(88 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on its function as a catheter for measuring physiological parameters and providing gastric access.
No
Explanation: The device is described as being used for the determination of regional PCO2 and intramucosal pH, as well as for feeding and/or decompression or aspiration of stomach contents. These functions are diagnostic and supportive, not therapeutic.
Yes
Explanation: The device is described as being used for "determination of regional PCO2 (PrCO2) and intramucosal pH (pHi)", which are measurements used to diagnose conditions like suspected mesenteric ischemia.
No
The device description explicitly mentions a "TRIP Tonometry Catheter, 18F" and describes physical components like a sampling line, biofilter, and vented gastric sump, indicating it is a hardware device.
Based on the provided information, the TRIP Tonometry Catheter, 18F is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used for the "determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue". This involves analyzing a sample (presumably gas or fluid from the gastric mucosa) in vitro (outside the body) using the connected Tonocap™ monitor.
- Connection to a Monitor: The device acts as an "access device for connecting the Tonocap™ monitor," which is the instrument that performs the actual measurement and analysis of the sample. This is a key characteristic of IVD systems.
- Sampling Line and Biofilter: The presence of a "sampling line" and "biofilter" further supports the idea that the device is collecting and preparing a sample for analysis by the external monitor.
While the device also has other functions like feeding and decompression, its primary stated use for determining PrCO2 and pHi through connection to a monitor clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
73 CCK, 73 CBR, 78 KNT
Device Description
The TRIP Tonometry Catheter, 18F is a device that incorporates a vented gastric sump. It is used as a gastrointestinal tract access device. It includes a sampling line and biofilter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
gastric mucosal tissue
Indicated Patient Age Range
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Intended User / Care Setting
surgical/operating room patients, intensive care unit patients, emergency / trauma patients and hospital patients with suspected mesenteric ischemia.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo for the Department of Health. The logo consists of three stylized human figures in profile, arranged in a row. The figures are black and have a simple, abstract design. The text "DEPARTMENT OF HEALTH" is written vertically along the left side of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10088 MAY
Mr. Joel C. Kent Manager, Quality and Regulatory Affairs Datex Engstrom, Inc. Three Highwood Drive Tewksbury, MA 01876
Re: K980384
TRIP® Tonometry Catheter, 18F Dated: January 30, 1998 Received: February 2, 1998 Regulatory Class: II 21 CFR $868.1400/Procode: 73 CCK 21 CFR $868.1700/Procode: 73 CBR 21 CFR $876.5980/Procode: 78 KNT
Dear Mr. Kent:
We have reviewed your 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 devices marketed in interstate commerce prior to May 28, 1976, the exactment 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 Regulation (OS) 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/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known):
TRIP Tonometry Catheter, 18F Device Name:
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Dober R. Stilling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
Radiological Devices
510(k) Number K9806384