(105 days)
Not Found
No
The summary describes a standard temperature management system using conductive heat transfer and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used to lower or raise a patient's temperature and/or maintain a desired temperature to provide an actual therapy (hypothermia, hyperthermia, or normothermia treatment), which directly impacts the patient's physiological state. This distinguishes it from devices used solely for diagnostic or supportive purposes.
No
Explanation: The device is described as a temperature management system used to lower, raise, or maintain a patient's temperature through conductive heat transfer. Its function is therapeutic (heating or cooling) rather than diagnostic (identifying a disease or condition).
No
The device description clearly outlines hardware components such as a heater, compressor, circulating pump, and blankets/pads, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer." This is a therapeutic function performed directly on the patient's body.
- Device Description: The device description details a system that circulates heated or cooled water through blankets/pads applied to the patient's body. This is a physical intervention for temperature management.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a therapeutic medical device used for patient temperature management.
N/A
Intended Use / Indications for Use
The Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Temperature Management Systems are used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
The Blanketrol III/CoolBlue Hyper-Hypothermia System is a water (liquid) recirculating device providing either hypothermia, hyperthermia or normothermia treatment as determined by the health care provider.
Water is either heated or cooled depending on the need of the patient. The heated or cooled water is pumped through connecting flexible tubing to a disposable or reusable pad or blanket to provide patient therapy for a site specific external surface area or for whole body surface temperature therapy by the means of conductive heat transfer.
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
Not Found
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)
Bench testing was performed in order to validate the design according to the company's specified design requirements, and to demonstrate the new systems are substantially equivalent to the predicate devices.
The following bench tests were performed:
- Temperature Performance Testing .
- System Safety Limit Testing (high and low limits) .
- Transportation Testing .
- Blanket Structural Integrity Testing .
In addition, the new systems meet the applicable requirements of the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements . for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
All necessary testing has been performed for the Blanketrol III and CoolBlue Hyper-Hypothermia Temperature Management Systems to assure substantial equivalence to the predicate devices.
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
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).
0
510(k) Summary
-
- COMPANY INFORMATION
Cincinnati Sub-Zero, Inc. 12011 Mosteller Road Cincinnati, Ohio 45241-1528 Telephone: (513) 772-8810 FAX: (513) 772-9119
- COMPANY INFORMATION
SEP 2 0 2010
-
- CONTACT INFORMATION
Steve J. Berke President and CEO Telephone: (513) 772-8810 ext. 3212 FAX: (513) 772-9119 Email: sjberke@cszinc.com
- CONTACT INFORMATION
-
- DATE PREPARED: June 4, 2010 1
-
- DEVICE TRADE NAME: Blanketrol III Model 233 Hyper-Hypothermia System, CoolBlue Model 25-01 Hyper-Hypothermia System when sold by Innercool Therapies Inc.
-
- COMMON NAME: Temperature management system
-
- CLASSIFICATION NAME: System, Thermal Regulating
-
- CLASSIFICATION REGULATION: 21 CFR 870.5900
-
- CLASSIFICATION PRODUCT CODE: DWJ
-
- PANEL: CARDIOVASCULAR
-
- DEVICE CLASSIFICATION: Class II
11. IDENTIFICATION OF PREDICATES:
- a. Cincinnati Sub-Zero Blanketrol Hyper-Hypothermia System, Model 200 (pre-amendment device)
- b. Gaymar Industries MediTherm II Series 5900 Hyper/Hypothermia System (K912051)
- M.T.R.E Advanced Technology Ltd. CritiCool device (K083662) C.
1
Cincinnati Sub-Zero, Inc. 510(k) Premarket Notification for Blanketrol III Model 233/CoolBlue devices
DEVICE DESCRIPTION
The Blanketrol III/CoolBlue Hyper-Hypothermia System is a water (liquid) recirculating device providing either hypothermia, hyperthermia or normothermia treatment as determined by the health care provider.
Water is either heated or cooled depending on the need of the patient. The heated or cooled water is pumped through connecting flexible tubing to a disposable or reusable pad or blanket to provide patient therapy for a site specific external surface area or for whole body surface temperature therapy by the means of conductive heat transfer.
INTENDED USE
The Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper-Hypothermia Temperature Management Systems are used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer. The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
BENCH TESTS PERFORMED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Bench testing was performed in order to validate the design according to the company's specified design requirements, and to demonstrate the new systems are substantially equivalent to the predicate devices.
The following bench tests were performed:
- Temperature Performance Testing .
- System Safety Limit Testing (high and low limits) .
- Transportation Testing .
- Blanket Structural Integrity Testing .
In addition, the new systems meet the applicable requirements of the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements . for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
All necessary testing has been performed for the Blanketrol III and CoolBlue Hyper-Hypothermia Temperature Management Systems to assure substantial equivalence to the predicate devices.
SUBSTANTIAL EQUIVALENCE
The new devices have the same intended use as the predicates and similar technological characteristics that do not raise new types of questions of safety and effectiveness and are therefore substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cincinnati Sub-Zero c/o Mr. Steven J. Berke President and CEO 12011 Mosteller Road Cincinnati, OH 45241-1528
SEP 2 0 2010
Re: K101589
Blanketrol III Model 233 and CoolBlue Model 25-01 Hyper/Hypothermia Systems Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: September 13, 2010 Received: September 15, 2010
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
3
Page 2 - Mr. Steven J. Berke
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. 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.
Dunia R. Varner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ·
4
Indications for Use
K101589 SEP 2 0 2010
510(k) Number (if known): _ )