(270 days)
The TED 60T is intended to accurately measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and neonatal care. The TED 60T is intended for use only as a secondary measuring device to verify and spot check the concentration of oxygen in gas mixtures. The TED 60T should not be used as a primary monitoring device.
Not Found
I apologize, but the provided text from the FDA 510(k) premarket notification for the TED 60T Oxygen Analyzer does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is a letter from the FDA to the manufacturer, acknowledging the 510(k) submission and stating that the device is substantially equivalent to a legally marketed predicate device. It permits the manufacturer to market the device subject to general controls.
Specifically, the document lacks the following information:
- A table of acceptance criteria and the reported device performance: This is not present. The letter mentions that the device is intended to "accurately measure and display the concentration of oxygen," but no specific performance metrics or acceptance criteria are provided.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth... and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more typically associated with imaging-based AI devices, not a physical sensor like an oxygen analyzer.
- Standalone performance: While the device is standalone in terms of its function (an oxygen analyzer), no performance study of its standalone capabilities against specific criteria is detailed.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned. Oxygen analyzers are typically hardware devices; discussions of "training sets" are more relevant to software-based or AI/ML devices.
- How the ground truth for the training set was established: Not mentioned.
The document primarily focuses on the regulatory approval and the device's intended use. It does not delve into the specific technical studies or performance data that would have been submitted as part of the 510(k) application itself.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 1999
Mr. Ray Khajavi Teledyne Electronic Technologies Analytical Instruments 16830 Chestnut Street City of Industry, CA 91749-1580
- K990457 Re: Ted 60T Oxygen Analyzer Regulatory Class: II (two) Product Code: 73 CCL Dated: Auqust 10, 1999 Received: August 11, 1999
Dear Mr. Khajavi:
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 leqally 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, Druq, 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 aqainst 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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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.
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Page 2 - Mr. Ray Khajavi
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) 594-4586. 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" (21CFR 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,
I can't understand for,
Celia M. Witten, Ph.D.,M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TED 60T Indications for Use
・・.
510(k) Number:
The TED 60T is intended to accurately measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and neonatal care. The TED 60T is intended for use only as a secondary measuring device to verify and spot check the concentration of oxygen in gas mixtures. The TED 60T should not be used as a primary monitoring device.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use &
OR
Over the Counter Use
to H. Wmson
ion Sign-Off) vision of Cardiovascular, Respiratory, and Neurological Device 510(k) Number
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).