(21 days)
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The cardiac coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the body. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use are as follows:
The MR-RCC-150 Cardiac Coil is a receive-only multiple array coil used for MRI imaging of the heart, its surrounding structures.
The Echelon Cardiac Coil is a receive only RF phased array coil, used for obtaining diagnostic images of the cardiac region, in an open Magnetic Resonance Imaging (MRI) system.
The Cardiac coil is a receive-only coil designed to contour to the outline of the shoulder. The coil consists of 12 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
This 510(k) submission (K066513) is for a medical device called the Echelon™ MR-RCC-150 Cardiac Coil. This is a receive-only RF phased array coil intended for obtaining diagnostic images of the cardiac region in an open Magnetic Resonance Imaging (MRI) system.
The submitter, Hitachi Medical Systems America, Inc., states that the device is substantially equivalent to the predicate device, the Rapid Torso Coil (K041185). The submission focuses on demonstrating this substantial equivalence based on technological characteristics and intended use. Thus, the document does not contain an independent study with acceptance criteria and device performance evaluation as would be typically seen for a new device requiring performance testing.
The conclusion explicitly states: "It is the opinion of Hitachi Medical Systems America that the Echelon™ Cardiac Coil is substantially equivalent to the Rapid Torso coil (Cf. K041185). The technological characteristics and intended use are identical to the Predicate Device."
Therefore, I cannot provide the requested information in the format of a table demonstrating acceptance criteria and performance, nor details about a study conducted to prove the device meets specific criteria, as such a study is not present in the provided text. The regulatory approval is based on a claim of substantial equivalence to a predicate device.
§ 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.