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.

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.

AI/ML Overview

The provided document (K060865) is a Special 510(k) Modified Product Labeling submission for the Bair Paws® Temperature Management System. This type of submission is a declaration of substantial equivalence to a legally marketed predicate device rather than a study proving new performance claims or meeting specific acceptance criteria for a novel device.

Therefore, the document does not contain information regarding:

Acceptance criteria and reported device performance based on a study of the Bair Paws® system. Instead, it provides a comparison of technological characteristics to a predicate device.
Sample sizes for test sets, data provenance, or details of a study methodology.
Number of experts, their qualifications, or adjudication methods for ground truth establishment.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
Standalone (algorithm only) performance studies.
Types of ground truth used in a study.
Sample size for training sets or how ground truth for training sets was established.

Instead, the document focuses on demonstrating substantial equivalence to the Bair Hugger® Temperature Management System (K053645) by comparing their technological characteristics.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance
This document provides a comparison of technological characteristics between the Bair Paws® Temperature Management System and its predicate device, the Bair Hugger® Temperature Management System (K053645). It does not present specific acceptance criteria or performance data for the Bair Paws® system from a study. The implication is that since the Bair Paws® system is substantially equivalent to the predicate, it meets the existing performance expectations of that predicate.

Features	Bair Paws Temperature Management System	Bair Hugger Temperature Management System (Predicate)
Method of operation	Blower motor and heating element deliver warmed air through a hose connected to a port in a Bair Paws gown.	Blower motor and heating element deliver warmed air through a hose 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

2. Sample size used for the test set and the data provenance: Not applicable. This document is a 510(k) equivalency submission, not a study report. No test set or data provenance is detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a test set is not part of this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is described.

5. 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. This is not an AI-enabled device and no MRMC study information is provided.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device and no standalone performance study information is provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This document does not describe a study involving ground truth. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for a training set is mentioned.

Summary

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K060865

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:

Intended use of the device

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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 TemperatureManagement System	Bair Hugger TemperatureManagement System
Method of operation	The Bair Paws warming unit hasa blower motor and a heatingelement. The warming unitdelivers warmed air through ahose that is connected to a port ina Bair Paws gown.	The Bair Hugger warming unithas a blower motor and a heatingelement. The warming unitdelivers warmed air through ahose that is connected to a port ina Bair Hugger blanket or BairPaws gown.
Alarms	Over-temperature: color indicatorlight illuminates, heater andblower shut down.	Over-temperature: red lightilluminates with audible alarm,heater and blower shut down.
Areas for device use	Pre-op, intensive care unit, laborand delivery, recovery room,emergency rooms, ships, aircraft,EMT vehicles, accident sites,long-term care facilities, homehealth care and other areaswhere medical professionalswarm patients.	Pre-op, intensive care unit,operating room, labor anddelivery, recovery room,emergency rooms, ships, aircraft,EMT vehicles, accident sites,long-term care facilities, homehealth care and other areaswhere medical professionalswarm patients.
Intended patientpopulation	Adult and pediatric patients	Adult and pediatric patients
Patient Position	Stationary	Stationary
Device positioning	Can be set on table, shelf or otherhard surface; clamped to an I.V.pole; or hung on a bed rail; orattached to the wall using a wallmount bracket.	Can be set on table, floor, shelf orother hard surface; clamped to anI.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

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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.

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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 (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

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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

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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:

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_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

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Regulation Number and Section

§ 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).