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.
What You Need to Know? 👇
What are Extended Laparoscopy Devices (ELD) and how are they classified?
Extended Laparoscopy Devices are Class II medical devices that provide extracorporeal extension of pneumoperitoneum or allow surgeons to perform open surgery tasks within the pneumoperitoneum field, such as tactile contact or using standard manual surgical instruments.
What clinical study requirements does FDA expect for ELD 510(k) submissions?
FDA expects a two-phase clinical approach: an initial feasibility phase with 10-20 patients to establish product viability, followed by a pivotal phase with 50-200 patients at several sites comparing device performance to predicate devices or procedures.
What biocompatibility testing is required for ELD materials?
Complete material listings must be provided, comparing all materials to predicate devices. Biocompatibility data according to ISO 10993 standards is required for any materials not identifiable in a legally marketed predicate device.
What sterility requirements must ELD manufacturers meet for sterile devices?
Sterile ELD devices must provide sterilization method, validation method, sterility assurance level of 10^-6, and packaging information as detailed in ODE Blue Book Memorandum #K90-1.
What performance testing is mandatory for ELD 510(k) submissions?
Three types of testing are required: bench testing for pressure resistance and valve/seal integrity, animal testing for tissue compatibility and safety, and clinical studies to confirm safety and effectiveness impressions from previous testing phases.
What special labeling requirements apply to Extended Laparoscopy Devices?
Labels must include descriptions, intended use, directions, warnings, and cautions. A mandatory statement must advise users to be adequately trained in laparoscopic, laparoscopic-assisted, and open surgery approaches. Efficacy claims require clinical data substantiation.
What You Need to Do 👇
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