3M Bair Hugger Model 675 Total Temperature Management System

K171373 · 3M Company · DWJ · Oct 10, 2017 · Cardiovascular

Device Facts

• Record ID: K171373
• Device Name: 3M Bair Hugger Model 675 Total Temperature Management System
• Applicant: 3M Company
• Product Code: DWJ · Cardiovascular
• Decision Date: Oct 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Bair Hugger temperature management system is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.

Device Story

System comprises portable warming unit, flexible hose, and warming blanket/gown. Unit utilizes electrical resistance heater and fan/blower to generate forced warm air; air flows through hose into blanket/gown. Blanket/gown features small perforations to disperse air over patient skin. Used in clinical settings to prevent/treat hypothermia or provide thermal comfort. Controlled via user interface on unit; can provide ambient or warmed air. Affects patient body temperature; benefits include maintenance of normothermia and improved comfort.

Clinical Evidence

Bench testing only. Performance and safety validated against IEC 80601-2-35 standards to demonstrate equivalence to predicate device.

Technological Characteristics

Forced-air warming system; electrical resistance heater; fan/blower; flexible hose; warming blankets/gowns with perforations. Complies with IEC 80601-2-35. Portable unit with optional rolling cart.

Indications for Use

Indicated for adult and pediatric patients to prevent and treat hypothermia or provide 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

• Augustine Medical Bair Hugger Model 750 Total Temperature Management System (K001149)

Reference Devices

• Augustine Medical Bair Hugger Temperature Management System (K021473)

Submission Summary (Full Text)

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October 10, 2017

3M Company Jon Platt Regulatory Affairs Manager 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144

# Re: K171373

Trade/Device Name: 3M Bair Hugger Model 675 Total Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: DWJ Dated: July 7, 2017 Received: July 12, 2017

## Dear Jon Platt:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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 of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Nicole G. Ibrahim -S

for 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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| Form Approved: OMB No. | 0910-0120 |
|--------------------------|------------------|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. | |

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

| 510(k) Number (if known) | K171373 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | 3M Bair Hugger Model 675 Total Temperature Management System |
| Indications for Use (Describe) | The Bair Hugger temperature management system is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients. |

| Type of Use (Select one or both, as applicable) | <div><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> <div><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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3M™ Bair Hugger™ Model 675 Total Temperature Management System

#### 5.0 510(k) Summary

#### Sponsor Information:

3M Health Care 3M Center, Building 275-5W-06 St. Paul, MN 55144-1000

| Contact Person: | Jon Platt, Regulatory Affairs Manager |
|-----------------|---------------------------------------|
| Phone Number: | [phone] |
| FAX Number: | [phone] |
| eMail Address: | [e-mail] |

October 10, 2017 Date of Summary:

#### Device Name and Classification:

| Common or Usual Name | Patient warming system |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | 3MTM Bair HuggerTM Model 675 Total Temperature<br>Management System |
| Classification Name | Thermal regulating system (21 CFR § 870.5900) |
| Performance Standards | IEC 80601-2-35 Medical electrical equipment - Part 2-<br>35: Particular requirements for the basic safety and<br>essential performance of heating devices using blankets,<br>pads or mattresses and intended for heating in medical<br>use |

## Predicate Device:

Augustine Medical Bair Hugger Model 750 Total Temperature Management System, K001149.

Relevant chronological information regarding the predicate device

- K001149 was cleared on September 6, 2000 by Augustine Medical. .
- In 2003 the Augustine Medical company name was changed to Arizant. ●
- In October 2010 3M purchased Arizant. 3M is the current owner of this ● 510(k) and the Bair Hugger™ brand name and its products.

## Equivalent Marketed Device:

Augustine Medical Bair Hugger Temperature Management System K021473.

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Image /page/4/Picture/0 description: The image shows the 3M logo in red, with the text "Confidential" written in black below it. The 3M logo is a stylized version of the number "3" followed by the letter "M". The word "Confidential" is written in a simple, sans-serif font. The logo and text are aligned vertically, with the logo centered above the text.

# Description of Device:

The 3MTM Bair Hugger™ Model 675 Total Temperature Management System consists of a Model 675 portable warming unit (with optional rolling cart) along with a 3M Bair Hugger warming blanket or warming gown. The Bair Hugger warming unit provides forced warm air using an electrical resistance heater, fan/blower and a user control interface. Warmed air flows from the warming unit into a Bair Hugger warming blanket or warming gown by means of a flexible connecting hose. The Bair Hugger warming blanket or warming gown is placed over, around or underneath the patient. Small perforations in the blanket or gown allows the forced warm air to be gently dispersed over a patient's skin to prevent and treat hypothermia, and/or to provide patient thermal comfort. The warming unit may be controlled to provide only ambient (non-warmed) air.

## Indications for Use:

The Bair Hugger temperature management system is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.

## Comparative Data for Determining Substantial Equivalence of the New Device to the Predicate Device:

Information provided in this 510(k) submission documents that the 3MTM Bair Hugger™ Model 675 Total Temperature Management System has the same technological characteristics (i.e. same design, materials, chemical composition, and energy source) as the predicate device. In addition, nonclinical bench testing to IEC 80601-2-35, Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use documents that the 3M™ Bair Hugger™ Model 675 Total Temperature Management System provides the same warming performance and same safety features as the predicate device.

# Conclusion:

The 3M™ Bair Hugger™ Model 675 Total Temperature Management System has been bench tested to equivalent safety and performance standards, has equivalent technological characteristics, and has equivalent warming performance and safety features when compared to the predicate device. The 3MTM Bair Hugger™ Model 675 Total Temperature Management System performs as well as the predicate device. There are no new questions of safety or effectiveness.