MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000

K071341 · Medivance, Inc. · DWJ · Aug 3, 2007 · Cardiovascular

Device Facts

• Record ID: K071341
• Device Name: MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
• Applicant: Medivance, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Arctic Sun Model 2000 is a thermal regulating system for patient temperature management. System consists of a control module, flexible tubing, and single-use heat transfer pads applied to patient skin. A YSI 400 series temperature probe monitors patient core temperature. Control module circulates temperature-controlled water through pads to regulate patient temperature based on probe input. Used in clinical environments by healthcare professionals. Provides automated temperature control to assist in clinical decision-making regarding patient thermal status.

Clinical Evidence

Bench testing only. Included electrical safety testing per IEC601/EN60601 standards and functional safety and performance testing.

Technological Characteristics

Thermal regulating system; microprocessor-based temperature controller; YSI 400 series temperature probe; single-use heat transfer pads; water circulation system; electrical safety per IEC601/EN60601.

Indications for Use

Indicated for monitoring and controlling patient temperature in clinical settings. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Arctic Sun Temperature Management System Model 2000 (K010338)
• MediTherm II Series 5900 Hyper/Hypothermia System (K912051)
• Blanketrol II Hyper/Hypothermia System (K811742)

Submission Summary (Full Text)

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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<br>- 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

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.

## 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 [phone]. 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 [phone] or [phone] 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)

OR

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.

11. 11

Arctic Sun Model 2000