MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE

K965068 · Toshiba America Medical Systems, In.C · LNH · Jul 15, 1997 · Radiology

Device Facts

• Record ID: K965068
• Device Name: MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LNH · Radiology
• Decision Date: Jul 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Imaging of: - The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels and breast). [Application terms include MR Fluoroscopy, MR Urography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] - Fluid Visualization - 2D/3D Imaging - MR Angiography/MR Vascular Imaging

Device Story

VISART™/Hyper is a magnetic resonance imaging (MRI) system upgrade. It utilizes hydrogen nuclei excitation to generate diagnostic images of the whole body, including head, abdomen, heart, pelvis, spine, blood vessels, and extremities. The system features increased gradient field strength compared to the standard VISART™ system. It is operated by trained medical professionals in a clinical setting. The device produces 2D/3D images, MR angiography, and MR fluoroscopy data. Healthcare providers use these images for diagnostic assessment of anatomical structures and fluid visualization. The system includes noise absorption foam to mitigate acoustic noise levels. Patient benefit is derived from improved image quality and diagnostic capabilities provided by the software and hardware enhancements.

Clinical Evidence

Bench testing only. Performance was validated using sample phantom images and clinical images for all new sequences. Results demonstrated conformance with consensus standards for signal-to-noise ratio, uniformity, slice profiles, geometric distortion, and slice thickness/interslice spacing.

Technological Characteristics

1.5T static magnetic field strength; maximum rate of change of magnetic field 19.5 T/sec; RF power deposition <1.0 W/kg; acoustic noise levels 105.1 dB. Includes phased array coils and noise absorption foam. Software version 3.5. Operates on hydrogen nuclei excitation.

Indications for Use

Indicated for whole body MRI imaging, including head, abdomen, pelvis, limbs, extremities, spine, neck, TMJ, heart, blood vessels, and breast. Includes MR fluoroscopy, urography, MRCP, myelography, surface anatomy scans, dynamic scans, and cine imaging.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• VISART™ (K961092)

Submission Summary (Full Text)

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K965068
JUL 15 1997

# 510(k) Summary

## SUMMARY OF SAFETY AND EFFECTIVENESS

1. **Model Name:** MRT-150/H1 and MRT-150/F1
MRT-150/H2 and MRT-150/F2
**Device Name:** Magnetic Resonance Device
**Trade/Proprietary Name:** VISART™ and VISART™/Hyper

2. **Establishment Registration:** #2020563

3. **U.S. Agent Name and Address:** TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 Michelle Drive
P.O. Box 2068
Tustin, CA 92681-2068

**Contact Person:** Steven M. Kay
[phone]

4. **Manufacturing Site:** Toshiba Corporation
1385 Shimoishigami
Otawara-shi, Tochigi-Ken
Japan 324

5. **DATE OF SUBMISSION:** 16 December 1996

6. **DEVICE DESCRIPTION**
This submission consists of three upgrades to the MRT-150/H1 and MRT-150/F1 (VISART™) system. The first upgrades the software from V3.1 (which was the software cleared with the VISART™ in K961092) to V3.5. The second is the introduction of the VISART™/Hyper system, which increases the gradient field strength over that of the standard VISART™ with V3.5 software. The third is the introduction of optional phased array coils.

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# 7. SAFETY PARAMETERS

| | VISART™ V3.1 | VISART™ V3.5 | VISART™/Hyper V3.5 |
| --- | --- | --- | --- |
| Maximum static field strength: | 1.5T | Same | Same |
| Rate of change of magnetic field (τ = 1000ms): | 13.3T/sec, | 13.3T/sec. | 19.5T/sec. |
| Max. Radio frequency power deposition: | <1.0W/kg | <1.0W/kg | <1.0W/kg |
| Acoustic Noise levels: | 105.3 dB | 105.3 dB | 105.1 dB |
| (Maximum) | (Maximum) | (Maximum) | |

Acoustic noise data was measured in accordance with NEMA guidelines. In the labeling, the user is cautioned to have the patient wear acoustic noise protection during scanning. The VISART™/Hyper system includes additional noise absorption foam inside.

# 8. IMAGING PERFORMANCE PARAMETERS

| | | VISART™ V3.1 | VISART™ V3.5 | VISART™/Hyper V3.5 |
| --- | --- | --- | --- | --- |
| Specification volume: | Head: | 10 cm dsv | 16cm dsv | 16cm dsv |
| | Body: | 20 cm dsv | 28cm 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.

# 9. INTENDED USE

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. EQUIVALENCE INFORMATION

Toshiba America Medical Systems, Inc. (TAMS) believes that the VISART™ V3.5 software is substantially equivalent to the VISART™ V3.1 software because it consists of upgrades that improve the performance of the VISART™, without introducing new questions of safety or efficacy. The increased rate of change of the magnetic field is less than the Agency's acceptance limit of 20 T and that of other manufacturers systems currently on the market. This software upgrade provides improved image quality, but does not change the intended uses of the device. Good Manufacturing Practices requirements are unchanged from those already in effect for V3.1 and the VISART™.

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Steven M. Kay
Regulatory Affairs Specialist
Toshiba America Medical Systems, Inc.
2441 Michelle Drive
P.O. Box 2068
Tustin, CA 92681-2068

Re: K965068
Software Version 3.5 and Hardware Upgrades
For VISART
Dated: April 15, 1997
Received: April 16, 1997
Regulatory class: II
21 CFR 892.1000/Procode: 90 LNH

JUL 15 1997

Dear Mr. Kay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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510(k) Number (if known): _________________________________________________________

Device Name: **VISART™ Version 3.5 Software**

Indications for Use:

Imaging of:

- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels and breast). [Application terms include MR Fluoroscopy, MR Urography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization
- 2D/3D Imaging
- MR Angiography/MR Vascular Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymour
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number R765068

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________
(Optional Format 1-2-96)

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