not assess several other quality indicators. This study introduces a new “Cosmetic Level of Evidence And Recommendation” (CLEAR) classification that includes additional methodological criteria and compares this new classification with the existing system. Methods: All rated publications in the Cosmetic Section of Plastic and Reconstructive Surgery, July 2011 through June 2013, were evaluated. The published Level of Evidence rating (1–5) and criteria relevant to study design and methodology for each study were tabulated. A new CLEAR rating was assigned to each article, including a recommendation grade (A–D). The published Level of Evidence rating (1–5) was compared with the recommendation grade determined using the CLEAR classification. Results: Among the 87 cosmetic articles, 48 studies (55%) were designated as level 4. Three articles were assigned a level 1, but they contained deficiencies sufficient to undermine the conclusions. The correlation between the published Level of Evidence classification (1–5) and CLEAR Grade (A–D) was weak (ρ = 0.11, not significant). Only 41 studies (48%) evaluated consecutive patients or consecutive patients meeting inclusion criteria. Conclusions: The CLEAR classification considers methodological factors in evaluating study reliability. A prospective study among consecutive patients meeting eligibility criteria, with a reported inclusion rate, the use of contemporaneous controls when indicated, and consideration of confounders is a realistic goal. Such measures are likely to improve study quality. PMID:25289261

21 CFR 886.4275 - Intraocular fluid.

Code of Federal Regulations, 2010 CFR

2010-04-01

... performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment. (b) Classification. Class...

21 CFR 886.4275 - Intraocular fluid.

Code of Federal Regulations, 2011 CFR

2011-04-01

... performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment. (b) Classification. Class...

Optical correction and quality of vision of the French soldiers stationed in the Republic of Djibouti in 2009.

PubMed

Vignal, Rodolphe; Ollivier, Lénaïck

2011-03-01

To ensure vision readiness on the battlefield, the French military has been providing its soldiers with eyewear since World War I. A military refractive surgery program was initiated in 2008. A prospective questionnaire-based investigation on optical correction and quality of vision among active duty members with visual deficiencies stationed in Djibouti, Africa, was conducted in 2009. It revealed that 59.3% of the soldiers were wearing spectacles, 21.2% were wearing contact lenses--despite official recommendations--and 8.5% had undergone refractive surgery. Satisfaction rates were high with refractive surgery and contact lenses; 33.6% of eyeglass wearers were planning to have surgery. Eye dryness and night vision disturbances were the most reported symptoms following surgery. Military optical devices were under-prescribed before deployment. This suggests that additional and more effective studies on the use of military optical devices should be performed and policy supporting refractive surgery in military populations should be strengthened.

Key factors associated with postoperative complications in patients undergoing colorectal surgery.

PubMed

Manilich, E; Vogel, J D; Kiran, R P; Church, J M; Seyidova-Khoshknabi, Dilara; Remzi, F H

2013-01-01

Surgical outcomes are determined by complex interactions among a variety of factors including patient characteristics, diagnosis, and type of procedure. The aim of this study was to prioritize the effect and relative importance of the surgeon (in terms of identity of a surgeon and surgeon volume), patient characteristics, and the intraoperative details on complications of colorectal surgery including readmission, reoperation, sepsis, anastomotic leak, small-bowel obstruction, surgical site infection, abscess, need for transfusion, and portal and deep vein thrombosis. This study uses a novel classification methodology to measure the influence of various risk factors on postoperative complications in a large outcomes database. Using prospectively collected information from the departmental outcomes database from 2010 to 2011, we examined the records of 3552 patients who underwent colorectal surgery. Instead of traditional statistical methods, we used a family of 7000 bootstrap classification models to examine and quantify the impact of various factors on the most common serious surgical complications. For each complication, an ensemble of multivariate classification models was designed to determine the relative importance of potential factors that may influence outcomes of surgery. This is a new technique for analyzing outcomes data that produces more accurate results and a more reliable ranking of study variables in order of their importance in producing complications. Patients who underwent colorectal surgery in 2010 and 2011 were included. This study was conducted at a tertiary referral department at a major medical center. Postoperative complications were the primary outcomes measured. Factors sorted themselves into 2 groups: a highly important group (operative time, BMI, age, identity of the surgeon, type of surgery) and a group of low importance (sex, comorbidity, laparoscopy, and emergency). ASA score and diagnosis were of intermediate importance. The outcomes most influenced by variations in the highly important factors included readmission, transfusion, surgical site infection, and abscesses. This study was limited by the use of data from a single tertiary referral department at a major medical center. Body mass index, operative time, and the surgeon who performed the operation are the 3 most important factors influencing readmission rates, rates of transfusions, and surgical site infection. Identification of these contributing factors can help minimize complications.

A Heads-Up Display for Diabetic Limb Salvage Surgery

PubMed Central

Rankin, Timothy M.; Giovinco, Nicholas A.; Mills, Joseph L.; Matsuoka, Yoky

2014-01-01

Although the use of augmented reality has been well described over the past several years, available devices suffer from high cost, an uncomfortable form factor, suboptimal battery life, and lack an app-based developer ecosystem. This article describes the potential use of a novel, consumer-based, wearable device to assist surgeons in real time during limb preservation surgery and clinical consultation. Using routine intraoperative, clinical, and educational case examples, we describe the use of a wearable augmented reality device (Google Glass; Google, Mountain View, CA). The device facilitated hands-free, rapid communication, documentation, and consultation. An eyeglass-mounted screen form factor has the potential to improve communication, safety, and efficiency of intraoperative and clinical care. We believe this represents a natural progression toward union of medical devices with consumer technology. PMID:24876445

21 CFR 880.5300 - Medical absorbent fiber.

Code of Federal Regulations, 2012 CFR

2012-04-01

...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 880.5300 - Medical absorbent fiber.

Code of Federal Regulations, 2013 CFR

2013-04-01

...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 880.5300 - Medical absorbent fiber.

Code of Federal Regulations, 2014 CFR

2014-04-01

...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 868.6250 - Portable air compressor.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices. (b) Classification. Class II (performance...

