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.
Recommended Actions
- Determine if the catheter falls within standard scope or requires additional data
- Prepare comprehensive device description including materials and dimensions
- Conduct required performance testing per ASTM F 623-89
- Complete biocompatibility testing suite
- Develop and validate sterilization process
- For antimicrobial catheters:
- Design and conduct clinical trials
- Complete antimicrobial effectiveness testing
- Generate elution profile data
- Prepare detailed labeling including all required elements
- Document substantial equivalence to predicate devices
- 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
- Antimicrobial properties:
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms
- 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
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