(43 days)
The Nutricare Clear feeding tube is intented for insertion into the alimentary canal of pediatric subgroups; Newborn (Neonate), Infant, Child, Adolescent) through either the nasal or oral cavity for the purpose of supplying fluids, medication or nutrition, for up to 30 days.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the Nutricare Clear-ISOSAF Nasogastric Feeding Tube does not contain information about an AI/ML medical device, its acceptance criteria, or the study proving its performance.
The document is a standard FDA clearance letter for a physical medical device (nasogastric feeding tube), outlining:
- The device name and its intended use.
- The regulatory classification and product code.
- Confirmation of substantial equivalence to a predicate device.
- General controls and other regulatory requirements applicable to the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in 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.