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Extended Laparoscopy Devices - Premarket Notification (510k) Submissions

This guidance outlines requirements for preparing a Premarket Notification (510(k)) for Extended Laparoscopy Devices (ELD), which are Class II devices that provide extracorporeal extension of pneumoperitoneum and/or permit surgeons to perform tasks similar to open surgery within the pneumoperitoneum field.

  1. Identify appropriate predicate devices for comparison
  2. Prepare comprehensive materials documentation and comparison with predicate
  3. Develop and execute bench testing protocol for device strength and integrity
  4. Plan and conduct animal testing for tissue compatibility
  5. Design and implement clinical study protocol in two phases
  6. Prepare biocompatibility testing according to ISO 10993
  7. Develop comprehensive labeling including all required elements
  8. If applicable, validate sterilization process and packaging
  9. Document all performance data and clinical outcomes
  10. Prepare complete 510(k) submission package incorporating all required elements

Key Considerations

Clinical testing

  • Initial feasibility phase with 10-20 patients to establish product viability
  • Pivotal phase with 50-200 patients at several sites
  • Comparative data required for a single procedure with and without ELD
  • Parameters to measure: anesthesia time, blood loss, complications, duration of intensive care and hospitalization

Non-clinical testing

  • Bench testing required to demonstrate component strength against normal laparoscopic surgery pressures
  • Integrity testing of valves and seals during different operational phases
  • Animal testing to demonstrate tissue compatibility and device functionality

Human Factors

  • Users must be adequately trained in three approaches: laparoscopic, laparoscopic-assisted, and open surgery

Labelling

  • Must include labels and advertisements with descriptions
  • Intended use and directions for use
  • Appropriate warnings and cautions
  • Training requirement statement
  • Claims of enhanced efficacy or ease of use must be substantiated with clinical data

Biocompatibility

  • Biocompatibility data required for materials not identifiable in legally marketed predicate devices
  • Must follow ISO 10993 standard

Safety

  • For sterile devices:
    • Sterilization method must be validated
    • Sterility assurance level (SAL) must be 10^-6
    • Packaging information required

Other considerations

  • ISO 10993: Biological evaluation of medical devices

Original guidance

  • Extended Laparoscopy Devices - Premarket Notification (510k) Submissions
  • HTML / PDF
  • Issue date: 1994-08-29
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 2104c54bc65dea9e7f181be29a750669
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