Sure-Fine Insulin Syringes

Sure-Fine Insulin Syringes are hypodermic syringes designed for subcutaneous injection of U-100 insulin. The device consists of a graduated barrel, plunger rod, needle cap, protective end cap, and a permanently affixed needle. Available in multiple configurations with needle gauges from 27G to 31G and lengths from 1/4" to 1/2", and syringe volumes of 0.3cc, 0.5cc, and 1.0cc.

The proposed device is identical to the predicate in overall design, materials, and sterilization method. The key difference is that the proposed device includes three additional needle gauge/length combinations (27G 5/16", 28G 5/16", and 29G 5/16") compared to the predicate device K210848, providing expanded clinical options while maintaining the same underlying syringe and needle component design.

ISO 7864 (needle cleanliness, size, tolerances, defects, lubricant, point, patency, bond strength); ISO 9626 (needle materials, surface finish, cleanliness, acidity/alkalinity, dimension, stiffness, breakage resistance, corrosion resistance); ISO 8537 (syringe plunger design, piston fit, leakage); ISO 10993-1:2018 biocompatibility suite (cytotoxicity, hemolysis, intracutaneous reactivity, skin sensitization, acute/sub-acute systemic toxicity, pyrogenicity); ISO 11135:2014 (E.O. gas sterilization validation); ISO 11607-1:2006 and ISO 11607-2:2006 (shelf-life testing for 5 years).

The proposed device is substantially equivalent to predicate K210848 because both devices share identical syringe design, materials (polypropylene barrel/plunger, TPE piston, stainless steel needle), biocompatibility profiles, sterilization methods, and indications for use. The only difference—additional needle configurations—does not raise new safety or effectiveness questions, as the needle components conform to the same FDA-recognized standards (ISO 7864, ISO 9626) and the configurations are widely used clinically. All performance and biocompatibility testing meets acceptance criteria.