Review Criteria for Vitreous Aspiration and Cutting Devices

What You Need to Know? 👇

What is the FDA classification for vitreous aspiration and cutting devices?

Vitreous aspiration and cutting devices are classified as Class II medical devices under 21 CFR 886.4150, regulated through the 510(k) premarket notification process. They are placed in Tier II and fall under the Ophthalmic Devices Panel jurisdiction.

What are the main types of vitreous aspiration and cutting devices?

There are three main types: full function devices (incorporating aspiration, cutting, infusion, and illumination), divided systems (cutting/aspiration in handpiece with separate illumination/infusion probes), and handpiece accessories for ophthalmic microsurgery systems providing only aspiration and cutting functions.

What biocompatibility testing is required for these devices?

Biocompatibility testing following ISO-10993 standards is required for any direct or indirect patient-contacting materials that differ from predicate devices or are processed/sterilized differently. Testing must cover all materials including colorants, inks, and radiopaque materials.

What sterilization requirements apply to vitreous aspiration devices?

Devices must provide complete sterilization information including method, cycle validation, packaging materials, sterility assurance level (SAL), and residual levels for ETO sterilization. Critical devices require sterilization that destroys all microorganisms including bacterial spores.

What performance data is needed for 510(k) submission?

Performance data may include bench testing per industry standards, preclinical/animal testing compliant with GLP requirements, clinical testing, software validation, and sterility information. Testing should simulate actual device use conditions with statistically valid data collection.

What labeling requirements must be included for these devices?

Labeling must include the physician restriction statement per 21 CFR 801.109(b)(1), intended use, directions for use, maintenance procedures, contraindications, warnings, and adequate reprocessing instructions for reusable devices. All materials must comply with 21 CFR 801 requirements.

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What You Need to Do 👇

Recommended Actions

1. Prepare comprehensive device description including all components and accessories
2. Conduct necessary biocompatibility testing for patient-contacting materials
3. Perform electrical safety testing and obtain certification
4. Develop and validate sterilization procedures if applicable
5. Create complete labeling package including all required elements
6. Document ergonomic considerations and human factors evaluation
7. Prepare performance data demonstrating substantial equivalence
8. Establish quality assurance program
9. Submit detailed 510(k) summary comparing to predicate device
10. 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

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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

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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 ID: 3cb8082a710c6923c33ac64c50f24529