21 CFR 868.6250 - Portable air compressor.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices. (b) Classification. Class II (performance...

21 CFR 862.1815 - Vitamin E test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... treatment of infants with vitamin E deficiency syndrome. (b) Classification. Class I (general controls). The...

21 CFR 862.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...

77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... Mitigation measures Excessive laser power Electrical safety and electromagnetic compatibility (EMC... should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics; (4...

21 CFR 862.3850 - Sulfonamide test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862... monitoring sulfonamide levels to ensure appropriate therapy. (b) Classification. Class I. [52 FR 16122, May 1...

21 CFR 884.1185 - Endometrial washer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... with negative pressure. This device is used to study endometrial cytology (cells). (b) Classification. Class II. The special controls for this device are: (1) FDA's: (i) “Use of International Organization...

21 CFR 862.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...

21 CFR 862.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...

21 CFR 862.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...

21 CFR 862.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...

21 CFR 862.2730 - Osmometer for clinical use.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...

21 CFR 862.2730 - Osmometer for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...

21 CFR 862.2730 - Osmometer for clinical use.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...

21 CFR 862.2730 - Osmometer for clinical use.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...

21 CFR 892.1400 - Nuclear sealed calibration source.

Code of Federal Regulations, 2012 CFR

2012-04-01

... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...

21 CFR 892.1400 - Nuclear sealed calibration source.

Code of Federal Regulations, 2011 CFR

2011-04-01

... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...

21 CFR 892.1400 - Nuclear sealed calibration source.

Code of Federal Regulations, 2014 CFR

2014-04-01

... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...

21 CFR 892.1400 - Nuclear sealed calibration source.

Code of Federal Regulations, 2010 CFR

2010-04-01

... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...

21 CFR 892.1400 - Nuclear sealed calibration source.

Code of Federal Regulations, 2013 CFR

2013-04-01

... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...

Use of an ultrasonic osteotome device in spine surgery: experience from the first 128 patients.

PubMed

Hu, Xiaobang; Ohnmeiss, Donna D; Lieberman, Isador H

2013-12-01

The ultrasonic BoneScalpel is a tissue-specific device that allows the surgeon to make precise osteotomies while protecting collateral or adjacent soft tissue structures. The device is comprised of a blunt ultrasonic blade that oscillates at over 22,500 cycles/s with an imperceptible microscopic amplitude. The recurring impacts pulverize the noncompliant crystalline structure resulting in a precise cut. The more compliant adjacent soft tissue is not affected by the ultrasonic oscillation. The purpose of this study is to report the experience and safety of using this ultrasonic osteotome device in a variety of spine surgeries. Data were retrospectively collected from medical charts and surgical reports for each surgery in which the ultrasonic scalpel was used to perform any type of osteotomy (facetectomy, laminotomy, laminectomy, en bloc resection, Smith Petersen osteotomy, pedicle subtraction osteotomy, etc.). The majority of patients had spinal stenosis, degenerative or adolescent scoliosis, pseudoarthrosis, adjacent segment degeneration, and spondylolisthesis et al. Intra-operative complications were also recorded. A total of 128 consecutive patients (73 female, 55 male) beginning with our first case experience were included in this study. The mean age of the patients was 58 years (range 12-85 years). Eighty patients (62.5 %) had previous spine surgery and/or spinal deformity. The ultrasonic scalpel was used at all levels of the spine and the average levels operated on each patient were 5. The mean operation time (skin to skin) was 4.3 h and the mean blood loss was 425.4 ml. In all cases, the ultrasonic scalpel was used to create the needed osteotomies to facilitate the surgical procedure without any percussion on the spinal column or injury to the underlying nerves. There was a noticeable absence of bleeding from the cut end of the bone consistent with the ultrasonic application. There were 11 instances of dural injuries (8.6 %) and two of which were directly associated with the use of ultrasonic device. In no procedure was the use of the ultrasonic scalpel abandoned for use of another instrument due to difficulty in using the device or failure to achieve the desired osteotomy. Overall, the ultrasonic scalpel was safe and performed as desired when used as a bone cutting device to facilitate osteotomies in a variety of spine surgeries. However, caution should be taken to avoid potential thermal injury and dural tear. If used properly, this device may decrease the risk of soft tissue injury associated with the use of high speed burrs and oscillating saws during spine surgery.

21 CFR 886.3340 - Extraocular orbital implant.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3340 Extraocular orbital implant. (a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment...

Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial.

PubMed

Song, Taejong; Cho, Juhee; Kim, Tae-Joong; Kim, Im-Ryung; Hahm, Tae Soo; Kim, Byoung-Gie; Bae, Duk-Soo

2013-01-01

To compare cosmetic satisfaction with laparoendoscopic single-site surgery (LESS) compared with multi-port surgery. Randomized controlled trial (Canadian Task Force classification I). University hospital. Twenty women who underwent laparoscopically-assisted vaginal hysterectomy (LAVH) via LESS or multi-port surgery. Laparoendoscopic single-site surgery or multi-port surgery. Cosmetic satisfaction was assessed using the Body Image Questionnaire at baseline and at 1, 4, and 24 weeks after surgery. Of the 20 LESS procedures, 1 was converted to multi-port surgery because of severe adhesions, and 1 woman assigned to undergo multi-port surgery was lost to follow-up. The 2 surgery groups did not differ in clinical demographic data and surgical results or postoperative pain scores at 12, 24, and 36 hours. Compared with the multi-port group, the LESS group reported significantly higher cosmetic satisfaction at 1, 4, and 24 weeks after surgery (p < .01). Compared with multi-port surgery, LESS is not only a feasible approach with comparable operative outcomes but also has an advantage insofar as cosmetic outcome. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

Update on Minimally Invasive Glaucoma Surgery (MIGS) and New Implants

PubMed Central

Brandão, Lívia M.; Grieshaber, Matthias C.

