Sample records for class ii devices

  1. 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...

  2. 77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... into class II (special controls). FDA is proposing this reclassification on its own initiative based on... categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II...

  3. 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...

  4. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Implanted Blood... blood access devices may comply with the requirement of special controls for class II devices. This...

  5. 78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to... controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval...

  6. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

  7. 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...

  8. Medical devices; hematology and pathology devices; classification of cord blood processing system and storage container. Final rule.

    PubMed

    2007-02-01

    The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

  9. 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.

  10. 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...

  11. 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...

  12. Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

    PubMed

    2010-11-05

    The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

  13. 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...

  14. 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.

  15. Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

    PubMed

    2014-10-22

    The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

  16. 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.

  17. 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.

  18. Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

    PubMed

    2004-03-16

    The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

  19. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ...: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro...

  20. 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.

  1. Gastroenterology-urology devices; reclassification of implanted blood access devices. Final rule.

    PubMed

    2014-07-25

    The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.

  2. Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

    PubMed

    1998-11-03

    The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Indoor Tanning: The Risks of Ultraviolet Rays

    MedlinePlus

    ... Class I devices are low risk and are subject to the least regulatory controls. Class II devices, ... Compliance Federal, State & Local Officials Consumers Health Professionals Science & Research Industry Scroll back to top Popular Content ...

  8. 21 CFR 25.34 - Devices and electronic products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

  9. 21 CFR 25.34 - Devices and electronic products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

  10. 21 CFR 25.34 - Devices and electronic products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

  11. 21 CFR 25.34 - Devices and electronic products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

  12. 21 CFR 25.34 - Devices and electronic products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Devices and electronic products. 25.34 Section 25... ENVIRONMENTAL IMPACT CONSIDERATIONS Categorical Exclusions § 25.34 Devices and electronic products. The classes... substitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic...

  13. 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.

  14. 78 FR 36698 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three...

  15. 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.

  16. 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). ...

  17. 78 FR 17890 - Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket... issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of...

  18. 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.

  19. 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...

  20. 21 CFR 807.81 - When a premarket notification submission is required.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... equivalent to, (i) a device in commercial distribution before May 28, 1976, or (ii) a device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II. (2..., chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the...

  1. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that simply supports the intended...

  2. 21 CFR 872.3060 - Noble metal alloy.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... DEVICES DENTAL DEVICES Prosthetic Devices § 872.3060 Noble metal alloy. (a) Identification. A noble metal... “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the...

  3. 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.

  4. Orthodontic management by functional activator treatment: a case report.

    PubMed

    Aprile, Giuseppe; Ortu, Eleonora; Cattaneo, Ruggero; Pietropaoli, Davide; Giannoni, Mario; Monaco, Annalisa

    2017-12-02

    Managing orthodontic treatment is often very difficult for the orthodontist. Many devices are used during the orthopedic phase of orthodontic treatment, always with different functions. We describe a case of orthodontic management treated with the Equilibrator O.S.A. device (equilibrator designed by Ovidi, Santi, and Aprile for Eptamed SRL; Cesena, Italy; www.eptamed.com ). A healthy 10-year-old white boy presented with a skeletal class II, division 1 malocclusion, molar class II, exhibiting an overjet of 7 mm prior to treatment. For treatment, we only used the Equilibrator O.S.A. device. We successfully treated an orthopedic/orthodontic case with a particular device that we describe here.

  5. 78 FR 1574 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Infusion Pumps. 281 Requirements for the 0910-AG59 Testing and Reporting of Tobacco Product Constituents... Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Legal Authority: 21 U.S.C... proposing to amend the classification of infusion pumps from class II (performance standards) to class II...

  6. Hematology and pathology devices; reclassification of the automated differential cell counter. Final rule.

    PubMed

    2002-01-14

    The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA" as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is being undertaken based on new information submitted in a reclassification petition from the International Society for Laboratory Hematology (ISLH), under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.

  7. Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule.

    PubMed

    2011-04-25

    The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Medical Device Amendments of 1976 (the 1976 Amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,'' which will serve as the special control for this device.

  8. 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. ...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. Effectiveness of comprehensive fixed appliance treatment used with the Forsus Fatigue Resistant Device in Class II patients.

    PubMed

    Franchi, Lorenzo; Alvetro, Lisa; Giuntini, Veronica; Masucci, Caterina; Defraia, Efisio; Baccetti, Tiziano

    2011-07-01

    To assess the dental, skeletal, and soft tissue effects of comprehensive fixed appliance treatment combined with the Forsus Fatigue Resistant Device (FRD) in Class II patients. Thirty-two Class II patients (mean age 12.7 ± 1.2 years) were treated consecutively with the FRD protocol and compared with a matched sample of 27 untreated Class II subjects (mean age 12.8 ± 1.3 years). Lateral cephalograms were taken before therapy and at the completion of comprehensive therapy. The mean duration of comprehensive treatment was 2.4 ± 0.4 years. Statistical comparisons were carried out with the Student's t-test (P < .05). The success rate was 87.5%. The FRD group showed a significant restraint in the sagittal skeletal position of the maxilla (also at the soft tissue level), a significant increase in mandibular length, and a significant improvement in maxillo-mandibular sagittal skeletal relationships. The treated group exhibited a significant reduction in overjet and a significant increase in molar relationship. The lower incisors were significantly proclined and intruded, while the lower first molars moved significantly in a mesial and vertical direction. The FRD protocol is effective in correcting Class II malocclusion with a combination of skeletal (mainly maxillary) and dentoalveolar (mainly mandibular) modifications.

  14. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  15. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  16. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  17. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  18. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  19. Nonsurgical treatment of an adult with a skeletal Class II gummy smile using zygomatic temporary anchorage devices and improved superelastic nickel-titanium alloy wires.

    PubMed

    Ishida, Yuji; Ono, Takashi

    2017-11-01

    Patients with a severe gummy smile and a skeletal Class II profile are difficult to treat. This case report describes an effective treatment alternative for improving a gummy smile in a patient with a severe Class II molar relationship, severe crowding, and lip protrusion using zygomatic anchorage devices and improved superelastic nickel-titanium wires. A 36-year-old woman had an excessive overjet and a deep overbite with a bilateral Angle Class II molar relationship. The cephalometric analysis demonstrated a Class II skeletal relationship (ANB, 9.5°), retroclination of the mandible (FMA, 38.4°), and severe labial inclination of the mandibular incisors (IMPA, 101.9°). The main treatment objectives included normalizing the overjet and overbite, improving the gummy smile, and establishing a satisfactory occlusion. During treatment with fixed appliances, intrusion of the total maxillary dentition using skeletal anchorage and elimination of the bimaxillary protrusion were achieved. Improvement of the lateral profile and gummy smile enhanced facial esthetics. Intrusion and distalization of the maxillary dentition with skeletal anchorage and improved superelastic nickel-titanium wires provided a satisfactory dental occlusion, esthetic improvement, and adequate function. This approach should be considered as an alternative treatment option to orthognathic surgery for adults with high-angle skeletal Class II malocclusion and a gummy smile. Copyright © 2017 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

  20. 21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....4200 Section 870.4200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... class I if it does not involve an electrical connection to the patient. The device is exempt from the... (special controls). The device is classified as class II if it involves an electrical connection to the...

  1. 21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....4200 Section 870.4200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... class I if it does not involve an electrical connection to the patient. The device is exempt from the... (special controls). The device is classified as class II if it involves an electrical connection to the...

  2. 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... type of device is designed to achieve biological fixation to bone without the use of bone cement. This... bearing is rigidly secured to the metal tibial base plate. (b) Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint...

  3. 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. ...

  4. 75 FR 44172 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... document proposed to amend certain neurological and physical medicine device regulations to establish... to amend certain neurological device and physical medicine device regulations to establish special...

  5. 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. ...

  6. 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...

  7. 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...

  8. 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...

  9. Effects of rapid palatal expansion (RPE) and twin block mandibular advancement device (MAD) on pharyngeal structures in Class II pediatric patients from Cluj-Napoca, Romania.

    PubMed

    Rădescu, Ovidiu Dănuţ; Colosi, Horațiu Alexandru; Albu, Silviu

    2018-05-23

    To compare cephalometric changes of pharyngeal structures after rapid palatal expansion (RPE) with those induced by a twin block mandibular advancement device (MAD) with palatal expansion capability. This retrospective study investigated 55 Class II pediatric patients, divided into two groups: 29 patients treated with RPE and 26 patients treated with MAD. Lateral cephalometric measurements were compared before and after treatment. Changes in pharyngeal airway space were statistically significant in both groups (p < 0.001) from a pre-treatment mean distance measured between the lower posterior pharyngeal wall and the hyoid bone (LPF-H) of 25.42 mm in the MAD group and 28.62 mm in the RPE group, to a post-treatment mean LPF-H of 27.96 mm in the MAD group and 31.52 mm in the RPE group. Significant changes in pharyngeal space may be obtained in Class II patients through both rapid palatal expansion and mandibular advancement devices with palatal expansion capability.

  10. 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. ...

  11. 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. ...

  12. 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. ...

  13. 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. ...

  14. 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. ...

  15. 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...

  16. 21 CFR 888.3045 - Resorbable calcium salt bone void filler device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Resorbable calcium salt bone void filler device... salt bone void filler device. (a) Identification. A resorbable calcium salt bone void filler device is... entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for...

  17. 21 CFR 888.3045 - Resorbable calcium salt bone void filler device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Resorbable calcium salt bone void filler device... salt bone void filler device. (a) Identification. A resorbable calcium salt bone void filler device is... entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for...

  18. 21 CFR 888.3045 - Resorbable calcium salt bone void filler device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Resorbable calcium salt bone void filler device... salt bone void filler device. (a) Identification. A resorbable calcium salt bone void filler device is... entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for...

  19. 21 CFR 888.3045 - Resorbable calcium salt bone void filler device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Resorbable calcium salt bone void filler device... salt bone void filler device. (a) Identification. A resorbable calcium salt bone void filler device is... entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for...

  20. 21 CFR 888.3045 - Resorbable calcium salt bone void filler device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Resorbable calcium salt bone void filler device... salt bone void filler device. (a) Identification. A resorbable calcium salt bone void filler device is... entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for...

  1. 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...

  2. Treatment of Class II Division 2 Malocclusion Using the Forsus Fatigue Resistance Device and 5-Year Follow-Up

    PubMed Central

    Atik, Ezgi; Kocadereli, Ilken

    2016-01-01

    This case report presents the treatment of a 14-year-and-8-month-old boy with Class II division 2 mandibular retrusion, severe deep bite, and concave profile. The Forsus fatigue resistance device (FRD) was effective in correcting both skeletal and dental parameters. At 5-year posttreatment follow-up, the teeth were well aligned and the occlusion was stable. FRD application with appropriate treatment time can result with prominent changes in the facial profile and dentition, and the outcomes can be maintained at the long-term follow-up periods. PMID:27034855

  3. Distalization of maxillary arch and correction of Class II with mini-implants: A report of two cases

    PubMed Central

    Tekale, Pawankumar Dnyandeo; Vakil, Ketan K.; Vakil, Jeegar K.; Gore, Ketan A.

    2015-01-01

    This article reports the successful use of mini-screws in the maxilla to treat two patients of age 21-year and 17-year-old girls. Both the patients had a skeletal Class II malocclusion with protrusive maxillary teeth and angels Class II mal-occlusion. Temporary anchorage devices (TADs) in the posterior dental region between maxillary second premolar and maxillary first molar teeth on both sides were used as anchorage for the retraction and intrusion of her maxillary anterior teeth. Those appliances, combined with a compensatory curved maxillary archwire, eliminated spacing, deep bite, forwardly placed and proclined upper front teeth and the protrusive profile, corrected the molar relationship from Class II to Class I. With no extra TADs in the anterior region for intrusion, the treatment was workable and simple. The patient received a satisfactory occlusion and an attractive smile. This technique requires minimal compliance and is particularly useful for correcting Class II patients with protrusive maxillary front teeth and dental deep bite. PMID:26097360

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 75 FR 17093 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... proposing to amend certain neurological device and physical medicine device regulations to establish special..., FDA is proposing to amend the physical medicine devices regulation at Sec. 890.5850 (21 CFR 890.5850...

  10. Standards for Lithotripter Performance

    NASA Astrophysics Data System (ADS)

    Schultheiss, Reiner; Doerffel, Michael

    2008-09-01

    Standards for lithotripsy have been developed by the International Electrotechnical Commission (IEC) and the FDA. In addition to the existing regulations and norms for the manufacturers, special standards were developed to address a treatment method developed in the early 1980's using extracorporeal shock waves. Initially, the FDA regulated the premarket approval process for lithotripters as a Class III device but reclassified lithotripters in 2000 to a Class II device. The corresponding guidance document for showing the substantial equivalence of new devices with predicate devices will be described in detail. The FDA guidance document is very useful in helping device manufacturers: (i) develop technical performance testing for a shock wave lithotripter within the parameters of an FDA submission, and (ii) conduct clinical performance testing via at least one clinical confirmation study with a small number of subjects. Unfortunately although the submitted data are available at the FDA they are not available in the marketplace and this causes difficulties for physicians in deciding which device to use. The results of the technical performance testing of the LithoGold™ are provided.

  11. Medical devices; hematology and pathology devices: reclassification of automated blood cell separator device operating by centrifugal separation principle. Final rule.

    PubMed

    2007-11-30

    The Food and Drug Administration (FDA) is reclassifying from class III to class II the automated blood cell separator device operating by centrifugal separation principle and intended for the routine collection of blood and blood components. FDA is taking this action on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special controls for this device, as well as the special controls for the device with the same intended use but operating on a filtration separation principle.

  12. 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...

  13. 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...

  14. Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure. Final order.

    PubMed

    2016-02-12

    The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Although an individual device or accessory used in an ECMO circuit may already have its own classification regulation when the device or accessory is intended for short-term use (<=6 hours), such device or accessory will be subject to the same regulatory controls applied to the oxygenator (i.e., class II, special controls) when evaluated as part of the ECMO circuit for long-term use (>6 hours). On its own initiative, based on new information, FDA is revising the classification of the membrane lung device for long-term pulmonary support.

  15. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and... Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with...

  16. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ...: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy; Availability AGENCY...-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).'' This guidance document describes a means by which non-powered suction apparatus devices intended for NPWT may comply with...

  17. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ...: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requirements and... electromagnetic compatibility and electrical safety. Firms are now exempt from 510(k) requirements for vertical... Equipment--Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility...

  18. 21 CFR 870.5900 - Thermal regulating system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... system. (a) Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature. (b) Classification. Class II (performance standards). ...

  19. 18 CFR 806.25 - Water conservation standards.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., as applicable, by all classes of users. (ii) Prepare and distribute literature to customers... meters or other suitable devices or utilize acceptable flow measuring methods for accurate determination of water use by various parts of the company operation. (3) Install flow control devices which match...

  20. 18 CFR 806.25 - Water conservation standards.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., as applicable, by all classes of users. (ii) Prepare and distribute literature to customers... meters or other suitable devices or utilize acceptable flow measuring methods for accurate determination of water use by various parts of the company operation. (3) Install flow control devices which match...

  1. 18 CFR 806.25 - Water conservation standards.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., as applicable, by all classes of users. (ii) Prepare and distribute literature to customers... meters or other suitable devices or utilize acceptable flow measuring methods for accurate determination of water use by various parts of the company operation. (3) Install flow control devices which match...

  2. 21 CFR 870.5225 - External counter-pulsating device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle. (b) Classification. (1) Class II (special controls... angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative...

  3. Post-Retention Changes in Class II Correction With the Forsus (trademark) Appliance

    DTIC Science & Technology

    2015-06-01

    headgear combination showed long-term stability of Class II correction 12- 15 years out of 5 retention.25 One recent study on the FR-2 functional...L1-MP (deg) 4) U1-NA (mm) 5 ) L1-NB (mm) 6) Overjet (mm) 15 Figure 3: Points/Landmarks for Skeletal Vertical Measurements...extraction patients treated with the Forsus Fatigue Resistant Device versus intermaxillary elastics. Angle Orthod. 2008 Mar; 78(2):332-8. 5 ) Mihalik CA

  4. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  5. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  6. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  7. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  8. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  9. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  10. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  11. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  12. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  13. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  14. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  15. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  16. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  17. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  18. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  19. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  20. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  1. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  2. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  3. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  4. 21 CFR 876.4890 - Urological table and accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower...) Class II (special controls) for the electrically powered urological table and accessories. The device is... § 876.9. (2) Class I for the manually powered table and accessories, and for stirrups for electrically...

  5. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... for Safety--Collateral Standard: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair Lifts'') must validate electromagnetic...: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and...

  6. 21 CFR 884.5970 - Clitoral engorgement device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clitoral engorgement device. 884.5970 Section 884.5970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for...

  7. 21 CFR 882.1610 - Alpha monitor.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Alpha monitor. 882.1610 Section 882.1610 Food and... NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1610 Alpha monitor. (a) Identification. An alpha... electroencephalogram which is referred to as the alpha wave. (b) Classification. Class II (performance standards). ...

  8. 21 CFR 882.1610 - Alpha monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alpha monitor. 882.1610 Section 882.1610 Food and... NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1610 Alpha monitor. (a) Identification. An alpha... electroencephalogram which is referred to as the alpha wave. (b) Classification. Class II (performance standards). ...

  9. 21 CFR 882.1610 - Alpha monitor.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Alpha monitor. 882.1610 Section 882.1610 Food and... NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1610 Alpha monitor. (a) Identification. An alpha... electroencephalogram which is referred to as the alpha wave. (b) Classification. Class II (performance standards). ...

  10. A comparison of the treatment effects of the Forsus Fatigue Resistance Device and the Twin Block appliance in patients with class II malocclusions

    PubMed Central

    Hanoun, Abdulfatah; Al-Jewair, Thikriat S; Tabbaa, Sawsan; Allaymouni, Mhd Amer; Preston, Charles B

    2014-01-01

    Objectives We evaluated the skeletal and dentoalveolar effects of the Forsus Fatigue Resistance Device (FRD) and the Twin Block appliance (TB) in comparison with nontreated controls in the treatment of patients with class II division 1 malocclusion. Materials and methods This retrospective study included three groups: TB (n=37; mean age, 11.2 years), FRD (n=30; mean age, 12.9 years), and controls (n=25; mean age, 12.6 years). Lateral cephalograms were evaluated at T1 (pretreatment) and at T2 (postappliance removal/equivalent time frame in controls). Cephalometric changes were evaluated using the Clark analysis, including 27 measurements. Results Sagittal correction of class II malocclusion appeared to be mainly achieved by dentoalveolar changes in the FRD group. The TB was able to induce both skeletal and dentoalveolar changes. A favorable influence on facial convexity was achieved by both groups. Significant upper incisor retroclination occurred with the TB (−12.42°), whereas only −4° was observed in the FRD group. The lower incisors proclined more in the FRD group than the TB group. Incisor overjet reduction was 62% in the TB group versus 56% in the FRD group. Molar relation was corrected in both functional groups, resulting in a class I relation, although no change appeared in the control sample. Conclusion Both appliances were effective in correcting the class II malocclusion. Both the FRD and the TB induced significant maxillary and mandibular dentoalveolar changes; skeletal changes were induced by TB but not FRD therapy. PMID:25114591

  11. A comparison of the treatment effects of the Forsus Fatigue Resistance Device and the Twin Block appliance in patients with class II malocclusions.

    PubMed

    Hanoun, Abdulfatah; Al-Jewair, Thikriat S; Tabbaa, Sawsan; Allaymouni, Mhd Amer; Preston, Charles B

    2014-01-01

    We evaluated the skeletal and dentoalveolar effects of the Forsus Fatigue Resistance Device (FRD) and the Twin Block appliance (TB) in comparison with nontreated controls in the treatment of patients with class II division 1 malocclusion. THIS RETROSPECTIVE STUDY INCLUDED THREE GROUPS: TB (n=37; mean age, 11.2 years), FRD (n=30; mean age, 12.9 years), and controls (n=25; mean age, 12.6 years). Lateral cephalograms were evaluated at T1 (pretreatment) and at T2 (postappliance removal/equivalent time frame in controls). Cephalometric changes were evaluated using the Clark analysis, including 27 measurements. Sagittal correction of class II malocclusion appeared to be mainly achieved by dentoalveolar changes in the FRD group. The TB was able to induce both skeletal and dentoalveolar changes. A favorable influence on facial convexity was achieved by both groups. Significant upper incisor retroclination occurred with the TB (-12.42°), whereas only -4° was observed in the FRD group. The lower incisors proclined more in the FRD group than the TB group. Incisor overjet reduction was 62% in the TB group versus 56% in the FRD group. Molar relation was corrected in both functional groups, resulting in a class I relation, although no change appeared in the control sample. Both appliances were effective in correcting the class II malocclusion. Both the FRD and the TB induced significant maxillary and mandibular dentoalveolar changes; skeletal changes were induced by TB but not FRD therapy.

  12. Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015

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

    Connor, Michael J.; University of California Irvine School of Medicine, Irvine, California; Tringale, Kathryn

    Purpose: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non–radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. Methods and Materials: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Resultsmore » for RODs were compared with those for other devices by Pearson χ{sup 2} test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. Results: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). Conclusions: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.« less

  13. Treatment of class ii in adulthood by forsus frd device.

    PubMed

    DE Nuccio, F; D'Emidio, M M; DE Nuccio, F

    2016-01-01

    Scientific research data show that the Forsus FRD seems to have a great potential in the correction of Class II in childhood. The conclusions reached by the various Authors seem to support the hypothesis of an exclusively or mainly dentoalveolar correction, as the skeletal correction seems to have no - or little - appreciable results. In the light of such provided by different Authors, the potential of dentoalveolar compensation in adult patients with mild skeletal class II was investigated. At the UOC (Complex Operative Unit) of Orthodontics at "G. Eastman" Hospital Rome, 3 cases of skeletal class II mild (ANB <5 °) in adult patients were selected. They were treated with fixed multibracket appliance and Forsus EZ2 module. Cephalometric tracings were compared at the beginning and at the end of the treatment in order to assess the skeletal and dentoalveolar changes. The occlusal correction was achieved through a dentoalveolar compensation characterized by the flaring of the lower teeth. Forsus FRD equipment is an excellent compromise for the correction of mild Class II, even during the post development age. The resulting correction is appreciated at dental alveolar level with a mesial movement of the incisors and molars.

  14. An overview of the regulatory aspects of medical devices from the viewpoint of research and device manufacturing.

    PubMed

    Patrick, J

    1993-01-01

    To review the Food and Drug Administration's regulatory requirements for bringing a new or substantially changed medical device to market in the United States, noting the history and current requirements for the continuous spinal catheter. The relevant laws and guidelines for classifying, testing, and submitting a device to Food and Drug Administration approval are reviewed. The Food and Drug Administration categorizes medical devices into three classes, based on potential risk for illness or injury presented by a malfunction or failure. Class III devices are the most critical ones, and require a Premarket Approval that includes clinical trials before market introduction. Classes I and II usually require a 510(k), or premarket notification, which usually does not need any clinical data. Testing requirements include biocompatibility testing; physical, functional, and packaging testing; and sterility testing. The continuous spinal catheter (25-32 gauge) was marketed under a 510(k) claiming substantial equivalence to the Bizzarri-Giuffrida 24-gauge catheter, which was a pre-Amendment device. After incidences of cauda equina syndrome were reported with use of the continuous spinal technique, the Food and Drug Administration reclassified the small-gauge catheters as Class III devices, which require a Premarket Approval before being marketed.

  15. Asymmetric severe skeletal Class II division 1 patient with temporomandibular joint disorder treated with zygomatic anchorage devices and Ni-Ti alloy wires.

    PubMed

    Ishida, Takayoshi; Ono, Takashi

    2014-09-01

    To describe the orthodontic treatment of a nongrowing 30-year-old woman with asymmetric severe skeletal Class II malocclusions (asymmetric Angle Class II), large overjet (16 mm), large overbite (8 mm), two congenitally missing mandibular incisors (presenting a deciduous anterior tooth), and signs and symptoms of temporomandibular joint disorder (TMD). We used novel improved super-elastic Ni-Ti alloy wires (ISWs) combined with Ni-Ti alloy coil springs, power hooks, and a zygomatic implant as reinforced anchorage to provide a constant and continuous mild force to the dentition. We successfully distalized maxillary molars, premolars, and retracted anterior teeth and corrected the asymmetric Angle Class II molar relationship using this system of zygomatic anchorage in conjunction with ISWs, Ni-Ti alloy open-coil springs, and crimpable power hook. The maxillary molars were distalized, and postero-occlusal relationships were improved to achieve Class I canine and molar relationships on both sides. Intrusion of the upper molars made the mandibular plane close. Ideal overbite and overjet relationships were established. Facial esthetics were improved with decreased upper and lower lip protrusion, and no symptoms of TMD were observed after treatment. The orthodontic treatment described here is a promising anchorage technique alternative to traditional techniques to improve severe skeletal Class II with TMD.

  16. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  17. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  18. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  19. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  20. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  1. Maxillary molar distalization with MGBM-system in class II malocclusion

    PubMed Central

    Maino, Giuliano; Mariani, Lisa; Bozzo, Ida; Maino, Giovanna; Caprioglio, Alberto

    2013-01-01

    Aims: Objective of this retrospective study was to evaluate the treatment effects of the MGBM-System (G.B Maino, A. Giannelly, R. Bernard, P. Mura), a new intraoral device to treat Class II malocclusions Materials and Methods: A retrospective study was conducted to compare the pre-distalization and post-distalization cephalograms and dental model casts of 30 patients (15 male, 15 female) with Class II malocclusion treated with MGBM-System. Mean age at the beginning of treatment was 13.3 years (standard deviation 3.3). Angular, horizontal and vertical measurements were recorded to monitor skeletal and dental-alveolar changes. Molar movements in horizontal plane were monitored by making dental measurements on dental model casts. Results: The MGBM-System produced a rapid molar distalization and Class II relationship was corrected in 8 months ± 2.05, on average. The maxillary first molars were distalized of 4.14 (PTV-6 cemento-enamel junction), associated with a significant distal axis incline of 10. 5° referred to SN and a significant intrusion of 1.3 mm (PP). As for anchorage loss, the first premolar exhibited a significant mesial movement of 0.86 mm, associated with a significant mesial axis incline of 2.46°. No significative changes in either sagittal or vertical skeletal relationship were observed. Conclusion: The results suggest that the MGBM-System is an efficient and reliable device for distalizing the maxillary permanent first and second molars. PMID:24987649

  2. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw... intended to provide support for prostheses, such as dentures. (b) Classification. Class II. ...

  3. Rheological and molecular weight comparisons of approved hyaluronic acid products - preliminary standards for establishing class III medical device equivalence.

    PubMed

    Braithwaite, Gavin J C; Daley, Michael J; Toledo-Velasquez, David

    2016-01-01

    Hyaluronic acid of various molecular weights has been in use for the treatment of osteoarthritis knee pain for decades. Worldwide, these products are regulated as either as drugs or devices and in some countries as both. In the US, this class of products is regulated as Class III medical devices, which places specific regulatory requirements on developers of these materials under a Pre-Market Approval process, typically requiring data from prospective randomized controlled clinical studies. In 1984 pharmaceutical manufacturers became able to file an Abbreviated New Drug Application for approval of a generic drug, thus establishing standards for demonstrating equivalence to an existing chemical entity. Recently, the first biosimilar, or 'generic biologic', was approved. Biosimilars are biological products that are approved by the FDA because they are 'highly similar' to a reference product, and have been shown to have no clinically meaningful differences from the reference product. For devices, Class II medical devices have a pathway for declaring equivalence to an existing product by filing a 510 k application for FDA clearance. However, until recently no equivalent regulatory pathway was available to Class III devices. In this paper, we consider the critical mechanical performance parameters for intra-articular hyaluronic products to demonstrate indistinguishable characteristics. Analogous to the aforementioned pathways that allow for a demonstration of equivalence, we examine these parameters for an existing, marketed device and compare molecular weight and rheological properties of multiple batches of a similar product. We propose that this establishes a scientific rationale for establishing Class III medical device equivalence.

  4. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) intended for use in radiation therapy. This generic type of device may include signal analysis and display... accessories. (b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of...

  5. 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...

  6. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and... devices that have established safety and effectiveness profiles and for which it believes 510(k) review is... 510(k) requirement through rulemaking that would reclassify the Class II devices and amend the...

  7. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ...: Tissue Adhesive With Adjunct Wound Closure Device Intended for the Topical Approximation of Skin... Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin... intended for the topical approximation of skin may comply with the requirement of special controls for...

  8. 21 CFR 884.4260 - Hygroscopic Laminaria cervical dilator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... conical and expansible material made from the root of a seaweed (Laminaria digitata or Laminaria japonica). The device is used to induce abortion. (b) Classification. Class II (performance standards). ...

  9. The successful implantation of continuous-flow left ventricular assist device as a destination therapy in Korea: echocardiographic assessment.

    PubMed

    Lee, Ga Yeon; Park, Sung-Ji; Kim, Sujin; Choi, Namgyung; Jeong, Dong Seop; Jeon, Eun-Seok; Lee, Young Tak

    2014-01-01

    Left ventricular assist device (LVAD) is a good treatment option for the patients ineligible for cardiac transplantation. Several studies have demonstrated that a ventricular assist device improves the quality of life and prognosis of the patients with end-stage heart failure. A 75-yr-old man debilitated with New York Heart Association (NYHA) functional class III-IV due to severe left ventricular systolic dysfunction received LVAD implantation as a destination therapy. The patient was discharged with improved functional status (NYHA functional class II) after appropriate cardiac rehabilitation and education about how to manage the device and potential emergency situations. This is the first case of successful continuous-flow LVAD implantation as a destination therapy in Korea.

  10. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

  11. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

  12. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... diagnosis of various hematologic disorders, such as hemolytic anemia (anemia due to shortened in vivo... span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt...

  13. 21 CFR 862.1440 - Lactate dehydrogenase test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. (b) Classification. Class II (special controls). The device is...

  14. 21 CFR 862.1440 - Lactate dehydrogenase test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. (b) Classification. Class II (special controls). The device is...

  15. 21 CFR 868.1840 - Diagnostic spirometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. (b) Classification. Class II (performance standards). ...

  16. 21 CFR 868.1780 - Inspiratory airway pressure meter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... meter. (a) Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration. (b) Classification. Class II...

  17. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea. (b) Classification. Class II (performance standards). ...

  18. 21 CFR 868.5690 - Incentive spirometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation. (b) Classification. Class II...

  19. Treatment of class ii in adulthood by forsus frd device

    PubMed Central

    DE NUCCIO, F.; D’EMIDIO, M.M.; DE NUCCIO, F.

    2016-01-01

    SUMMARY Objectives Scientific research data show that the Forsus FRD seems to have a great potential in the correction of Class II in childhood. The conclusions reached by the various Authors seem to support the hypothesis of an exclusively or mainly dentoalveolar correction, as the skeletal correction seems to have no – or little – appreciable results. In the light of such provided by different Authors, the potential of dentoalveolar compensation in adult patients with mild skeletal class II was investigated. Materials and methods At the UOC (Complex Operative Unit) of Orthodontics at “G. Eastman” Hospital Rome, 3 cases of skeletal class II mild (ANB <5 °) in adult patients were selected. They were treated with fixed multibracket appliance and Forsus EZ2 module. Cephalometric tracings were compared at the beginning and at the end of the treatment in order to assess the skeletal and dentoalveolar changes. Results The occlusal correction was achieved through a dentoalveolar compensation characterized by the flaring of the lower teeth. Conclusions Forsus FRD equipment is an excellent compromise for the correction of mild Class II, even during the post development age. The resulting correction is appreciated at dental alveolar level with a mesial movement of the incisors and molars. PMID:28280539

  20. Treatment effects of the Forsus Fatigue Resistant Device used with miniscrew anchorage.

    PubMed

    Aslan, Belma I; Kucukkaraca, Ebru; Turkoz, Cagri; Dincer, Mufide

    2014-01-01

    To evaluate the dentofacial effects of the Forsus Fatigue Resistant Device (FRD) used with miniscrew anchorage (FRDMS) and compare them with those of conventional FRD and an untreated Class II control group. The sample consisted of 48 Class II subjects. Sixteen patients (13.68 ± 1.09 years of age) were treated with FRDMS, whereas 17 subjects (14.64 ± 1.56 years of age) were treated with only FRD. Also, a control sample of 15 untreated Class II subjects (14.13 ± 1.50 years of age) was constructed. Angular and linear measurements were made on 96 lateral cephalograms. Paired t, one-way analysis of variance, and Tukey tests were used for statistical analysis. Class I molar relationship and overjet correction were achieved in an average period of 6.5 ± 1.97 and 5.5 ± 1.80 months in the FRDMS and FRD groups, respectively. No skeletal effect was determined in both treatment groups. Greater overbite correction was found in the FRD group. Retrusion and extrusion of maxillary incisors, distalization of maxillary molars, and extrusion of mandibular molars were significant in both treatment groups. Labial tipping of mandibular incisors was significantly greater in the FRD group than in the FRDMS group. Overjet and molar correction was totally dentoalveolar. Unfavorable labial tipping of mandibular incisors was effectively minimized with the usage of miniscrews.

  1. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  2. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  3. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  4. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  5. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact. (b) Classification. Class II. ...

  11. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact. (b) Classification. Class II. ...

  12. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact. (b) Classification. Class II. ...

