Heel Incision Safety Lancet (SteriHeel 2)

The Heel Incision Safety Lancet (SteriHeel 2) is a single-use medical device designed for capillary blood sampling from the heels of newborns, preemies, and toddlers. It consists of an outer cover, press carrier, and blade holder with an integrated blade that retracts after use for sharps injury prevention. The device is sterilized by radiation.

The subject device has a simplified three-component design (outer cover, press carrier, blade holder with blade) compared to the predicate's eight-component design. The subject device uses ABS, POM, and PE materials, while the predicate uses different material combinations. Incision dimensions differ slightly: the subject offers 0.65×1.40mm, 0.85×1.75mm, 1.00×2.50mm, and 2.00×3.00mm options, while the predicate includes 1.14×2.80mm as an additional option.

Biocompatibility testing followed FDA Guidance for Industry and ISO 10993-1 (Biological evaluation of medical devices - Part 1). Bench testing included assessment of puncture function, safety performance, cutting depth/width, hardness, surface roughness, corrosion resistance, and sharpness.

The device is substantially equivalent because it maintains the same intended use, regulatory classification (Class II), product code (FMK), sterilization method (radiation at SAL 10⁻⁶), and single-use design as the predicate. Although components and materials differ, all materials are established biocompatible materials used in similar devices. Incision dimension variations do not raise safety or effectiveness concerns and were verified through performance testing. Bench testing demonstrates equivalent performance in critical characteristics including puncture function, safety features, and cutting specifications.