(143 days)
The HypothermX® is intended to warm blood, blood products and intravenous solutions prior to administration. The HypothermX® is intended to be used by healthcare professionals in clinical and field environments.
The HypothermX® Intravenous Fluid and Blood Warmer consists of a single unit that is placed between a standard IV infusion set and a standard IV extension set. HypothermX® is designed to warm blood, blood products and intravenous fluids at flow rates of up to and including 50-200 ml/min. HypothermXo will deliver temperatures of 38°C-3°C. HypothermX's® fluid path is sterile and the entire warming unit is disposable after use. HypothermXo is battery operated. Blood, blood products and intravenous fluids travel through the sterile tubing and are heated by flameless catalytic combustion. The temperature of the device is accurately controlled by the device's electronics.
Here's an analysis of the provided text regarding the HypothermX® HX100 Intravenous Fluid and Blood Warmer, focusing on acceptance criteria and study details.
It's important to note that the provided text is a 510(k) summary, which is a regulatory document. As such, it often focuses on demonstrating substantial equivalence to predicate devices rather than providing exhaustive details of every study conducted with the same level of detail as a peer-reviewed clinical trial.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the HypothermX® HX100 are primarily derived from its intended use and comparison to predicate devices, particularly regarding temperature output and flow rates.
| Acceptance Criteria Aspect | Description / Target | Reported Device Performance (HypothermX® HX100) |
|---|---|---|
| Intended Output Temp. | Optimal infusion temperature for warming blood/fluids. | $38 \pm 3$ °C |
| Flow Rate Range | Range of flow rates the device can effectively warm fluids. | 50-200 ml/minute |
| Alarm Condition: \46°C | Illumination and audible alarm for high temperature. | Red Illumination; Audible alarm (every 1-2 seconds) |
| Safety Cut-off Temp. | Automatic shut-off to prevent overheating. | Safety ITCO switch turns off @ 50°C |
| Biocompatibility | Materials in fluid pathway must be biocompatible. | Sterilized fluid pathway materials demonstrated to be biocompatible. |
| Hemolytic Effect | Minimal or no hemolytic effect during operation. | Laboratory evaluations conducted; presumed to meet acceptance criteria (details not specified). |
| Sterility | Fluid path must be sterile. | Fluid path is sterile. |
Study Details
Based on the provided 510(k) summary, the studies conducted were primarily non-clinical evaluations to support substantial equivalence. Information on human clinical trials (MRMC studies, standalone AI performance) is not part of this submission, as the device is a fluid warmer and not an AI/diagnostic device.
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Sample Size used for the Test Set and the Data Provenance:
- The document describes "laboratory evaluations" and "studies conducted on the sterilized fluid pathway" and "performance data."
- Test Set Sample Size: Not explicitly stated regarding the number of runs, volumes of fluid, or specific test conditions. The context implies bench testing rather than a clinical dataset.
- Data Provenance: The studies were internal laboratory evaluations. There is no indication of country of origin of data as it's not a data-driven AI device. These would be prospective bench tests conducted for the purpose of this submission.
- Retrospective/Prospective: The tests described (performance, biocompatibility, hemolytic effect) would be prospective bench tests.
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Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This question is not applicable in the context of this device. A fluid warmer's performance (temperature accuracy, flow rate, safety cut-offs) is typically measured using calibrated laboratory equipment, not human expert interpretation to establish "ground truth." The "truth" is objective physical measurements.
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Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is objective measurement by calibrated sensors and instruments, there is no need for human adjudication of results.
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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:
- No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic or interpretive tools, not for a medical device like an intravenous fluid warmer. The device's function is to warm fluid; it does not involve human interpretation of images or data that AI would assist with.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the AI sense. The HypothermX is a standalone device in that it performs its function (warming fluid) automatically. It does not have an "algorithm" in the typical AI sense that would have a standalone performance measured against a human-in-the-loop. Its performance is measured directly by its physical output (temperature, flow).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established through objective physical measurements using calibrated instruments (e.g., thermometers, flow meters) under controlled laboratory conditions. For biocompatibility, it would be established by validated test methods according to relevant ISO standards.
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The sample size for the training set:
- Not applicable. This device is hardware-based with embedded electronics for control. It does not utilize machine learning or AI algorithms that require a "training set" of data in the typical sense. Its control parameters are engineered and calibrated, not learned from a dataset.
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How the ground truth for the training set was established:
- Not applicable. As there is no "training set" for AI/ML, there is no ground truth established for one. The device's operational parameters are based on engineering design and validation.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).