BAIR HUGGER BLOOD/FLUID WARMER

K973741 · Augustine Medical, Inc. · BSB · Apr 30, 1998 · Hematology

Device Facts

• Record ID: K973741
• Device Name: BAIR HUGGER BLOOD/FLUID WARMER
• Applicant: Augustine Medical, Inc.
• Product Code: BSB · Hematology
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.9205
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.

Device Story

Bair Hugger Blood/Fluid Warmer warms blood, blood products, and IV liquids; flow rates up to 500 ml/min. Device consists of warming unit and sterile disposable set. Fluid warming bag within disposable set contacts heated aluminum plates inside warming unit; plates heated via electrical resistance. PID-controlled electronics manage temperature; thermocouples monitor temperature. Device provides audible/visual alarms for over/under temperature conditions. Used in clinical settings by healthcare providers to prevent hypothermia during transfusion or fluid administration. Output is warmed fluid delivered to patient; helps maintain normothermia.

Clinical Evidence

Bench testing only. Hemolytic effect of heat on RBCs evaluated during flow and stop-flow conditions. Results demonstrated minimal damage to RBCs; findings were not clinically significant.

Technological Characteristics

Warming unit with aluminum plates heated by electrical resistance. PID-controlled electronics. Thermocouple temperature sensing. Flow rates: KVO to 500 ml/min. Max temperature: 42°C. Compliance with UL 2601, IEC 601-1, and EN 60601. Sterile disposable fluid warming bags.

Indications for Use

Indicated for warming blood, blood products, and intravenous liquids for patients requiring fluid therapy. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.

Predicate Devices

• Dupaco Counterflo 300 (BK950038)
• Bair Hugger® 241® Fluid Warming Set (BK940032)

Submission Summary (Full Text)

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#### APR 3 0 1998 F. 510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety & Effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The device is a Class II device called the Bair Hugger® Blood/Fluid Warmer.

K973741

#### Submitter:

Augustine Medical, Inc. 10393 West 70th Street, Eden Prairie, MN 55344

Date propared: September 10, 1997

Trade Proprietary Name: Bair Hugger® Blood/Fluid Warmer

Common/Usual Name: Blood/Fluid Warmer

Classification Name: Warmer, Thermal, Infusion Fluid

Predicate Devices: Dupaco Counterflo 300, Augustine Medical Bair Hugger® 241® Fluid Warming Set

# Description of Device

The Bair Hugger Blood/Fluid Warmer consists of a warming device and a disposable set. The warming device is designed to warm blood, blood products, and intravenous liquids at flow rates of up to and including 500 ml/min. The Bair Hugger Blood/Fluid Warmer can deliver temperatures as high as and including 42°C, (temperatures in accordance with the American Association of Blood Banks (AABB) Standards for Blood Banks and Transfusion Services).

Two types of sterile disposable sets are available. The disposables are composed of the same materials used in the predicate devices. The fluid warming bag, attached to the disposable set, is placed inside the warming device and contacts heated aluminum plates. Blood, blood products, and liquids pass through the warming bag and are heated as they flow through. The warming device controls the temperature of the aluminum plates, which are heated by means of electrical resistance. The device meets the requirements of UL 2601, IEC 601-1, and EN 60601.

## Intended Use

The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.

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# Comparison of the Technological Characteristics of the New Device and Predicate Devices

The Bair Hugger® Blood/Fluid Warmer is substantially equivalent to the Dupaco Counterflo 300 Blood/Fluid Warmer (BK950038) and the Bair Hugger® 241 Fluid Warming Set (BK940032).

| Feature | Bair Hugger Blood/Fluid Warmer | Dupaco Counterflo 300 | 241 Fluid Warming Set |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Flow rates | KVO - 500 ml/min | 15 to 300 ml/min | 0 - 50 ml/min |
| Method of Operation | Metal plate heated by electrical<br>resistance; disposable bag<br>contacts plate | Metal plate heated by<br>electrical resistance;<br>disposable bag contacts plate | Hose conduit heated by<br>forced air; disposable<br>tubing surrounded by<br>heated air |
| Electronics | PID-controlled | PID-controlled | Electronically controlled |
| Temperature<br>Control | Thermocouples | RTD sensor | User adjustable set point;<br>thermocouple |
| Alarms | Audible and visual over and<br>under temperature; alarms<br>activate when temperature is at<br>32°C, at 43° C, and at 46°C. | Audible and visual over and<br>under temperature alarms;<br>alarms activate when<br>temperature is below 34°C,<br>and at 42° and 43-44.5°. | Audible and visual over<br>temperature alarms;<br>alarms activate when<br>temperature reaches 53°C. |

### Comparison of Technological Features

# Discussion of Nonclinical Studies

Studies were conducted to evaluate the hemolytic effect of heat on RBCs while flowing through the Bair Hugger Blood/Fluid Warmer. Percent hemolysis was evaluated during flow and stop flow conditions. Minimal damage to RBCs was demonstrated; the results were not clinically significant.

## Conclusion

The Bair Hugger Blood/Fluid Warmer has similar technological characteristics, components, and materials, and the same intended use as devices currently on the market. Therefore, because of the similarities to the predicate devices, Augustine Medical believes this new device does not raise any new safety or effectiveness issues.

Contact: Scott D. Augustine, M.D., CEO Augustine Medical, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 1998

Scott D. Auqustine, MD ·Augustine Medical 10393 West 70th Street 55344 USA Eden Prairie, Minnesota

Re : K973741 Bair Hugger Blood/Fluid Warmer Trade Name: Requlatory Class: II Product Code: BSB Dated: February 11, 1998 February 12, 1998 Received:

Dear Dr. Augustine:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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#### Page 2 - Dr. Augustine

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) number: Not known

Device name: The Bair Hugger® Blood/Fluid Warmer

Indications for use:

ter .

The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Dental, Infection,<br>and General Hospital | |
| 510(k) Number | K973741 |

| Prescription Use<br>(Per 21 CFR 801-109) | X | or | Over the Counter Use |
|------------------------------------------|---|----|----------------------|
|------------------------------------------|---|----|----------------------|

AUGUSTINE MEDICAL