BD Nexiva™ Closed IV Catheter System

The BD Nexiva™ Closed IV Catheter System is an over-the-needle, peripheral intravascular catheter intended for short-term use to sample blood, monitor blood pressure, or administer fluids (single-port) or to sample blood or administer fluids (dual-port). It incorporates a radiopaque polyurethane catheter with integrated extension tubing, a closed needle-free system with blood-containment design, and pre-attached needle-free connectors in some configurations.

The subject device is substantially equivalent to its predicate in fundamental technology: both are closed peripheral intravascular catheter systems with integrated extension sets, single or dual-port injection sites, and Instaflash™ needle technology. Component materials, catheter dimensions (18–24 GA, 0.56–1.75 inches), product configurations, and sterilization method (ethylene oxide) are identical. The only material modification is the stainless steel needle grade, which does not raise new safety or effectiveness questions.

ISO 80369-7 (in place of previous ISO 594-1 and ISO 594-2 standards), ISO 11607-1, plus performance testing for Frequency Response, Kink Resistance, and Blood Fill Time.

The subject device meets substantial equivalence because it maintains identical indications for use (with clarifying addition of "peripheral" and narrowing of dual-port IFU to exclude blood pressure monitoring), uses the same technological principles and component materials as the predicate, and demonstrates compliance with the same or updated consensus standards (ISO 80369-7). Performance testing confirms the device meets all predetermined acceptance criteria. The modifications (performance specification refinements and narrowed IFU scope) do not introduce new safety or effectiveness questions and remain within the predicate's intended clinical function.