ProSeal™ Transfer Injector (421120, 421130, 421140)

The ProSeal™ Transfer Injector is a fully encapsulated syringe unit with an integrated ProSeal™ Injector Plus connector permanently attached to prevent accidental disconnections. It is used as a component of the ProSeal™ Closed System drug Transfer Device (CSTD) to minimize worker and environmental exposure to hazardous and antineoplastic drugs by mechanically prohibiting environmental contaminants from entering and drug vapors from escaping the system.

The subject device differs from the predicate by including an attached hypodermic syringe barrel, plunger, and plunger stopper integrated with the injector, whereas the predicate device is the injector component alone without a syringe. Both devices share identical materials (POM, TPE, PC, PP, stainless steel, ABS), connection mechanisms (collet-style fitting with elastomeric membranes), needle-stick protection, sterilization method (ethylene oxide), and shelf-life (3 years).

ISO 7864:2016 (sterile hypodermic needles), ISO 7886-1:2017 (sterile hypodermic syringes), ISO 8536-4:2019 (infusion equipment), ISO 23908:2011 (sharps injury protection), ISO 80369-7:2016 (small-bore connectors), ISO 10993 series (biocompatibility), ISO 11135:2014 (ethylene oxide sterilization), ASTM D4169-16 (shipping), ASTM F1980-21 (shelf-life aging), and USP standards for particulate matter and pyrogens.

The ProSeal™ Transfer Injector is substantially equivalent to the ProSeal™ Injector Plus predicate because both devices share the same indications for use, product code (ONB), regulatory class (II), intended user population, drug type, and core technological characteristics. The addition of an integrated syringe does not raise new safety or effectiveness concerns, as comprehensive functional testing including syringe-specific tests (graduated capacity, plunger stopper design, dead space, leakage, and force requirements) demonstrate the subject device meets all applicable performance standards.