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The Secusion Catheter is indicated for localized infusion and aspiration of various therapeutic agents in isolated segments of the peripheral venous vasculature. The Seclusion Catheter may be repositioned for multiple treatments with the same patient. The Seclusion Catheter is not indicated for use in the neurovasculature.

The Seclusion Catheter is indicated for localized infusion and aspiration of various therapeutic and diagnostic agents in isolated segments of the peripheral venous vasculature. The Seclusion Catheter may be repositioned for multiple treatments with the same patient. A photograph of the Seclusion Catheter is shown in the figures below. The device is EtO sterilized and is a single-use device.

This document is a 510(k) summary for a medical device called the "Seclusion Catheter." It is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

The provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria, especially in the context of an AI/ML powered device. The document describes a physical medical device (a catheter), not a software or AI-powered one. The performance data section refers to traditional physical device testing like "Visual and Dimensional Testing," "Cycle and Simulated Use Testing," "Physical Characteristics Testing," "Functional Testing," "Usability Testing," "Packaging Testing," and "Biocompatibility testing."

Therefore, I cannot fulfill your request for information related to acceptance criteria, AI/ML device performance, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, or training set details, as these concepts are not addressed in the provided documentation for the Seclusion Catheter.

The document is a standard FDA 510(k) submission for a non-software medical device.

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