Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

The Profoject™ Insulin Syringes and Profoject™ Safelock Disposable Insulin Syringe are sterile, single-use piston syringes designed for subcutaneous injection of U-40 and U-100 insulin in diabetes treatment. The Safelock variant includes a manually operated needle-stick prevention safety feature that guards against accidental needle sticks once activated.

The proposed devices differ from predicates in needle gauge/length (27G–31G vs. 32G–31G), lubricant composition (polydimethylsiloxane vs. aminofunctional siloxane), materials (stainless steel 304 needle tube, polypropylene barrel/plunger/hub vs. polyisoprene rubber piston in predicate), sterilization method for Safelock (EO vs. gamma radiation), and needle cap colors for U-40 insulin (red vs. orange only). All maintain SAL 10⁻⁶ sterilization.

ISO 7864, ISO 9626, ISO 8537, ISO 23908, ASTM F1886, ASTM F1140, ASTM F88, ASTM F1929, ASTM F756, USP <71>, <85>, <788>, ISO 10993 (biocompatibility parts 4, 5, 7, 10, 11, 23), ISO 11135, ISO 11607-1, ISTA 3A, and FDA guidance on sharps injury prevention features.

The devices are substantially equivalent because they share the same intended use, regulatory classification (Class II piston syringes under 21 CFR 880.5860), operating principle, and core design. Differences in needle gauge, lubricant, and materials do not raise new safety or effectiveness questions, as demonstrated by biocompatibility and performance testing per ISO 8537 and ISO 10993. The Safelock's sterilization method difference (EO vs. gamma) does not affect safety since both achieve identical SAL 10⁻⁶ sterility assurance levels.