(459 days)
The Y2K2 Enteral Feeding Manager functions to provide enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. The device will accurately deliver small volumes enterally, and be capable of intermittently measuring residual volumes
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Y2K2 Enteral Feeding Manager". It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.
The letter is a regulatory approval document and not a performance study report. Therefore, I cannot extract the requested information.
To elaborate on why the requested information isn't available in the provided text:
- Acceptance Criteria and Reported Device Performance: This document is an approval letter, not a technical report detailing performance metrics.
- Sample size and data provenance for test set: Not mentioned.
- Number of experts and qualifications to establish ground truth for test set: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone algorithm performance: Not mentioned, and this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not mentioned.
- Sample size for training set: Not mentioned.
- How ground truth for training set was established: Not mentioned.
§ 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.