BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter

The BD Insyte™ Autoguard™ Shielded IV Catheter (in three variants: standard, BC, and BC Pro) is an over-the-needle peripheral intravascular catheter designed for short-term blood sampling, blood pressure monitoring, and fluid administration. It incorporates an active needlestick safety mechanism that retracts the needle into the barrel when a button is depressed, and the BC variants include a blood control technology that prevents blood flow until a Luer connection is made. The 22–18 GA devices are suitable for use with power injectors up to 300 psi.

The subject devices achieve their intended use through the same fundamental technology and principles of operation as the predicate: a peripheral intravascular catheter with BD Autoguard™ Push-button Shielding Technology, BD Instaflash™ needle visualization, and (for BC variants) a one-time use blood control septum. All device dimensions, materials (polyurethane catheter tubing, polycarbonate components, stainless steel needle and spring), sterilization method (ethylene oxide), and color-coding schemes are identical to the predicate. The only material change is qualification of a new green pigment subsupplier for the catheter adapter, maintaining the same CAS number and concentration.

ISO 80369-7 (2021-05) for Luer connector testing; ISO 11607-1 (2019-02) for packaging of terminally sterilized medical devices; ASTM F2096-11 (Reapproved 2019) for detecting gross leaks in packaging; ASTM F88/F88M-15 for seal strength of flexible barrier materials; ISO 10993-1:2018 for biocompatibility evaluation; ISO 10993-5:2009 for in vitro cytotoxicity testing.

The subject device is substantially equivalent because it addresses the same indications for use (peripheral vascular access for sampling, monitoring, and infusion) and achieves identical intended purposes using the same technological principles as the predicate K201075. Performance testing demonstrates that the subject device meets all predetermined acceptance criteria for frequency response, kink resistance, blood fill time, catheter separation force, and Luer compatibility. The catheter dimensions, materials, and sterilization method are unchanged; the only modification (a new green pigment supplier) maintains identical CAS number and concentration with no impact on device performance or safety. Risk analysis confirmed that proposed modifications do not alter the safety or effectiveness profile.