MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS

K053645 · Arizant Healthcare, Inc. · DWJ · Mar 9, 2006 · Cardiovascular

Device Facts

• Record ID: K053645
• Device Name: MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
• Applicant: Arizant Healthcare, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Bair Hugger temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management systems can be used with adult and pediatric patients.

Device Story

Bair Hugger temperature management system consists of portable forced-air warming unit, disposable forced-air blankets, and disposable warming gowns. Device provides thermal regulation or comfort to adult and pediatric patients. System operates by circulating forced air through blankets or gowns to manage patient body temperature. Used in clinical settings to treat hyper/hypothermia or maintain normothermia. Healthcare providers operate the unit to adjust temperature settings based on clinical need. Output is controlled thermal air delivery, which helps stabilize patient temperature or improve comfort during medical procedures or recovery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System comprises a portable forced-air warming unit, disposable forced-air blankets, and disposable warming gowns. Operates via forced-air convection. Class II device (21 CFR 870.5900).

Indications for Use

Indicated for adult and pediatric patients who are hyperthermic, hypothermic, or normothermic requiring induced temperature therapy or thermal comfort.

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

• Bair Hugger temperature management system (K041686)

Submission Summary (Full Text)

{0}------------------------------------------------

K053645

# SMDA Summary-- Special 510(k) Modified Product Labeling

## Submitted by:

Arizant Healthcare Inc. 10393 West 70th Street Eden Prairie, MN 55344 Telephone: [phone]

### Contact person:

David Westlin Senior Director, Regulatory Affairs and Quality Assurance

Summary date: December 30, 2005

Device name/trade name: Bair Hugger family of Temperature Management System

Common/usual name: Hyper/Hypothermia System

Classification name: System, Thermal, Regulating, DWJ

# Equivalent marketed device:

Bair Hugger temperature management system (K041686).

#### Device description:

The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.

# Intended use of the device

The Bair Hugger temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management systems can be used with adult and pediatric patients.

## Technological characteristics

The technological characteristics of the cleared devices do not change with this modification to product labeling.

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 9

Arizant Healthcare, Inc. c/o Mr. David Westlin Senior Director of Regulatory Affairs and Quality Assurance 10393 West 70th Street Eden Prairie, MN 55344

Re: K053645

Bair Hugger® Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (Two) Product Code: DWJ Dated: February 14, 2006 Received: February 17, 2006

Dear Mr. Westlin:

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 gencral 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

{2}------------------------------------------------

Page 2 - Mr. David Westlin

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 (OS) 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

Sincerely vours.

Dana R. Vochner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known): K05364 كي

Device Name: Bair Hugger® Temperature Management System

The Bair Hugger family of temperature management systems consist of portable forced-air The Dail Trugger family of temperature Bair Hugger forced-air blankets and Bair Paws warming gowns.

Indications For Use:

The Bair Hugger family of temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

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)

Isma R. Jaimes
(Print Name)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko5 36 4 ك

Arizant Healthcare Inc. 12/30/05