(45 days)
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.
Hand Held Pulse Oximeter, Device Model: MTEK-40. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.
This document is a 510(k) clearance letter for the MAGNATEK 40 Hand Held Pulse Oximeter (model MTEK-40). It primarily concerns the regulatory approval of the device and does not contain detailed information about specific acceptance criteria, study methodologies, or performance statistics typically found in a clinical study report.
Therefore, I cannot provide the requested information. The document focuses on confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing its market entry, rather than detailing its performance against specific acceptance criteria.
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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 (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. 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
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).