Premarket Notification Requirements for Urine Drainage Bags and Accessories
This guidance outlines the requirements for premarket notifications (510(k)) for urine drainage bags and accessories, covering both Class I (external catheter use) and Class II (indwelling catheter use) devices. It provides specific information needed to determine substantial equivalence to existing devices.
Recommended Actions
- Prepare detailed device description with labeled diagrams and specifications
- Conduct comprehensive bench testing for functional performance
- Perform required biocompatibility testing based on device classification
- Develop complete labeling package including IFU and warnings
- Validate sterilization processes if applicable
- Document any modifications from predicate devices with supporting data
- Prepare clinical data if making infection reduction claims
- Create testing protocols for any absorbent materials or adhesives
- Ensure compliance with all applicable regulations and standards
- Maintain documentation of all testing and validation activities
Key Considerations
Clinical testing
- Clinical data may be required to support claims concerning reduced possibility for infection or contamination
Non-clinical testing
- Water backflow pressure through anti-reflux valve
- 24-hour inversion leakage test
- Standing column test for drainage efficiency
- Drainage time test
- For absorbent materials: confirmation of amount and maximum fluid absorption
- For adhesives: strength and removability testing
Labeling
- Device and package labels must include:
- Device name, corporation name, address, telephone number
- Sterility status, expiration date
- Disposable/single use information
- Quantity, size
- Prescription device statement
- Comprehensive instructions for use
- Contraindications, warnings, and precautions
- No implied FDA approval in promotional materials
Biocompatibility
- Chemical composition identification for adhesives and absorbent materials
- Testing according to Tripartite Biocompatibility Guidance for:
- External devices contacting breached surfaces
- Externally communicating devices contacting intact natural channels
Safety
- Sterilization validation for sterile devices
- Assessment of sterilization effects on absorbent materials
- Documentation of significant modifications affecting safety
Other considerations
- Physical description including volume and unique features
- Identification of disposable parts
- Documentation for any significant modifications from predicate devices
Relevant Guidances
- 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
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 21 CFR 876.5250: Medical devices classification regulation for urine collectors and accessories
- 21 CFR 807.87: Requirements for premarket notification submissions
- 21 CFR 801.109: Prescription devices labeling requirements
Original guidance
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