(29 days)
The Monarch™ Transshaping Gastrostomy Tube is to be used as a percutaneous replacement gastrostomy tube for a patient with a well-established gastrostomy tract. This device will assist in providing nutrition by connection of an established stoma in a patient who is unable to consume nutrition by other means and allow for decompression of the stomach.
Monarch™ Transshaping Gastrostomy Tube
I am sorry. I cannot provide the information in the requested format based on the given input. The provided text is a regulatory clearance letter from the FDA (K012476 for the Monarch™ Transshaping Gastrostomy Tube), which does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on:
- Confirming substantial equivalence to a predicate device.
- Outlining regulatory compliance requirements (GMP, labeling, etc.).
- Listing the indications for use.
Therefore, I cannot fulfill your request for details on the device's acceptance criteria and the study proving it meets those criteria.
§ 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.