Hemodialysis Blood Tubing Sets - Performance, Testing, and Labeling Requirements
This guidance document is limited to hemodialysis blood tubing sets used as the extracorporeal blood circuit during hemodialysis treatment, as classified under 21 CFR 876.5820 (product codes FJK and KOC). It does not include tubing or devices used for vascular access or peritoneal dialysis.
Recommended Actions
- Conduct complete performance testing battery as outlined
- Perform biocompatibility testing per ISO 10993
- Validate sterilization process and pyrogenicity
- Complete expiration date validation testing
- Develop comprehensive labeling including all required elements
- Document material composition and compare to predicates
- Validate compatibility with specified hemodialysis delivery systems
- Prepare abbreviated 510(k) submission with test results and acceptance criteria
- Implement color coding requirements for connectors
- Establish quality controls for manufacturing and testing
Key Considerations
Non-clinical testing
- Pressure leak testing up to 1.5x maximum labeled pressures
- Endurance testing of pump segment at maximum flow rates
- Endurance testing of injection ports
- Priming volume assessment
- Tensile testing of joints and materials
- Pressure transducer leakage testing
- Clamp performance testing
- Kink resistance testing
- 4-hour system compatibility testing with blood analog fluid at 37°C
Labeling
- Include expiration date
- Color coding requirements (red for arterial, blue for venous connectors)
- Single use warning
- Device description including components, dimensions, compatibility
- Storage conditions
- Sterility status and method
- Lot number
- Warnings about hemolysis risks
Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
- Acute systemic toxicity
- Hemocompatibility
- Genotoxicity
Safety
- Sterility assurance level (SAL) of 1x10-6
- Pyrogenicity testing
- Package integrity testing
Other considerations
- Material description and comparison to predicates
- Expiration date validation through real-time or accelerated aging
Relevant Guidances
- Quality Assurance Guidelines for Hemodialysis Devices and Facilities
- Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
- Special Controls for Implanted Blood Access Devices for Hemodialysis
Related references and norms
- ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- ANSI/AAMI ST 72:2002: Bacterial endotoxins - Test methodologies, routine monitoring, and alternatives to batch testing
Original guidance
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