2013-01-01

Traditional glaucoma surgery has been challenged by the advent of innovative techniques and new implants in the past few years. There is an increasing demand for safer glaucoma surgery offering patients a timely surgical solution in reducing intraocular pressure (IOP) and improving their quality of life. The new procedures and devices aim to lower IOP with a higher safety profile than fistulating surgery (trabeculectomy/drainage tubes) and are collectively termed “minimally invasive glaucoma surgery (MIGS).” The main advantage of MIGS is that they are nonpenetrating and/or bleb-independent procedures, thus avoiding the major complications of fistulating surgery related to blebs and hypotony. In this review, the clinical results of the latest techniques and devices are presented by their approach, ab interno (trabeculotomy, excimer laser trabeculotomy, trabecular microbypass, suprachoroidal shunt, and intracanalicular scaffold) and ab externo (canaloplasty, Stegmann Canal Expander, suprachoroidal Gold microshunt). The drawback of MIGS is that some of these procedures produce a limited IOP reduction compared to trabeculectomy. Currently, MIGS is performed in glaucoma patients with early to moderate disease and preferably in combination with cataract surgery. PMID:24369494

21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Electrosurgical cutting and coagulation device and accessories. 878.4400 Section 878.4400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878...

21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Electrosurgical cutting and coagulation device and accessories. 878.4400 Section 878.4400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878...

21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Electrosurgical cutting and coagulation device and accessories. 878.4400 Section 878.4400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878...

21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Electrosurgical cutting and coagulation device and accessories. 878.4400 Section 878.4400 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878...

Neuroprotective effect of subretinal implants in the RCS rat.

PubMed

Pardue, Machelle T; Phillips, Michael J; Yin, Hang; Sippy, Brian D; Webb-Wood, Sarah; Chow, Alan Y; Ball, Sherry L

2005-02-01

Retinal prosthetics have been designed to interface with the neural retina by electrically stimulating the remaining retinal circuits after photoreceptor degeneration. However, the electrical stimulation provided by the subretinal implant may also stimulate neurotrophic factors that provide neuroprotection to the retina. This study was undertaken to determine whether electrical stimulation from a subretinal photodiode-based implant has a neuroprotective effect on photoreceptors in the RCS rat, a model of photoreceptor degeneration. Eyes of RCS rats were implanted with an active or inactive device or underwent sham surgery before photoreceptor degeneration. Outer retinal function was assessed with electroretinogram (ERG) recordings weekly until 8 weeks after surgery, at which time retinal tissue was collected and processed for morphologic assessment, including photoreceptor cell counts and retinal layer thickness. At 4 to 6 weeks after surgery, the ERG responses in the active-implant eyes were 30% to 70% greater in b-wave amplitude than the responses from eyes implanted with inactive devices, those undergoing sham surgery, or the nonsurgical control eyes. At 8 weeks after surgery the ERG responses from active-implant eyes were not significantly different from the control groups. However, the number of photoreceptors in eyes implanted with the active or inactive device was significantly greater in the regions over and around the implant versus sham-surgical and nonsurgical control eyes. These results suggest that subretinal electrical stimulation provides temporary preservation of retinal function in the RCS rat. In addition, implantation of an active or inactive device into the subretinal space causes morphologic preservation of photoreceptors in the RCS rat until 8 weeks after surgery. Further studies are needed to determine whether the correlation of neuropreservation with subretinal implantation is due to electrical stimulation and/or a mechanical presence of the implant in the subretinal space.

A Mechanomodulatory Device to Minimize Incisional Scar Formation

PubMed Central

Wong, Victor W.; Beasley, Bill; Zepeda, John; Dauskardt, Reinhold H.; Yock, Paul G.; Longaker, Michael T.; Gurtner, Geoffrey C.

2013-01-01

Objective To mechanically control the wound environment and prevent cutaneous scar formation. Approach We subjected various material substrates to biomechanical testing to investigate their ability to modulate skin behavior. Combinations of elastomeric materials, adhesives, and strain applicators were evaluated to develop topical stress-shielding devices. Noninvasive imaging modalities were utilized to characterize anatomic site-specific differences in skin biomechanical properties in humans. The devices were tested in a validated large animal model of hypertrophic scarring. Phase I within-patient controlled clinical trials were conducted to confirm their safety and efficacy in scar reduction in patients undergoing abdominoplasty surgery. Results Among the tested materials and device applicators, a polymer device was developed that effectively off-loaded high tension wounds and blocked pro-fibrotic pathways and excess scar formation in red Duroc swine. In humans, different anatomic sites exhibit unique biomechanical properties that may correlate with the propensity to form scars. In the clinical trial, utilization of this device significantly reduced incisional scar formation and improved scar appearance for up to 12 months compared with control incisions that underwent routine postoperative care. Innovation This is the first device that is able to precisely control the mechanical environment of incisional wounds and has been demonstrated in multiple clinical trials to significantly reduce scar formation after surgery. Conclusion Mechanomodulatory strategies to control the incisional wound environment can significantly reduce pathologic scarring and fibrosis after surgery. PMID:24527342

78 FR 9349 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... MR incompatibility or the conditions for safe use in an MR environment. Labeling will mitigate the... Amendments of 1976 (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and the Food and...) and nonclinical testing evaluating the compatibility of the device in a MR environment. In addition...

New York State Thruway Authority automatic vehicle classification (AVC) : research report.

DOT National Transportation Integrated Search

2008-03-31

In December 2007, the N.Y.S. Thruway Authority (Thruway) concluded a Federal : funded research effort to study technology and develop a design for retrofitting : devices required in implementing a fully automated vehicle classification system i...

Improvement of an algorithm for recognition of liveness using perspiration in fingerprint devices

NASA Astrophysics Data System (ADS)

Parthasaradhi, Sujan T.; Derakhshani, Reza; Hornak, Lawrence A.; Schuckers, Stephanie C.

