TED 191

K963177 · Teledyne Brown Engineering · CCL · Nov 13, 1997 · Anesthesiology

Device Facts

• Record ID: K963177
• Device Name: TED 191
• Applicant: Teledyne Brown Engineering
• Product Code: CCL · Anesthesiology
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Intended 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.

Device Story

Teledyne TED 191 oxygen monitor measures oxygen concentration in static or dynamic gaseous environments (gas streams or enclosed volumes). Used in clinical settings for oxygen therapy and ventilatory monitoring; also checks purity of compressed air/oxygen. Device provides real-time concentration data to clinicians to assist in managing patient respiratory support. Benefits include ensuring accurate oxygen delivery and monitoring gas purity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen monitor for gaseous environments. Measures oxygen concentration in static or dynamic gas streams. Designed for medical oxygen therapy and ventilatory monitoring applications.

Indications for Use

Indicated for monitoring oxygen concentration in medical applications including oxygen therapy and ventilatory support, or for checking purity of compressed air/oxygen mixtures in clinical settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
NOV 13 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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 registration, 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 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/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.

62081.w11

(Division Sign-Off)
Division of Cardiovascular Respiratory,
and Neurological Devices
$10(k) Number K963177