(30 days)
This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to small bowel. This device is indicated for adult use only.
The subject device is packaged with: a nasal feeding tube, a nasal transfer tube, a wire guide, and two feeding adapters. The single lumen nasal feeding tube is composed of radiopaque polyvinyl chloride with ink markings that are endoscopically visible and assist with tube placement. The nasal feeding tube is available in two diameters, 8 Fr and 10 Fr. with a length of 240 cm and 10 feeding ports. The nasal transfer tube has a diameter of 14 Fr, is composed of clear PVC and is 20 inches in length. The wire guide is stainless steel coated with polytetrafluoroethylene (PTFE) and is 250 cm in length. Two feeding adapters are provided; one as a friction fit version and one ENFit compatible.
This document is a 510(k) Premarket Notification from the FDA for the Entuit Nasal Jejunal Feeding Tube. It focuses on establishing substantial equivalence to a predicate device, primarily due to the addition of an ENFit connector. The document does not provide information about clinical studies with acceptance criteria for device performance in the context of diagnostic accuracy, AI assistance, or human reader performance.
Therefore, I cannot populate the requested tables and information segments because they are related to clinical performance studies, often seen with AI/ML-based devices or diagnostic tools, which are not applicable to the information provided in this 510(k) summary for a medical device like a feeding tube.
The "Performance Data" section explicitly states: "Performance testing consisting of non-clinical bench testing demonstrates the subject device meets the performance requirements to fulfill the intended use." and "The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirms that the subject device performs as intended: ENFit Connector Testing per ISO 80369-3: 2016 and Design Verification of Feeding Adapters."
This indicates that the evaluation was based on bench testing for physical and mechanical properties, not clinical trials impacting accuracy or human performance.
§ 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.