(178 days)
The A.M.T. Low Profile Feeding Set Accessories are to be used with the Mic-Key Skin Level (low profile) feeding system gastrostomy devices in place of the Mic-Key" Secure-Lok feeding accessories. The purpose of the AMT Low Profile Feeding Accessory Feeding Devices are for administering feeding, medications, and when indicated, decompression.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Low Profile Feeding Set Accessory" and its accompanying "Indications For Use Statement." It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Medical devices like this typically undergo laboratory testing and performance evaluations, but the details of such studies are not present in these FDA documents.
Therefore, I cannot provide the requested information from the given input. The document is primarily an administrative letter confirming the device's substantial equivalence to a predicate device and its regulatory classification.
§ 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.