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Tonometers for Measuring Intraocular Pressure - Testing and Performance Requirements

This guidance applies to manual and AC-powered tonometers intended to measure intraocular pressure (IOP) for glaucoma diagnosis. It covers contact tonometers (including Schiotz type, applanation type, and strain gauge) and non-contact (air-puff) tonometers, as well as devices that adjust IOP based on other ocular parameters.

  1. Conduct comprehensive bench testing for accuracy and repeatability
  2. Perform clinical testing if device is non-Goldmann-type
  3. Validate all cleaning and sterilization procedures
  4. Complete biocompatibility evaluation for patient-contacting materials
  5. Verify electrical safety and EMC compliance
  6. Prepare detailed device description including principles of operation
  7. Develop comprehensive labeling including all required elements
  8. Document software validation if applicable
  9. Conduct risk analysis and implement mitigations
  10. Prepare 510(k) submission including all test results and documentation

Key Considerations

Clinical testing

  • Required for non-Goldmann-type tonometers only
  • Comparison with calibrated Goldmann-type applanation tonometer
  • Sample size of 150 eyes recommended
  • Follow ANSI Z80.10-2003 protocol or equivalent
  • Analysis should include scatter plots, Bland-Altman plots, and comparability assessment

Non-clinical testing

  • Accuracy testing across nominal pressure range
  • Repeatability testing with minimum 3 eyes per pressure value
  • 10 measurements per eye
  • Validation of any IOP adjustment features

Software

  • Information based on “level of concern” as per FDA software guidance

Labeling

  • Clear instructions for use
  • Performance testing summary
  • List of single use, disposable, and reusable parts
  • Sterilization instructions if applicable
  • Indications for use statement
  • Scientific basis for IOP adjustment features

Biocompatibility

  • Evaluation per ISO-10993 for limited contact with intact corneas
  • List of patient-contacting materials

Safety

  • Electrical safety per IEC 60601-1
  • Electromagnetic compatibility per IEC 60601-1-2
  • Sterility assurance level (SAL) of 1x10-6 for sterile devices

Other considerations

  • ANSI Z80.10-2003: Tonometers for measuring intraocular pressure
  • ISO-10993: Biological Evaluation of Medical Devices Part 1
  • IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety
  • IEC 60601-1-2: Electromagnetic Compatibility Requirements and Tests

Original guidance

  • Tonometers for Measuring Intraocular Pressure - Testing and Performance Requirements
  • HTML / PDF
  • Issue date: 2006-03-27
  • Last changed date: 2020-03-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket
  • ReguVirta summary file ID: 9f37569d9b61c51f52c95cede47a2f65
This post is licensed under CC BY 4.0 by the author.