BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850

K060865 · Arizant Healthcare, Inc. · DWJ · Apr 24, 2006 · Cardiovascular

Device Facts

• Record ID: K060865
• Device Name: BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
• Applicant: Arizant Healthcare, Inc.
• Product Code: DWJ · Cardiovascular
• Decision Date: Apr 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Bair Paws Temperature Management System is a forced-air warming device. System consists of a portable warming unit with a blower motor and heating element, a flexible hose, and disposable warming gowns. Operated by medical professionals in clinical settings (pre-op, ICU, L&D, recovery, ER, transport) and home health care. Warmed air is delivered through the hose into the gown to warm the patient. Device provides thermal regulation or comfort. Safety features include an over-temperature indicator light that triggers heater and blower shutdown if limits are exceeded. Benefits include maintenance of normothermia or patient comfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Forced-air thermal regulating system. Components: blower motor, heating element, flexible hose (1.5" diameter), and disposable warming gowns. Materials: plastic/metal. Power source: electrical. Positioning: table, shelf, I.V. pole, bed rail, or wall mount. Safety: over-temperature indicator light with automatic heater/blower shutdown.

Indications for Use

Indicated for adult and pediatric patients experiencing hyperthermia, hypothermia, or requiring normothermic maintenance/localized temperature therapy for clinical indications 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 (K053645)

Submission Summary (Full Text)

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K060865

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

#### Submitted by:

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

APS, 2 4 1006

#### Contact person:

David Westlin Senior Director, Regulatory Affairs and Quality Assurance

## Summary date:

March 31, 2006

# Device name/trade name:

Bair Paws® Temperature Management System

## Common/usual name:

Hyper/Hypothermia System

## Classification name: System, Thermal, Regulating, DWJ

## Equivalent marketed device:

Bair Hugger® Temperature Management System (K053645)

### 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 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.

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## Comparison of the Technological Characteristics of the New Device and Predicate Devices

The Bair Paws® Temperature Management System is substantially equivalent to the Bair Hugger® Temperature Management System (K053645).

| Features | Bair Paws Temperature<br>Management System | Bair Hugger Temperature<br>Management System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method of operation | The Bair Paws warming unit has<br>a blower motor and a heating<br>element. The warming unit<br>delivers warmed air through a<br>hose that is connected to a port in<br>a Bair Paws gown. | The Bair Hugger warming unit<br>has a blower motor and a heating<br>element. The warming unit<br>delivers warmed air through a<br>hose that is connected to a port in<br>a Bair Hugger blanket or Bair<br>Paws gown. |
| Alarms | Over-temperature: color indicator<br>light illuminates, heater and<br>blower shut down. | Over-temperature: red light<br>illuminates with audible alarm,<br>heater and blower shut down. |
| Areas for device use | Pre-op, intensive care unit, labor<br>and delivery, recovery room,<br>emergency rooms, ships, aircraft,<br>EMT vehicles, accident sites,<br>long-term care facilities, home<br>health care and other areas<br>where medical professionals<br>warm patients. | Pre-op, intensive care unit,<br>operating room, labor and<br>delivery, recovery room,<br>emergency rooms, ships, aircraft,<br>EMT vehicles, accident sites,<br>long-term care facilities, home<br>health care and other areas<br>where medical professionals<br>warm patients. |
| Intended patient<br>population | Adult and pediatric patients | Adult and pediatric patients |
| Patient Position | Stationary | Stationary |
| Device positioning | Can be set on table, shelf or other<br>hard surface; clamped to an I.V.<br>pole; or hung on a bed rail; or<br>attached to the wall using a wall<br>mount bracket. | Can be set on table, floor, shelf or<br>other hard surface; clamped to an<br>I.V. pole; or hung on a bed rail. |
| Materials | Plastic/metal | Plastic/metal |
| Warming unit hose | Detachable, flexible, fixed length,<br>washable, 1.5" diameter | Detachable, flexible, fixed length,<br>washable, 2.5" diameter |

## Comparison of Technological Features

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2006

Arizant Healthcare Inc. c/o Mr. David Westlin Senior Director, Regulatory Affairs and Quality Assurance 10393 Westh 7011 Street Eden Prairie, MN 55344

Re: K060865

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: March 29, 2006 Received: March 30, 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 general controls provisions of the Act include requirements for annual registration. Ilsting 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 vour 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]. 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.

R. Wulwick

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ري 1 Bram D. Zuckerman, M.D.
Paris Director 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): _Kرك فا كلك باعكك باعككككككككككك

Device Name: Bair Hugger® Temperature Management System

The Bair Hugger family of temperature management systems consist of portable forced-air temperature management units, disposable 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 _____________________________________________________________________________________________________________________________________________________________ (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 (ODF)

Darlene P. Lockhart
(Full Legal Name)

(Division Si- 1-Off) Division of Catalovascular Devices

510(k) Number_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

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