(486 days)
To provide nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means.
Not Found
This FDA letter is a 510(k) clearance for a medical device (AMT G-Tube Balloon Replacement Gastrostomy Tube), not a study report. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or other details typically found in a study proving a device meets acceptance criteria.
The letter primarily states that the FDA has reviewed the manufacturer's notification and determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar indications for use and technological characteristics to a device already on the market and does not raise new questions of safety and effectiveness.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report. This 510(k) clearance letter does not provide the requested information.
§ 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.