(211 days)
Dupaco Counterflo 300, Augustine Medical Bair Hugger® 241® Fluid Warming Set
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No
The description details a device that uses electrical resistance and heated plates to warm fluids, with no mention of AI or ML technologies.
No
The device is intended to warm blood, blood products, and liquids, which is a supportive function rather than directly treating a disease or condition.
No
The device is described as a warmer for blood, blood products, and liquids, with the purpose of heating them for patient use. It does not mention any function for detecting, analyzing, or diagnosing medical conditions.
No
The device description explicitly states it consists of a "warming device" and a "disposable set," which are hardware components. It also mentions heated aluminum plates and electrical resistance for heating, further confirming it is not software-only.
Based on the provided information, the Bair Hugger Blood/Fluid Warmer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "warm blood, blood products, and liquids." This is a therapeutic or supportive function, not a diagnostic one. IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a device that physically warms fluids. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing any kind of diagnostic result.
- Performance Studies: The performance studies focus on the effect of warming on red blood cells (hemolysis), which is relevant to the safety and efficacy of warming blood for transfusion, not for diagnostic purposes.
In summary, the Bair Hugger Blood/Fluid Warmer is a medical device used to prepare fluids for administration to a patient, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Bair Hugger Blood/Fluid Warmer is intended to warm blood, blood products, and liquids.
Product codes (comma separated list FDA assigned to the subject device)
BSB
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Dupaco Counterflo 300, Augustine Medical Bair Hugger® 241® Fluid Warming Set
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).
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§ 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.
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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.
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.
1
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 | ||
| resistance; disposable bag | |||
| contacts plate | Metal plate heated by | ||
| electrical resistance; | |||
| disposable bag contacts plate | Hose conduit heated by | ||
| forced air; disposable | |||
| tubing surrounded by | |||
| heated air | |||
| Electronics | PID-controlled | PID-controlled | Electronically controlled |
| Temperature | |||
| Control | Thermocouples | RTD sensor | User adjustable set point; |
| thermocouple | |||
| Alarms | Audible and visual over and | ||
| under temperature; alarms | |||
| activate when temperature is at | |||
| 32°C, at 43° C, and at 46°C. | Audible and visual over and | ||
| under temperature alarms; | |||
| alarms activate when | |||
| temperature is below 34°C, | |||
| and at 42° and 43-44.5°. | Audible and visual over | ||
| temperature alarms; | |||
| alarms activate when | |||
| 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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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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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