(8 days)
The Bair Hugger temperature management system is 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 system 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 system can be used with adult and pediatric patients.
The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700 units) and a disposable Bair Hugger forced-air blanket (various models).
This document is a 510(k) summary for a modified product labeling for the Bair Hugger Temperature Management System. It primarily focuses on regulatory approval based on substantial equivalence to previously cleared devices.
Therefore, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states:
- "The technological characteristics of the cleared devices do not change with this modification to product labeling." This indicates that no new performance studies were conducted or required, as the device's technical specifications and function remain the same. The submission is for modifying the product labeling, not for a new or significantly modified device requiring new performance evaluations.
As a result, I cannot provide the requested information from the given text.
To address your request, if this were a document detailing a new device or significant modification requiring performance studies, I would look for sections describing:
- Performance data/clinical data: This would typically include tables of results, statistical analyses, and comparisons to established benchmarks or predicate devices.
- Test methods: Descriptions of how the device was tested.
- Ground truth establishment: How the "correct" answers or outcomes were determined for the study.
- Sample sizes: The number of subjects or cases included in the study.
- Expert qualifications and adjudication: If human evaluation was part of the ground truth or study design.
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JUN 3 0 2004
SMDA Summary- Special 510(k) Modified Product Labeling
Submitted by :
Arizant Healtheare Inc. 10393 West 70" Street Eden Prairie, MN 55344 Telephone: 952-947-1200
Contact person:
David Westlin Senior Director, Regulatory Affairs and Quality Assurance
Summary date:
June 21, 2004
Device name/trade name:
Bair Hugger Temperature Management System
Common/usual name: Hyper/Hypothermia System
Classification name: System, Thermal, Regulating, DWJ
Equivalent marketed device:
Bair Hugger temperature management system (K021473, K001149, K960167, K903360, K873745).
Device description:
The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700 units) and a disposable Bair Hugger forced-air blanket (various models).
Intended use of the device
The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system 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 system 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.
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Public Health Service
Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle.
JUN 3 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arizant Healthcare Inc. c/o Mr. David Westlin Senior Director, Regulatory Affairs and Quality Assurance 10393 West 70th Street Eden Prairie, MN 55344
Re: K041686
Bair Hugger Temperature Management System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulatory System Regulatory Class: Class II (two) Product Code: DWJ Dated: June 21, 2004 Received: June 22, 2004
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 general 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 Federal Register.
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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 (QS) 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Dung R. Vo chines
( 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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Indications for Use
510(k) Number (if known):
Bair Hugger® Temperature Management System Device Name:
The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700) and a disposable Bair Hugger forced-air blanket (various models).
Indications For Use:
The Bair Hugger temperature management system is 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 system 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 system can be used with adult and pediatric patients.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
P. vochner
ision Sign-Off) sion of Cardiovascular Devices
ما 04/06/2010(k) Number_k 04/168
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§ 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).