(18 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard physiological monitoring parameters.
No.
The device is a monitor (capnometer) used for measuring CO2 and respiration rate, rather than actively treating a medical condition.
Yes.
The device provides real-time breath indications, End-Tidal CO2, and respiration rate, which are physiological parameters used to assess a patient's condition and help in diagnosis, even for "spot checking".
No
The device description explicitly states "Hand Held CO2 Monitor (Capnometer) Model: MTEK-80", indicating a physical hardware device.
Based on the provided information, the MagnaTek 80 hand held CO2 Monitor (Capnometer) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device measures CO2 directly from the patient's breath, which is a physiological measurement, not an analysis of a biological specimen.
- The intended use describes monitoring physiological parameters (End-Tidal CO2 and respiration rate) in a clinical setting. This aligns with the function of a patient monitor, not an IVD.
Therefore, the MagnaTek 80 is a patient monitoring device, specifically a capnometer, not an IVD.
N/A
Intended Use / Indications for Use
The MagnaTek 80 hand held CO2 Monitor (Capnometer) is intended to be used as a transportable capnometer, providing End-Tidal CO2, respiration rate, and real-time breath indications for use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The Capnometer can be used for patient checking (spot checking) and data logging of End Tidal CO2 and respiration rate.
Product codes
73 CCK
Device Description
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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
clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The device is restricted for use by or on the order of a qualified physician only.
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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§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1998
Ms. Annie Velez Magna Advanced Technologies, Inc. 7200 N.W. 7th Street Miami, FL 33126
Re: K983114 Hand-Held CO2 Monitor (Capnometer) Model 80 Regulatory Class: II (two) Product Code: 73 CCK Dated: August 10, 1998 Received: September 4, 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 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 Act --for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. .
1
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 leqally 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. Callahon
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: Not yet available
Device Name: Hand Held CO2 Monitor (Capnometer)
Device Model: MTEK-80
Indications for Use:
The MagnaTek 80 hand held CO2 Monitor (Capnometer) is intended to be used as a transportable capnometer, providing End-Tidal CO2, respiration rate, and real-time breath indications for use in clinical settings including patient transport, ICU, CCU, ER, OR, and recovery room. The Capnometer can be used for patient checking (spot checking) and data logging of End Tidal CO2 and respiration 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) | |
|---|---|
| -------------------------------------------------------- | -- |
| (Division Sign-Off) | Division of Cardiovascular, Respiratory, and Neurological Devices |
|---|---|
| 510(k) Number | K983114 |
| Prescription Use | X |
|---|---|
| ------------------ | --- |
OR
| Over the Counter Use | _________________ |
|---|---|
| ---------------------- | ------------------- |
(Per 21 CFR 801.109)
| Leuk L. Medoo 9-21-98 | |
|---|---|
| -- | ----------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | _________________________________________________________________________________________________________________________________________________________________ |