3DOSE 1ml Syringe

The 3DOSE 1ml Syringe is a sterile, single-use, disposable manual syringe intended for general-purpose fluid aspiration and injection by healthcare professionals. It is a piston syringe with a 1 ml capacity, Luer Lock nozzle, sterilized by ethylene oxide, with a 5-year shelf life.

The subject device differs from its predicate in three ways: (1) syringe volume is limited to 1 ml only, versus the predicate's range of 1–60 ml; (2) plunger material is polyacetal instead of polypropylene; (3) nozzle type is Luer Lock only, whereas the predicate offers both Luer Slip and Luer Lock. Most significantly, the subject device includes a ratcheting lock mechanism with locking arm and plastic housing that provides audible and tactile feedback during injection, which the predicate lacks.

ISO 7886-1:2017 (sterile hypodermic syringes for manual use), ISO 80369-7:2016 (small-bore connectors for intravascular applications), ISO 80369-20:2015 (connector test methods), ISO 11135 (sterilization validation), ISO 11607-1 and 11607-2 (sterile barrier systems), ISO 10993 series (biocompatibility), and USP <788> (endotoxins).

Although the subject device includes a novel ratcheting lock mechanism with audible/tactile feedback and uses polyacetal plungers instead of polypropylene, these differences do not raise new safety or effectiveness questions because: (1) the lock mechanism enhances ease of use but does not alter the fundamental operating principle; (2) in-process quality control testing confirmed the audio-tactile mechanism functions correctly without negatively affecting overall performance; (3) biocompatibility testing of the polyacetal plunger demonstrated safety; (4) both devices comply with identical performance standards (ISO 7886-1, ISO 80369); and (5) all other materials, sterilization methods, shelf-life, and intended use remain substantially identical.