(76 days)
The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to any enteral feeding device accepting standard enteral step connectors. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S
The provided document is a 510(k) clearance letter from the FDA for a medical device: CORFLO Anti-I.V. Enteral Feeding Extension Set Model# 20-1030AIV-LB-S.
**This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.
The letter is a regulatory document confirming that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new premarket approval application (PMA). This determination is based on the safety and effectiveness information submitted in the 510(k) premarket notification, but the letter itself does not describe the specific studies or data generated to support that substantial equivalence. These details would typically be found in the original 510(k) submission itself if it were publicly available.
Therefore, I cannot provide the requested table and information based on the text provided.
§ 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.