(270 days)
Not Found
Not Found
No
The summary describes a device for measuring oxygen concentration and contains no mention of AI, ML, or related concepts.
No
The device measures oxygen concentration in gas mixtures for medical applications, but it is explicitly stated that it is a "secondary measuring device" and "should not be used as a primary monitoring device," indicating it is for measurement and verification, not for directly treating or preventing a disease.
No
The device measures oxygen concentration in gas mixtures for medical applications, serving as a secondary measuring device for verification and spot checks. It is not used to diagnose a medical condition in a patient.
No
The device description is not found, but the intended use clearly describes a device that measures oxygen concentration in gas mixtures. This function typically requires hardware sensors and components to interact with the gas, making it highly unlikely to be a software-only device.
Based on the provided information, the TED 60T is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device measures the concentration of oxygen in gas mixtures. IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- No mention of biological specimens: There is no indication that the TED 60T interacts with or analyzes any biological samples.
- Focus on gas analysis: The entire description revolves around the analysis of gases used in medical applications.
Therefore, the TED 60T falls under the category of a medical device used for monitoring or measuring parameters related to gas delivery, not for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
73 CCL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three parallel lines curving upwards, resembling a human profile.
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.
1
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
2
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