(50 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 ECHELON Specialty Coils are receive-only devices that detect the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved cross-sectional 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 for the ECHELON Specialty Coils are as follows:
- The MR-HRF-150, ECHELON High Resolution Foot Coil is a receive-only multiple ● array device used for MRI imaging of the ankle.
- The MR-LBC-150, ECHELON Long Bone Coil is a receive-only multiple array device . used for MRI imaging of the extremities.
The MR-HRF-150, ECHELON High Resolution Foot Coil is a receive-only multiple array device used for MRI imaging of the ankle.
The MR-LBC-150. ECHELON Long Bone Coil is a receive-only multiple array device used for MRI imaging of the extremities.
Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen. which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2.
A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
The MR-HRF-150. ECHELON High Resolution Foot Coil is a receive-only device suitable for imaging the ankle. The coil consists of 8 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-LBC-150. ECHELON Long Bone Coil is a receive-only device suitable for imaging extremities. The coil consists of 4 channels. The signal output of each element is independently processed by the MRI system to enhance performance.
The provided text is a 510(k) summary for the ECHELON High Resolution Foot Coil and ECHELON Long Bone Coil. This document establishes substantial equivalence to predicate devices rather than undergoing a de novo approval process based on acceptance criteria and performance studies.
Therefore, the submission does not contain the information requested regarding specific acceptance criteria and a study proving the device meets those criteria. The main argument for market clearance is that "the ECHELON High Resolution Foot Coil and ECHELON Long Bone Coil are substantially equivalent to the listed predicate devices."
Here's why the requested information isn't present in this type of submission:
- Acceptance Criteria and Reported Device Performance: These are typically established and tested for novel devices or when a device claims superior performance to existing ones. Substantial equivalence relies on demonstrating that the new device shares similar technological characteristics and intended use with already-approved predicate devices, implying similar safety and effectiveness without needing to redefine performance metrics.
- Sample Size for Test Set and Data Provenance: Performance studies require a test set. Since a new performance study to establish new acceptance criteria was not conducted, this information is not provided.
- Number of Experts and Qualifications: Ground truth establishment by experts is part of performance studies.
- Adjudication Method: Related to ground truth establishment in performance studies.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: These are typically conducted to quantify the impact of AI on human reader performance. This is not relevant here as the device is an MR coil, not an AI diagnostic tool.
- Standalone Performance: This would apply to diagnostic algorithms, not an MR coil.
- Type of Ground Truth Used: Not applicable in this context.
- Sample Size for Training Set: Training sets are used for machine learning models and AI, which this device is not.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the 510(k) process for substantial equivalence, as presented in this document, focuses on comparing the new device's characteristics and intended use to existing, legally marketed devices, rather than establishing and demonstrating adherence to new performance acceptance criteria through clinical studies.
§ 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.