2004-08-01

Previous work in our laboratory and others have demonstrated that spoof fingers made of a variety of materials including silicon, Play-Doh, clay, and gelatin (gummy finger) can be scanned and verified when compared to a live enrolled finger. Liveness, i.e. to determine whether the introduced biometric is coming from a live source, has been suggested as a means to circumvent attacks using spoof fingers. We developed a new liveness method based on perspiration changes in the fingerprint image. Recent results showed approximately 90% classification rate using different classification methods for various technologies including optical, electro-optical, and capacitive DC, a shorter time window and a diverse dataset. This paper focuses on improvement of the live classification rate by using a weight decay method during the training phase in order to improve the generalization and reduce the variance of the neural network based classifier. The dataset included fingerprint images from 33 live subjects, 33 spoofs created with dental impression material and Play-Doh, and fourteen cadaver fingers. 100% live classification was achieved with 81.8 to 100% spoof classification, depending on the device technology. The weight-decay method improves upon past reports by increasing the live and spoof classification rate.

Novel Positional Devices for the Treatment of Positional Obstructive Sleep Apnea, and How This Relates to Sleep Surgery.

PubMed

Ravesloot, Madeline J L; Benoist, Linda; van Maanen, Peter; de Vries, Nico

2017-01-01

If untreated, obstructive sleep apnea (OSA) develops as a gradual progressive disease. In the early stage of the disease most patients with OSA are positional. The archetypical patient might progress from simple positional snoring via positional early-stage mild disease to less positional moderate and finally nonpositional severe OSA. At first, the apnea-hypopnea index (AHI) is high only in the supine position, and later is high in all sleeping positions. The phenomenon is reversible. After partial effective treatment, patients with severe OSA can reverse to less severe positional OSA or, in other words, the AHI drops more in the lateral position than in supine position. This has been shown for palatal surgery, multilevel surgery, bimaxillary osteotomies, and bariatric surgery. The absence or presence of positional dependency has a great influence on sleep surgery. First, the results of sleep surgery might be worse in positional patients. Second, the addition of positional therapy to sleep surgery might improve the overall outcome and, as such, enhance the indication of sleep surgery as an alternative to continuous positive airway pressure and mandibular advancement device treatment. © 2017 S. Karger AG, Basel.

Re-Evaluation of Open Partial Horizontal Laryngectomies at Our Institution According to the New Classification Recommended by the European Laryngological Society.

PubMed

Bozkurt, Gülpembe; Ünsal, Özlem; Coşkun, Berna Uslu

2016-06-01

The aim of this study was to re-evaluate the open partial horizontal laryngectomies (OPHLs) performed at our institution in terms of the new classification of the European Laryngological Society and compare the differences with the new classification system. A retrospective analysis of 45 patients diagnosed with T1b, T2, and T3 laryngeal carcinoma who were treated with OPHLs in our department between 2010 and 2016 were conducted. All supraglottic laryngectomies (31 operations) were classified as OPHL Type 1. Among these, 11 operations required a resection of an additional structure including arytenoid (ARY) in five operations, piriform sinus (PIR) in four operations, the base of tongue (BOT) in one surgery, and ARY + PIR in one patient. Five supracricoid laryngectomies with cricohyoidoepiglottopexy (CHEP), five supracricoid laryngectomies with cricohyoidopexy (CHP), and four near-total laryngectomy operations constituted Type 2 OPHL (7 operations) and Type 3 OPHL (7 operations). Among these operations, two were classified into Type 2b OPHL and four into Type 3b OPHL as the superior margin of incision included epiglottis. We consider that, this new classification, because it allows understanding the content of the surgery from the related title, will be useful in comparing different series and techniques.

Development of CMTD (Curved Multi-Tubed Device) -system III and its application to the needle-insertion for liver.

PubMed

Furusho, Junji; Kobayashi, Hiroshi; Kikuchi, Takehito; Yamamoto, Tatsuro; Tanaka, Hidekazu; Terayama, Motokazu; Monden, Morito

2008-01-01

The purpose of this study is to realize the mechanically-controllable needle-insertion system using the CMTD (Curved Multi-Tube Device) which was developed by Furusho Laboratory. A CMTD, was developed for minimally-invasive surgery and needle insertion. And we use ultrasonograph as a sensing device to detect the position of bible duct or tumor and the orientation and position of the needle which is inserted into liver. This system makes safe minimally-invasive surgery possible, because all complex mechanisms are arranged outside of the body.

SVM classifier on chip for melanoma detection.

PubMed

Afifi, Shereen; GholamHosseini, Hamid; Sinha, Roopak

2017-07-01

Support Vector Machine (SVM) is a common classifier used for efficient classification with high accuracy. SVM shows high accuracy for classifying melanoma (skin cancer) clinical images within computer-aided diagnosis systems used by skin cancer specialists to detect melanoma early and save lives. We aim to develop a medical low-cost handheld device that runs a real-time embedded SVM-based diagnosis system for use in primary care for early detection of melanoma. In this paper, an optimized SVM classifier is implemented onto a recent FPGA platform using the latest design methodology to be embedded into the proposed device for realizing online efficient melanoma detection on a single system on chip/device. The hardware implementation results demonstrate a high classification accuracy of 97.9% and a significant acceleration factor of 26 from equivalent software implementation on an embedded processor, with 34% of resources utilization and 2 watts for power consumption. Consequently, the implemented system meets crucial embedded systems constraints of high performance and low cost, resources utilization and power consumption, while achieving high classification accuracy.

21 CFR 878.4020 - Occlusive wound dressing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Occlusive wound dressing. 878.4020 Section 878...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4020 Occlusive wound dressing. (a) Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device...

21 CFR 878.4020 - Occlusive wound dressing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Occlusive wound dressing. 878.4020 Section 878...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4020 Occlusive wound dressing. (a) Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device...

Single-Use Devices in Argentina: Cost Comparison Analysis of a "Re-Use" versus a "Single-Use" Policy for Trocars, Endocutters, Linear Cutters, and Harmonic Scalpels.

