Safety lancet (XXXVII)

The Safety Lancet (XXXVII) is a single-use medical device designed for capillary blood sampling. It is intended for use by healthcare personnel, patients, and lay persons for collecting blood samples for diagnostic purposes.

The proposed device uses a dual-spring internal configuration for needle activation and retraction, whereas the predicate device uses a single-spring configuration. Both devices have identical intended use, user interface, operating steps, needle gauges (16G–38G), materials (stainless steel needle with silicone oil, ABS/PS/PP housing), sterilization method (radiation to SAL 10⁻⁶), and 5-year shelf-life.

ISO 13485 (Quality Management System), ISO 10993 series (biocompatibility including ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization/irritation, ISO 10993-11 systemic toxicity and pyrogenicity), ISO 23908 (sharps injury prevention), and FDA Guidance on Medical Devices with Sharps Injury Prevention Features (August 9, 2005).

The proposed device is substantially equivalent to predicate K240806 because both devices have identical indications for use, materials, sterilization methods, and performance specifications. Although the internal spring mechanism differs (dual vs. single), non-clinical performance testing and simulated clinical use testing demonstrated that the proposed device performs equivalently and does not raise new safety or effectiveness concerns.