(168 days)
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.
§ 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.