  13. Radiographic versus clinical extension of Class II carious lesions using an F-speed film.

    PubMed

    Kooistra, Scott; Dennison, Joseph B; Yaman, Peter; Burt, Brian A; Taylor, George W

    2005-01-01

    This study investigated the difference in the apparent radiographic and true clinical extension of Class II carious lesions. Sixty-two lesions in both maxillary and mandibular premolars and molars were radiographed using Insight bitewing film. Class II lesions were scored independently by two masked examiners using an 8-point lesion severity scale. During the restoration process the lesions were dissected in a stepwise fashion from the occlusal aspect. Intraoperative photographs (2x) of the lesions were made, utilizing a novel measurement device in the field as a point of reference. Subsequently, the lesions were all given clinical scores using the same 8-point scale. Statistical analysis showed a significant difference between the true clinical extension of the lesions compared to the radiographic score. "Aggressive" and "Conservative" radiographic diagnoses underestimated the true clinical extent by 0.66 mm and 0.91 mm, respectively. No statistical difference was found between premolars and molars or maxillary and mandibular arches. The results of this study help to define the parameters for making restorative treatment decisions involving Class II carious lesions.

  14. 21 CFR 860.134 - Procedures for “new devices” under section 513(f) of the act and reclassification of certain...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... allows the petitioner to supplement a deficient petition. Within 30 days after any supplemental material... on it, the Commissioner may for good cause shown refer the petition to the appropriate classification... has classified the device into class I or class II in response to a petition for reclassification...

  15. 21 CFR 861.1 - Purpose and scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

  16. 21 CFR 861.1 - Purpose and scope.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

  17. 21 CFR 861.1 - Purpose and scope.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

  18. 21 CFR 861.1 - Purpose and scope.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

  19. 21 CFR 861.1 - Purpose and scope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... section 514 of the Federal Food, Drug, and Cosmetic Act (the act) with respect to the establishment... controls for class II devices in § 860.7(b) of this chapter, is necessary to provide reasonable assurance...

  20. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  1. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  2. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  3. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  4. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  5. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  6. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  7. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  8. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  9. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  10. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  11. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  12. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  13. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  14. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  15. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  16. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  17. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  18. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  19. 21 CFR 866.5220 - Cohn fraction II immunolog-ical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of plasma containing protein gamma globulins, predominantly of the IgG class. The device may be used... subclasses, and to reduce nonspecific adsorption of plasma proteins in immunoassay techniques. Measurement of...

  20. 21 CFR 874.3300 - Hearing Aid.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but... subpart E of part 807 of this chapter subject to § 874.9. (2) Class II for the bone-conduction hearing aid...

  1. 21 CFR 874.3300 - Hearing Aid.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but... subpart E of part 807 of this chapter subject to § 874.9. (2) Class II for the bone-conduction hearing aid...

  2. 21 CFR 874.3300 - Hearing Aid.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but... subpart E of part 807 of this chapter subject to § 874.9. (2) Class II for the bone-conduction hearing aid...

  3. 21 CFR 874.3300 - Hearing Aid.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but... subpart E of part 807 of this chapter subject to § 874.9. (2) Class II for the bone-conduction hearing aid...

  4. 21 CFR 874.3300 - Hearing Aid.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but... subpart E of part 807 of this chapter subject to § 874.9. (2) Class II for the bone-conduction hearing aid...

  5. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  6. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  7. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  8. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  9. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  10. Treatment effects produced by the Twin-block appliance vs the Forsus Fatigue Resistant Device in growing Class II patients.

    PubMed

    Giuntini, Veronica; Vangelisti, Andrea; Masucci, Caterina; Defraia, Efisio; McNamara, James A; Franchi, Lorenzo

    2015-09-01

    To compare the dentoskeletal changes produced by the Twin-block appliance (TB) followed by fixed appliances vs the Forsus Fatigue Resistant Device (FRD) in combination with fixed appliances in growing patients having Class II division 1 malocclusion. Twenty-eight Class II patients (19 females and 9 males; mean age, 12.4 years) treated consecutively with the TB followed by fixed appliances were compared with a group of 36 patients (16 females and 20 males; mean age, 12.3 years) treated consecutively with the FRD in combination with fixed appliances and with a sample of 27 subjects having untreated Class II malocclusion (13 females and 14 males; mean age, 12.2 years). Mean observation interval was 2.3 years in all groups. Cephalometric changes were compared among the three groups by means of ANOVA and Tukey's post hoc tests. The FRD produced a significant restraint of the maxilla compared with the TB and control samples (SNA, -1.1° and -1.8°, respectively). The TB sample exhibited significantly greater mandibular advancement and greater increments in total mandibular length than either the FRD or control groups (SNB, 1.9° and 1.5°, respectively; and Co-Gn, 2.0 mm and 3.4 mm, respectively). The FRD produced a significantly greater amount of proclination of the mandibular incisors than what occurred with the TB or the control samples (2.9° and 5.6°, respectively). The TB appliance produced greater skeletal effects in terms of mandibular advancement and growth stimulation while the Forsus caused significant proclination of the mandibular incisors.

  11. Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA

    PubMed Central

    Abels, Esther; Pantanowitz, Liron

    2017-01-01

    The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo. This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use. PMID:28584684

  12. Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA.

    PubMed

    Abels, Esther; Pantanowitz, Liron

    2017-01-01

    The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo . This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use.

  13. Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

    PubMed

    2003-04-22

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

  14. 21 CFR 872.5500 - Extraoral orthodontic headgear.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to... patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth. (b) Classification. Class II. ...

  15. Treatment effects of a fixed intermaxillary device to correct class II malocclusions in growing patients.

    PubMed

    Heinrichs, Dean A; Shammaa, Imad; Martin, Chris; Razmus, Thomas; Gunel, Erdogan; Ngan, Peter

    2014-01-01

    The objective of this study was to evaluate the treatment effects of Forsus™ Fatigue Resistant Device (FRD; 3M Unitek, Monrovia, CA, USA) in growing patients with Class II non-extraction malocclusions. A retrospective sample of 24 class II patients treated consecutively with the FRD followed by comprehensive orthodontic treatment was compared to a sample of untreated control subjects from the Bolton Brush Study who was matched in age, sex, and craniofacial morphology. Lateral cephalometric radiographs were taken before treatment (T1) and after removal of fixed appliances (T2). Growth changes were subtracted from the treatment changes to obtain the treatment effects of the appliance. Data were analyzed using ANOVA and a match paired t test. Significant differences were found between the treated and control groups for 12 of the 29 measured variables (Co-Gn minus Co-Apt, Wits, Is-OLp, Ii-OLp, overjet, Mi-OLp, molar relationship, overbite, Mic-ML, SNA, ANB, and Ii-ML). With 27.8 months of treatment, all patients were corrected to a class I dental arch relationship. Overjet and molar relationships were improved by an average of 4.7 and 3.1 mm, respectively. This was contributed by a 1.2 mm of restraint in forward maxillary growth, 0.7 mm of forward movement of the mandible, 1.5 mm of backward movement of the maxillary incisors, 1.3 mm forward movement of the mandibular incisors, 0.5 mm backward movement of the maxillary molars, and 1.3 mm of forward movement of the mandibular molars. The overbite was decreased by 2 mm with no significant change in the occlusal, palatal, or mandibular plane. Individual variations in response to the FRD treatment were large for most of the parameters tested. Significant differences in treatment changes between male and female subjects were found only in a few parameters measured. These results demonstrate that significant overjet and overbite corrections can be obtained with the Forsus FRD in conjunction with comprehensive orthodontic treatment.

  16. Understanding the C-pulse device and its potential to treat heart failure.

    PubMed

    Sales, Virna L; McCarthy, Patrick M

    2010-03-01

    The Sunshine Heart C-Pulse (C-Pulse; Sunshine Heart Inc., Tustin, CA) device is an extra-aortic implantable counterpulsation pump designed as a non-blood contacting ambulatory heart assist device, which may provide relief from symptoms for class II-III congestive heart failure patients. It has a comparable hemodynamic augmentation to intra-aortic balloon counterpulsation devices. The C-Pulse cuff is implanted through a median sternotomy, secured around the ascending aorta, and pneumatically driven by an external system controller. Pre-clinical studies in the acute pig model, and initial temporary clinical studies in patients undergoing off-pump coronary bypass surgery have shown substantial increase in diastolic perfusion of the coronary vessels, which translated to a favorable improvement in ventricular function. A U.S. prospective multi-center trial to evaluate the safety and efficacy of the C-Pulse in class III patients with moderate heart failure is now in progress.

  17. Comparison of Forsus FRD EZ and Andresen activator in the treatment of class II, division 1 malocclusions.

    PubMed

    Bilgiç, Fundagül; Başaran, Güvenç; Hamamci, Orhan

    2015-03-01

    Purpose of this study is to evaluate the effects of Forsus Fatigue-Resistant Device (FRD) EZ and Andresen activator in terms of skeletal, dental, and soft tissue changes in actively growing patients presenting with class II, division 1 malocclusion. Study sample included 60 subjects. Inclusion criteria were as follows: class II division 1 malocclusion, retrognathic mandible, normal or low-angle growth pattern, and peak growth period. The first study group consisted of 20 patients who were treated with Forsus appliance, and the second group of 20 patients received treatment with Andresen activator. Control group received no treatment. Our results revealed that both appliances enhanced mandibular growth, helped increase the length of the mandible, and had a restraining growth effect on the maxilla. Anterior face height increased in both of treatment groups, whereas posterior face height had a significant increase in the activator group only. More mandibular incisors protrusion and intrusion were seen with the Forsus appliance. Moreover, occlusal plane and palatal plane rotated significantly in clockwise direction as a result of dentoalveolar changes only in the Forsus group. As well as the Forsus appliances corrected class II discrepancies mostly through dentoalveolar changes as compared to the activator group, both appliances proved effective in the treatment of growing individuals having class II malocclusions with mandibular retrognathia. By this investigation, two treatment methods, which are currently used in clinical practice, will be evaluated, and the results will be useful for clinicians.

  18. Tetradentate Schiff base platinum(II) complexes as new class of phosphorescent materials for high-efficiency and white-light electroluminescent devices.

    PubMed

    Che, Chi-Ming; Chan, Siu-Chung; Xiang, Hai-Feng; Chan, Michael C W; Liu, Yu; Wang, Yue

    2004-07-07

    The capabilities of readily prepared and sublimable Pt(II) Schiff base triplet emitters as OLED dopants have been examined; maximum luminous and power efficiencies and luminance of 31 cd A(-1), 14 lm W(-1), and 23,000 cd m(-2), respectively, and white EL (CIE: 0.33, 0.35) by simultaneous host/dopant emission, have been achieved.

  19. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  20. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  1. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  2. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  3. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  4. 21 CFR 876.4770 - Urethrotome.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Urethrotome. 876.4770 Section 876.4770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES.... Some urethrotomes incorporate an optical channel for visual control. (b) Classification. Class II...

  5. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  6. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  7. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  8. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  9. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  10. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

  11. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

  12. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

  13. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  14. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  15. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  16. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  17. 21 CFR 864.8100 - Bothrops atrox reagent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen... the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen). (b) Classification. Class II (performance standards). [45...

  18. 21 CFR 864.8100 - Bothrops atrox reagent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen... the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen). (b) Classification. Class II (performance standards). [45...

  19. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

  20. 21 CFR 884.5200 - Hemorrhoid prevention pressure wedge.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hemorrhoid prevention pressure wedge. 884.5200... Devices § 884.5200 Hemorrhoid prevention pressure wedge. (a) Identification. A hemorrhoid prevention... hemorrhoids associated with vaginal childbirth. (b) Classification. Class II (special controls). The special...

  1. 21 CFR 884.5200 - Hemorrhoid prevention pressure wedge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hemorrhoid prevention pressure wedge. 884.5200... Devices § 884.5200 Hemorrhoid prevention pressure wedge. (a) Identification. A hemorrhoid prevention... hemorrhoids associated with vaginal childbirth. (b) Classification. Class II (special controls). The special...

  2. 21 CFR 884.5200 - Hemorrhoid prevention pressure wedge.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hemorrhoid prevention pressure wedge. 884.5200... Devices § 884.5200 Hemorrhoid prevention pressure wedge. (a) Identification. A hemorrhoid prevention... hemorrhoids associated with vaginal childbirth. (b) Classification. Class II (special controls). The special...

  3. Guidelines: Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Management of Patients With Positional Plagiocephaly: The Role of Repositioning.

    PubMed

    Klimo, Paul; Lingo, Patrick Ryan; Baird, Lissa C; Bauer, David F; Beier, Alexandra; Durham, Susan; Lin, Alexander Y; McClung-Smith, Catherine; Mitchell, Laura; Nikas, Dimitrios; Tamber, Mandeep S; Tyagi, Rachana; Mazzola, Catherine; Flannery, Ann Marie

    2016-11-01

    Plagiocephaly, involving positional deformity of the calvarium in infants, is one of the most common reasons for pediatric neurosurgical consultation. To answer the question: "what is the evidence for the effectiveness of repositioning for positional plagiocephaly?" Treatment recommendations are provided based on the available evidence. The National Library of Medicine MEDLINE database and the Cochrane Library were queried using MeSH headings and key words relevant to repositioning as a means to treat plagiocephaly and brachycephaly. Abstracts were reviewed to identify which studies met the inclusion criteria. An evidentiary table was assembled summarizing the studies and the quality of evidence (Classes I-III). Based on the quality of the literature, a recommendation was rendered (Level I, II, or III). There were 3 randomized trials (Class I), 1 prospective cohort study (Class II), and 6 retrospective cohort studies (Class III). Repositioning education was found to be equal to a repositioning device and inferior to a physical therapy program. Five of the 7 cohort studies comparing repositioning with a helmet reported helmets to be better and take less time. Within the limits of this systematic review, repositioning education is effective in affording some degree of correction in virtually all infants with positional plagiocephaly or brachycephaly. Most studies suggest that a molding helmet corrects asymmetry more rapidly and to a greater degree than repositioning education. In a Class I study, repositioning education was as effective as repositioning education in conjunction with a repositioning wrap/device. Another Class I study demonstrated that a bedding pillow was superior to physical therapy for some infants. However, in keeping with the American Academy of Pediatrics' warning against the use of soft positioning pillows in the sleeping environment, the Task Force recommends physical therapy over any positioning device. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_3.

  4. Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Management of Patients With Positional Plagiocephaly: The Role of Repositioning.

    PubMed

    Klimo, Paul; Lingo, Patrick Ryan; Baird, Lissa C; Bauer, David F; Beier, Alexandra; Durham, Susan; Lin, Alexander Y; McClung-Smith, Catherine; Mitchell, Laura; Nikas, Dimitrios; Tamber, Mandeep S; Tyagi, Rachana; Mazzola, Catherine; Flannery, Ann Marie

    2016-11-01

    Plagiocephaly, involving positional deformity of the calvarium in infants, is one of the most common reasons for pediatric neurosurgical consultation. To answer the question: "what is the evidence for the effectiveness of repositioning for positional plagiocephaly?" Treatment recommendations are provided based on the available evidence. The National Library of Medicine MEDLINE database and the Cochrane Library were queried using MeSH headings and key words relevant to repositioning as a means to treat plagiocephaly and brachycephaly. Abstracts were reviewed to identify which studies met the inclusion criteria. An evidentiary table was assembled summarizing the studies and the quality of evidence (Classes I-III). Based on the quality of the literature, a recommendation was rendered (Level I, II, or III). There were 3 randomized trials (Class I), 1 prospective cohort study (Class II), and 6 retrospective cohort studies (Class III). Repositioning education was found to be equal to a repositioning device and inferior to a physical therapy program. Five of the 7 cohort studies comparing repositioning with a helmet reported helmets to be better and take less time. Within the limits of this systematic review, repositioning education is effective in affording some degree of correction in virtually all infants with positional plagiocephaly or brachycephaly. Most studies suggest that a molding helmet corrects asymmetry more rapidly and to a greater degree than repositioning education. In a Class I study, repositioning education was as effective as repositioning education in conjunction with a repositioning wrap/device. Another Class I study demonstrated that a bedding pillow was superior to physical therapy for some infants. However, in keeping with the American Academy of Pediatrics' warning against the use of soft positioning pillows in the sleeping environment, the Task Force recommends physical therapy over any positioning device. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_3.

  5. Treatment and posttreatment effects induced by the Forsus appliance: A controlled clinical study.

    PubMed

    Cacciatore, Giorgio; Ghislanzoni, Luis Tomas Huanca; Alvetro, Lisa; Giuntini, Veronica; Franchi, Lorenzo

    2014-11-01

    To evaluate treatment and posttreatment dentoskeletal effects induced by the Forsus device (FRD) in growing patients with Class II malocclusion in a retrospective controlled clinical study. Thirty-six Class II patients (mean [SD] age 12.3 [1.2] years) were treated consecutively with the FRD protocol and compared with a sample of 20 subjects with untreated Class II malocclusion (mean [SD] age 12.2 [0.9] years). Lateral cephalograms were taken at the beginning of treatment, at the end of comprehensive treatment (after 2.3 ± 0.4 years), and at a postretention period (after 2.3 ± 1.1 years from the end of comprehensive treatment). Statistical comparisons were carried out with the unpaired t-test and Benjamini-Hochberg correction (P < .05). After comprehensive treatment, the FRD sample showed a significant restriction of the sagittal maxillary growth together with a significant correction in overjet, overbite, and molar relationship. During the overall observation interval, the FRD group exhibited no significant sagittal or vertical skeletal changes, while significant improvements were recorded in overjet (-3.8 mm), overbite (-1.5 mm), and molar relationship (+3.7 mm). The FRD protocol was effective in correcting Class II malocclusion mainly at the dentoalveolar level when evaluated 2 years after the end of comprehensive treatment.

  6. The John Kay Williams Gold Medal of the Royal College of Surgeons of England and Glasgow 2013.

    PubMed

    Clayton, Christopher Jonathan

    2015-06-01

    This paper describes the clinical treatment of two cases treated by the recipient of the 2013 Membership in Orthodontics John Kay Williams Gold Medal of the Royal College of Surgeons of England and Glasgow. The first case describes the management of a 12-year-old male with a class II division 1 malocclusion complicated by Molar Incisal Hypominaralization, an increased overjet and severe upper arch crowding using fixed appliances with anchorage support from temporary anchorage devices. The second case involves the management of a class II division 2 malocclusion complicated by crowding of the upper and lower arches treated on an extraction basis using fixed appliances.

  7. The new collaborative path in medical device development: the medical device innovation consortium.

    PubMed

    Kampfrath, Thomas; Cotten, Steven W

    2013-10-01

    The United States medical device market is the world's largest with over $100 billion in sales in 2011. Despite robust industry growth, the efficiency of the FDA approval process for moderate-risk (Class II) and high-risk devices (Class III) requiring 510(k) submission or pre-market approval (PMA) has been criticized. Recently, the FDA's Center for Devices and Radiological Health (CDRH) announced the creation of a Medical Device Innovation Consortium (MDIC), a public-private partnership (PPP) to share knowledge in regulatory science. Overarching goals include creating a forum for the exchange of ideas among the FDA, industry, and non-profit entities; providing monetary investments for project proposals prioritized by key working groups; and developing tools that support cost effective innovation, data-driven methodology, and implementation strategies. Clinical chemists and clinical laboratory scientists have several unique opportunities to contribute to the MDIC. These laboratory professionals have invaluable experience with the real-life performance of a variety of medical devices and their expertise can recognize unmet needs and contribute towards the acceleration of device development. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  8. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  9. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  10. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  11. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  12. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  13. 21 CFR 870.5300 - DC-defribrillator (including paddles).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  14. 21 CFR 866.5735 - Prothrombin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  15. 21 CFR 870.3720 - Pacemaker electrode function tester.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker electrode function tester. 870.3720... electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is... measuring the patient's pacing threshold and intracardiac R-wave potential. (b) Classification. Class II...

  16. 21 CFR 864.7415 - Abnormal hemoglobin assay.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864... hemoglobin assay. (a) Identification. An abnormal hemoglobin assay is a device consisting of the reagents... hemoglobin types. (b) Classification. Class II (performance standards). [45 FR 60618, Sept. 12, 1980] ...

  17. 21 CFR 864.7415 - Abnormal hemoglobin assay.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864... hemoglobin assay. (a) Identification. An abnormal hemoglobin assay is a device consisting of the reagents... hemoglobin types. (b) Classification. Class II (performance standards). [45 FR 60618, Sept. 12, 1980] ...

  18. 21 CFR 870.5300 - DC-defribrillator (including paddles).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  19. 21 CFR 870.5300 - DC-defribrillator (including paddles).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  20. 21 CFR 870.5300 - DC-defibrillator (including paddles).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  1. 21 CFR 870.5300 - DC-defibrillator (including paddles).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  2. 21 CFR 868.5935 - External negative pressure ventilator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ventilator. (a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. (b) Classification. Class II...

  3. Effect of removable functional appliances on mandibular length in patients with class II with retrognathism: systematic review and meta-analysis.

    PubMed

    Santamaría-Villegas, Adriana; Manrique-Hernandez, Rubén; Alvarez-Varela, Emery; Restrepo-Serna, Claudia

    2017-02-01

    Orthopedic functional devices, are used to improve mandibular length in skeletal class II patients. However, the orthopedic functional device with the best effect to increasing the mandibular length, has not been identified before. Thus, the aim of the present investigation was to evaluate Randomized Controlled Trials (RCT), to determine the best functional appliance improving mandibular length in subjects with retrognathism. A systematic review and meta-analysis was performed, including studies published and indexed in databases between 1966 and 2016. RCTs evaluating functional appliances' effects on mandibular length (Condilion-Gnation (Co-Gn) and Condilion-Pogonion (Co-Po)), were included. Reports' structure was evaluated according to 2010 CONSORT guide. The outcome measure was distance between Co-Gn and/or Co-Po after treatment. Data were analyzed with Cochran Q Test and random effects model. Five studies were included in the meta-analysis. The overall difference in mandibular length was 1.53 mm (Confidence Interval (CI) 95% 1.15-1.92) in comparison to non-treated group. The Sander Bite Jumping reported the greatest increase in mandibular length (3.40 mm; CI 95% 1.69-5.11), followed by Twin Block, Bionator, Harvold Activator and Frankel devices. All removable functional appliances, aiming to increase mandibular length, are useful. Sander Bite Jumping was observed to be the most effective device to improve the mandibular length.

  4. 42 CFR 84.152 - Breathing tube test; minimum requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...: (i) Be employed on Type C supplied-air respirators of the demand and pressure-demand class; and (ii... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Supplied-Air Respirators § 84.152 Breathing tube test; minimum requirements. (a)(1) Type A and Type B supplied-air...

  5. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  6. 21 CFR 862.1295 - Folic acid test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow. (b) Classification. Class II. [52 FR 16122, May 1, 1987; 53 FR....1295 Folic acid test system. (a) Identification. A folic acid test system is a device intended to...

  7. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  8. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  9. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  10. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  11. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  12. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  13. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  14. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  15. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  16. Treatment of a skeletal Class II malocclusion using fixed functional appliance with miniplate anchorage

    PubMed Central

    Celikoglu, Mevlut; Unal, Tuba; Bayram, Mehmet; Candirli, Celal

    2014-01-01

    Based on our literature search, we found that the use of miniplate anchorage with Forsus fatigue-resistance device (FRD) has not yet been reported. Therefore, the aim of the present case report was to present the treatment of a patient with skeletal Class II malocclusion with mandibular retrusion using Forsus FRD with miniplate anchorage. Fixed appliances with 0.022-inch slots were attached to the maxillary teeth and after 8 months of the leveling and alignment of the upper arch, 0.019 × 0.025-inch stainless steel archwire was inserted and cinched back. Two weeks after the placement of the miniplates bilaterally at the symphysis of the mandible, Forsus FRD was adjusted to the miniplates with a 35-mm length of rod chosen. Nine months after the skeletal anchored Forsus worn, Class I canine and molar relations were achieved and overjet was eliminated. PMID:24966783

  17. The reentry catheter: a second chance for endoluminal reentry at difficult lower extremity subintimal arterial recanalizations.

    PubMed

    Etezadi, Vahid; Benenati, James F; Patel, Parag J; Patel, Rahul S; Powell, Alex; Katzen, Barry T

    2010-05-01

    From January 2005 to July 2008, a retrospective study was conducted at a single institution to investigate technical success of the use of a reentry device (Outback LTD reentry catheter) in aortoiliac and femoropopliteal artery recanalization in 34 patients (18 men; mean age +/- SD, 72 years +/- 11) in whom the conventional guide wires and catheters failed to reenter the true lumen. True lumen reentry was achieved in 87% (n = 23) and 91% (n = 11) of patients with femoropopliteal and aortoiliac occlusions, respectively. The overall technical success rate with the device was 88% (n = 34). The device success rate in Transatlantic Inter-Society Consensus II class D lesions was significantly lower than in lower lesion classes (71.4% vs 100%; P < .05). No procedure-related complications were encountered. In conclusion, the use of the reentry catheter enhances the likelihood of successful subintimal recanalization of chronic occlusions in femoropopliteal and aortoiliac arteries.

  18. Class II malocclusion with complex problems treated with a novel combination of lingual orthodontic appliances and lingual arches.

    PubMed

    Yanagita, Takeshi; Nakamura, Masahiro; Kawanabe, Noriaki; Yamashiro, Takashi

    2014-07-01

    This case report describes a novel method of combining lingual appliances and lingual arches to control horizontal problems. The patient, who was 25 years of age at her first visit to our hospital with a chief complaint of crooked anterior teeth, was diagnosed with skeletal Class II and Angle Class II malocclusion with anterior deep bite, lateral open bite, premolar crossbite, and severe crowding in both arches. She was treated with premolar extractions and temporary anchorage devices. Conventionally, it is ideal to use labial brackets simultaneously with appliances, such as a lingual arch, a quad-helix, or a rapid expansion appliance, in patients with complex problems requiring horizontal, anteroposterior, and vertical control; however, this patient strongly requested orthodontic treatment with lingual appliances. A limitation of lingual appliances is that they cannot be used with other conventional appliances. In this report, we present the successful orthodontic treatment of a complex problem using modified lingual appliances that enabled combined use of a conventional lingual arch. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  19. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  20. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  1. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  2. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  3. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  4. 21 CFR 866.5785 - Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies to S. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection of S. cerevisiae antibodies may aid in the diagnosis of Crohn's disease. (b) Classification. Class II (special...

  5. 21 CFR 878.4493 - Absorbable poly(glycolide/l-lactide) surgical suture.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Absorbable poly(glycolide/l-lactide) surgical suture. 878.4493 Section 878.4493 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and...

  6. Shock progression and survival after use of a condom uterine balloon tamponade package in women with uncontrolled postpartum hemorrhage.

    PubMed

    Burke, Thomas F; Danso-Bamfo, Sandra; Guha, Moytrayee; Oguttu, Monica; Tarimo, Vincent; Nelson, Brett D

    2017-10-01

    To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device. In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement. Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25). The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony. © 2017 International Federation of Gynecology and Obstetrics.

  7. Tanning lamps: health effects and reclassification by the Food and Drug Administration.

    PubMed

    Ernst, Alexander; Grimm, Amanda; Lim, Henry W

    2015-01-01

    Tanning lamps have long been considered a class I medical device under regulation by the Food and Drug Administration (FDA). A growing body of research has repeatedly documented the association between elective indoor tanning and several negative health consequences. These accepted findings have prompted action by the FDA to officially reclassify tanning lamps as a class II medical device. The main purpose of this review is to update practitioners on the current state of tanning lamp classification and highlight the practical implications of this recent change. This information can be used by clinicians to easily reference this important action, and empower patients with a better understanding of the risks associated with indoor tanning. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  8. Treatment outcomes of Class II malocclusion cases treated with miniscrew-anchored Forsus Fatigue Resistant Device: A randomized controlled trial.

    PubMed

    Eissa, Osama; El-Shennawy, Mahmoud; Gaballah, Safaa; El-Meehy, Ghada; El Bialy, Tarek

    2017-11-01

    To evaluate the skeletal, dental, and soft tissue effects of the Forsus Fatigue Resistant Device (FRD) used with miniscrew anchorage and compare them with those of the conventional Forsus FRD. This study was carried out on 38 patients. These patients were randomly allocated into three groups. The 14 patients in group 1 (aged 12.76 ± 1.0 years) were treated with the FRD appliance. In group 2, the 15 patients (aged 12.52 ± 1.12 years) received treatment with FRD using miniscrew anchorage, and the 9 patients in group 3 (aged 12.82 ± 0.9 years) received no treatment as a control group. Linear and angular measurements were made on lateral cephalograms before and immediately after Forsus treatment. Data were analyzed statistically using paired t-, ANOVA, and Tukey tests. Class I molar relationship and overjet correction were achieved in both treatment groups. Although mandibular growth was statistically nonsignificant, there was a significant headgear effect on the maxilla. Mandibular incisor proclination, maxillary incisor retroclination, and distalization of maxillary molars were significant in both treatment groups. However, no significant differences were found between the treatment groups. Class II correction was mainly dentoalveolar in both treatment groups. Use of miniscrews with Forsus did not enhance mandibular forward growth nor prevent labial tipping of the mandibular incisors.

  9. [Industry regulation and its relationship to the rapid marketing of medical devices].

    PubMed

    Matsuoka, Atsuko

    2012-01-01

    In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").

  10. Surface modification of biomaterials and biomedical devices using additive manufacturing.

    PubMed

    Bose, Susmita; Robertson, Samuel Ford; Bandyopadhyay, Amit

    2018-01-15

    The demand for synthetic biomaterials in medical devices, pharmaceutical products and, tissue replacement applications are growing steadily due to aging population worldwide. The use for patient matched devices is also increasing due to availability and integration of new technologies. Applications of additive manufacturing (AM) or 3D printing (3DP) in biomaterials have also increased significantly over the past decade towards traditional as well as innovative next generation Class I, II and III devices. In this review, we have focused our attention towards the use of AM in surface modified biomaterials to enhance their in vitro and in vivo performances. Specifically, we have discussed the use of AM to deliberately modify the surfaces of different classes of biomaterials with spatial specificity in a single manufacturing process as well as commented on the future outlook towards surface modification using AM. It is widely understood that the success of implanted medical devices depends largely on favorable material-tissue interactions. Additive manufacturing has gained traction as a viable and unique approach to engineered biomaterials, for both bulk and surface properties that improve implant outcomes. This review explores how additive manufacturing techniques have been and can be used to augment the surfaces of biomedical devices for direct clinical applications. Copyright © 2017 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

  11. A comparision of Twin-block and Forsus (FRD) functional appliance--a cephalometric study.

    PubMed

    Mahamad, Irfanulla Khan; Neela, Praveen Kumar; Mascarenhas, Rohan; Husain, Akhter

    2012-01-01

    The aim was to compare the effects of Twin-block & Forsus (FRD) functional appliances in the correction of Angles Class II division 1 malocclusions. Pre- and post-treatment lateral cephalograms of 25 patients who underwent treatment with twin block for the correction of class II div 1 were compared with 25 patients who underwent treatment with Forsus appliance. These were again compared with the pre follow up and post follow up lateral cephalograms of 25 patients who have not undergone any treatment during this period. All the 3 group patients were compared for skeletal, dental and soft tissue parameters. Cephalometric analysis revealed that both Twin-block & Forsus Fatigue Resistant Device (FRD) appliances stimulated mandibular growth. Statistically significant differences between the two groups were found. Twin-block patients showed statistically very high significant (p < 0.001) increase in mandibular length (6.02 mm) whereas Forsus appliance patients showed significant (p < 0.05) increase in mandibular length (1.6 mm) when compared with control group (0.3 mm). No significant restriction of maxillary growth was found in either of the two experimental groups when compared to control group. Significant increase in lower anterior facial height & posterior facial height was observed in both experimental groups in relation to control group. Significant reduction of overjet and overbite was observed in both experimental groups. Class I molar relationship and improvement in the soft tissue profile were achieved in both treatment groups compared with control group. Both Twin Block and Forsus were effective in the treatment of Class II Div 1 malocclusion. Class II correction with Twin-block is more due to mandibular skeletal and dentoalveolar changes whereas in Forsus, it is more due to dentoalveolar changes and less skeletal changes.

  12. Orthodontic Protocol Using Mini-Implant for Class II Treatment in Patient with Special Needs

    PubMed Central

    Carvalho Ferreira, Fernando Pedrin; de Paula, Eliana de Cássia Molina; Ferreira Conti, Ana Claudia de Castro; Valarelli, Danilo Pinelli; de Almeida-Pedrin, Renata Rodrigues

    2016-01-01

    Improving facial and dental appearance and social interaction are the main factors for special needs (SN) patients to seek orthodontic treatment. The cooperation of SN patients and their parents is crucial for treatment success. Objective. To show through a case report the satisfactory results, both functional and esthetic, in patients with intellectual disability, congenital nystagmus, and severe scoliosis. Materials Used. Pendulum device with mini-implants as anchorage unit. Results. Improvement of facial and dental esthetics, correction of Class II malocclusion, and no root resorption shown in the radiographic follow-up. Conclusion. Knowing the limitations of SN patients, having a trained team, motivating and counting on the cooperation of parents and patients, and employing quick and low-cost orthodontic therapy have been shown to be the essential factors for treatment success. PMID:27847652

  13. Soft tissue effects of three different Class II/1-camouflage treatment strategies.

    PubMed

    Atik, Ezgi; Akarsu-Guven, Bengisu; Kocadereli, Ilken

    2017-03-01

    Aim of this retrospective study was to compare soft tissue effects of Class II treatments with the forsus fatigue resistant device (FRD), the pendulum appliance, and the extraction of two maxillary premolars, all of which were combined with pre-adjusted fixed appliances. The sample of 54 patients with Class II malocclusions was divided in three groups: group I patients (mean age = 15.91 years) were treated with the FRD concurrently used with fixed appliances; group II patients (mean age = 16.08 years) were treated with the pendulum appliance combined with a Nance and headgear followed by fixed appliances; and group III patients (mean age = 19.04 years) were treated with the extraction of two maxillary premolars with miniscrew anchorage. Soft tissue and dentoskeletal parameters were measured on pretreatment (T1) and posttreatment (T2) lateral cephalograms. The changes from T1 to T2 were compared between the groups using Kruskal-Wallis test, and treatment differences were evaluated with the Wilcoxon test at p < 0.05. Soft tissue measurement changes related to the upper and lower lips were significantly greater in group II than in group III (p < 0.05). Upper incisor measurement changes were significantly different between groups II and III. Lower incisor measurement changes were significantly different between groups I and III and groups II and III (p < 0.05). Pendulum and extraction treatment groups showed significant differences in relation with the upper and lower lip positional changes, which were significantly greater in the pendulum group. Treatment time with the extraction treatment was statistically shorter than with the nonextraction protocols.

