(78 days)
The EntraCare Gastrostomy Feeding Tube is indicated for use as a replacement gastrostomy tube in an established stoma tract for patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning stomach who require long term feeding support.
Not Found
This document is a 510(k) premarket notification for a medical device called the "EntraCare Gastrostomy Feeding Tube." It's a regulatory approval document from the FDA, not a study report or technical specification outlining acceptance criteria and performance data for a device.
Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from this document.
This document primarily states:
- The device name: EntraCare Gastrostomy Feeding Tube
- Its intended use: as a replacement gastrostomy tube in an established stoma tract for patients who cannot consume an adequate diet orally, and who have a functioning stomach requiring long-term feeding support.
- That the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
To provide the requested details, a different type of document, such as a validation study report, clinical trial results, or a technical design specification with performance data, would be needed.
§ 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.