(174 days)
This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to the small bowel. The device is supplied sterile and is intended for single use only.
The proposed Nasal Jejunal Feeding Tube is a single lumen, radiopaque PVC tube. The 8Fr and 10Fr diameter tubes are intended to be introduced endoscopically and are supplied with a wire guide. The 14FR tube with flaps is intended to be introduced manually in conjunction with peristalsis into the jejunum. The distal portions of all tubes have feed ports for delivery of liquid nutrition and/or medication. All tube kits include a nasal transfer tube and feeding adapters.
The provided text is a 510(k) Summary for the Wilson-Cook Nasal Jejunal Feeding Tubes. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria, detailed study designs, performance data (other than a general statement of "performance characteristics tested"), sample sizes, or expert involvement.
Therefore, I cannot provide the requested table and information based on the given text.
The only "performance data" mentioned is:
"We believe the proposed device to be substantially equivalent to the named predicate based on performance characteristics tested." This statement is too vague to extract any specific acceptance criteria or study details.
In summary, the document lacks the necessary information to answer your questions thoroughly.
§ 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.