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Premarket Notification Requirements for Gastroenterology and Urology Biopsy Devices

This guidance outlines the requirements for premarket notifications (510(k)) for biopsy devices used in gastroenterology and urology, including biopsy instruments, endoscopes and accessories, and endoscopic electrosurgical units and accessories classified as Class II devices.

  1. Prepare comprehensive device description including physical specifications and diagrams
  2. Conduct required biocompatibility testing for patient-contacting materials
  3. Perform functional testing appropriate for the device type
  4. Develop complete labeling package with all required elements
  5. Prepare sterilization validation if applicable
  6. Document substantial equivalence comparison with predicate devices
  7. Compile material and component information
  8. Prepare kit certification if marketing as a kit
  9. Validate electrical safety for powered devices
  10. Ensure all testing follows accepted industry standards

Key Considerations

Non-clinical testing

  • Functional testing required for:
    • Cytology brushes: electrical compatibility, motor speeds, brush rotation, suction pressures
    • Automatic biopsy devices: needle advancement and penetration testing
    • Electric biopsy forceps: electrical compatibility and safety testing
  • Testing should be conducted with statistically valid sample sizes
  • Testing should follow accepted industry standards

Labelling

  • Must include device name, U.S. point of contact, corporation details
  • Specific intended use statement with anatomical sites and target population
  • Comprehensive directions for use including preparation, operation, and maintenance
  • Contraindications, precautions, and warnings
  • Sterility status and expiration date if applicable
  • Single use/disposable parts identification

Biocompatibility

  • Required testing for short-term implants:
    • Irritation
    • Sensitization
    • Cytotoxicity
    • Acute systemic toxicity
    • Implantation
  • Testing needed for any material or colorant changes

Safety

  • Electrical safety testing for powered devices
  • Sterility validation if sold sterile
  • Sterilization instructions if sold non-sterile
  • Pyrogen testing if labeled as pyrogen-free

Other considerations

  • 21 CFR 876.1075: Gastroenterology-Urology Biopsy Instruments
  • 21 CFR 876.1500: Endoscopes and Accessories
  • 21 CFR 876.4300: Endoscopic Electrosurgical Unit and Accessories
  • 21 CFR 807.87: Content requirements for premarket notification

Original guidance

  • Premarket Notification Requirements for Gastroenterology and Urology Biopsy Devices
  • HTML
  • Issue date: 1993-02-09
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 0ff9c0c6cf1265e03112b8cb0ac2d92b
This post is licensed under CC BY 4.0 by the author.