(214 days)
Comparable to single tube Gastric lavage and stomach evacuator tubes.
Disposable, non-sterile tube for gastric lavage.
The lavage tube is used as a two way conduit from a lavage bag set to the stomach.
The tube is made of a flexible PVC that is easy to insert and comfortable for the patient. Water is released from a fluid source and flows into the stomach. The larger the tube, depending on patient age, the quicker the lavage can be completed. Once in the stomach, the water is drawn back up the tube and into a drainage bag. Pill fragments from the overdose are part of the discharged fluid. The extra port in the lavage tube simply allows better "back and forth" flow. This is done by allowing air to quickly replace the fluid drawn out during drainage.
The dual lumen lavage tube is an improvement to Ethox's current tubes to allow a quicker lavage. The extra lumen is a small diameter airway that acts as a vent allowing the lavage fluid in the main tube to pass in and out of the stomach without any "vapor lock" action.
This document is a 510(k) summary for a medical device called a "DUAL LUMEN GASTRIC LAVAGE TUBE". It is not a study demonstrating the performance of an AI/ML powered medical device against acceptance criteria.
Therefore, I cannot provide the requested information as it pertains to AI/ML device studies. The document describes a traditional medical device and its function, comparing it to existing similar devices. It does not involve algorithms, expert reviews, ground truth establishment, or any of the other criteria mentioned in your prompt that are specific to AI/ML powered devices.
§ 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.