SURFLO Hybria Closed System Safety IV Catheter

The SURFLO Hybria Closed System Safety IV Catheter is an over-the-needle intravascular catheter intended for short-term peripheral vascular access to sample blood, monitor blood pressure, or administer fluids in any patient population. It features a safety shield that covers the needle tip after blood return is visualized, a closed design to prevent blood leakage, and a pre-attached needle-free connector (in some configurations). When used with a power injector, the needle-free connector must be removed and the maximum pressure limit is 325 psi (2.24 MPa).

Both the subject device and predicate (BD Nexiva Closed IV Catheter System, K102520) are manual over-the-needle catheters with identical design/construction per ISO 10555-1, same catheter gauges (18G, 20G, 22G, 24G), EO sterilization to SAL 10-6, 3-year shelf life, and MR Conditional status. Material differences exist (subject uses polycarbonate catheter hub vs. predicate's copolyester; subject safety shield is stainless steel vs. predicate's polycarbonate + stainless steel), but biocompatibility and chemical characterization testing confirmed no new safety concerns. The subject device specifies a 325 psi maximum pressure versus the predicate's 300 psi, aligned with clinically used power injectors.

ISO 10555-1 (intravascular catheter design), ISO 11135:2014 (EO sterilization), ISO 10993-1 to -23 (biocompatibility), ASTM F2052-21 (magnetically induced displacement force), ASTM F2213-2017 (magnetically induced torque), ASTM F2119-07(2013) (MR image artifacts). Testing performed at t=0 and t=36 months accelerated age.

The SURFLO Hybria Closed System Safety IV Catheter is substantially equivalent to BD Nexiva in intended use, technology/principle of operation, materials, and performance. Both are short-term peripheral IV catheters with identical design, construction standards, sterilization methods, and shelf life. Material differences do not raise new safety or effectiveness questions based on completed biocompatibility and performance testing. The 325 psi vs. 300 psi pressure difference aligns with real-world power injector specifications and does not create new safety concerns. Comprehensive non-clinical testing including MRI compatibility and biocompatibility throughout shelf life supports substantial equivalence.