BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

The BD Nexiva™ Diffusics™ Closed IV Catheter System is an over-the-needle peripheral intravascular catheter designed for short-term use to sample blood, monitor blood pressure, and administer fluids. It features a radiopaque BD Vialon™ catheter with three diffuser holes near the tip to optimize power injection procedures and includes BD Instaflash™ technology for flashback visualization. A variant model includes a BD MaxZero™ needle-free connector for additional safety.

Both subject devices are substantially identical to their predicates in fundamental design: closed peripheral intravascular catheter systems with integrated extension sets, single-port injection sites, and diffuser holes to reduce contrast media velocity during CT scans. Materials, catheter dimensions (18–24 GA, 0.75–1.25 or 1.75 inches), sterilization (ethylene oxide, SAL 1×10⁻⁶), and product configurations remain unchanged. Minor corrections were made to predicate descriptions (e.g., clarifying material suppliers) with no material formulation changes.

ISO 80369-7:2021 (small-bore connectors for intravascular applications), ISO 11607-1:2019-02 (packaging for sterilized medical devices), ASTM F2096-11 (gross leak detection by internal pressurization), and ASTM F88/F88M-15 (seal strength of flexible barrier materials). BD internal testing included frequency response, kink resistance, and blood fill time testing.

The subject devices achieve substantial equivalence because they maintain identical indications for use, fundamental closed-catheter technology, and all critical design parameters as their predicates (K173354 and K233529). Performance testing confirmed the devices meet predetermined acceptance criteria under all applicable standards and BD internal requirements. Packaging modifications and material supplier clarifications do not raise new safety or effectiveness questions, as demonstrated by passing all performance tests. The addition of 'monitor blood pressure' to the MaxZero variant's indications is supported by established evidence and does not introduce new risks, as confirmed by kink resistance and frequency response testing.