BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM

K041686 · Arizant Healthcare, Inc. · DWJ · Jun 30, 2004 · Cardiovascular

Device Facts

• Record ID: K041686
• Device Name: BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
• Applicant: Arizant Healthcare, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Bair Hugger temperature management system is 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 system 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 system can be used with adult and pediatric patients.

Device Story

System consists of portable forced-air temperature management unit (series 500 or 700) and disposable forced-air blanket; provides thermal regulation or comfort to patients. Used in clinical settings; operated by healthcare professionals. Device delivers warmed or cooled air through disposable blankets to patient surface to manage body temperature or provide comfort. No changes to technological characteristics in this modification.

Clinical Evidence

No clinical data provided; this is a labeling modification.

Technological Characteristics

Forced-air temperature management unit (series 500 or 700) and disposable forced-air blankets. Thermal regulating system (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 (K021473)
• Bair Hugger temperature management system (K001149)
• Bair Hugger temperature management system (K960167)
• Bair Hugger temperature management system (K903360)
• Bair Hugger temperature management system (K873745)

Submission Summary (Full Text)

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# JUN 3 0 2004

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

#### Submitted by :

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

#### Contact person:

David Westlin Senior Director, Regulatory Affairs and Quality Assurance

#### Summary date:

June 21, 2004

#### Device name/trade name:

Bair Hugger Temperature Management System

Common/usual name: Hyper/Hypothermia System

Classification name: System, Thermal, Regulating, DWJ

#### Equivalent marketed device:

Bair Hugger temperature management system (K021473, K001149, K960167, K903360, K873745).

#### Device description:

The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700 units) and a disposable Bair Hugger forced-air blanket (various models).

#### Intended use of the device

The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system 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 system 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.

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Public Health Service

Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle.

JUN 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041686

Bair Hugger Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulatory System Regulatory Class: Class II (two) Product Code: DWJ Dated: June 21, 2004 Received: June 22, 2004

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 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.

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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 (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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Dung R. Vo chines

( 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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## Indications for Use

510(k) Number (if known):

Bair Hugger® Temperature Management System Device Name:

The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700) and a disposable Bair Hugger forced-air blanket (various models).

Indications For Use:

The Bair Hugger temperature management system is 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 system 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 system can be used with adult and pediatric patients.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

P. vochner

ision Sign-Off) sion of Cardiovascular Devices

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