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

These are disposable blood tubing lines used in hemodialysis procedures to provide extracorporeal access to a patient's blood. The devices include arterial and venous tubing, drip chambers, infusion lines, pressure monitoring lines, ports, clamps, and filters. They are intended for adult patients with acute and chronic renal failure treated in hospitals and dialysis clinics, and are packaged sterile for single use only.

The subject device has the same intended use, design, configuration, and scientific principles of operation as the predicate device. It differs in three respects: compatibility with the DBB-06 PRO hemodialysis delivery system, sterilization method, and certain materials. The subject device uses PVC, polycarbonate, polypropylene, silicone rubber, PTFE, and SEBS, whereas the predicate also included MABS and isoprene rubber.

ISO 10993-1 for biological evaluation of medical devices was referenced. Testing followed FDA guidance documents on pyrogen and endotoxin testing, hemodialysis blood tubing sets, sterility submissions, and shelf life.

The subject device is substantially equivalent because it has identical intended use and design compared to the predicate device, uses only existing materials (no new materials introduced), and comprehensive bench testing confirmed compatibility with the dialysis machine. While the sterilization method and specific dialysis machine model differ, performance testing demonstrated the subject device performs equivalently to the predicate with no new safety or effectiveness concerns raised.