  14. Evaluation of the effects of skeletal anchoraged Forsus FRD using miniplates inserted on mandibular symphysis: A new approach for the treatment of Class II malocclusion.

    PubMed

    Unal, Tuba; Celikoglu, Mevlut; Candirli, Celal

    2015-05-01

    To evaluate the skeletal, dentoalveolar, and soft tissue effects of the Forsus Fatigue Resistant Device (FRD) appliance with miniplate anchorage for the treatment of skeletal Class II malocclusion. The prospective clinical study group included 17 patients (11 girls and 6 boys; mean age 12.96 ± 1.23 years) with Class II malocclusion due to mandibular retrusion and treated with skeletal anchoraged Forsus FRD. After 0.019 × 0.025-inch stainless steel archwire was inserted and cinched back in the maxillary arch, two miniplates were placed bilaterally on the mandibular symphysis. Then, the Forsus FRD EZ2 appliance was adjusted to the miniplates without leveling the mandibular arch. The changes in the leveling and skeletal anchoraged Forsus FRD phases were evaluated by means of the Paired and Student's t-tests using the cephalometric lateral films. The success rate of the miniplates was found to be 91.5% (38 of 42 miniplates). The mandible significantly moved forward (P < .001) and caused a significant restraint in the sagittal position of the maxilla (P < .001). The overjet correction (-5.11 mm) was found to be mainly by skeletal changes (A-VRL, -1.16 mm and Pog-VRL, 2.62 mm; approximately 74%); the remaining changes were due to the dentoalveolar contributions. The maxillary and mandibular incisors were significantly retruded (P < .001). This new approach was an effective method for treating skeletal Class II malocclusion due to the mandibular retrusion via a combination of skeletal and dentoalveolar changes.

  15. Crossbar nanoarchitectonics of the crosslinked self-assembled monolayer

    PubMed Central

    2014-01-01

    A bottom-up approach was devised to build a crossbar device using the crosslinked SAM of the 5,5′-bis (mercaptomethyl)-2,2′-bipyridine-Ni2+ (BPD- Ni2+) on a gold surface. To avoid metal diffusion through the organic film, the author used (i) nanoscale bottom electrodes to reduce the probability of defects on the bottom electrodes and (ii) molecular crosslinked technology to avoid metal diffusion through the SAMs. The properties of the crosslinked self-assembled monolayer were determined by XPS. I-V characteristics of the device show thermally activated hopping transport. The implementation of this type of architecture will open up new vistas for a new class of devices for transport, storage, and computing. PMID:24994952

  16. MHC class II expression in lung cancer.

    PubMed

    He, Yayi; Rozeboom, Leslie; Rivard, Christopher J; Ellison, Kim; Dziadziuszko, Rafal; Yu, Hui; Zhou, Caicun; Hirsch, Fred R

    2017-10-01

    Immunotherapy is an exciting development in lung cancer research. In this study we described major histocompatibility complex (MHC) Class II protein expression in lung cancer cell lines and patient tissues. We studied MHC Class II (DP, DQ, DR) (CR3/43, Abcam) protein expression in 55 non-small cell lung cancer (NSCLC) cell lines, 42 small cell lung cancer (SCLC) cell lines and 278 lung cancer patient tissues by immunohistochemistry (IHC). Seven (12.7%) NSCLC cell lines were positive for MHC Class II. No SCLC cell lines were found to be MHC Class II positive. We assessed 139 lung cancer samples available in the Hirsch Lab for MHC Class II. There was no positive MHC Class II staining on SCLC tumor cells. MHC Class II expression on TILs in SCLC was significantly lower than that on TILs in NSCLC (P＜0.001). MHC Class II was also assessed in an additional 139 NSCLC tumor tissues from Medical University of Gdansk, Poland. Patients with positive staining of MHC Class II on TILs had longer regression-free survival (RFS) and overall survival (OS) than those whose TILs were MHC Class II negative (2.980 years, 95% CI 1.628-4.332 vs. 1.050 years, 95% CI 0.556-1.554, P=0.028) (3.230 years, 95% CI 2.617-3.843 vs. 1.390 years, 95% CI 0.629-2.151, P=0.014). MHC Class II was expressed both in NSCLC cell lines and tissues. However, MHC Class II was not detected in SCLC cell lines or tissue tumor cells. MHC Class II expression was lower on SCLC TILs than on NSCLC TILs. Loss of expression of MHC Class II on SCLC tumor cells and reduced expression on SCLC TILs may be a means of escaping anti-cancer immunity. Higher MHC Class II expression on TILs was correlated with better prognosis in patients with NSCLC. Copyright © 2017. Published by Elsevier B.V.

  17. 25 CFR 522.10 - Individually owned class II and class III gaming operations other than those operating on...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Individually owned class II and class III gaming... GAMING COMMISSION, DEPARTMENT OF THE INTERIOR APPROVAL OF CLASS II AND CLASS III ORDINANCES AND RESOLUTIONS SUBMISSION OF GAMING ORDINANCE OR RESOLUTION § 522.10 Individually owned class II and class III...

  18. Contrasting evolutionary histories of MHC class I and class II loci in grouse—Effects of selection and gene conversion

    USGS Publications Warehouse

    Minias, Piotr; Bateson, Zachary W.; Whittingham, Linda A.; Johnson, Jeff A.; Oyler-McCance, Sara J.; Dunn, Peter O.

    2016-01-01

    Genes of the major histocompatibility complex (MHC) encode receptor molecules that are responsible for recognition of intracellular and extracellular pathogens (class I and class II genes, respectively) in vertebrates. Given the different roles of class I and II MHC genes, one might expect the strength of selection to differ between these two classes. Different selective pressures may also promote different rates of gene conversion at each class. Despite these predictions, surprisingly few studies have looked at differences between class I and II genes in terms of both selection and gene conversion. Here, we investigated the molecular evolution of MHC class I and II genes in five closely related species of prairie grouse (Centrocercus and Tympanuchus) that possess one class I and two class II loci. We found striking differences in the strength of balancing selection acting on MHC class I versus class II genes. More than half of the putative antigen-binding sites (ABS) of class II were under positive or episodic diversifying selection, compared with only 10% at class I. We also found that gene conversion had a stronger role in shaping the evolution of MHC class II than class I. Overall, the combination of strong positive (balancing) selection and frequent gene conversion has maintained higher diversity of MHC class II than class I in prairie grouse. This is one of the first studies clearly demonstrating that macroevolutionary mechanisms can act differently on genes involved in the immune response against intracellular and extracellular pathogens.

  19. Contrasting evolutionary histories of MHC class I and class II loci in grouse—effects of selection and gene conversion

    PubMed Central

    Minias, P; Bateson, Z W; Whittingham, L A; Johnson, J A; Oyler-McCance, S; Dunn, P O

    2016-01-01

    Genes of the major histocompatibility complex (MHC) encode receptor molecules that are responsible for recognition of intracellular and extracellular pathogens (class I and class II genes, respectively) in vertebrates. Given the different roles of class I and II MHC genes, one might expect the strength of selection to differ between these two classes. Different selective pressures may also promote different rates of gene conversion at each class. Despite these predictions, surprisingly few studies have looked at differences between class I and II genes in terms of both selection and gene conversion. Here, we investigated the molecular evolution of MHC class I and II genes in five closely related species of prairie grouse (Centrocercus and Tympanuchus) that possess one class I and two class II loci. We found striking differences in the strength of balancing selection acting on MHC class I versus class II genes. More than half of the putative antigen-binding sites (ABS) of class II were under positive or episodic diversifying selection, compared with only 10% at class I. We also found that gene conversion had a stronger role in shaping the evolution of MHC class II than class I. Overall, the combination of strong positive (balancing) selection and frequent gene conversion has maintained higher diversity of MHC class II than class I in prairie grouse. This is one of the first studies clearly demonstrating that macroevolutionary mechanisms can act differently on genes involved in the immune response against intracellular and extracellular pathogens. PMID:26860199

  20. Catalysts for oxidation of mercury in flue gas

    DOEpatents

    Granite, Evan J [Wexford, PA; Pennline, Henry W [Bethel Park, PA

    2010-08-17

    Two new classes of catalysts for the removal of heavy metal contaminants, especially mercury (Hg) from effluent gases. Both of these classes of catalysts are excellent absorbers of HCl and Cl.sub.2 present in effluent gases. This adsorption of oxidizing agents aids in the oxidation of heavy metal contaminants. The catalysts remove mercury by oxidizing the Hg into mercury (II) moieties. For one class of catalysts, the active component is selected from the group consisting of iridium (Ir) and iridum-platinum (Ir/Pt) alloys. The Ir and Ir/Pt alloy catalysts are especially corrosion resistant. For the other class of catalyst, the active component is partially combusted coal or "Thief" carbon impregnated with Cl.sub.2. Untreated Thief carbon catalyst can be self-activating in the presence of effluent gas streams. The Thief carbon catalyst is disposable by means of capture from the effluent gas stream in a particulate collection device (PCD).

  1. [Requirements for CE-marking of apps and wearables].

    PubMed

    Berensmann, Michael; Gratzfeld, Markus

    2018-03-01

    Depending on the intended use, apps and wearables can be medical devices. In such cases, the manufacturer has to provide evidence that the requirements stated in directive 93/42/EWG are fulfilled. Depending on the classification of the medical device, several so-called conformity assessment procedures are possible. Once the conformity assessment procedure has been finished successfully, the manufacturer attaches the CE-marking to the product. This assures that all requirements of the directive have been fulfilled and the manufacturer is therefore authorized to put the product onto the market in all member states of the European union. In this article, the possible and practical conformity assessment procedures for apps and wearables are described and their implementation is outlined.For medical devices with sufficiently high-risk classification, the manufacturer has to involve a Notified Body. For the conformity assessment procedure according to annex II, the manufacturer implements a full quality management system and compiles technical documentation. These are supervised and evaluated by Notified Body audits. Especially for startups, it is important for the development of apps and wearables to implement a quality management system early and to fulfill the regulatory requirements, for example, related to the software life-cycle model. This also includes considering accompanying processes during development like risk management, usability engineering, and clinical evaluation.Additionally, it should be pointed out, that according to the new medical device regulation almost all apps will fall at least into class IIa. Thus, the involvement of a Notified Body in the related conformity assessment procedures would be required. Apps that have already been put onto the market as class I devices, and are now upgraded to a higher class, need the approval of a notified body starting from 26 May 2020.

  2. The Impact of Obesity on Patients Bridged to Transplantation With Continuous-Flow Left Ventricular Assist Devices.

    PubMed

    Clerkin, Kevin J; Naka, Yoshifumi; Mancini, Donna M; Colombo, Paolo C; Topkara, Veli K

    2016-10-01

    This study sought to determine if obese patients had worse post-left ventricular assist device (LVAD) implantation outcomes and if the implantation of an LVAD allowed for weight loss. Obesity is a risk factor for cardiovascular disease including heart failure. Obese heart failure patients have better outcomes than those with normal weight; however, obese patients have worse outcomes after heart transplantation. Patients were identified in the United Network for Organ Sharing (UNOS) database that underwent LVAD implantation as bridge to transplantation from May 2004 and April 2014, with follow-up through June 2014. Patients were grouped according to body mass index (BMI) based on the World Health Organization classification. Among 3,856 patients, the risk of death or delisting was not significantly different between BMI groups (p = 0.347). There was no increased risk of death (p = 0.234) or delisting (p = 0.918). The risk of complication requiring UNOS status upgrade was increased for those with class II obesity or greater (hazard ratio: 1.48; p = 0.004), driven by increased infection and thromboembolism. Obese patients had worse post-transplantation outcomes. Weight loss substantial enough to decrease BMI group was achieved by a small proportion of patients listed with class I obesity or greater (9.6% to 15.5%). Patients with obesity had similar freedom from death or delisting while on LVAD support. However, class II obese or greater patients had an increased risk of complications requiring UNOS status upgrade compared with those with normal BMI during LVAD support and decreased post-transplantation survival. Weight loss on device therapy was possible, but uncommon. Careful consideration is needed when a bridge to weight loss strategy is proposed. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Evaluation of four microbial Class II fructose 1,6-bisphosphate aldolase enzymes for use as biocatalysts.

    PubMed

    Labbé, Geneviève; de Groot, Sarah; Rasmusson, Timothy; Milojevic, Gorica; Dmitrienko, Gary I; Guillemette, J Guy

    2011-12-01

    Fructose 1,6-bisphosphate (FBP) aldolase has been used as biocatalyst in the synthesis of several pharmaceutical compounds such as monosaccharides and analogs. Is has been suggested that microbial metal-dependant Class II aldolases could be better industrial catalysts than mammalian Class I enzyme because of their greater stability. The Class II aldolases from four microbes were subcloned into the Escherichia coli vector pT7-7, expressed and purified to near homogeneity. The kinetic parameters, temperature stability, pH profile, and tolerance to organic solvents of the Class II enzymes were determined, and compared with the properties of the Class I aldolase from rabbit muscle. Contrary to results obtained previously with the E. coli Class II aldolase, which was reported to be more stable than the mammalian enzyme, other recombinant Class II aldolases were found to be generally less stable than the Class I enzyme, especially in the presence of organic solvents. Class II aldolase from Bacillus cereus showed higher temperature stability than the other enzymes tested, but only the Mycobacterium tuberculosis Class II aldolase had a stability comparable to the Class I mammalian enzyme under assay conditions. The turnover number of the recombinant M. tuberculosis and Magnaporthe grisea Class II type A aldolases was comparable or higher than that of the Class I enzyme. The recombinant B. cereus and Pseudomonas aeruginosa Class II type B aldolases had very low turnover numbers and low metal content, indicating that the E. coli overexpression system may not be suitable for the Class II type B aldolases from these microorganisms. Copyright © 2011 Elsevier Inc. All rights reserved.

  4. 25 CFR 547.3 - What are the definitions for this part?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... TECHNICAL STANDARDS FOR GAMING EQUIPMENT USED WITH THE PLAY OF CLASS II GAMES § 547.3 What are the... Commission. Class II game. The same as “class II gaming” in 25 U.S.C. 2703(7)(A). Class II gaming system. All..., that function together to aid the play of one or more Class II games, including accounting functions...

  5. 25 CFR 547.3 - What are the definitions for this part?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... TECHNICAL STANDARDS FOR GAMING EQUIPMENT USED WITH THE PLAY OF CLASS II GAMES § 547.3 What are the... Commission. Class II game. The same as “class II gaming” in 25 U.S.C. 2703(7)(A). Class II gaming system. All..., that function together to aid the play of one or more Class II games, including accounting functions...

  6. 25 CFR 547.3 - What are the definitions for this part?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... TECHNICAL STANDARDS FOR GAMING EQUIPMENT USED WITH THE PLAY OF CLASS II GAMES § 547.3 What are the... Commission. Class II game. The same as “class II gaming” in 25 U.S.C. 2703(7)(A). Class II gaming system. All..., that function together to aid the play of one or more Class II games, including accounting functions...

  7. Comparison between Herbst appliances with or without miniscrew anchorage

    PubMed Central

    Manni, Antonio; Pasini, Marco; Mauro, Cozzani

    2012-01-01

    Background: Herbst appliance is largely used in orthodontics for the correction of Class II. The aim of this paper was to analyze dental and skeletal effects of a splints Herbst-miniscrews combined device in comparison to a mandibular splints Herbst appliance. Materials and Methods: Fifty Class II division 1 patients (27 males and 23 females with a mean age of 11.8 ± 1.7 years) were included in the study. Lateral headfilms of 25 patients with a mandibular resin splint and a miniscrew anchorage (test group) and of 25 patients with mandibular acrylic resin splints (control group) were analyzed before (T0) and after (T1) the Herbst treatment. The mean and standard deviation (SD) of each variable were calculated; paired t-test was used to evaluate statistical changes before and after the treatment, in each group and Student t-test was used to compare the two groups. Results: Significant differences were observed for P < 0.05. At the end of the Herbst treatment, mandibular incisor proclination was significantly lower in the test group (2.8°) in comparison to the control group (7.4°). Conclusions: The miniscrew-Herbst system, described in the present study, allows correction of Class II malocclusion, with a lower anchorage loss, in form of mandibular incisor proclination, during the treatment, in comparison to mandibular acrylic splints Herbst. PMID:23814587

  8. Electromyographic evaluation in children orthodontically treated for skeletal Class II malocclusion: Comparison of two treatment techniques.

    PubMed

    Ortu, Eleonora; Pietropaoli, Davide; Adib, Fray; Masci, Chiara; Giannoni, Mario; Monaco, Annalisa

    2017-11-16

    Objective To compare the clinical efficacy of two techniques for fabricating a Bimler device by assessing the patient's surface electromyography (sEMG) activity at rest before treatment and six months after treatment. Methods Twenty-four patients undergoing orthodontic treatment were enrolled in the study; 12 formed the test group and wore a Bimler device fabricated with a Myoprint impression using neuromuscular orthodontic technique and 12 formed the control group and were treated by traditional orthodontic technique with a wax bite in protrusion. The "rest" sEMG of each patient was recorded prior to treatment and six months after treatment. Results The neuromuscular-designed Bimler device was more comfortable and provided better treatment results than the traditional Bimler device. Conclusion This study suggests that the patient group subjected to neuromuscular orthodontic treatment had a treatment outcome with more relaxed masticatory muscles and better function versus the traditional orthodontic treatment.

  9. Alveolar bone thickness and lower incisor position in skeletal Class I and Class II malocclusions assessed with cone-beam computed tomography

    PubMed Central

    Ucar, Faruk Izzet; Buyuk, Suleyman Kutalmis; Ozer, Torun; Uysal, Tancan

    2013-01-01

    Objective To evaluate lower incisor position and bony support between patients with Class II average- and high-angle malocclusions and compare with the patients presenting Class I malocclusions. Methods CBCT records of 79 patients were divided into 2 groups according to sagittal jaw relationships: Class I and II. Each group was further divided into average- and high-angle subgroups. Six angular and 6 linear measurements were performed. Independent samples t-test, Kruskal-Wallis, and Dunn post-hoc tests were performed for statistical comparisons. Results Labial alveolar bone thickness was significantly higher in Class I group compared to Class II group (p = 0.003). Lingual alveolar bone angle (p = 0.004), lower incisor protrusion (p = 0.007) and proclination (p = 0.046) were greatest in Class II average-angle patients. Spongious bone was thinner (p = 0.016) and root apex was closer to the labial cortex in high-angle subgroups when compared to the Class II average-angle subgroup (p = 0.004). Conclusions Mandibular anterior bony support and lower incisor position were different between average- and high-angle Class II patients. Clinicians should be aware that the range of lower incisor movement in high-angle Class II patients is limited compared to average- angle Class II patients. PMID:23814708

  10. Alveolar bone thickness and lower incisor position in skeletal Class I and Class II malocclusions assessed with cone-beam computed tomography.

    PubMed

    Baysal, Asli; Ucar, Faruk Izzet; Buyuk, Suleyman Kutalmis; Ozer, Torun; Uysal, Tancan

    2013-06-01

    To evaluate lower incisor position and bony support between patients with Class II average- and high-angle malocclusions and compare with the patients presenting Class I malocclusions. CBCT records of 79 patients were divided into 2 groups according to sagittal jaw relationships: Class I and II. Each group was further divided into average- and high-angle subgroups. Six angular and 6 linear measurements were performed. Independent samples t-test, Kruskal-Wallis, and Dunn post-hoc tests were performed for statistical comparisons. Labial alveolar bone thickness was significantly higher in Class I group compared to Class II group (p = 0.003). Lingual alveolar bone angle (p = 0.004), lower incisor protrusion (p = 0.007) and proclination (p = 0.046) were greatest in Class II average-angle patients. Spongious bone was thinner (p = 0.016) and root apex was closer to the labial cortex in high-angle subgroups when compared to the Class II average-angle subgroup (p = 0.004). Mandibular anterior bony support and lower incisor position were different between average- and high-angle Class II patients. Clinicians should be aware that the range of lower incisor movement in high-angle Class II patients is limited compared to average- angle Class II patients.

  11. Effect of monoclonal antibodies (MoAb) to class I and class II HLA antigens on lectin- and MoAb OKT3-induced lymphocyte proliferation.

    PubMed

    Akiyama, Y; Zicht, R; Ferrone, S; Bonnard, G D; Herberman, R B

    1985-04-01

    We have examined the effect of several monoclonal antibodies (MoAb) to monomorphic determinants of class II HLA antigens, and MoAb to monomorphic determinants of class I HLA antigens and to beta-2-microglobulin (beta 2-mu) on lectin- and MoAb OKT3-induced proliferation of human peripheral blood mononuclear cells (PBMNC) and cultured T cells (CTC). Some, but not all, anti-class II HLA MoAb inhibited the proliferative response of PBMNC to MoAb OKT3 and pokeweed mitogen (PWM). The degree of inhibitory effect varied considerably. This effect was not limited to anti-class II HLA MoAb since anti-class I HLA MoAb and anti-beta 2-mu MoAb also inhibited MoAb OKT3- or PWM-induced proliferative responses. In contrast, the response of PBMNC to phytohemagglutinin (PHA) and concanavalin A (Con A) was not blocked by any anti-class II HLA MoAb. However, some anti-class II HLA MoAb also inhibited the proliferative response of CTC plus allogeneic peripheral blood adherent accessory cells (AC) to PHA or Con A as well as to MoAb OKT3 or PWM. This may be attributable to the substantially greater class II HLA antigen expression by CTC than by fresh lymphocytes. Pretreatment of either CTC or AC with anti-class II HLA MoAb inhibited OKT3-induced proliferation. In contrast, pretreatment of CTC, but not AC, with anti-class I HLA MoAb inhibited the proliferative response of CTC to OKT3. Pretreatment of CTC with anti-class I HLA MoAb inhibited PHA-, Con A and PWM-induced proliferation, to a greater degree than the anti-class II HLA MoAb. It appears as if lymphocyte activation by different mitogens exhibits variable requirements for the presence of cells expressing major histocompatibility determinants. Binding of Ab to membrane markers may interfere with lymphocyte-AC cooperation, perhaps by inhibiting binding of mitogens to their receptors or by interfering with lymphocyte and AC function. We also have examined the role of class II HLA antigens on CTC by depleting class II HLA-positive cells. As expected, elimination of class II HLA-positive AC with anti-class II HLA MoAb plus complement caused a decrease in proliferation of CTC in response to all the mitogens tested. In contrast, elimination of class II HLA-positive CTC was shown to clearly increase proliferation of CTC, perhaps because this may deplete class II HLA-positive suppressor cells.

  12. Comparison of the Pendulum appliance and the Jones Jig: A prospective comparative study.

    PubMed

    Shetty, Sushruth; Maurya, Rajkumar; Raj, H V Pruthvi; Patil, Anand

    2017-01-01

    To compare two molar distalization devices, the Pendulum appliance (PA) and the Jones Jig (JJ) in dental Class II patients. Pretreatment and postdistalization lateral cephalograms and study models of 20 subjects (6 males, 14 females) Class II malocclusion subjects were examined. PA and JJ group both consisted of 10 patients each with a mean pretreatment age of 12 years 1 month for females and 12 years 5 months for males. The PA and the JJ appliance were activated once in a month until Class II molar relationship was corrected to a super Class I molar relationship in both groups. Initial and final measurements and treatment changes were compared by means of Paired t -test. Maxillary first molar distalized an average of 3.85 mm in the PA and 2.75 mm in the JJ between T1 and T2; rate of molar distalization was 1.59 mm/month for PA, and the JJ appliance averaged 0.88 mm/month, distal molar tipping was greater in PA (6.2°) than in the JJ (3.9°). Average mesial movement of the premolars was 2.2 mm with PA and JJ both. JJ showed a greater rotation of first molars after distalization as compared to PA. The increase in vertical facial height was also greater for JJ as compared to PA. Both the appliances were effective in molar distalization with PA requiring less distalization time (16 days less than JJ). Some adverse effects were noted with both which one should strive to control.

  13. Emergency department visits for medical device-associated adverse events among children.

    PubMed

    Wang, Cunlin; Hefflin, Brock; Cope, Judith U; Gross, Thomas P; Ritchie, Mary Beth; Qi, Youlin; Chu, Jianxiong

    2010-08-01

    The purposes of this study were to provide national estimates of emergency department (ED) visits for medical device-associated adverse events (MDAEs) in the pediatric population and to characterize these events further. ED medical record reports from the National Electronic Injury Surveillance System All Injury Program database from January 1, 2004, through December 21, 2005, were reviewed. MDAEs among pediatric patients were identified, and data were abstracted. National estimates for pediatric MDAEs were determined according to medical specialty, device category and class, injury diagnosis, and patient characteristics and outcome. The total estimated number of pediatric MDAEs during the 24-month period was 144,799 (95% confidence interval: 113,051-183,903), involving devices from 13 medical specialties. Contact lenses accounted for most MDAEs (23%), followed by hypodermic needles (8%). The distribution of MDAEs according to medical specialty varied according to age subgroup. The most-prevalent types of injuries included contusions/abrasions, foreign-body intrusions, punctures, lacerations, and infections. The most-frequently affected body parts were the eyeball, pubic region, finger, face, and ear. The majority of pediatric MDAEs involved class II (moderate-risk) devices. The incidence of pediatric MDAEs decreased with increasing age from early to late childhood and then spiked after 10 years of age. More girls than boys were affected at older ages (16-21 years) and more boys than girls at younger ages (< or =10 years). Hospitalizations were more likely to involve invasive or implanted devices. This study provides national estimates of pediatric MDAEs resulting in ED visits and highlights the need to develop interventions to prevent pediatric device-related injuries.

  14. Immunological Functions of the Membrane Proximal Region of MHC Class II Molecules

    PubMed Central

    Harton, Jonathan; Jin, Lei; Hahn, Amy; Drake, Jim

    2016-01-01

    Major histocompatibility complex (MHC) class II molecules present exogenously derived antigen peptides to CD4 T cells, driving activation of naïve T cells and supporting CD4-driven immune functions. However, MHC class II molecules are not inert protein pedestals that simply bind and present peptides. These molecules also serve as multi-functional signaling molecules delivering activation, differentiation, or death signals (or a combination of these) to B cells, macrophages, as well as MHC class II-expressing T cells and tumor cells. Although multiple proteins are known to associate with MHC class II, interaction with STING (stimulator of interferon genes) and CD79 is essential for signaling. In addition, alternative transmembrane domain pairing between class II α and β chains influences association with membrane lipid sub-domains, impacting both signaling and antigen presentation. In contrast to the membrane-distal region of the class II molecule responsible for peptide binding and T-cell receptor engagement, the membrane-proximal region (composed of the connecting peptide, transmembrane domain, and cytoplasmic tail) mediates these “non-traditional” class II functions. Here, we review the literature on the function of the membrane-proximal region of the MHC class II molecule and discuss the impact of this aspect of class II immunobiology on immune regulation and human disease. PMID:27006762

  15. Mini-implant-borne Pendulum B appliance for maxillary molar distalisation: design and clinical procedure.

    PubMed

    Wilmes, Benedict; Katyal, Vandana; Drescher, Dieter

    2014-11-01

    A treatment objective of upper molar distalisation may often be required during the correction of a malocclusion. Distalisation is not only indicated for the management of Class II patients, but also for Class III surgery patients who require decompensation in the upper arch if upper incisor retrusion is needed. Unfortunately, most conventional intra-oral devices for non-compliance maxillary molar distalisation experience anchorage loss. A Pendulum type of appliance and a mini-implant-borne distalisation mechanism have been designed which can be inserted at chair-side, without a prior laboratory procedure and immediately after mini-implant placement. For re-activation purposes, a distal screw may be added to the Pendulum B appliance.

  16. 25 CFR 522.5 - Disapproval of a class II ordinance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Disapproval of a class II ordinance. 522.5 Section 522.5 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR APPROVAL OF CLASS II AND CLASS III ORDINANCES AND RESOLUTIONS SUBMISSION OF GAMING ORDINANCE OR RESOLUTION § 522.5 Disapproval of a class II...

  17. Comprehensive analysis of MHC class II genes in teleost fish genomes reveals dispensability of the peptide-loading DM system in a large part of vertebrates

    PubMed Central

    2013-01-01

    Background Classical major histocompatibility complex (MHC) class II molecules play an essential role in presenting peptide antigens to CD4+ T lymphocytes in the acquired immune system. The non-classical class II DM molecule, HLA-DM in the case of humans, possesses critical function in assisting the classical MHC class II molecules for proper peptide loading and is highly conserved in tetrapod species. Although the absence of DM-like genes in teleost fish has been speculated based on the results of homology searches, it has not been definitively clear whether the DM system is truly specific for tetrapods or not. To obtain a clear answer, we comprehensively searched class II genes in representative teleost fish genomes and analyzed those genes regarding the critical functional features required for the DM system. Results We discovered a novel ancient class II group (DE) in teleost fish and classified teleost fish class II genes into three major groups (DA, DB and DE). Based on several criteria, we investigated the classical/non-classical nature of various class II genes and showed that only one of three groups (DA) exhibits classical-type characteristics. Analyses of predicted class II molecules revealed that the critical tryptophan residue required for a classical class II molecule in the DM system could be found only in some non-classical but not in classical-type class II molecules of teleost fish. Conclusions Teleost fish, a major group of vertebrates, do not possess the DM system for the classical class II peptide-loading and this sophisticated system has specially evolved in the tetrapod lineage. PMID:24279922

  18. Lumbar Spinous Process Fixation and Fusion: A Systematic Review and Critical Analysis of an Emerging Spinal Technology.

    PubMed

    Lopez, Alejandro J; Scheer, Justin K; Dahdaleh, Nader S; Patel, Alpesh A; Smith, Zachary A

    2017-11-01

    A systematic review. The available literature on interspinous rigid fixation/fusion devices (IFD) was systematically reviewed to explore the devices' efficacy and complication profile. The clinical application of new spinal technologies may proceed without well-established evidence, as is the case with IFDs. IFDs are plate-like devices that are attached to the lateral aspects of 2 adjacent spinous processes to promote rigidity at that segment. Despite almost a decade since the devices' introduction, the literature regarding efficacy and safety is sparse. Complications have been reported but no definitive study is known to the authors. A systematic review of the past 10 years of English literature was conducted according to PRISMA guidelines. The timeframe was chosen based on publication of the first study containing a modern IFD, the SPIRE, in 2006. All PubMed publications containing MeSH headings or with title or abstract containing any combination of the words "interspinous," "spinous process," "fusion," "fixation," "plate," or "plating" were included. Exclusion criteria consisted of dynamic stabilization devices (X-Stop, DIAM, etc.), cervical spine, pediatrics, and animal models. The articles were blinded to author and journal, assigned a level of evidence by Oxford Centre of Evidence-Based Medicine (OCEBM) criteria, and summarized in an evidentiary table. A total of 293 articles were found in the initial search, of which 15 remained after examination for exclusion criteria. No class I or class II evidence regarding IFDs was found. IFDs have been shown by methodologically flawed and highly biased class III evidence to reduce instability at 1 year, without statistical comparison of complication rates against other treatment modalities. Although IFDs are heavily marketed and commonly applied in modern practice, data on safety and efficacy are inadequate. The paucity of evidence warrants reexamination of these devices' value and indications by the spine surgery community.

  19. The overlooked "nonclassical" functions of major histocompatibility complex (MHC) class II antigens in immune and nonimmune cells.

    PubMed

    Altomonte, M; Pucillo, C; Maio, M

    1999-06-01

    Besides their "classical" antigenic peptide-presenting activity, major histocompatibility complex (MHC) class II antigens can activate different cellular functions in immune and nonimmune cells. However, this "nonclassical" role and its functional consequences are still substantially overlooked. In this review, we will focus on these alternative functional properties of MHC class II antigens, to reawaken attention to their present and foreseeable immunobiologic and pathogenetic implications. The main issues that will be addressed concern 1) the role of MHC class II molecules as basic components of exchangeable oligomeric protein complexes with intracellular signaling ability; 2) the nonclassical functions of MHC class II antigens in immune cells; 3) the pathogenetic role of MHC class II antigens in inflammatory/autoimmune and infectious disease; and 4) the functional role of MHC class II antigens in solid malignancies.

