Review Criteria for Vitreous Aspiration and Cutting Devices
This guidance provides review criteria for Vitreous Aspiration and Cutting devices, which are Class II medical devices intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens. The guidance covers three main device types: full function devices, divided systems, and handpiece accessories to ophthalmic microsurgery systems.
Recommended Actions
- Prepare comprehensive device description including all components and accessories
- Conduct necessary biocompatibility testing for patient-contacting materials
- Perform electrical safety testing and obtain certification
- Develop and validate sterilization procedures if applicable
- Create complete labeling package including all required elements
- Document ergonomic considerations and human factors evaluation
- Prepare performance data demonstrating substantial equivalence
- Establish quality assurance program
- Submit detailed 510(k) summary comparing to predicate device
- Ensure all testing follows applicable standards and GLP requirements
Key Considerations
Non-clinical testing
- Bench testing should be conducted according to accepted industry standards
- Testing should be representative of actual use conditions
- Testing should include sampling across product line range when necessary
- All preclinical/animal testing must comply with 21 CFR Part 58 GLP requirements
Human Factors
- Ergonomic features should be considered and described (audible/visible alarms, control panel design, data presentation)
- Size and location of parts should be evaluated for safety and efficacy
- Readability of labeling and instructions should be assessed
Software
- Software-controlled devices must follow FDA guidance for computer-controlled medical devices
- Software testing documentation required if applicable
Biocompatibility
- Testing required for any direct or indirect patient-contacting materials
- Must follow ISO-10993 standards
- Documentation needed for colorants and markings that contact patient
- Validation required for reusable materials
Safety
- Electrical safety certification required
- Compliance with recognized electrical safety standards
- Device must meet critical item requirements for sterilization
Labeling
- Must include caution statement per 21 CFR 801.109(b)(1)
- Device identification, company information, and specifications required
- Clear instructions for use, maintenance, and troubleshooting
- Contraindications, precautions, warnings must be included
- Sterilization/reprocessing instructions if applicable
Other considerations
- Quality assurance program description required
- Performance data must demonstrate substantial equivalence
- Sterility information required for sterile devices
- Device modifications require detailed description and rationale
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Design Controls for Medical Device Manufacturers
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms
- ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
Original guidance
- Review Criteria for Vitreous Aspiration and Cutting Devices
- HTML
- Issue date: 1997-01-30
- Last changed date: 2020-03-18
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket
- ReguVirta summary file ID: 3cb8082a710c6923c33ac64c50f24529
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