(37 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "MTEK-1400". It does not contain information about acceptance criteria, study details, or performance data as requested. The letter confirms substantial equivalence to a predicate device but does not provide the supporting study data.
Therefore, I cannot answer your request based on the provided 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 (301) 594-4648: Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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 305 261-2211 · Fax 305 261-4492
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).