Verifine Safety Lancets

The VeriFine Safety Lancet is a sterile, single-use, spring-loaded device designed for capillary blood sampling. It features a dual-spring mechanism where pressing a push button on top deploys a needle into the skin, which immediately retracts into a protective shield to reduce needlestick injury risk. The device is available in needle and blade types with multiple gauge and length options for different patient populations.

The subject device uses push-button activation compared to the predicate's pressure-against-finger activation. The shield material is polypropylene (PP) instead of acrylonitrile butadiene styrene (ABS). The subject device offers a broader range of needle gauges (17G–33G) and lengths (1.0–3.0 mm) compared to the predicate. Both devices employ the same dual-spring mechanism for needle deployment and retraction and are disposable, sterile, single-patient-use devices.

ISO 9626:2016 (physical characterization and mechanical testing), ISO 11137-1:2006 (sterilization validation), ISO 11137-2:2013 (sterilization validation), and USP-NF M98810_01_01. Testing included physical characterization, mechanical testing (bond strength, spring elasticity, puncture performance), corrosion resistance, and sterility testing achieving a sterility assurance level of 10⁻⁶.

The subject device has the same intended use as predicate K221368 for capillary blood sampling. Although technological differences exist in activation mechanism, shield material, and needle specifications, these differences do not alter the fundamental dual-spring operating principle or raise new safety and effectiveness concerns. Nonclinical performance testing demonstrated equivalent performance, establishing substantial equivalence.