Post

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This is a draft guidance. Not for implementation.

  1. Establish comprehensive design control process including validation procedures
  2. Develop detailed documentation of the guide design process and parameters
  3. Conduct thorough non-clinical testing program including mechanical, accuracy and usability testing
  4. Implement appropriate biocompatibility testing program
  5. Establish sterilization validation and shelf-life testing
  6. Create comprehensive labeling including all required elements
  7. Develop quality control measures for the entire manufacturing process
  8. Establish procedures for handling modifications to the device
  9. Implement cybersecurity measures if applicable
  10. 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

  • 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

  • Patient-Matched Orthopedic Surgical Guides: Testing, Documentation and Safety Requirements
  • HTML / PDF
  • Issue date: 2023-06-28
  • Last changed date: 2023-06-28
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Orthopedic, Premarket
  • ReguVirta summary file ID: 177baa66d550a87816c931b54869dc77
This post is licensed under CC BY 4.0 by the author.