(83 days)
A non-IV connector for use with Infant Feeding tubes that are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to
The proposed modification to Infant Feeding Tube is to change the fittings from a standard slip fit luer to a non-IV (luer) size connector. The feeding tubes are a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile. We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of a kit.
The provided text describes a 510(k) premarket notification for a medical device called "Infant Feeding Tube with Non-IV fittings". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria in the context of an AI/ML medical device.
Therefore, the input does not contain the information requested for an AI/ML medical device study, such as acceptance criteria in the form of metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.
The document is a regulatory submission for a physical medical device (an infant feeding tube) that has been modified to change the connector type. The "performance" section explicitly states "None under Section 514", indicating that specific performance data (like clinical trials or performance assessments with acceptance criteria) were not required for this type of submission. The comparison is primarily focused on design features, indications for use, and materials to establish substantial equivalence.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.