HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM

K122813 · Cincinnati Sub-Zero Products, Inc. · DWC · Dec 18, 2012 · Cardiovascular

Device Facts

• Record ID: K122813
• Device Name: HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
• Applicant: Cincinnati Sub-Zero Products, Inc.
• Product Code: DWC · Cardiovascular
• Decision Date: Dec 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4250
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hemotherm® Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

Device Story

Hemotherm 400CE is a dual-reservoir, water-recirculating cooler/heater system; provides temperature-controlled water to external blood heat exchangers for cardiopulmonary bypass (adult/pediatric/infant patients); optionally supplies same-temperature water to hyper/hypothermia blankets for conductive re-warming. Device does not contact patient or blood; water is separated from blood by heat exchanger. Operated by healthcare professionals in clinical settings. System maintains water temperature between 3°C and 42°C. Output allows clinicians to manage patient body temperature during surgery. Benefits include precise thermal regulation during bypass and supplemental patient warming.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM F-2196 for temperature and pressure. Electrical safety testing per IEC 60601-1 and electromagnetic compatibility testing per IEC 60601-1-2. Package and transportation testing per ISTA standards.

Technological Characteristics

Dual-reservoir water recirculating system; conductive heat transfer; temperature range 3°C to 42°C. Manual mode operation. Performance testing per ASTM F-2196. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Packaging per ISTA standards.

Indications for Use

Indicated for adult, pediatric, and infant patients undergoing cardiopulmonary bypass procedures (≤6 hours) requiring blood temperature control via heat exchanger, or patient re-warming via conductive hyper/hypothermia blanket.

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.

Predicate Devices

• Cincinnati Sub-Zero Hemotherm Model 400 Cooler/Heater System (K811742)
• Jostra HCU 30 Heater-Cooler Device (K031544)
• Cincinnati Sub-Zero Blanketrol III Model 233 and blankets (K101589)

Submission Summary (Full Text)

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K122813

Cincinnati Sub-Zero Products, Inc. Traditional 510(k) Premarket Notification for Hemotherm Model 400CE

# 510(k) Summary

#### 1. COMPANY INFORMATION

DEC 1 8 2012 .

Cincinnati Sub-Zero Products, Inc. 12011 Mosteller Road Cincinnati, Ohio 45241-1528 Telephone: [phone] FAX: [phone]

#### 2. CONTACT INFORMATION

Steve Berke President and CEO Telephone: [phone] ext 3212 FAX: [phone] Email: [e-mail]

- 3. DATE PREPARED: September 12, 2012
- 4. DEVICE TRADE NAME: Hemotherm® Model 400CE Cooler/Heater System and Blankets
- 5. COMMON NAME: Heater-Cooler temperature control device
- CLASSIFICATION NAME: Cardiopulmonary bypass temperature controller 6.
- 7. CEASSIFICATION REGULATION: 21 CFR 870.4250 for use with heat exchanger, 21CFR870.5900 for use with hypo-hyperthermia blanket
- CLASSIFICATION PRODUCT CODE: DWC when used as cardiopulmonary 8. bypass temperature controller, DWJ when used with a hypo-hyperthermia blanket
- 9. PANEL: Cardiovascular
- 10. DEVICE CLASSIFICATION: Class II
- 11. IDENTIFICATION OF PREDICATES:
- K811742 Cincinnati Sub-Zero Hemotherm Model 400 Cooler/Heater . System
- . K031544 Jostra HCU 30 Heater-Cooler Device
- K101589 Cincinnati Sub-Zero Blanketrol III Model 233 and blankets .

#### DEVICE DESCRIPTION

The Hemotherm® Model 400CE Cooler/Heater System is a dual reservoir, water recirculating device that supplies temperature controlled water to a heat exchanger. The

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### Cincinnati Sub-Zero Products, Inc. Traditional 510(k) Premarket Notification for Hemotherm Model 400CE

device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients. The device uses conductive heat transfer. When ordered by the health care professional, the device can also simultaneously supply temperature controlled water to a blanket to provide additional patient re-warming therapy. If the blanket is used at the same time as the heat exchanger, the blanket is supplied the same water that circulates to the heat exchanger.

#### Water Cooling System Operation

Water is cooled to the desired set point temperature and pumped from the device to a commercially available heat exchanger via connecting hoses/tubes. The temperature controlled water is circulated through the heat exchanger to cool the blood in the heat exchanger and then the water is returned back to the Hemotherm. The Hemotherm device does not contact the patient or the patient's blood. The water being circulated by the Hemotherm is separated from the blood by the heat exchanger.

