OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)

The OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) is a short-term intravascular catheter designed for blood sampling, blood pressure monitoring, or intravenous fluid administration. It features a closed system that contains blood during insertion to prevent exposure, and is compatible with power injectors rated up to 325 psi when connected to a male luer lock.

The subject device is similar to the predicate in being a short-term, radiopaque, disposable peripheral catheter with integrated needle shielding, extension tube, pinch clamp, and porous vent plug. The key difference is the addition of a pink wire slider, wire slider track, and stainless steel guidewire mechanism that advances the catheter through the needle and is removed after deployment. Catheter length is 3.25 inches versus 1.37 inches in the predicate, with slightly larger outer and inner diameters.

ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 80369-20, ISO 8536-8, ISO 7864, ISO 9626, ISO 8536-4, ISO 23908, ISO 11070, ISO 10993 series (parts 3–6, 10–12), ISO 14937, AAMI TIR56, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F1886, ASTM F2096, ASTM F1929, ASTM F88, and USP <788>.

The subject device shares the same indications for use, classification, regulatory requirements, and core design principles (catheter-through-needle, spring-loaded needle retraction, integrated extension tube, power injector compatibility) with the predicate K231626. Although it adds a guidewire-slider mechanism for ease of deployment, the materials of construction for all new components are identical to or compatible with the predicate, and biocompatibility testing per ISO 10993-1 confirmed no additional safety or effectiveness concerns. The longer catheter length and modified deployment procedure do not raise different questions of safety or effectiveness compared to the predicate's intended use.