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Review Criteria for Phacofragmentation Systems Used in Cataract Surgery

This guidance provides review criteria for Phacofragmentation System devices submitted for 510(k) premarket notification. The device is an AC-powered device with a fragmenting needle intended for cataract surgery to disrupt and extract cataracts using ultrasound.

  1. Prepare comprehensive device description including all components and accessories
  2. Conduct required performance testing (bench, preclinical as needed)
  3. Complete biocompatibility testing per ISO-10993
  4. Validate sterilization methods and document procedures
  5. Develop complete labeling package with all required elements
  6. Document electrical safety compliance
  7. Prepare detailed comparison to predicate devices
  8. Include quality assurance program description
  9. Validate any reprocessing instructions
  10. Ensure software documentation if applicable
  11. Prepare truthful and accurate statement per 21 CFR 807.87

Key Considerations

Non-clinical testing

  • Bench testing should be conducted according to accepted industry standards
  • Testing should be representative of actual device use
  • Statistically valid data required to establish device performance
  • Preclinical/animal testing must comply with 21 CFR Part 58 GLP requirements

Human Factors

  • Ergonomic features should be described (alarms, control panel, data presentation)
  • Size and location of parts should be considered
  • Readability of labeling and instructions should be evaluated
  • Testing of instructions may be necessary

Software

  • Must follow FDA “Reviewer Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review”
  • Software testing data required for software-controlled devices

Biocompatibility

  • Testing required for any direct/indirect patient-contacting materials different from predicate
  • Must follow ISO-10993 and ODE Guidance G95-1
  • Colorants/markings must be identified and tested if patient-contacting

Safety

  • Must comply with recognized electrical safety standards
  • Certification or electrical safety test data required
  • Device must be labeled as critical requiring sterilization

Labeling

  • Must include caution statement per 21 CFR 801.109(b)(1)
  • Device name, company info, sterility status required on labels
  • Must include intended use, directions, contraindications, warnings
  • Reprocessing instructions if reusable
  • Maintenance and troubleshooting procedures required

Other considerations

  • ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing

Original guidance

  • Review Criteria for Phacofragmentation Systems Used in Cataract Surgery
  • HTML / PDF
  • Issue date: 1997-01-31
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices
  • ReguVirta summary file ID: 0b1b2ed2244ebf8d7523656024c7b4d5
This post is licensed under CC BY 4.0 by the author.