Keratoprostheses - Special Controls and Testing Requirements for 510k Submissions
This guidance serves as a special control for the regulation of temporary and permanent keratoprostheses through 510(k) submissions. It specifically applies to devices intended for use in patients with opacified corneas, where temporary devices are used intraoperatively for visualization, and permanent devices are implanted to provide a transparent optical pathway.
Recommended Actions
- Determine device classification (temporary or permanent) and applicable requirements
- Develop comprehensive biocompatibility testing plan
- Establish and validate sterilization processes
- Design and validate packaging system
- Prepare detailed labeling according to requirements
- For permanent devices:
- Plan clinical investigation under IDE
- Develop protocol with required elements
- Establish data collection and analysis procedures
- Conduct optical performance testing
- Prepare documentation demonstrating compliance with dimensional and surface quality requirements
- Establish shelf-life validation program
- Create quality control procedures for manufacturing and testing
Key Considerations
Clinical testing
- Required for permanent keratoprostheses only
- Minimum of 20 subjects
- One-year follow-up duration
- Specific reporting periods from pre-operative to 330-420 days postoperatively
- Documentation of all adverse events and complications
Non-clinical testing
- Optical testing for dioptric power (±2.0 D tolerance for permanent devices)
- Field of view and magnification requirements for temporary devices
- Dimensions and surface quality inspection at 6X magnification
Labelling
- Manufacturer name and trade name
- Material description and device diagram
- Dioptric power (permanent) or field of view/magnification (temporary)
- Lot/batch number
- Indications for use
- Instructions for use
- Clinical results including adverse events
- Sterility information
- Single-use statement where applicable
Biocompatibility
- Cytotoxicity testing
- Genotoxicity testing
- Maximization sensitization test
- Intramuscular animal implantation test
- Ocular implantation test
- Chemical testing for residual monomers
- Extractables and hydrolytic stability testing (permanent devices only)
Safety
- Sterility validation for permanent devices
- Package integrity testing
- Shelf-life validation
- Residual limits for sterilization methods
Other considerations
- Packaging must protect device and maintain sterility
- Real-time aging preferred for shelf-life determination
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- ISO 10993-5: Biological evaluation of medical devices - Tests for cytotoxicity
- ISO 10993-3: Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-10: Biological evaluation of medical devices - Tests for irritation and sensitization
- ISO 11607: Packaging for terminally sterilized medical devices
- ANSI/AAMI/ISO 11134-1993: Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization
- ANSI/AAMI/ISO 11135-1994: Medical devices - Validation and routine control of ethylene oxide sterilization
- ANSI/AAMI/ISO 11137: Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
Original guidance
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