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The TRIP Tonometry Catheter, 18F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter built into the device serve as a means of connecting the catheter to the TONOCAP™ monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. Since it incorporates a vented gastric sump it is also used for feeding and/or decompression or aspiration of the contents of the stomach. It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency / trauma patients and hospital patients with suspected mesenteric ischemia.

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The provided document is a 510(k) clearance letter from the FDA for the TRIP Tonometry Catheter, 18F. This type of letter confirms the substantial equivalence of a new medical device to a legally marketed predicate device. It does not typically contain detailed information about acceptance criteria or specific study results that prove a device meets those criteria.

Therefore, based solely on the provided text, I cannot extract the information required to populate the table and answer the study-related questions. The letter simply states that the device is substantially equivalent to pre-amendments devices for the indications for use stated in the enclosure.

To answer your questions, I would need to review the actual 510(k) submission document (K980384) which would contain the performance data and testing details.

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