THERMAL ANGEL

K984640 · Estill Medical Technologies, Inc. · BSB · Jul 1, 1999 · Hematology

Device Facts

• Record ID: K984640
• Device Name: THERMAL ANGEL
• Applicant: Estill Medical Technologies, Inc.
• Product Code: BSB · Hematology
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.9205
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thermal Angel™ 200 Blood/Fluid Warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in clinical and field environments. Thermal Angel™ is an in-line intravenous fluid and blood warmer. Thermal Angel™ is indicated for use whenever parenteral introduction of normothermic fluids are desired or indicated, whether in field or clinical settings.

Device Story

Thermal Angel™ 200 is a single-use, in-line blood/fluid warmer placed between standard IV drip and extension sets. It warms blood, blood products, and IV liquids up to 200 ml/min to 38°C. The device features stainless steel tubing surrounded by an electrical resistance heating blanket. Operation is managed by a microprocessor-controlled system using DS1821S temperature sensors. It is intended for use by healthcare professionals in clinical and field environments. The device provides visual LED status indicators for power and heat levels, with a safety switch that deactivates the unit at 41.0°C. By maintaining normothermic fluid temperatures, the device helps prevent hypothermia during fluid administration.

Clinical Evidence

Bench testing only. Evaluation of hemolytic effect during flow, stop flow, and maximum flow rate conditions was performed to ensure no clinically significant hemolysis occurs.

Technological Characteristics

Materials: Stainless steel tubing, heating blanket. Energy: 12V battery system, electrical resistance heating. Control: Microprocessor-based with DS1821S temperature sensors. Safety: Automatic shut-off at 41.0°C. Form factor: In-line disposable unit. Standards: Designed in accordance with UL 2601 and CSA 601.

Indications for Use

Indicated for warming blood products and intravenous solutions prior to administration in patients requiring parenteral fluid therapy in clinical or field settings.

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)
• Level 1 Technologies, Inc. Hotline™ Fluid Warmer (K911383)
• Baxter Thermacy|™ Blood/Fluid Warmer (K770232)

Submission Summary (Full Text)

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KA984640

## 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 referred to as the Themal Angel™.

### Submitter:

Estill Medical Technologies. Inc. 17440 N. Dallas Parkway, Suite 100 Dallas, TX 75287

#### Contact:

Thomas L. Kistner, President Phone: [phone] Fax: [phone]

Date Prepared: December 30, 1998

Trade/Proprietary Name: Themal Angel™ 200 Blood/Fluid Warmer

Classification Name: Warmer, blood, nonelectromagnetic

Predicate Devices: Augustine Medical Bair Hugger™ Blood/Fluid Warmer, Level 1 Technologies, Inc. Hotline™ Fluid Warmer, Baxter Thermacy|™ Blood/Fluid Warmer.

### Description of device:

The Thermal Angel™ 200 Blood/Fluid Warmer consists of a single unit that is placed in-line between a standard IV drip set and a standard IV extension set. Thermal Angel™ is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures at 38°C. 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°C.

Thermal Angel's™ fluid path is sterile and the entire unit is disposable after use. Blood, blood products or intravenous fluids travel through stainless steel tubing which is surrounded by a heating blanket and heated by means of 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:

The Thermal Angel™ 200 Blood/Fluid Warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals

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in clinical and field environments.

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

The Thermal Angel™ 200 Blood/Fluid Warmer is substantially equivalent to the Augustine Medical Bair Hugger™ Blood/Fluid Warmer (K973741), the Baxter Thermacy™ Blood/Fluid Warmer (K770232) and the Level 1 Technologies, Inc. Hotline™ Fluid Warmer (K911383). A comparison of technological features are on the following page.

## Discussion of Nonclinical Studies:

Studies will be conducted to evaluate the hemolytic effect of the new device prior to marketing. Percent hemolysis will be evaluated during flow, stop flow and highest flow rate possible conditions. Hemolysis must show to be none or not clinically significant before introduction into commerce.

## Conclusion:

The Thermal Angel™ 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 predicate devices, Estill Medical Technologies, Inc. believes this new device does not raise any new safety or effectiveness issues.

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| Comparison of Technological Features | | | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------|
| Features | Thermal Angel 200 | Bair Hugger Blood/Fluid Warmer | Baxter Thermacyl Blood/Fluid Warmer | Level I Technologies, Inc. Hotline Fluid Warmer |
| (k)# | Not yet assigned | K973741 | K770232 | K911383 |
| Heating Method | Heating blanket covering stainless steel tubing; heated by electrical resistance | Metal plate heated by electrical resistance | Metal cylinder heated by electrical resistance | Cirulating water heated by regulated resistance heater |
| Temperature Control | DS1821S Temp Sensors | Thermocouples | Thermistors (2 inlet; 2 outlet) | Water temp is displayed |
| Alarm | Visual; LED indicators | Audio/Visual | Audio/Visual | Audible |
| Alarm Conditions | Illumination: Red fading to dim or no light = no power<br>Green fading to dim or no light = decrease in heat.<br>Safety switch turns off TA @ 41.0*C | Temperature @ 32.0*C; 43.0*C 46.0*C | Temperature exceeds 42.0*C or thermisters differ by 5.0*C | Red "overtemperature" indicator illuminated alarm @ 41.0*C |
| Electronics | Microprocessor Control | PID Controlled | UL2601; CSA601 | Proportional controller |
| Operation | 12V Battery system | | | 120V-AC |
| Flow | TK0-200 ml/min | 0-500 ml/min | up to 500 ml/min | 5.0-50 ml/min |
| Infusion Temp. | 38*C | 42.0*C Max | Up to 42.0*C | 35.0*C-39.0*C |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

Mr. Thomas L. Kistner President Estill Medical Technologies, Incorporated 17440 North Dallas Parkway 75287 Dallas, Texas

Re : K984640 Thermal Angel™ Trade Name: Requlatory Class: II Product Code: BSB Dated: April 5, 1999 Received: April 6, 1999

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 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 general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Reqister.

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Page 2 - Mr. Kistner

this response to your premarket notification Please note: 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 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 ene regaración offication" (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, UND

imothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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| 510 (k) Number (if Known): | K984640 |
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| Device Name: | Thermal Angel™ |
| Indications for use: Thermal Angel™ is an in-line intravenous fluid and blood warmer. Thermal Angel™ is indicated for use whenever parenteral introduction of normothermic fluids are desired or indicated, whether in field or clinical settings. | |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|----|--------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801 109) | OR | Over-The-Counter-Use<br>(Optional format 1-2-96) |


(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

| 510(k) Number | K984640 |
|---------------|---------|
|---------------|---------|