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 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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Hemotherm Model 400CE based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria Description	Reported Device Performance	Study that Proves Device Meets Acceptance Criteria
Electrical Safety	Compliance with IEC60601-1	Passed	Electrical safety testing
Electromagnetic Compatibility (EMC)	Compliance with IEC60601-1-2	Passed	Electromagnetic compatibility testing
Package and Transportation	Compliance with ISTA standards	Passed	Package and transportation testing
Performance (Temperature and Pressure)	Compliance with ASTM F-2196	Passed	Performance testing
Temperature Range	3°C to 42°C (as a predicate)	3°C to 42°C	Comparison to predicate device and performance testing (implied)

Additional Study Information

There is limited information provided in the 510(k) summary regarding specific aspects of the studies typically found for AI/ML device evaluations. This submission is for a traditional 510(k) for a hardware device, not an AI/ML software device, which explains the absence of certain categories.

2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not specified. The document states the "Hemotherm 400CE system was subjected to and passed" various tests, but does not detail the number of units or test points used.
* Data Provenance: Not applicable in the context of patient data for a medical device that does not directly interact with patients or process patient data. The provenance would refer to the testing environment and protocols, which are covered by the standards cited (e.g., IEC, ASTM, ISTA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
* Not applicable. This device is a cooler/heater system, and its performance (e.g., temperature accuracy, electrical safety) is evaluated against objective engineering standards and physical measurements, not subjective expert assessment of medical imaging or clinical data.

4. Adjudication Method for the Test Set:
* Not applicable. As noted above, the evaluation relies on objective measurements against established technical standards, not on expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
* No, an MRMC study was not done. This is a hardware device (cooler/heater system) and not an AI/ML diagnostic or assistive technology for human readers. Therefore, this type of study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
* No, a standalone algorithm performance study was not done. This device does not have an AI/ML algorithm. Its performance is evaluated in a standalone manner as a mechanical/electrical system.

7. The Type of Ground Truth Used:
* Objective Engineering Standards and Physical Measurements: The ground truth for this device's performance is derived from internationally recognized electrical safety standards (IEC60601-1), electromagnetic compatibility standards (IEC60601-1-2), packaging and transportation standards (ISTA), and performance standards related to temperature and pressure (ASTM F-2196). These standards define acceptable ranges and parameters for the device's operation.

8. The Sample Size for the Training Set:
* Not applicable. As a hardware device without AI/ML components, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:
* Not applicable, for the same reason as above.

Summary

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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: (513) 772-8810 FAX: (513) 772-9119

2. CONTACT INFORMATION

Steve Berke President and CEO Telephone: (513) 772-8810 ext 3212 FAX: (513) 772-9119 Email: siberke@cszinc.com

1. DATE PREPARED: September 12, 2012
1. DEVICE TRADE NAME: Hemotherm® Model 400CE Cooler/Heater System and Blankets
1. COMMON NAME: Heater-Cooler temperature control device
CLASSIFICATION NAME: Cardiopulmonary bypass temperature controller 6.
1. 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
1. PANEL: Cardiovascular
1. DEVICE CLASSIFICATION: Class II
1. 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-ZeroHemotherm400CE(New Device)	Cincinnati Sub-ZeroHemotherm 400(K811742)	JostraHCU 300(K031544)	Cincinnati Sub-ZeroBlanketrol IIIModel 233 withblankets(K101589)
Applications	Fluid cooling orwarming usingbloodoxygenator/heatexchanger andadditionalwarming with ablanket	Fluid cooling orwarming usingbloodoxygenator/heatexchanger.	Total-bodyheating/cooling,independentcardioplegia (dualhyper-hypothermiasystem)	To raise or lowera patient'stemperature ormaintain a desiredpatienttemperature
PatientPopulation	Adults, pediatrics,infants.	Adults andpediatrics	Adults and pediatrics.	Adults, pediatric,infants
Design	Heated or cooledwater pumpedthrough heatexchanger forconductive heattransfer	Heated or cooledwater pumpedthrough heatexchanger forconductive heattransfer	Heated or cooledwater pumpedthrough heatexchange circuits forconductive heattransfer to fluid	Heated or cooledwater pumpedthrough blanketsfor conductiveheat transfer
OperatingMode	Manual mode(Water Temp)	Manual mode (WaterTemp)	Manual mode (WaterTemp)	Manual mode(Water Temp)
TemperatureRange	3°C to 42°C.	3°C to 42°C.	1°C to 41°C.	4°C to 42°C
Energy	Conductive heattransfer	Conductive heattransfer	Conductive heattransfer	Conductive heattransfer

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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The logo is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.

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 (800) 638-2041 or (301) 796-7100 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:

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)

Regulation Number and Section

§ 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).