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The Avalon Elite™ Bi-Caval Dual Lumen Catheter is intended for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.

The Avalon Elite™ Bi-Caval Dual Lumen Catheter is a single catheter with two lumens within the cannula body to collect, separate, and return the blood. The product is offered in a range of sizes to address varying patient size requirements. Inlet ports/openings at the distal tip, and proximally, collect blood from the inferior and superior vena cavae and deliver it to the extracorporeal components consisting of at least, a pump and gas exchange device. Blood returns to the patient through the infusion lumen of the cannula where it exits at a port located in the right atrium. The lumens within the cannula body are completely separate throughout their length. This separation is achieved via a thin septum that divides the otherwise circular internal cross section of the main cannula body. The lumens become separate, or split out, at the proximal end of the cannula as is typical of many types of dual lumen cannulae/catheters so that they may be attached by conventional tube fittings. The ratio of the drainage lumen to reinfusion lumen cross sectional area is approximately 2 to 1 deriving from typical pre and post pump pressure/flow characteristics. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre positioned standard guidewire (not supplied.) The device is supplied sterile, non-pryogenic and is intended for single use via prescription.

This submission pertains to the Avalon Elite™ Bi-Caval Dual Lumen Catheter. The provided information is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical study to establish novel performance criteria. Therefore, the acceptance criteria and study details discussed below will reflect this regulatory pathway.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are generally demonstrated through substantial equivalence to a legally marketed predicate device across various characteristics and performance tests. The specific numerical acceptance criteria are not explicitly stated as they would be for a direct performance claim; instead, the "performance" here refers to the device meeting the same functional and safety requirements as its predicate.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of a clinical trial or a dataset for an AI algorithm. Instead, it refers to performance testing conducted on the device itself (e.g., Pressure/Burst, Simulated Use, Kink Resistance, etc.).

• Sample Size: The exact number of catheters or test specimens used for each performance test (Pressure/Burst, Simulated Use, Kink Resistance, Tensile Strength, Flow Characteristics, Hemolysis, and Biocompatibility) is not provided in this summary.
• Data Provenance: The provenance of the data (e.g., country of origin, retrospective/prospective) is not specified. These tests would typically be conducted in a laboratory setting by the manufacturer (Avalon Laboratories, LLC).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this 510(k) submission. The "ground truth" concept is typically associated with studies involving subjective interpretation (e.g., medical imaging, pathology) where expert consensus is needed to define the correct outcome. For a physical medical device like a catheter, "ground truth" is established by objective engineering and safety standards, and validated through the performance tests mentioned above, not by expert human interpretation of a dataset.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3. Adjudication methods (e.g., 2+1, 3+1) are relevant for reconciling differing expert opinions on a "ground truth" in subjective data analysis, not for direct physical performance testing of a 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

This information is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human performance in diagnostic tasks, typically involving interpretation of medical images or data by multiple readers. This 510(k) summary is for a physical medical device (catheter), not an AI diagnostic tool. No AI component is mentioned.

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

This information is not applicable. No AI algorithm is described or evaluated in this submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

As discussed, the concept of "ground truth" in the context of expert interpretation is not applicable here. For this physical device, the "ground truth" for performance is established by objective engineering specifications and recognized safety standards validated through laboratory performance tests (e.g., burst pressure exceeding a certain threshold, flow rates matching specifications, non-hemolytic properties, biocompatibility according to ISO standards). It's based on empirical measurements against predefined criteria.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device submission.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set, there is no ground truth for a training set to be established.

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