(121 days)
The CORGRIP Nasogastric/Nasointestinal (NG/NI) Tube Retention System is indicated for use with CORPAK MedSystems enteral feeding tubes of 8 Fr and greater to prevent inadvertent removal or displacement of the tubes for adult patients.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called CORGRIP. It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter itself does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
Therefore, I cannot provide the requested information based on the text provided. The document confirms the FDA clearance but does not detail the technical performance studies that likely underpinned that approval.
§ 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.