(30 days)
The Flexiflo/ROSS Enteral Feeding Tube is intended for nasoenteric placement into the stomach or small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. This device is also indicated for small bowel feeding of patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The tube may also be used for gastric decompression or evacuation of gastric contents.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Flexiflo/ROSS Enteral Feeding Tube. This document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.
The letter primarily focuses on:
- Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices. This means it has similar indications for use and technological characteristics to a device already on the market.
- Regulatory Classification: The device is classified as Class II, under 21 CFR §876.5980, with Procode: 78 KNT.
- Conditions for Marketing: It outlines the general controls provisions of the Act that the manufacturer must adhere to.
- Indications for Use (from the enclosure): The tube is intended for nasoenteric placement into the stomach or small bowel for enteral feeding in pediatric, adult, or elderly patients, and for gastric decompression or evacuation of gastric contents.
Therefore, I cannot provide the requested information as it is not present in the given document.
To answer your request, I would need a document that describes the specific performance study conducted for the Flexiflo/ROSS Enteral Feeding Tube, including its methodology, results, and the pre-defined acceptance criteria it aimed to meet.
§ 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.