ProSeal™ Vented Universal Vial Adaptor

The ProSeal™ Vented Universal Vial Adaptor is a component of a closed system drug transfer device (CSTD) used for reconstitution and transfer of antineoplastic and hazardous drugs. It connects standard vials to ProSeal™ CSTD component devices via interface membranes, enabling closed-system fluid transfer while minimizing exposure to drug vapors, aerosols, and spills, and preventing microbial contamination for up to 7 days.

The subject device differs from the predicate (Arisure® CSTD Vial Adaptor) in several aspects: different material composition (polypropylene vs. ABS/polycarbonate for vial spike; polyisoprene vs. TPE for membrane), smaller overall dimensions, a finer air-vent filter (0.1 micron vs. 0.2 micron), different sterilization method (ethylene oxide vs. gamma), and compatibility with ProSeal™ Injector rather than Arisure™ Syringe Adaptor. Both employ dual-lumen spike design and double-membrane septum technology.

Testing conforms to ISO 8871-5:2016, ISO 8536-2:2010, ISO 8536-4:2019, ISO 22413:2010/2021, NIOSH 2016 CSTD protocol, ANSI AAMI CN27:2021, ISO 10993 series (biocompatibility), ISO 11135:2014 (EO sterilization), ASTM D4169-16, ASTM F1980-16, ASTM F88/F88M-21, ASTM F1929-15, EN 868-5:2018, and USP standards for pyrogens and particulates.

Material and dimensional differences do not raise new safety or effectiveness concerns because the subject device's polyisoprene membrane and polypropylene spike are identical materials used in the separately-cleared ToxiSeal™ Vial Adaptor (K241823), and biocompatibility and functional performance testing demonstrate equivalence. The finer 0.1-micron air-vent also matches the cleared ToxiSeal™ device and meets the same performance standards. Both devices employ identical closed-system mechanism (double-membrane with cannula perforation), achieve the same residual fluid levels (<0.05 mL), share equivalent biocompatibility classification, and maintain the same 36-month shelf-life and SAL 10⁻⁶ sterility assurance.