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 Description

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.

AI/ML Overview

Based on the provided text, the device in question is the 3M Bair Hugger Model 675 Total Temperature Management System, which is a medical device designed to prevent and treat hypothermia and provide thermal comfort. This is not an AI/ML powered device, so many of the requested criteria related to AI/ML software validation (like MRMC studies, training/test set details, expert ground truth adjudication) are not applicable to this submission.

The acceptance criteria and the study proving the device meets them are focused on demonstrating substantial equivalence to an existing predicate device through nonclinical bench testing to recognized performance standards.

Here's a breakdown of the requested information based on the provided document, with notes where information is not applicable (N/A) due to the nature of the device:

Acceptance Criteria and Device Performance (Based on "Comparative Data for Determining Substantial Equivalence")

The acceptance criteria are implicitly that the new device performs "as well as" and has "equivalent" safety and performance features as the predicate device, specifically regarding warming performance and safety.

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Technological Characteristics	Equivalent design, materials, chemical composition, and energy source as the predicate device (Augustine Medical Bair Hugger Model 750 Total Temperature Management System, K001149).	The submission documents that the 3M™ 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.
Performance - Warming	Demonstrate "equivalent warming performance" to the predicate device. This is assessed via nonclinical bench testing conforming to IEC 80601-2-35.	Nonclinical bench testing to IEC 80601-2-35 documents that the 3M™ Bair Hugger™ Model 675 Total Temperature Management System provides the same warming performance as the predicate device.
Safety Features	Demonstrate "equivalent safety features" to the predicate device. This is assessed via nonclinical bench testing conforming to IEC 80601-2-35.	Nonclinical bench testing to IEC 80601-2-35 documents that the 3M™ Bair Hugger™ Model 675 Total Temperature Management System provides the same safety features as the predicate device.
Overall Equivalence	No new questions of safety or effectiveness are raised compared to the predicate device. The device should perform "as well as" the predicate device.	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. There are no new questions of safety or effectiveness.

Study Details:

A table of acceptance criteria and the reported device performance:
- See table above.
Sample sizes used for the test set and the data provenance:
- This submission relies on nonclinical bench testing to international standards (IEC 80601-2-35). Therefore, "sample size" in the context of human data or AI test sets is not applicable. The "test set" would refer to the physical units of the device tested in the lab. The document does not specify the number of units tested.
- Data Provenance: The testing was nonclinical bench testing, presumably conducted by the manufacturer (3M Company). The document does not specify the country of origin of the data, but 3M Company is located in St. Paul, Minnesota, USA. The testing is retrospective in the sense that it evaluates a completed device design against established standards and a predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a hardware medical device; the "ground truth" for its performance is established through objective physical measurements and adherence to engineering and safety standards, not through expert human interpretation as would be the case for an AI diagnostic device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for establishing human consensus ground truth in image analysis or similar tasks. This is a nonclinical bench test of a physical device.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device does not involve human readers or AI assistance. It's a stand-alone patient warming system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. While the device itself operates "standalone" in providing warmth, it's not an algorithm in the sense of AI/ML software. The performance demonstrated is the standalone performance of the physical device as measured by bench testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance and safety is its adherence to established engineering and safety standards (specifically IEC 80601-2-35) and its direct equivalency in functional characteristics (warming performance) and safety features to the predicate device, as determined by objective physical measurements during bench testing.
The sample size for the training set:
- N/A. This is not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established:
- N/A. Not an AI/ML algorithm.

Summary of Approach:

The regulatory strategy for the 3M Bair Hugger Model 675 Total Temperature Management System was to demonstrate substantial equivalence to a previously cleared predicate device (Augustine Medical Bair Hugger Model 750 Total Temperature Management System, K001149). This was achieved primarily through:

Comparison of Technological Characteristics: Showing the new device has the same design, materials, chemical composition, and energy source as the predicate.
Nonclinical Bench Testing: Performing tests according to the recognized international standard IEC 80601-2-35 to objectively demonstrate equivalent warming performance and safety features compared to the predicate device.

The FDA's clearance (K171373) confirms that, based on this evidence, the device is considered substantially equivalent and raises no new questions of safety or effectiveness.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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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:	(651) 736-1850
FAX Number:	(651) 737-5320
eMail Address:	jcplatt1@mmm.com

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 TemperatureManagement System
Classification Name	Thermal regulating system (21 CFR § 870.5900)
Performance Standards	IEC 80601-2-35 Medical electrical equipment - Part 2-35: Particular requirements for the basic safety andessential performance of heating devices using blankets,pads or mattresses and intended for heating in medicaluse

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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Description of Device:

Indications for Use:

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.

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
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.(b)
Classification. Class II (performance standards).