The Arctic Sun Temperature Management System is a device used to monitor and control patient temperature. It consists of single-use heat transfer pads, which are adhered to areas of the patient's skin, and a control module that circulates temperature-controlled water. The control module is connected to the pads by flexible tubing. A commercially available temperature probe connected to the control module senses the patient's core temperature. The system can control the patient's core temperature by altering the temperature of the circulating water.

AI/ML Overview

The provided text is a 510(k) summary for the Arctic Sun™ Temperature Management System, Model 2000. It details the device's purpose, comparison to predicate devices, and conclusions about safety and effectiveness. However, it does not include specific information about acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for an AI/ML medical device.

Here's an analysis based on the limited information provided and what is missing:

The document describes a thermal regulating system, not an AI/ML device. Therefore, the questions related to AI/ML specific studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission.

The "study" mentioned is primarily focused on electrical safety and functional performance testing in accordance with existing standards, rather than a clinical study evaluating diagnostic or prognostic accuracy with a defined ground truth.

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

Acceptance Criteria (Implied)	Reported Device Performance
Electrical safety in accordance with IEC601/EN60601 series.	Tested and demonstrated compliance.
Functional safety and performance as a thermal regulating system.	Performs as intended; raises no new safety or effectiveness issues.
Substantial equivalence to predicate devices.	Determined to be substantially equivalent to K010338, K912051, K811742.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not explicitly stated. The testing described is for electrical safety and functional performance of the device unit, not clinical data involving patient test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a thermal regulating system, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See #3.

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. This is not an AI/ML device, so an MRMC study is not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of device, ground truth relates to the accuracy of temperature regulation and safety, established through engineering and performance testing against defined specifications, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of what the document does indicate about the "study":

The "study" referred to in the document is primarily engineering and performance testing of the device's control unit.

Testing Scope: Electrical safety testing (IEC601/EN60601 series) and functional safety and performance testing.
Conclusion: Based on this testing and comparison to predicate devices, the Arctic Sun™ Temperature Management System, Model 2000, performs as intended and raises no new safety or effectiveness issues, supporting its substantial equivalence claim.

Summary

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AUG - 3 2007

K071341

11. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION Premarket Notification [510(K)] Summary

(per 21 CFR 807.92)

Company Name

Medivance, Inc. 1172 Century Drive. Suite 240 Louisville, Colorado 80027

Contact Person:	Lynne Aronson
	Director, Regulatory Affairs and Quality Assurance
Telephone:	303-926-1917
Facsimile:	303-926-1924

Device Name

Trade/Proprietary Name:Arctic Sun™ Temperature Management System, Model 2000 Common/Usual Name: Hypo/Hyperthermia System Classification Name: System, Thermal Regulating (per 21 CFR 870.5900)

Predicate Devices

The Arctic Sun™ Temperature Management System, Model 200, is substantially equivalent to the following predicate devices:

Arctic Sun Temperature Management System- Model 2000	Medivance, Inc.	K010338
MediTherm II Series 5900 Hyper/Hypothermia System	Gaymar Industries	K912051
Blanketrol II Hyper/Hypothermia System	Cincinnati Sub Zero	K811742

Intended use of the device

The Arctic Sun Temperature Management System Model 2000 is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Description of the Device

Summary of the technological characteristics of the device compared to the predicate device.

The Arctic Sun Temperature Management System Model 2000 and the above referenced predicate devices are thermal regulating systems as defined in 21 CFR 870.5900. These external systems consist of a device that is placed in contact with the patient and a temperature controller for the device. These devices utilize pads in contact with the patient. In these

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devices, the microprocessor-based temperature controllers circulate water through the pads to regulate the patient's temperature. Patient temperature is monitored by YS1 400 series temperature probe.

Testing

Testing of the Arctic Sun Temperature Management System, Model 2000 Control Unit, included electrical safety testing in accordance with the IEC601/EN60601 series of standards and functional safety and performance testing.

Conclusions

Based upon the testing and comparison to the predicate device, the Arctic Sun Temperature Management System, consisting of the modified Arctic Sun™ Model 2000 Control Unit, performs as intended and raises no new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2007

Medivance, Inc. c/o Ms. Lynne Aronson Director, Regulatory Affairs and Quality Assurance 1172 Century Drive, Suite 240 Louisville, CO 80027

Re: K071341

Artic Sun® Temperature Management System - Model 2000 Control Unit Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: July 13, 2007 Received: July 16, 2007

Dear Ms. Aronson:

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. Iisting 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. Lynne Aronson

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 yours,

Duma R. Vochner

A 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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5. STATEMENT OF INDICATIONS FOR USE (FDA FORM)

510(k):

1341

Device:

Arctic Sun Temperature Management System

Indications for Use:

The Arctic Sun™ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Prescription Use × (Per 21 CFR 801.109)

Over-the-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mura R. de Mines

sion Sign-Off Division of Cardiovascular Devices

510(k) Number K07134

(Optional Format 1-2-96)

Medivance, Inc.

Arctic Sun Model 2000

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).