(90 days)
The Vygon Neo-Sump is a collection and aspirate measuring device designed for the aspiration of the stomach contents in the newborn using wall line suction.
Not Found
This document is an FDA 510(k) clearance letter for the Vygon Neo-Sump, a collection and aspirate measuring device. It does not contain information about acceptance criteria or specific study details to prove the device meets those criteria.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This is a regulatory finding, not a performance study report.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- The number or qualifications of experts, or adjudication methods.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set or how its ground truth was established.
§ 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.