  20. Assessment: transcranial Doppler ultrasonography: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.

    PubMed

    Sloan, M A; Alexandrov, A V; Tegeler, C H; Spencer, M P; Caplan, L R; Feldmann, E; Wechsler, L R; Newell, D W; Gomez, C R; Babikian, V L; Lefkowitz, D; Goldman, R S; Armon, C; Hsu, C Y; Goodin, D S

    2004-05-11

    To review the use of transcranial Doppler ultrasonography (TCD) and transcranial color-coded sonography (TCCS) for diagnosis. The authors searched the literature for evidence of 1) if TCD provides useful information in specific clinical settings; 2) if using this information improves clinical decision making, as reflected by improved patient outcomes; and 3) if TCD is preferable to other diagnostic tests in these clinical situations. TCD is of established value in the screening of children aged 2 to 16 years with sickle cell disease for stroke risk (Type A, Class I) and the detection and monitoring of angiographic vasospasm after spontaneous subarachnoid hemorrhage (Type A, Class I to II). TCD and TCCS provide important information and may have value for detection of intracranial steno-occlusive disease (Type B, Class II to III), vasomotor reactivity testing (Type B, Class II to III), detection of cerebral circulatory arrest/brain death (Type A, Class II), monitoring carotid endarterectomy (Type B, Class II to III), monitoring cerebral thrombolysis (Type B, Class II to III), and monitoring coronary artery bypass graft operations (Type B to C, Class II to III). Contrast-enhanced TCD/TCCS can also provide useful information in right-to-left cardiac/extracardiac shunts (Type A, Class II), intracranial occlusive disease (Type B, Class II to IV), and hemorrhagic cerebrovascular disease (Type B, Class II to IV), although other techniques may be preferable in these settings.

  1. 25 CFR 547.8 - What are the minimum technical software standards applicable to Class II gaming systems?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF CLASS II GAMES § 547.8 What are the minimum technical software standards applicable to Class II... of Class II games. (a) Player interface displays. (1) If not otherwise provided to the player, the player interface shall display the following: (i) The purchase or wager amount; (ii) Game results; and...

  2. 25 CFR 547.8 - What are the minimum technical software standards applicable to Class II gaming systems?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... OF CLASS II GAMES § 547.8 What are the minimum technical software standards applicable to Class II... of Class II games. (a) Player interface displays. (1) If not otherwise provided to the player, the player interface shall display the following: (i) The purchase or wager amount; (ii) Game results; and...

  3. 25 CFR 547.8 - What are the minimum technical software standards applicable to Class II gaming systems?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... OF CLASS II GAMES § 547.8 What are the minimum technical software standards applicable to Class II... of Class II games. (a) Player interface displays. (1) If not otherwise provided to the player, the player interface shall display the following: (i) The purchase or wager amount; (ii) Game results; and...

  4. The Impact of Obesity on Patients Bridged to Transplantation with Continuous-Flow Left Ventricular Assist Devices

    PubMed Central

    Clerkin, Kevin J.; Naka, Yoshifumi; Mancini, Donna M.; Colombo, Paolo C.; Topkara, Veli K.

    2017-01-01

    Objectives This study sought to determine if obese patients had worse post-LVAD implantation outcomes and if the implantation of an LVAD allowed for weight loss. Background Obesity is a risk factor for cardiovascular disease including heart failure. Obese heart failure patients have better outcomes than those with normal weight; however obese patients have worse outcomes following heart transplantation. Methods Patients were identified in the UNOS database that underwent LVAD implantation as bridge to transplantation from May 2004 and April 2014, with follow-up through June 2014. Patients were grouped according to BMI based on the WHO classification Results Among 3,856 patients the risk of death or delisting was not significantly different between BMI groups (p=0.347). There was no increased risk of death (p=0.234) or delisting (p=0.918). The risk of complication requiring UNOS status upgrade was increased for those with Class II obesity or greater (HR 1.48, 95% CI 1.14–1.93, p=0.004), driven by increased infection and thromboembolism. Obese patients had worse post-transplant outcomes. Weight loss substantial enough to decrease BMI group was achieved by a small proportion of patients listed with Class I obesity or greater (9.6–15.5%). Conclusions Patients with obesity had similar freedom from death or delisting while on LVAD support. However, Class II obese or greater patients had an increased risk of complications requiring UNOS status upgrade compared with those with normal BMI during LVAD support and decreased post-transplant survival. Weight loss on device therapy was possible, but uncommon. Careful consideration is needed when a bridge to weight loss strategy is proposed. PMID:27614942

  5. Effects of porosity distribution and porosity volume fraction on the electromechanical properties of 3-3 piezoelectric foams

    NASA Astrophysics Data System (ADS)

    Nguyen, B. V.; Challagulla, K. S.; Venkatesh, T. A.; Hadjiloizi, D. A.; Georgiades, A. V.

    2016-12-01

    Unit-cell based finite element models are developed to completely characterize the role of porosity distribution and porosity volume fraction in determining the elastic, dielectric and piezoelectric properties as well as relevant figures of merit of 3-3 type piezoelectric foam structures. Eight classes of foam structures which represent structures with different types and degrees of uniformity of porosity distribution are identified; a Base structure (Class I), two H-type foam structures (Classes II, and III), a Cross-type foam structure (Class IV) and four Line-type foam structures (Classes V, VI, VII, and VIII). Three geometric factors that influence the electromechanical properties are identified: (i) the number of pores per face, pore size and the distance between the pores; (ii) pore orientation with respect to poling direction; (iii) the overall symmetry of the pore distribution with respect to the center of the face of the unit cell. To assess the suitability of these structures for such applications as hydrophones, bone implants, medical imaging and diagnostic devices, five figures of merit are determined via the developed finite element model; the piezoelectric coupling constant (K t ), the acoustic impedance (Z), the piezoelectric charge coefficient (d h ), the hydrostatic voltage coefficient (g h ), and the hydrostatic figure of merit (d h g h ). At high material volume fractions, foams with non-uniform Line-type porosity (Classes V and VII) where the pores are preferentially distributed perpendicular to poling direction, are found to exhibit the best combination of desirable piezoelectric figures of merit. For example, at about 50% volume fraction, the d h , g h , and d h g h figures of merit are 55%, 1600% and 2500% higher, respectively, for Classes V and VII of Line-like foam structures compared with the Base structure.

  6. 40 CFR 147.3200 - Fort Peck Indian Reservation: Assiniboine & Sioux Tribes-Class II wells.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...: Assiniboine & Sioux Tribes-Class II wells. 147.3200 Section 147.3200 Protection of Environment ENVIRONMENTAL... INJECTION CONTROL PROGRAMS Assiniboine and Sioux Tribes § 147.3200 Fort Peck Indian Reservation: Assiniboine & Sioux Tribes—Class II wells. The UIC program for Class II injection wells on all lands within the...

  7. 40 CFR 147.3200 - Fort Peck Indian Reservation: Assiniboine & Sioux Tribes-Class II wells.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...: Assiniboine & Sioux Tribes-Class II wells. 147.3200 Section 147.3200 Protection of Environment ENVIRONMENTAL... INJECTION CONTROL PROGRAMS Assiniboine and Sioux Tribes § 147.3200 Fort Peck Indian Reservation: Assiniboine & Sioux Tribes—Class II wells. The UIC program for Class II injection wells on all lands within the...

  8. 40 CFR 147.3200 - Fort Peck Indian Reservation: Assiniboine & Sioux Tribes-Class II wells.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...: Assiniboine & Sioux Tribes-Class II wells. 147.3200 Section 147.3200 Protection of Environment ENVIRONMENTAL... INJECTION CONTROL PROGRAMS Assiniboine and Sioux Tribes § 147.3200 Fort Peck Indian Reservation: Assiniboine & Sioux Tribes—Class II wells. The UIC program for Class II injection wells on all lands within the...

  9. 78 FR 24061 - Minimum Technical Standards for Class II Gaming Systems and Equipment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... Register that established technical standards for ensuring the integrity of electronic Class II games and aids. 73 FR 60508, Oct. 10, 2008. The technical standards were designed to assist tribal gaming... Class II gaming systems. The standards did not classify which games were Class II games and which games...

  10. 40 CFR 147.3400 - Navajo Indian lands-Class II wells.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 23 2014-07-01 2014-07-01 false Navajo Indian lands-Class II wells... Indian Lands § 147.3400 Navajo Indian lands—Class II wells. The UIC program for Class II injection wells... outside those exterior boundaries (collectively referred to as “Navajo Indian lands for which EPA has...

  11. Differential Transmembrane Domain GXXXG Motif Pairing Impacts Major Histocompatibility Complex (MHC) Class II Structure*

    PubMed Central

    Dixon, Ann M.; Drake, Lisa; Hughes, Kelly T.; Sargent, Elizabeth; Hunt, Danielle; Harton, Jonathan A.; Drake, James R.

    2014-01-01

    Major histocompatibility complex (MHC) class II molecules exhibit conformational heterogeneity, which influences their ability to stimulate CD4 T cells and drive immune responses. Previous studies suggest a role for the transmembrane domain of the class II αβ heterodimer in determining molecular structure and function. Our previous studies identified an MHC class II conformer that is marked by the Ia.2 epitope. These Ia.2+ class II conformers are lipid raft-associated and able to drive both tyrosine kinase signaling and efficient antigen presentation to CD4 T cells. Here, we establish that the Ia.2+ I-Ak conformer is formed early in the class II biosynthetic pathway and that differential pairing of highly conserved transmembrane domain GXXXG dimerization motifs is responsible for formation of Ia.2+ versus Ia.2− I-Ak class II conformers and controlling lipid raft partitioning. These findings provide a molecular explanation for the formation of two distinct MHC class II conformers that differ in their inherent ability to signal and drive robust T cell activation, providing new insight into the role of MHC class II in regulating antigen-presenting cell-T cell interactions critical to the initiation and control of multiple aspects of the immune response. PMID:24619409

  12. Reporting guide for laser-light shows and displays (21 CFR 1002)

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

    Not Available

    The guide is to be used for reporting laser-light shows or displays incorporating Class IIIb or Class IV lasers only. Separate reports are not required for shows or displays that incorporate Class I, IIa, II, or IIIa laser-projection systems. Such show descriptions must be included in the user instructions and the report for the laser projector. Laser projectors used in any light shows or displays regardless of the class of the projector must be certified by the manufacturer and reported using the guide titled, Guide for Preparing Initial Reports and Model Change Reports on Lasers and Products Containing Lasers, HHSmore » Publication FDA 86-8259. These guides assist manufacturers in providing the information that the Center for Devices and Radiological Health (CDRH) needs to determine how laser-light-shown projections and laser-light shows comply with the Federal standard for laser products (21 CDR 1040.10 and 1040.11) and with the conditions of an approved variance.« less

  13. 40 CFR 144.19 - Transitioning from Class II to Class VI.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... primary purpose of long-term storage into an oil and gas reservoir must apply for and obtain a Class VI geologic sequestration permit when there is an increased risk to USDWs compared to Class II operations. In... Class II operations and a Class VI permit is required. In order to make this determination the Director...

  14. A Triad of Molecular Regions Contribute to the Formation of Two Distinct MHC Class II Conformers

    PubMed Central

    Drake, Lisa A.; Drake, James R.

    2016-01-01

    MHC class II molecules present antigen-derived peptides to CD4 T cells to drive the adaptive immune response. Previous work has established that class II αβ dimers can adopt two distinct conformations, driven by the differential pairing of transmembrane domain GxxxG dimerization motifs. These class II conformers differ in their ability to be loaded with antigen-derived peptide and to effectively engage CD4 T cells. Motif 1 (M1) paired I-Ak class II molecules are efficiently loaded with peptides derived from the processing of B cell receptor-bound antigen, have unique B cell signaling properties and high T cell stimulation activity. The 11-5.2 mAb selectively binds M1 paired I-Ak class II molecules. However, the molecular determinants of 11-5.2 binding are currently unclear. Here, we report the ability of a human class II transmembrane domain to drive both M1 and M2 class II conformer formation. Protease sensitivity analysis further strengthens the idea that there are conformational differences between the extracellular domains of M1 and M2 paired class II. Finally, MHC class II chain alignments and site directed mutagenesis reveals a triad of molecular regions that contributes to 11-5.2 mAb binding. In addition to transmembrane GxxxG motif domain pairing, 11-5.2 binding is influenced directly by α chain residue Glu-71 and indirectly by the region around the inter-chain salt bridge formed by α chain Arg-52 and β chain Glu-86. These findings provide insight into the complexity of 11-5.2 mAb recognition of the M1 paired I-Ak class II conformer and further highlight the molecular heterogeneity of peptide-MHC class II complexes that drive T cell antigen recognition. PMID:27148821

  15. Maxillary and mandibular contribution to the establishment of class II malocclusion in an adult Lebanese population.

    PubMed

    El Hajj, Nadine; Bassil-Nassif, Nayla; Tauk, Alain; Mouhanna-Fattal, Carole; Bouserhal, Joseph P

    2017-12-01

    The main aim of this study was to describe the contribution of the maxilla and the mandible to the establishment of a Class II skeletal malocclusion in an adult Lebanese population. Secondary aims were to detect the presence of sex-based dimorphism and to study the influence of the vertical dimension on the Class II skeletal pattern. A sample of 90 adults in skeletal Class II was recruited and equally distributed according to sex and vertical typology. The study describes the skeletal and dentoalveolar cephalometric characteristics of the Class II sample, essentially according to Coben's cephalometric analysis. The total effective depth of the cranial base and the anterior cranial base angle (SN-BaH) were both greater in the Class II sample. In females, the effective depth of the maxilla (Ptm-A) was larger than normal while SNB was smaller. The parameters describing the size and shape of the body of the mandible were significantly different from those of normal subjects. The upper incisors were in a retrusive position, while the axis of the lower incisors was located normally. The mandibular molars had a more distal sagittal position. Hyperdivergent subjects had more significant posterior alveolar growth, a more retrusive mandibular position and smaller mandibular dimensions than the other two vertical sub-groups. The cranial base contributes to the establishment of a Class II malocclusion, and mandibular retrusion cannot be considered as a characteristic shared by all skeletal Class II subjects. Lessening of the absolute length of the mandibular body is the second most frequent etiological factor noted in the Class II sample studied. Most individuals in skeletal Class II have an associated dental Class II malocclusion, and the vertical dimension has an influence on the Class II skeletal pattern. Copyright © 2017 CEO. Published by Elsevier Masson SAS. All rights reserved.

  16. Dual MAPK inhibition is an effective therapeutic strategy for a subset of class II BRAF mutant melanoma.

    PubMed

    Dankner, Matthew; Lajoie, Mathieu; Moldoveanu, Dan; Nguyen, Tan-Trieu; Savage, Paul; Rajkumar, Shivshankari; Huang, Xiu; Lvova, Maria; Protopopov, Alexei; Vuzman, Dana; Hogg, David; Park, Morag; Guiot, Marie-Christine; Petrecca, Kevin; Mihalcioiu, Catalin; Watson, Ian R; Siegel, Peter M; Rose, April A N

    2018-06-14

    Dual MAPK pathway inhibition (dMAPKi) with BRAF and MEK inhibitors improves survival in BRAF V600E/K mutant melanoma, but the efficacy of dMAPKi in non-V600 BRAF mutant tumors is poorly understood. We sought to characterize the responsiveness of class II (enhanced kinase activity, dimerization dependent) BRAF mutant melanoma to dMAPKi. Tumors from patients with BRAF WT, V600E (class I) and L597S (class II) metastatic melanoma were used to generate patient-derived-xenografts (PDX). We assembled a panel of melanoma cell lines with class IIa (activation segment) or IIb (p-loop) mutations and compared these to wild-type or V600E/K BRAF mutant cells. Cell lines and PDXs were treated with BRAFi (vemurafenib, dabrafenib, encorafenib, LY3009120), MEKi (cobimetinib, trametinib, binimetinib) or the combination. We identified two patients with BRAF L597S metastatic melanoma who were treated with dMAPKi. BRAFi impaired MAPK signalling and cell growth in class I and II BRAF mutant cells. dMAPKi was more effective than either single MAPKi at inhibiting cell growth in all class II BRAF mutant cells tested. dMAPKi caused tumor regression in two melanoma PDXs with class II BRAF mutations, and prolonged survival of mice with class II BRAF mutant melanoma brain metastases. Two patients with BRAF L597S mutant melanoma clinically responded to dMAPKi. Class II BRAF mutant melanoma are growth inhibited by dMAPKi. Responses to dMAPKi have been observed in two patients with class II BRAF mutant melanoma. This data provides rationale for clinical investigation of dMAPKi in patients with class II BRAF mutant metastatic melanoma. Copyright ©2018, American Association for Cancer Research.

  17. Equine bone marrow-derived mesenchymal stromal cells are heterogeneous in MHC class II expression and capable of inciting an immune response in vitro

    PubMed Central

    2014-01-01

    Introduction The horse is a valuable species to assess the effect of allogeneic mesenchymal stromal cells (MSCs) in regenerative treatments. No studies to date have examined recipient response to major histocompatibility complex (MHC)-mismatched equine MSCs. The purposes of this study were to immunophenotype MSCs from horses of known MHC haplotype and to compare the immunogenicity of MSCs with differing MHC class II expression. Methods MSCs and peripheral blood leukocytes (PBLs) were obtained from Thoroughbred horses (n = 10) of known MHC haplotype (ELA-A2, -A3, and -A9 homozygotes). MSCs were cultured through P8; cells from each passage (P2 to P8) were cryopreserved until used. Immunophenotyping of MHC class I and II, CD44, CD29, CD90, LFA-1, and CD45RB was performed by using flow cytometry. Tri-lineage differentiation assays were performed to confirm MSC multipotency. Recombinant equine IFN-γ was used to stimulate MHC class II negative MSCs in culture, after which expression of MHC class II was re-examined. To assess the ability of MHC class II negative or positive MSCs to stimulate an immune response, modified one-way mixed leukocyte reactions (MLRs) were performed by using MHC-matched and mismatched responder PBLs and stimulator PBLs or MSCs. Proliferation of gated CFSE-labeled CD3+ responder T cells was evaluated via CFSE attenuation by using flow cytometry and reported as the number of cells in the proliferating T-cell gate. Results MSCs varied widely in MHC class II expression despite being homogenous in terms of “stemness” marker expression and ability to undergo trilineage differentiation. Stimulation of MHC class II negative MSCs with IFN-γ resulted in markedly increased expression of MHC class II. MLR results revealed that MHC-mismatched MHC class II-positive MSCs caused significantly increased responder T-cell proliferation compared with MHC-mismatched MHC class II-negative and MHC-matched MSCs, and equivalent to that of the positive control of MHC-mismatched leukocytes. Conclusions The results of this study suggest that MSCs should be confirmed as MHC class II negative before allogeneic application. Additionally, it must be considered that even MHC class II-negative MSCs could upregulate MHC class II expression if implanted into an area of active inflammation, as demonstrated with in vitro stimulation with IFN-γ. PMID:24461709

  18. Sealing of minimally invasive Class II fillings (slot) using an adhesive patch: sealant margin extension for prevention.

    PubMed

    Schmidlin, Patrick R; Seemann, Rainer; Filli, Tilla; Attin, Thomas; Imfeld, Thomas

    2007-01-01

    A laboratory study was performed to assess the potential of an adhesive patch to seal small, unbeveled, Class II, box-only (slot) composite fillings. After minimal access cavity preparation with an 80 pm diamond bur, 40 box-only Class II cavities were prepared mesially and distally in 20 extracted human molars using a u-shaped PCS insert (EMS). One cavity per tooth was adhesively filled with a hybrid composite material in one increment. A patch, acting as an adhesive matrice, was applied to the other cavity of each tooth to seal the restoration. The margin of the patch was located in areas easily accessible to oral hygiene measures and self-cleaning. All the teeth were subjected to thermo-mechanical stress in a computer-controlled masticator device. In 10 teeth, caries was induced in a microbial-based artificial mouth model and quantitatively determined by confocal laser scanning microscopy. Microleakage was assessed in the other 10 teeth in two planar sections after immersion in 0.5% basic fuchsin solution. The results showed no demineralization at the filling margins protected with the patch. Microleakage was observed in one sample only and was limited to the enamel. In contrast, the margins of fillings without the patch application showed a mean demineralization depth of 146 +/- 42 microm and dye penetration into the dentin in five sections. This innovative approach to sealing restorative margins with an adhesive patch results in less leakage and filling margin demineralization and merits further investigation.

  19. The Hybrid Aesthetic Functional (HAF) Appliance: A Less Visible Proposal for Functional Orthodontics

    PubMed Central

    2013-01-01

    In modern orthodontics, aesthetics appear to have a decisive influence on orthodontic appliance preferences and acceptability. This paper reports the early application of a newly emerged functional device with enhanced aesthetics in a Class II treatment. Patient perspectives and technical considerations are discussed along with recommendations for further design development. It can be assumed that the use of thermoplastic material-based appliances may meet both the therapeutic and aesthetic demands of young age groups. PMID:23956884

  20. 49 CFR 1150.35 - Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 8 2014-10-01 2014-10-01 false Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers. 1150.35 Section 1150.35 Transportation Other Regulations.... 10901 § 1150.35 Procedures and relevant dates—transactions that involve creation of Class I or Class II...

  1. 49 CFR 1150.35 - Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 8 2013-10-01 2013-10-01 false Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers. 1150.35 Section 1150.35 Transportation Other Regulations.... 10901 § 1150.35 Procedures and relevant dates—transactions that involve creation of Class I or Class II...

  2. 49 CFR 1150.35 - Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 8 2012-10-01 2012-10-01 false Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers. 1150.35 Section 1150.35 Transportation Other Regulations.... 10901 § 1150.35 Procedures and relevant dates—transactions that involve creation of Class I or Class II...

  3. 49 CFR 1150.35 - Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 8 2011-10-01 2011-10-01 false Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers. 1150.35 Section 1150.35 Transportation Other Regulations.... 10901 § 1150.35 Procedures and relevant dates—transactions that involve creation of Class I or Class II...

  4. 49 CFR 1150.35 - Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Procedures and relevant dates-transactions that involve creation of Class I or Class II carriers. 1150.35 Section 1150.35 Transportation Other Regulations.... 10901 § 1150.35 Procedures and relevant dates—transactions that involve creation of Class I or Class II...

  5. 49 CFR 572.127 - Test conditions and instrumentation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) Forces—Class 1000; (ii) Moments—Class 600; (iii) Pendulum acceleration—Class 180; (iv) Rotation—Class 60 (if used). (3) Thorax: (i) Rib acceleration—Class 1000; (ii) Spine and pendulum accelerations—Class...

  6. 49 CFR 572.127 - Test conditions and instrumentation.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) Forces—Class 1000; (ii) Moments—Class 600; (iii) Pendulum acceleration—Class 180; (iv) Rotation—Class 60 (if used). (3) Thorax: (i) Rib acceleration—Class 1000; (ii) Spine and pendulum accelerations—Class...

  7. 49 CFR 572.127 - Test conditions and instrumentation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) Forces—Class 1000; (ii) Moments—Class 600; (iii) Pendulum acceleration—Class 180; (iv) Rotation—Class 60 (if used). (3) Thorax: (i) Rib acceleration—Class 1000; (ii) Spine and pendulum accelerations—Class...

  8. 49 CFR 572.127 - Test conditions and instrumentation.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) Forces—Class 1000; (ii) Moments—Class 600; (iii) Pendulum acceleration—Class 180; (iv) Rotation—Class 60 (if used). (3) Thorax: (i) Rib acceleration—Class 1000; (ii) Spine and pendulum accelerations—Class...

  9. 49 CFR 572.127 - Test conditions and instrumentation.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) Forces—Class 1000; (ii) Moments—Class 600; (iii) Pendulum acceleration—Class 180; (iv) Rotation—Class 60 (if used). (3) Thorax: (i) Rib acceleration—Class 1000; (ii) Spine and pendulum accelerations—Class...

  10. Postoperative surgical complications of lymphadenohysterocolpectomy

    PubMed Central

    Marin, F; Pleşca, M; Bordea, CI; Voinea, SC; Burlănescu, I; Ichim, E; Jianu, CG; Nicolăescu, RR; Teodosie, MP; Maher, K; Blidaru, A

    2014-01-01

    Rationale The current standard surgical treatment for the cervix and uterine cancer is the radical hysterectomy (lymphadenohysterocolpectomy). This has the risk of intraoperative accidents and postoperative associated morbidity. Objective The purpose of this article is the evaluation and quantification of the associated complications in comparison to the postoperative morbidity which resulted after different types of radical hysterectomy. Methods and results Patients were divided according to the type of surgery performed as follows: for cervical cancer – group A- 37 classic radical hysterectomies Class III Piver - Rutledge -Smith ( PRS ), group B -208 modified radical hysterectomies Class II PRS and for uterine cancer- group C -79 extended hysterectomies with pelvic lymphadenectomy from which 17 patients with paraaortic lymphnode biopsy . All patients performed preoperative radiotherapy and 88 of them associated radiosensitization. Discussion Early complications were intra-abdominal bleeding ( 2.7% Class III PRS vs 0.48% Class II PRS), supra-aponeurotic hematoma ( 5.4% III vs 2.4% II) , dynamic ileus (2.7% III vs 0.96% II) and uro - genital fistulas (5.4% III vs 0.96% II).The late complications were the bladder dysfunction (21.6% III vs 16.35% II) , lower limb lymphedema (13.5% III vs 11.5% II), urethral strictures (10.8% III vs 4.8% II) , incisional hernias ( 8.1% III vs 7.2% II), persistent pelvic pain (18.91% III vs 7.7% II), bowel obstruction (5.4% III vs 1.4% II) and deterioration of sexual function (83.3% III vs 53.8% II). PRS class II radical hysterectomy is associated with fewer complications than PRS class III radical hysterectomy , except for the complications of lymphadenectomy . A new method that might reduce these complications is a selective lymphadenectomy represented by sentinel node biopsy . In conclusion PRS class II radical hysterectomy associated with neoadjuvant radiotherapy is a therapeutic option for the incipient stages of cervical cancer. Abbreviations: PRS- Piver Rutledge-Smith, II- class II, III- class III PMID:24653760

  11. 49 CFR 572.146 - Test conditions and instrumentation.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) Head acceleration—Class 1000 (2) Neck (i) Force—Class 1000 (ii) Moments—Class 600 (iii) Pendulum... acceleration—Class 1000 (ii) Spine and pendulum accelerations—Class 180 (iii) Sternum deflection—Class 600 (iv...

  12. 49 CFR 572.146 - Test conditions and instrumentation.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...) Head acceleration—Class 1000 (2) Neck (i) Force—Class 1000 (ii) Moments—Class 600 (iii) Pendulum... acceleration—Class 1000 (ii) Spine and pendulum accelerations—Class 180 (iii) Sternum deflection—Class 600 (iv...

  13. 49 CFR 572.146 - Test conditions and instrumentation.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...) Head acceleration—Class 1000 (2) Neck (i) Force—Class 1000 (ii) Moments—Class 600 (iii) Pendulum... acceleration—Class 1000 (ii) Spine and pendulum accelerations—Class 180 (iii) Sternum deflection—Class 600 (iv...

  14. 49 CFR 572.146 - Test conditions and instrumentation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) Head acceleration—Class 1000 (2) Neck (i) Force—Class 1000 (ii) Moments—Class 600 (iii) Pendulum... acceleration—Class 1000 (ii) Spine and pendulum accelerations—Class 180 (iii) Sternum deflection—Class 600 (iv...

  15. 49 CFR 572.146 - Test conditions and instrumentation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) Head acceleration—Class 1000 (2) Neck (i) Force—Class 1000 (ii) Moments—Class 600 (iii) Pendulum... acceleration—Class 1000 (ii) Spine and pendulum accelerations—Class 180 (iii) Sternum deflection—Class 600 (iv...

  16. [Effects of breathing exercises on breathing pattern and thoracoabdominal motion after gastroplasty].

    PubMed

    Tomich, Georgia Miranda; França, Danielle Corrêa; Diniz, Marco Túlio Costa; Britto, Raquel Rodrigues; Sampaio, Rosana Ferreira; Parreira, Verônica Franco

    2010-01-01

    To evaluate breathing pattern and thoracoabdominal motion during breathing exercises. Twenty-four patients with class II or III obesity (18 women; 6 men) were studied on the second postoperative day after gastroplasty. The mean age was 37 +/- 11 years, and the mean BMI was 44 +/- 3 kg/m(2). Diaphragmatic breathing, incentive spirometry with a flow-oriented device and incentive spirometry with a volume-oriented device were performed in random order. Respiratory inductive plethysmography was used in order to measure respiratory variables and thoracoabdominal motion. Comparisons among the three exercises showed significant differences: tidal volume was higher during incentive spirometry (with the flow-oriented device or with the volume-oriented device) than during diaphragmatic breathing; the respiratory rate was lower during incentive spirometry with the volume-oriented device than during incentive spirometry with the flow-oriented device; and minute ventilation was higher during incentive spirometry (with the flow-oriented device or with the volume-oriented device) than during diaphragmatic breathing. Rib cage motion did not vary during breathing exercises, although there was an increase in thoracoabdominal asynchrony, especially during incentive spirometry with the flow-oriented device. Among the breathing exercises evaluated, incentive spirometry with the volume-oriented device provided the best results, because it allowed slower, deeper inhalation.

  17. A simple device to illustrate the Einthoven triangle.

    PubMed

    Jin, Benjamin E; Wulff, Heike; Widdicombe, Jonathan H; Zheng, Jie; Bers, Donald M; Puglisi, Jose L

    2012-12-01

    The Einthoven triangle is central to the field of electrocardiography, but the concept of cardiac vectors is often a difficult notion for students to grasp. To illustrate this principle, we constructed a device that recreates the conditions of an ECG reading using a battery to simulate the electrical vector of the heart and three voltmeters for the main electrocardiographic leads. Requiring minimal construction with low cost, this device provides hands-on practice that enables students to rediscover the principles of the Einthoven triangle, namely, that the direction of the cardiac dipole can be predicted from the deflections in any two leads and that lead I + lead III = lead II independent of the position of heart's electrical vector. We built a total of 6 devices for classes of 30 students and tested them in the first-year Human Physiology course at the University of California-Davis School of Medicine. Combined with traditional demonstrations with ECG machines, this equipment demonstrated its ability to help medical students obtain a solid foundation of the basic principles of electrocardiography.

  18. Major histocompatibility complex class II molecule expression on muscle cells is regulated by differentiation: implications for the immunopathogenesis of muscle autoimmune diseases.

    PubMed

    Mantegazza, R; Gebbia, M; Mora, M; Barresi, R; Bernasconi, P; Baggi, F; Cornelio, F

    1996-08-01

    Major histocompatibility complex (MHC) class II molecules are expressed on myoblasts after interferon-gamma (IFN-gamma) treatment, suggesting a muscle cell involvement in antigen presentation in inflammatory myopathies. However, they were not observed on normal or pathological myofibers. This discrepancy might be related to different responsiveness of developmentally differentiated muscle cells to IFN-gamma. Myoblasts expressed class II transcripts and proteins after IFN-gamma, while myotubes and innervated contracting muscle cells did not show staining for class II molecules. At all cell stages no loss of IFN-gamma receptor was detected indicating that myofiber maturation blocks their capacity to express MHC class II molecules. This suggests that completely differentiated myofibers cannot participate in class II restricted immunological reactions.

  19. Self-esteem in adolescents with Angle Class I, II and III malocclusion in a Peruvian sample.

    PubMed

    Florián-Vargas, Karla; Honores, Marcos J Carruitero; Bernabé, Eduardo; Flores-Mir, Carlos

    2016-01-01

    To compare self-esteem scores in 12 to 16-year-old adolescents with different Angle malocclusion types in a Peruvian sample. A cross-sectional study was conducted in a sample of 276 adolescents (159, 52 and 65 with Angle Class I, II and III malocclusions, respectively) from Trujillo, Peru. Participants were asked to complete the Rosenberg Self-Esteem Scale (RSES) and were also clinically examined, so as to have Angle malocclusion classification determined. Analysis of covariance (ANCOVA) was used to compare RSES scores among adolescents with Class I, II and III malocclusions, with participants' demographic factors being controlled. Mean RSES scores for adolescents with Class I, II and III malocclusions were 20.47 ± 3.96, 21.96 ± 3.27 and 21.26 ± 4.81, respectively. The ANCOVA test showed that adolescents with Class II malocclusion had a significantly higher RSES score than those with Class I malocclusion, but there were no differences between other malocclusion groups. Supplemental analysis suggested that only those with Class II, Division 2 malocclusion might have greater self-esteem when compared to adolescents with Class I malocclusion. This study shows that, in general, self-esteem did not vary according to adolescents' malocclusion in the sample studied. Surprisingly, only adolescents with Class II malocclusion, particularly Class II, Division 2, reported better self-esteem than those with Class I malocclusion. A more detailed analysis assessing the impact of anterior occlusal features should be conducted.

  20. Occlusal status in Asian male adults: prevalence and ethnic variation.

    PubMed

    Soh, Jen; Sandham, Andrew; Chan, Yiong Huak

    2005-09-01

    The purpose of this study was to determine the occlusal status in young Asian male adults of three ethnic groups. Study models of a sample of male army recruits (N = 339, age 17-22 years) with no history of orthodontic treatment were assessed. The ethnic proportions of the sample were Chinese 76.1% (n = 258), Malay 17.7% (n = 60), and Indian 6.2% (n = 21). British Standard Institute (BSI) and Angle's classification were used to determine incisor and molar relationships, respectively. Chi-square test or Fisher's Exact test was performed to compare the occlusal traits between ethnic groups. The distribution of incisor relationships of the total sample consisted of Class I = 48.1%, Class II/1 = 26.3%, Class II/2 = 3.2%, and Class III = 22.4%. Right Angle's molar relationships were 49.9%, 24.5%, and 24.2% whereas left Angle's molar relationships were 53.1%, 25.1%, and 21.2% for Class I, II, and III, respectively. Comparison between ethnic groups found that Indian subjects were more likely to have Class II/1 malocclusions and clinically missing permanent teeth (P < .05). The study found that the overall prevalence of malocclusion (BSI) was Class I, Class II/1, Class III, and Class II/2 in descending order of proportions. Angle's Class I molar was most prevalent followed by Class II and Class III relations. A significant difference in occlusal status between the ethnic groups was found regarding incisor relationship and missing permanent teeth (P < .05).