PubMed

Garay, Osvaldo Ulises; Elorrio, Ezequiel Garcia; Rodríguez, Viviana; Spira, Cintia; Augustovski, Federico; Pichon-Riviere, Andrés

2017-12-01

Re-use of medical devices labeled and marketed for single use only is a current practice around the world. To estimate the average difference per surgery in device-related costs (DRCs) when performed with single-use devices under a single-use policy (SUP) instead of a re-use policy (RP) from the perspective of the private health sector of Argentina. An analytical model was developed in Microsoft Excel and populated with data from a literature review, a Delphi-like panel, and local cost estimations. Four single-use devices were selected for analysis: plastic trocars, endocutters, linear cutters, and harmonic scalpels. DRCs were expressed in 2012 US dollars and divided into four cost categories: devices, adverse events, device failure, and surgical time extension. Outputs were expressed as DRCs per surgery under a SUP, under a RP, the difference between them expressed in US dollars (Diff_$), and the difference between them expressed as a percentage of surgery costs (Diff_%S). Deterministic and probabilistic sensitivity analyses were performed to analyze the impact of uncertainty on results. Expected DRCs per surgery were as follows: for trocars: SUP, US $424.6; RP, US $244.2; Diff_$, US $-180.4; and Diff_%S, -3.8%; for endocutters: SUP, US $1667.4; RP, US $1102.3; Diff_$, US $-565.1; and Diff_%S, -11.1%; for linear cutters: SUP, US $1228.1; RP, US $1045.9; Diff_$, US $-182.2; and Diff_%S, -3.4%; and for harmonic scalpels: SUP, US $1040.9; RP, US $292.4; Diff_$, US $-748.5; and Diff_%S, -14.8%. Sensitivity analyses showed results to be robust. RP was shown to be less costly in all devices and scenarios considered. Nevertheless, the real frequency of adverse events and their cost implications are still uncertain. More research is needed to assess the effectiveness and safety of these off-label policies. Copyright © 2017. Published by Elsevier Inc.

21 CFR 868.1430 - Carbon monoxide gas analyzer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... techniques such as infrared absorption or gas chromatography. (b) Classification. Class II (performance... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Carbon monoxide gas analyzer. 868.1430 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1430 Carbon monoxide gas analyzer. (a...

21 CFR 868.1430 - Carbon monoxide gas analyzer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... techniques such as infrared absorption or gas chromatography. (b) Classification. Class II (performance... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Carbon monoxide gas analyzer. 868.1430 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1430 Carbon monoxide gas analyzer. (a...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 870.2390 - Phonocardiograph.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 868.5270 - Breathing system heater.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller. (b) Classification. Class II...

Feasibility Study of Utilization of Action Camera, GoPro Hero 4, Google Glass, and Panasonic HX-A100 in Spine Surgery.

PubMed

Lee, Chang Kyu; Kim, Youngjun; Lee, Nam; Kim, Byeongwoo; Kim, Doyoung; Yi, Seong

2017-02-15

Study for feasibility of commercially available action cameras in recording video of spine. Recent innovation of the wearable action camera with high-definition video recording enables surgeons to use camera in the operation at ease without high costs. The purpose of this study is to compare the feasibility, safety, and efficacy of commercially available action cameras in recording video of spine surgery. There are early reports of medical professionals using Google Glass throughout the hospital, Panasonic HX-A100 action camera, and GoPro. This study is the first report for spine surgery. Three commercially available cameras were tested: GoPro Hero 4 Silver, Google Glass, and Panasonic HX-A100 action camera. Typical spine surgery was selected for video recording; posterior lumbar laminectomy and fusion. Three cameras were used by one surgeon and video was recorded throughout the operation. The comparison was made on the perspective of human factor, specification, and video quality. The most convenient and lightweight device for wearing and holding throughout the long operation time was Google Glass. The image quality; all devices except Google Glass supported HD format and GoPro has unique 2.7K or 4K resolution. Quality of video resolution was best in GoPro. Field of view, GoPro can adjust point of interest, field of view according to the surgery. Narrow FOV option was the best for recording in GoPro to share the video clip. Google Glass has potentials by using application programs. Connectivity such as Wi-Fi and Bluetooth enables video streaming for audience, but only Google Glass has two-way communication feature in device. Action cameras have the potential to improve patient safety, operator comfort, and procedure efficiency in the field of spinal surgery and broadcasting a surgery with development of the device and applied program in the future. N/A.

A Novel Wearable Device for Food Intake and Physical Activity Recognition

PubMed Central

Farooq, Muhammad; Sazonov, Edward

2016-01-01

Presence of speech and motion artifacts has been shown to impact the performance of wearable sensor systems used for automatic detection of food intake. This work presents a novel wearable device which can detect food intake even when the user is physically active and/or talking. The device consists of a piezoelectric strain sensor placed on the temporalis muscle, an accelerometer, and a data acquisition module connected to the temple of eyeglasses. Data from 10 participants was collected while they performed activities including quiet sitting, talking, eating while sitting, eating while walking, and walking. Piezoelectric strain sensor and accelerometer signals were divided into non-overlapping epochs of 3 s; four features were computed for each signal. To differentiate between eating and not eating, as well as between sedentary postures and physical activity, two multiclass classification approaches are presented. The first approach used a single classifier with sensor fusion and the second approach used two-stage classification. The best results were achieved when two separate linear support vector machine (SVM) classifiers were trained for food intake and activity detection, and their results were combined using a decision tree (two-stage classification) to determine the final class. This approach resulted in an average F1-score of 99.85% and area under the curve (AUC) of 0.99 for multiclass classification. With its ability to differentiate between food intake and activity level, this device may potentially be used for tracking both energy intake and energy expenditure. PMID:27409622

A Novel Wearable Device for Food Intake and Physical Activity Recognition.

PubMed

Farooq, Muhammad; Sazonov, Edward

2016-07-11

Presence of speech and motion artifacts has been shown to impact the performance of wearable sensor systems used for automatic detection of food intake. This work presents a novel wearable device which can detect food intake even when the user is physically active and/or talking. The device consists of a piezoelectric strain sensor placed on the temporalis muscle, an accelerometer, and a data acquisition module connected to the temple of eyeglasses. Data from 10 participants was collected while they performed activities including quiet sitting, talking, eating while sitting, eating while walking, and walking. Piezoelectric strain sensor and accelerometer signals were divided into non-overlapping epochs of 3 s; four features were computed for each signal. To differentiate between eating and not eating, as well as between sedentary postures and physical activity, two multiclass classification approaches are presented. The first approach used a single classifier with sensor fusion and the second approach used two-stage classification. The best results were achieved when two separate linear support vector machine (SVM) classifiers were trained for food intake and activity detection, and their results were combined using a decision tree (two-stage classification) to determine the final class. This approach resulted in an average F1-score of 99.85% and area under the curve (AUC) of 0.99 for multiclass classification. With its ability to differentiate between food intake and activity level, this device may potentially be used for tracking both energy intake and energy expenditure.

