The 3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation is part of the 3M patient temperature management system') when used with Bair Hugger™ 700 series or 675 warming unit. The system, monitored and controlled by a trained clinician, is used perioperatively to prevent and treat hypothermia.

Device Description

The 3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation is a disposable, single-patient perioperative warming gown with 3M™ Thinsulate™ Insulation. The warming gown is intended to be worn throughout the entire journey: before, during and after surgery.

Bair Hugger™ warming gowns are part of the Bair Hugger™ warming system; there are two parts to the system: the warming gown and warming unit (temperature management unit). The Universal Warming Gown is available in three sizes (small, standard, and x-large) and is intended to be used with the Bair Hugger™ 700 series or 675 warming unit. The system, monitored and controlled by a trained clinician, is used perioperatively to prevent and treat hypothermia.

The warming gown has two patient warming options: an integrated lower body insert and a removable multi-position warming blanket. The lower body insert has a lower midline hose port, and the warming blanket is to be removed from a pocket in the front upper section of the gown. The warming blanket can be used alone or in combination with the warming gown during surgery.

After surgery, the warming gown should be re-domed and used to warm the patient using the lower midline hose port.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device: the "3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation." This document focuses on proving substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating improved patient outcomes or AI performance.

Therefore, many of the requested details regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment (which are typical for AI/ML medical devices) are not applicable to this submission. This document describes a new version of a thermal regulating system, primarily undergoing performance and biocompatibility testing.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not applicable or not provided:

Acceptance Criteria and Device Performance (Based on Provided Text)

The document indicates that the device's performance was verified through specific tests. While explicit numeric acceptance criteria are not detailed in the provided excerpt, the "reported device performance" is a statement of passing these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Pass Thermal Performance per IEC-80601-2-35	Device samples passed thermal performance testing.
Pass Biocompatibility Tests: Cytotoxicity, Sensitization, Irritation per ISO 10993-1	Device samples passed cytotoxicity, sensitization, and irritation tests.

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:
- Sample Size: Not explicitly stated for performance or biocompatibility tests (e.g., how many gowns were tested). The text mentions "Device samples."
- Data Provenance: Not specified (e.g., country of origin). The tests are described as "performance testing" and "biocompatibility testing." The nature of the device (a warming gown) suggests these would be laboratory-based tests on the device itself, rather than human subject data. The submission is from 3M Company, St. Paul, Minnesota, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission focuses on physical device performance and biocompatibility, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth from patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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:
- No. This is not an AI-assisted device. The study described is performance and biocompatibility testing of a physical medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-only device. The study described is performance and biocompatibility testing of a physical medical device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Objective Test Standards: The "ground truth" for this device's performance is based on the specified international standards and their criteria for passing (e.g., IEC-80601-2-35 for thermal performance, ISO 10993-1 for biocompatibility). These are objective, measurable outcomes determined through physical and chemical testing, not clinical consensus or patient outcomes in the sense of a clinical trial.
The sample size for the training set:
- Not applicable. This type of device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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April 29, 2021

3M Company Hilary Hovde Regulatory Affairs Specialist 2510 Conway Ave. St. Paul, Minnesota 55144

Re: K210605

Trade/Device Name: 3MTM Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: February 26, 2021 Received: March 1, 2021

Dear Hilary Hovde:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette Assistant Director (Acting) DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

Device Name

3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation

Indications for Use (Describe)

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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510(k) Summary for 3MTM Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation

3M Company 3M Health Care 2510 Conway Ave. 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Contact: Hilary B. Hovde Regulatory Affairs Specialist Phone Number: (651) 736-0364

Submission Date: February 26, 2021

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Device Name and Classification

Trade Name:	3M™ Bair Hugger™ Universal Warming Gown made withThinsulate™ Insulation
Common/Usual Name:	Thermal Regulating System
Device Classification:	Class II
Classification Name:	Thermal Regulating System[21 CFR § 870.5900, DWJ]

Predicate Device

3M™ Bair Hugger™ Model 675 Total Temperature Management System, K171373

Reference Devices

Bair Paws® Temperature Management System. K060865

Indications for Use

The 3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation is part of the 3M patient temperature management system ('the system') when used with Bair Hugger 700 series or 675 warming unit. The system, monitored and controlled by a trained clinician, is used perioperatively to prevent and treat hypothermia.

Description of Device

The warming gown has two patient warming options: an integrated lower body insert and a removable multi-position warming blanket. The lower body insert has a lower midline hose port,

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TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation

and the warming blanket is to be removed from a pocket in the front upper section of the gown. The warming blanket can be used alone or in combination with the warming gown during surgery.

After surgery, the warming gown should be re-domed and used to warm the patient using the lower midline hose port.

Comparison of Technological Characteristics with the Predicate and Reference Devices

The 3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation was shown to be substantially equivalent to the 3M™ Bair Hugger™ Model 675 Total Temperature Management System cleared per K171373. 3M™ Bair Hugger™ Warming Gowns are part of the 3M™ Bair Hugger™ Temperature Management System; there are two parts to the system: the warming gown and warming unit (temperature management unit). This 510(k) is for a new warming gown which incorporates a layer of Thinsulate™ Insulation to provide added insulation. There is no change to the patient warming unit part of this system. Safety and efficacy of the new warming gown was demonstrated through biocompatibility testing and performance testing with the gown and unit used as a system as intended.

Substantial Equivalence and Summary of Studies

The difference between the subject and predicate device has been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for the 3MTM Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation.

The device performance was verified through the following tests:

. Thermal Performance Testing per IEC-80601-2-35
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process as recognized by FDA. The 3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation is categorized as a surface contacting device, with intact skin contact of limited duration (< 24 hours) in accordance with ISO 10993-1 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process. " The battery of tests included the following:
Cytotoxicity ●
. Sensitization
. Irritation

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TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Bair Hugger™ Universal Warming Gown made with Thinsulate™ Insulation

Conclusion

Based on the intended use, technological characteristics, performance data, and non-clinical tests performed, the subject device is substantially equivalent to the 3M™ Bair Hugger™ Model 675 Total Temperature Management System (cleared under K171373), Class II, product code DWJ and does not raise 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).