Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

The Microliter Dosing Syringe is a single-use, manually operated piston syringe available in six sizes (9, 20, 25, 37.5, 50, and 100 microliter models) intended to inject fluid into or withdraw fluid from the body. It is specifically indicated for intravitreal use in ophthalmology and is sterilized by electron-beam irradiation.

The subject device uses a cyclic olefin polymer barrel, polycarbonate plunger rod with glass fiber, and chlorinated butyl rubber plunger stopper with fluoropolymer coating. It has a Luer lock connector, 0.35 mL syringe volume, 2-year shelf life, and ±3 µL target dose accuracy. The predicate uses polypropylene barrel, polyethylene plunger, polyisoprene stopper, pre-attached needle, 0.25 mL volume, and 1-year shelf life, with ethylene oxide sterilization rather than electron beam.

ISO 7886-1 (piston syringe performance), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis), USP <788> and <789> (particulate matter testing), USP <85> (endotoxin testing), and ASTM F756 and F1980-21 (blood compatibility and shelf life stability).

Although materials, volumes, shelf life, connector type, and sterilization method differ from the predicate, these differences do not raise new safety or effectiveness questions because: (1) comprehensive biocompatibility testing per ISO 10993-1 demonstrates equivalent biological safety with no evidence of cytotoxicity, sensitization, or irritation; (2) performance testing per ISO 7886-1 and USP standards confirms equivalent functional characteristics; (3) endotoxin testing confirms suitability for ophthalmic use; and (4) electron-beam sterilization achieves the same 10⁻⁶ sterility assurance level as ethylene oxide. The intended use, mechanism of action, and target population remain identical to the predicate.