(69 days)
The Bair Hugger family of temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.
The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.
This document K053645 is a Special 510(k) for modified product labeling of the Bair Hugger family of Temperature Management Systems. It states that the "Technological characteristics of the cleared devices do not change with this modification to product labeling." This type of submission, concerning only labeling changes and explicitly stating no change in technological characteristics, typically does not involve new performance studies or acceptance criteria beyond ensuring the new labeling accurately reflects the existing, cleared device. Therefore, the information requested in the prompt regarding acceptance criteria and performance studies is not present in this document.
To answer your specific questions based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in this Special 510(k) submission, as it relates to a labeling modification, not a new device or significant performance change study.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for this type of submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of submission.
- 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: Not applicable. The device is a thermal regulating system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a thermal regulating system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for this type of submission.
- The sample size for the training set: Not applicable for this type of submission.
- How the ground truth for the training set was established: Not applicable for this type of submission.
{0}------------------------------------------------
SMDA Summary-- Special 510(k) Modified Product Labeling
Submitted by:
Arizant Healthcare Inc. 10393 West 70th Street Eden Prairie, MN 55344 Telephone: 952-947-1200
Contact person:
David Westlin Senior Director, Regulatory Affairs and Quality Assurance
Summary date: December 30, 2005
Device name/trade name: Bair Hugger family of Temperature Management System
Common/usual name: Hyper/Hypothermia System
Classification name: System, Thermal, Regulating, DWJ
Equivalent marketed device:
Bair Hugger temperature management system (K041686).
Device description:
The Bair Hugger family of temperature management systems consist of a portable forcedair temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.
Intended use of the device
The Bair Hugger temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management systems can be used with adult and pediatric patients.
Technological characteristics
The technological characteristics of the cleared devices do not change with this modification to product labeling.
{1}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 9
Arizant Healthcare, Inc. c/o Mr. David Westlin Senior Director of Regulatory Affairs and Quality Assurance 10393 West 70th Street Eden Prairie, MN 55344
Re: K053645
Bair Hugger® Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (Two) Product Code: DWJ Dated: February 14, 2006 Received: February 17, 2006
Dear Mr. Westlin:
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 gencral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
{2}------------------------------------------------
Page 2 - Mr. David Westlin
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
Sincerely vours.
Dana R. Vochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K05364 كي
Device Name: Bair Hugger® Temperature Management System
The Bair Hugger family of temperature management systems consist of portable forced-air The Dail Trugger family of temperature Bair Hugger forced-air blankets and Bair Paws warming gowns.
Indications For Use:
The Bair Hugger family of temperature management systems are indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management systems can be used with adult and pediatric patients.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Isma R. Jaimes
(Print Name)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko5 36 4 ك
Arizant Healthcare Inc. 12/30/05
§ 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).