FLEXART,FLEXART/HYPER, VISART, VISART/HYPER

K983110 · Toshiba America Mri, Inc. · LNH · Feb 25, 1999 · Radiology

Device Facts

• Record ID: K983110
• Device Name: FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Diagnostic imaging of the whole body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities), fluid visualization, 2D and 3D imaging, MR angiography/MR Vascular Imaging and MR fluoroscopy. [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac Tagging.]

Device Story

Software upgrade for FLEXART and VISART MRI systems; enables new imaging sequences including cardiac tagging and BOLD imaging. Device processes magnetic resonance signals to produce diagnostic images of human anatomy. Operated by trained MRI technologists/radiologists in clinical settings. Output viewed by clinicians to assist in diagnostic decision-making for various pathologies. Benefits include enhanced diagnostic capabilities for cardiac and vascular assessment.

Clinical Evidence

Bench testing only. Acoustic noise levels measured per NEMA guidelines. Imaging performance parameters (specification volumes) provided. Sample clinical images presented for new sequences.

Technological Characteristics

MRI diagnostic accessory; software upgrade for existing systems. Operates at 0.5T (FLEXART) and 1.5T (VISART). SAR <0.4 W/kg (FLEXART) and <1.0 W/kg (VISART). Acoustic noise levels 98.5-105.3 dB. Supports 2D/3D imaging, MR angiography, MR fluoroscopy, and BOLD imaging.

Indications for Use

Indicated for diagnostic imaging of the whole body, including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities, for patients requiring MR imaging, fluid visualization, 2D/3D imaging, MR angiography, MR vascular imaging, MR fluoroscopy, and BOLD 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

• FLEXART (K970573)
• VISART (K965068)
• Cardiac Tagging Techniques (K973799)
• FLEXART (K962138)

Submission Summary (Full Text)

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K98 3110

# 510(k) Premarket Notification

# SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. | DEVICE NAME:<br>Model Number: | Magnetic Resonance Diagnostic Device Accessory<br>MRT-50GP /E2 (FLEXARTTM), /H2 (FLEXARTTM/Hyper)<br>MRT-150 /F1 (VISARTTM), /F2 (VISARTTM/Hyper) | | |
|----------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|
| | Trade/Proprietary Name: | FLEXARTTM, FLEXARTTM/Hyper, VISARTTM,<br>VISARTTM/Hyper | | |
| 2. | ESTABLISHMENT REGISTRATION: | 2636923 | | |
| 3. | U.S. AGENT NAME AND ADDRESS: | Toshiba America MRI, Inc.<br>280 Utah Avenue<br>South San Francisco, CA 94080 | | |
| | CONTACT PERSON: | Ken Nehmer<br>[phone] ext. 6083 | | |
| 4. | MANUFACTURING SITE: | Toshiba Corporation<br>1385 Shimoisigami<br>Otawara-shi, Tochigi-Ken<br>Japan 324 | | |
| 5. | DATE OF SUBMISSION: | September 1, 1998 | | |
| 6. | DEVICE DESCRIPTION: | This submission consists of a software upgrade to the MRT-<br>50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper),<br>MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper) | | |
| 7. | SAFETY PARAMETERS:<br>Maximum static field strength: | FLEXARTTM &<br>FLEXARTTM/Hyper | V3.5 s/w<br>0.5 T | V4.0 s/w<br>0.5 T |
| | | VISARTTM &<br>VISARTTM/Hyper | 1.5T | 1.5T |
| | Rate of change of magnetic field: | FLEXARTTM<br>FLEXARTTM/Hyper | 11 T/sec.<br>13.3 T/sec. | 11 T/sec.<br>13.3 T/sec. |
| | | VISARTTM<br>VISARTTM/Hyper | 13.3 T/sec.<br>19.5 T/sec. | 13.3 T/sec.<br>19.5 T/sec. |
| Maximum radio frequency power<br>deposition (SAR): | | V3.5 s/w | V4.0 s/w | |
| FLEXART™ &<br>FLEXART™/Hyper | | <0.4 W/kg | <0.4 W/kg | |
| VISART™ &<br>VISART™/Hyper | | <1.0 W/kg | <1.0 W/kg | |
| Acoustic noise levels (maximum): | | | | |
| FLEXART™ | | 100.2 dB(A) | 100.2 dB(A) | |
| FLEXART™/Hyper | | 98.5 dB(A) | 98.5 dB(A) | |
| VISART™ | | 105.3 dB | 105.3 dB | |
| VISART™/Hyper | | 105.1 dB | 105.1 dB | |

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Acoustic noise data was measured in accordance with NEMA guidelines. The user is cautioned to have the patient wear acoustic noise protection during scanning.

