(88 days)
The AMT T-Fastener Anchor Kit is to be used to affix the gastric wall to the anterior abdominal wall for formation of a new stoma tract and subsequent placement of a percutaneous gastrostomy device. Gastropexy during initial placement of a percutaneous gastrostomy device may be indicated for patients with a functioning gut who require long-term tube feeding. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
Not Found
I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device (AMT T-Fastener Anchor Kit), which indicates the device is substantially equivalent to legally marketed predicate devices.
While it mentions the device and its intended use, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details).
This type of information is typically found in the scientific and clinical sections of a 510(k) submission, which are not provided in this document. The letter itself is a regulatory outcome, not the study report.
§ 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.