(88 days)
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.
Not Found
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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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
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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
§ 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).