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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.

Therefore, I cannot fulfill your request based on the provided input.

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The EndoScout is intended to provide physicians and surgeons with the means to track a device during MRF-guided interventional procedures. The EndoScout provides in real time the position (location and orientation) of the entire device during MR scanning 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 used to destroy tissue, like RF ablation, fasci ablation or cryo-therapy probes, or devices used to deliver various substances (e.g. drugs, genetic vectors, stem cells, etc.) and various support tools (e.g. suction tips, pointers).

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Robin Medical, Inc. regarding their EndoScout Tracking System. This document does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter primarily:

• Acknowledges receipt and review of the 510(k) submission.
• States that the device is "substantially equivalent" to legally marketed predicate devices.
• Grants permission to market the device, subject to general controls.
• Provides contact information for regulatory guidance.
• Includes a separate "Indications for Use" section.

Therefore, I cannot fulfill your request for detailed study information based on this document. The information you are seeking would typically be found in the 510(k) submission itself, which is not provided here.

Ask a specific question about this device