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.

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.

AI/ML Overview

The provided text describes the RapidCool™ Patient Temperature Management System, which is a thermal regulating system. It outlines the device's description, indications for use, and a statement about performance data, but does not contain the detailed study information required to answer all parts of your request.

The document states: "Performance data was submitted which demonstrated that the system performs as intended." However, it does not elaborate on the specific acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth methods.

Here's a breakdown of what can be extracted and what is missing based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the document. The general indication is "temperature reduction in patients where clinically indicated" and "monitoring of patient temperature." Specific numerical or performance targets (e.g., cooling rate, accuracy of temperature maintenance, or deviation from a set point) are not provided.
Reported Device Performance: The document only states: "Performance data was submitted which demonstrated that the system performs as intended." No specific quantitative results or performance metrics are reported in this summary.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not mentioned in the provided text.
Data Provenance: Not mentioned in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document doesn't detail any study involving human experts establishing ground truth.

4. Adjudication method for the test set

This information is not provided as no specific study involving adjudication is described.

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

Not applicable/Not mentioned. This device is a temperature management system, not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm in the context of typical AI medical device studies. The performance assessment would focus on the device's physical function. While the system has "thermostatic control features," the performance reported is not about an "algorithm only" in the sense of AI.

7. The type of ground truth used

Not explicitly stated. For a thermal regulating system, "ground truth" would likely refer to the actual patient temperature achieved or maintained, perhaps measured by a highly accurate reference thermometer, compared against the device's readings and control capabilities. However, the document does not specify.

8. The sample size for the training set

Not applicable/Not mentioned. This device does not appear to be an AI/machine learning device that requires a "training set" in the traditional sense. Its function is based on physical principles of heat exchange and thermostatic control.

9. How the ground truth for the training set was established

Not applicable/Not mentioned for the same reasons as #8.

In summary, the provided 510(k) summary is a high-level document that confirms performance data was submitted, but it lacks the detailed description of the performance study and acceptance criteria that you are requesting.

Summary

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K070112

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 Incorporated30 Washington StreetWellesley, Massachusetts 02481
Contact Person:	Maureen O'ConnellO'Connell Regulatory Consultants, Inc.5 Timber LaneNorth Reading, MA 01864
Summary Preparation Date:	January 9, 2007

1. Names

Device Name:	RapidCool™ Patient TemperatureManagement System
Classification Name:	Thermal Regulating SystemProduct 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

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cooling appliances. The esophageal temperature sensor is connected to the control console and is used to display and patient body temperature.

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

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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.

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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

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Indications for Use

510(k) Number (if known):

Device Name:

RapidCool™ Patient Temperature Management System

Indications For Use:

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)

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko Z O LLZ

Regulation Number and Section

§ 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).