Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

The Profoject enteral/oral feeding syringe product line comprises disposable and reusable syringes with ENFit connectors for delivering fluids orally or enterally, plus optional ENFit adaptors and tip caps. Devices are available in sizes from 0.5 mL to 60 mL in sterile and non-sterile forms, intended for use by clinicians and laypersons in clinical and home settings across all age groups.

Proposed devices feature polypropylene barrels with ENFit connectors compliant with ISO 80369-3, plungers with gasket or stopper designs, and optional syringe caps and adaptors. Main differences from predicates include expanded size ranges (0.5–60 mL vs. predicate ranges), reusable models with O-ring gaskets, additional syringe cap models, and 5-year shelf life (vs. 3 years for adaptor predicate). All are sterilized by ethylene oxide to SAL 10⁻⁶.

ISO 20695 (enteral feeding systems design and testing), ISO 7886-1 (sterile syringes), ISO 80369-1, 80369-3, and 80369-20 (small-bore connectors), ISO 11737-1 (sterilization validation), ISO 10993 series (biocompatibility), ISO 11135 (EO sterilization), ASTM F88, F1140, F1886, F1929, and ST98 (seal and packaging testing).

The proposed devices are substantially equivalent because they comply with the same regulatory classification (Class II, 21 CFR 876.5980), product codes, and indications for use as their predicates (K183540, K140581, K152857). Non-clinical testing demonstrates equivalent safety, biocompatibility, and performance per applicable ISO standards; differences in size range, configuration, and materials do not raise new safety or effectiveness concerns given successful validation testing.