ARCTIC BLAST INTRAVENOUS FLUID CHILLER

K080899 · Medivance, Inc. · NCX · Aug 7, 2008 · Cardiovascular

Device Facts

• Record ID: K080899
• Device Name: ARCTIC BLAST INTRAVENOUS FLUID CHILLER
• Applicant: Medivance, Inc.
• Product Code: NCX · Cardiovascular
• Decision Date: Aug 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.

Device Story

Arctic Blast Intravenous Fluid Chiller cools sterile IV solutions for patient temperature reduction. Device consists of heat exchanger assembly and adsorption cooling module. Heat exchanger connects to IV fluid bag and standard infusion set. Cooling module utilizes adsorption process; activated by button press; requires no external power; remains physically isolated from sterile fluid path. Used in clinical settings to facilitate therapeutic cooling. Healthcare providers administer cooled fluid to patients to achieve temperature reduction goals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Heat exchanger assembly constructed of materials standard for IV infusion sets. Cooling module utilizes adsorption process. No external power source required. Fully sealed cooling module; no direct contact with sterile fluid path.

Indications for Use

Indicated for patients requiring reduction of body temperature via the administration of cooled sterile intravenous solutions.

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

• IV Fluid Cooler / Warmer (Alsius)
• System 1025 Fast Flow Blood and Fluid Warmer (Level 1)
• Celsius Control System (InnerCool)
• Thermosuit (Life Recovery System)

Submission Summary (Full Text)

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KOrorg9

AUG - 7 2008

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

### Device Name

Arctic Blast Intravenous Fluid Chiller

## Manufacturer Name , Address and Contact Information

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

Contact: Lynne Aronson, Director RA/QA Phone: [phone] Fax:

#### Common, Classification & Proprietary Names

| Common Name: | thermal regulating system |
|----------------------|---------------------------------------------|
| Classification Name: | system, hypothermia, intravenous, cooling |
| Proprietary Name: | Arctic Blast Intravenous (IV) Fluid Chiller |

#### Device Classification

| Classification: | Class II |
|----------------------------|----------------|
| Classification Panel: | Cardiovascular |
| Classification Regulation: | 870.5900 |
| Product Code: | NCX |

#### Indications for Use

The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.

#### Device Description

The Arctic Blast Intravenous Fluid Chiller is composed of two main components: a heat exchanger assembly and an adsorption cooling module.

The sterile fluid path is incorporated in the heat exchange assembly, which consists of the heat exchanger, a spike with vented drip chamber at the heat exchanger inlet, and a spike receptacle at the heat exchanger outlet. Prior to activation, the heat exchanger assembly inlet (spike) is connected to a liter bag of sterile fluid, and the outlet (spike port) is connected to a standard commercially-available intravenous infusion set.

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The heat exchanger assembly is constructed of materials and components which are commonly used in the manufacture of commercially-available intravenous infusion sets.

The cooling module provides the cooling capability of the device via an adsorption process. The cooling module does not require an external power source. The cooling process is activated by pressing a button on the module. The cooling module is fully sealed and does not come into direct contact with the sterile fluid path.

### Predicate Devices

| Device Name | Manufacturer |
|----------------------------------------------|----------------------|
| IV Fluid Cooler / Warmer | Alsius |
| System 1025 Fast Flow Blood and Fluid Warmer | Level 1 |
| Celsius Control System | InnerCool |
| Thermosuit | Life Recovery System |

#### Substantial Equivalence

The Arctic Blast Intravenous Fluid Chiller was shown to be substantially equivalent in intended use, design, technological characteristics, materials and system features and functions to the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2008

Medivance, Inc. % Ms. Lynne Aronson Director, RA/QA 1172 Century Drive, Suite 240 Louisville, Colorado 80027

Re: K080899

Trade/Device Name: Arctic Blast Intravenous Fluid Chiller Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: July 10, 2008 Received: July 15, 2008

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 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.

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.

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## Page 2 - Ms. Lynne Aronson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Petmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark M. Wilkinson

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# STATEMENT OF INDICATIONS FOR USE (FDA Form)

510(k):

K080899

Device:

### Arctic Blast Intravenous Fluid Chiller

Indications for Use:

The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.

Prescription Use____X Use (Per 21 CFR 801.109) OR

Over-the-Counter

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alvah A. Mellers

(Division Sign-Off) (Division Sign:On)
Division of General, Restorative, Division of Neurological Devices

(Optional Format 1-2-96)

**510(k) Number**