(75 days)
Not Found
Not Found
No
The summary describes a physical catheter device used for sampling and connecting to a monitor, with no mention of AI or ML capabilities in its function or analysis.
No
The device is described as being used for "determination of regional PCO2 (PrCO2) and intramucosal pH (pHi)" and for "feeding and/or decompression or aspiration". These are diagnostic and supportive functions, not therapeutic ones that treat or cure a disease.
Yes.
The device is used for the "determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue", which are measurements used to diagnose conditions like suspected mesenteric ischemia.
No
The device description clearly describes a physical catheter with lumens, a sampling line, and a biofilter, indicating it is a hardware device, not software-only.
Based on the provided information, the TRIP Tonometry Catheter, 14F is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- TRIP Tonometry Catheter Function: The description clearly states that the catheter is used as a "gastrointestinal tract access device" to connect to a monitor (Tonocap™) for the "determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue". This process involves measuring parameters in vivo (within the body) through direct access to the tissue.
- No Specimen Analysis: The device itself doesn't analyze a specimen outside the body. It facilitates the measurement of physiological parameters within the body.
While the measurements obtained (PrCO2 and pHi) are used for diagnostic purposes (suspected mesenteric ischemia), the device itself is a tool for in vivo measurement and access, not in vitro analysis of a specimen.
N/A
Intended Use / Indications for Use
TRIP Tonometry Catheter, 14F 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 a Tonocap™ monitor (Regional and Airway capnometer) . The sampling line and biofilter 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.
It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency/trauma patients and hospital patients with suspected mesenteric ischemia.
Product codes
78 KNT, 73 CCK, 73 CBR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric mucosal tissue, stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
and the control control of the control of the control of the control of the control of the contribution of the contribution of the contribution of the contribution of the con
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
DEC 1 5 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel C. Kent FDA Official Correspondent Manager, Quality and Regulatory Affairs Datex-Ohmeda, Inc. Three Highwood Drive Tewksbury, MA 01876
Re: K993296 TRIP Tonometry Catheter, 14F Dated: September 28, 1999 Received: October 1, 1999 Regulatory Class: Il 21 CFR §876.5980/Procode: 78 KNT 21 CFR §868.1400/Procode: 73 CCK 21 CFR §868.1700/Procode: 73 CBR
Dear Mr. Kent:
We have reviewed vour Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K993296
Device Name: TRIP Tonometry Catheter, 14F
Indications For Use:
TRIP Tonometry Catheter, 14F 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 a Tonocap™ monitor (Regional and Airway capnometer) . The sampling line and biofilter 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.
It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency/trauma patients and hospital patients with suspected mesenteric ischemia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 1 (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
(Division Sign-Off) (Division Sign-Off)
Division of Repreductive, Abdominal, ENT, and Radiological Device 510(k) Number .