(29 days)
C-scan is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, call and knee, but excluding the thigh.
C-scan MR images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
The C-scan device is a magnetic resonance (MR) system. The changes performed on the C-scan device, with respect to the cleared version - Artoscan C K010057 -, are due to the improvement of the system performance. These modifications do not affect the intended use or alter the fundamental scientific technology of the device and are the following:
- Upgrading of the electronics.
- New pulse sequences.
- A new software release.
- Mobile installation.
The system is composed of three main parts:
- Patient Positioning Seat
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
- Electronics and Magnetic Unit
The provided document is a 510(k) summary for the C-scan MR system, indicating it's a submission for modifications to an already cleared device (Artoscan C K010057) rather than a de novo submission. As such, the focus is on demonstrating substantial equivalence to the predicate device, not necessarily on entirely new clinical studies to prove effectiveness or diagnostic accuracy against specific acceptance criteria for a novel device.
The "study" described here is a comparison of technical specifications and performance characteristics between the modified C-scan and the predicate Artoscan C, to show that the modifications do not alter the intended use and maintain or improve performance within the established safety and effectiveness profile of an MR diagnostic device.
Here's an attempt to extract the requested information based on the provided text, acknowledging that some fields may not be directly applicable or explicitly stated in a 510(k) summary focused on technical equivalence for an MR system upgrade:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The device under review, the C-scan MR System, is a modified version of the previously cleared Artoscan C (K010057). The acceptance criteria are implicitly based on demonstrating that the performance of the C-scan, with its upgraded electronics, new pulse sequences, new software, and mobile installation capability, is equivalent to or improved compared to the predicate device, without negatively affecting its intended use or fundamental scientific technology. The study presented is a technical comparison focusing on various system characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Characteristic | Acceptance Criteria (Implied: Equivalence/Improvement to Predicate) | Reported Device Performance (C-scan) |
|---|---|---|
| Pulse Sequences | Maintained or enhanced range of pulse sequences. | New sequences added: Spin Echo T1 3D (SET1_3D), Short TI Inversion Recovery 3D (STIR_3D), Short Time Inversion Recovery Gradient Echo 3D (GE_STIR_3D), and several High Resolution sequences (se_26, se_26_hf, se_18_he, tse_80, tme, ge_16). Existing sequences retained. |
| Sequence Parameters | Maintained or improved parameter ranges, especially for new sequences. | SET1_3D: TR 60-5000 ms, TE 24 ms, min FOV 100 mm, FOV 3D 40-200 mm. |
| STIR_3D: TR 150-5000 ms, TE 24 ms, TI 20-200 ms, min FOV 100 mm, FOV 3D 40-200 mm. | ||
| GE_STIR_3D: TR 150-5000 ms, TE 16 ms, TI 20-200 ms, FA 90°, min FOV 100 mm, FOV 3D 40-200 mm. | ||
| High Resolution Sequences: Fixed TEs (e.g., SE T1 at 26ms, GE at 16ms), increased max acquisition matrix to 512x512, ensuring best S/N for high resolution. | ||
| Spatial Resolution | Maintained or improved spatial resolution. | Improved: Up to 0.2 mm (nominal value), compared to Artoscan C's 0.4 mm. Achieved by increasing acquisition matrix (min pixel size = min FOV / max matrix size = 100x100mm / 512x512). |
| Acquisition Matrix | Sufficient matrices for standard & high resolution imaging. | 2D FT: 192x128 to 256x256 (non-High Resolution); 192x128 to 512x512 (High Resolution). |
| 3D FT: 192x128 to 256x256, slice encoding from 24 to 128. | ||
| Control System (Gradients) | Modernized and capable control system. | Digital electronic, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (upgrade from DSP SHARC 21062@40 MHz). Software ramp generation (from hardware). |
| Magnetic Compensation | Robust and technologically current compensation system. | "Open loop" control, digital elaboration of signal in separated channels (DC - 50/60 Hz - 16.6 Hz). Digital electronic, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (technological updating from microcontroller HC11). |
| A/D Conversion (RF System) | Technologically updated and efficient A/D conversion. | For each channel: 3 MHz conversion, A/D converter 14 bit 20 MHz sampling (upgrade from 2 A/D converter 16 bit 78 kHz sampling). Digital demodulation and low-pass filter with wider bandwidth. |
| Synthesizer (RF System) | Improved frequency, amplitude, and phase modulation capabilities and stability. | Digital, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (upgrade from DSP SHARC 66 Mips). Improved resolutions (e.g., 28.4 µHz frequency, 4096 levels amplitude) and stability ( |
§ 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.