Date of Publication: 23-Jul-2026
INTELLIGENT OVERVIEW
The U.S. Food and Drug Administration (FDA) has issued an updated guidance document titled “Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff”. Superseding the previous version dated April 23, 2008, this update modernizes submission expectations and aligns recommendations with current international standards and quality management frameworks.
Scope and Classification: This guidance applies specifically to extracorporeal blood circuits used during hemodialysis treatment.
Product Codes: FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve) and KOC (Accessories, Blood Circuit, Hemodialysis)
Exclusions: Tubing or devices used for vascular access (such as hemodialysis catheters) or peritoneal dialysis tubing.
Key 510(k) Submission Recommendations
1. Device Description & Predicate Comparison
Submissions must include a complete system description, labeled diagrams, dimension specifications (inner/outer diameters, length), individual component functionalities (heparin lines, drip chambers, transducer protectors), and compatible legally marketed delivery systems. A thorough comparison to a predicate device in tabular format is recommended across key areas like intended use, design features, and performance specifications.
2. Comprehensive Performance Testing
Testing data must demonstrate functionality under operational conditions. Key bench testing recommendations include:
- Pressure Leak Testing: Tubing must withstand up to 1.5 times maximum labeled positive/negative pressures.
- Transducer Protector Resistance: Ability to withstand pressure up to 2 times maximum labeled pressure to prevent “strikethrough”.
- 4-Hour Simulated Run: Tubing sets must be evaluated with a blood analog fluid for 4 hours at $37^\circ\text{C}$ on each specified delivery system to check for kinking or tubing failures.
- Additional Assessments: Pump segment endurance, injection port durability, tensile testing of joints, clamp occlusion, priming volume assessment, and post-pump kinking resistance.
3. Biocompatibility & Material Characterization
Hemodialysis blood tubing sets are categorized as externally communicating devices in long-term contact with circulating blood (Category C) due to cumulative exposure in chronic kidney disease patients. Submissions should specify all contact materials, plasticizers (e.g., DEHP), colorants, and additives.
Biocompatibility evaluation should align with ISO 10993-1 guidelines. Crucial endpoints to evaluate include cytotoxicity, hemocompatibility, pyrogenicity, genotoxicity, subacute/chronic toxicity, and carcinogenicity.
4. Sterility, Packaging & Expiration
- Sterility Assurance Level (SAL): Recommended to be $1 \times 10^{-6}$.
- Pyrogenicity: Endotoxin testing details (e.g., LAL or recombinant reagent assays) must be provided.
- Shelf-Life Support: Expiration dates must be supported by real-time or accelerated aging test data alongside package integrity testing.
Labeling Highlights
- Color Coding: Arterial connectors (patient and dialyzer) should be red, and venous connectors should be blue.
- Critical Warnings: Specific warnings must be included regarding the potential for significant hemolysis of red blood cells in kinked blood tubing, especially in the post-pump arterial segment.
- Single-Use Indication: Clear statement indicating that the device is single-use, non-pyrogenic, and sterile if the package is intact.
REFERENCE: https://www.fda.gov/media/71429/download