(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).
§ 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.