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.
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
Original guidance
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