Keratomes and Replacement Keratome Blades for Corneal Surgery
This guidance applies to keratomes and replacement keratome blades intended to shave tissue from sections of the cornea for lamellar transplants or LASIK procedures. It covers AC-powered keratomes (HNO), battery-powered keratomes (HMY), and reprocessed keratome blades (NKY). Water jet keratomes and laser keratomes are excluded from this guidance.
What You Need to Know? 👇
What are the key requirements for a 510(k) submission for keratome devices?
A 510(k) submission must include device description, risk analysis, preclinical validation testing, software validation (if applicable), electrical safety assessment, biocompatibility testing, sterilization validation, and appropriate labeling. FDA recommends an Abbreviated 510(k) approach for these devices.
Which product codes apply to keratomes and replacement blades under FDA regulations?
Keratomes fall under 21 CFR 886.4370 with product codes HNO (AC-powered), HMY (battery-powered), and NKY (reprocessed keratome blades). Water jet keratomes (MYD) and laser keratomes under 21 CFR 878.4810 are excluded from this guidance.
What preclinical testing is required to validate keratome performance?
Validation testing should demonstrate accuracy, precision, and quality of corneal flaps using statistically justifiable numbers of pig or cadaver eyes (e.g., 30 eyes per diameter/thickness). Testing must cover all combinations of flap thicknesses, diameters, and hinge widths.
How should replacement keratome blades demonstrate equivalence to OEM blades?
Manufacturers must provide side-by-side comparisons including dimensions, materials, hardness, and sharpness measurements. Preclinical validation testing must demonstrate equivalency, with documentation explaining similarities and impact of any differences on blade performance.
What biocompatibility testing standards apply to keratome devices?
FDA recommends following ISO-10993 guidance for biological evaluation. Keratome blades are considered devices with limited contact with breached surfaces. Testing should reflect actual use conditions, and identical materials from predicate devices may reference existing biocompatibility data.
What electrical safety standards must keratomes meet for FDA clearance?
Devices must comply with IEC 60601-1 for general safety requirements and IEC 60601-1-2 for electromagnetic compatibility. Testing should cover emissions (RF electromagnetic, conducted) and immunity (ESD, radiated RF fields, electrical transients, surges, voltage variations).
What You Need to Do 👇
Recommended Actions
- Conduct comprehensive device description including technical specifications and principles of operation
- Perform validation testing of cut performance using animal/cadaver models
- Complete software validation if device is automated
- Conduct electrical safety and EMC testing
- Perform biocompatibility testing
- Validate sterilization processes
- Develop comprehensive labeling including all required elements
- For replacement blades: provide detailed comparison with OEM blades
- Document risk analysis and mitigation measures
- Prepare 510(k) submission including all test reports and documentation
Key Considerations
Non-clinical testing
- Validation testing of cut performance (flap thickness, diameter, hinge width) using pig or cadaver eyes
- System level validation testing of hardware and software functionality
- Validation of alarms and warnings under fault conditions
- For epikeratomes: testing of successful flaps, partial cuts, torn flaps, and cellular debris
Software
- Software validation and risk analysis required for automated devices
- Documentation according to FDA software guidance
- Compliance with Design Controls requirements
Labeling
- Clear instructions for use
- Indications for use statement
- Nominal values, mean values, repeatability limits for flap parameters
- Cleaning and sterilization procedures if applicable
- Training recommendations
Biocompatibility
- Testing according to ISO 10993-1 for devices with limited contact with breached surfaces
- Sample preparation reflecting actual conditions of use
Safety
- Electrical safety testing according to IEC 60601-1
- EMC testing according to IEC 60601-1-2 for emissions and immunity
Other considerations
- Sterilization validation to SAL 10-6 for sterile devices
- Description of sterile packaging
- Validation of cleaning/sterilization methods for reusable devices
Relevant Guidances 🔗
- Labeling Requirements for Keratomes Used in LASIK Surgery
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
Related references and norms 📂
- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety
- IEC 60601-1-2: Medical Electrical Equipment - Electromagnetic Compatibility Requirements and Tests
- ISO 10993-1: Biological Evaluation of Medical Devices