(161 days)
This product must be used only under a doctor's prescription. Its indications for use are medical situations wherein the patient is nourished by an appropriate formula by various means passed into the stomach from the nasal passage. It is used for patients means of a taoo passod into the steman and to masticate or swallow food. The product is not for intravenous feeding.
The Enteral Nutrition device is equivalent to the RPI Enteral Feeding Bag, manufactured by Ridge Products, Inc., carrying 510(k) number K902641. The device is a common enteral feeding bag.
This K970849 submission for the "Enteral Nutrition" device, an enteral feeding bag and accessories, does not contain information about acceptance criteria or a study proving the device meets said criteria.
The submission explicitly states:
- "Clinical data is not needed for most devices cleared by the 510(k) process."
- The device is "identical to units on the market with the exception of our private label" and is "equivalent to the RPI Enteral Feeding Bag, manufactured by Ridge Products, Inc., carrying 510(k) number K902641."
This indicates that the device was cleared through the 510(k) pathway based on substantial equivalence to a predicate device, rather than through new performance studies with acceptance criteria. Therefore, the requested information categories cannot be filled from the provided text.
§ 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.