FDA BRIEF: Week of August 8, 2016
SCOPE:
Bipolar electrosurgical vessel sealers are designed to seal isolated blood and lymphatic vessels for hemostasis (as an alternative to ties) through the use of high-frequency electrical current between two electrodes in close proximity.
CONTENT: 510(k) submissions for intended for use in general surgery.
- Device Description: Indications for Use, Device Design
- Substantial Equivalence Comparison: Indications for Use, Electrosurgical Unit (ESU), Active Components/Accessories, Miscellaneous Accessories, Vessels
- Performance Data: ESU, Active Components/Accessories, Miscellaneous Components/Accessories, System Testing, Chronic Animal Study
- Clinical Testing
- Labeling: Instructions for Use (User Manual), Device Labels, Package, Special Components
SCOPE:
Electrosurgical devices intended for use in general surgery are designed to cut and/or remove tissue and control bleeding through the use of highfrequency electrical current. Devices may also be called radiofrequency (RF) devices or high-frequency (HF) devices.
GUIDANCE: 510(k) submissions for intended for use in general surgery.
- Device Description.: Indications for Use, Device Design
- Substantial Equivalence Comparison
- Software
- Biocompatibility
- Sterility.
- Reprocessing.
- Pyrogenicity
- Shelf Life
- Performance Data: ESU, Active Components/Accessories, Neutral Electrodes, Miscellaneous Components/Accessories System Testing
- Electrical Safety and Electromagnetic Compatibility
- Clinical Testing
- Labeling
CATEGORIES
- Advertising: e.g. Health Care Economic Information in Labeling and Advertising, Internet/Social Media Advertising , Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft
- Biopharmaceutics: e.g. Bioavailabiolity/Bioequivalence studies, food effect
- Biosimilarity: e.g. Interchangeability, Labeling, Statistical Approaches
- Clinical/Antimicrobial: e.g. Inhalation Anthrax, HIV-1 Infection, Bacterial Vaginosis, Chronic Hepatitis C, Herpes Labialis, Vulvovaginal Candidiasis
- Clinical/Medical: e.g. Allergic Rhinitis, Exocrine Pancreatic Insufficiency, Natural History Studies for Rare Disease, Nonallergic Rhinitis, Pediatric Oncology , Pregnant Women in Clinical Trials, Varicose Vein, Ulcerative Colitis
- Clinical Pharmacology: e.g. Drug Interactions,Lactation Trials, In vitro Metabolism-and-Transporter Mediated, Impaired Renal Function, Pregnancy and the Postpartum Period, Population Pharmacokinetics
- Labeling : e.g. Child Resistant Closures, Gluten, Hormonal Contraceptives
- Pharmaceutical Quality/CMC: e.g. Immunogenicity Testing, Comparability Protocols, Elemental Impurities, Compendial Standards, Abuse Deterrent Properties
- Pharmaceutical Quality/Manufacturing Standards (CGMP)
- Pharmacology/Toxicology
- Procedural