  1. Outcomes of HeartWare Ventricular Assist System support in 141 patients: a single-centre experience.

    PubMed

    Wu, Long; Weng, Yu-Guo; Dong, Nian-Guo; Krabatsch, Thomas; Stepanenko, Alexander; Hennig, Ewald; Hetzer, Roland

    2013-07-01

    A third-generation ventricular assist device, the HeartWare Ventricular Assist System, has demonstrated its reliability and durability in animal models and clinical experience. However, studies of a large series of applications are still lacking. We evaluate the safety and efficacy of the HeartWare pump in 141 patients with end-stage heart failure at a single centre. A total of 141 patients (116 men and 25 women with a mean age of 52 years) in New York Heart Association (NYHA) Class IV received implantation of the HeartWare Ventricular Assist System between August 2009 and April 2011 at the Deutsches Herzzentrum Berlin. The outcomes were measured in terms of laboratory data, adverse events, NYHA functional class and survival during device support. The HeartWare system provided an adequate haemodynamic support for patients both inside and outside the hospital. NYHA class improved to I-II. Organ function and pulmonary vascular resistance improved significantly. In this cohort of patients, 14 patients underwent heart transplantation, one had had the device explanted following myocardial recovery, one had changed to another assist device, 81 were on ongoing support and 44 died. The overall actuarial survival rates at 6 and 12 months were 70 and 67%, respectively, and the 3-, 6- and 12-month survival rates on a left ventricular assist device (LVAD) support for bridge to transplantation patients were 82, 81 and 79%, respectively. Infection and bleeding were the main adverse events. Four patients underwent an LVAD exchange for pump thrombosis. The HeartWare system provides a safe and effective circulatory support in a population with a wide range of body surface areas, with a satisfactory actuarial survival time and an improved quality of life. It can be used for univentricular or biventricular support, being implanted into the pericardial space with simplified surgical techniques.

  2. Sequence, distribution and chromosomal context of class I and class II pilin genes of Neisseria meningitidis identified in whole genome sequences

    PubMed Central

    2014-01-01

    Background Neisseria meningitidis expresses type four pili (Tfp) which are important for colonisation and virulence. Tfp have been considered as one of the most variable structures on the bacterial surface due to high frequency gene conversion, resulting in amino acid sequence variation of the major pilin subunit (PilE). Meningococci express either a class I or a class II pilE gene and recent work has indicated that class II pilins do not undergo antigenic variation, as class II pilE genes encode conserved pilin subunits. The purpose of this work was to use whole genome sequences to further investigate the frequency and variability of the class II pilE genes in meningococcal isolate collections. Results We analysed over 600 publically available whole genome sequences of N. meningitidis isolates to determine the sequence and genomic organization of pilE. We confirmed that meningococcal strains belonging to a limited number of clonal complexes (ccs, namely cc1, cc5, cc8, cc11 and cc174) harbour a class II pilE gene which is conserved in terms of sequence and chromosomal context. We also identified pilS cassettes in all isolates with class II pilE, however, our analysis indicates that these do not serve as donor sequences for pilE/pilS recombination. Furthermore, our work reveals that the class II pilE locus lacks the DNA sequence motifs that enable (G4) or enhance (Sma/Cla repeat) pilin antigenic variation. Finally, through analysis of pilin genes in commensal Neisseria species we found that meningococcal class II pilE genes are closely related to pilE from Neisseria lactamica and Neisseria polysaccharea, suggesting horizontal transfer among these species. Conclusions Class II pilins can be defined by their amino acid sequence and genomic context and are present in meningococcal isolates which have persisted and spread globally. The absence of G4 and Sma/Cla sequences adjacent to the class II pilE genes is consistent with the lack of pilin subunit variation in these isolates, although horizontal transfer may generate class II pilin diversity. This study supports the suggestion that high frequency antigenic variation of pilin is not universal in pathogenic Neisseria. PMID:24690385

  3. Comparison of second molar eruption patterns in patients with skeletal Class II and skeletal Class I malocclusions.

    PubMed

    Brin, Ilana; Camasuvi, Semin; Dali, Nasser; Aizenbud, Dror

    2006-12-01

    The eruptive positions of the second molars in Class I and Class II malocclusions were studied. Pretreatment records of 221 patients with a mean age of 11.3 years were evaluated. About 19% of them had skeletal Class I, 31% had skeletal maxillary Class II, and 50% had skeletal mandibular Class II malocclusions. The mean values of the dental and chronologic ages of the subjects were similar. The eruptive positions in relation to a reference line, the developmental stages of the patients' second molars and dental ages were recorded from the panoramic roentgenograms. The distribution of the various developmental stages in each malocclusion group was similar, and no association between skeletal malocclusion and dental developmental stage of the second molars was encountered. The eruptive position of the maxillary second molars was more occlusal only in the oldest maxillary Class II group, above 12 years of age (P = .02). These results support, in part, previous reports suggesting that the maxillary second molars may erupt earlier in patients with skeletal maxillary Class II malocclusions.

  4. Antigen-B Cell Receptor Complexes Associate with Intracellular major histocompatibility complex (MHC) Class II Molecules*

    PubMed Central

    Barroso, Margarida; Tucker, Heidi; Drake, Lisa; Nichol, Kathleen; Drake, James R.

    2015-01-01

    Antigen processing and MHC class II-restricted antigen presentation by antigen-presenting cells such as dendritic cells and B cells allows the activation of naïve CD4+ T cells and cognate interactions between B cells and effector CD4+ T cells, respectively. B cells are unique among class II-restricted antigen-presenting cells in that they have a clonally restricted antigen-specific receptor, the B cell receptor (BCR), which allows the cell to recognize and respond to trace amounts of foreign antigen present in a sea of self-antigens. Moreover, engagement of peptide-class II complexes formed via BCR-mediated processing of cognate antigen has been shown to result in a unique pattern of B cell activation. Using a combined biochemical and imaging/FRET approach, we establish that internalized antigen-BCR complexes associate with intracellular class II molecules. We demonstrate that the M1-paired MHC class II conformer, shown previously to be critical for CD4 T cell activation, is incorporated selectively into these complexes and loaded selectively with peptide derived from BCR-internalized cognate antigen. These results demonstrate that, in B cells, internalized antigen-BCR complexes associate with intracellular MHC class II molecules, potentially defining a site of class II peptide acquisition, and reveal a selective role for the M1-paired class II conformer in the presentation of cognate antigen. These findings provide key insights into the molecular mechanisms used by B cells to control the source of peptides charged onto class II molecules, allowing the immune system to mount an antibody response focused on BCR-reactive cognate antigen. PMID:26400081

  5. Adverse effects of ultraviolet radiation from the use of indoor tanning equipment: time to ban the tan.

    PubMed

    Lim, Henry W; James, William D; Rigel, Darrell S; Maloney, Mary E; Spencer, James M; Bhushan, Reva

    2011-04-01

    The incidence of melanoma skin cancer is increasing rapidly, particularly among young women in the United States. Numerous studies have documented an association between the use of indoor tanning devices and an increased risk of skin cancer, especially in young women. Studies have shown that ultraviolet exposure, even in the absence of erythema or burn, results in DNA damage. Countries and regulatory bodies worldwide have recognized the health risks associated with indoor tanning. In the United States, 32 states have passed legislation to regulate the indoor tanning industry, but there is an urgent need to restrict the use of indoor tanning devices at the federal level. The Food and Drug Administration is currently reviewing the classification of these devices. For all of these reasons, the Food and Drug Administration should prohibit the use of tanning devices by minors and reclassify tanning devices to at least class II to protect the public from the preventable cancers and other adverse effects caused by ultraviolet radiation from indoor tanning. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  6. The Ia.2 Epitope Defines a Subset of Lipid Raft Resident MHC Class II Molecules Crucial to Effective Antigen Presentation1

    PubMed Central

    Busman-Sahay, Kathleen; Sargent, Elizabeth; Harton, Jonathan A.; Drake, James R.

    2016-01-01

    Previous work has established that binding of the 11-5.2 anti-I-Ak mAb, which recognizes the Ia.2 epitope on I-Ak class II molecules, elicits MHC class II signaling, whereas binding of two other anti-I-Ak mAb that recognize the Ia.17 epitope fail to elicit signaling. Using a biochemical approach, we establish that the Ia.2 epitope recognized by the widely used 11-5.2 mAb defines a subset of cell surface I-Ak molecules predominantly found within membrane lipid rafts. Functional studies demonstrate that the Ia.2 bearing subset of I-Ak class II molecules is critically necessary for effective B cell–T cell interactions especially at low antigen doses, a finding consistent with published studies on the role of raft-resident class II molecules in CD4 T cell activation. Interestingly, B cells expressing recombinant I-Ak class II molecules possessing a β chain-tethered HEL peptide lack the Ia.2 epitope and fail to partition into lipid rafts. Moreover, cells expressing Ia.2 negative tethered peptide-class II molecules are severely impaired in their ability to present both tethered peptide or peptide derived from exogenous antigen to CD4 T cells. These results establish the Ia.2 epitope as defining a lipid raft-resident MHC class II confomer vital to the initiation of MHC class II restricted B cell–T cell interactions. PMID:21543648

  7. 40 CFR 82.70 - Nonessential Class II products and exceptions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Nonessential Class II products and... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Ban on Nonessential Products Containing Class I Substances and Ban on Nonessential Products Containing or Manufactured With Class II Substances § 82.70...

  8. 40 CFR 82.70 - Nonessential Class II products and exceptions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 18 2012-07-01 2012-07-01 false Nonessential Class II products and... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Ban on Nonessential Products Containing Class I Substances and Ban on Nonessential Products Containing or Manufactured With Class II Substances § 82.70...

  9. 40 CFR 82.70 - Nonessential Class II products and exceptions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Nonessential Class II products and... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Ban on Nonessential Products Containing Class I Substances and Ban on Nonessential Products Containing or Manufactured With Class II Substances § 82.70...

  10. 40 CFR 82.70 - Nonessential Class II products and exceptions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 18 2013-07-01 2013-07-01 false Nonessential Class II products and... PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE Ban on Nonessential Products Containing Class I Substances and Ban on Nonessential Products Containing or Manufactured With Class II Substances § 82.70...

  11. 14 CFR 61.5 - Certificates and ratings issued under this part.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...-control aircraft. (2) Airplane class ratings— (i) Single-engine land. (ii) Multiengine land. (iii) Single-engine sea. (iv) Multiengine sea. (3) Rotorcraft class ratings— (i) Helicopter. (ii) Gyroplane. (4) Lighter-than-air class ratings— (i) Airship. (ii) Balloon. (5) Weight-shift-control aircraft class ratings...

  12. 14 CFR 61.5 - Certificates and ratings issued under this part.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...-control aircraft. (2) Airplane class ratings— (i) Single-engine land. (ii) Multiengine land. (iii) Single-engine sea. (iv) Multiengine sea. (3) Rotorcraft class ratings— (i) Helicopter. (ii) Gyroplane. (4) Lighter-than-air class ratings— (i) Airship. (ii) Balloon. (5) Weight-shift-control aircraft class ratings...

  13. 14 CFR 61.5 - Certificates and ratings issued under this part.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...-control aircraft. (2) Airplane class ratings— (i) Single-engine land. (ii) Multiengine land. (iii) Single-engine sea. (iv) Multiengine sea. (3) Rotorcraft class ratings— (i) Helicopter. (ii) Gyroplane. (4) Lighter-than-air class ratings— (i) Airship. (ii) Balloon. (5) Weight-shift-control aircraft class ratings...

  14. HLA Class II Defects in Burkitt Lymphoma: Bryostatin-1-Induced 17 kDa Protein Restores CD4+ T-Cell Recognition

    PubMed Central

    Hossain, Azim; God, Jason M.; Radwan, Faisal F. Y.; Amria, Shereen; Zhao, Dan; Bethard, Jennifer R.; Haque, Azizul

    2011-01-01

    While the defects in HLA class I-mediated Ag presentation by Burkitt lymphoma (BL) have been well documented, CD4+ T-cells are also poorly stimulated by HLA class II Ag presentation, and the reasons underlying this defect(s) have not yet been fully resolved. Here, we show that BL cells are deficient in their ability to optimally stimulate CD4+ T cells via the HLA class II pathway. The observed defect was not associated with low levels of BL-expressed costimulatory molecules, as addition of external co-stimulation failed to result in BL-mediated CD4+ T-cell activation. We further demonstrate that BL cells express the components of the class II pathway, and the defect was not caused by faulty Ag/class II interaction, because antigenic peptides bound with measurable affinity to BL-associated class II molecules. Treatment of BL with broystatin-1, a potent modulator of protein kinase C, led to significant improvement of functional class II Ag presentation in BL. The restoration of immune recognition appeared to be linked with an increased expression of a 17 kDa peptidylprolyl-like protein. These results demonstrate the presence of a specific defect in HLA class II-mediated Ag presentation in BL and reveal that treatment with bryostatin-1 could lead to enhanced immunogenicity. PMID:22162713

  15. Mechanisms regulating enhanced HLA class II-mediated CD4+ T cell recognition of human B-cell lymphoma by resveratrol

    PubMed Central

    RADWAN, FAISAL F. Y.; ZHANG, LIXIA; HOSSAIN, AZIM; DOONAN, BENTLY P.; GOD, JASON; HAQUE, AZIZUL

    2015-01-01

    Malignant B-cells express measurable levels of HLA class II proteins, but often escape immune recognition by CD4+ T cells. Resveratrol (Resv) has been the focus of numerous investigations due to its potential chemopreventive and anti-cancer effects, but it has never been tested in the regulation of immune components in B-cell tumors. Here, we show for the first time that Resv treatment enhances HLA class II-mediated immune detection of B-cell lymphomas by altering immune components and class II presentation in tumor cells. Resv treatment induced an upregulation of both classical and non-classical HLA class II proteins (DR and DM) in B-lymphoma cells. Resv also altered endolysosomal cathepsins (Cat S, B and D) and a thiol reductase (GILT), increasing HLA class II-mediated antigen (Ag) processing in B-cell lymphomas and their subsequent recognition by CD4+ T cells. Mechanistic study demonstrated that Resv treatment activated the recycling class II pathway of Ag presentation through upregulation of Rab 4B protein expression in B-lymphoma cells. These findings suggest that HLA class II-mediated immune recognition of malignant B-cells can be improved by Resv treatment, thus encouraging its potential use in chemoimmunotherapy of B-cell lymphoma. PMID:21854084

  16. Shark class II invariant chain reveals ancient conserved relationships with cathepsins and MHC class II.

    PubMed

    Criscitiello, Michael F; Ohta, Yuko; Graham, Matthew D; Eubanks, Jeannine O; Chen, Patricia L; Flajnik, Martin F

    2012-03-01

    The invariant chain (Ii) is the critical third chain required for the MHC class II heterodimer to be properly guided through the cell, loaded with peptide, and expressed on the surface of antigen presenting cells. Here, we report the isolation of the nurse shark Ii gene, and the comparative analysis of Ii splice variants, expression, genomic organization, predicted structure, and function throughout vertebrate evolution. Alternative splicing to yield Ii with and without the putative protease-protective, thyroglobulin-like domain is as ancient as the MHC-based adaptive immune system, as our analyses in shark and lizard further show conservation of this mechanism in all vertebrate classes except bony fish. Remarkable coordinate expression of Ii and class II was found in shark tissues. Conserved Ii residues and cathepsin L orthologs suggest their long co-evolution in the antigen presentation pathway, and genomic analyses suggest 450 million years of conserved Ii exon/intron structure. Other than an extended linker preceding the thyroglobulin-like domain in cartilaginous fish, the Ii gene and protein are predicted to have largely similar physiology from shark to man. Duplicated Ii genes found only in teleosts appear to have become sub-functionalized, as one form is predicted to play the same role as that mediated by Ii mRNA alternative splicing in all other vertebrate classes. No Ii homologs or potential ancestors of any of the functional Ii domains were found in the jawless fish or lower chordates. Copyright © 2011 Elsevier Ltd. All rights reserved.

  17. Acculturation levels and personalizing orthognathic surgery for the Asian American patient.

    PubMed

    Sy, A A; Kim, W S; Chen, J; Shen, Y; Tao, C; Lee, J S

    2016-10-01

    This study was performed to investigate whether the level of acculturation among Asians living in the USA plays a significant role in their opinion of facial profiles. One hundred and ninety-eight Asian American subjects were asked to complete a pre-validated survey to measure their level of acculturation and to evaluate four sets of pictures that displayed a class II male, class II female, class III male, and class III female. Each set consisted of three lateral profile pictures: an initial unaltered photo, a picture simulating a flatter profile (orthodontic camouflage in class II; mandibular setback in class III), and a picture simulating a fuller profile (mandibular advancement in class II; maxillary advancement in class III). For the class II male, subjects who were more acculturated indicated that a flatter profile (orthodontic camouflage) was less attractive. For the class II female, higher acculturated subjects chose expansive treatment (mandibular advancement) as more aesthetic compared to the less acculturated subjects. Each of these scenarios had statistically significant odds ratios. In general, highly acculturated subjects preferred a fuller facial profile, while low acculturated subjects preferred a flatter facial profile appearance, except for the class III female profile, which did not follow this trend. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  18. Evaluation of skeletal and dental asymmetries in Angle Class II subdivision malocclusions with cone-beam computed tomography.

    PubMed

    Minich, Craig M; Araújo, Eustáquio A; Behrents, Rolf G; Buschang, Peter H; Tanaka, Orlando M; Kim, Ki Beom

    2013-07-01

    The purpose of this study was to determine whether Angle Class II subdivision malocclusions have skeletal or dental asymmetries between the Class II and Class I sides. A sample of 54 untreated Angle Class II subdivision patients with pretreatment photos and cone-beam computed tomography (CBCT) scans was used. The photos were used to identify the Class II subdivision malocclusion and to record the amount of crowding per quadrant. Landmarks were plotted on each CBCT volume so that direct 3-dimensional measurements could be made to compare the positions and dimensions of the skeletal and dental structures on the Class II side vs the Class I side. Significant differences were found for 2 skeletal measurements: the position of the maxilla relative to the cranial base, and the mandibular dimension from the mandibular foramen to the mental foramen. Statistically significant dental differences were found for the position of the mandibular first molars and canines in relation to the maxilla and the mandible. Statistically significant differences were found for the maxillary first molars and canines in relation to the mandible. There were significant skeletal and dental differences between the Class I and Class II sides. The dental asymmetries accounted for about two thirds of the total asymmetry. Copyright © 2013 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  19. 25 CFR 522.11 - Individually owned class II gaming operations operating on September 1, 1986.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false Individually owned class II gaming operations operating on September 1, 1986. 522.11 Section 522.11 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR APPROVAL OF CLASS II AND CLASS III ORDINANCES AND RESOLUTIONS SUBMISSION OF GAMING...

  20. Glass ionomer-silver cermet Class II tunnel-restorations for primary molars.

    PubMed

    Croll, T P

    1988-01-01

    Tunnel preparations preserve the anatomical marginal ridge and minimize the loss of healthy tooth structure adjacent to the carious lesion. When the practitioner has developed proficiency in restoring class II carious lesions with tunnel restorations, less treatment time is required than with traditional class II preparations. The technique for restoring a primary first molar with a class II carious lesion, using a tunnel preparation and Ketac-Silver restorative material is described.

  1. Diversity and evolutionary patterns of immune genes in free-ranging Namibian leopards (Panthera pardus pardus).

    PubMed

    Castro-Prieto, Aines; Wachter, Bettina; Melzheimer, Joerg; Thalwitzer, Susanne; Sommer, Simone

    2011-01-01

    The genes of the major histocompatibility complex (MHC) are a key component of the mammalian immune system and have become important molecular markers for fitness-related genetic variation in wildlife populations. Currently, no information about the MHC sequence variation and constitution in African leopards exists. In this study, we isolated and characterized genetic variation at the adaptively most important region of MHC class I and MHC class II-DRB genes in 25 free-ranging African leopards from Namibia and investigated the mechanisms that generate and maintain MHC polymorphism in the species. Using single-stranded conformation polymorphism analysis and direct sequencing, we detected 6 MHC class I and 6 MHC class II-DRB sequences, which likely correspond to at least 3 MHC class I and 3 MHC class II-DRB loci. Amino acid sequence variation in both MHC classes was higher or similar in comparison to other reported felids. We found signatures of positive selection shaping the diversity of MHC class I and MHC class II-DRB loci during the evolutionary history of the species. A comparison of MHC class I and MHC class II-DRB sequences of the leopard to those of other felids revealed a trans-species mode of evolution. In addition, the evolutionary relationships of MHC class II-DRB sequences between African and Asian leopard subspecies are discussed.

  2. [Clinical study of extraction treatment of Class II division I malocclusion with Empower self-ligating brackets].

    PubMed

    Chen, Xi-hua; Hua, Yong-mei; Xie, Xing-qian; Yu, Xiao-jia; Wang, Jian; Liu, Li-ming

    2013-06-01

    To evaluate and compare the treatment efficiency of Empower interactive self-ligating brackets and traditional brackets in Class II division I extraction patients. Forty patients with Class II division I malocclusion were randomly divided into 2 groups. Twenty patients received Empower self-ligating technique (group A) and the other 20 patients received MBT technique (group B). Four first premolars were extracted and without any other anchorage devices added in both groups. The duration of treatment, the number of visits and chair-side time were recorded. Cephalometric analysis was performed before and after treatment. The data was analyzed with SPSS 13.0 software package for paired t test. Treatment time and number of visits in group A were more than in group B, but there was no significant difference between the 2 groups. Chair-side time in group A reduced 151.15s on average compared with group B. Significant changes were observed in both groups after treatment. Upper and lower anterior teeth retracted and convex profile improved.U1-SN, U1-NA, L1-MP, L1-NB, UI-PTV, LI-PTV, UL-EP, LL-EP decreased. Significant differences were found in UM-PTV between the 2 groups(P<0.05). Compared with traditional brackets, Empower self-ligating brackets can save chair-side time, control anterior teeth torque and posterior teeth anchorage effectively, but can not reduce the treatment time or number of visits. Supported by Youth Research Project of Shanghai Municipal Health Bureau(2010Y155).

  3. Comparison of temporomandibular joint and ramus morphology between class II and class III cases before and after bi-maxillary osteotomy.

    PubMed

    Iguchi, Ran; Yoshizawa, Kunio; Moroi, Akinori; Tsutsui, Takamitsu; Hotta, Asami; Hiraide, Ryota; Takayama, Akihiro; Tsunoda, Tatsuya; Saito, Yuki; Sato, Momoko; Baba, Nana; Ueki, Koichiro

    2017-12-01

    The purpose of this study was to compare changes in temporomandibular joint (TMJ) and ramus morphology between class II and III cases before and after sagittal split ramus osteotomy (SSRO) and Le Fort I osteotomy. The subjects were 39 patients (78 sides) who underwent bi-maxillary surgery. They consisted of 2 groups (18 class II cases and 21 class III cases), and were selected randomly from among patients who underwent surgery between 2012 and 2016. The TMJ disc tissue and joint effusion were assessed by magnetic resonance imaging (MRI) and the TMJ space, condylar height, ramus height, ramus inclination and condylar square were assessed by computed tomography (CT), pre- and post-operatively. The number of joints with anterior disc displacement in class II was significantly higher than that in class III (p < 0.0001). However, there were no significant differences between the two classes regarding ratio of joint symptoms and ratio of joint effusion pre- and post-operatively. Class II was significantly better than class III regarding reduction ratio of condylar height (p < 0.0001) and square (p = 0.0005). The study findings suggest that condylar morphology could change in both class II and III after bi-maxillary surgery. The findings of the numerical analysis also demonstrated that reduction of condylar volume occurred frequently in class II, although TMJ disc position classification did not change significantly, as previously reported. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  4. Resonance Properties of Class I and Class II Neurons Differentially Modulated by Channel Noise

    NASA Astrophysics Data System (ADS)

    Wang, Lei

    2018-01-01

    Resonance properties of two different neuron types (Class I and Class II) induced by channel noise are investigated in this study. It is found that for Class I neuron, spiking activity is enhanced when certain noise intensity is presented, especially under weak current stimuli -- a typical phenomenon of stochastic resonance (SR); while for Class II neuron, in addition to perform the SR, certain noise intensity would inhibit neuronal activity under some current stimuli -- a typical phenomenon of inverse stochastic resonance (ISR). Moreover, we show that only sodium channel noise or potassium channel noise variation can achieve the similar phenomena. Consequently, the model results suggest that channel noise may exert differential roles in modulating the resonance properties of Class I and Class II neurons.

  5. Thin-plate spline analysis of craniofacial growth in Class I and Class II subjects.

    PubMed

    Franchi, Lorenzo; Baccetti, Tiziano; Stahl, Franka; McNamara, James A

    2007-07-01

    To compare the craniofacial growth characteristics of untreated subjects with Class II division 1 malocclusion with those of subjects with normal (Class I) occlusion from the prepubertal through the postpubertal stages of development. The Class II division 1 sample consisted of 17 subjects (11 boys and six girls). The Class I sample also consisted of 17 subjects (13 boys and four girls). Three craniofacial regions (cranial base, maxilla, and mandible) were analyzed on the lateral cephalograms of the subjects in both groups by means of thin-plate spline analysis at T1 (prepubertal) and T2 (postpubertal). Both cross-sectional and longitudinal comparisons were performed on both size and shape differences between the two groups. The results showed an increased cranial base angulation as a morphological feature of Class II malocclusion at the prepubertal developmental phase. Maxillary changes in either shape or size were not significant. Subjects with Class II malocclusion exhibited a significant deficiency in the size of the mandible at the completion of active craniofacial growth as compared with Class I subjects. A significant deficiency in the size of the mandible became apparent in Class II subjects during the circumpubertal period and it was still present at the completion of active craniofacial growth.

  6. Influence of pharyngeal airway respiration pressure on Class II mandibular retrusion in children: A computational fluid dynamics study of inspiration and expiration.

    PubMed

    Iwasaki, T; Sato, H; Suga, H; Takemoto, Y; Inada, E; Saitoh, I; Kakuno, K; Kanomi, R; Yamasaki, Y

    2017-05-01

    To examine the influence of negative pressure of the pharyngeal airway on mandibular retraction during inspiration in children with nasal obstruction using the computational fluid dynamics (CFD) method. Sixty-two children were divided into Classes I, II (mandibular retrusion) and III (mandibular protrusion) malocclusion groups. Cone-beam computed tomography data were used to reconstruct three-dimensional shapes of the nasal and pharyngeal airways. Airflow pressure was simulated using CFD to calculate nasal resistance and pharyngeal airway pressure during inspiration and expiration. Nasal resistance of the Class II group was significantly higher than that of the other two groups, and oropharyngeal airway inspiration pressure in the Class II (-247.64 Pa) group was larger than that in the Class I (-43.51 Pa) and Class III (-31.81 Pa) groups (P<.001). The oropharyngeal airway inspiration-expiration pressure difference in the Class II (-27.38 Pa) group was larger than that in the Class I (-5.17 Pa) and Class III (0.68 Pa) groups (P=.006). Large negative inspiratory pharyngeal airway pressure due to nasal obstruction in children with Class II malocclusion may be related to their retrognathia. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Disruption of HLA class II antigen presentation in Burkitt lymphoma: implication of a 47 000 MW acid labile protein in CD4+ T-cell recognition

    PubMed Central

    God, Jason M; Zhao, Dan; Cameron, Christine A; Amria, Shereen; Bethard, Jennifer R; Haque, Azizul

    2014-01-01

    While Burkitt lymphoma (BL) has a well-known defect in HLA class I-mediated antigen presentation, the exact role of BL-associated HLA class II in generating a poor CD4+ T-cell response remains unresolved. Here, we found that BL cells are deficient in their ability to optimally stimulate CD4+ T cells via the HLA class II pathway. This defect in CD4+ T-cell recognition was not associated with low levels of co-stimulatory molecules on BL cells, as addition of external co-stimulation failed to elicit CD4+ T-cell activation by BL. Further, the defect was not caused by faulty antigen/class II interaction, because antigenic peptides bound with measurable affinity to BL-associated class II molecules. Interestingly, functional class II–peptide complexes were formed at acidic pH 5·5, which restored immune recognition. Acidic buffer (pH 5·5) eluate from BL cells contained molecules that impaired class II-mediated antigen presentation and CD4+ T-cell recognition. Biochemical analysis showed that these molecules were greater than 30 000 molecular weight in size, and proteinaceous in nature. In addition, BL was found to have decreased expression of a 47 000 molecular weight enolase-like molecule that enhances class II-mediated antigen presentation in B cells, macrophages and dendritic cells, but not in BL cells. These findings demonstrate that BL likely has multiple defects in HLA class II-mediated antigen presentation and immune recognition, which may be exploited for future immunotherapies. PMID:24628049

  8. Sibling rivalry: competition between MHC class II family members inhibits immunity.

    PubMed

    Denzin, Lisa K; Cresswell, Peter

    2013-01-01

    Peptide loading of major histocompatibility complex (MHC) class II molecules in the endosomes and lysosomes of antigen-presenting cells is catalyzed by human leukocyte antigen-DM (HLA-DM) and modulated by HLA-DO. In a structural study in this issue, Guce et al. show that HLA-DO is an MHC class II mimic and functions as a competitive and essentially irreversible inhibitor of HLA-DM activity, thereby inhibiting MHC class II antigen presentation.

  9. 25 CFR 547.9 - What are the minimum technical standards for Class II gaming system accounting functions?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... OF CLASS II GAMES § 547.9 What are the minimum technical standards for Class II gaming system... digits to accommodate the design of the game. (3) Accounting data displayed to the player may be... audit, configuration, recall and test modes; or (ii) Temporarily, during entertaining displays of game...

  10. 25 CFR 547.9 - What are the minimum technical standards for Class II gaming system accounting functions?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... OF CLASS II GAMES § 547.9 What are the minimum technical standards for Class II gaming system... digits to accommodate the design of the game. (3) Accounting data displayed to the player may be... audit, configuration, recall and test modes; or (ii) Temporarily, during entertaining displays of game...

  11. 25 CFR 547.9 - What are the minimum technical standards for Class II gaming system accounting functions?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF CLASS II GAMES § 547.9 What are the minimum technical standards for Class II gaming system... digits to accommodate the design of the game. (3) Accounting data displayed to the player may be... audit, configuration, recall and test modes; or (ii) Temporarily, during entertaining displays of game...

  12. Finishing occlusion in Class II or Class III molar relation: therapeutic Class II and III.

    PubMed

    Nangia, A; Darendeliler, M A

    2001-11-01

    The most frequent extraction regime consists of the removal of upper and lower premolars. Depending on anchorage requirements, camouflage treatment options, surgical intervention, or the absence of teeth in only one arch, it may become necessary to finalize the occlusion with a one-dental-unit discrepancy between the upper and lower dental arches. Guidelines are presented for finishing occlusions in Class II or Class III molar relation.

  13. Evolution and Distribution of Class II-Related Endogenous Retroviruses†

    PubMed Central

    Gifford, Robert; Kabat, Peter; Martin, Joanne; Lynch, Clare; Tristem, Michael

    2005-01-01

    Endogenous retroviruses (ERVs) are widespread in vertebrate genomes and have been loosely grouped into “classes” on the basis of their phylogenetic relatedness to the established genera of exogenous retroviruses. Four of these genera—the lentiviruses, alpharetroviruses, betaretroviruses, and deltaretroviruses—form a well-supported clade in retroviral phylogenies, and ERVs that group with these genera have been termed class II ERVs. We used PCR amplification and sequencing of retroviral fragments from more than 130 vertebrate taxa to investigate the evolution of the class II retroviruses in detail. We confirm that class II retroviruses are largely confined to mammalian and avian hosts and provide evidence for a major novel group of avian retroviruses, and we identify additional members of both the alpha- and the betaretrovirus genera. Phylogenetic analyses demonstrated that the avian and mammalian viruses form distinct monophyletic groups, implying that interclass transmission has occurred only rarely during the evolution of the class II retroviruses. In contrast to previous reports, the lentiviruses clustered as sister taxa to several endogenous retroviruses derived from rodents and insectivores. This topology was further supported by the shared loss of both the class II PR-Pol frameshift site and the class II retrovirus G-patch domain. PMID:15858031

  14. Antiviral CD8+ T Cells Restricted by Human Leukocyte Antigen Class II Exist during Natural HIV Infection and Exhibit Clonal Expansion.