Surgical management of glaucoma: An Indian perspective

PubMed Central

Ramakrishnan, R; Khurana, Mona

2011-01-01

Glaucoma is a serious sight-threatening disorder aptly named the Silent thief of sight. India, being the second most populous country in the world, has about 20% of the world glaucoma population. The complex geographical and socioeconomic architecture and the economic extremes have a profound effect on its health system. The present times are abundant with fresh developments in the field of glaucoma. Though newer modalities are present in India, they are not ample and are unequally distributed. Adherence and persistence with medical therapy is an issue owing to a multitude of factors. In such a setting, most of the ophthalmologists find themselves performing glaucoma surgeries quite often. In the present era, there are a number of new surgeries to choose from, especially procedures which are nonpenetrating and blebless. Faced with a spectrum of surgeries from shunts to canal surgeries and trabecular bypass devices, the surgeon is often in a dilemma. Still, trabeculectomy remains the gold standard with an increasing trend toward glaucoma drainage devices. The new procedures and devices are worth exploring but await long-term results, good training of surgeons and cost effectiveness. PMID:21150023

Development of a novel controllable, multidirectional, reusable metallic port with a wide working space.

PubMed

Hosaka, Seiji; Ohdaira, Takeshi; Umemoto, Satoshi; Hashizume, Makoto; Kawamoto, Shunji

2013-12-01

Endoscopic surgery is currently a standard procedure in many countries. Furthermore, conventional four-port laparoscopic cholecystectomy is developing into a single-port procedure. However, in many developing countries, disposable medical products are expensive and adequate medical waste disposable facilities are absent. Advanced medical treatments such as laparoscopic or single-port surgeries are not readily available in many areas of developing countries, and there are often no other sterilization methods besides autoclaving. Moreover, existing reusable metallic ports are impractical and are thus not widely used. We developed a novel controllable, multidirectional single-port device that can be autoclaved, and with a wide working space, which was employed in five patients. In all patients, laparoscopic cholecystectomy was accomplished without complications. Our device facilitates single-port surgery in areas of the world with limited sterilization methods and offers a novel alternative to conventional tools for creating a smaller incision, decrease postoperative pain, and improve cosmesis. This novel device can also lower the cost of medical treatment and offers a promising tool for major surgeries requiring a wide working space.

New Technologies for Surgery of the Congenital Cardiac Defect

PubMed Central

Kalfa, David; Bacha, Emile

2013-01-01

The surgical repair of complex congenital heart defects frequently requires additional tissue in various forms, such as patches, conduits, and valves. These devices often require replacement over a patient’s lifetime because of degeneration, calcification, or lack of growth. The main new technologies in congenital cardiac surgery aim at, on the one hand, avoiding such reoperations and, on the other hand, improving long-term outcomes of devices used to repair or replace diseased structural malformations. These technologies are: 1) new patches: CorMatrix® patches made of decellularized porcine small intestinal submucosa extracellular matrix; 2) new devices: the Melody® valve (for percutaneous pulmonary valve implantation) and tissue-engineered valved conduits (either decellularized scaffolds or polymeric scaffolds); and 3) new emerging fields, such as antenatal corrective cardiac surgery or robotically assisted congenital cardiac surgical procedures. These new technologies for structural malformation surgery are still in their infancy but certainly present great promise for the future. But the translation of these emerging technologies to routine health care and public health policy will also largely depend on economic considerations, value judgments, and political factors. PMID:23908869

Classification of team sport activities using a single wearable tracking device.

PubMed

Wundersitz, Daniel W T; Josman, Casey; Gupta, Ritu; Netto, Kevin J; Gastin, Paul B; Robertson, Sam

2015-11-26

Wearable tracking devices incorporating accelerometers and gyroscopes are increasingly being used for activity analysis in sports. However, minimal research exists relating to their ability to classify common activities. The purpose of this study was to determine whether data obtained from a single wearable tracking device can be used to classify team sport-related activities. Seventy-six non-elite sporting participants were tested during a simulated team sport circuit (involving stationary, walking, jogging, running, changing direction, counter-movement jumping, jumping for distance and tackling activities) in a laboratory setting. A MinimaxX S4 wearable tracking device was worn below the neck, in-line and dorsal to the first to fifth thoracic vertebrae of the spine, with tri-axial accelerometer and gyroscope data collected at 100Hz. Multiple time domain, frequency domain and custom features were extracted from each sensor using 0.5, 1.0, and 1.5s movement capture durations. Features were further screened using a combination of ANOVA and Lasso methods. Relevant features were used to classify the eight activities performed using the Random Forest (RF), Support Vector Machine (SVM) and Logistic Model Tree (LMT) algorithms. The LMT (79-92% classification accuracy) outperformed RF (32-43%) and SVM algorithms (27-40%), obtaining strongest performance using the full model (accelerometer and gyroscope inputs). Processing time can be reduced through feature selection methods (range 1.5-30.2%), however a trade-off exists between classification accuracy and processing time. Movement capture duration also had little impact on classification accuracy or processing time. In sporting scenarios where wearable tracking devices are employed, it is both possible and feasible to accurately classify team sport-related activities. Copyright © 2015 Elsevier Ltd. All rights reserved.

Measuring hospital performance in congenital heart surgery: Administrative vs. clinical registry data

PubMed Central

Pasquali, Sara K.; He, Xia; Jacobs, Jeffrey P.; Jacobs, Marshall L.; Gaies, Michael G.; Shah, Samir S.; Hall, Matthew; Gaynor, J. William; Peterson, Eric D.; Mayer, John E.; Hirsch-Romano, Jennifer C.

