(147 days)
The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of feeding tubes of 8 FF or larger in the stomach or small bowel of patients requiring enteral feeding. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.
Not Found
This document is extremely limited in the information it provides regarding the acceptance criteria and study details. It is a 510(k) clearance letter for the CORTRAKT™ device and does not include the detailed study results or acceptance criteria.
Therefore, I cannot provide the requested information from the provided document. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics.
To answer your questions, one would need to review the actual 510(k) submission (K041987) which would contain the performance data and the specifics of the studies conducted. This document only serves as the FDA's clearance notice.
§ 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.