    PubMed

    Ranasinghe, Srinika; Lamothe, Pedro A; Soghoian, Damien Z; Kazer, Samuel W; Cole, Michael B; Shalek, Alex K; Yosef, Nir; Jones, R Brad; Donaghey, Faith; Nwonu, Chioma; Jani, Priya; Clayton, Gina M; Crawford, Frances; White, Janice; Montoya, Alana; Power, Karen; Allen, Todd M; Streeck, Hendrik; Kaufmann, Daniel E; Picker, Louis J; Kappler, John W; Walker, Bruce D

    2016-10-18

    CD8 + T cell recognition of virus-infected cells is characteristically restricted by major histocompatibility complex (MHC) class I, although rare examples of MHC class II restriction have been reported in Cd4-deficient mice and a macaque SIV vaccine trial using a recombinant cytomegalovirus vector. Here, we demonstrate the presence of human leukocyte antigen (HLA) class II-restricted CD8 + T cell responses with antiviral properties in a small subset of HIV-infected individuals. In these individuals, T cell receptor β (TCRβ) analysis revealed that class II-restricted CD8 + T cells underwent clonal expansion and mediated killing of HIV-infected cells. In one case, these cells comprised 12% of circulating CD8 + T cells, and TCRα analysis revealed two distinct co-expressed TCRα chains, with only one contributing to binding of the class II HLA-peptide complex. These data indicate that class II-restricted CD8 + T cell responses can exist in a chronic human viral infection, and may contribute to immune control. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

  15. Variations in tooth size and arch dimensions in Malay schoolchildren.

    PubMed

    Hussein, Khalid W; Rajion, Zainul A; Hassan, Rozita; Noor, Siti Noor Fazliah Mohd

    2009-11-01

    To compare the mesio-distal tooth sizes and dental arch dimensions in Malay boys and girls with Class I, Class II and Class III malocclusions. The dental casts of 150 subjects (78 boys, 72 girls), between 12 and 16 years of age, with Class I, Class II and Class III malocclusions were used. Each group consisted of 50 subjects. An electronic digital caliper was used to measure the mesio-distal tooth sizes of the upper and lower permanent teeth (first molar to first molar), the intercanine and intermolar widths. The arch lengths and arch perimeters were measured with AutoCAD software (Autodesk Inc., San Rafael, CA, U.S.A.). The mesio-distal dimensions of the upper lateral incisors and canines in the Class I malocclusion group were significantly smaller than the corresponding teeth in the Class III and Class II groups, respectively. The lower canines and first molars were significantly smaller in the Class I group than the corresponding teeth in the Class II group. The lower intercanine width was significantly smaller in the Class II group as compared with the Class I group, and the upper intermolar width was significantly larger in Class III group as compared with the Class II group. There were no significant differences in the arch perimeters or arch lengths. The boys had significantly wider teeth than the girls, except for the left lower second premolar. The boys also had larger upper and lower intermolar widths and lower intercanine width than the girls. Small, but statistically significant, differences in tooth sizes are not necessarily accompanied by significant arch width, arch length or arch perimeter differences. Generally, boys have wider teeth, larger lower intercanine width and upper and lower intermolar widths than girls.

  16. Evaluation of maxillary molar distalization with the distal jet: a comparison with other contemporary methods.

    PubMed

    Bolla, Eugenio; Muratore, Filippo; Carano, Aldo; Bowman, S Jay

    2002-10-01

    Maxillary molar distalization is an increasingly popular option for the resolution of Class II malocclusions. This communication describes the effects of one particular molar distalizing appliance, the distal jet, in a sample of 20 consecutively treated and growing subjects (11 females, nine males; mean starting age of 13) and compares these effects with those of similar devices. Pre- and postdistalization cephalometric radiographs and dental models were analyzed to determine the dental and skeletal effects. The distal jet appliances were constructed using a biomechanical couple to direct the distalizing force to the level of the maxillary first molar's center of resistance. The distal jet was the only appliance used during the distalization phase of treatment. Examination of the cephalometric tracings demonstrated that the crowns of the maxillary first molars were distalized an average of 3.2 mm into a Class I molar relationship. In the process, the first molars were tipped distally an average of 3.1 degrees, however, the amount of tipping in each case was influenced by the state of eruption of the second molar. In subjects whose second molars had erupted only to the level of the apical third of the first molar roots, distal tipping was almost twice that seen when the second molar had completed their eruption. Anchorage loss measured at the first premolars averaged 1.3 mm, but the crowns tipped 3.1 degrees distally because of the design of the appliance. The maxillary incisors were proclined an average of 0.6 degrees with minimal effect on the mandibular plane angle and lower facial height. This study suggests that the distal jet appliance effectively moves the maxillary molars distally into a Class I molar relationship with minimal distal tipping, however, some loss of anchorage is to be expected during this process. The distal jet appliance compares favorably with other intraoral distalization devices and with mechanics featuring mandibular protraction for the resolution of patients with Class II, despite the fact that these types of mechanics address different jaws.

  17. Regulatory aspects of noninvasive glucose measurements.

    PubMed

    Gutman, Steve; Bernhardt, Patricia; Pinkos, Arleen; Moxey-Mims, Marva; Knott, Thomas; Cooper, Jean

    2002-01-01

    The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.

  18. 77 FR 50760 - Notice and request for comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... rehabilitation to Class II and Class III railroad infrastructure damaged by hurricanes, floods, and natural... issued by the President ( http://www.fema.gov/news/disasters.fema#sev1 ). Class II and Class III railroad...

  19. Polymorphism at Expressed DQ and DR Loci in Five Common Equine MHC Haplotypes

    PubMed Central

    Miller, Donald; Tallmadge, Rebecca L.; Binns, Matthew; Zhu, Baoli; Mohamoud, Yasmin Ali; Ahmed, Ayeda; Brooks, Samantha A.; Antczak, Douglas F.

    2016-01-01

    The polymorphism of Major Histocompatibility Complex (MHC) class II DQ and DR genes in five common Equine Leukocyte Antigen (ELA) haplotypes was determined through sequencing of mRNA transcripts isolated from lymphocytes of eight ELA homozygous horses. Ten expressed MHC class II genes were detected in horses of the ELA-A3 haplotype carried by the donor horses of the equine Bacterial Artificial Chromosome (BAC) library and the reference genome sequence: four DR genes and six DQ genes. The other four ELA haplotypes contained at least eight expressed polymorphic MHC class II loci. Next Generation Sequencing (NGS) of genomic DNA of these four MHC haplotypes revealed stop codons in the DQA3 gene in the ELA-A2, ELA-A5, and ELA-A9 haplotypes. Few NGS reads were obtained for the other MHC class II genes that were not amplified in these horses. The amino acid sequences across haplotypes contained locus-specific residues, and the locus clusters produced by phylogenetic analysis were well supported. The MHC class II alleles within the five tested haplotypes were largely non-overlapping between haplotypes. The complement of equine MHC class II DQ and DR genes appears to be well conserved between haplotypes, in contrast to the recently described variation in class I gene loci between equine MHC haplotypes. The identification of allelic series of equine MHC class II loci will aid comparative studies of mammalian MHC conservation and evolution and may also help to interpret associations between the equine MHC class II region and diseases of the horse. PMID:27889800

  20. 40 CFR 82.23 - Transfers of allowances of class II controlled substances.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., any production, and allowable imports and exports of class II controlled substances reported by the... quantity of the transferor's class II consumption allowances, production allowances, export production... EPA; and (G) For trades of consumption allowances, production allowances, export production allowances...

  1. Interaction of Mycobacterium avium-containing phagosomes with the antigen presentation pathway.

    PubMed

    Ullrich, H J; Beatty, W L; Russell, D G

    2000-12-01

    Pathogenic mycobacteria infect macrophages where they replicate in phagosomes that minimize contact with late endosomal/lysosomal compartments. Loading of Ags to MHC class II molecules occurs in specialized compartments with late endosomal characteristics. This points to a sequestration of mycobacteria-containing phagosomes from the sites where Ags meet MHC class II molecules. Indeed, in resting macrophages MHC class II levels decreased strongly in phagosomes containing M. avium during a 4-day infection. Phagosomal MHC class II of early (4 h) infections was partly surface-derived and associated with peptide. Activation of host macrophages led to the appearance of H2-M, a chaperon of Ag loading, and to a strong increase in MHC class II molecules in phagosomes of acute (1 day) infections. Comparison with the kinetics of MHC class II acquisition by IgG-coated bead-containing phagosomes suggests that the arrest in phagosome maturation by mycobacteria limits the intersection of mycobacteria-containing phagosomes with the intracellular trafficking pathways of Ag-presenting molecules.

  2. Bone-anchored intermaxillary elastics in an asymmetric Class II malocclusion: A case report.

    PubMed

    Manni, Antonio; Lupini, Daniela; Cozzani, Mauro

    2017-06-01

    A 13-year-old male patient, presenting a Class II, division 1 malocclusion and crowding was treated by an innovative technique. After rapid palatal expansion by a Hyrax appliance, the teeth were bonded with straightwire brackets. Two miniscrews were inserted, one per side, in the mandibular buccal bone between the roots of the mandibular first molar and the second premolar. On the right side, the miniscrew implant was connected to the hook clamped on a 0.021×0.028″ SS wire with a twisted SS ligature in order to maintain the inclination of the frontal incisors during the Class II mechanics. On the left side, where the Class II relationship was more marked, intermaxillary elastics were applied from the upper left hook clamped on the archwire to the lower first molar and a power chain (100g) was stretched from the lower left hook to the miniscrew implant. Class II correction was accomplished using sequential Class II elastics of progressive strength coupled with rectangular stainless steel wires. After 22 months of active treatment, the results were balanced facial esthetics and a good occlusion. This dual anchorage set-up of Class II elastics reinforced with TADs produced protrusive action on the mandible with minimal side effects and with no significant change in the vertical dimension during the sagittal correction of the Class II malocclusion. Copyright © 2017 CEO. Published by Elsevier Masson SAS. All rights reserved.

  3. Anteroposterior condylar position: a comparative study between subjects with normal occlusion and patients with Class I, Class II Division 1, and Class III malocclusions.

    PubMed

    Fraga, Marcelo Reis; Rodrigues, Andréia Fialho; Ribeiro, Luiz Claudio; Campos, Marcio José da Silva; Vitral, Robert Willer Farinazzo

    2013-10-29

    The present study aimed to determine and compare the anteroposterior position of the condyle in the mandibular fossa between groups of asymptomatic subjects with normal occlusion and asymptomatic subjects with Class I, Class II Division 1, and Class III malocclusions. Thirty persons with normal occlusion, 30 with Class I malocclusion, 30 with Class II Division 1, and 30 with Class III had computed tomography scans of their temporomandibular joints. The anterior joint space/posterior joint space (AJS/PJS) ratio was determined for the right and left joints. The paired t test was used to analyze the AJS/PJS ratio between both sides for each group. The ANOVA test was applied to verify the differences between the groups for the measurements of the right and left sides. In case the ANOVA test confirmed significance, the Dunnett's t test was performed to compare the groups of malocclusion with that of normal occlusion. The paired t test between the AJS/PJS relationships in the right and left sides showed the following p values: Class I (0.168), Class II Division 1 (0.662), Class III (0.991), and normal occlusion (0.390). The ANOVA test showed a p value of 0.445 for the comparisons of the right side and 0.040 for the left side. The Dunnett's t test demonstrated a statistically significant difference between the Class II group and the normal occlusion group (p value of 0.026) in the joints of the left side. Bilateral symmetry and lack of condyle centralization were common characteristics among all groups. The greatest condylar decentralization was observed in the Class II group, whereas the least condylar decentralization was found in the normal occlusion group.

  4. Differential effects of donor-specific HLA antibodies in living versus deceased donor transplant.

    PubMed

    Kamburova, E G; Wisse, B W; Joosten, I; Allebes, W A; van der Meer, A; Hilbrands, L B; Baas, M C; Spierings, E; Hack, C E; van Reekum, F E; van Zuilen, A D; Verhaar, M C; Bots, M L; Drop, A C A D; Plaisier, L; Seelen, M A J; Sanders, J S F; Hepkema, B G; Lambeck, A J A; Bungener, L B; Roozendaal, C; Tilanus, M G J; Voorter, C E; Wieten, L; van Duijnhoven, E M; Gelens, M; Christiaans, M H L; van Ittersum, F J; Nurmohamed, S A; Lardy, N M; Swelsen, W; van der Pant, K A; van der Weerd, N C; Ten Berge, I J M; Bemelman, F J; Hoitsma, A; van der Boog, P J M; de Fijter, J W; Betjes, M G H; Heidt, S; Roelen, D L; Claas, F H; Otten, H G

    2018-02-21

    The presence of donor-specific anti-HLA antibodies (DSAs) is associated with increased risk of graft failure after kidney transplant. We hypothesized that DSAs against HLA class I, class II, or both classes indicate a different risk for graft loss between deceased and living donor transplant. In this study, we investigated the impact of pretransplant DSAs, by using single antigen bead assays, on long-term graft survival in 3237 deceased and 1487 living donor kidney transplants with a negative complement-dependent crossmatch. In living donor transplants, we found a limited effect on graft survival of DSAs against class I or II antigens after transplant. Class I and II DSAs combined resulted in decreased 10-year graft survival (84% to 75%). In contrast, after deceased donor transplant, patients with class I or class II DSAs had a 10-year graft survival of 59% and 60%, respectively, both significantly lower than the survival for patients without DSAs (76%). The combination of class I and II DSAs resulted in a 10-year survival of 54% in deceased donor transplants. In conclusion, class I and II DSAs are a clear risk factor for graft loss in deceased donor transplants, while in living donor transplants, class I and II DSAs seem to be associated with an increased risk for graft failure, but this could not be assessed due to their low prevalence. © 2018 The Authors. American Journal of Transplantation published by Wiley Periodicals, Inc. on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons.

  5. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... order) for the preceding month: (1) The Class II price; (2) The Class II butterfat price; (3) The Class... the following month: (1) The Class I price; (2) The Class I skim milk price; (3) The Class I butterfat...; (7) The butterfat price; (8) The nonfat solids price; (9) The protein price; (10) The other solids...

  6. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... order) for the preceding month: (1) The Class II price; (2) The Class II butterfat price; (3) The Class... the following month: (1) The Class I price; (2) The Class I skim milk price; (3) The Class I butterfat...; (7) The butterfat price; (8) The nonfat solids price; (9) The protein price; (10) The other solids...

  7. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... order) for the preceding month: (1) The Class II price; (2) The Class II butterfat price; (3) The Class... the following month: (1) The Class I price; (2) The Class I skim milk price; (3) The Class I butterfat...; (7) The butterfat price; (8) The nonfat solids price; (9) The protein price; (10) The other solids...

  8. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... order) for the preceding month: (1) The Class II price; (2) The Class II butterfat price; (3) The Class... the following month: (1) The Class I price; (2) The Class I skim milk price; (3) The Class I butterfat...; (7) The butterfat price; (8) The nonfat solids price; (9) The protein price; (10) The other solids...

  9. 7 CFR 1000.53 - Announcement of class prices, component prices, and advanced pricing factors.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... order) for the preceding month: (1) The Class II price; (2) The Class II butterfat price; (3) The Class... the following month: (1) The Class I price; (2) The Class I skim milk price; (3) The Class I butterfat...; (7) The butterfat price; (8) The nonfat solids price; (9) The protein price; (10) The other solids...

  10. Comparison of BMI, AHI, and apolipoprotein E ε4 (APOE-ε4) alleles among sleep apnea patients with different skeletal classifications.

    PubMed

    Roedig, Jason J; Phillips, Barbara A; Morford, Lorri A; Van Sickels, Joseph E; Falcao-Alencar, Gabriel; Fardo, David W; Hartsfield, James K; Ding, Xiuhua; Kluemper, G Thomas

    2014-04-15

    This case-control study investigated whether variations within the APOE-ε gene were associated with having a convex facial profile (skeletal Class II) compared to exhibiting a straight or concave facial profile (Class I or Class III) among patients with obstructive sleep apnea (OSA). Associations between the apnea-hypopnea index (AHI) and body mass index (BMI) scores for these OSA patients were also examined in the context of facial profile. OSA patients with an AHI ≥ 15 were recruited from a sleep clinic and classified by facial and dental occlusal relationships based on a profile facial analysis, lateral photographs, and dental examination. Saliva was collected as a source of DNA. The APOE-ε1-4 allele-defining single nucleotide polymorphisms (SNPs) rs429358 and rs7412 were genotyped. A χ(2) analysis was used to assess Hardy-Weinberg equilibrium and for association analysis (significance at p < 0.05). ANOVA and Fisher exact test were also used. Seventy-six Caucasian OSA patients participated in the study-25 Class II cases and 51 non-Class II cases. There was no association of the APOE-ε4 allele with facial profile among these OSA patients. Class II OSA patients had significantly lower BMIs (30.7 ± 5.78) than Class I (37.3 ± 6.14) or Class III (37.8 ± 6.17) patients (p < 0.001), although there was no statistical difference in AHI for Class II patients compared with other groups. OSA patients with Class II convex profile were more likely to have a lower BMI than those in other skeletal groups. In fact 20% of them were not obese, suggesting that a Class II convex profile may influence or be associated with OSA development independent of BMI.

  11. A cephalometric analysis of Class II dentate subjects to establish a formula to determine the occlusal plane in Class II edentate subjects: A neo adjunct.

    PubMed

    Sinha, Nikita; Reddy, K Mahendranadh; Gupta, Nidhi; Shastry, Y M

    2017-01-01

    Occlusal plane (OP) differs considerably in participants with skeletal Class I and Class II participants. In this study, cephalometrics has been used to help in the determination of orientation of the OP utilizing the nonresorbable bony anatomic landmarks in skeletal Class II participants and an attempt has been made to predict and examine the OP in individuals with skeletal class II jaw relationship. One hundred dentulous participants with skeletal Class II malocclusion who came to the hospital for correcting their jaw relationship participated in the study. Their right lateral cephalogram was taken using standardized procedures, and all the tracings were manually done by a single trained examiner. The cephalograms which were taken for the diagnostic purpose were utilized for the study, and the patient was not exposed to any unnecessary radiation. The numerical values obtained from the cephalograms were subjected to statistical analysis. Pearson's correlation of <0.001 was considered significant, and a linear regression analysis was performed to determine a formula which would help in the determination of orientation of the OP in Class II edentulous participants. Pearson's correlation coefficient and linear regression analysis were performed, and a high correlation was found between A2 and (A2 + B2)/(B2 + C2) with " r " value of 0.5. A medium correlation was found between D2 and (D2 + E2)/(E2 + F2) with " r " value of 0.42. The formula obtained for posterior reference frame through linear regression equation was y = 0.018* × +0.459 and the formula obtained for anterior reference frame was y1 = 0.011* × 1 + 0.497. It was hypothesized that by substituting these formulae in the cephalogram obtained from the Class II edentate individual, the OP can be obtained and verified. It was concluded that cephalometrics can be useful in examining the orientation of OP in skeletal Class II participants.

  12. A simple device to illustrate the Einthoven triangle

    PubMed Central

    Jin, Benjamin E.; Wulff, Heike; Widdicombe, Jonathan H.; Zheng, Jie; Bers, Donald M.

    2012-01-01

    The Einthoven triangle is central to the field of electrocardiography, but the concept of cardiac vectors is often a difficult notion for students to grasp. To illustrate this principle, we constructed a device that recreates the conditions of an ECG reading using a battery to simulate the electrical vector of the heart and three voltmeters for the main electrocardiographic leads. Requiring minimal construction with low cost, this device provides hands-on practice that enables students to rediscover the principles of the Einthoven triangle, namely, that the direction of the cardiac dipole can be predicted from the deflections in any two leads and that lead I + lead III = lead II independent of the position of heart's electrical vector. We built a total of 6 devices for classes of 30 students and tested them in the first-year Human Physiology course at the University of California-Davis School of Medicine. Combined with traditional demonstrations with ECG machines, this equipment demonstrated its ability to help medical students obtain a solid foundation of the basic principles of electrocardiography. PMID:23209014

  13. Effects of miniplate anchored and conventional Forsus Fatigue Resistant Devices in the treatment of Class II malocclusion.

    PubMed

    Turkkahraman, Hakan; Eliacik, Sule Kocabas; Findik, Yavuz

    2016-11-01

    To compare the skeletal, dentoalveolar, and soft tissue effects of the miniplate anchored Forsus Fatigue Resistant Device (FRD) and the conventional Forsus FRD in the treatment of Class II malocclusion. The study was carried out with 30 patients (10 girls, 20 boys). In the MA-Forsus group, 15 patients (2 girls, 13 boys) were treated with a miniplate anchored Forsus FRD for 9.40 ± 2.25 months. In the C-Forsus group, 15 patients (8 girls, 7 boys) were treated with a conventional Forsus FRD for 9.46 ± 0.81 months. A total of 16 measurements were calculated and statistically analyzed to find intragroup and intergroup differences. Statistically significant differences were found between the groups in IMPA, SN/Occ, SN/GoGn, overjet, overbite, and Li-S measurements (P < .05). In the C-Forsus group, a substantial amount of lower incisor protrusion was observed, whereas retrusion was found in the MA-Forsus group (P < .001). The mandible rotated backward in the MA-Forsus group, whereas it remained unchanged in the C-Forsus group (P < .05). Reductions in overjet (P < .001) and overbite were greater in the C-Forsus group (P < .05). Stimulation of mandibular growth and inhibition of maxillary growth were achieved in both treatment groups. In the C-Forsus group, a substantial amount of lower incisor protrusion was observed, whereas retrusion of lower incisors was found in the MA-Forsus group. The MA-Forsus group was found to be more advantageous as it had no dentoalveolar side effects on mandibular dentition.

  14. 77 FR 32465 - Technical Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... minimum odds for Class II games; amend standards for test labs; remove references to the Federal... the Play of Class II Games. 73 FR 60508. The rule added a new part to the Commission's regulations establishing a process for ensuring the integrity of electronic Class II games and aids. The standards were...

  15. 40 CFR 147.1600 - State-administered program-Class II wells.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) WATER PROGRAMS (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS New Mexico § 147.1600 State-administered program—Class II wells. The UIC program for Class II wells in the State of New Mexico, except for those on Indian lands, is the program administered by the New...

  16. 40 CFR 144.22 - Existing Class II enhanced recovery and hydrocarbon storage wells.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... and hydrocarbon storage wells. 144.22 Section 144.22 Protection of Environment ENVIRONMENTAL... of Underground Injection by Rule § 144.22 Existing Class II enhanced recovery and hydrocarbon storage wells. (a) An existing Class II enhanced recovery or hydrocarbon storage injection well is authorized by...

  17. 40 CFR 144.22 - Existing Class II enhanced recovery and hydrocarbon storage wells.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... and hydrocarbon storage wells. 144.22 Section 144.22 Protection of Environment ENVIRONMENTAL... of Underground Injection by Rule § 144.22 Existing Class II enhanced recovery and hydrocarbon storage wells. (a) An existing Class II enhanced recovery or hydrocarbon storage injection well is authorized by...

  18. 40 CFR 82.24 - Recordkeeping and reporting requirements for class II controlled substances.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... kilograms) of production of each class II controlled substance used in processes resulting in their...) The quantity (in kilograms) of production of each class II controlled substance used in processes... processes resulting in their transformation or eventual destruction; (vi) A list of the quantities and names...

  19. Effect of immunodepletion of MHC class II-positive cells from pancreatic islets on generation of cytotoxic T-lymphocytes in mixed islet-lymphocyte coculture.

    PubMed

    Stock, P G; Ascher, N L; Platt, J L; Kaufman, D B; Chen, S; Field, M J; Sutherland, D E

    1989-01-01

    In vitro manipulation of pancreatic islets to decrease islet immunogenicity before transplantation has largely been directed at eliminating the major histocompatibility complex (MHC) class II-positive passenger leukocytes from the islets. The mixed islet-lymphocyte coculture (MILC) system was used to quantitate the efficacy of immunodepletion of MHC class II-positive cells from pancreatic islets in terms of reducing immunogenicity. With these experiments we compared the in vitro immunogenicity of MHC class II-depleted islets with untreated islets. B10.BR (H-2k) islets were treated with anti-Iak alloserum followed by complement. This treatment successfully eliminated MHC class II-positive cells from the islets, as demonstrated by indirect immunofluorescence techniques. Depleted islets generated slightly lower amounts of allospecific cytotoxic T-lymphocyte (CTL) activity when exposed to C57BL/6 (H-2b) splenocytes in the MILC than untreated control islets. Although the amount of CTL generated by the depleted islets was slightly less than that generated by untreated islets, there was significant stimulation of CTL by the MHC class II-depleted islets. Therefore, the presence or absence of MHC class II cells within the islet is unlikely to be the decisive factor contributing to islet immunogenicity.

  20. Skeletal effects in Angle Class II/1 patients treated with the functional regulator type II : Cephalometric and tensor analysis.

    PubMed

    Schulz, Simone; Koos, Bernd; Duske, Kathrin; Stahl, Franka

    2016-11-01

    The purpose of this work was to employ both cephalometric and tensor analysis in characterizing the skeletal changes experienced by patients with Angle Class II/1 malocclusion during functional orthodontic treatment with the functional regulator type II. A total of 23 patients with Class II/1 malocclusion based on lateral cephalograms obtained before and after treatment with the functional regulator type II were analyzed. Another 23 patients with Angle Class II/1 malocclusion who had not undergone treatment were included as controls. Our cephalometric data attest to significant therapeutic effects of the functional regulator type II on the skeletal mandibular system, including significant advancement of the mandible, increases in effective mandibular length with enhancement of the chin profile, and reduction of growth-related bite deepening. No treatment-related effects were observed at the cranial-base and midface levels. In addition, tensor analysis revealed significant stimulation of mandibular growth in sagittal directions, without indications of growth effects on the maxilla. Its growth-pattern findings differed from those of cephalometric analysis by indicating that the appliance did promote horizontal development, which supports the functional orthodontic treatment effect in Angle Class II/1 cases. Tensor analysis yielded additional insights into sagittal and vertical growth changes not identifiable by strictly cephalometric means. The functional regulator type II was an effective treatment modality for Angle Class II/1 malocclusion and influenced the skeletal development of these patients in favorable ways.

  1. Preliminary Results From the C-Pulse OPTIONS HF European Multicenter Post-Market Study.

    PubMed

    Schulz, Antonia; Krabatsch, Thomas; Schmitto, Jan D; Hetzer, Roland; Seidel, Mirko; Dohmen, Pascal M; Hotz, Holger

    2016-02-18

    BACKGROUND The C-Pulse System is an extra-aortic balloon counterpulsation device. It is used to treat patients with heart failure disease in NYHA functional class III or ambulatory class IV. MATERIAL AND METHODS We present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study. RESULTS Between May 2013 and March 2014, the C-Pulse System was implanted in 8 patients (7 male) with a mean age of 61.6±9.3 years. Four had ischemic and 4 had non-ischemic cardiomyopathy. No stroke, myocardial infarction, major bleeding, or major infection due to the device were reported. One patient developed non-device-related refractory tachycardia with worsening heart failure 12 h after surgery and underwent left ventricular assist device implantation. Within 6 months of observation, functional status improved from NYHA III to II in 5 patients, and 2 remained in NYHA III. Mean left ventricular ejection fraction increased from 24.3±7.9% to 44.5±4.5% (p<0.0001). Mean Kansas City Cardiomyopathy Questionnaire overall score improved from 28.6±19.1 to 59.1±22.5 (p=0.0183). Six-minute walk test was performed in 6 out of 7 patients at follow-up. The mean distance improved from 252.0±85.1 m to 279.2±87.5 m (p>0.05). One patient was weaned off the device after 6 months of support. CONCLUSIONS The C-Pulse System provides a therapeutic option for patients with moderate-to-severe heart failure and seems to improve quality of life and cardiac function over time.

  2. Haemophilus ducreyi Cutaneous Ulcer Strains Diverged from Both Class I and Class II Genital Ulcer Strains: Implications for Epidemiological Studies.

    PubMed

    Gangaiah, Dharanesh; Spinola, Stanley M

    2016-12-01

    Haemophilus ducreyi has emerged as a major cause of cutaneous ulcers (CU) in yaws-endemic regions of the tropics in the South Pacific, South East Asia and Africa. H. ducreyi was once thought only to cause the genital ulcer (GU) disease chancroid; GU strains belong to 2 distinct classes, class I and class II. Using whole-genome sequencing of 4 CU strains from Samoa, 1 from Vanuatu and 1 from Papua New Guinea, we showed that CU strains diverged from the class I strain 35000HP and that one CU strain expressed β-lactamase. Recently, the Center for Disease Control and Prevention released the genomes of 11 additional CU strains from Vanuatu and Ghana; however, the evolutionary relationship of these CU strains to previously-characterized CU and GU strains is unknown. We performed phylogenetic analysis of 17 CU and 10 GU strains. Class I and class II GU strains formed two distinct clades. The class I strains formed two subclades, one containing 35000HP and HD183 and the other containing the remainder of the class I strains. Twelve of the CU strains formed a subclone under the class I 35000HP subclade, while 2 CU strains formed a subclone under the other class I subclade. Unexpectedly, 3 of the CU strains formed a subclone under the class II clade. Phylogenetic analysis of dsrA-hgbA-ncaA sequences yielded a tree similar to that of whole-genome phylogenetic tree. CU strains diverged from multiple lineages within both class I and class II GU strains. Multilocus sequence typing of dsrA-hgbA-ncaA could be reliably used for epidemiological investigation of CU and GU strains. As class II strains grow relatively poorly and are relatively more susceptible to vancomycin than class I strains, these findings have implications for methods to recover CU strains. Comparison of contemporary CU and GU isolates would help clarify the relationship between these entities.

  3. Effectiveness of laparoscopic Roux-en-Y gastric bypass on obese class I type 2 diabetes mellitus patients.

    PubMed

    Xu, Lu; Yin, Jun; Mikami, Dean J; Portenier, Dana D; Zhou, Xiaojun; Mao, Zhongqi

    2015-01-01

    Laparoscopic Roux-en-Y gastric bypass (LRYGB) can dramatically improve type 2 diabetes mellitus (T2D) in obese class II and III patients. There is increasing evidence that shows bariatric surgery can also ameliorate T2D in patients with BMI between 30 kg/m(2) and 35 kg/m(2) (obese class I). To compare the effectiveness of LRYGB on T2D in obese class I patients with that of obese class II and III T2D patients. University Hospital, China A prospective study was performed in the authors' center from March 2010 to July 2011. Forty-two consecutive obese patients were included in the study. Anthropometric and metabolism parameters were compared between obese class II and III patients and obese class I patients before and after LRYGB. No patients were lost to follow up. After 36 months, metabolic parameters significantly improved in both groups. Partial remission rates between the 2 groups at each time point (12 months, 24 months, and 36 months) were comparable. Obese class II and III patients had higher complete remission rates at 12 months and 24 months, but no difference was observed at 36 months. Both obese class II and III patients and obese class I T2D patients showed significant improvement in multiple parameters after LRYGB. Obese class II and III patients had a higher complete remission rate than obese class I patients. Standardized remission criteria are needed to make outcomes form different centers comparable. Large prospective studies are needed and long-term outcomes have to be observed to better evaluate effectiveness of LRYGB on obese class I T2D patients. Copyright © 2015 American Society for Bariatric Surgery. All rights reserved.

  4. Pathognomonic features of Angle's Class II division 2 malocclusion: A comparative cephalometric and arch width study

    PubMed Central

    Prasad, Singamsetty E.R.V.; Indukuri, Ravikishore Reddy; Singh, Rupesh; Nooney, Anitha; Palagiri, Firoz Babu; Narayana, Veera

    2014-01-01

    Background: A thorough knowledge of the salient features of malocclusion helps the clinician in arriving at a proper diagnosis and treatment plan, and also to predict the prognosis, prior to the onset of treatment process. Among the four classes of Angle's classification of malocclusion, Class II division 2 occurs with the least frequency. There is still continuing debate in the literature whether the Class II division 2 patients ascribe the pathognomonic skeletal and dental features. Aim of the study: The aim of this study is to describe the unique features of Angle's Class II division 2 malocclusion to differentiate it from Angle's Class II division 1 malocclusion. Materials and Methods: A total of 582 pre-treatment records (study models and cephalograms), with the age of patients ranging from 15 to 22 years, were obtained from the hospital records of Vishnu Dental College, Bhimavaram and Geetam's Dental College, Visakhapatnam. Out of these, 11 pre-treatment records were excluded because of lack of clarity. In the rest of the sample, 283 were Class II division 1 and 288 were Class II division 2. The lateral cephalograms were analyzed by using digiceph and the arch width analysis was done based on the anatomical points described by Staley et al. and Sergl et al. Results: An intergroup evaluation was done by using unpaired Student's “t” test. The skeletal vertical parameters, dental parameters, and the maxillary arch width parameters revealed a statistically significant difference between the two groups of malocclusion. Conclusion: Angle's Class II division 2 malocclusion has a pronounced horizontal growth pattern with decreased lower anterior facial height, retroclined upper anteriors, and significantly increased maxillary arch width parameters. PMID:25558449

  5. Extra-oral Appliances in Orthodontic Treatment.

    PubMed

    Almuzian, Mohammed; Alharbi, Fahad; McIntyre, Grant

    2016-01-01

    Extra-oral appliances are used in orthodontics to apply forces to the jaws, dentition or both and the popularity of these appliances is cyclical. Although the use of retraction headgear for the management of Class II malocclusion has declined over the last 20 years with the refinement of non-compliance approaches, including temporary anchorage devices, headgear still has a useful role in orthodontics. The use of protraction headgear has increased as more evidence of its effectiveness for the treatment of Class lIl malocclusion has become available. This paper describes the mechanics and contemporary uses of headgear in orthodontics for primary care dentists and specialist orthodontists. CPD/CLINICAL RELEVANCE: Extra-oral appliances have specific uses in orthodontic biomechanics. Clinicians using retraction headgear and protraction headgear should be familiar with their clinical indications, the potential problems and how these can be avoided.

  6. Analysis of class II (hydrolytic) and class I (beta-lyase) apurinic/apyrimidinic endonucleases with a synthetic DNA substrate.

