(47 days)
The Spirit III TotalSENSE Cardiac Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging.
The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Siemens Magnetom Trio 3.0T MRI scanner manufactured by Siemens Medical Solutions, Inc.
The indications for use are the same as for standard imaging:
The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Spirit III TotalSENSE Cardiac Coil is an eight element receive only phased array coil. The coil is composed of a flexible top piece and a rigid bottom piece. The flexible top piece allows for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible and rigid plastic housings, which are fire rated. All rigid plastic housing parts have a high impact and tensile strength.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria for the Spirit III TotalSENSE Cardiac Coil. The document is a 510(k) premarket notification summary and a letter from the FDA determining substantial equivalence to predicate devices, focusing on the device's intended use, description, and comparison to existing technology. It does not include specific performance metrics, study designs, or data about the device's performance against predefined acceptance criteria.
§ 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.