(57 days)
The TRIP® Tonometry Catheter, 8F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric or colonic mucosal tissue when used as a gastrointestinal tract access device for connecting a Tonocap™ monitor (Regional and Airway capnometer) . The sampling line and biofitter built into the device serve as a means of connecting the catheter to the monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. It incorporates a second lumen used for feeding and/or decompression or aspiration of the contents of the stomach or colon.
It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency/trauma patients and hospital patients with suspected mesenteric ischemia.
The TRIP® Tonometry Catheter, 8F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric or colonic mucosal tissue when used as a gastrointestinal tract access device for connecting a Tonocap™ monitor (Regional and Airway capnometer) . The sampling line and biofitter built into the device serve as a means of connecting the catheter to the monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. It incorporates a second lumen used for feeding and/or decompression or aspiration of the contents of the stomach or colon.
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "TRIP® Tonometry Catheter, 8F". It describes the device's intended use and FDA's determination of substantial equivalence to predicate devices.
However, this document does not contain any information about acceptance criteria or a study proving the device meets said criteria. It is a regulatory notification, not a technical report or study summary. Therefore, I cannot extract the requested information from 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.