(60 days)
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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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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§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.