(456 days)
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No
The document describes a standard oxygen monitor and does not mention any AI or ML capabilities.
No
The device is an oxygen monitor, designed to measure and display oxygen concentration. While it may be used in medical applications like oxygen therapy, it is a monitoring device, not a device that directly provides therapy.
Yes
The device is described as an "oxygen monitor" that "measure[s], display[s], and monitor[s] the actual oxygen concentration present in a defined gaseous environment". This measurement provides information about a physiological state (oxygen concentration), which can be used to diagnose conditions related to oxygen levels in medical applications like oxygen therapy and ventilatory monitoring.
No
The device description explicitly states it "measure[s], display[s], and monitor[s] the actual oxygen concentration present in a defined gaseous environment," which requires hardware components (sensors, display, etc.) to perform these functions.
Based on the provided information, the Teledyne TED 191 oxygen monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the TED 191 measures oxygen concentration in a "defined gaseous environment," which can be a gas stream or an enclosed body of gas. This is measuring the environment, not a biological sample from a patient.
- The applications mentioned are related to monitoring the oxygen content of gases used in medical procedures (oxygen therapy, ventilatory monitoring) or for checking gas purity. These are not tests performed on patient samples to diagnose or monitor a medical condition.
Therefore, the Teledyne TED 191 oxygen monitor falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Teledyne TED 191 oxygen monitor is designed to accurately measure, display, and monitor the actual oxygen concentration present in a defined gaseous environment, either static or dynamic (i.e. either a gas stream or an enclosed body of gas). The device is primarily intended for use in medical applications such as oxygen therapy and ventilatory monitoring, although it may be used in ancillary applications such as checking the purity of compressed air and oxygen, or mixes thereof.
Product codes
73 CCL
Device Description
The Teledyne TED 191 oxygen monitor is designed to accurately measure, display, and monitor the actual oxygen concentration present in a defined gaseous environment, either static or dynamic (i.e. either a gas stream or an enclosed body of gas).
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 13 1997
Mr. Keith A. Barritt Teledyne Electronic Technologies Analytical Instruments c/o Fish & Richardson P.C. 601 13th Street, N.W. Washington, D.C. 20005
Re: K963177 TED 191 Regulatory Class: II (two) Product Code: 73 CCL Dated: September 26, 1997 Received: September 29, 1997
Dear Mr. Barritt:
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 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 reqistration, 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 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 (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 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. Keith A. Barritt
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) 594-4648. 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 requlation 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph. D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Purpose
The Teledyne TED 191 oxygen monitor is designed to accurately measure, display, and monitor the actual oxygen concentration present in a defined gaseous environment, either static or dynamic (i.e. either a gas stream or an enclosed body of gas). The device is primarily intended for use in medical applications such as oxygen therapy and ventilatory monitoring, although it may be used in ancillary applications such as checking the purity of compressed air and oxygen, or mixes thereof.
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| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Respiratory. | |
| and Neurological Devices | |
| 510(k) Number | K963177 |