(54 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-PVC-150, ECHELON RAPID PV Coil is a receive-only multiple array device . used for MRI imaging of the lower body region.
- The MR-RFC-150, ECHELON RAPID Foot Coil is a receive-only multiple array device . used for MRI imaging of the feet.
- The MR-RKC-150N, ECHELON RAPID Knee Coil is a receive-only multiple array device used for MRI imaging of the knee.
The MR-PVC-150, ECHELON RAPID PV Coil is a receive-only multiple array device used for MRI imaging of the lower body region.
The MR-RFC-150. ECHELON RAPID Foot Coil is a receive-only multiple array device used for MRI imaging of the feet.
The MR-RKC-150N. ECHELON RAPID Knee Coil is a receive-only multiple array device used for MRI imaging of the knee.
This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through a detailed clinical study with acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment.
Instead, the submission focuses on:
- Device Description: Explaining the function, scientific concepts (MRI principles), and physical/performance characteristics of the ECHELON RAPID PV Coil, Foot Coil, and Knee Coil.
- Intended Use: Specifying what the coils are used for (MRI imaging of the lower body, feet, and knee, respectively).
- Technological Characteristics: Stating that the technological characteristics are "similar to the predicate devices."
- Substantial Equivalence: Concluding that the devices are substantially equivalent to listed predicate devices.
Here's why the requested information is absent:
- Acceptance Criteria & Performance Study: For a 510(k) submission of this type (MR coils), the primary "acceptance criterion" is typically demonstrating that the new device performs at least as well as, and presents no new safety risks compared to, an existing predicate device. This is often done through engineering tests, phantom studies, and qualitative comparison to predicate device performance, not a clinical study with detailed performance metrics like sensitivity/specificity against a clinical ground truth. The document explicitly states, "The technological characteristics of the ECHELON RAPID PV Coil, ECHELON RAPID Foot Coil, and ECHELON RAPID Knee Coil are similar to the predicate devices as listed in Section 10 - Substantial Equivalence Discussion." This implies that the justification for performance relies on similarity to existing devices, not a new, independently conducted study designed to meet specific quantitative performance targets.
- Sample Size, Experts, Adjudication, Ground Truth: These details are relevant for clinical performance studies, especially those involving human interpretation or AI/CAD systems that rely on a ground truth established by experts. Since this submission doesn't present such a study, these details are not provided.
- MRMC Study, Standalone Performance: These are specific types of studies usually conducted for AI/CAD devices or devices where human interpretation is a key component to assess improvement with assistance or the algorithm's performance alone. As this is a hardware component (MRI coils), these types of studies are not applicable or presented.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and results.
§ 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.