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Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention

This guidance outlines the requirements for premarket notifications (510(k)) for conventional and antimicrobial Foley catheters, which are class II devices used to pass fluids to or from the urinary tract. It specifically covers catheters intended for short-term use (less than 30 days) with balloon retention features.

  1. Determine if the catheter falls within standard scope or requires additional data
  2. Prepare comprehensive device description including materials and dimensions
  3. Conduct required performance testing per ASTM F 623-89
  4. Complete biocompatibility testing suite
  5. Develop and validate sterilization process
  6. For antimicrobial catheters:
    • Design and conduct clinical trials
    • Complete antimicrobial effectiveness testing
    • Generate elution profile data
  7. Prepare detailed labeling including all required elements
  8. Document substantial equivalence to predicate devices
  9. Compile comprehensive 510(k) submission including all test data and documentation

Key Considerations

Clinical testing

  • Randomized controlled clinical studies required for antimicrobial catheters to demonstrate:
    • Statistically significant decrease in infection rates compared to conventional catheters
    • Safety and effectiveness data
    • Duration of use data
    • Support for any additional claims including reprocessing
  • Patient history documentation including UTI history and medications
  • Urine culture data requirements

Non-clinical testing

  • Flow rate testing through drainage lumen
  • Balloon resistance to rupture (7-day test)
  • Balloon retention force testing
  • Balloon inflation maintenance testing
  • Manufacturing tolerances verification
  • Balloon deflation reliability testing

Labelling

  • Must include caution statement per 21 CFR 801.109(b)(1)
  • Device identification and specifications
  • Intended use statement
  • Directions for use including insertion/removal procedures
  • Maximum indwelling time
  • Antimicrobial information (if applicable)
  • Contraindications, precautions, warnings
  • Reprocessing instructions (if reusable)

Biocompatibility

  • Testing required for short-term externally communicating devices:
    • Mucosal irritation
    • Sensitization
    • Cytotoxicity
    • Acute systemic toxicity
    • Implantation

Safety

  • Sterility information including:
    • Sterilization method
    • Validation method
    • Packaging materials
    • Sterility assurance level
    • Residuals testing (if applicable)

Other considerations

  • ASTM F 623-89: Standard Performance Specification for Foley Catheters
  • ASTM D 1894: Standard Test Method for Static and Kinetic Coefficients of Friction

Original guidance

  • Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention
  • HTML
  • Issue date: 1994-09-11
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Antimicrobial Resistance, Premarket
  • ReguVirta summary file ID: dc261ca70d722be37a9b910515c24ec2
This post is licensed under CC BY 4.0 by the author.