(301 days)
The Veritract Enteral Feeding Tube System is intended for use in those patients who require intermittent or continuous tube feeding via the nasogastric route. The vision and steering provided by the Veritract System is intended as an adjunct to current practices to aid qualified clinicians with experience in placing naso-enteric feeding tubes into the stomach or small bowel of patients requiring enteral feeding. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required prior to commencing administration. The Veritract Enteral Feeding Tube has not been tested for use longer than shortterm use (
Not Found
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "Veritract Enteral Feeding Tube System," which indicates that the device has been found substantially equivalent to a legally marketed predicate device.
The letter discusses:
- The device name, regulation number, and product code.
- The FDA's determination of substantial equivalence.
- General controls provisions and other regulations applicable to the device.
- Contact information for various FDA offices.
- The Indications for Use Statement (Section 4), which describes how the device is intended to be used, but not performance metrics or acceptance criteria from a study.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, ground truth establishment, MRMC studies, or standalone performance, as these details are not present in the provided document.
§ 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.