(63 days)
The CORFLO Anti-IV Enteral Feeding Extension Set is intended to be used to deliver enteral formula from the nutritional source to the Anti IV Enteral feeding tube. The CORFLO Anti-IV Enteral Feeding Extension Set is for pediatric and neonatal use only.
Not Found
I am sorry, but the provided text from the FDA 510(k) K083786 for the "CORFLO Anti-IV Enteral Feeding Extension Set" does not contain any information regarding acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
This document is a clearance letter for a traditional medical device (an enteral feeding extension set), not an AI/ML device. The letter focuses on:
- Substantial equivalence to a legally marketed predicate device.
- Regulatory classifications and general controls.
- Contact information for various FDA departments.
- Indications for Use.
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions you've asked (about sample sizes, ground truth, experts, MRMC studies, etc.) are highly specific to the evaluation of AI/ML algorithms, which is not applicable to this particular document.
§ 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.