BD Insyte™ IV Catheter

The BD Insyte™ IV Catheter is a peripheral intravenous catheter designed for short-term use in patients' peripheral vascular systems to sample blood, monitor blood pressure, or administer fluids. The device is available in multiple gauges (14–24 GA) with optional wings and includes a needle with flash chamber and removable vent plug. Certain gauges (22–18 GA) are rated for use with power injectors at up to 300 psi.

The subject device uses the same fundamental technology as the predicate: an over-the-needle intravascular catheter with BD Vialon™ catheter material, stainless steel needle, polypropylene needle cover, and polypropylene catheter hub. Catheter dimensions, sterilization method (ethylene oxide), shelf life (5 years), and materials composition are identical to the predicate. Updates include compliance with ISO 80369-7 instead of withdrawn ISO 594-1/594-2, and modifications to unit packaging materials (nylon thermoforming film for bottom web instead of copolymer resin).

ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 11607, ISO 10993-1/3/4/5/6/10/11/23, ISO 11135-1, ISO 14971, ASTM D4169, ASTM F1980, and USP <151>, <788>. Packaging validation per ISO 11607-1:2019 and biocompatibility per ISO 10993-1:2018 with FDA guidance from September 2023.

The subject device is substantially equivalent because it has identical intended use, same technological principles and materials as the predicate (K151698), and identical catheter dimensions and performance characteristics. All performance tests—including blood fill time, frequency response, catheter kink resistance, instaflash performance, power injection suitability, and comprehensive biocompatibility testing—met predetermined acceptance criteria, demonstrating continued safety and effectiveness equivalent to the predicate device.