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.
What You Need to Know? 👇
What are the key performance tests required for hemodialysis blood tubing sets in 510(k) submissions?
FDA recommends pressure leak testing, endurance testing of pump segments, injection port testing, priming volume assessment, tensile testing, transducer leakage testing, clamp occlusion testing, hemocompatibility testing, and kinking resistance evaluation on three or more tubing sets per model.
Which biocompatibility tests are needed for hemodialysis blood tubing materials?
For materials without predicate equivalence, FDA recommends cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, hemocompatibility, and genotoxicity testing. These devices are classified as externally communicating, circulating blood contact, prolonged contact Class II.
What sterility requirements apply to hemodialysis blood tubing sets?
FDA recommends sterility assurance level (SAL) of 1 x 10⁻⁶ and pyrogenicity testing using methods like LAL. Testing should assess all clinically relevant contact surfaces and follow USP or ANSI/AAMI ST 72:2002 standards.
How should expiration dating be validated for hemodialysis blood tubing?
Validation requires biocompatibility testing, performance testing, and package integrity testing on aged samples. Accelerated aging conditions may be used with scientific rationale, but real-time testing should be initiated upon 510(k) submission.
What labeling requirements are specific to hemodialysis blood tubing sets?
Labels must include hemolysis warnings for kinked tubing, single-use warnings, device description with priming volume, compatible hemodialysis systems, maximum pressures, sterility status, and color coding (red for arterial, blue for venous connections).
Can an Abbreviated 510(k) be used for hemodialysis blood tubing submissions?
Yes, FDA recommends Abbreviated 510(k) as the least burdensome approach when following this guidance. It requires an abbreviated summary report explaining how the guidance was used, test methods, and acceptance criteria rather than full data presentation.
What You Need to Do 👇
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