MAGNATEK 40

K982907 · Magna Advanced Technologies, Inc. · DQA · Oct 2, 1998 · Cardiovascular

Device Facts

• Record ID: K982907
• Device Name: MAGNATEK 40
• Applicant: Magna Advanced Technologies, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Oct 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

The MTEK-40 hand held pulse oximeter is used to measure the percent arterial oxygen saturation by using a completely non-invasive finger sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-40 can also measure pulse rate and pulse strength. Continuous arterial oxygen saturation monitoring is valuable in any situation where oxygen administration is indicated. Real time information allows for earlier detection of hypoxia or hyperoxia tan arterial sampling. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Device Story

MTEK-40 is a handheld pulse oximeter; utilizes non-invasive finger sensor with dual-wavelength LEDs; measures light absorption through pulsating vascular bed; calculates arterial oxygen saturation (SpO2), pulse rate, and pulse strength; provides real-time monitoring; used by clinicians to detect hypoxia or hyperoxia; aids in clinical decision-making regarding oxygen administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Handheld pulse oximeter; non-invasive finger sensor; dual-wavelength LED light source; measures light transmission through vascular bed; provides SpO2, pulse rate, and pulse strength measurements.

Indications for Use

Indicated for patients requiring continuous or spot-check monitoring of arterial oxygen saturation, pulse rate, and pulse strength. 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1998

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

K982907 Re: MAGNATEK 40 Requlatory Class: II (two) Product Code: 74 DQA Dated: August 3, 1998 Received: Auqust 18, 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, 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 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 Requlation (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 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/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, 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: K982907

Device Name: Hand Held Pulse Oximeter

Device Model: MTEK-40

Indications for Use:

The MTEK-40 hand held pulse oximeter is used to measure the percent arterial oxygen saturation by using a completely non-invasive finger sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.

The MTEK-40 can also measure pulse rate and pulse strength. Continuous arterial oxygen saturation monitoring is valuable in any situation where oxygen administration is indicated. Real time information allows for earlier detection of hypoxia or hyperoxia tan arterial sampling.

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)

OR

Prescription Use

Over the Counter Use

(Per 21 CFR 801.109)

Mark Kiamie

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number