Keratomes and Replacement Keratome Blades for Corneal Surgery

Recommended Actions

1. Conduct comprehensive device description including technical specifications and principles of operation
2. Perform validation testing of cut performance using animal/cadaver models
3. Complete software validation if device is automated
4. Conduct electrical safety and EMC testing
5. Perform biocompatibility testing
6. Validate sterilization processes
7. Develop comprehensive labeling including all required elements
8. For replacement blades: provide detailed comparison with OEM blades
9. Document risk analysis and mitigation measures
10. 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

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Original guidance

• Keratomes and Replacement Keratome Blades for Corneal Surgery
• HTML / PDF
• Issue date: 2006-09-18
• Last changed date: 2020-03-19
• Status: FINAL
• Official FDA topics: Medical Devices, 510(k), Premarket
• ReguVirta summary file ID: 6eaa56185337157b99ce61ab725e9363