(51 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 OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, obligue, and/or curved crosssectional images that display the internal structure of 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 OASIS Specialty Coils are as follows:
- . The MR-RHC-150N, ECHELON RAPID Head Coil is a recieve-only multiple array device used for MRI imaging of the brain.
- The MR-RBC-150N, ECHELON RAPID Torso Coil is a recieve-only multiple . array device used for MRI imaging of the abdomen.
The MR-RHC-150N, ECHELON RAPID Head Coil is a recieve-only multiple array device used for MRI imaging of the brain.
The MR-RBC-150N, ECHELON RAPID Torso Coil is a recieve-only multiple array device used for MRI imaging of the abdomen.
The provided text is a 510(k) summary for MRI coils. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness as would be expected for AI/software devices.
Therefore, the requested information regarding acceptance criteria, specific study design elements (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance), and ground truth establishment is not available in the provided document.
The document primarily focuses on:
- Device Description: Function, scientific concepts (how MRI works), and physical/performance characteristics of the ECHELON RAPID Head Coil and Torso Coil.
- Intended Use/Indications for Use: MRI imaging of the brain (Head Coil) and abdomen (Torso Coil).
- Technological Characteristics: Stating that they are similar to predicate devices.
- Substantial Equivalence Claim: The core of the 510(k) submission, asserting the new coils are equivalent to existing ones.
No clinical performance studies or acceptance criteria of the type requested are present. The "performance characteristics" mentioned refer to the physical and technical attributes of the coils themselves (e.g., 16 elements, receive-only) rather than clinical performance metrics or reader 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.