Verisafe Safety Retractable Insulin Syringes

The Verisafe Safety Retractable Insulin Syringes are sterile, single-use devices designed for aspiration and subcutaneous injection of insulin. After injection, the needle retracts into the syringe barrel via a spring-activated safety mechanism when the plunger is fully depressed, minimizing accidental needlestick injuries and exposure to contaminated needles.

Type 5 is a new syringe variant with a fixed needle, offered in 0.5 mL and 1.0 mL volumes with needle gauges 28G–32G and lengths 5–12 mm. The needle cap material changed from PP to PE for Type 5 and is color-coded (red for U40, orange for U100) per ISO 8537:2016 to indicate insulin concentration. The core retraction mechanism, materials (plastic, stainless steel, silicone), sterilization method (EO), and shelf-life (3 years) remain unchanged from the predicate.

ISO 9626, ISO 7864, ISO 8537, ISO 23908 (syringe performance); EN ISO 11135 (sterilization validation); ISO 10993 series (biocompatibility including cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogen, and particulate matter); ISO 10993-1:2018 (material biocompatibility assessment); USP <788> (particulate matter).

The subject device is substantially equivalent because it shares the same fundamental design, safety mechanism, principle of operation, and performance standards as the predicate device (K231792). Type 5 represents a narrowed indication (insulin only) and reduced specifications (smaller volumes and needle gauges) compared to the predicate, which do not introduce new risks. All verification and validation tests passed, confirming that modifications maintain safety and effectiveness without raising new effectiveness or safety questions.