    PubMed Central

    Levin, J D; Demple, B

    1990-01-01

    We have developed simple and sensitive assays that distinguish the main classes of apurinic/apyrimidinic (AP) endonucleases: Class I enzymes that cleave on the 3' side of AP sites by beta-elimination, and Class II enzymes that cleave by hydrolysis on the 5' side. The distinction of the two types depends on the use of a synthetic DNA polymer that contains AP sites with 5'-[32P]phosphate residues. Using this approach, we now show directly that Escherichia coli endonuclease IV and human AP endonuclease are Class II enzymes, as inferred previously on the basis of indirect assays. The assay method does not exhibit significant interference by nonspecific nucleases or primary amines, which allows the ready determination of different AP endonuclease activities in crude cell extracts. In this way, we show that virtually all of the Class II AP endonuclease activity in E. coli can be accounted for by two enzymes: exonuclease III and endonuclease IV. In the yeast Saccharomyces cerevisiae, the Class II AP endonuclease activity is totally dependent on a single enzyme, the Apn1 protein, but there are probably multiple Class I enzymes. The versatility and ease of our approach should be useful for characterizing this important class of DNA repair enzymes in diverse systems. PMID:1698278

  7. Using Personal Portable Devices as Learning Tools in the English Class

    ERIC Educational Resources Information Center

    Herrera Díaz, Luz Edith; Cruz Ramos, María de los Milagros; Sandoval Sánchez, Mario Alberto

    2014-01-01

    A group of university students used a variety of personal portable devices (cellphones, tablets, laptops, and netbooks) which distracted them in English class. This qualitative action research aimed to implement activities entailing the use of such devices and to learn their impact on students' learning and the use of English in class. Thus, a…

  8. 40 CFR 147.2201 - State-administered program-Class II wells

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Application to Oil, Gas, and Geothermal Resource Operations, sections .051.02.02.000 to .051.02.02.080... wells 147.2201 Section 147.2201 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Texas § 147.2201 State-administered program—Class II wells The UIC program for Class II wells in the...

  9. 38 CFR 17.162 - Eligibility for Class II dental treatment without rating action.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... dental treatment without rating action. 17.162 Section 17.162 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Dental Services § 17.162 Eligibility for Class II dental treatment without rating action. When an application has been made for class II dental treatment under § 17.161(b...

  10. 38 CFR 17.162 - Eligibility for Class II dental treatment without rating action.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... dental treatment without rating action. 17.162 Section 17.162 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Dental Services § 17.162 Eligibility for Class II dental treatment without rating action. When an application has been made for class II dental treatment under § 17.161(b...

  11. 38 CFR 17.162 - Eligibility for Class II dental treatment without rating action.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... dental treatment without rating action. 17.162 Section 17.162 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Dental Services § 17.162 Eligibility for Class II dental treatment without rating action. When an application has been made for class II dental treatment under § 17.161(b...

  12. 38 CFR 17.162 - Eligibility for Class II dental treatment without rating action.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... dental treatment without rating action. 17.162 Section 17.162 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Dental Services § 17.162 Eligibility for Class II dental treatment without rating action. When an application has been made for class II dental treatment under § 17.161(b...

  13. 38 CFR 17.162 - Eligibility for Class II dental treatment without rating action.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... dental treatment without rating action. 17.162 Section 17.162 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS MEDICAL Dental Services § 17.162 Eligibility for Class II dental treatment without rating action. When an application has been made for class II dental treatment under § 17.161(b...

  14. 40 CFR 147.2201 - State-administered program-Class II wells

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Application to Oil, Gas, and Geothermal Resource Operations, sections .051.02.02.000 to .051.02.02.080... wells 147.2201 Section 147.2201 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Texas § 147.2201 State-administered program—Class II wells The UIC program for Class II wells in the...

  15. The Effect of MHC Class II Transactivator on the Growth and Metastasis of Breast Tumors

    DTIC Science & Technology

    1999-06-01

    F. Manca, and R. S. Accolla. 1998. HLA class II expression in uninducible hepatocarcinoma cells after transfection of AIR-1 gene product CIITA...Cestari, A. D’Agostino, ’ A M Megiovanni, F. Manca, and R. S. Accolla. 1998. HLA class II expression in uninducible hepatocarcinoma cells after

  16. 40 CFR 82.23 - Transfers of allowances of class II controlled substances.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... section. (2) Inter-pollutant transfers will be permitted at any time during the control period and during... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Transfers of allowances of class II... § 82.23 Transfers of allowances of class II controlled substances. (a) Inter-company transfers...

  17. 40 CFR 82.23 - Transfers of allowances of class II controlled substances.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... section. (2) Inter-pollutant transfers will be permitted at any time during the control period and during... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Transfers of allowances of class II... § 82.23 Transfers of allowances of class II controlled substances. (a) Inter-company transfers...

  18. Major histocompatibility complex (MHC) class I and II alleles which confer susceptibility or protection in the Morphea in Adults and Children (MAC) cohort

    PubMed Central

    Jacobe, Heidi; Ahn, Chul; Arnett, Frank; Reveille, John D.

    2014-01-01

    Objective To determine human leukocyte antigen class I (HLA-class I) and II (HLA-class II) alleles associated with morphea (localized scleroderma) in the Morphea in Adults and Children (MAC) cohort by a nested case–control association study. Methods Morphea patients were included from MAC cohort and matched controls from the NIH/NIAMS Scleroderma Family Registry and DNA Repository and Division of Rheumatology at the University of Texas Health Science Center at Houston. HLA- Class II genotyping and SSCP typing was performed of HLA-A, -B, -C alleles. Associations between HLA-Class I and II alleles and morphea as well as its subphenotypes were determined. Results There were 211 cases available for HLA-class I typing with 726 matched controls and 158 cases available for HLA Class-II typing with 1108 matched controls. The strongest associations were found with DRB1*04:04 (OR 2.3, 95% CI 1.4–4.0 P=0.002) and HLA-B*37 conferred the highest OR among Class I alleles (3.3, 95% CI 1.6–6.9, P= 0.0016). Comparison with risk alleles in systemic sclerosis determined using the same methods and control population revealed one common allele (DRB*04:04). Conclusion Results of the present study demonstrate specific HLA Class I and II alleles are associated with morphea and likely generalized and linear subtypes. The associated morphea alleles are different than in scleroderma, implicating morphea is also immunogenetically distinct. Risk alleles in morphea are also associated with conditions such as rheumatoid arthritis (RA) and other autoimmune conditions. Population based studies indicate patients with RA have increased risk of morphea, implicating a common susceptibility allele. PMID:25223600

  19. Evolution of major histocompatibility complex class I and class II genes in the brown bear

    PubMed Central

    2012-01-01

    Background Major histocompatibility complex (MHC) proteins constitute an essential component of the vertebrate immune response, and are coded by the most polymorphic of the vertebrate genes. Here, we investigated sequence variation and evolution of MHC class I and class II DRB, DQA and DQB genes in the brown bear Ursus arctos to characterise the level of polymorphism, estimate the strength of positive selection acting on them, and assess the extent of gene orthology and trans-species polymorphism in Ursidae. Results We found 37 MHC class I, 16 MHC class II DRB, four DQB and two DQA alleles. We confirmed the expression of several loci: three MHC class I, two DRB, two DQB and one DQA. MHC class I also contained two clusters of non-expressed sequences. MHC class I and DRB allele frequencies differed between northern and southern populations of the Scandinavian brown bear. The rate of nonsynonymous substitutions (dN) exceeded the rate of synonymous substitutions (dS) at putative antigen binding sites of DRB and DQB loci and, marginally significantly, at MHC class I loci. Models of codon evolution supported positive selection at DRB and MHC class I loci. Both MHC class I and MHC class II sequences showed orthology to gene clusters found in the giant panda Ailuropoda melanoleuca. Conclusions Historical positive selection has acted on MHC class I, class II DRB and DQB, but not on the DQA locus. The signal of historical positive selection on the DRB locus was particularly strong, which may be a general feature of caniforms. The presence of MHC class I pseudogenes may indicate faster gene turnover in this class through the birth-and-death process. South–north population structure at MHC loci probably reflects origin of the populations from separate glacial refugia. PMID:23031405

  20. Evolution of major histocompatibility complex class I and class II genes in the brown bear.

    PubMed

    Kuduk, Katarzyna; Babik, Wiesław; Bojarska, Katarzyna; Sliwińska, Ewa B; Kindberg, Jonas; Taberlet, Pierre; Swenson, Jon E; Radwan, Jacek

    2012-10-02

    Major histocompatibility complex (MHC) proteins constitute an essential component of the vertebrate immune response, and are coded by the most polymorphic of the vertebrate genes. Here, we investigated sequence variation and evolution of MHC class I and class II DRB, DQA and DQB genes in the brown bear Ursus arctos to characterise the level of polymorphism, estimate the strength of positive selection acting on them, and assess the extent of gene orthology and trans-species polymorphism in Ursidae. We found 37 MHC class I, 16 MHC class II DRB, four DQB and two DQA alleles. We confirmed the expression of several loci: three MHC class I, two DRB, two DQB and one DQA. MHC class I also contained two clusters of non-expressed sequences. MHC class I and DRB allele frequencies differed between northern and southern populations of the Scandinavian brown bear. The rate of nonsynonymous substitutions (dN) exceeded the rate of synonymous substitutions (dS) at putative antigen binding sites of DRB and DQB loci and, marginally significantly, at MHC class I loci. Models of codon evolution supported positive selection at DRB and MHC class I loci. Both MHC class I and MHC class II sequences showed orthology to gene clusters found in the giant panda Ailuropoda melanoleuca. Historical positive selection has acted on MHC class I, class II DRB and DQB, but not on the DQA locus. The signal of historical positive selection on the DRB locus was particularly strong, which may be a general feature of caniforms. The presence of MHC class I pseudogenes may indicate faster gene turnover in this class through the birth-and-death process. South-north population structure at MHC loci probably reflects origin of the populations from separate glacial refugia.

  1. Maxillary molar distalization with first class appliance

    PubMed Central

    Ramesh, Namitha; Palukunnu, Biswas; Ravindran, Nidhi; Nair, Preeti P

    2014-01-01

    Non-extraction treatment has gained popularity for corrections of mild-to-moderate class II malocclusion over the past few decades. The distalization of maxillary molars is of significant value for treatment of cases with minimal arch discrepancy and mild class II molar relation associated with a normal mandibular arch and acceptable profile. This paper describes our experience with a 16-year-old female patient who reported with irregularly placed upper front teeth and unpleasant smile. The patient was diagnosed to have angles class II malocclusion with moderate maxillary anterior crowding, deep bite of 4 mm on a skeletal class II base with an orthognathic maxilla and retrognathic mandible and normal growth pattern. She presented an ideal profile and so molar distalization was planned with the first-class appliance. Molars were distalised by 8 mm on the right and left quadrants and class I molar relation achieved within 4 months. The space gained was utilised effectively to align the arch and establish a class I molar and canine relation. PMID:24577171

  2. In vitro assessment of polymerization procedures in Class II restorations: sealing, FTIR, and microhardness evaluations.

    PubMed

    Tassery, H; de Donato, P; Barrès, O; Déjou, J

    2001-01-01

    This study was undertaken to evaluate several polymerization and filling procedures (incremental, bulk, light-tip, soft-cured, plasma devices) in Class II restorations through (1) a sealing evaluation of restorations filled with Tetric Ceram (TC) and Bisfil 2B (B2B, self-cured composite used as a control), (2) a FTIR analysis measuring the variations of the degree of conversion in terms of area unit ratio of the relevant resin composites and (3) a microhardness test to corroborate the FTIR analysis. The length of the tracer penetration was measured from the gingival margin up to the cavity wall with an episcope on sectioned teeth. A ceramic mould, simulating a Class II, was filled according to the different groups and the samples were analyzed with a Bruker IFS 55 spectrometer on ultrathin sections (3 mu). The results were analyzed in terms of area unit ratio and total exposed energy. Under the same conditions, a microhardness test was run with a Frank Weihem machine. The results of the sealing evaluation for light-tip, incremental and self-cured techniques did not differ. The plasma procedure failed in this evaluation as the bottom increment was not polymerized. The smallest area unit ratio (the best degree of conversion) was observed in 2 groups: one, the combination of the light-tip and soft process, and two, the self-cured resin composite (B2B). The distance at which the plasma procedure failed to cure the resin composite was between 3.5 and 4.5 mm. The microhardness test confirmed the FTIR analysis except for the group G2 (TC + light-tip). As also shown by FTIR analysis, no difference between the two relevant levels was observed with the hardness test. The dentin marginal sealing efficiency of Tetric Ceram restorations was increased with the light-tip technique, but was not better than the self-cured resin composite (B2B). For Tetric Ceram, the combination of the light-tip and soft process leads to a higher degree of conversion than the other groups. There is no linear relationship between the degree of conversion, the microhardness and the total exposed energy. The combination of the soft polymerization and the light-tip device might be an alternative restorative technique to the current incremental technique.

  3. 25 CFR 547.7 - What are the minimum technical hardware standards applicable to Class II gaming systems?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... OF CLASS II GAMES § 547.7 What are the minimum technical hardware standards applicable to Class II... the game, and are specially manufactured or proprietary and not off-the-shelf, shall display a unique... outcome or integrity of any game, progressive award, financial instrument, cashless transaction, voucher...

  4. 25 CFR 547.7 - What are the minimum technical hardware standards applicable to Class II gaming systems?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF CLASS II GAMES § 547.7 What are the minimum technical hardware standards applicable to Class II... the game, and are specially manufactured or proprietary and not off-the-shelf, shall display a unique... outcome or integrity of any game, progressive award, financial instrument, cashless transaction, voucher...

  5. 25 CFR 547.7 - What are the minimum technical hardware standards applicable to Class II gaming systems?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... OF CLASS II GAMES § 547.7 What are the minimum technical hardware standards applicable to Class II... the game, and are specially manufactured or proprietary and not off-the-shelf, shall display a unique... outcome or integrity of any game, progressive award, financial instrument, cashless transaction, voucher...

  6. 40 CFR 82.24 - Recordkeeping and reporting requirements for class II controlled substances.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... transformation; (v) The date on which the class II controlled substances were imported; (vi) The port of entry.... Customs entry form; (xiv) Dated records documenting the sale or transfer of class II controlled substances... source facility; (vii) The U.S. port of entry for the import, the expected date of shipment and the...

  7. 40 CFR 82.24 - Recordkeeping and reporting requirements for class II controlled substances.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... transformation; (v) The date on which the class II controlled substances were imported; (vi) The port of entry.... Customs entry form; (xiv) Dated records documenting the sale or transfer of class II controlled substances... source facility; (vii) The U.S. port of entry for the import, the expected date of shipment and the...

  8. 25 CFR 547.6 - What are the minimum technical standards for enrolling and enabling Class II gaming system...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and enabling Class II gaming system components? 547.6 Section 547.6 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT OF THE INTERIOR HUMAN SERVICES MINIMUM TECHNICAL STANDARDS FOR GAMING EQUIPMENT USED WITH THE PLAY OF CLASS II GAMES § 547.6 What are the minimum technical standards for enrolling and...

  9. 40 CFR Appendix B to Subpart A of... - Class II Controlled Substances a

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Class II Controlled Substances a B Appendix B to Subpart A of Part 82 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED..., Subpt. A, App. B Appendix B to Subpart A of Part 82—Class II Controlled Substances a Controlled...

  10. 40 CFR 82.17 - Apportionment of baseline production allowances for class II controlled substances.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... allowances for class II controlled substances. 82.17 Section 82.17 Protection of Environment ENVIRONMENTAL... Consumption Controls § 82.17 Apportionment of baseline production allowances for class II controlled... 1,759,681 MDA Manufacturing HCFC-22 2,383,835 Solvay Solexis HCFC-142b 6,541,764 [ 74 FR 66446, Dec...

  11. 40 CFR 144.21 - Existing Class I, II (except enhanced recovery and hydrocarbon storage) and III wells.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... recovery and hydrocarbon storage) and III wells. 144.21 Section 144.21 Protection of Environment... hydrocarbon storage) and III wells. (a) An existing Class I, II (except enhanced recovery and hydrocarbon... decision; or (9) For Class II wells (except enhanced recovery and hydrocarbon storage), five years after...

  12. 40 CFR 144.21 - Existing Class I, II (except enhanced recovery and hydrocarbon storage) and III wells.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... recovery and hydrocarbon storage) and III wells. 144.21 Section 144.21 Protection of Environment... hydrocarbon storage) and III wells. (a) An existing Class I, II (except enhanced recovery and hydrocarbon... decision; or (9) For Class II wells (except enhanced recovery and hydrocarbon storage), five years after...

  13. 77 FR 24978 - Notice of Proposed Class II Reinstatement of Terminated Oil and Gas Leases, Utah.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... Proposed Class II Reinstatement of Terminated Oil and Gas Leases, Utah. AGENCY: Bureau of Land Management, Interior. ACTION: Notice of Proposed Class II Reinstatement of Terminated Oil and Gas Leases, Utah. SUMMARY: In accordance with Title IV of the Federal Oil and Gas Royalty Management Act (Pub. L. 97-451...

  14. 76 FR 14686 - Notice of Proposed Class II Reinstatement of Terminated Oil and Gas Lease, Utah

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

    ... Proposed Class II Reinstatement of Terminated Oil and Gas Lease, Utah AGENCY: Bureau of Land Management, Interior. ACTION: Notice of Proposed Class II Reinstatement of Terminated Oil and Gas Lease, Utah. SUMMARY: In accordance with Title IV of the Federal Oil and Gas Royalty Management Act (Pub. L. 97-451...

  15. Assessment of the changes in quality of life of patients with class II and III deformities during and after orthodontic-surgical treatment.

    PubMed

    Baherimoghaddam, T; Tabrizi, R; Naseri, N; Pouzesh, A; Oshagh, M; Torkan, S

    2016-04-01

    The aim of this longitudinal study was to assess and compare the oral health-related quality of life (OHRQoL) of patients with class II and III deformities during and after orthodontic-surgical treatment. Thirty class III and 28 class II patients were evaluated at baseline (T0), just prior to surgery (T1), at 6 months after surgery (T2), and at 12 months after debonding (T3). OHRQoL was assessed using the Oral Health Impact Profile (OHIP-14). Friedman two-way analysis of variance and the Wilcoxon signed-rank test were performed to compare the relative changes in OHRQoL during treatment. Significant changes in the overall OHIP-14 scores were observed during and after orthodontic-surgical treatment in both groups. During the pre-surgical stage, psychological discomfort and psychological disability decreased in class III patients, and class II patients experienced a significant deterioration in psychological discomfort during the same period. Six months after surgery, patients in both groups showed improvements in psychological discomfort, social disability, and handicap. Physical disability and functional limitation showed further improvement at 12 months after debonding in class II patients. This study reaffirms that orthodontic-surgical treatment has a significant effect on the OHRQoL of class III and class II patients. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  16. Th-1 polarization is regulated by dendritic-cell comparison of MHC class I and class II antigens

    PubMed Central

    Xing, Dongxia; Li, Sufang; Robinson, Simon N.; Yang, Hong; Steiner, David; Komanduri, Krishna V.; Shpall, Elizabeth J.

    2009-01-01

    In the control of T-helper type I (Th-1) polarization, dendritic cells (DCs) must interpret a complex array of stimuli, many of which are poorly understood. Here we demonstrate that Th-1 polarization is heavily influenced by DC-autonomous phenomena triggered by the loading of DCs with antigenically matched major histocompatibility complex (MHC) class I and class II determinants, that is, class I and II peptide epitopes exhibiting significant amino acid sequence overlap (such as would be physiologically present during infectious processes requiring Th-1 immunity for clearance). Data were derived from 13 independent antigenic models including whole-cell systems, single-protein systems, and 3 different pairs of overlapping class I and II binding epitopes. Once loaded with matched class I and II antigens, these “Th-1 DCs” exhibited differential cytokine secretion and surface marker expression, a distinct transcriptional signature, and acquired the ability to enhance generation of CD8+ T lymphocytes. Mechanistically, tRNA-synthetases were implicated as components of a putative sensor complex involved in the comparison of class I and II epitopes. These data provide rigorous conceptual explanations for the process of Th-1 polarization and the antigenic specificity of cognate T-cell help, enhance the understanding of Th-1 responses, and should contribute to the formulation of more effective vaccination strategies. PMID:19171878

  17. DMA and DMB are the only genes in the class II region of the human MHC needed for class II-associated antigen processing

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

    Ceman, S.; Rudersdorf, R.A.; Petersen, J.M.

    1995-03-15

    Previous studies have shown that homozygous mutations between the LMP2 and DNA loci in the human MHC cause class II molecules to be abnormally conformed and unstable in the presence of SDS at low temperature, and impede class II-associated Ag processing and presentation. These abnormalities result from impaired ability to form intracellular class II/peptide complexes that predominate in normal cells. We show in this work that this defect results from deficient expression of either the DMA or the DMB gene. Human B-LCL.174 (DR3) cells, which have a deletion of all known expressible genes in the class II region, express transgene-encodedmore » HLA-DR3, but have the abnormalities. Transfer of cosmid HA14, which contains the DMA and DMB genes, into .174 (DR3) cells restored normal DR3 conformation, stability in 0.4% SDS at 0{degrees}, and ability to process and present tetanus toxoid, but only when both DMA and DMB mRNAs were present. The requirement for both genetic expressions in engendering normal phenotypes was confirmed by transferring the cloned genes into .174 (DR3) cells separately or together. Because normal phenotypes were fully restored in transferent cells expressing DMA plus DMB, other genes in the {approximately} 1-mb homozygous class II region deletion in .174 (DR3) cells either do not participate in or are dispensable for apparently normal production of intracellular class II/peptide complexes. The properties of DM-deficient EBV-transformed B lymphoblastoid cell lines (LCLs) suggest ways of identifying humans in whom DM deficiency contributes to congenital immunodeficiency and malignancy. 67 refs., 5 figs., 1 tab.« less

  18. A retrospective study of Class II mixed-dentition treatment.

    PubMed

    Oh, Heesoo; Baumrind, Sheldon; Korn, Edward L; Dugoni, Steven; Boero, Roger; Aubert, Maryse; Boyd, Robert

    2017-01-01

    To consider the effectiveness of early treatment using one mixed-dentition approach to the correction of moderate and severe Class II malocclusions. Three groups of Class II subjects were included in this retrospective study: an early treatment (EarlyTx) group that first presented at age 7 to 9.5 years (n = 54), a late treatment (LateTx) group whose first orthodontic visit occurred between ages 12 and 15 (n = 58), and an untreated Class II (UnTx) group to assess the pretreatment comparability of the two treated groups (n = 51). Thirteen conventional cephalometric measurements were reported for each group and Class II molar severity was measured on the study casts of the EarlyTx and LateTx groups. Successful Class II correction was observed in approximately three quarters of both the EarlyTx group and the LateTx group at the end of treatment. EarlyTx patients had fewer permanent teeth extracted than did the LateTx patients (5.6% vs 37.9%, P < .001) and spent less time in full-bonded appliance therapy in the permanent dentition than did LateTx patients (1.7 ± 0.8 vs 2.6 ± 0.7years, P < .001). When supervision time is included, the EarlyTx group had longer total treatment time and averaged more visits than did the LateTx group (53.1 ± 18. 8 vs 33.7 ± 8.3, P < .0001). Fifty-five percent of the LateTx extraction cases involved removal of the maxillary first premolars only and were finished in a Class II molar relationship. EarlyTx comprehensive mixed-dentition treatment was an effective modality for early correction of Class II malocclusions.

  19. HLA-G and MHC Class II Protein Expression in Diffuse Large B-Cell Lymphoma.

    PubMed

    Jesionek-Kupnicka, Dorota; Bojo, Marcin; Prochorec-Sobieszek, Monika; Szumera-Ciećkiewicz, Anna; Jabłońska, Joanna; Kalinka-Warzocha, Ewa; Kordek, Radzisław; Młynarski, Wojciech; Robak, Tadeusz; Warzocha, Krzysztof; Lech-Maranda, Ewa

    2016-06-01

    The expression of human leukocyte antigen-G (HLA-G) and HLA class II protein was studied by immunohistochemical staining of lymph nodes from 148 patients with diffuse large B-cell lymphoma (DLBCL) and related to the clinical course of the disease. Negative HLA-G expression was associated with a lower probability of achieving a complete remission (p = 0.04). Patients with negative HLA-G expression tended towards a lower 3-year overall survival (OS) rate compared to those with positive expression of HLA-G (p = 0.08). When restricting the analysis to patients receiving chemotherapy with rituximab, the estimated 3-year OS rate of patients with positive HLA-G expression was 73.3 % compared with 47.5 % (p = 0.03) in those with negative expression. Patients with negative HLA class II expression presented a lower 3-year OS rate compared to subjects with positive expression (p = 0.04). The loss of HLA class II expression (p = 0.05) and belonging to the intermediate high/high IPI risk group (p = 0.001) independently increased the risk of death. HLA class II expression also retained its prognostic value in patients receiving rituximab; the 3-year OS rate was 65.3 % in patients with positive HLA class II expression versus 29.6 % (p = 0.04) in subjects that had loss of HLA class II expression. To our knowledge, for the first time, the expression of HLA-G protein in DLBCL and its association with the clinical course of the disease was demonstrated. Moreover, the link between losing HLA class II protein expression and poor survival of patients treated with immunochemotherapy was confirmed.

  20. Selection and Trans-Species Polymorphism of Major Histocompatibility Complex Class II Genes in the Order Crocodylia

    PubMed Central

    Jaratlerdsiri, Weerachai; Isberg, Sally R.; Higgins, Damien P.; Miles, Lee G.; Gongora, Jaime

    2014-01-01

    Major Histocompatibility Complex (MHC) class II genes encode for molecules that aid in the presentation of antigens to helper T cells. MHC characterisation within and between major vertebrate taxa has shed light on the evolutionary mechanisms shaping the diversity within this genomic region, though little characterisation has been performed within the Order Crocodylia. Here we investigate the extent and effect of selective pressures and trans-species polymorphism on MHC class II α and β evolution among 20 extant species of Crocodylia. Selection detection analyses showed that diversifying selection influenced MHC class II β diversity, whilst diversity within MHC class II α is the result of strong purifying selection. Comparison of translated sequences between species revealed the presence of twelve trans-species polymorphisms, some of which appear to be specific to the genera Crocodylus and Caiman. Phylogenetic reconstruction clustered MHC class II α sequences into two major clades representing the families Crocodilidae and Alligatoridae. However, no further subdivision within these clades was evident and, based on the observation that most MHC class II α sequences shared the same trans-species polymorphisms, it is possible that they correspond to the same gene lineage across species. In contrast, phylogenetic analyses of MHC class II β sequences showed a mixture of subclades containing sequences from Crocodilidae and/or Alligatoridae, illustrating orthologous relationships among those genes. Interestingly, two of the subclades containing sequences from both Crocodilidae and Alligatoridae shared specific trans-species polymorphisms, suggesting that they may belong to ancient lineages pre-dating the divergence of these two families from the common ancestor 85–90 million years ago. The results presented herein provide an immunogenetic resource that may be used to further assess MHC diversity and functionality in Crocodylia. PMID:24503938

  1. Changes in Cranial Base Morphology in Class I and Class II Division 1 Malocclusions

    PubMed Central

    Agarwal, Anirudh; Pandey, Harsh; Bajaj, Kamal; Pandey, Lavesh

    2013-01-01

    Introduction: The cranial base plays a key role in craniofacial growth; it helps to integrate spatially and functionally different patterns of growth in various adjoining regions of the skull such as components of the brain, the nasal and oral cavity and the pharynx. The aim of this study was to evaluate the difference in cranial base flexure between skeletal and dental Class I and Class II division 1. Materials & Methods: Lateral cephalometric radiograph, of Class I and Class II with an average growth pattern were analyzed and compared. A total of 103 patients having class I (n=52) and class II (n=51) malocclusion, were taken from Department of Orthodontics, Rajasthan Dental College & Hospital, Jaipur. Cranial base angle (N-S-Ar) and ANB were measured on pre treatment lateral cephalograms. Results: In this study cranial base angle did not show statistically significant difference between the two groups studied. Conclusion: In the assessment of orthodontic problems involving anteroposterior malrelationships of the jaws, the problem is usually the result of size, form and position of the jaw. The present study failed to find any differences in cranial base angle between sagittal malocclusions. How to cite this article: Agarwal A, Pandey H, Bajaj K, Pandey L. Changes in Cranial Base Morphology in Class I and Class II Division 1 Malocclusion. J Int Oral Health 2013; 5(1):39-42. PMID:24155576

  2. Investigation into the Emerging Role of the Basic Amino Acid L-Lysine in Enhancing Solubility and Permeability of BCS Class II and BCS Class IV Drugs.

    PubMed

    Abdelkader, Hamdy; Fathalla, Zeinab

    2018-06-18

    The search for a simple and scalable approach that can improve the two key biopharmaceutical processes (solubility and permeability) for BCS Class II and BCS Class IV has still been unmet need. In this study, L-lysine was investigated as a potential excipient to tackle problems with solubility and permeability. Bendazac (Class II); quercetin and rutin (Class IV) were employed. Drugs-lysine complexes in 1:1 M ratios were prepared by co-precipitation and co-grinding; characterized for solubility, partition coefficient, DSC, FTIR, SEM, dissolution rate and permeability. Chemical stability of quercetin-lysine and rutin-lysine was studied by assessing antioxidant capacity using Trolox and CUPRAC assays. Drugs-lysine salt/complexes were confirmed. Solubility enhancement factors ranged from 68- to 433-fold increases and dissolution rates were also significantly enhanced by up to 6-times, compared with drugs alone. With the exception of rutin-lysine, P app for bendazac-lysine and quercetin-lysine enhanced by 2.3- to 4-fold. P app for quercetin (Class IV) benefited more than bendazac (Class II) when complexed with lysine. This study warrants the use of L-lysine as a promising excipient for enhanced solubility and permeability of Class II and Class IV, providing that the solubility of the drug is ensured at 'the door step' of absorption sites.

  3. MHC class II is an important genetic risk factor for canine systemic lupus erythematosus (SLE)-related disease: implications for reproductive success.

    PubMed

    Wilbe, M; Andersson, G

    2012-01-01

    Major histocompatibility complex (MHC) class II genes are important genetic risk factors for development of immune-mediated diseases in mammals. Recently, the dog (Canis lupus familiaris) has emerged as a useful model organism to identify critical MHC class II genotypes that contribute to development of these diseases. Therefore, a study aimed to evaluate a potential genetic association between the dog leukocyte antigen (DLA) class II region and an immune-mediated disease complex in dogs of the Nova Scotia duck tolling retriever breed was performed. We show that DLA is one of several genetic risk factors for this disease complex and that homozygosity of the risk haplotype is disadvantageous. Importantly, the disease is complex and has many genetic risk factors and therefore we cannot provide recommendations for breeders exclusively on the basis of genetic testing for DLA class II genotype. © 2012 Blackwell Verlag GmbH.

  4. In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen.

    PubMed

    Tsume, Yasuhiro; Langguth, Peter; Garcia-Arieta, Alfredo; Amidon, Gordon L

    2012-10-01

    The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS class III and BCS class II have been proposed, in particular, BCS class II weak acids. However, a discrepancy between the in vivo BE results and in vitro dissolution results for BCS class II acids was recently observed. The objectives of this study were to determine the oral absorption of BCS class II weak acids via simulation software and to determine if the in vitro dissolution test with various dissolution media could be sufficient for in vitro bioequivalence studies of ibuprofen and ketoprofen as models of carboxylic acid drugs. The oral absorption of these BCS class II acids from the gastrointestinal tract was predicted by GastroPlus™. Ibuprofen did not satisfy the bioequivalence criteria at lower settings of intestinal pH of 6.0. Further the experimental dissolution of ibuprofen tablets in a low concentration phosphate buffer at pH 6.0 (the average buffer capacity 2.2 mmol l (-1) /pH) was dramatically reduced compared with the dissolution in SIF (the average buffer capacity 12.6 mmol l (-1) /pH). Thus these predictions for the oral absorption of BCS class II acids indicate that the absorption patterns depend largely on the intestinal pH and buffer strength and must be considered carefully for a bioequivalence test. Simulation software may be a very useful tool to aid the selection of dissolution media that may be useful in setting an in vitro bioequivalence dissolution standard. Copyright © 2012 John Wiley & Sons, Ltd.

  5. In Silico Prediction of Drug Dissolution and Absorption with variation in Intestinal pH for BCS Class II Weak Acid Drugs: Ibuprofen and Ketoprofen§

    PubMed Central

    Tsume, Yasuhiro; Langguth, Peter; Garcia-Arieta, Alfredo; Amidon, Gordon L.

