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The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician Intended for nasogastric or orogastric placement Lumited to

The proposed modification to Infant Feeding Tube and accessories is to add additional materials that the feeding tube may be made from, 1 e , silicone and polyurethane In addition, we offer accessories an enteral extension set and syringe with non-IV connector These may be sold with the Feeding tubes or separately There is an option of the connectors being standard IV luer lock or a special non-IV connector which was cleared under K072756

The feeding tubes are a small diameter tube of various diameters, 4, 5, and 8 French, and various lengths They have an integral female fitting There are 2 eyelets near the tup of the tube They have markings along the shaft of the tubing and an integral radiopaque line They are provided sterile We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of the package, which was also cleared under K072756

The provided text is a Premarket Notification 510(k) Summary for the SafeChild Infant Feeding Tube and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with specific acceptance criteria and outcome metrics.

Therefore, the document does not contain information on an acceptance criteria table, reported device performance, sample size for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for "the device."

The entire document describes the device, its indications for use, and then compares it to existing predicate devices to show it is substantially equivalent. The "Performance" section within the comparison to predicate devices explicitly states "None under Section 514," which refers to performance standards rather than a clinical or analytical performance study. This indicates that a study demonstrating unique acceptance criteria and performance for this specific device was not required or provided for this 510(k) submission.

The comparison table provided in the document is used to demonstrate substantial equivalence to predicate devices, not to report on an independent performance study against acceptance criteria.

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