Lancing device (HH-XV-T)

The HH-XV-T is a spring-driven lancing device used with lancets to obtain capillary blood samples from fingertips, palms, or forearms for blood testing. It is a reusable, single-patient device with a service life of at least 3,000 uses and is available in two configurations: one for fingertip use only and one with a clear cap for expanded sampling sites.

The device is made of ABS, POM, PC, and PS plastics with a carbon steel spring. It features a cocking barrel with releasing button mechanism and penetration depths of 0.50–1.70±0.30 mm (fingertip configuration) or 3.2±0.30 mm (clear cap configuration). Overall length is 107 mm with specified diameter tolerances. The device is non-sterile and supports two cleaning methods: Super Sani-Cloth or Discide® Ultra Disinfecting Wipes.

Not stated in this summary.

The proposed device is substantially equivalent to predicate K243306 because it shares the same fundamental spring-driven technology, materials, mechanical firing function, and performance characteristics. The expanded indication for use and additional disinfection method do not alter device design or performance specifications. All verification and validation testing confirmed no new safety or effectiveness concerns, including penetration depth verification, simulated use testing, and disinfection compatibility validation.