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The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRI-quided interventional procedures. The EndoScout provides in realtime the position (location and orientation) of the device during MR scanning. This data enables the users to guide an interventional procedure to a target inside the body, using minimal invasive approach.

Devices and tools to be tracked may include: diagnostic devices (e.g. biopsy needles, aspiration needles), therapeutic devices (including devices used to destroy tissue, like RF ablation, laser ablation or cryo-therapy probes, or devices used to deliver therapeutic agents like drugs, chemotherapy agents, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the "EndoScout Tracking System". It confirms the device's substantial equivalence to a legally marketed predicate device and outlines general regulatory information.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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