(80 days)
The MRI Equipment Cover is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under Magnetic Resonance Imaging (“MRI”).
Not Found
This looks like a 510(k) clearance letter for a medical device. The document explicitly states that the device is an "MRI EQUIPMENT COVER" and its intended use is to "provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under Magnetic Resonance Imaging ('MRI')."
Because this is a Class II device and the clearance is based on substantial equivalence, the FDA does not require a clinical study proving efficacy against specific acceptance criteria in the same way a Class III device would. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device. Therefore, a study demonstrating specific acceptance criteria with performance metrics, ground truth, and expert evaluation is not provided in this document because it was not a requirement for this type of clearance.
The clearance letter primarily confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to devices marketed prior to May 28, 1976. This usually means that the manufacturer provided comparisons to an existing predicate device regarding design, materials, sterilization methods (given it's a sterile cover), and intended use, rather than a clinical trial with performance endpoints.
Therefore, I cannot extract the information requested in your bullet points from this document, as it pertains to a clinical efficacy study, which was not the basis for this 510(k) clearance.
§ 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.