#### Water Heating System Operation

Water is heated to the desired set point temperature and pumped from the device to a commercially available heat exchanger via connecting hoses/tubes. The temperature controlled water is circulated through the heat exchanger to heat the blood in the heat exchanger and then the water is returned back to the Hemotherm. The Hemotherm device does not contact the patient or the patient's blood. The water being circulated by the Hemotherm is separated from the blood by the heat exchanger. If ordered by the health care professional, while in the heat mode, the Hemotherm may also be simultaneously connected to a blanket to provide additional patient re-warming therapy. The blanket is supplied the same water from the same reservoir as the heat exchanger, thus the blanket receives water of the same temperature as the heat exchanger.

#### INTENDED USE

The Hemotherm® Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

#### SUBSTANTIAL EQUIVALENCE

The new device has the same intended uses as the predicate devices and similar technological characteristics that do not raise new types of questions of safety and effectiveness thus meeting the definition of substantial equivalence. In addition, testing of the device shows that it meets applicable electrical safety and EMC standards. Temperature safety testing shows the device to meet the same requirements as the predicate:

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# COMPARISON TABLE

| | Cincinnati Sub-<br>Zero<br>Hemotherm<br>400CE<br>(New Device) | Cincinnati Sub-<br>Zero<br>Hemotherm 400<br>(K811742) | Jostra<br>HCU 300<br>(K031544) | Cincinnati Sub-<br>Zero<br>Blanketrol III<br>Model 233 with<br>blankets<br>(K101589) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Applications | Fluid cooling or<br>warming using<br>blood<br>oxygenator/heat<br>exchanger and<br>additional<br>warming with a<br>blanket | Fluid cooling or<br>warming using<br>blood<br>oxygenator/heat<br>exchanger. | Total-body<br>heating/cooling,<br>independent<br>cardioplegia (dual<br>hyper-hypothermia<br>system) | To raise or lower<br>a patient's<br>temperature or<br>maintain a desired<br>patient<br>temperature |
| Patient<br>Population | Adults, pediatrics,<br>infants. | Adults and<br>pediatrics | Adults and pediatrics. | Adults, pediatric,<br>infants |
| Design | Heated or cooled<br>water pumped<br>through heat<br>exchanger for<br>conductive heat<br>transfer | Heated or cooled<br>water pumped<br>through heat<br>exchanger for<br>conductive heat<br>transfer | Heated or cooled<br>water pumped<br>through heat<br>exchange circuits for<br>conductive heat<br>transfer to fluid | Heated or cooled<br>water pumped<br>through blankets<br>for conductive<br>heat transfer |
| Operating<br>Mode | Manual mode<br>(Water Temp) | Manual mode (Water<br>Temp) | Manual mode (Water<br>Temp) | Manual mode<br>(Water Temp) |
| Temperature<br>Range | 3°C to 42°C. | 3°C to 42°C. | 1°C to 41°C. | 4°C to 42°C |
| Energy | Conductive heat<br>transfer | Conductive heat<br>transfer | Conductive heat<br>transfer | Conductive heat<br>transfer |

# TESTING SUMMARY ·

The Hemotherm 400CE system was subjected to and passed:

- electrical safety testing in accordance with IEC60601-1, .
- electromagnetic compatibility testing in accordance with IEC60601-1-2, .
- package and transportation testing in accordance with ISTA standards .
- performance testing in accordance with ASTM F-2196 (temperature and pressure).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DEC 1 8 2012

Cincinnati Sub-Zero c/o Mr. Steven J. Berke President and CEO 12011 Mosteller Road Cincinnati, OH 45241-1528

Re: K122813

Hemotherm® Model 400CE Dual Reservoir Cooler/Heater System Regulation Number: 21 CFR 870.4250 Regulation Name: Controller, Temperature, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DWC Dated: November 8, 2012 Received: November 9, 2012

Dear Mr. Berke:

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. 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 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.

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### Page 2 - Mr. Steven J. Berke

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 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 medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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.

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/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 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 its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

for 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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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Hemotherm® Model 400CE Dual Reservoir Cooler/Heater

Indications for Use:

The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

Page 1 of 1

W.G. Helle

Division Sian-Off) Division of Cardiovascular Devices

510(k) Number_ K122813

(Posted November 13, 2003)