Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single-use peripheral intravascular catheter designed for short-term venous access (less than 30 days) to sample blood, administer fluids, and perform high-pressure contrast injections up to 325 psi, as well as for short-term arterial use to monitor blood pressure and obtain blood samples. The device includes a passive needle safety mechanism to minimize sharps injuries and is available in 18 gauge with an 8 cm usable length.

The subject device differs from the predicate primarily in three areas: (1) shelf life reduced from 2 years to 6 months due to business needs; (2) catheter body material changed from Tecoflex to Quadraflex polyurethane with addition of an MDX silicone coating; and (3) minor design changes to the sidearm clamp (pinch vs. slide), juncture hub advancer (half-circle vs. round suture wings), and handle (added lower needle support, removed catheter release tab). All other characteristics including classification, intended use, insertion technique, principle of operation, and functional specifications remain identical.

The document cites ISO 10993-1 for biocompatibility assessment. Beyond that, specific test standards are not named; instead, the submission lists 33 bench tests performed (surface defects, wire guide advancement, MR compatibility, insertion force, flow rates, pressure injection, leakage, particulate analysis, etc.) to verify functional performance equivalence.

Substantial equivalence is established through identical intended use, indications for use, classification, and fundamental design and operation compared to predicate K163513. Although the subject device incorporates material and design modifications (different polyurethane type with silicone coating, modified clamp and hub design, altered shelf life), bench testing on all critical performance parameters demonstrates these differences do not introduce new safety or effectiveness concerns. The modified materials remain biocompatible per ISO 10993-1, and functional testing confirms equivalent performance in insertion force, flow rates, pressure injection capacity, and leakage characteristics. The design refinements (clamp type, hub geometry, handle features) do not affect the fundamental operation or clinical safety profile of the catheter.