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.
Recommended Actions
- Identify appropriate predicate devices for comparison
- Prepare comprehensive materials documentation and comparison with predicate
- Develop and execute bench testing protocol for device strength and integrity
- Plan and conduct animal testing for tissue compatibility
- Design and implement clinical study protocol in two phases
- Prepare biocompatibility testing according to ISO 10993
- Develop comprehensive labeling including all required elements
- If applicable, validate sterilization process and packaging
- Document all performance data and clinical outcomes
- 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
- Classification as Class II device under 78GCJ
- May use combination of devices for intended use technical criteria
- Complete listing of materials used in fabrication required
- Comparison with predicate device materials needed
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Design Considerations for Medical Device Pivotal Clinical Studies
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms
- ISO 10993: Biological evaluation of medical devices
Original guidance
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