Profoject™ Enteral Feeding Syringe

The Profoject™ Enteral Feeding Syringe is a single-use device available in sizes from 0.5 mL to 60 mL, designed to dispense, measure, and transfer fluids for oral or enteral delivery. It consists of a plunger, plunger stopper, and barrel with an ENFit connector, and is available in sterile (EO-sterilized to SAL 10⁻⁶) or non-sterile form with a 5-year shelf life.

The proposed device uses a polypropylene barrel with a purple-colored polypropylene plunger and polyisoprene rubber plunger stopper, whereas the predicate uses a white-pigmented plunger and silicone rubber piston. The proposed device offers additional size options (0.5 mL, 1 mL, 5 mL variants and expanded standard sizes) and omits the tip cap, relying instead on the barrel design to meet ISO 20695 requirements for graduated containers and pressure-creating means.

ISO 20695, ISO 7886-1, ISO 80369-1, ISO 80369-3, ISO 80369-20, ISO 11737-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-7, ISO 11135, ASTM F1886, ASTM F1140, ASTM F88, ASTM F1929, USP <62>, USP <71>, and ISTA 3A:2018.

Both devices share identical product codes (PNR), regulations (21 CFR 876.5980), device class (II), indications for use, single-use design, performance standards, sterilization method (EO to SAL 10⁻⁶), and biocompatibility profiles (no cytotoxicity, irritation, or sensitization). Material differences (plunger and plunger stopper composition) and design variations (omission of tip cap, expanded size offerings) do not raise new safety or effectiveness questions because the proposed device meets all applicable performance standards and biocompatibility requirements, and the tip cap is not a required component under ISO 20695.