SmartSiteTM Vented Vial Access Device

The 20mm SmartSite™ Vented Vial Access Device is a sterile, single-use, needle-free device that permits access to medication vials for reconstitution or dispensing. It is intended for use by healthcare professionals, patients, and caregivers in healthcare and home environments with standard 20 mm rubber-stopper medication vials. The device maintains drug sterility for up to 7 days in USP<797>-compliant compounding environments.

The subject device is identical to the predicate in all technical aspects: it features a dual-lumen vial spike for fluid and filtered air, a locking shroud with retention tabs, a SmartSite™ needle-free valve for Luer access, and a hydrophobic filter membrane. Both use the same polymeric (MABS) and elastomeric materials, identical principle of operation, and identical performance specifications. The only difference is more detailed Instructions for Use targeting lay users.

ISO 10993-1 (biocompatibility endpoints including cytotoxicity, irritation, sensitization, acute systemic toxicity, and hemocompatibility); ISO 8536-4:2019 and ISO 8536-10:2015 (chemical characterization testing for reducing oxidizable matter, metal ions, acidity/alkalinity, non-volatile residue, and UV absorption).

The subject device is substantially equivalent because it is physically and functionally identical to the predicate device with no changes to design, geometry, materials, technology, or principle of operation. Performance specifications are identical, and the predicate's test data apply in full. The expansion of intended users to include patients and caregivers in home environments, supported by human factors and usability studies, does not create new safety or effectiveness concerns. The only difference—improved Instructions for Use for lay users—does not alter device performance or safety profile.