(112 days)
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Not Found
No
The summary describes a temperature control device for medical procedures and contains no mention of AI, ML, or related concepts like image processing or data analysis that would typically indicate AI/ML use.
No
The device aids in patient temperature control during procedures by supplying temperature-controlled water to other heat exchange devices, but it does not directly treat a disease or condition.
No
The device is described as supplying temperature-controlled water to heat exchange devices to assist in controlling a patient's temperature, which is a therapeutic function, not a diagnostic one.
No
The device is described as a "Modular Cooler-Heater" which supplies temperature-controlled water, indicating it is a hardware device with a physical function, not solely software.
Based on the provided information, the CardioQuip Modular Cooler-Heater (MCH) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device supplies temperature-controlled water to heat exchange devices to help control a patient's temperature during cardiopulmonary bypass procedures. This is a direct interaction with the patient's body (indirectly through heat exchange devices) for therapeutic purposes (temperature control).
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
The CardioQuip MCH's function is to regulate temperature for a patient during a medical procedure, which falls under the category of a therapeutic or supportive medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
Product codes (comma separated list FDA assigned to the subject device)
DWC
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 (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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§ 870.4250 Cardiopulmonary bypass temperature controller.
(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
1 9 2010 NOV
CardioQuip, LLP c/o Mr. Douglas E. Platt Vice President of Operations 3827 Old College Road Bryan, TX 77801
Re: K102147
Trade Name: CardioQuip Modular Cooler-Heater ("MCH") Regulation Number: 21 CFR 870.4250 Regulation Name: Cardiopulmonary Bypass Temperature Controller Regulatory Class: Class II (two) Product Code: DWC Dated: November 1, 2010 Received: November 1, 2010
Dear Mr. Platt:
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 (Act that do not require approval of the Federal Food, Drug,
You may, therefore, market the douise, subject to the Federal 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations of class III (PMA)
may be subject to additional controls. Existing major regulations affecting your device
1
Page 2 – Mr. Douglas Platt
!
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements, Title 21, Parts 800 to 898. In additions
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. of the comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of listing);
device-related adverse events) (21 CFR Part 801); medical device reporting of medi device-related adverse events) (21 CFR 803); good manufacturing of medical
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the sector as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if ap production of the Jordins (QS) regulation (21 CFR Part 820); and if applicable, the elections of the elections
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/aboutFDA/CentersOffices/CDRH/Offices/ucm/21 CFR Part 801), please
the Center for Devices and Radiological Health: (CDRH/Offices/wcm) 1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, him for
note the regulation entitled. "Mishranding by references note the regulation entitled, "Misbranding by reference to premarket notification".
807.97). For questions regarding by reference to premarket notification" (21CFR Part 807.97 more months . Thisolanding of reference to premarke notification" (21CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulatio CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at trom the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free num (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
private/devices/Resourcestor You/industry/default.htm.
Sincerely yours.
Dma R. V. hmer
B
D
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use
510(k) Number: K102147
な
==.
Device Name: CardioQuip Modular Cooler-Heater (MCH)
Indications for Use: The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
Prescription Use _ X _________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.V. Annes
(Division Sign-Off)
Division of Cardiovascular Devices
210(k) Number KID Art