Testing Considerations for Percutaneous Transluminal Angioplasty (PTA) and Specialty Balloon Catheters
This guidance covers class II PTA balloon catheters and specialty catheters regulated under 21 CFR 870.1250 and 21 CFR 870.1210. It specifically addresses devices like infusion catheters, standard peripheral angioplasty balloon catheters, and balloon catheters with unique design characteristics (e.g., cutting/scoring). Class III drug-coated balloons are excluded from this guidance.
Recommended Actions
- Develop comprehensive test plan covering all required performance testing based on device type
- Conduct biocompatibility evaluation according to ISO 10993-1
- Establish and validate sterilization process
- Develop and validate packaging system
- Create detailed labeling including all required information
- For coated devices, implement coating integrity testing protocol
- Consider need for animal studies based on device novelty
- Evaluate need for clinical data based on device characteristics and intended use
- Document all testing and validation in design history file
- Consider pre-submission consultation with FDA for novel devices or testing approaches
Key Considerations
Clinical testing
- Generally unnecessary for most PTA balloon and specialty catheters
- May be required for:
- Indications dissimilar from legally marketed devices
- New technology
- Cases where engineering/animal testing raise issues requiring clinical evaluation
Non-clinical testing
- Dimensional verification
- Simulated use testing
- Balloon rated burst pressure testing
- Balloon fatigue testing
- Balloon compliance testing
- Balloon inflation/deflation time testing
- Catheter bond strength testing
- Tip pull testing
- Flexibility and kink testing
- Torque strength testing
- Radiopacity testing
Labeling
- Must include adequate information for practitioner use
- Should include indications, contraindications, warnings, product information
- Must include directions for use
- Should include compliance chart for balloon diameters vs. pressure
- Must be labeled as non-pyrogenic if contacting cardiovascular system
Biocompatibility
- Must evaluate following endpoints:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Material-mediated pyrogenicity
- Hemocompatibility (direct/indirect hemolysis, complement activation, thrombogenicity)
Safety
- Must demonstrate sterility
- Must meet pyrogen limit specifications
- Must demonstrate package integrity
- Must demonstrate shelf-life stability
Other considerations
- For coated devices:
- Coating integrity testing required
- Particulate evaluation may be required
- Additional testing for specialty catheters (e.g., scoring/cutting balloons)
- Animal testing may be required for new designs or significant modifications
Relevant Guidances
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Submission Requirements for Terminally Sterilized Medical Devices
- 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
- ISO 10555-1: Intravascular Catheters – Sterile and Single-Use Intravascular Catheters – Part 1: General Requirements
- ISO 10555-4: Sterile and Single-Use Intravascular Catheters – Part 4: Balloon Dilatation Catheters
- ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F2096: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
Original guidance
- Testing Considerations for Percutaneous Transluminal Angioplasty (PTA) and Specialty Balloon Catheters
- HTML / PDF
- Issue date: 2023-04-14
- Last changed date: 2023-04-13
- Status: FINAL
- Official FDA topics: Medical Devices, Cardiovascular, 510(k), Labeling, Premarket
- ReguVirta summary file ID: 3221a4a7b55cc33888c5b4c85b62ebe2
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