Patient-Matched Orthopedic Surgical Guides: Testing, Documentation and Safety Requirements (DRAFT)
This guidance addresses patient-matched guides intended for use with legally marketed orthopedic implant systems that include recommended alignment parameters relative to rigid anatomical structures identifiable on pre-operative imaging.
This is a draft guidance. Not for implementation.
Recommended Actions
- Establish comprehensive design control process including validation procedures
- Develop detailed documentation of the guide design process and parameters
- Conduct thorough non-clinical testing program including mechanical, accuracy and usability testing
- Implement appropriate biocompatibility testing program
- Establish sterilization validation and shelf-life testing
- Create comprehensive labeling including all required elements
- Develop quality control measures for the entire manufacturing process
- Establish procedures for handling modifications to the device
- Implement cybersecurity measures if applicable
- Create documentation system for design history file
Key Considerations
Clinical testing
- Generally not necessary unless:
- Indications dissimilar from legally marketed devices
- Significantly different technological characteristics
- Engineering/cadaveric testing raises issues needing clinical evaluation
- Claims about improved outcomes or reduced surgical time
- Surgical approach differs from implant manufacturer recommendations
Non-clinical testing
- Intra and inter-designer variability testing across representative patient datasets
- Mechanical integrity testing after shipping, processing and clinical use
- Debris generation testing with specified surgical instruments
- Implant alignment accuracy and guide usability testing in cadaveric models
- Multiple surgeons with varied experience levels should validate the guides
Human Factors
- Usability testing should be conducted in cadaveric models
- Documentation of guide usability within implant surgical techniques
- Assessment of guide’s unique and stable fit to anatomy
Software
- Full description of software supporting pre-operative planning and guide design
- Documentation level based on FDA software guidance
- Additional documentation for off-the-shelf software
- Cybersecurity considerations as appropriate
Cybersecurity
- Information required for devices with cybersecurity aspects
- Special considerations for off-the-shelf software
Labelling
- Must include adequate information for intended users
- Instructions for assessing proper guide alignment
- Instructions for converting to traditional techniques
- Irrigation instructions when debris generated
- Graphical illustrations of key steps
- Patient identification directly on guide
Biocompatibility
- Testing required for all patient-contacting materials
- Risk assessment if no similar predicate device
- Testing endpoints: cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity
Safety
- Sterility assurance level (SAL) of 10-6 required
- Package integrity testing
- Shelf life validation
- Impact of sterilization on guide geometry
Other considerations
- Maximum time between image acquisition and surgery
- Design process documentation
- Quality control measures
- Modifications requiring new 510(k) submission
Relevant Guidances
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- ANSI/AAMI/ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
- ANSI/AAMI/ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F1877: Standard Practice for Characterization of Particles
Original guidance
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