Conventional Foley Urinary Catheters - Performance Testing and Labeling Requirements
This guidance covers conventional Foley catheters intended for drainage and/or irrigation of the urinary tract, specifically: - Class II devices regulated under 21 CFR 876.5130 (product code EZL) - French sizes 12 through 26 - Retention balloon volume ≤ 30 cm³ - Two lumen catheters - Single-use devices with indwelling time ≤ 30 days Excludes: Three lumen catheters, lubricity-enhanced catheters, suprapubic catheters, and antimicrobial catheters.
Recommended Actions
- Verify device specifications match the scope requirements
- Conduct all required mechanical testing according to ASTM F623
- Perform complete biocompatibility evaluation
- Validate sterilization process if device is labeled sterile
- Prepare packaging validation documentation
- Submit Declaration of Conformity (DoC) for applicable tests
- Prepare test results summary for all evaluations
- Consider Pre-Submission if additional testing beyond guidance is needed
- Document any protocol deviations with justification
- Ensure compliance with dimensional tolerances for French size specifications
Key Considerations
Non-clinical testing
- Dimensional Analysis according to ASTM F623
- Flow Rate testing (minimum 100 cm³/min for sizes 14-26, 70 cm³/min for size 12)
- Balloon Integrity testing
- Inflated Balloon Response to Traction
- Balloon Volume Maintenance
- Balloon Size and Shaft Size verification
- Deflation Reliability testing
Labelling
- French size must correspond to actual diameter specifications
- Sterility status must be indicated if applicable
Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Sub-acute/Sub-chronic Toxicity
- Genotoxicity
- Implantation
Safety
- Sterilization validation for devices labeled as sterile
- Sterility assurance level of 10⁻⁶
- Package integrity validation
Other considerations
- Manufacturing process documentation if claiming substantial equivalence
- Packaging description and test methods
Relevant Guidances
- Premarket Notification Requirements for Conventional and Antimicrobial Foley Catheters with Balloon Retention
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation
- Submission Requirements for Terminally Sterilized Medical Devices
Related references and norms
- ASTM F623: Standard Performance Specifications for Foley Catheters
- ISO 17665-1: Sterilization of health care products – Moist heat
- ISO 11135-1: Sterilization of health care products – Ethylene oxide
- ISO 11137-1: Sterilization of health care products – Radiation
- ISO 20857: Sterilization of health care products – Dry heat
- ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1
- ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2
- ISO 10993-1: Biological evaluation of medical devices
Original guidance
This post is licensed under CC BY 4.0 by the author.