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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.

  1. Prepare comprehensive device description and intended use documentation
  2. Conduct optical equivalency and radiation safety testing
  3. Perform electrical safety testing or obtain certification
  4. Develop and validate cleaning/disinfection procedures
  5. Create compliant labeling including all required warnings and information
  6. Prepare software documentation if applicable
  7. Complete side-by-side comparison with predicate device
  8. Ensure no flammable materials are near light source
  9. Prepare declaration of conformity to applicable standards
  10. 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

  • 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

Original guidance

  • AC-Powered Slit Lamp Biomicroscopes - Requirements for 510k Submissions
  • HTML / PDF
  • Issue date: 1998-07-07
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 819ca441ba92444c92e995626bc4cf90
This post is licensed under CC BY 4.0 by the author.