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.
What You Need to Know? 👇
What is the regulatory classification of phacofragmentation systems under FDA guidelines?
Phacofragmentation systems are classified as Class II medical devices under 21 CFR 886.4670, regulated through the 510(k) premarket notification process. They are typically placed in Tier II and fall under the Ophthalmic Devices Panel jurisdiction.
What biocompatibility testing is required for phacofragmentation device submissions?
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 include all colorants, inks, and markings used in device fabrication.
Can phacofragmentation systems with vitreous cutting handpieces undergo third-party review?
No, phacofragmentation systems with vitreous cutting handpieces become combination devices and are not eligible for third-party review. Only single-function phacofragmentation systems qualify for this streamlined review pathway under current FDA guidance.
What sterilization documentation is required for reusable phacofragmentation components?
Manufacturers must provide complete sterilization validation including method, cycle parameters, packaging materials, sterility assurance level (SAL), and instructions for disassembly, cleaning, and re-sterilization. Flash sterilization parameters must include time, temperature, and wrapping requirements.
What electrical safety standards must phacofragmentation systems meet for FDA clearance?
Devices must comply with appropriate domestic or internationally recognized electrical safety standards. Manufacturers should provide certification of compliance or supply electrical safety data documenting device safety, including power requirements and specifications.
What predicate device comparison requirements exist for substantial equivalence determination?
The submission must include a detailed comparison table showing similarities and differences in intended use, design, materials, sterilization methods, biocompatibility factors, and performance characteristics between the proposed device and legally marketed predicate devices.
What You Need to Do 👇
Recommended Actions
- Prepare comprehensive device description including all components and accessories
- Conduct required performance testing (bench, preclinical as needed)
- Complete biocompatibility testing per ISO-10993
- Validate sterilization methods and document procedures
- Develop complete labeling package with all required elements
- Document electrical safety compliance
- Prepare detailed comparison to predicate devices
- Include quality assurance program description
- Validate any reprocessing instructions
- Ensure software documentation if applicable
- 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
- Quality assurance program description required
- Sterilization validation and methods must be documented
- Performance comparison to predicate devices required
- Device modifications require detailed description and rationale
Relevant Guidances 🔗
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Content of Premarket Submissions for Device Software Functions
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms 📂
- ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing