CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

K102147 · Cardioquip Llp · DWC · Nov 19, 2010 · Cardiovascular

Device Facts

• Record ID: K102147
• Device Name: CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000
• Applicant: Cardioquip Llp
• Product Code: DWC · Cardiovascular
• Decision Date: Nov 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

CardioQuip Modular Cooler-Heater (MCH) provides temperature-controlled water to external heat exchange devices, such as cardiopulmonary bypass (CPB) heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets. Used in clinical settings during cardiopulmonary bypass procedures; operated by trained medical personnel. Device functions by circulating water at controlled temperatures to assist in patient temperature management. Output is temperature-regulated water delivered to connected heat exchange equipment. Benefits include precise thermal control during surgical procedures.

Clinical Evidence

No clinical data provided; device is a temperature controller for external heat exchange equipment.

Technological Characteristics

Modular cooler-heater system; provides temperature-controlled water circulation; intended for use with CPB heat exchangers and thermal blankets; Class II device (21 CFR 870.4250).

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures lasting up to six hours, requiring temperature-controlled water for heat exchangers or thermal regulating blankets.

Regulatory Classification

Identification

A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.

Submission Summary (Full Text)

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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

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Page 2 – Mr. Douglas Platt

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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 [phone] or [phone] 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
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K102147.

## Indications For Use

510(k) Number: K102147

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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