(69 days)
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No
The summary describes a standard pulse oximeter and ECG monitor without mentioning any AI or ML capabilities.
No
The device is described as a pulse oximeter which measures arterial oxygen saturation, pulse rate, and ECG waveforms. These are diagnostic functions, not therapeutic.
Yes
The device is used to measure percent of arterial oxygen saturation and pulse rate, and can monitor ECG waveforms to measure cardiac activity, all of which provide information about a patient's health status. It is also indicated for use by a "qualified physician only," suggesting a medical diagnostic purpose.
No
The device description explicitly mentions hardware components like LEDs and sensors, indicating it is not a software-only device.
Based on the provided information, the MTEK-1000 unit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- MTEK-1000 Function: The MTEK-1000 unit is described as a pulse oximeter that measures arterial oxygen saturation and pulse rate using a non-invasive sensor applied to the body. It also monitors ECG waveforms. These are all measurements taken directly from the patient's body without the need for collecting and analyzing a specimen outside the body.
Therefore, the MTEK-1000 falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.
The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity.
Product codes
74 DQA
Device Description
The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.
The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity.
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
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Indicated Patient Age Range
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Intended User / Care Setting
qualified physician
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, superimposed over a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 7 1998
Ms. Annie Velez Magna Advanced Technologies, Inc. 7200 N.W. 7th Street Miami, FL 33126
Re: K982405 MTEK-1000 Regulatory Class: II (two) Product Code: 74 DQA Dated: June 26, 1998 Received: July 10, 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 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 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 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 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 (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. Gallahan, 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: K982405
Pulse Oximeter Device Name:
MTEk-1000 Device Model:
Indications for Use:
The MTEK-1000 unit is to be used to measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.
The MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity.
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
Prescription Use
OR Over the Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_