(29 days)
The Promaxo Magnetic Resonance Imaging (MRI) System II is an office-based MRI system for producing images that display the prostate and adjoining tissues. When used by a trained urologist or interventional/urologic radiologist, the system is intended to be used for targeting prostatic lesions under MR quidance in alignment with the current standard of care. Promaxo MR images are not intended to be used for diagnostic purposes, and either a 1.5T or 3T MR image acquired without an endorectal coil is a required input for guidance using the Promaxo MRI System.
The Promaxo MRI system is an open configuration MRI system composed of an array of permanent magnets arranged to provide a constant in-plane magnetic field strength and a built-in z-gradient within its field of view. The system utilizes electromagnetic gradient coils, RF coils, and other components such as the spectrometer and signal amplifiers to capture, reconstruct and display magnetic resonance images of objects within its field of view.
The provided text is a 510(k) summary for the Promaxo MRI System II. It states that the device is identical to its predicate (K202518) with the exception of a modification to the Indications for Use statement. This modification involves including "co-registration with a diagnostic 1.5T MR image acquired without an endorectal coil."
The document explicitly states that no new performance data is required, as the design of the device and its intended use are identical to the predicate. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, or ground truth establishment.
Specifically, the document states:
- "No design modifications have been made to the cleared Promaxo MRI System. The only change is to the Indications for Use. An assessment of the change was performed and it was determined that the modified Indications for Use any new risks. Thus, testing previously performed for the Promaxo MRI System is appropriate and sufficient for Use. Therefore, no additional performance data is required."
- "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device."
Based on this, I cannot provide the requested information.
§ 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.