MTEK-1000

K982405 · Magna Advanced Technologies, Inc. · DQA · Sep 17, 1998 · Cardiovascular

Device Facts

• Record ID: K982405
• Device Name: MTEK-1000
• Applicant: Magna Advanced Technologies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Device Story

MTEK-1000 is a non-invasive pulse oximeter and ECG monitor. Device utilizes LEDs emitting two specific light wavelengths through a pulsating vascular bed to measure arterial oxygen saturation and pulse rate. Integrated ECG functionality allows monitoring of cardiac waveforms and activity. Used in clinical settings under physician direction; provides real-time physiological data to assist clinicians in assessing patient cardiovascular and respiratory status.

Technological Characteristics

Non-invasive pulse oximetry sensor using dual-wavelength LEDs; ECG monitoring capability; prescription-only device.

Indications for Use

Indicated for patients requiring non-invasive monitoring of arterial oxygen saturation, pulse rate, and ECG waveforms/cardiac activity. Restricted to use by or on the order of a qualified physician.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, superimposed over a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP | 7 1998

Ms. Annie Velez Magna Advanced Technologies, Inc. 7200 N.W. 7th Street Miami, FL 33126

Re: K982405 MTEK-1000 Regulatory Class: II (two) Product Code: 74 DQA Dated: June 26, 1998 Received: July 10, 1998

Dear Ms. Velez:

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 legally 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, 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 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 - Ms. Annie Velez

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 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Gallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT

510(k) Number: K982405

Pulse Oximeter Device Name:

MTEk-1000 Device Model:

Indications for Use:

The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.

The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity.

Federal Law restricts the use of this device by or on the order of a qualified physician only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Kramer

Prescription Use

OR Over the Counter Use

(Per 21 CFR 801.109)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_