Chemfort Female Luer Lock Adaptor

The Chemfort Female Luer Lock Adaptor is a single-use, sterile closed system transfer device that mechanically prevents the release of hazardous and antineoplastic drugs in vapor, aerosol, or liquid form during drug preparation and administration. It minimizes exposure to healthcare personnel and the environment while preventing microbial and airborne contaminants from entering the drug or fluid path for up to 7 days. The device connects male luer connections to Chemfort syringe adaptors and allows safe drug transfer between syringes or connection to IV sets.

The proposed device differs from the predicate device K192866 only in its luer connection type: this device has a female luer lock connection on the distal end (connecting to any standard male luer), whereas the predicate has a male luer lock connection (connecting to any standard female luer). Both devices use identical polypropylene and polyisoprene materials, employ the same septum-to-septum contact safety mechanism with mechanical snap connections, support up to 10 proximal reconnections, and are sterilized via ethylene oxide to SAL 10-6.

ISO 80369-7:2021 (small-bore connectors for intravascular applications), ISO 10993-1 through 10993-18 (biocompatibility evaluation), ISO 11135:2014 and ISO 11607-1:2019 (sterilization and packaging), ISO 14971:2019 (risk management), USP <788> (particulate matter), USP <85> (bacterial endotoxins), and USP <161> (transfusion and infusion assemblies).

The device is substantially equivalent because it shares identical indications for use, raw materials, principles of operation, technological features, and sterilization methods with the predicate device. The only difference is the luer connection gender (female versus male), but performance testing to ISO 80369-7:2021 demonstrates this difference does not raise new safety or effectiveness issues. All other design features, biocompatibility, manufacturing, and functional testing are equivalent to the predicate device.