(15 days)
For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio/Verio magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
The 1.5T and 3T array coils consist of a birdcage volume transmit coil and an array of 15 local receive coils. The 3T CP Knee coil consists of a birdcage coil, which is used as a volume transmit coil and also as a receive coil.
The coil elements are enclosed in a rigid plastic housing which is fire-rated and has impact and tensile strength. The split-top mechanical housing is designed to accommodate patients of various sizes. The knee coil is mounted on a rigid base which allows the coil to move freely in the left-to-right direction to accommodate imaging of both patient knees. Foam pads also aid in positioning and enhance patient comfort.
This submission is a 510(k) premarket notification for a magnetic resonance (MR) knee coil and does not contain information from a study of the type requested in the prompt. The 510(k) submission is for a new MR coil (TxRx 15Ch Knee Coil 1.5T, TxRx 15Ch Knee Coil 3T, and TxRx CP Extremity Coil 3T) and asserts its substantial equivalence to previously cleared predicate devices (HRK-63 Knee Array Coil, HRK-123 Knee Array Coil, and Leo III Tx/Rx Quadrature Knee Coil).
The document states that the new device and predicate devices are designed for "use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio/Verio magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician." The conclusion is based on the devices having "similar designs and are constructed of similar materials" with the "main differences [being] the number of channels in the array coils."
Therefore, this document does not contain the information required to populate the requested table and study details (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for the training set). This is a typical approach for demonstrating substantial equivalence for MR coils, where the focus is on technical specifications and safety rather than diagnostic performance studies comparing the new coil against a clinical gold standard.
§ 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.