Extension Feeding Set with ENFit™ Connectors

The Extension Feeding Set with ENFit™ connectors is a sterile, single-patient-use tube device intended as an extension set for Low-Profile Gastrostomy Replacement Tubes (G. Button). It delivers enteral nutrition from administration media via ENFit™ connectors and secure lock connectors to a gastric feeding device for a maximum of two weeks. It is used when patients cannot consume adequate calories orally due to underlying conditions and is indicated for adults and children older than one month.

The subject device comprises a hollow polyvinylchloride tube with an ENFit™ connector on one end (for connecting to administration media) and a secure lock connector on the other (for connecting to the gastric feeding device). Available lengths are 5 cm (2"), 30.5 cm (12"), or 61 cm (24"). The connectors are ENFit™ ISO 80369-3 compliant. Minor material differences exist in the ENFit™ connectors, tube, and clamp compared to the predicate, but these do not affect patient safety or effectiveness.

ISO 80369-3 for ENFit™ connectors. Testing included visual and dimensional inspection, small-bore connectors testing, leakage testing, tensile strength testing, clamp functionality, flow rate testing, gravity flow testing, packaging testing, and biocompatibility testing.

Both the subject and predicate devices serve the identical intended use as extension sets for gastric feeding tubes, delivering nutrition via ENFit™ connectors. The technological characteristics are substantially the same in design, material, and chemical composition; minor differences in material do not introduce new risks or affect device safety and effectiveness. Comprehensive nonclinical testing confirmed the subject device meets applicable standards and performs equivalently to the predicate, supporting substantial equivalence based on identical indications and demonstrated technological parity.