MTEK-1400

K982846 · Magna Advanced Technologies, Inc. · CCK · Sep 18, 1998 · Anesthesiology

Device Facts

• Record ID: K982846
• Device Name: MTEK-1400
• Applicant: Magna Advanced Technologies, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Sep 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The MTEK-1400 unit is to be used to in order to measure CO2 concentration using the principles of infrared absorption spectrometry. This unit provides continuous non-invasive information used to aid the clinician in assessing a patient's cardiopulmonary function and metabolic state. It is extremely effective in determining the efficacy of various respiratory treatments. Capnography can aid in detecting esophageal intubations, disconnections, apnea, malignant hyperthermia and air emboli. The MTEK-1400 can also measure respiration rate and capnography. The MTEX-1400 Plus model is capable of measuring percent arterial oxygen saturation and pulse rate. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Device Story

MTEK-1400 is a CO2 monitor utilizing infrared absorption spectrometry to measure CO2 concentration; provides continuous non-invasive data for assessing cardiopulmonary function and metabolic state. Used by clinicians to evaluate respiratory treatment efficacy and detect clinical events including esophageal intubations, disconnections, apnea, malignant hyperthermia, and air emboli. MTEK-1400 Plus model includes pulse oximetry for arterial oxygen saturation and pulse rate measurement. Device output assists physicians in clinical decision-making regarding patient respiratory status and ventilation management.

Technological Characteristics

Infrared absorption spectrometry for CO2 measurement; non-invasive sensing; MTEK-1400 Plus model includes pulse oximetry for SpO2 and pulse rate. Device is a monitor for cardiopulmonary and metabolic assessment.

Indications for Use

Indicated for continuous non-invasive monitoring of CO2 concentration, respiration rate, and capnography in patients to assess cardiopulmonary function and metabolic state. The MTEK-1400 Plus model is additionally indicated for monitoring arterial oxygen saturation and pulse rate. Restricted to prescription use by or on the order of a qualified physician.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 1998

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

Re : K982846 MTEK-1400 Regulatory Class: II (two) Product Code: 73 CCK Dated: June 26, 1998 Received: August 12, 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 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 ...... 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 beqin 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. Callehan

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

K982846 510(k) Number: CO2 Monitor Device Name:

MTEK-1400 Device Model:

Indications for Use:

The MTEK-1400 unit is to be used to in order to measure CO2 concentration using the principles of infrared absorption spectrometry. This unit provides continuous non-invasive information used to aid the clinician in assessing a patient's cardiopulmonary function and metabolic state. It is extremely effective in determining the efficacy of various respiratory treatments. Capnography can aid in detecting esophageal intubations, disconnections, apnea, malignant hyperthermia and air emboli.

The MTEK-1400 can also measure respiration rate and capnography. The MTEX-1400 Plus model is capable of measuring percent arterial oxygen saturation and pulse rate.

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

OR Over the Counter Use _

(Per 21 CFR 801.109)

Prescription Use

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

510(k) Number

Magna Advanced Technologies, Inc. 7200 N.W. 7th Street · Miami, FL 33126 USA Telephone [phone] · Fax [phone]