Small Volume 0.2mL Syringe

The Small Volume 0.2mL Syringe is a manual, single-use piston syringe intended for medical injection and withdrawal of fluids from the body. It features a polypropylene barrel, ABS plunger, TPE stopper, and Luer-lock connection to hypodermic needles. The device includes optional protective components (Luer cap and plunger shield) and comes in six models, three with enhanced dosing technology markings.

The device is a 0.2 mL syringe with Luer-lock connection, lower dead space (≤0.0058 mL vs. predicate's ≤0.023 mL), uses different materials (ABS plunger, TPE stopper vs. predicate's PP and rubber), includes optional protective caps and shields, and achieves lower total volume than the 1 mL predicate while maintaining the same sterilization method (EO gas, SAL 10^-6) and 3-year shelf-life.

ISO 7886-1 (syringe performance), ISO 80369-7 and ISO 80369-20 (Luer connector), ISO 10993-1 (biocompatibility: cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, pyrogenicity), ISO 11135 (sterilization validation), ASTM F1980 (accelerated aging), ASTM D4169-22 (shipping simulation), USP <788> (particulate matter), USP <85> (bacterial endotoxins), and ASTM F88/F88-15 and ASTM F1929-15 (seal strength and leak testing).

The device differs from its predicate (K210443) in syringe volume (0.2 mL vs. 1 mL), dead space specification (lower volume achieved), component materials (ABS and TPE vs. PP and rubber), and inclusion of optional protective components. These differences do not raise new safety or effectiveness questions because: (1) the smaller volume is accompanied by proportionally lower dead space, both meeting ISO 7886-1 performance requirements; (2) biocompatibility is demonstrated per ISO 10993-1 for all materials; (3) the protective caps and shields are discarded before use and do not affect mechanism of action; and (4) sterilization, shelf-life, and intended use remain identical.