AC-Powered Slit Lamp Biomicroscopes - Requirements for 510k Submissions
This guidance outlines the requirements for AC-powered slit lamp biomicroscopes, which are Class II medical devices intended for eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule, to aid in the diagnosis of diseases or trauma.
What You Need to Know? 👇
What are the key regulatory requirements for slit lamp biomicroscope 510(k) submissions?
Slit lamps require standard 510(k) documentation plus device-specific requirements including optical radiation safety certification, electrical safety compliance, side-by-side predicate comparison, materials safety (no flammable materials near light source), disinfection procedures, and specific phototoxicity labeling requirements.
How do I demonstrate optical radiation safety for slit lamp devices?
You can demonstrate optical safety by: 1) Certifying compliance with ISO 10939 section 4.4, 2) Showing emissions don’t exceed ACGIH TLVs under worst-case conditions, or 3) Providing side-by-side comparison of critical optical elements or radiation emissions with a predicate device.
What electrical safety standards are acceptable for slit lamp biomicroscopes?
FDA accepts compliance with IEC 60601-1, UL 544, UL 2601-1, or other recognized electrical safety standards. You can demonstrate compliance through bench testing, declaration of conformance to FDA-recognized standards, or certification with testing data if required.
What specific labeling requirements apply to slit lamp devices?
Labeling must include prescription device caution statement, cleaning/disinfection procedures, comprehensive phototoxicity warnings about retinal damage risks, exposure time limitations, and special considerations for infants, aphakes, and diseased eyes. Laser products need additional 21 CFR 1040.10(g) labeling.
Are there special considerations for slit lamps with software components?
Yes, devices with software must comply with FDA’s Computer Controlled Medical Devices guidance or declare conformance with IEC 60601-1-4. Software documentation should follow ODE guidance for premarket submissions containing software to ensure proper validation and risk management.
What materials restrictions apply to slit lamp manufacturing?
The primary materials restriction is that no flammable materials may be positioned near the light source due to fire safety concerns. Additionally, patient-contact surfaces must be easily disinfectable or protected by single-use disposable covers for infection control.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description and intended use documentation
- Conduct optical equivalency and radiation safety testing
- Perform electrical safety testing or obtain certification
- Develop and validate cleaning/disinfection procedures
- Create compliant labeling including all required warnings and information
- Prepare software documentation if applicable
- Complete side-by-side comparison with predicate device
- Ensure no flammable materials are near light source
- Prepare declaration of conformity to applicable standards
- Compile complete 510(k) submission package including all required elements
Key Considerations
Non-clinical testing
- Optical equivalency and radiation safety testing required (except for Class 1 lasers)
- Demonstrate compliance with ISO 10939 or ACGIH Threshold Limit Values
- Comparative testing with predicate devices for beam geometry, light source characteristics, and optical radiation emissions
Software
- Must comply with FDA guidance for computer-controlled medical devices
- Alternative: declare conformance with IEC 60601-1-4
Labelling
- Must include manufacturer name and address
- Prescription device caution statement required
- Cleaning and disinfection procedures
- Phototoxicity warnings and information
- Specific laser product labeling if applicable
Safety
- No flammable materials near light source
- Electrical safety demonstration through testing or conformance to recognized standards
- Parts contacting patient/operator must be easily disinfected or protected by disposable cover
- Maximum temperature limits for operator/patient-accessible parts
Other considerations
- Side-by-side comparison with predicate device required
- Device description and intended use documentation
- Manufacturing facility information
Relevant Guidances 🔗
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Content of Premarket Submissions for Device Software Functions
- Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms 📂
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for safety
- IEC 60601-1-4: Medical electrical equipment - Programmable electrical medical systems
- ISO 10939: Ophthalmic instruments - Slit-lamp microscopes
- ISO 15004: Ophthalmic instruments - General requirements and test methods
- UL 544: Professional Medical and Dental Equipment
- UL 2601-1: Medical electrical equipment - Part 1: General requirements for safety