(28 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.
Yes
The device is used to warm fluids administered to patients, which is a therapeutic intervention, as it directly impacts the patient's physiological state (body temperature) for medical benefit.
No
The device is a blood/fluid warmer, which is a therapeutic device, not a diagnostic one. Its purpose is to warm fluids prior to administration, not to diagnose a condition.
No
The device description clearly outlines hardware components such as stainless steel tubing, a heating blanket, electrical resistance heating, and battery operation, indicating it is a physical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm blood, blood products, and intravenous fluids prior to administration to a patient. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device description focuses on the mechanism of warming fluids that are being administered to a patient. It does not describe any process of analyzing biological samples to obtain diagnostic information.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVD devices, such as "diagnosis," "detection," "measurement of analytes," "in vitro," or "specimen."
- Performance Studies: The performance study mentioned evaluates the hemolytic effect on blood during warming and flow, which is relevant to the safety and efficacy of the warming process for administration, not for diagnostic purposes.
- Predicate Devices: The predicate devices listed are also blood/fluid warmers, which are not IVD devices.
In summary, the Thermal Angel™ model 200 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 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.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.
Product codes (comma separated list FDA assigned to the subject device)
BSB, LGZ
Device Description
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.
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)
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.
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.
K973741, K770232, K911383, K984640
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
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: (214) 561-1939 (214) 561-1930 Fax: dannykistner@estillmed.com
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:
1
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.
2
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
3
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 (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 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 (800) 638-2041 or (301) 443-6597 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
4
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 .