(51 days)
Imaging of:
- -The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization -
- -2D/3D Imaging
- MR Angiography/MR Vascular Imaging -
The Extra Large Body coil is an enlarged version of the current OPART™ Large Body Coil. This coil is an optional coil which was developed to allow positioning of larger sized patients in the OPART™ system. The Extra Large Body coil can be used as a standalone coil, or in conjunction with the T-spine surface coil (cleared with OPART™ system K962933). Signal is received in QD mode when used in conjunction with the T-spine surface coil.
The Extra Large Body Coil is constructed with the same materials that are currently in use for the released coil set for OPART™.
This document describes the design and regulatory approval of an "Extra Large Body Coil" for an MRI system, the OPART™. The information provided primarily focuses on establishing the device's substantial equivalence to a previously cleared device, rather than a clinical study evaluating its performance against specific acceptance criteria in a medical context.
Based on the provided text, there is no clinical study that explicitly defines and proves the device meets specific performance acceptance criteria in the way typically expected for a diagnostic AI/medical device. Instead, the submission focuses on substantial equivalence for a physical component (the coil) of an MRI system.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for algorithms or diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not applicable here because this is a hardware accessory submission based on substantial equivalence. The "performance" being evaluated is related to physical and safety parameters of the MRI coil.
| Acceptance Criteria (Benchmarking/Safety/Physical) | Reported Device Performance (Extra Large Body Coil) |
|---|---|
| Safety Parameters: | |
| Maximum static field strength | 0.35 Tesla |
| Rate of change of magnetic field | 19 T/second |
| Maximum radio frequency power deposition (SAR) |
§ 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.