2015-01-01

Background In congenital heart surgery, hospital performance has historically been assessed using widely available administrative datasets. Recent studies have demonstrated inaccuracies in case ascertainment (coding and inclusion of eligible cases) in administrative vs. clinical registry data, however it is unclear whether this impacts assessment of performance on a hospital-level. Methods Merged data from the Society of Thoracic Surgeons (STS) Database (clinical registry), and Pediatric Health Information Systems Database (administrative dataset) on 46,056 children undergoing heart surgery (2006–2010) were utilized to evaluate in-hospital mortality for 33 hospitals based on their administrative vs. registry data. Standard methods to identify/classify cases were used: Risk Adjustment in Congenital Heart Surgery (RACHS-1) in the administrative data, and STS–European Association for Cardiothoracic Surgery (STAT) methodology in the registry. Results Median hospital surgical volume based on the registry data was 269 cases/yr; mortality was 2.9%. Hospital volumes and mortality rates based on the administrative data were on average 10.7% and 4.7% lower, respectively, although this varied widely across hospitals. Hospital rankings for mortality based on the administrative vs. registry data differed by ≥ 5 rank-positions for 24% of hospitals, with a change in mortality tertile classification (high, middle, or low mortality) for 18%, and change in statistical outlier classification for 12%. Higher volume/complexity hospitals were most impacted. Agency for Healthcare Quality and Research methods in the administrative data yielded similar results. Conclusions Inaccuracies in case ascertainment in administrative vs. clinical registry data can lead to important differences in assessment of hospital mortality rates for congenital heart surgery. PMID:25624057

Classification, disease, and diagnosis.

PubMed

Jutel, Annemarie

2011-01-01

Classification shapes medicine and guides its practice. Understanding classification must be part of the quest to better understand the social context and implications of diagnosis. Classifications are part of the human work that provides a foundation for the recognition and study of illness: deciding how the vast expanse of nature can be partitioned into meaningful chunks, stabilizing and structuring what is otherwise disordered. This article explores the aims of classification, their embodiment in medical diagnosis, and the historical traditions of medical classification. It provides a brief overview of the aims and principles of classification and their relevance to contemporary medicine. It also demonstrates how classifications operate as social framing devices that enable and disable communication, assert and refute authority, and are important items for sociological study.

Clinically orientated classification incorporating shoulder balance for the surgical treatment of adolescent idiopathic scoliosis.

PubMed

Elsebaie, H B; Dannawi, Z; Altaf, F; Zaidan, A; Al Mukhtar, M; Shaw, M J; Gibson, A; Noordeen, H

2016-02-01

The achievement of shoulder balance is an important measure of successful scoliosis surgery. No previously described classification system has taken shoulder balance into account. We propose a simple classification system for AIS based on two components which include the curve type and shoulder level. Altogether, three curve types have been defined according to the size and location of the curves, each curve pattern is subdivided into type A or B depending on the shoulder level. This classification was tested for interobserver reproducibility and intraobserver reliability. A retrospective analysis of the radiographs of 232 consecutive cases of AIS patients treated surgically between 2005 and 2009 was also performed. Three major types and six subtypes were identified. Type I accounted for 30 %, type II 28 % and type III 42 %. The retrospective analysis showed three patients developed a decompensation that required extension of the fusion. One case developed worsening of shoulder balance requiring further surgery. This classification was tested for interobserver and intraobserver reliability. The mean kappa coefficients for interobserver reproducibility ranged from 0.89 to 0.952, while the mean kappa value for intraobserver reliability was 0.964 indicating a good-to-excellent reliability. The treatment algorithm guides the spinal surgeon to achieve optimal curve correction and postoperative shoulder balance whilst fusing the smallest number of spinal segments. The high interobserver reproducibility and intraobserver reliability makes it an invaluable tool to describe scoliosis curves in everyday clinical practice.

Categorization of intraoperative ureteroscopy complications using modified Satava classification system.

PubMed

Tepeler, Abdulkadir; Resorlu, Berkan; Sahin, Tolga; Sarikaya, Selcuk; Bayindir, Mirze; Oguz, Ural; Armagan, Abdullah; Unsal, Ali

2014-02-01

To review our experience with ureteroscopy (URS) in the treatment of ureteral calculi and stratify intraoperative complications of URS according to the modified Satava classification system. We performed a retrospective analysis of 1,208 patients (672 males and 536 females), with a mean age of 43.1 years (range 1-78), who underwent ureteroscopic procedures for removal of ureteral stones. Intraoperative complications were recorded according to modified Satava classification system. Grade 1 complications included incidents without consequences for the patient; grade 2 complications, which are treated intraoperatively with endoscopic surgery (grade 2a) or required endoscopic re-treatment (grade 2b); and grade 3 complications included incidents requiring open or laparoscopic surgery. The stones were completely removed in 1,067 (88.3%) patients after primary procedure by either simple extraction or after fragmentation. The overall incidence of intraoperative complications was 12.6%. The most common complications were proximal stone migration (3.9%), mucosal injury (2.8%), bleeding (1.9%), inability to reach stone (1.8%), malfunctioning or breakage of instruments (0.8%), ureteral perforation (0.8%) and ureteral avulsion (0.16%). According to modified Satava classification system, there were 4.5% grade 1; 4.4% grade 2a; 3.2% grade 2b; and 0.57% grade 3 complications. We think that modified Satava classification is a quick and simple system for describing the severity of intraoperative URS complications and this grading system will facilitate a better comparison for the surgical outcomes obtained from different centers.

Virtual Reality and Augmented Reality in Plastic Surgery: A Review.

PubMed

Kim, Youngjun; Kim, Hannah; Kim, Yong Oock

2017-05-01

Recently, virtual reality (VR) and augmented reality (AR) have received increasing attention, with the development of VR/AR devices such as head-mounted displays, haptic devices, and AR glasses. Medicine is considered to be one of the most effective applications of VR/AR. In this article, we describe a systematic literature review conducted to investigate the state-of-the-art VR/AR technology relevant to plastic surgery. The 35 studies that were ultimately selected were categorized into 3 representative topics: VR/AR-based preoperative planning, navigation, and training. In addition, future trends of VR/AR technology associated with plastic surgery and related fields are discussed.

