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The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.

The Arctic Blast Intravenous Fluid Chiller is composed of two main components: a heat exchanger assembly and an adsorption cooling module. The sterile fluid path is incorporated in the heat exchange assembly, which consists of the heat exchanger, a spike with vented drip chamber at the heat exchanger inlet, and a spike receptacle at the heat exchanger outlet. Prior to activation, the heat exchanger assembly inlet (spike) is connected to a liter bag of sterile fluid, and the outlet (spike port) is connected to a standard commercially-available intravenous infusion set. The heat exchanger assembly is constructed of materials and components which are commonly used in the manufacture of commercially-available intravenous infusion sets. The cooling module provides the cooling capability of the device via an adsorption process. The cooling module does not require an external power source. The cooling process is activated by pressing a button on the module. The cooling module is fully sealed and does not come into direct contact with the sterile fluid path.

The provided text does not contain specific acceptance criteria or a study detailing the device's performance against such criteria. The document is a 510(k) summary for the Arctic Blast Intravenous Fluid Chiller, focusing on its substantial equivalence to predicate devices rather than a detailed performance study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given information.

However, based on the provided text, I can state what is available regarding the device's characteristics and the regulatory review process:

1. A table of acceptance criteria and the reported device performance:

• Information not available in the provided text. The document asserts substantial equivalence based on intended use, design, technological characteristics, materials, and system features/functions to predicate devices. It does not provide specific performance metrics or acceptance criteria for the Arctic Blast itself.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Information not available in the provided text. The document does not describe any specific test set or clinical study for performance evaluation.

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):

• Information not available in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Information not available in the provided text.

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 thermal regulating system, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This device is a thermal regulating system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Information not available in the provided text. As no specific performance study is detailed, the type of ground truth for any such study is also not mentioned. The substantial equivalence relies on comparison to predicate devices, which would have established their own safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.

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