(96 days)
Not Found
No
The summary describes a water recirculating device for temperature control and does not mention any AI or ML components or functionalities.
Yes.
The device is used to cool or warm blood and to provide patient re-warming therapy, which are therapeutic actions.
No
The device is used to cool or warm blood and patients during cardiopulmonary bypass procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly indicates it is a physical system with reservoirs, water recirculation, and conductive heat transfer, requiring electrical and electromagnetic compatibility testing, which are characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to control the temperature of water flowing through a blood oxygenator/heat exchanger to warm or cool blood during cardiopulmonary bypass procedures. It also mentions use with a hyper/hypothermia blanket for patient warming. These are all procedures performed on the patient or with the patient's blood in vivo (within the body) or during a procedure that directly affects the patient's body temperature.
- Device Description: The description reinforces that the device supplies temperature-controlled water to a heat exchanger to warm or cool blood and can also supply water to a blanket for patient re-warming. This is a physical intervention to control temperature, not a diagnostic test performed on a sample in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device's function is purely therapeutic/supportive in controlling temperature.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWC, DWJ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, pediatrics, infants.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
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
-
- DATE PREPARED: September 12, 2012
-
- DEVICE TRADE NAME: Hemotherm® Model 400CE Cooler/Heater System and Blankets
-
- COMMON NAME: Heater-Cooler temperature control device
- CLASSIFICATION NAME: Cardiopulmonary bypass temperature controller 6.
-
- 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
-
- PANEL: Cardiovascular
-
- DEVICE CLASSIFICATION: Class II
-
- IDENTIFICATION OF PREDICATES:
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
1
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:
2
COMPARISON TABLE
| | Cincinnati Sub-
Zero
Hemotherm
400CE
(New Device) | Cincinnati Sub-
Zero
Hemotherm 400
(K811742) | Jostra
HCU 300
(K031544) | Cincinnati Sub-
Zero
Blanketrol III
Model 233 with
blankets
(K101589) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Applications | Fluid cooling or
warming using
blood
oxygenator/heat
exchanger and
additional
warming with a
blanket | Fluid cooling or
warming using
blood
oxygenator/heat
exchanger. | Total-body
heating/cooling,
independent
cardioplegia (dual
hyper-hypothermia
system) | To raise or lower
a patient's
temperature or
maintain a desired
patient
temperature |
| Patient
Population | Adults, pediatrics,
infants. | Adults and
pediatrics | Adults and pediatrics. | Adults, pediatric,
infants |
| Design | Heated or cooled
water pumped
through heat
exchanger for
conductive heat
transfer | Heated or cooled
water pumped
through heat
exchanger for
conductive heat
transfer | Heated or cooled
water pumped
through heat
exchange circuits for
conductive heat
transfer to fluid | Heated or cooled
water pumped
through blankets
for conductive
heat transfer |
| Operating
Mode | Manual mode
(Water Temp) | Manual mode (Water
Temp) | Manual mode (Water
Temp) | Manual mode
(Water Temp) |
| Temperature
Range | 3°C to 42°C. | 3°C to 42°C. | 1°C to 41°C. | 4°C to 42°C |
| Energy | Conductive heat
transfer | Conductive heat
transfer | Conductive heat
transfer | Conductive heat
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).
3
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.
4
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
5
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)