(182 days)
Not Found
No
The description focuses on electrical resistance heating and electronic temperature control, with no mention of AI or ML algorithms for temperature regulation or other functions.
No.
The device's function is to warm intravenous fluids and blood to a normothermic temperature, which supports a physiological function rather than treating or diagnosing a specific disease or condition. While maintaining normothermia can be beneficial in certain medical situations, the device itself is not directly therapeutic but rather a supportive accessory.
No
Explanation: The device is described as an "in-line intravenous fluid and blood warmer" designed to warm blood, blood products, and intravenous liquids. Its function is to modify the temperature of fluids administered to patients, not to diagnose a medical condition.
No
The device description clearly outlines physical components like stainless steel tubing, a heating blanket, and electronics, indicating it is a hardware device with integrated electronics for temperature control.
Based on the provided information, the Thermal Angel™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to warm intravenous fluids and blood before they are introduced into the patient's body. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the mechanism of heating fluids and blood, not on analyzing samples of bodily fluids or tissues to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. The Thermal Angel™ operates on the fluids before they enter the body and does not perform any analysis on bodily specimens.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BSB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in clinical and field environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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).
Not Found
§ 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.
0
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: (972) 818-1872 Fax: (972) 818-4329
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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Image /page/1/Picture/1 description: The image shows a black and white speckled pattern. The specks are scattered across the white background, with varying sizes and densities. The distribution of the specks appears random, creating a textured effect.
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.
2
| 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 | |||
| Green fading to dim or no light = decrease in heat. | ||||
| Safety switch turns off TA @ 41.0*C | Temperature @ 32.0C; 43.0C 46.0*C | Temperature exceeds 42.0C or thermisters differ by 5.0C | 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 | 35.0C-39.0C |
.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by wavy lines at the bottom. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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.
4
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 (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 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 (800) 638-2041 or (301) 443-6597 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 |
|---|---|
| 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 | ||
| (Per 21 CFR 801 109) | OR | Over-The-Counter-Use |
| (Optional format 1-2-96) |
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K984640 |
|---|---|
| --------------- | --------- |