VITAL Tubing Sets for Hemodialysis

VITAL Tubing Sets for Hemodialysis are sterile, single-use arterial and venous blood lines designed for exclusive use with specific hemodialysis systems (AK98, Fresenius 2008/5008X, and Braun Dialog series). The tubing sets form the extracorporeal blood circuit that transports blood from the patient through a hemodialyzer and back to the patient, with the pump line interfacing with the hemodialysis machine's pump rotor mechanism.

The proposed device differs from the predicate in sterilization method (ethylene oxide vs. e-beam), materials composition (includes PCTG, PETG, MABS in addition to predicate materials), priming volumes that vary by model (88–201 mL depending on tubing length), and conformance to updated ISO standards (ISO 8637-2:2024 and ISO 80369-7:2021 vs. older ISO 8638:2010 and ISO 594-2:1998). Main configuration, features, and pressure limitations (±500 mmHg) remain substantially the same.

ISO 11607-1:2019 and ISO 11607-2:2019 (packaging); ISO 8637-2:2024 and ISO 80369-7:2021 (performance); ASTM F88/F88M-23, F1929-23, F1980-21, D4169-23, and F2096-11 (mechanical/packaging testing); EN ISO 10993 series (biocompatibility and chemical characterization); EN ISO 11135:2014 (ethylene oxide sterilization validation); USP <85> (bacterial endotoxin).

The proposed devices are substantially equivalent because they serve the same intended use (extracorporeal blood circuit in hemodialysis), have compatible system specifications with documented bench testing, and all functional and safety-critical characteristics match the predicate. Design differences in sterilization method, materials, and priming volumes do not introduce new safety or effectiveness issues, as demonstrated by comprehensive performance testing, biocompatibility studies, and compliance with applicable standards. Updated ISO standards do not create new risks.