VaporShield

The VaporShield is a sterile, single-use closed system transfer device (CSTD) consisting of a 1 mL syringe with a 22-gauge needle and pre-assembled drug vial holder. It is designed for healthcare professionals to draw medication from a drug vial and then inject hazardous or non-hazardous drugs subcutaneously or intramuscularly in adults and adolescents. The device includes an automatic needle retraction safety mechanism activated by full plunger depression to prevent needlesticks and device reuse.

The subject device differs from the predicate PowerPAK Syringe in several ways: it has a 1 mL volume versus 3 mL, includes a pre-assembled drug vial holder (which the predicate lacks), incorporates a non-venting retraction mechanism with vapor containment capability, and provides adjustable needle length exposure (0.5 or 0.75 inches) rather than fixed length. Both use the same syringe type, needle gauge, sterilization method, and shelf life, and both have manually activated safety mechanisms with re-use prevention features.

Testing included ISO 7886-1:2017 (syringe performance), ISO 7864:2016 (needle requirements), ISO 23908:2011 (needle safety mechanisms), ISO 7886-4:2018 (re-use prevention), ISO 10993 series (biocompatibility), ISO 10993-18:2020 (chemical characterization), ASTM F1140/F1140M-13 (pressure resistance), ASTM standards for packaging integrity, and the draft NIOSH Vapor Containment Performance Protocol for closed system transfer devices.

The VaporShield is substantially equivalent to the PowerPAK Syringe because both are Class II piston syringes with identical intended use for hazardous drug injection, same sterilization and shelf life, and equivalent performance on all core safety and functionality tests. Additional features like the drug vial holder, smaller volume, and vapor containment capability were demonstrated through performance testing to not raise new safety or effectiveness concerns compared to the predicate device.