(69 days)
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.
The MTEK-1000 unit is a pulse oximeter. 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.
This is a submission for a 510(k) premarket notification for the MTEK-1000 Pulse Oximeter, which was cleared by the FDA in 1998. The document provided does not contain the detailed study information typically required to answer your questions about acceptance criteria and device performance in the format you've requested.
The document primarily states that the MTEK-1000 is substantially equivalent to legally marketed predicate devices. For 510(k) submissions, manufacturers typically compare their device to existing devices rather than conducting extensive clinical trials with detailed acceptance criteria and standalone performance studies as might be done for a PMA (Premarket Approval).
Therefore, based solely on the provided text, I cannot provide the specific details regarding:
- 1. A table of acceptance criteria and the reported device performance: This information is not present in the letter. A 510(k) summary (which is a separate document) or the full 510(k) submission would contain performance data used to demonstrate substantial equivalence, but it's not in this clearance letter.
- 2. Sample size used for the test set and the data provenance: Not available in this document.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- 4. Adjudication method for the test set: Not available.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies are generally not required for 510(k) clearances, especially for devices like pulse oximeters, and are not mentioned here.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a pulse oximeter in this context. While the device itself is a "standalone" measurement tool, the concept of "algorithm only" performance or "human-in-the-loop" is typically associated with AI/ML diagnostic software, which this device is not.
- 7. The type of ground truth used: Not available.
- 8. The sample size for the training set: Not applicable as this device is not an AI/ML algorithm that requires a "training set" in the modern sense.
- 9. How the ground truth for the training set was established: Not applicable.
What the document does tell us:
- Device: MTEK-1000 Pulse Oximeter
- Indications for Use: To measure percent of arterial oxygen saturation and pulse rate by using a completely non-invasive sensor. Also, "MTEK-1000-US oximeters are equipped to monitor ECG waveforms and can be used to measure cardiac activity."
- Regulatory Class: II
- Product Code: 74 DQA (Pulse Oximeter)
- Regulatory Pathway: 510(k) Premarket Notification
- Outcome: Substantial Equivalence to legally marketed predicate devices, allowing the device to be marketed.
To get the specific data you're looking for, one would typically need to review the 510(k) Summary (often publicly available) or the full 510(k) submission itself, which would contain the performance data and comparisons to predicate devices that led to the FDA's substantial equivalence determination. This letter is the official notification of clearance, not the detailed technical review.
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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_
§ 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).