BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)

The BD PhaSeal™ Optima Connecting Set (C83-O) and Spike Set (C180-O) are sterile, single-use closed system drug transfer devices (CSTDs) designed to safely prepare and administer hazardous parenteral drugs in healthcare settings. They mechanically prevent environmental contaminants from entering the system and block drug vapor escape, while preventing microbial ingress for up to 168 hours through self-sealing elastomeric double membranes.

Both subject devices use collet-style fittings with elastomeric double membranes for drug transfer, Luer lock connectors for external devices, and ethylene oxide sterilization (SAL 10⁻⁶). The Connecting Set interfaces with the patient IV line via an Infusion Adapter Port (same technology as predicate), while the Spike Set is a bag access device. Duration of use is up to 168 hours and/or 10 membrane penetrations, with injector continuous use not exceeding 24 hours when paired with other devices.

ISO 8536-4:2019 (infusion sets), ISO 80369-1:2018 and ISO 80369-7:2021 (small-bore connectors), ISO 80369-20:2015 (connector test methods), ISO 11135:2014 and ISO 11737-1/2:2019 (sterilization and sterility), ISO 11607-1/2:2019 (packaging), ISO 10993-1:2018 (biocompatibility), and USP <788> (particulate matter); microbial ingress testing per FDA guidance from July 2008.

The subject devices have identical indications for use, sterilization method, and principle of operation as the predicate (K181221). Both use the same collet-style fitting mechanism with elastomeric double membranes, same duration limits (168 hours/10 penetrations), and same Luer lock standards. Minor differences in materials and specific mating components (e.g., Infusion Adapter Port vs. predicate's Luer Lock connection) do not change intended use or raise new safety concerns, as demonstrated by biocompatibility, particulate, and microbial ingress testing all meeting FDA-recognized consensus standards.