Virtual Reality and Augmented Reality in Plastic Surgery: A Review

PubMed Central

Kim, Youngjun; Kim, Hannah

2017-01-01

Recently, virtual reality (VR) and augmented reality (AR) have received increasing attention, with the development of VR/AR devices such as head-mounted displays, haptic devices, and AR glasses. Medicine is considered to be one of the most effective applications of VR/AR. In this article, we describe a systematic literature review conducted to investigate the state-of-the-art VR/AR technology relevant to plastic surgery. The 35 studies that were ultimately selected were categorized into 3 representative topics: VR/AR-based preoperative planning, navigation, and training. In addition, future trends of VR/AR technology associated with plastic surgery and related fields are discussed. PMID:28573091

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2011 CFR

2011-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2012 CFR

2012-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2013 CFR

2013-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2014 CFR

2014-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 874.5550 - Powered nasal irrigator.

Code of Federal Regulations, 2010 CFR

2010-04-01

... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

21 CFR 872.1720 - Pulp tester.

Code of Federal Regulations, 2011 CFR

2011-04-01

... DENTAL DEVICES Diagnostic Devices § 872.1720 Pulp tester. (a) Identification. A pulp tester is an AC or... current transmitted by an electrode to stimulate the nerve tissue in the dental pulp. (b) Classification...

21 CFR 872.1720 - Pulp tester.

Code of Federal Regulations, 2014 CFR

2014-04-01

... DENTAL DEVICES Diagnostic Devices § 872.1720 Pulp tester. (a) Identification. A pulp tester is an AC or... current transmitted by an electrode to stimulate the nerve tissue in the dental pulp. (b) Classification...

21 CFR 884.1550 - Amniotic fluid sampler (amniocentesis tray).

Code of Federal Regulations, 2011 CFR

2011-04-01

... accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks... when used to assess fetal maturity. (b) Classification. Class I (general controls). The device is...

21 CFR 884.1550 - Amniotic fluid sampler (amniocentesis tray).

Code of Federal Regulations, 2010 CFR

2010-04-01

... accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks... when used to assess fetal maturity. (b) Classification. Class I (general controls). The device is...

21 CFR 862.1305 - Formiminoglutamic acid (FIGLU) test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 862.1305 - Formiminoglutamic acid (FIGLU) test system.

Code of Federal Regulations, 2011 CFR

2011-04-01

... measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 878.3720 - Tracheal prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...

21 CFR 878.3720 - Tracheal prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...

21 CFR 878.3720 - Tracheal prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...

21 CFR 876.5210 - Enema kit.

Code of Federal Regulations, 2010 CFR

2010-04-01

... to promote evacuation of the contents of the lower colon. The device consists of a container for... irrigation system (§ 876.5220). (b) Classification. Class I (general controls). The device is exempt from the...

21 CFR 886.1800 - Schirmer strip.

Code of Federal Regulations, 2010 CFR

2010-04-01

... device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears. (b) Classification. Class I (general controls). If the device is...

Detecting underwater improvised explosive threats (DUIET)

NASA Astrophysics Data System (ADS)

Feeley, Terry

2010-04-01

Improvised Explosive Devices (IEDs) have presented a major threat in the wars in Afghanistan and Iraq. These devices are powerful homemade land mines that can be small and easily hidden near roadsides. They are then remotely detonated when Coalition Forces pass by either singly or in convoys. Their rapid detection, classification and destruction is key to the safety of troops in the area. These land based bombs will have an analogue in the underwater theater especially in ports, lakes, rivers and streams. These devices may be used against Americans on American soil as an element of the global war on terrorism (GWOT) Rapid detection and classification of underwater improvised explosive devices (UIED) is critical to protecting innocent lives and maintaining the day to day flow of commerce. This paper will discuss a strategy and tool set to deal with this potential threat.

Online image classification under monotonic decision boundary constraint

NASA Astrophysics Data System (ADS)

Lu, Cheng; Allebach, Jan; Wagner, Jerry; Pitta, Brandi; Larson, David; Guo, Yandong

2015-01-01

Image classification is a prerequisite for copy quality enhancement in all-in-one (AIO) device that comprises a printer and scanner, and which can be used to scan, copy and print. Different processing pipelines are provided in an AIO printer. Each of the processing pipelines is designed specifically for one type of input image to achieve the optimal output image quality. A typical approach to this problem is to apply Support Vector Machine to classify the input image and feed it to its corresponding processing pipeline. The online training SVM can help users to improve the performance of classification as input images accumulate. At the same time, we want to make quick decision on the input image to speed up the classification which means sometimes the AIO device does not need to scan the entire image to make a final decision. These two constraints, online SVM and quick decision, raise questions regarding: 1) what features are suitable for classification; 2) how we should control the decision boundary in online SVM training. This paper will discuss the compatibility of online SVM and quick decision capability.

21 CFR 886.4300 - Intraocular lens guide.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Intraocular lens guide. 886.4300 Section 886.4300...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct...

21 CFR 878.5650 - Topical oxygen chamber for extremities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Topical oxygen chamber for extremities. 878.5650... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5650 Topical oxygen chamber for extremities. (a) Identification. A topical oxygen chamber for extremities is a device intended...

21 CFR 878.5650 - Topical oxygen chamber for extremities.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Topical oxygen chamber for extremities. 878.5650... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5650 Topical oxygen chamber for extremities. (a) Identification. A topical oxygen chamber for extremities is a device that is...

21 CFR 878.5650 - Topical oxygen chamber for extremities.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Topical oxygen chamber for extremities. 878.5650... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5650 Topical oxygen chamber for extremities. (a) Identification. A topical oxygen chamber for extremities is a device that is...

21 CFR 878.5650 - Topical oxygen chamber for extremities.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Topical oxygen chamber for extremities. 878.5650... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5650 Topical oxygen chamber for extremities. (a) Identification. A topical oxygen chamber for extremities is a device intended...