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This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What are patient-matched guides for orthopedic implants and how do they work?
Patient-matched guides are custom devices designed to implement pre-operative surgical plans for orthopedic implant placement. They use patient-specific imaging data to create guides that assist surgeons in positioning implants according to predetermined alignment parameters based on anatomical landmarks.
What regulatory pathway do patient-matched orthopedic guides typically follow for FDA clearance?
Most patient-matched orthopedic guides follow the 510(k) premarket notification pathway as Class II devices. However, some may require PMA approval depending on their specific design and intended use. The regulatory classification depends on the device’s risk profile and predicate device availability.
What types of performance testing are required for patient-matched orthopedic guides?
Required testing includes intra- and inter-designer variability studies, mechanical integrity testing post-processing, debris generation assessment, and implant alignment accuracy validation. Cadaveric testing with multiple surgeon experience levels is recommended to demonstrate usability and accuracy within surgical workflows.
Are clinical studies typically required for patient-matched orthopedic guide submissions?
Clinical studies are generally not required for standard patient-matched guides. However, they may be necessary for devices with novel indications, significantly different technological characteristics, or claims about improved patient outcomes that cannot be adequately supported through bench testing alone.
What software documentation is needed for patient-matched guide systems?
Software documentation should follow FDA’s “Content of Premarket Submissions for Device Software Functions” guidance. This includes comprehensive descriptions of pre-operative planning and guide design software, verification/validation protocols, and cybersecurity considerations commensurate with the appropriate Documentation Level.
What biocompatibility testing endpoints must be addressed for patient-matched orthopedic guides?
Required biocompatibility endpoints include cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity. These devices are classified as external-communicating devices with limited tissue/bone/blood contact duration per ISO 10993-1 standards.
What You Need to Do 👇
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 đź”—
- 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 đź“‚
- 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