(89 days)
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No
The provided text describes a standard electrocardiograph for stress testing and does not mention any AI or ML capabilities.
No
The device is an electrocardiograph designed for stress testing, which provides diagnostic information about cardiac function, but does not directly treat a condition.
Yes
The device is an electrocardiograph used for cardiological stress testing, which involves assessing heart function or identifying abnormalities, indicating a diagnostic purpose.
No
The device description is not found, but the intended use clearly describes a physical electrocardiograph (Quark C12/T12) which is a hardware device, even if it has a telemetric version. It also mentions integration with metabolic carts, which are also hardware.
Based on the provided information, the COSMED Quark C12 (and Quark T12) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as an "electrocardiograph designed for cardiological stress testing, or cardiopulmonary stress testing". This involves measuring electrical activity of the heart and potentially respiratory parameters during physical exertion.
- Nature of IVDs: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: An electrocardiograph measures physiological signals directly from the patient's body, not from a specimen.
Therefore, the COSMED Quark C12/T12 falls under the category of a medical device used for physiological monitoring and testing, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The COSMED Quark C12 (Quark T12 in telemetric version) is an electrocardiograph designed for cardiological stress testing, or cardiopulmonary stress testing, if used integrated with a COSMED metabolic cart (Quark b², Quark PFT ergo or K4 b²).
Product codes
DPS
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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2002
COSMED S.R.L. c/o Mr. Robert Schiff, Ph.D. President Schiff & Company 1129 Bloomfield Avenue West Caldwell, NJ 07006
Re: K014262
Trade Name: Quark C12/Quark T12 Electrocardiograph for Stress Exercise Testing Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: December 26, 2001 Received: December 27, 2001
Dear Dr. Schiff:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Robert Schiff, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Crth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
K. Dea Tuch
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health .
Enclosure
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510(k) PREMARKET NOTIFICATION COSMED SRL, ITALY COSMED QUARK C12 AND QUARK T12
STATEMENT OF INDICATION FOR USE
510(k) Number (if known): Device Name: Not assigned yet Quark C12 / Quark T12 stress exercise testing electrocardiograph
Indications for Use:
The COSMED Quark C12 (Quark T12 in telemetric version) is an electrocardiograph designed for cardiological stress testing, or cardiopulmonary stress testing, if used integrated with a COSMED metabolic cart (Quark b², Quark PFT ergo or K4 b²).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K014262
Prescription use (Per 21 CFR 801.109)
or
Over-the-Counter Use (Optional format 1-2-96)