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.
What You Need to Know? 👇
What are the FDA classification requirements for urine drainage bags?
Urine drainage bags are classified as Class II devices when used with indwelling catheters and Class I when used with external catheters, as defined in 21 CFR 876.5250. The classification depends on the intended use and connection type.
What biocompatibility testing is required for urine drainage bag materials?
Materials must undergo biocompatibility testing per Tripartite Biocompatibility Guidance for external devices contacting breached surfaces or externally communicating devices. Adhesives and absorbent materials require chemical composition identification and appropriate biocompatibility tests.
What bench testing must be performed for urine drainage bags?
Required tests include water backflow pressure through anti-reflux valves, 24-hour inversion leakage testing, standing column drainage efficiency tests, and drainage time assessments. Additional testing for absorbent materials and adhesive strength may be required.
What labeling requirements apply to urine drainage bag 510(k) submissions?
Labels must include device name, manufacturer information, sterility status, expiration date, and prescription device statement per 21 CFR 801.109(b)(1). Labeling must provide comprehensive use instructions, contraindications, warnings, and supported claims.
When is sterilization data required for urine drainage bag submissions?
Complete sterilization information is required for devices sold sterile, following DRAERD 510(k) screening checklist requirements. For bags with absorbent materials used with indwelling catheters, sterilization effects on material composition and properties must be addressed.
What constitutes a significant modification requiring additional 510(k) data?
Modifications that could significantly affect safety, effectiveness, or create new indications require supporting documentation. This includes rationale, bench testing, clinical studies, or other valid scientific data demonstrating the changes don’t compromise safety or effectiveness.
What You Need to Do 👇
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