Insulin Syringes

The Insulin Syringes are sterile, single-use syringes available in 0.3 mL, 0.5 mL, and 1.0 mL volumes designed for subcutaneous injection of U100 or U40 insulin. They consist of a graduated barrel, plunger rod, and needle/hub assembly in various needle gauges (25G–31G) and lengths (6 mm, 8 mm, 12.7 mm). The device is indicated for both prescription and over-the-counter use.

The subject device maintains identical design, materials, and sterilization method to the predicate: graduated barrel, plunger rod, and needle/hub assembly made of polypropylene, polystyrene, polyethylene, and stainless steel 304, with medical-grade silicone lubricant and ethylene oxide sterilization to SAL=10⁻⁶. The primary differences are expanded needle gauge options (adding 25G, 26G, and 28G to the predicate's 27G, 29G, 30G, and 31G) and new syringe/needle size combinations, all within established FDA-cleared ranges.

ISO 8537 (sterile single-use insulin syringes), ISO 7886-1 (sterile hypodermic syringes for manual use), ISO 9626 (stainless steel needle tubing), ISO 7864 (sterile hypodermic needles), ISO 11135 (ethylene oxide sterilization validation), and ASTM F1980-16 (accelerated aging of sterile barrier systems). Biocompatibility conforms to ISO 10993-1.

The subject device is substantially equivalent because it uses identical design principles, materials, sterilization methods, and biocompatibility standards as the predicate K201044. The new needle gauge sizes (25G, 26G, 28G) fall within FDA-cleared ranges established for similar devices such as the BD Eclipse Hypodermic Needle (K161170, ranging 18G–30G for general injection use), and other insulin syringes with the same indicated use include both prescription and over-the-counter options. Expanded packaging and size options do not introduce new safety or effectiveness concerns compared to the predicate, as they involve the same intended use and target population under the same treatment method.