(182 days)
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.
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.
The provided document is a 510(k) summary for the Thermal Angel™ 200 Blood/Fluid Warmer. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain information about a study that assesses performance against acceptance criteria in the format typically used for AI/ML device evaluations.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating AI/ML performance.
However, I can extract information related to the device's technical specifications and general claims of achieving certain performance.
Here's an analysis based on the provided document, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" for a study in the context of device performance as one might expect for an AI/ML device (e.g., target sensitivity, specificity). Instead, it focuses on demonstrating that its technological characteristics are comparable to predicate devices and that certain output parameters are achieved.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flow Rate | Comparable to predicate devices, up to 200 ml/min. | Up to and including 200 ml/min. |
| Delivery Temperature | 38°C, with smooth return after flow changes. | Delivers temperatures at 38°C. Will drop a few degrees and return smoothly within seconds to 38°C after major flow rate changes. |
| Heating Method | Electrical resistance, similar to predicates. | Heating blanket covering stainless steel tubing; heated by electrical resistance. |
| Temperature Control | Accurate control. | DS1821S Temp Sensors, microprocessor control. |
| Safety Switch | Turns off at a specified temperature. | Safety switch turns off TA @ 41.0°C. |
| Hemolytic Effect | None or not clinically significant. | Studies will be conducted to evaluate prior to marketing. (Outcome not reported in this summary) |
| Electrical Requirements | In accordance with UL 2601 and CSA 601. | Designed in accordance with UL 2601 and CSA 601. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes a medical device (blood/fluid warmer), not an AI/ML system, and therefore does not refer to test sets for algorithm evaluation.
- The document mentions "studies will be conducted" regarding hemolytic effect, but details of these studies (sample size, data provenance) are not included in this 510(k) summary; only the intent is stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information pertains to AI/ML model development, which is not the subject of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No such test set or adjudication process is mentioned for this type of device.
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 device is a physical warmer and does not involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm component described for this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the context of AI/ML evaluation. For a physical device like a warmer, "ground truth" would refer to direct measurements of physical parameters (e.g., actual fluid temperature, flow rate, assessment of hemolysis in laboratory tests). The document only states the desired outcomes for these physical parameters (e.g., 38°C delivery temperature, none or not clinically significant hemolysis).
8. The sample size for the training set:
- Not applicable. No AI/ML training set is referenced.
9. How the ground truth for the training set was established:
- Not applicable. No AI/ML training set is referenced.
Summary of what the document does provide:
- Predicate Devices: The device is being compared to existing, legally marketed blood/fluid warmers (Augustine Medical Bair Hugger™, Level 1 Technologies, Inc. Hotline™, Baxter Thermacyl™).
- Technological Equivalence: The document primarily uses a comparison chart to demonstrate that the Thermal Angel™ 200 has similar technological characteristics (heating method, temperature control, alarms) to these predicate devices.
- Intended Use Equivalence: The intended use is stated to be the same as currently marketed devices.
- Future Studies Mentioned: It notes that nonclinical studies to evaluate the hemolytic effect will be conducted prior to marketing, with the acceptance criterion being "none or not clinically significant hemolysis." However, the results of these studies are not included in this summary.
In conclusion, this 510(k) summary is for a physical medical device and is primarily based on demonstrating substantial equivalence to predicate devices through a comparison of technical specifications and intended use, rather than a clinical performance study with defined acceptance criteria and statistical outcomes for an AI/ML component.
§ 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.