TSK Syringe

The TSK Syringe is a low dead volume piston syringe intended for injection and withdrawal of substances for examination, treatment, diagnosis, or prevention in patients. It comes in two sizes (0.7 mL and 1.0 mL) and is designed for manual use with a needle by healthcare professionals.

The TSK Syringe uses a copolyester barrel with an elastomer gasket and polypropylene plunger, incorporating silicone lubricant. It features a Luer-Lock tip, maintains dead space ≤0.023 mL, is gamma-sterilized with a 5-year shelf life, and includes a 0.7 mL size not present in the predicate. The predicate uses polypropylene barrel, rubber plunger, EO gas sterilization, and 3-year shelf life.

ISO 10993 series (biocompatibility including cytotoxicity, sensitization, hemolysis, pyrogenicity, irritation, acute systemic toxicity); ISO 7886-1:2017 and ISO 80369-7:2021 (hypodermic syringe and connector standards); ISO 11137-1:2006/Amd 2:2018 (sterilization validation); USP<788> (particulate matter); USP<85> (bacterial endotoxins); ISO 11607-1:2019 (packaging); ASTM standards for leak detection and accelerated aging.

The TSK Syringe is substantially equivalent because it shares the same regulatory classification, intended use, principle of operation, and dead space specification as the predicate device. Material differences (copolyester vs. polypropylene barrel, addition of silicone lubricant, gamma vs. EO sterilization) do not raise new safety or effectiveness questions, as demonstrated by comprehensive biocompatibility and performance testing per FDA-recognized standards. The smaller 0.7 mL size is established in the syringe classification. All testing confirmed the device met specified criteria without new safety concerns compared to the predicate.