Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)

The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single-use peripheral intravascular catheter for short-term venous and arterial access (less than 30 days). It allows blood sampling, fluid administration, high-pressure contrast injections up to 325 psi, arterial blood pressure monitoring, and includes a passive needle safety feature to minimize sharps injury risk.

The subject device differs from its predicate in several design elements: catheter body material (Quadraflex Polyurethane with silicone coating versus Tecoflex Polyurethane without coating), shelf life (6 months versus 2 years), sidearm clamp design (pinch versus slide), juncture hub advancer geometry, handle design features, and gauge availability (20 and 22 gauge only, versus 18, 20, and 22 gauge). Core functionality, insertion technique, principle of operation, needle safety mechanism, pressure limits, and sterilization method remain identical.

ISO 10993-1 biocompatibility standard cited for material assessment. The document does not cite specific testing standards for performance validation; instead, it references proprietary bench testing protocols (pressure injection, insertion force, flow rate, kink resistance, etc.) without reference to published consensus standards like ASTM or IEC.

Substantial equivalence is established because all design differences are non-functional or have been demonstrated through bench testing to cause no new safety or effectiveness concerns. The material changes (Quadraflex polyurethane with silicone coating and shorter shelf life) are supported by biocompatibility and bench testing showing equivalent performance. Gauge reduction (removal of 18 Ga) is a narrower product line, not a safety issue. Design refinements (clamp type, handle features, hub geometry) represent manufacturing improvements without altering the fundamental insertion technique, operational principle, or clinical performance. The predicate device already cleared for the same indications provides the safety and effectiveness baseline.