(183 days)
No
The description focuses on a thermostatic control system and does not mention any AI or ML components.
Yes
The device is indicated for temperature reduction in patients where clinically indicated, such as in hyperthermic patients, which is a therapeutic intervention.
No
The device is described as a "thermal regulating system indicated for temperature reduction... and monitoring of patient temperature." It actively treats hyperthermia by removing heat and monitors temperature. It does not diagnose medical conditions.
No
The device description clearly lists multiple hardware components including a Control Console, body surface cooling appliances, tubing sets, and an esophageal temperature sensor. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- RapidCool System Function: The RapidCool Patient Temperature Management System directly interacts with the patient's body to regulate their temperature. It uses surface cooling appliances and an esophageal temperature sensor to achieve this. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "temperature reduction in patients where clinically indicated... and monitoring of patient temperature." This is a therapeutic and monitoring function performed on the patient, not a diagnostic test performed on a sample.
The device is a therapeutic and monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RapidCool™ Patient Temperature Management System is a thermal regulating system indicated for temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and monitoring of patient temperature.
Product codes
DWJ
Device Description
The RapidCool™ Patient Temperature Management System reduces, and/or maintains patient body temperature at a desired level by removing heat from a patient's body. The major components of the RapidCool system consist of a Control Console, body surface cooling appliances, tubing sets, and an esophageal temperature sensor. The body surface cooling appliances consist of a back cooling pad, a right axilla-cooling pad, a neck cooling pad, and a head-cooling cap. The control console supplies cold water to the surface cooling appliances, and controls the operation of the system. Tubing sets connect the control console to the surface cooling appliances. The esophageal temperature sensor is connected to the control console and is used to display and patient body temperature.
Body temperature can be reduced and/or maintained in a temperature range between 32 to 37 degrees centigrade by a thermostatic control feature of the control console. The operator can select the desired body temperature within this range.
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)
Performance data was submitted which demonstrated that the system performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 1 3 2007
510(k) Summary for the RapidCool™ Patient Temperature Management System
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | MedCool Incorporated
30 Washington Street
Wellesley, Massachusetts 02481 |
|---------------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading, MA 01864 |
| Summary Preparation Date: | January 9, 2007 |
-
- Names
| Device Name: | RapidCool™ Patient Temperature
Management System |
|----------------------|-----------------------------------------------------|
| Classification Name: | Thermal Regulating System
Product Code: DWJ |
3. Predicate Devices
The RapidCool Patient Temperature Management System is substantially equivalent to a combination of the Life Recovery Systems ThermoSuit System (K061023) and the Cincinnati Sub Zero Blanketrol (K811742).
4. Device Description
The RapidCool™ Patient Temperature Management System reduces, and/or maintains patient body temperature at a desired level by removing heat from a patient's body. The major components of the RapidCool system consist of a Control Console, body surface cooling appliances, tubing sets, and an esophageal temperature sensor. The body surface cooling appliances consist of a back cooling pad, a right axilla-cooling pad, a neck cooling pad, and a head-cooling cap. The control console supplies cold water to the surface cooling appliances, and controls the operation of the system. Tubing sets connect the control console to the surface
1
cooling appliances. The esophageal temperature sensor is connected to the control console and is used to display and patient body temperature.
Body temperature can be reduced and/or maintained in a temperature range between 32 to 37 degrees centigrade by a thermostatic control feature of the control console. The operator can select the desired body temperature within this range.
5. Indications for Use
The RapidCool Patient Temperature Management System is a thermal regulating system indicated for temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and monitoring of patient temperature.
6. Performance Data
Performance data was submitted which demonstrated that the system performs as intended.
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 13 2007
MedCool, Inc. c/o Ms. Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
Re: K070112
RapidCool™ Patient Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: June 25, 2007 Received: June 28, 2007
Dear Ms. O'Connell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Maureen O'Connell
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
R. Kochner
O 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
510(k) Number (if known):
Device Name:
RapidCool™ Patient Temperature Management System
Indications For Use:
The RapidCool™ Patient Temperature Management System is a thermal regulating system indicated for temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients, and monitoring of patient temperature.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
inima
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko Z O LLZ