(45 days)
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No
The summary describes a standard pulse oximeter using established optical principles and does not mention any AI/ML components or capabilities.
No
The device is used for monitoring physiological parameters (oxygen saturation and pulse rate) and providing real-time information for detection, not for treating a condition.
Yes
Explanation: The device is used to measure percent arterial oxygen saturation and pulse rate, providing "real time information [that] allows for earlier detection of hypoxia or hyperoxia," which are conditions that require diagnosis. Its use is also restricted "by or on the order of a qualified physician," indicating its role in medical assessment and diagnosis.
No
The device description explicitly mentions hardware components like LEDs and a finger sensor, indicating it is a physical device, not software-only.
No, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. They are used to diagnose diseases or conditions based on the analysis of these samples.
- This device, the MTEK-40 pulse oximeter, measures physiological parameters within the body (in vivo) using a non-invasive sensor. It measures oxygen saturation and pulse rate by shining light through the finger.
The description clearly states it uses a "completely non-invasive finger sensor" and measures parameters "through a pulsating vascular bed." This is characteristic of an in vivo diagnostic device, not an in vitro one.
N/A
Intended Use / 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.
Product codes
74 DQA
Device Description
Hand Held Pulse Oximeter, Model: MTEK-40. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Finger (non-invasive finger sensor)
Indicated Patient Age Range
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Intended User / Care Setting
Qualified physician only / Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The image is likely a header or title for a document or website related to the Department of Health & Human Services.
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract human profiles facing to the right, with three curved lines above them, possibly representing movement or energy.
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