#### IMAGING PERFORMANCE PARAMETERS: 8.

| Specification volume: Head: | FLEXART™ &<br>VISART™ † | V3.5 s/w | V4.0 s/w |
|-----------------------------|-------------------------|----------|----------|
| | | 16cm dsv | 16cm dsv |
| Body: | FLEXART™ &<br>VISART™ † | 28cm dsv | 28cm dsv |

t = specifications for both standard and hyper versions

Sample clinical images are presented for new sequences.

### 9. INTENDED USE

| | Anatomical regions: Head, body, extremity, spine, neck, TMJ, and heart |
|-----------------|----------------------------------------------------------------------------------|
| Nuclei excited: | Hydrogen |
| Diagnostic use: | Diagnostic imaging of the whole body (including head, abdomen, breast, |
| | heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities), |
| | fluid visualization, 2D and 3D imaging, MR angiography/MR Vascular Imaging |
| | and MR fluoroscopy. [Application terms include MRCP (MR |
| | Cholangiopancreatography), MR Urography, MR Myelography, SAS (Surface |
| | Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac Tagging.] |

#### 10. EQUIVALENCY INFORMATION:

Toshiba America MRI, Inc. (TAMI), believes that the Version 4.0 software upgrade for the FLEXART™ and VISART™ systems is substantially equivalent to the software version 3.5 for FLEXART™ (K970573) which was cleared on 7/21/97 and VISART™ (K965068) which was cleared on 7/15/97. TAMI believes that the introduction of cardiac tagging in V4.0 is substantially equivalent to Cardiac Tagging Techniques (K973799) which was cleared on 1/2/98, and CINE Imaging which was cleared with version 3.1 for FLEXART™ (K962138) on 12/23/96. The modifications added to the Version 4.0 software do not raise new questions of safety or efficacy.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three abstract shapes that resemble birds in flight. The shapes are arranged in a diagonal line, with the largest shape at the top and the smallest shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 25 1999

Ken Nehmer Quality Engineer Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 Re:

K983110 Software Version 4.0 for Flexart and Visart Dated: December 17, 1998 . Received: December 21, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Nehmer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have vie nave reviewed your occain oroly nealisations for uses stated in the encosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the manical 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 r cocial rood, Drag, and e comers controls provisions of the Act include requirements for annual registration, listing of provisions of the Act. "The general ce, 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 if your device to such additional controls. Existing major regulations affecting your device can be found in the Code of be subject o battractional controlly equivalent determination assumes compliance with r occurrent Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for the Gallers Good management (21 CFR Part 820) and that, through periodic QS inspections, the Food and Mculan Donoral rogalerity such assumptions. Failure to comply with the GMP regulation may result in Drug Action. In addition, FDA may publish further announcements concerning your device in the Eederal regarding about. In addition - 27 has 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 I his reter will and you to bogin markeding your os 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 if you doon opeonices), 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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

| "

510(k) Number (if known):

K983110 ______________________________________________________________________________________________________________________________________________________________________

Device Name:

Version 4,0 Software Upgrade (FLEXART™ & VISART™)

Indications for Use:

Imaging of:

-

- The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, The Whole Doug (inoluding noad, are ities). [Application terms include MRCP (MR spirie, blood vessels , linios and oxientition ("Myelography, MR Fluoroscopy, SAS Onolanglopanoroatography); manic Scan, Cine Imaging, and Cardiac tagging.]
- Fluid Visualization -
- 2D/3D Imaging •
- MR Angiography/MR Vascular Imaging "
- Blood Oxygenation Level Dependent (BOLD) Imaging .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K983110 |

| Prescription Use (Per 21 CFR§801.109) | |
|---------------------------------------|--|
|---------------------------------------|--|

OR

| Over-The-Counter Use (Optional Format 1-2-96) | |
|-----------------------------------------------|--|
|-----------------------------------------------|--|

CONFIDENTIAL