BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

Blood tubing lines for hemodialysis (AL Series Archloop and C18 Series) are disposable sterile bloodline sets that provide extracorporeal vascular access during hemodialysis. They are indicated for adult patients with acute and chronic renal failure treated in hospitals and dialysis clinics under physician supervision and are compatible with the DBB-06 PRO Hemodialysis Delivery System.

The subject device has the same intended use, design, configuration, scientific technology, principles of operation, and sterilization method (ethylene oxide) as the predicate device. Materials are similar (PVC, polycarbonate, polypropylene, silicone rubber, SEBS). The subject device differs only in the dialysis machine model compatibility and the shape of the pressure measurement connection part.

ISO 10993-1 (biological evaluation of medical devices); FDA guidance on pyrogen and endotoxins testing (June 2012); guidance on hemodialysis blood tubing sets (April 2008); and standards for sterility, shelf life, and non-clinical bench performance testing.

Substantial equivalence is supported by identical intended use and design between subject and predicate devices. Bench testing confirmed compatibility with the dialysis machine despite differences in connector shape and machine model. Materials used are not new; the subject device removes some materials (MABS, PTFE, isoprene rubber) used in the predicate but introduces none not already known. Comprehensive biological safety and performance testing demonstrated the subject device poses no new safety or effectiveness questions.