(88 days)
Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy
The OPART™ is a modification of the Flexart™ 0.5T system that employes a 0.35T open architecture vertical field superconducting magnet. The computer architecture. operational characteristics and user software follow the same design considerations cleared with the Flexart™ and Visart™ systems. The vertical magnetic field concept is similar to that developed for the Access™ permanent magnet system but uses the same 0.35T field strength as that employed by the MRT-35A. The patient couch allows both manually controlled left/right and in/out horizontal movements similar to the Access Compass Bed.
The provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document describes a Magnetic Resonance Device (OPART™) and compares its safety and imaging performance parameters to two other MR systems (Flexart™ and Visart™).
Specifically, the text is a 510(k) summary for a medical device (an MRI system), which is focused on demonstrating substantial equivalence to a predicate device rather than on the performance of a software algorithm that would typically have acceptance criteria and a detailed study.
Therefore, I cannot provide the requested information from the given input.
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510(k) Summary
- OCT 2 5 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
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- DEVICE NAME: Magnetic Resonance Device Model Number: ' MRT-600 Trade/Proprietary Name: OPARTTM 2. ESTABLISHMENT REGISTRATION: 2936923 3. U.S. Agent Name and Address: TOSHIBA AMERICA MRI, INC. 280 Utah Ave. South San Francisco, CA 94080 Contact Person: Steven M. Kay (714) 730-5000
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- Manufacturing Site: Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080
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- DATE OF SUBMISSION: July 26, 1996
6. DEVICE DESCRIPTION
The OPART™ is a modification of the Flexart™ 0.5T system that employes a 0.35T open architecture vertical field superconducting magnet. The computer architecture. operational characteristics and user software follow the same design considerations cleared with the Flexart™ and Visart™ systems. The vertical magnetic field concept is similar to that developed for the Access™ permanent magnet system but uses the same 0.35T field strength as that employed by the MRT-35A. The patient couch allows both manually controlled left/right and in/out horizontal movements similar to the Access Compass Bed.
7. SAFETY PARAMETERS
| OPART | Flexart | Visart | |
|---|---|---|---|
| Maximum static field strength: | 0.35T | 0.5T | 1.5T |
| Rate of change of magnetic field (T = 1000ms): | 18.5 T/sec | 11 T/sec, | 13.3T/sec. |
| Max. Radio frequency power deposition: | <0.244W/kg | <0.256 W/kg | <0.4W/kg |
| Acoustic Noise levels: | 98.4 dB (A)(Maximum) | 100.2 dB (A)(Maximum) | 105.3 dB(Maximum) |
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510(k) Summary (cont'd)
SUMMARY OF SAFETY AND EFFECTIVENESS
IMAGING PERFORMANCE PARAMETERS 8.
| OPART | Flexart | Visart | ||
|---|---|---|---|---|
| Specification volume: | Head: | 10cm dsv | 10.4cm dsv | 16cm dsv |
| Body: | 20cm dsv | 10.4cm dsv | 28cm dsv |
Sample phantom images and clinical images were presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion and Slice Thickness/Interslice Spacing.
INTENDED USE 9.
| Anatomical Region: | Head, Body, Extremity, Spine, Neck, TMJ, and Heart |
|---|---|
| Nuclei excited: | Hydrogen |
| Diagnostic Use: | Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy |
10. EQUIVALENCY INFORMATION
Toshiba America MRI, Inc. (TAMI) believes the OPART™ is substantially equivalent to the Flexart™ and Access™ diagnostic magnetic resonance systems because it consists of hardware and software modifications that do not introduce new questions of safety or efficacy, nor does it introduce new indications for use. OPART™ uses a superconducting magnet that has a static magnetic field less than that of the cleared Flexart™ and in the same orientation as the Access™. The gradient field strength is less than the IEC standard and that of other manufacturers systems currently on the market. New surface coils for this system are designed to be compatible with the vertical field of the magnet, as compared with the horizontal field of the standard Flexart™ system. Toshiba has prior experience designing vertical field coils for its Access system. The new magnet offers siting, shipping and patient access advantages, but does not change the system's intended use. Good Manufacturing Practices requirements and software development procedures are unchanged from those already in effect for the Flexart™. The patient couch is similar to the cleared Compass Bed.
§ 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.