MAGNATEK80

K983114 · Magna Advanced Technologies, Inc. · CCK · Sep 22, 1998 · Anesthesiology

Device Facts

• Record ID: K983114
• Device Name: MAGNATEK80
• Applicant: Magna Advanced Technologies, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The MagnaTek 80 hand held CO2 Monitor (Capnometer) is intended to be used as a transportable capnometer, providing End-Tidal CO2, respiration rate, and real-time breath indications for use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The Capnometer can be used for patient checking (spot checking) and data logging of End Tidal CO2 and respiration rate. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Device Story

MagnaTek 80 is a transportable capnometer for clinical use (ICU, CCU, ER, OR, patient transport). Device measures CO2 levels and respiration rate; provides real-time breath monitoring; supports spot checking and data logging. Operated by healthcare professionals. Output displayed for clinician review to assess patient respiratory status and guide clinical decision-making. Benefits include portable, continuous or intermittent monitoring of ventilation status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Transportable capnometer; measures End-Tidal CO2 and respiration rate; provides real-time breath monitoring and data logging capabilities.

Indications for Use

Indicated for patients requiring monitoring of End-Tidal CO2 and respiration rate in clinical settings including transport, ICU, CCU, ER, OR, and recovery rooms. Restricted to 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

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

Re: K983114 Hand-Held CO2 Monitor (Capnometer) Model 80 Regulatory Class: II (two) Product Code: 73 CCK Dated: August 10, 1998 Received: September 4, 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 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 - 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 leqally 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. Callahon

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: Not yet available

Device Name: Hand Held CO2 Monitor (Capnometer)

Device Model: MTEK-80

Indications for Use:

The MagnaTek 80 hand held CO2 Monitor (Capnometer) is intended to be used as a transportable capnometer, providing End-Tidal CO2, respiration rate, and real-time breath indications for use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The Capnometer can be used for patient checking (spot checking) and data logging of End Tidal CO2 and respiration 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) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

| (Division Sign-Off) | Division of Cardiovascular, Respiratory, and Neurological Devices |
|---------------------|-------------------------------------------------------------------|
| 510(k) Number | K983114 |

| Prescription Use | X |
|------------------|---|
|------------------|---|

OR

| Over the Counter Use | _________________ |
|----------------------|-------------------|
|----------------------|-------------------|

(Per 21 CFR 801.109)

| | Leuk L. Medoo 9-21-98 |
|--|-----------------------|
|--|-----------------------|

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