MODIFICATION TO THERMAL ANGEL

K012031 · Estill Medical Technologies, Inc. · BSB · Jul 26, 2001 · Hematology

Device Facts

• Record ID: K012031
• Device Name: MODIFICATION TO THERMAL ANGEL
• Applicant: Estill Medical Technologies, Inc.
• Product Code: BSB · Hematology
• Decision Date: Jul 26, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.9205
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thermal Angel™ model 200 Blood/Fluid Warmer is Indicated for the warming of blood, blood products and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in clinical and field environments.

Device Story

Thermal Angel™ model 200 is a portable, battery-operated (12V DC) in-line blood and fluid warmer. Device consists of a disposable unit placed between an IV set and extension set. Fluids flow through stainless steel tubing surrounded by a heating blanket; electrical resistance heating is controlled by internal electronics to maintain 38°C (100.4°F) at flow rates up to 200 ml/min. Used by healthcare professionals in clinical and field environments to prevent hypothermia during fluid administration. Device provides immediate, automated temperature regulation, returning to set temperature within seconds after flow rate changes. Benefits include delivery of normothermic fluids to patients, reducing risk of hypothermia.

Clinical Evidence

Bench testing only. Laboratory evaluations assessed hemolytic effects during various flow conditions (flow, stop flow, high flow). Results indicated hemolysis was none or not clinically significant.

Technological Characteristics

Disposable in-line warming unit; stainless steel fluid path; electrical resistance heating; 12V DC battery power; UL 2601 and CSA 601 compliant; electronic temperature control; sterile and nonpyrogenic fluid path.

Indications for Use

Indicated for warming blood, blood products, and intravenous/irrigation fluids prior to administration in clinical or field settings where normothermic parenteral fluids are required.

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

• Augustine Medical Bair Hugger™ Blood/Fluid Warmer (K973741)
• Level1 Technologies, Inc Hotline™ Fluid Warmer (K911383)
• Baxter Thermacyl™ Blood/Fluid Warmer (K770232)
• Thermal Angel™ (K984640)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. This device is a Class II device per 21 CFR 864.9205. nonelectromagnetic blood and plasma warming device; henceforth reforred to as the Thermal Angel™.

### Submitter;

Estill Medical Technologies, Inc 4144 North Central Expressway, Suite 260 Dallas, TX 75204

# Contact:

Daniel T Kistner QA/RA Phone: [phone] [phone] Fax: [e-mail]

Date Prepared:

July 23, 2001

Trade/Proprietary Name:

Thermal Angel™ model 200 Blood/Fluid Warmer

Classification Name:

Predicate Devices:

Augustine Medical Bair Hugger™ Blood/Fluid

Warmer, blood, nonelectromagnetic

Warmer, Level1 Technologies, Inc Hotline™ Fluid Warmer, Baxter Thermacyl™ Blood/Fluid Warmer, Thermal Angel™ (K984640)

# Description of Device:

The Thermal Angel™ model 200 Blood/Fluid Warmer consists of a single unit that is placed The Themal Angel - The set and a standard IV extension set. Thermal Angel™ is designed to warm blood, blood products and intravenous fluics at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures of 38°C (100.4°F). While the temperature will drop immediately after making major changes in flow rate, it will drop only a few degrees and return smoothly and within seconds, to 38℃ (100.4°F).

Thermal Angel's™ fluid path is sterile and nonpyrogenic, and the entire warming unit is disposable after use. Thermal Angel™ is battery operated, powered by a 12V DC system. Blood, blood and intravenous fluids travel through stainless steel tubing which is surrounded by a heating blanket and heated by electrical resistance. The temperature of the device is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601 and CSA 601.

### Statement of Intended Use:

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The Thermal Angel™ model 200 Blood/Fluid Warmer is Indicated for the warming of blood, blood products and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in clinical and field environments.

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

The Thermal Angel™ model 200 Blood/Fluid Warmer is substantially equivalent to the Augustine Medical Bair Hugger ™ Blood/Fluld Warmer (K973741), the Baxter Thermacy™ Blood/Fluid Warmer (K770232), the Level1 Technologies, Inc Hotline™ Fluid Warmer (K911383) and the Thermal Angel™ (K984640). Comparisons of technological features are on the following page.

#### Discussion of Nonclinical Studies:

Laboratory evaluations have been conducted to evaluate the hemolytic effect of the Thermal Angel™ model 200 Blood/Fluid Warmer during flow, stop flow, and high flow rates. Hemolysis was shown to be none or not clinically signiticant.

### Conclusion:

The Therma! Angel™ model 200 Blood/Fluid Warmer has similar technological characteristics and the same intended use as devices currently on the market. Therefore, because of the similarities to the prodicate devices, Estill Medical Technologies, Inc., believes these modifications do not raise any new safety or effectiveness issues.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 6 2001

Mr. Daniel T. Kistner QA/Regulatory Affairs Estill Medical Technologies, Incorporated 4144 North Central Expressway, Suite 260 Dallas, Texas 75204

Re : K012031 Trade/Device Name: Modification To Thermal Angel Regulation Number: 864.9205 Requlatory Class: II Product Code: BSB and LGZ Dated: May 31, 2001 Received: June 28, 2001

Dear Mr. Kistner:

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 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). 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, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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

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Page 2 - Mr. Kistner

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 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 regulation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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.oov/cdrh/dsma/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 (if known): #904040 KO | 203 |

Device Name: Thermal Angel™ model 200 Blood and Fluid Warmer

Indications for Use: Thermal Angel™ model 200 Blood and Fluid Warmer is an

in-line, intravenous blood and fluid warmer. Thermal Angel™ is indicated for use

whenever introduction of normothermic, parenteral (intravenous or irrigation)

fluids are desired or indicated, whether in field or clinical settings.

(Attachment A)

(Please do not write below this line-Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (21 CFR 801.109)

ા

Over-the-Counter Use Optional format 1-2-96

(Division Sign-Off) (Division of Dental, Infection Control, and General Medical Devices

510(k) Number

Patricia Cucenile

on Control, on of Dental, Infec neral Hospital Devic 012031 510/k) Number .