SureFine Pen Needle

The SureFine Pen Needle is a sterile, disposable needle designed for subcutaneous insulin injection using a pen injector. It consists of a needle, hub, and shield assembly, offered in gauges 29G–32G and lengths 4mm–12.7mm, sterilized with ethylene oxide and claimed to have a 5-year shelf life.

The proposed device is identical to the predicate in components, needle gauges, and lengths. The primary differences are: (1) type of use expanded from prescription-only to both prescription and over-the-counter, and (2) shelf life increased from 3 years to 5 years, supported by shelf-life testing.

ISO 9626 (materials, cleanliness, dimensions, stiffness, corrosion resistance), ISO 11608-2 (needle performance including flow rate, hub-needle bond, needle point defects, and injector compatibility), ISO 10993-1 and related biocompatibility standards (cytotoxicity, sensitization, hemolysis, systemic toxicity, pyrogenicity), and ISO 11135 (sterilization validation).

The device is substantially equivalent because it is manufactured by the same company, shares identical intended use (subcutaneous insulin injection), has the same components and needle specifications as the predicate K152877, and passes all the same performance and biocompatibility test standards. The addition of over-the-counter use and extended shelf-life do not alter safety or effectiveness; the extended shelf life is validated by testing and does not raise new safety questions. The device differs only in regulatory labeling pathway and demonstrated durability, not in design or fundamental performance.