(57 days)
The CORTRAK 2 System is an electrical device designed to aid qualified operators in the placement of the CORPAK MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK 2 can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.
The CORTRAK 2 System is an electrical device.
This document is a 510(k) clearance letter from the FDA for the CORTRAK 2 Enteral Access Device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory obligations.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.