Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements
This guidance provides recommendations for premarket notification (510(k)) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature. It covers devices regulated under 21 CFR 870.1330 with product codes DQX (coronary and peripheral) and MOF (neurovascular).
Recommended Actions
- Determine device classification and applicable product code
- Develop comprehensive test plan covering all required performance testing
- Conduct biocompatibility risk assessment and testing
- Perform sterilization validation
- Establish and validate shelf life
- Develop complete labeling package including all required elements
- Prepare detailed device description and predicate comparison
- For coated devices, implement additional coating integrity and particulate testing
- Document all test protocols and results according to FDA guidance
- Consider need for clinical data based on device novelty and risk profile
Key Considerations
Clinical testing
- Generally unnecessary for most guidewires
- May be required for:
- Complex clinical scenarios (e.g., crossing chronic total occlusions)
- Cases where engineering/animal testing raise concerns
- Dissimilar indications from legally marketed devices
- New technology
Non-clinical testing
- Dimensional verification
- Visual inspection
- Simulated use testing
- Tensile strength testing
- Tip pull testing
- Torque strength testing
- Torqueability testing
- Kink resistance testing
- Tip flexibility testing
- Radiopacity testing
Labeling
- Device description identifying important components and functions
- Indications for use statement
- Contraindications
- Warnings/precautions
- Potential adverse events
- Directions for use
- For coated devices: specific preparation instructions
Biocompatibility
- Testing required for all patient-contacting materials
- Endpoints to address:
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
- Acute systemic toxicity
- Material-mediated pyrogenicity
- Complement activation
- In vivo thrombogenicity
- Direct and indirect hemolysis
Safety
- Sterility testing required
- Pyrogenicity testing required
- Shelf life validation required
- Package integrity testing required
Other considerations
- Coating integrity testing for coated devices
- Particulate evaluation
- Lubricity testing for coated devices
- Corrosion resistance testing
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Recommended Format and Content for Non-Clinical Bench Performance Testing in Medical Device Premarket Submissions
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- AAMI/ANSI/ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
- AAMI/ANSI/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 F640: Standard Test Method for Determining Radiopacity for Medical Use
- ISO 10555-1: Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements
Original guidance
- Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements
- HTML / PDF
- Issue date: 2019-10-10
- Last changed date: 2019-10-09
- Status: FINAL
- Official FDA topics: Medical Devices, Cardiovascular, 510(k), Premarket, Neurological
- ReguVirta summary file ID: 501487dcf501222c2bede1903545e8b2
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