ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

The ProSeal™ Bag Spike with Additive Port is a closed system transfer device (CSTD) component that connects intravenous bags to ProSeal™ CSTD components, enabling safe closed-system fluid transfer of parenteral drugs. It has two ports: a closed-system injection site for medication addition via ProSeal™ Injectors, and a spiking port compatible with standard IV spikes and administration sets. The device prevents environmental contamination entry, drug vapor escape, and microbial ingress for up to 7 days.

The subject device differs from the predicate by adding a third access point—a spiking port with a thermoplastic elastomer (TPE) stopper for connection to standard IV spikes, whereas the predicate has only two access points. Both use collet-style fittings with elastomeric double membranes, polyisoprene injection site membranes, and polypropylene spike ports. Both are single-use, sterile, ethylene oxide sterilized, have 3-year shelf lives, and use identical sterilization and packaging methods.

ANSI AAMI CN27:2021 (Luer activated valves); ISO 8536-4:2019 (infusion sets); ISO 15747:2018 (plastic containers); ISO 22413:2010 (transfer sets); ISO 80369-7:2016 (small-bore connectors); ISO 10993 series (biocompatibility); ISO 11135:2014 (ethylene oxide sterilization); ASTM D4169-16 (shipping); ASTM F1980-21 (accelerated aging); ASTM F88/F88M-21 (seal strength); ASTM F1929-23 (dye penetration); USP <788> (particulate matter).

The subject device is substantially equivalent because it shares identical indications for use, intended user population, drug type, regulatory classification, and all critical performance characteristics with the predicate. The addition of a spiking port does not raise new safety or effectiveness concerns because: (1) the same TPE stopper material is used in the cleared K223674 device; (2) extensive bench testing on the subject and referred-to devices confirms leak integrity, tensile strength, flow rate, and microbial ingress prevention; (3) biocompatibility testing on component materials (isoprene, polypropylene, TPE) was completed on predicate and cleared devices; and (4) the functional difference merely expands compatibility to standard IV spikes without compromising the closed-system barrier mechanism.