3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
Device Facts
| Record ID | K210605 |
|---|---|
| Device Name | 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation |
| Applicant | 3M Company |
| Product Code | DWJ · Cardiovascular |
| Decision Date | Apr 29, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5900 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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 Story
Disposable perioperative warming gown; incorporates Thinsulate™ insulation for added thermal retention. Used as part of 3M Bair Hugger™ temperature management system; requires connection to Bair Hugger™ 700 series or 675 warming unit. Features integrated lower body insert and removable multi-position warming blanket; worn by patient before, during, and after surgery. Clinician operates warming unit to deliver forced-air heat to gown; gown distributes heat to patient to prevent/treat hypothermia. Re-doming of gown allows post-operative warming via lower midline hose port. Benefits include maintenance of normothermia during surgical journey.
Clinical Evidence
Bench testing only. Performance verified via thermal performance testing per IEC 80601-2-35. Biocompatibility testing conducted per ISO 10993-1 for surface-contacting devices with limited duration (<24 hours) contact, including cytotoxicity, sensitization, and irritation tests.
Technological Characteristics
Disposable warming gown with Thinsulate™ insulation. System utilizes forced-air warming via external unit (Bair Hugger™ 700 series or 675). Thermal performance tested per IEC 80601-2-35. Biocompatibility per ISO 10993-1. Available in small, standard, and x-large sizes.
Indications for Use
Indicated for perioperative prevention and treatment of hypothermia in patients requiring temperature management, monitored by a trained clinician.
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
- 3M™ Bair Hugger™ Model 675 Total Temperature Management System (K171373)
Reference Devices
- Bair Paws® Temperature Management System (K060865)
Submission Summary (Full Text)
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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)
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.
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 with<br>Thinsulate™ Insulation |
|------------------------|-----------------------------------------------------------------------------|
| Common/Usual Name: | Thermal Regulating System |
| Device Classification: | Class II |
| Classification Name: | Thermal Regulating System<br>[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 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,
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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.