    2012-01-01

    The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS Class III and BCS class II have been proposed, particularly, BCS class II weak acids. However, a discrepancy between the in vivo- BE results and in vitro- dissolution results for a BCS class II acids was recently observed. The objectives of this study were to determine the oral absorption of BCS class II weak acids via simulation software and to determine if the in vitro dissolution test with various dissolution media could be sufficient for in vitro bioequivalence studies of ibuprofen and ketoprofen as models of carboxylic acid drugs. The oral absorption of these BCS class II acids from the gastrointestinal tract was predicted by GastroPlus™. Ibuprofen did not satisfy the bioequivalence criteria at lower settings of intestinal pH=6.0. Further the experimental dissolution of ibuprofen tablets in the low concentration phosphate buffer at pH 6.0 (the average buffer capacity 2.2 mmol L-1/pH) was dramatically reduced compared to the dissolution in SIF (the average buffer capacity 12.6 mmol L -1/pH). Thus these predictions for oral absorption of BCS class II acids indicate that the absorption patterns largely depend on the intestinal pH and buffer strength and must be carefully considered for a bioequivalence test. Simulation software may be very useful tool to aid the selection of dissolution media that may be useful in setting an in vitro bioequivalence dissolution standard. PMID:22815122

  6. Haemophilus ducreyi Cutaneous Ulcer Strains Diverged from Both Class I and Class II Genital Ulcer Strains: Implications for Epidemiological Studies

    PubMed Central

    Gangaiah, Dharanesh

    2016-01-01

    Background Haemophilus ducreyi has emerged as a major cause of cutaneous ulcers (CU) in yaws-endemic regions of the tropics in the South Pacific, South East Asia and Africa. H. ducreyi was once thought only to cause the genital ulcer (GU) disease chancroid; GU strains belong to 2 distinct classes, class I and class II. Using whole-genome sequencing of 4 CU strains from Samoa, 1 from Vanuatu and 1 from Papua New Guinea, we showed that CU strains diverged from the class I strain 35000HP and that one CU strain expressed β-lactamase. Recently, the Center for Disease Control and Prevention released the genomes of 11 additional CU strains from Vanuatu and Ghana; however, the evolutionary relationship of these CU strains to previously-characterized CU and GU strains is unknown. Methodology/Principal Findings We performed phylogenetic analysis of 17 CU and 10 GU strains. Class I and class II GU strains formed two distinct clades. The class I strains formed two subclades, one containing 35000HP and HD183 and the other containing the remainder of the class I strains. Twelve of the CU strains formed a subclone under the class I 35000HP subclade, while 2 CU strains formed a subclone under the other class I subclade. Unexpectedly, 3 of the CU strains formed a subclone under the class II clade. Phylogenetic analysis of dsrA-hgbA-ncaA sequences yielded a tree similar to that of whole-genome phylogenetic tree. Conclusions/Significance CU strains diverged from multiple lineages within both class I and class II GU strains. Multilocus sequence typing of dsrA-hgbA-ncaA could be reliably used for epidemiological investigation of CU and GU strains. As class II strains grow relatively poorly and are relatively more susceptible to vancomycin than class I strains, these findings have implications for methods to recover CU strains. Comparison of contemporary CU and GU isolates would help clarify the relationship between these entities. PMID:28027326

  7. Association of maternal anti-HLA class II antibodies with protection from allergy in offspring.

    PubMed

    Jones, M; Jeal, H; Harris, J M; Smith, J D; Rose, M L; Taylor, A N; Cullinan, P

    2013-09-01

    Recent studies have suggested that the birth order effect in allergy may be established during the prenatal period and that the protective effect may originate in the mother. HLA class II disparity between mother and foetus has been associated with significantly increased Th1 production. In this study, we investigated whether production of HLA antibodies 4 years after pregnancy with index child is associated with allergic outcomes in offspring at 8 years. Anti-HLA class I and II antibodies were measured in maternal serum (n = 284) and levels correlated to numbers of pregnancies and birth order, and allergic outcomes in offspring at 8 years of age. Maternal anti-HLA class I and II antibodies were significantly higher when birth order, and the number of pregnancies were larger. Anti-HLA class II, but not class I antibodies were associated with significantly less atopy and seasonal rhinitis in the offspring at age 8 years. Mothers with nonatopic (but not atopic) offspring had a significant increase in anti-HLA class I and II antibodies with birth order. This study suggests that the 'birth order' effect in children may be due to parity-related changes in the maternal immune response to foetal antigens. We have observed for the first time an association between maternal anti-HLA class II antibodies and protection from allergy in the offspring. Further work is required to determine immunologically how HLA disparity between mother and father can protect against allergy. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. 30 CFR 57.22227 - Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines).

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines). 57.22227 Section 57.22227 Mineral Resources MINE SAFETY AND... Ventilation § 57.22227 Approved testing devices (I-A, I-B, I-C, II-A, II-B, III, IV, V-A, and V-B mines). (a...

  9. 25 CFR 547.12 - What are the minimum technical standards for downloading on a Class II gaming system?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... OF CLASS II GAMES § 547.12 What are the minimum technical standards for downloading on a Class II... software, files, data, and prize schedules. (2) Downloads of software, games, prize schedules, or other... performed in a manner that will not affect game play. (5) Downloads shall not affect the integrity of...

  10. 25 CFR 547.12 - What are the minimum technical standards for downloading on a Class II gaming system?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... OF CLASS II GAMES § 547.12 What are the minimum technical standards for downloading on a Class II... software, files, data, and prize schedules. (2) Downloads of software, games, prize schedules, or other... performed in a manner that will not affect game play. (5) Downloads shall not affect the integrity of...

  11. 25 CFR 547.12 - What are the minimum technical standards for downloading on a Class II gaming system?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... OF CLASS II GAMES § 547.12 What are the minimum technical standards for downloading on a Class II... software, files, data, and prize schedules. (2) Downloads of software, games, prize schedules, or other... performed in a manner that will not affect game play. (5) Downloads shall not affect the integrity of...

  12. 40 CFR 147.650 - State-administrative program-Class I, II, III, IV, and V wells.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... CONTROL PROGRAMS Idaho § 147.650 State-administrative program—Class I, II, III, IV, and V wells. The UIC program for Class I, II, III, IV, and V wells in the State of Idaho, other than those on Indian lands, is the program administered by the Idaho Department of Water Resources, approved by EPA pursuant to...

  13. 40 CFR Appendix B to Subpart A of... - Class II Controlled Substances a

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Class II Controlled Substances a B..., Subpt. A, App. B Appendix B to Subpart A of Part 82—Class II Controlled Substances a Controlled... the highest ODP, and the lower value is the estimate of the ODP of the isomer with the lowest ODP...

  14. Poster - Thur Eve - 07: CNSC Update: "What's New in Class II".

    PubMed

    Heimann, M

    2012-07-01

    The Accelerators and Class II Facilities Division (ACFD) of the Canadian Nuclear Safety Commission (CNSC), is responsible for the oversight of radiotherapy facilities containing Class II prescribed equipment in Canada. This poster will highlight a number of new initiatives that the CNSC has implemented recently that have an impact on radiotherapy facility licensees. The presentation will discuss the recent policy decision to regulate particle accelerators of above 1 MeV. Challenges and progress with respect to the implementation of the policy will be presented. Other initiatives which will be described include: • The new ACFD webspace on the CNSC website, with direct links to relevant information on licensing, compliance and Class II prescribed equipment • The improved structure of the Appendix of Licence Documents that is part of every Class II licence • Updated licence application guides • Changes to Annual Compliance reporting requirements and progress on the ACR-Online initiative • Changes to some regulatory expectations related to medical accelerator facilities • Consolidation of Class II facility licences The poster will also include other initiatives that may be of particular interest to COMP membership. © 2012 American Association of Physicists in Medicine.

  15. Class II G Protein-Coupled Receptors and Their Ligands in Neuronal Function and Protection

    PubMed Central

    Martin, Bronwen; de Maturana, Rakel Lopez; Brenneman, Randall; Walent, Tom; Mattson, Mark P.; Maudsley, Stuart

    2008-01-01

    G protein-coupled receptors (GPCRs) play pivotal roles in regulating the function and plasticity of neuronal circuits in the nervous system. Among the myriad of GPCRs expressed in neural cells, class II GPCRs which couples predominantly to the Gs–adenylate cyclase–cAMP signaling pathway, have recently received considerable attention for their involvement in regulating neuronal survival. Neuropeptides that activate class II GPCRs include secretin, glucagon-like peptides (GLP-1 and GLP-2), growth hormone-releasing hormone (GHRH), pituitary adenylate cyclase activating peptide (PACAP), corticotropin-releasing hormone (CRH), vasoactive intestinal peptide (VIP), parathyroid hormone (PTH), and calcitonin-related peptides. Studies of patients and animal and cell culture models, have revealed possible roles for class II GPCRs signaling in the pathogenesis of several prominent neurodegenerative conditions including stroke, Alzheimer's, Parkinson's, and Huntington's diseases. Many of the peptides that activate class II GPCRs promote neuron survival by increasing the resistance of the cells to oxidative, metabolic, and excitotoxic injury. A better understanding of the cellular and molecular mechanisms by which class II GPCRs signaling modulates neuronal survival and plasticity will likely lead to novel therapeutic interventions for neurodegenerative disorders. PMID:16052036

  16. Enhanced, rapid occlusion of carotid and vertebral arteries using the AMPLATZER Vascular Plug II device: the Duke Cerebrovascular Center experience in 8 patients with 22 AMPLATZER Vascular Plug II devices.

    PubMed

    Mihlon, Frank; Agrawal, Abishek; Nimjee, Shahid M; Ferrell, Andrew; Zomorodi, Ali R; Smith, Tony P; Britz, Gavin W

    2015-01-01

    Therapeutic embolization of the common carotid artery (CCA), internal carotid artery (ICA), and vertebral artery (VA) is necessary in the treatment of a subset of chronic arteriovenous fistulas (AVFs), hemorrhages, highly vascularized neoplasms before resection, and giant aneurysms. There are currently no reports of the use of the AMPLATZER Vascular Plug II (AVP II) device to occlude the CCA, ICA, or VA. The objective of this article is to present the Duke Cerebrovascular Center experience using the AVP II device in neurointerventional applications. This case series is a retrospective review of all of the cases at Duke University Hospital in which an AVP II device was used in the CCA, ICA, or VA up to September 2012. The AVP II device was often used in conjunction with embolization coils or as multiple AVP II devices deployed in tandem. During 2010-2012, 8 cases meeting criteria were performed. These included 2 chronic VA to internal jugular AVFs, 1 hemorrhagic CCA to internal jugular AVF secondary to invasive head and neck squamous cell carcinoma, 1 ICA hemorrhage secondary to invasive head and neck squamous cell carcinoma, 1 ICA hemorrhage secondary to trauma, 1 ruptured ICA aneurysm, 1 giant petrous ICA aneurysm, and 1 case of cervical vertebral sarcoma requiring preoperative VA embolization. Successful occlusion of the target vessel was achieved in all 8 cases. There was 1 major complication that consisted of a watershed distribution cerebral infarct; however, this was related to emergent occlusion of the ICA in the setting of intracranial hemorrhage and was not a problem intrinsic to the AVP II device. The AVP II device is relatively large, self-expanding vascular occlusion device that safely allows enhanced, rapid take-down of the CCA, ICA, and VA with low risk of distal migration. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. 49 CFR 1150.45 - Procedures and relevant dates-transactions under section 10902 that involve creation of Class I...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Procedures and relevant dates-transactions under section 10902 that involve creation of Class I or Class II rail carriers. 1150.45 Section 1150.45... dates—transactions under section 10902 that involve creation of Class I or Class II rail carriers. (a...

  18. 49 CFR 1150.45 - Procedures and relevant dates-transactions under section 10902 that involve creation of Class I...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 8 2014-10-01 2014-10-01 false Procedures and relevant dates-transactions under section 10902 that involve creation of Class I or Class II rail carriers. 1150.45 Section 1150.45... dates—transactions under section 10902 that involve creation of Class I or Class II rail carriers. (a...

  19. 49 CFR 1150.45 - Procedures and relevant dates-transactions under section 10902 that involve creation of Class I...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 8 2011-10-01 2011-10-01 false Procedures and relevant dates-transactions under section 10902 that involve creation of Class I or Class II rail carriers. 1150.45 Section 1150.45... dates—transactions under section 10902 that involve creation of Class I or Class II rail carriers. (a...

  20. 49 CFR 1150.45 - Procedures and relevant dates-transactions under section 10902 that involve creation of Class I...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 8 2013-10-01 2013-10-01 false Procedures and relevant dates-transactions under section 10902 that involve creation of Class I or Class II rail carriers. 1150.45 Section 1150.45... dates—transactions under section 10902 that involve creation of Class I or Class II rail carriers. (a...

  1. 49 CFR 1150.45 - Procedures and relevant dates-transactions under section 10902 that involve creation of Class I...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 8 2012-10-01 2012-10-01 false Procedures and relevant dates-transactions under section 10902 that involve creation of Class I or Class II rail carriers. 1150.45 Section 1150.45... dates—transactions under section 10902 that involve creation of Class I or Class II rail carriers. (a...

  2. Prevalence of class-I, class-II and class-III obesity in Australian adults between 1995 and 2011-12.

    PubMed

    Keating, Catherine; Backholer, Kathryn; Gearon, Emma; Stevenson, Christopher; Swinburn, Boyd; Moodie, Marj; Carter, Rob; Peeters, Anna

    2015-01-01

    To compare the prevalence of class-I, II and III obesity in Australian adults between 1995, 2007-08 and 2011-12. Prevalence data for adults (aged 18+ years) were sourced from customised data from the nationally representative National Nutrition Survey (1995), the National Health Survey (2007-08), and the Australian Health Survey (2011-12) conducted by the Australian Bureau of Statistics. Obesity classifications were based on measured height and weight (class-I body mass index: 30.0-34.9 kg/m(2), class-II: 35.0-39.9 kg/m(2) and class-III: ≥ 40.0 kg/m(2)). Severe obesity was defined as class-II or class-III obesity. Between 1995 and 2011-12, the prevalence of obesity (all classes combined) increased from 19.1% to 27.2%. During this 17 year period, relative increases in class I, II and III obesity were 1.3, 1.7 and 2.2-fold respectively. In 2011-12, the prevalence of class I, II and III obesity was 19.4, 5.9 and 2.0 per cent respectively in men, and 16.1, 6.9 and 4.2 per cent respectively in women. One in every ten people was severely obese, increasing from one in twenty in 1995, and women were disproportionally represented in this population. Obesity prevalence increased with increasing levels of area-level socioeconomic disadvantage, particularly for the more severely obese classes. Severe obesity affected 6.2% and 13.4% in the least and most disadvantaged quintiles respectively. Over the last two decades, there have been substantial increases in the prevalence of obesity, particularly the more severe levels of obesity. This study highlights high risk groups who warrant targeted weight gain prevention interventions. Copyright © 2015 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  3. Predominant typologies of psychopathology in the United States: a latent class analysis.

    PubMed

    El-Gabalawy, Renée; Tsai, Jack; Harpaz-Rotem, Ilan; Hoff, Rani; Sareen, Jitender; Pietrzak, Robert H

    2013-11-01

    Latent class analysis (LCA) offers a parsimonious way of classifying common typologies of psychiatric comorbidity. We used LCA to identify the nature and correlates of predominant typologies of Axis I and II disorders in a large and comprehensive population-based sample of U.S. adults. We analyzed data from Wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions (2004-2005; n = 34,653), a population-based sample of U.S. adults. We derived latent classes based on all assessed Axis I and II disorders and examined the relationship between the identified Axis I classes and lifetime psychiatric disorders and suicide attempts, and physical and mental health-related quality of life. A four-class solution was optimal in characterizing predominant typologies of both Axis I and II disorders. For Axis I disorders, these included low psychopathology (n = 28,935, 84.0%), internalizing (n = 3693, 9.9%), externalizing (n = 1426, 4.5%), and high psychopathology (n = 599, 1.6%) classes. For Axis II disorders, these included no/low personality disorders (n = 31,265, 90.9%), obsessive/paranoid (n = 1635, 4.6%), borderline/dysregulated (n = 1319, 3.4%), and highly comorbid (n = 434, 1.1%) classes. Compared to the low psychopathology class, all other Axis I classes had significantly increased odds of mental disorders, elevated Axis II classes, suicide attempts and poorer quality of life, with the high psychopathology class having the overall highest rates of these correlates, with the exception of substance use disorders. Compared to the low psychopathology class, the internalizing and externalizing classes had increased rates of mood and anxiety disorders, and substance use disorders, respectively. Axis I and II psychopathology among U.S. adults may be best represented by four predominant typologies. Characterizing co-occurring patterns of psychopathology using person-based typologies represents a higher-order classification system that may be useful in clinical and research settings. Published by Elsevier Ltd.

  4. Human umbilical cord mesenchymal stromal cells suppress MHC class II expression on rat vascular endothelium and prolong survival time of cardiac allograft

    PubMed Central

    Qiu, Ying; Yun, Mark M; Han, Xia; Zhao, Ruidong; Zhou, Erxia; Yun, Sheng

    2014-01-01

    Background: Human umbilical cord mesenchymal stromal cells (UC-MSCs) have low immunogenicity and immune regulation. To investigate immunomodulatory effects of human UC-MSCs on MHC class II expression and allograft, we transplanted heart of transgenic rats with MHC class II expression on vascular endothelium. Methods: UC-MSCs were obtained from human umbilical cords and confirmed with flow cytometry analysis. Transgenic rat line was established using the construct of human MHC class II transactivator gene (CIITA) under mouse ICAM-2 promoter control. The induced MHC class II expression on transgenic rat vascular endothelial cells (VECs) was assessed with immunohistological staining. And the survival time of cardiac allograft was compared between the recipients with and without UC-MSC transfusion. Results: Flow cytometry confirmed that the human UC-MSCs were positive for CD29, CD44, CD73, CD90, CD105, CD271, and negative for CD34 and HLA-DR. Repeated infusion of human UC-MSCs reduced MHC class II expression on vascular endothelia of transplanted hearts, and increased survival time of allograft. The UC-MSCs increased regulatory cytokines IL10, transforming growth factor (TGF)-β1 and suppressed proinflammatory cytokines IL2 and IFN-γ in vivo. The UC-MSC culture supernatant had similar effects on cytokine expression, and decreased lymphocyte proliferation in vitro. Conclusions: Repeated transfusion of the human UC-MSCs reduced MHC class II expression on vascular endothelia and prolonged the survival time of rat cardiac allograft. PMID:25126177

  5. Class II ADP-ribosylation factors are required for efficient secretion of dengue viruses.

    PubMed

    Kudelko, Mateusz; Brault, Jean-Baptiste; Kwok, Kevin; Li, Ming Yuan; Pardigon, Nathalie; Peiris, J S Malik; Bruzzone, Roberto; Desprès, Philippe; Nal, Béatrice; Wang, Pei Gang

    2012-01-02

    Identification and characterization of virus-host interactions are very important steps toward a better understanding of the molecular mechanisms responsible for disease progression and pathogenesis. To date, very few cellular factors involved in the life cycle of flaviviruses, which are important human pathogens, have been described. In this study, we demonstrate a crucial role for class II Arf proteins (Arf4 and Arf5) in the dengue flavivirus life cycle. We show that simultaneous depletion of Arf4 and Arf5 blocks recombinant subviral particle secretion for all four dengue serotypes. Immunostaining analysis suggests that class II Arf proteins are required at an early pre-Golgi step for dengue virus secretion. Using a horseradish peroxidase protein fused to a signal peptide, we show that class II Arfs act specifically on dengue virus secretion without altering the secretion of proteins through the constitutive secretory pathway. Co-immunoprecipitation data demonstrate that the dengue prM glycoprotein interacts with class II Arf proteins but not through its C-terminal VXPX motif. Finally, experiments performed with replication-competent dengue and yellow fever viruses demonstrate that the depletion of class II Arfs inhibits virus secretion, thus confirming their implication in the virus life cycle, although data obtained with West Nile virus pointed out the differences in virus-host interactions among flaviviruses. Our findings shed new light on a molecular mechanism used by dengue viruses during the late stages of the life cycle and demonstrate a novel function for class II Arf proteins.

  6. Class II ADP-ribosylation Factors Are Required for Efficient Secretion of Dengue Viruses*

    PubMed Central

    Kudelko, Mateusz; Brault, Jean-Baptiste; Kwok, Kevin; Li, Ming Yuan; Pardigon, Nathalie; Peiris, J. S. Malik; Bruzzone, Roberto; Desprès, Philippe; Nal, Béatrice; Wang, Pei Gang

    2012-01-01

    Identification and characterization of virus-host interactions are very important steps toward a better understanding of the molecular mechanisms responsible for disease progression and pathogenesis. To date, very few cellular factors involved in the life cycle of flaviviruses, which are important human pathogens, have been described. In this study, we demonstrate a crucial role for class II Arf proteins (Arf4 and Arf5) in the dengue flavivirus life cycle. We show that simultaneous depletion of Arf4 and Arf5 blocks recombinant subviral particle secretion for all four dengue serotypes. Immunostaining analysis suggests that class II Arf proteins are required at an early pre-Golgi step for dengue virus secretion. Using a horseradish peroxidase protein fused to a signal peptide, we show that class II Arfs act specifically on dengue virus secretion without altering the secretion of proteins through the constitutive secretory pathway. Co-immunoprecipitation data demonstrate that the dengue prM glycoprotein interacts with class II Arf proteins but not through its C-terminal VXPX motif. Finally, experiments performed with replication-competent dengue and yellow fever viruses demonstrate that the depletion of class II Arfs inhibits virus secretion, thus confirming their implication in the virus life cycle, although data obtained with West Nile virus pointed out the differences in virus-host interactions among flaviviruses. Our findings shed new light on a molecular mechanism used by dengue viruses during the late stages of the life cycle and demonstrate a novel function for class II Arf proteins. PMID:22105072

  7. Morphometric analysis of long-term dentoskeletal effects induced by treatment with Balters bionator.

    PubMed

    Bigliazzi, Renato; Franchi, Lorenzo; Bertoz, André Pinheiro de Magalhães; McNamara, James A; Faltin, Kurt; Bertoz, Francisco Antonio

    2015-09-01

    To evaluate the long-term effects of the standard (Class II) Balters bionator in growing patients with Class II malocclusion with mandibular retrusion by using morphometrics (thin-plate spline [TPS] analysis). Twenty-three Class II patients (8 male, 15 female) were treated consecutively with the Balters bionator (bionator group). The sample was evaluated at T0, start of treatment; T1, end of bionator therapy; and T2, long-term observation (including fixed appliances). Mean age at the start of treatment was 10 years 2 months (T0); at posttreatment, 12 years 3 months (T1); and at long-term follow-up, 18 years 2 months (T2). The control group consisted of 22 subjects (11 male, 11 female) with untreated Class II malocclusion. Lateral cephalograms were analyzed at the three time points for all groups. TPS analysis evaluated statistical differences (permutation tests) in the craniofacial shape and size between the bionator and control groups. TPS analysis showed that treatment with the bionator is able to produce favorable mandibular shape changes (forward and downward displacement) that contribute significantly to the correction of the Class II dentoskeletal imbalance. These results are maintained at a long-term observation after completion of growth. The control group showed no statistically significant differences in the correction of Class II malocclusion. This study suggests that bionator treatment of Class II malocclusion produces favorable results over the long term with a combination of skeletal and dentoalveolar shape changes.

  8. Modified Angle's Classification for Primary Dentition.

    PubMed

    Chandranee, Kaushik Narendra; Chandranee, Narendra Jayantilal; Nagpal, Devendra; Lamba, Gagandeep; Choudhari, Purva; Hotwani, Kavita

    2017-01-01

    This study aims to propose a modification of Angle's classification for primary dentition and to assess its applicability in children from Central India, Nagpur. Modification in Angle's classification has been proposed for application in primary dentition. Small roman numbers i/ii/iii are used for primary dentition notation to represent Angle's Class I/II/III molar relationships as in permanent dentition, respectively. To assess applicability of modified Angle's classification a cross-sectional preschool 2000 children population from central India; 3-6 years of age residing in Nagpur metropolitan city of Maharashtra state were selected randomly as per the inclusion and exclusion criteria. Majority 93.35% children were found to have bilateral Class i followed by 2.5% bilateral Class ii and 0.2% bilateral half cusp Class iii molar relationships as per the modified Angle's classification for primary dentition. About 3.75% children had various combinations of Class ii relationships and 0.2% children were having Class iii subdivision relationship. Modification of Angle's classification for application in primary dentition has been proposed. A cross-sectional investigation using new classification revealed various 6.25% Class ii and 0.4% Class iii molar relationships cases in preschool children population in a metropolitan city of Nagpur. Application of the modified Angle's classification to other population groups is warranted to validate its routine application in clinical pediatric dentistry.

  9. Functional condition of masseters muscles of patients with class ?? subdivision.

    PubMed

    Kuroyedova, Vera D; Makarova, Alexandra N; Chicor, Tatyana A

    Main functional characteristics of masticator muscles in patients with class ?? malocclusions is activity dominance of m. temporalis in comparison with m. ?asseter. We have not found datum about functional status of the masticators in patients with class II subdivision. The purpose of our study was to investigate the functional characteristics of m. ?asseter, m. temporalis in adult patients with class II subdivision malocclusion. There have been carried out the surface electromyographic study of m. masseter, m. temporalis in 17 adult patients with class II subdivision. It was realized quantitative analysis of 271 electromyogram, it was determined the average bioelectric activity, index activity, symmetry and torsion index. It was observed predominance of the bioelectrical activity of m. temporales on m. masseter for all persons with class II subdivision. Bioelectrical activity for m. masseter was bigger on side of distal ratio and for m. temporales on side of neutral ratio. In class ?? subdivision right, the mandible was deviated to the left side and in class ?? subdivision left is deviated to the right side. Thus, rotational moment generated during compression of the jaws, causes deviation of the lower jaw to the side, with a neutral molar ratio. During voluntary chewing bioelectrical activity of m. masseter and m. temporalis was higher in the right side. In accordance with the functional condition of the masticatory muscles of class II subdivision is characterized with functional features of distal occlusion.

  10. 47 CFR 15.101 - Equipment authorization of unintentional radiators.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    .... TV interface device Declaration of Conformity or Certification. Cable system terminal device Declaration of Conformity. Stand-alone cable input selector switch Verification. Class B personal computers... used with Class B personal computers Declaration of Conformity or Certification. 1 Class B personal...

  11. 47 CFR 15.101 - Equipment authorization of unintentional radiators.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    .... TV interface device Declaration of Conformity or Certification. Cable system terminal device Declaration of Conformity. Stand-alone cable input selector switch Verification. Class B personal computers... used with Class B personal computers Declaration of Conformity or Certification. 1 Class B personal...

  12. 47 CFR 15.101 - Equipment authorization of unintentional radiators.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    .... TV interface device Declaration of Conformity or Certification. Cable system terminal device Declaration of Conformity. Stand-alone cable input selector switch Verification. Class B personal computers... used with Class B personal computers Declaration of Conformity or Certification. 1 Class B personal...

  13. 47 CFR 15.101 - Equipment authorization of unintentional radiators.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    .... TV interface device Declaration of Conformity or Certification. Cable system terminal device Declaration of Conformity. Stand-alone cable input selector switch Verification. Class B personal computers... used with Class B personal computers Declaration of Conformity or Certification. 1 Class B personal...

  14. 47 CFR 15.101 - Equipment authorization of unintentional radiators.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    .... TV interface device Declaration of Conformity or Certification. Cable system terminal device Declaration of Conformity. Stand-alone cable input selector switch Verification. Class B personal computers... used with Class B personal computers Declaration of Conformity or Certification. 1 Class B personal...

  15. 78 FR 37998 - Electronic One Touch Bingo System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... decision regarding the classification of server based electronic bingo system games that can be played... Class II or Class III game. DATES: The agency must receive comments on or before August 26, 2013... from the regulated community regarding the status of one touch bingo as a Class II or a Class III game...

  16. 77 FR 52109 - Agency Information Collection Activities; Revision of Currently-Approved Information Collection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... Request: Annual Report of Class I and Class II Motor Carriers of Property AGENCY: Federal Motor Carrier.... FMCSA requests approval to revise an ICR entitled, ``Annual Report of Class I and Class II Motor... be addressed to the attention of the Desk Officer, Department of Transportation/Federal Motor Carrier...

  17. HLA Class I and Genetic Susceptibility to Type 1 Diabetes

    PubMed Central

    Noble, Janelle A.; Valdes, Ana Maria; Varney, Michael D.; Carlson, Joyce A.; Moonsamy, Priscilla; Fear, Anna Lisa; Lane, Julie A.; Lavant, Eva; Rappner, Rebecca; Louey, Anthony; Concannon, Patrick; Mychaleckyj, Josyf C.; Erlich, Henry A.

    2010-01-01

    OBJECTIVE We report here genotyping data and type 1 diabetes association analyses for HLA class I loci (A, B, and C) on 1,753 multiplex pedigrees from the Type 1 Diabetes Genetics Consortium (T1DGC), a large international collaborative study. RESEARCH DESIGN AND METHODS Complete eight-locus HLA genotyping data were generated. Expected patient class I (HLA-A, -B, and -C) allele frequencies were calculated, based on linkage disequilibrium (LD) patterns with observed HLA class II DRB1-DQA1-DQB1 haplotype frequencies. Expected frequencies were compared to observed allele frequencies in patients. RESULTS Significant type 1 diabetes associations were observed at all class I HLA loci. After accounting for LD with HLA class II, the most significantly type 1 diabetes–associated alleles were B*5701 (odds ratio 0.19; P = 4 × 10−11) and B*3906 (10.31; P = 4 × 10−10). Other significantly type 1 diabetes–associated alleles included A*2402, A*0201, B*1801, and C*0501 (predisposing) and A*1101, A*3201, A*6601, B*0702, B*4403, B*3502, C*1601, and C*0401 (protective). Some alleles, notably B*3906, appear to modulate the risk of all DRB1-DQA1-DQB1 haplotypes on which they reside, suggesting a class I effect that is independent of class II. Other class I type 1 diabetes associations appear to be specific to individual class II haplotypes. Some apparent associations (e.g., C*1601) could be attributed to strong LD to another class I susceptibility locus (B*4403). CONCLUSIONS These data indicate that HLA class I alleles, in addition to and independently from HLA class II alleles, are associated with type 1 diabetes. PMID:20798335

  18. Class II malocclusion with accentuated occlusal plane inclination corrected with miniplate: a case report

    PubMed Central

    Farret, Marcel Marchiori; Farret, Milton M. Benitez

    2016-01-01

    ABSTRACT Introduction: A canted occlusal plane presents an unesthetic element of the smile. The correction of this asymmetry has been typically considered difficult by orthodontists, as it requires complex mechanics and may sometimes even require orthognathic surgery. Objective: This paper outlines the case of a 29-year-old woman with Class II malocclusion, pronounced midline deviation and accentuated occlusal plane inclination caused by mandibular deciduous molar ankylosis. Methods: The patient was treated with a miniplate used to provide anchorage in order to intrude maxillary teeth and extrude mandibular teeth on one side, thus eliminating asymmetry. Class II was corrected on the left side by means of distalization, anchored in the miniplate as well. On the right side, maxillary first premolar was extracted and molar relationship was kept in Class II, while canines were moved to Class I relationship. The patient received implant-prosthetic rehabilitation for maxillary left lateral incisor and mandibular left second premolar. Results: At the end of treatment, Class II was corrected, midlines were matched and the canted occlusal plane was totally corrected, thereby improving smile function and esthetics. PMID:27409658

  19. Unbiased quantitative testing of conventional orthodontic beliefs.

    PubMed

    Baumrind, S

    1998-03-01

    This study used a preexisting database to test in hypothesis from the appropriateness of some common orthodontic beliefs concerning upper first molar displacement and changes in facial morphology associated with conventional full bonded/banded treatment in growing subjects. In an initial pass, the author used data from a stratified random sample of 48 subjects drawn retrospectively from the practice of a single, experienced orthodontist. This sample consisted of 4 subgroups of 12 subjects each: Class I nonextraction, Class I extraction, Class II nonextraction, and Class II extraction. The findings indicate that, relative to the facial profile, chin point did not, on average, displace anteriorly during treatment, either overall or in any subgroup. Relative to the facial profile, Point A became significantly less prominent during treatment, both overall and in each subgroup. The best estimate of the mean displacement of the upper molar cusp relative to superimposition on Anterior Cranial Base was in the mesial direction in each of the four subgroups. In only one extraction subject out of 24 did the cusp appear to be displaced distally. Mesial molar cusp displacement was significantly greater in the Class II extraction subgroup than in the Class II nonextraction subgroup. Relative to superimposition on anatomical "best fit" of maxillary structures, the findings for molar cusp displacement were similar, but even more dramatic. Mean mesial migration was highly significant in both the Class II nonextraction and Class II extraction subgroups. In no subject in the entire sample was distal displacement noted relative to this superimposition. Mean increase in anterior Total Face Height was significantly greater in the Class II extraction subgroup than in the Class II nonextraction subgroup. (This finding was contrary to the author's original expectation.) The generalizability of the findings from the initial pass to other treated growing subjects was then assessed by retesting modified hypotheses against a second database stored sample that earlier had been drawn randomly from two other orthodontic practices. The implications of the author's study strategy to the design of future shared digital databases is discussed briefly.

  20. Cone-beam computed tomographic evaluation of the temporomandibular joint and dental characteristics of patients with Class II subdivision malocclusion and asymmetry

    PubMed Central

    Huang, Mingna; Hu, Yun; Yu, Jinfeng; Sun, Jicheng; Ming, Ye

    2017-01-01

    Objective Treating Class II subdivision malocclusion with asymmetry has been a challenge for orthodontists because of the complicated characteristics of asymmetry. This study aimed to explore the characteristics of dental and skeletal asymmetry in Class II subdivision malocclusion, and to assess the relationship between the condyle-glenoid fossa and first molar. Methods Cone-beam computed tomographic images of 32 patients with Class II subdivision malocclusion were three-dimensionally reconstructed using the Mimics software. Forty-five anatomic landmarks on the reconstructed structures were selected and 27 linear and angular measurements were performed. Paired-samples t-tests were used to compare the average differences between the Class I and Class II sides; Pearson correlation coefficient (r) was used for analyzing the linear association. Results The faciolingual crown angulation of the mandibular first molar (p < 0.05), sagittal position of the maxillary and mandibular first molars (p < 0.01), condylar head height (p < 0.01), condylar process height (p < 0.05), and angle of the posterior wall of the articular tubercle and coronal position of the glenoid fossa (p < 0.01) were significantly different between the two sides. The morphology and position of the condyle-glenoid fossa significantly correlated with the three-dimensional changes in the first molar. Conclusions Asymmetry in the sagittal position of the maxillary and mandibular first molars between the two sides and significant lingual inclination of the mandibular first molar on the Class II side were the dental characteristics of Class II subdivision malocclusion. Condylar morphology and glenoid fossa position asymmetries were the major components of skeletal asymmetry and were well correlated with the three-dimensional position of the first molar. PMID:28861389

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