ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000

K101092 · Medivance, Inc. · DWJ · Jul 16, 2010 · Cardiovascular

Device Facts

• Record ID: K101092
• Device Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
• Applicant: Medivance, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jul 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Arctic Sun Temperature Management System (Model 5000) is a thermoregulatory device for patient temperature control. System comprises a control module and disposable ArcticGel Pads. Input: patient temperature via connected probe. Operation: internal control algorithm automatically adjusts circulating water temperature (4°C to 42°C) through pads to achieve clinician-set target (32°C to 38.5°C). Output: heat exchange between water and patient to maintain target temperature. Used in clinical environments; operated by healthcare professionals. Model 5000 features an integrated PC with color GUI and touchscreen, replacing previous LCD/membrane interface. Output allows clinicians to monitor and manage patient thermal state, potentially benefiting patients requiring temperature regulation.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included full system software, performance, functional, and inspection testing. Testing confirmed functionality of the new GUI and its communication with internal control and monitor processors.

Technological Characteristics

Thermal regulating system consisting of a control module and disposable ArcticGel Pads. Circulates water (4°C-42°C) for heat exchange. Model 5000 features an integrated PC with color GUI and touchscreen. Software-based control algorithm manages patient temperature feedback loop. Class II device.

Indications for Use

Indicated for monitoring and controlling patient temperature in clinical settings.

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 (K010338)
• Arctic Sun Temperature Management System Model 2000 (K071341)

Submission Summary (Full Text)

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K101092

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

### Company Name

Medivance, Inc. 321 South Taylor Avenue, Suite 200 Louisville, Colorado 80027

JUL 1 32010

| 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 5000, is substantially equivalent to the following predicate devices:

| Arctic Sun Temperature Management System | Medivance, Inc. | K010338 |
|------------------------------------------|-----------------|---------|
| - Model 2000 | | K071341 |

#### Intended use of the device

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

#### Description of the Device

The Arctic Sun Temperature Management System is a thermoregulatory device that monitors and controls patient temperature within a range of 32°C to 38.5 C (89.6°F to 101.3 F). The Arctic Sun System consists of the Arctic Sun Control Module and disposable ArcticGel Pads.

A patient temperature probe connected to the Control Module provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician.

The Arctic Sun pulls temperature-controlled water ranging between 4°C and 42°C (39.2°F and 107.6°F) through the ArcticGel Pads, resulting in heat exchange between the water and the patient.

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

The Arctic Sun Temperature Management System Model 5000 includes the following modifications:

- . Changed user interface from a LCD with membrane switch to an integrated PC with color graphical user interface (GUI) and touch screen, which also provides for the following new device features:
- . New streamlined industrial design of the console:
- Associated software modifications required to implement the new graphical user I interface and console configuration.

### Testing

Full system software, performance, functional, and inspection verifications were performed on the Arctic Sun Model 5000.

Design verification of the system requirements and software validation of the control and monitor processors software requirements involved repeating the same or similar testing conducted on the predicate Arctic Sun Model 2000. Additionally, design verification and software validation of the new control panel software requirements was performed that confirmed functionality of the new control panel graphic user interface and the associated software, as well as communications with the internal control and monitor processors.

The verification and validation test results demonstrate that the new control panel graphic user interface functions as designed and the Arctic Sun Model 5000 is safe and effective for its intended use.

#### Conclusions

Based upon the testing and comparison to the predicate device, the Arctic Sun Temperature Management System performs as intended and raises no new safety or effectiveness issues.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 1 6 2010

Medivance c/o Ms. Lynne Aronson Director, Regulatory Affairs and Quality Assurance 321 South Taylor Avenue Suite 200 Louisville, CO 80027

Re: K101092

Arctic Sun® Temperature Management System - Model 5000 Control Unit Regulation Number: 21 CFR 870.5900 Regulation Name: System, Thermal Regulating Regulatory Class: Class II Product Code: DWJ Dated: June 1, 2010 Received: June 2, 2010

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, 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 additional controls. Existing major regulations affecting your device can be

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Page 2 - Ms. Lynne Aronson

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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

R. vacher

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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# STATEMENT: INDICATION FOR USE

510 (k) Number: K101092

Arctic Sun Temperature Management System Device Name:

# Indications for Use:

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

Prescription Use Over the Counter Use X (Part 21 CFR 801 Subpart D) and/or (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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