Sparta Infusion Set for Insulin

The Sparta Infusion Set for Insulin is a sterile, single-use subcutaneous infusion set that delivers insulin from an external portable pump to patients. It consists of a 6 mm, 90° soft cannula inserted via a preloaded mechanical inserter, connected to a 23-inch tubing set that terminates in a Luer connector. It is indicated for subcutaneous insulin infusion in adult and pediatric users weighing greater than 10 kg, for single use up to 72 hours.

The Sparta set uses a polypropylene cannula (versus PTFE in the predicate) and requires a simplified 4-step insertion procedure (versus 5 steps in the predicate). Both devices feature 6 mm, 90° cannulas, automatic needle retraction, preloaded inserters, transparent tubing, non-woven adhesive, EO sterilization at 10⁻⁶ SAL, and up to 72-hour wear duration. The Sparta tubing length of 23 inches (58.4 cm) falls within the predicate's range of 46–110 cm.

ISO 10993-1:2018 (biocompatibility), ISO 11135:2014+A1:2018 (EO sterilization), ISO 11138-1:2017 and ISO 11138-2:2017 (biological indicators), ISO 11737-1:2021 and ISO 11737-2:2019 (sterility testing), ANSI/AAMI ST72:2019, ASTM F1980-16 (shelf life), ISO 10993-7:2008+A1:2019 (sterilization validation), ISO 11607-1:2019 (packaging and sterility), ISO 62366:2020 (human factors), and FDA guidance on biocompatibility and usability engineering.

Both devices share identical intended use (subcutaneous insulin delivery via external pump), the same regulatory classification (21 CFR 880.5440, Class II), and fundamental operating principles. Material differences (polypropylene vs. PTFE cannula, simplified insertion steps, slightly shorter tubing) are minor and do not raise new safety or efficacy concerns; human factors testing confirmed the simplified procedure is safe and effective. Biocompatibility testing, bench performance testing, sterilization validation, and performance across leak resistance, insertion, needle safety, and occlusion all support equivalence. The subject device's user population (>10 kg, adults and pediatrics) is fully covered by the predicate's user population for medication infusion.