safety lancet

The Safety Lancet (Model XXXVI) is a single-use medical device designed to collect capillary blood samples from patients. It is intended for use by healthcare professionals, patients, and lay persons, and is marketed over-the-counter. The device features an integral sharps injury prevention mechanism that retracts the needle after use.

The proposed device is substantially identical to the predicate device K240806 in all material respects. The only modification is the addition of a protective cap to the housing and button components (made of ABS, PS, PP, and calcium powder); all other components, materials (stainless steel needle with silicone oil, plastics), sterilization method (radiation at SAL 10⁻⁶), gauge ranges (16G–38G), shelf-life (5 years), design, and functionality remain unchanged.

ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2010 (skin sensitization and intracutaneous reactivity), ISO 10993-11:2017 (acute systemic toxicity and pyrogenicity), ISO 23908 (simulated clinical use), and FDA Guidance for Medical Devices with Sharps Injury Prevention Features (August 9, 2005). Biocompatibility evaluation followed the 2023 FDA Guidance on ISO 10993-1.

The device is substantially equivalent because it incorporates only cosmetic and dimensional changes (addition of a protective cap) from the predicate device K240806. All verification and validation testing confirmed the modified device meets the same performance specifications and safety standards, with no new risks introduced. The formulation, processing, sterilization geometry, and nature/duration of patient contact remain identical to the predicate, and simulated clinical use testing on 500 samples demonstrated the safety mechanism functions as required.