(28 days)
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.
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.
Here's an analysis of the provided text regarding the Thermal Angel™ model 200 Blood/Fluid Warmer, structured to address your questions.
Important Note: The provided text is a 510(k) Summary and correspondence from the FDA. It describes the device and its intended use, and states that laboratory evaluations were conducted. However, it does not include the detailed results of a study with acceptance criteria and specific performance metrics in the format requested. The document primarily focuses on establishing "substantial equivalence" to predicate devices. Therefore, many of your specific questions regarding acceptance criteria and detailed study performance cannot be answered from the provided text.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the primary performance criteria explicitly stated are:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Deliver temperature of | 38°C (100.4°F) |
| Warm blood, blood products, and IV fluids at flow rates | Up to and including 200 ml/min |
| Temperature drop during major flow rate changes | "Only a few degrees" (implicitly acceptable) |
| Return to 38°C (100.4°F) after flow rate changes | "Smoothly and within seconds" (implicitly acceptable) |
| Hemolytic effect | "None or not clinically significant" during flow, stop flow, and high flow rates |
Study that Proves Device Meets Acceptance Criteria:
The document states, "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 significant."
For the temperature and flow rate performance, the document describes the design: "Thermal Angel™ is designed to warm blood, blood products and intravenous fluids at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures of 38°C (100.4°F)." It also states, "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)." This suggests these performance characteristics were verified during product development and testing, typical of a Class II device submission, but the specific study details (e.g., number of test runs, data collected, statistical analysis) are not provided in this summary.
Additional Study Details:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text mentions "Laboratory evaluations" for hemolysis. It does not specify the sample size for these evaluations, nor does it provide details on data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable and not provided. This device is a fluid warmer, not an AI/diagnostic device that typically requires expert-established ground truth for a test set in the way a medical image analysis device would. The "ground truth" for its performance would be objective measurements (temperature, flow, hemolysis assays).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided. (See explanation for #3).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/diagnostic device, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The device's performance is standalone in the sense that the device itself performs the heating function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For temperature performance and flow rates, the ground truth would be physical measurements of temperature and flow. For hemolysis, the ground truth would typically be laboratory assays for free hemoglobin.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its design and performance are based on engineering principles and physical testing.
9. How the ground truth for the training set was established
Not applicable. (See explanation for #8).
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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: (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:
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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 (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
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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 .
§ 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.