Coronary, Peripheral, and Neurovascular Guidewires - Performance Testing and Documentation Requirements

What You Need to Know? 👇

What are the key biocompatibility endpoints required for guidewire testing according to FDA guidance?

Per ISO 10993-1, guidewires require evaluation for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, complement activation, in vivo thrombogenicity, and direct/indirect hemolysis as externally communicating devices with limited blood contact.

Which performance tests are most critical for coated guidewires in premarket submissions?

Coating integrity and particulate evaluation are essential, especially for coronary and neurovascular devices. Testing should include pre/post-simulated use microscopy (≥40X magnification), particle characterization by size and count, and assessment of coating delamination or degradation risks.

What anatomical model requirements apply to neurovascular guidewire testing?

Neurovascular models must include a full three-dimensional path from access site to target location, incorporating the ICA siphon, two 180-degree turns, and two 360-degree turns at the distal portion to simulate clinically challenging tortuosity.

When is clinical testing required for guidewire 510(k) submissions?

Clinical evidence is generally unnecessary but may be required for complex scenarios like chronic total occlusions, when engineering/animal testing raises concerns, for dissimilar indications from predicate devices, or for new technology requiring further evaluation.

What modifications to cleared guidewires typically require new 510(k) submissions?

Changes requiring new 510(k)s include core material modifications, coating location/material/processing changes, dimensions beyond previously cleared ranges, tip configuration alterations, and expansion to additional vasculature due to altered safety/effectiveness profiles.

What are the essential labeling requirements for guidewire instructions for use?

Labels must include device description with dimensions and coating characteristics, indications for use statement, contraindications, warnings about single-use and fluoroscopic guidance requirements, potential adverse events, and specific directions for device preparation and clinical use.

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What You Need to Do 👇

Recommended Actions

1. Determine device classification and applicable product code
2. Develop comprehensive test plan covering all required performance testing
3. Conduct biocompatibility risk assessment and testing
4. Perform sterilization validation
5. Establish and validate shelf life
6. Develop complete labeling package including all required elements
7. Prepare detailed device description and predicate comparison
8. For coated devices, implement additional coating integrity and particulate testing
9. Document all test protocols and results according to FDA guidance
10. 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

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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

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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 ID: 501487dcf501222c2bede1903545e8b2