BD Cathena™ Safety IV Catheter

The BD Cathena™ Safety IV Catheter is an over-the-needle peripheral intravascular catheter intended for short-term use to sample blood, monitor blood pressure, or administer fluids. It includes a radiopaque catheter, passive safety needle shield, flash chamber, and is available with or without multi-access blood control technology and wings. The device is suitable for use with power injectors up to 325 psi.

The subject device uses identical fundamental technology to the predicate: a peripheral intravascular catheter with passive needlestick safety mechanism, multi-use blood control septum (optional), and BD Instaflash™ technology for flashback visualization. Primary material composition is substantially equivalent except for a new green colorant supplier (same CAS# and concentration) and a new needle lubricant supplier (same chemistry, molecular weight, and viscosity). All catheter dimensions, gauges, lengths, and product configurations remain identical.

ISO 11135 (sterilization by ethylene oxide), ISO 10993-7 (biocompatibility), ISO 80369-7 (small-bore connectors), and ISO 14971:2019 (risk management). Internal performance testing included frequency response, kink resistance, blood fill time, average system drag, air vent time, procedural leak time, and instaflash time.

The device is substantially equivalent because it has identical indications for use, identical fundamental scientific technology and operating principles, and identical catheter dimensions and configurations to the predicate device (K220584). The only material composition changes are supplier qualifications for the green colorant and needle lubricant, which maintain identical chemistry and specifications. Design verification testing confirmed these supplier changes do not affect device performance, and all performance testing met predetermined acceptance criteria, demonstrating functional equivalence to the predicate.