(29 days)
Not Found
No
The description details a forced-air warming system with basic controls and heating elements, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to prevent and treat hypothermia, which are therapeutic claims.
No
The device is described as a "temperature management system" that "provides forced warm air" and "can be used to prevent and treat hypothermia" and "provide patient thermal comfort." It does not mention diagnosing any medical conditions.
No
The device description clearly outlines hardware components including a portable warming unit, electrical resistance heater, fan/blower, user control interface, flexible connecting hose, and warming blankets/gowns.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prevent and treat hypothermia" and "provide patient thermal comfort." This is a therapeutic and comfort-based application, not a diagnostic one.
- Device Description: The device description details a system that provides forced warm air to a patient's skin. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Bair Hugger system is a medical device used for patient temperature management, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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 continuations exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Product codes
DWJ
Device Description
The 3MM Bair Hugger™ Temperature Management System, Model 675 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical 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 3MTM Bair Hugger™ Temperature Management System, Model 675 provides the same warming performance and safety as compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
March 30, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
3M Company Brian Kleiber Regulatory Affairs Specialist 3M Center, 2510 Conway Ave. Bldg. 275-5W-06 St. Paul, Minnesota 55144
Re: K210603
Trade/Device Name: 3MTM Bair Hugger™ Temperature Management System (Model 675) 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 Brian Kleiber:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 medical devices and radiation-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,
for Fernando Aguel Assistant Director 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
3MTM Bair HuggerTM Temperature Management System, Model 675
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 continuations 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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Image /page/3/Picture/0 description: The image shows the 3M logo in red, with the word "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 is likely used to indicate that the document or information is confidential and should not be shared with unauthorized individuals.
3MTM Bair Hugger™ Temperature Management System, Model 675
510(k) Summary
Sponsor Information:
3M Company 3M Center,2510 Conway Ave. Building 275-5W-06 St. Paul, MN 55144-1000
| Contact Person: | Brian Kleiber, Regulatory Specialist |
|---|---|
| Phone Number: | (651) 737-0195 |
| FAX Number: | (651) 737-5320 |
| eMail Address: | bkleiber@mmm.com |
Date of Summary: February 24, 2021
Device Name and Classification:
| Common or Usual Name | Patient warming system |
|---|---|
| Proprietary Name | 3M™ Bair Hugger™ Temperature Management System, |
| Model 675 | |
| Classification Name | Thermal regulating system (21 CFR § 870.5900) |
| Device Classification | Class II |
| Product Code | DWJ |
Predicate Device:
3MTM Bair Hugger™ Temperature Management System, Model 675 (K171373)
Description of Device:
The 3MM Bair Hugger™ Temperature Management System, Model 675 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.
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Image /page/4/Picture/0 description: The image shows the 3M logo in red, with the word "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 likely used to indicate that the document or information is private and should not be shared with unauthorized individuals.
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™ Temperature Management System, Model 675 has the same technological characteristics (i.e. same design, energy source) as the predicate device. In addition, nonclinical 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 3MTM Bair Hugger™ Temperature Management System, Model 675 provides the same warming performance and safety as compared to the predicate device. Additional software upgrades have been made.
Conclusion:
The 3MTM Bair Hugger™ Temperature Management System, Model 675 meets all applicable standards, has equivalent technological characteristics, and has equivalent warming performance and safety features when compared to the predicate device. The 3MTM Bair Hugger™ Temperature Management System, Model 675 performs as well as the predicate device. There are no new questions of safety or effectiveness.