Arisure® Closed Male Luer with Spike Adapter (YM060)

The Arisure Closed Male Luer with Spike Adapter is a sterile, single-use connector device that serves as an intermediary between an intravenous (IV) container and a standard IV administration set. It enables needle-free, drip-free fluid delivery from IV bags or rigid containers to a patient's vascular system, allowing preservation of the administration set when using multiple drug therapies.

The subject device extends the predicate Closed Male Luer by adding a Male Luer Lock Connector and an Extended Spike Adapter with a pierceable septum that interfaces with ISO 8536-4 standard IV set spikes. Both devices use identical plastic and elastomeric materials and maintain normally-closed valves at the CML end. The subject device is sterilized via E-beam irradiation (versus the predicate's Gamma irradiation) and has a 3-year shelf-life compared to the predicate's 1-year shelf-life.

ISO 8536-4:2019 (infusion sets), ISO 80369-7:2021 (small bore connectors), ISO 10993 series (biocompatibility), ISO 11137 series (radiation sterilization), ISO 11607 series (packaging), ISO 15747:2018 (plastic containers for IV injections), ASTM F1980-21 (accelerated aging), ASTM F88/F88M-21 (seal strength), IEC 62366-1:2020 (usability engineering), and ISO 22413:2021 (transfer sets).

The subject device is substantially equivalent because it retains the identical Closed Male Luer mechanism and principle of operation as the predicate, including the same materials, valve closure behavior, and bi-directional functionality. The additional spike adapter components at the distal end are a minor design extension that do not alter the core safety or effectiveness of the device; all performance testing (flow rate, leakage, separation force, microbial ingress, chemical compatibility, etc.) demonstrates equivalence to the predicate. Biocompatibility categorization and testing protocols are identical between devices, and the different sterilization method (E-beam vs. Gamma) achieves the same SAL of 10⁻⁶ using established, safe approaches.