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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bair Hugger Blood/Fluid Warmer, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally doesn't include the detailed, extensive clinical utility studies often seen for novel devices. The "studies" mentioned here are likely bench tests and comparisons directly related to the safety and fundamental function for achieving substantial equivalence.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Warm blood, blood products, and intravenous liquids	Intended use states it warms blood, blood products, and liquids.	This is the primary functional requirement.
Flow rates up to and including 500 ml/min	Capable of flow rates KVO - 500 ml/min.	The device meets or exceeds this requirement.
Deliver temperatures as high as and including 42°C	Can deliver temperatures as high as and including 42°C.	Meets the specified temperature range.
Temperatures in accordance with AABB Standards for Blood Banks and Transfusion Services	Delivers temperatures in accordance with AABB Standards.	This implies compliance with a recognized standard for blood products.
Minimal damage to RBCs (hemolysis)	Minimal damage to RBCs demonstrated during flow and stop flow conditions; results were not clinically significant.	This addresses a critical safety aspect when warming blood.

Study Details

The provided document describes nonclinical studies rather than extensive clinical trials for efficacy.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The studies evaluated "percent hemolysis" during "flow and stop flow conditions." This suggests controlled laboratory experiments, not patient data.
- Data Provenance: Not specified, but given the nature of the device (blood/fluid warmer), these would be in-vitro laboratory tests using blood samples, not human patient data from a specific country.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The studies mentioned (hemolysis evaluation) involve objective measurements of a physical/biological property (hemolysis percentage) rather than subjective expert interpretation for establishing a "ground truth" in the way it's used for diagnostic imaging or clinical assessment. The "ground truth" here would be the measured hemolysis itself.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective assessments (like medical image interpretation) where multiple experts might disagree. These studies involve direct physical/chemical measurements.
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 device is a medical warming device, not an AI diagnostic tool or an imaging system. Therefore, MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is a standalone warming unit that performs its function without a human "in the loop" in terms of continuous algorithmic decision-making. The "study" focused on its performance characteristics directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective Measurement/Biochemical Analysis: The ground truth for the hemolysis study would be the measured percentage of hemolysis in the blood samples, determined through standard laboratory techniques.
The sample size for the training set:
- Not applicable in the context of this device and the described studies. The studies are evaluating the physical performance and biological effects of the warming device itself, not training an algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an algorithm.

Summary

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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

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 electricalresistance; disposable bagcontacts plate	Metal plate heated byelectrical resistance;disposable bag contacts plate	Hose conduit heated byforced air; disposabletubing surrounded byheated air
Electronics	PID-controlled	PID-controlled	Electronically controlled
TemperatureControl	Thermocouples	RTD sensor	User adjustable set point;thermocouple
Alarms	Audible and visual over andunder temperature; alarmsactivate when temperature is at32°C, at 43° C, and at 46°C.	Audible and visual over andunder temperature alarms;alarms activate whentemperature is below 34°C,and at 42° and 43-44.5°.	Audible and visual overtemperature alarms;alarms activate whentemperature 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines representing hair or clothing.

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 (301) 594-4692. 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" (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 (800) 638-2041 or (301) 443-6597 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,and General Hospital
510(k) Number	K973741

Prescription Use(Per 21 CFR 801-109)	X	or	Over the Counter Use
------------------------------------------	---	----	----------------------

AUGUSTINE MEDICAL

Regulation Number and Section

§ 864.9205 Blood and plasma warming device.

(a)
Nonelectromagnetic blood or plasma warming device —(1)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.(2)
Classification. Class II (performance standards).(b)
Electromagnetic blood and plasma warming device —(1)Identification. 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.(2)
Classfication. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.