Nutrifit

Nutrifit is a system of feeding tubes and extension sets designed for nasogastric or oralgastric enteral nutrition in adults and children. The tubes are single-use, disposable devices available in multiple lengths (40, 50, 75, 90, 125, and 160 cm) and materials (PVC or polyurethane). They incorporate safety connectors to prevent accidental intravenous administration through the feeding tube.

Nutrifit shares similar technological characteristics with the predicate device Nutrisafe 2, including PVC feeding tubes, polyurethane feeding tubes, extension line sets, and accessory components. The proposed device includes additional lengths of feeding tubes and extension sets compared to the predicate. All tubes feature centimeter numerical markings and are ENFit-compliant per ISO 80369-3 for small-bore connectors on enteral medical devices.

ISO 80369-3 (small-bore connector design and functional performance for enteral devices); ISO 14971:2019 (Risk Management Application to Medical Devices); FDA guidance on Gravity Flow Rate Testing in Enteral Tubes. Bench testing included resistance to separation, disconnection, fluid leakage, stress cracking, and axial load per ISO 80369-3 specifications.

Nutrifit is substantially equivalent because it shares the same technological characteristics and indications for use as Nutrisafe 2. Although Nutrifit offers additional tube lengths and extension set configurations, these design differences do not introduce new safety or efficacy issues, as demonstrated by bench testing showing conformance to ISO 80369-3 and risk management assessment per ISO 14971:2019. All tests met acceptance criteria with no safety concerns raised, confirming the device performs as intended and maintains substantial equivalence to the predicate.