(25 days)
Not Found
No
The summary describes a forced-air temperature management system and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated, which aligns with therapeutic use.
No
The device is a temperature management system used to warm or cool patients. Its intended use is therapeutic (managing patient temperature for various clinical reasons or comfort), not diagnostic (identifying diseases or conditions).
No
The device description explicitly states that the system consists of a portable forced-air temperature management unit, disposable blankets, and disposable gowns, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "temperature management system" that uses forced air and blankets/gowns to regulate patient temperature. Its intended use is for managing the temperature of patients, not for analyzing samples from the body.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the Bair Hugger family of temperature management systems falls under the category of therapeutic or supportive medical devices, not In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWJ
Device Description
The Bair Hugger family of temperature management systems consist of a portable forced-air temperature management unit, disposable Bair Hugger forced-air blankets, and disposable Bair Paws warming gowns.
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
Pre-op, intensive care unit, labor and delivery, recovery room, emergency rooms, ships, aircraft, EMT vehicles, accident sites, long-term care facilities, home health care and other areas where medical professionals warm patients.
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)
Not Found
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
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
APS, 2 4 1006
Contact person:
David Westlin Senior Director, Regulatory Affairs and Quality Assurance
Summary date:
March 31, 2006
Device name/trade name:
Bair Paws® Temperature Management System
Common/usual name:
Hyper/Hypothermia System
Classification name: System, Thermal, Regulating, DWJ
Equivalent marketed device:
Bair Hugger® Temperature Management System (K053645)
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 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.
1
Comparison of the Technological Characteristics of the New Device and Predicate Devices
The Bair Paws® Temperature Management System is substantially equivalent to the Bair Hugger® Temperature Management System (K053645).
| Features | Bair Paws Temperature
Management System | Bair Hugger Temperature
Management System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method of operation | The Bair Paws warming unit has
a blower motor and a heating
element. The warming unit
delivers warmed air through a
hose that is connected to a port in
a Bair Paws gown. | The Bair Hugger warming unit
has a blower motor and a heating
element. The warming unit
delivers warmed air through a
hose that is connected to a port in
a Bair Hugger blanket or Bair
Paws gown. |
| Alarms | Over-temperature: color indicator
light illuminates, heater and
blower shut down. | Over-temperature: red light
illuminates with audible alarm,
heater and blower shut down. |
| Areas for device use | Pre-op, intensive care unit, labor
and delivery, recovery room,
emergency rooms, ships, aircraft,
EMT vehicles, accident sites,
long-term care facilities, home
health care and other areas
where medical professionals
warm patients. | Pre-op, intensive care unit,
operating room, labor and
delivery, recovery room,
emergency rooms, ships, aircraft,
EMT vehicles, accident sites,
long-term care facilities, home
health care and other areas
where medical professionals
warm patients. |
| Intended patient
population | Adult and pediatric patients | Adult and pediatric patients |
| Patient Position | Stationary | Stationary |
| Device positioning | Can be set on table, shelf or other
hard surface; clamped to an I.V.
pole; or hung on a bed rail; or
attached to the wall using a wall
mount bracket. | Can be set on table, floor, shelf or
other hard surface; clamped to an
I.V. pole; or hung on a bed rail. |
| Materials | Plastic/metal | Plastic/metal |
| Warming unit hose | Detachable, flexible, fixed length,
washable, 1.5" diameter | Detachable, flexible, fixed length,
washable, 2.5" diameter |
Comparison of Technological Features
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2006
Arizant Healthcare Inc. c/o Mr. David Westlin Senior Director, Regulatory Affairs and Quality Assurance 10393 Westh 7011 Street Eden Prairie, MN 55344
Re: K060865
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: March 29, 2006 Received: March 30, 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 general controls provisions of the Act include requirements for annual registration. Ilsting 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 vour device in the Federal Register.
3
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 (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 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Wulwick
Image /page/3/Picture/5 description: The image contains a close-up of the word "Bra" which is likely part of a larger text or document. The text is in a serif font and appears to be printed on a white background. The lighting is even, and the focus is sharp, making the text easily readable.
ري 1 Bram D. Zuckerman, M.D.
Paris Director Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _Kرك فا كلك باعكك باعككككككككككك
Device Name: Bair Hugger® Temperature Management System
The Bair Hugger family of temperature management systems consist of portable forced-air temperature management units, disposable 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 _____________________________________________________________________________________________________________________________________________________________ (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 (ODF)
Darlene P. Lockhart
(Full Legal Name)
(Division Si- 1-Off) Division of Catalovascular Devices
510(k) Number_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Page 1 of __ i
Arizant Healtheare Inc. () 3/3 | 106
iii