(41 days)
The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a Siemens Medical Systems 1.5 Tesla MRI Scanner with Total imaging matrix (Tim) option.
SV Brain Array, Model# 1500SV-SMS64
The provided document is a 510(k) clearance letter from the FDA for the SV Brain Array, Model # 1500SV-SMS64. This type of document declares substantial equivalence to a predicate device and permits marketing. It is not a study report or clinical trial documentation, and therefore does not contain the detailed information required to answer the prompt regarding acceptance criteria, device performance, and study specifics.
The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the device was deemed substantially equivalent based on comparisons to a predicate device, not necessarily extensive new clinical studies with defined acceptance criteria and performance metrics as might be found in a PMA (Premarket Approval) application or a detailed clinical study report.
Therefore, I cannot provide the requested information from this document. To answer your prompt, I would need access to the actual 510(k) submission document or any underlying performance studies referenced within that submission.
§ 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.