EXCELART VANTAGE ZGV

K060003 · Toshibamedical Systems Corporation · LNH · Jan 18, 2006 · Radiology

Device Facts

• Record ID: K060003
• Device Name: EXCELART VANTAGE ZGV
• Applicant: Toshibamedical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Jan 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Imaging of: The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] Fluid Visualization . 2D / 3D Imaging MR Angiography / MR Vascular Imaging . Blood Oxygenation Level Dependent (BOLD) imaging ● Perfusion / Diffusion Imaging . Proton Spectroscopy .

Device Story

EXCELART Vantage™ ZGV is a 1.5T MRI system; utilizes magnetic resonance to generate diagnostic images of human anatomy. Inputs: RF signals and magnetic field gradients; processed via system CPU (3.2GHz) to reconstruct 2D/3D images. System features upgraded gradient coils and power supply for higher strength/slew rates compared to predicate. Operated by trained clinicians/technicians in clinical settings. Output: Diagnostic images for physician review to aid clinical decision-making. Benefits: Enhanced imaging performance (Min.TR/TE/Slice thickness) and expanded coil compatibility (Flex coils, QD Knee/Foot). Supports 1st level SAR operating mode per IEC 60601-2-33.

Clinical Evidence

Bench testing only. No clinical data provided. Imaging performance parameters were verified as unchanged from the previous submission (K032490).

Technological Characteristics

1.5T MRI system. Hardware: Upgraded gradient coils and power supply. CPU: 3.2GHz. Connectivity: Supports various RF coils (Flex, QD Knee/Foot). Safety: Complies with IEC 60601-2-33 (2002) for 1st level SAR operating mode. Imaging: 2D/3D, BOLD, perfusion/diffusion, proton spectroscopy. Software: Controls RF coils and SAR limitations.

Indications for Use

Indicated for whole-body MRI imaging, including head, abdomen, pelvis, extremities, spine, neck, TMJ, heart, and vasculature. Supports 2D/3D imaging, angiography, BOLD, perfusion/diffusion, and proton spectroscopy. No specific age or gender contraindications listed.

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

• EXCELART Vantage™ XGV/AGV (K032490)

Reference Devices

• QD Knee/Foot coil (K051763)

Submission Summary (Full Text)

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# JAN 1 8 2006

06 0003

Appendix 1

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory |
|--------------------------------|------------------------------------------------|
| Model Name: | MRT-1503/P5 |
| Trade/Proprietary Name: | EXCELART Vantage™ ZGV |
| 2. ESTABLISHMENT REGISTRATION: | 2020563 |

TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 3. U.S. Agent Name and Address: 2441 MICHELLE DRIVE TUSTIN, CA 92780

Paul Biggins Contact Person: (714) 730 - 5000

- TOSHIBA CORPORATION Manufacturing Site: 4. MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- December 22, 2005 DATE OF SUBMISSION: 5.

#### DEVICE DESCRIPTION 6.

The EXCELART Vantage™ ZGV system is comparable to the current EXCELART Vantage™ XGV/AGV system; with the following exceptions.

- The maximum gradient strength and the maximum slew rate have been increased. .
- The clock of CPU of computer system was increased from 2.8GHz to 3.2GHz. ,
- SAR 1st level operating mode as specified in IEC 60601-2-33 (2002). .
- Thel performance (Min.TR/Min.TE / Min.Slice thickness ) of a sequence has been , improved.

| Model Number with suffix | Trade/Proprietary Name |
|--------------------------|------------------------|
| MRT-1503/P5 | EXCELART Vantage™ ZGV |

# 6.1. SUMMARY OF MAJOR HARDWARE CHANGES

- A. The gradient coil was changed for higher gradient strength and slew rate .
- B. The gradient power supply was changed for higher gradient strength and slew rate.
- C: The clock of CPU was changed from 2.8GHz to 3.2GHz.
- D. Flex coils (70, 100, 150, 200mm, Rectangular) are added to the available coil list.
- E. QD Knee/Foot coil ( K051763) is added.

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# 6.2. SUMMARY OF MAJOR SOFTWARE CHANGES

- A. New CPU correspondence.
- B. New RF coil control.
- C. SAR limitation control.

## 7. SAFETY PARAMETERS

| | Current EXCELART<br>Vantage™ XGV/AGV (No<br>changes from the previous<br>submission, K032490 ) | New EXCELART<br>Vantage™ ZGV |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted<br>acoustic noise: | 110 dB (A-weighted) | Same |
| c. Operational modes: | 1st operating mode for dB/dt | 1st operating mode<br>for dB/dt and SAR |
| i. Safety parameter display: | SAR, dB/dt | Same |
| ii. Operating mode access<br>requirements: | Not applicable because used<br>only in normal operating<br>mode | Allows access to 1st<br>level operating mode |
| d. Maximum SAR | Normal operating mode<br>specified in IEC 60601-2-33<br>(2002) | 1st operating mode<br>specified in IEC<br>60601-2-33 (2002) |
| e. Maximum dB/dt | <1st operating mode specified<br>in IEC 60601-2-33 (2002) | Same |
| and Gradient coil dimensions: | 692 x 893 x 1405<br>(unit: mm) | Same |
| f. Potential emergency<br>conditions and means provided<br>for shutdown: | Shut down by Emergency<br>Ramp Down Unit for collision<br>hazard by ferromagnetic<br>objects | Same |
| g. Biocompatibility of materials: | Not applicable | Same |

#### IMAGING PERFORMANCE PARAMETERS 8.

No changes from the previous submission, K032490 .

## 9. INTENDED USE

No changes from the previous submission, K032490 .

# 10. EQUIVALENCY INFORMATION

TOSHIBA Medical Systems Corporation believes that the new EXCELART Vantage™ ZGV (model MRT-1503/P5) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART Vantage™ XGV/AGV (model MRT-1503/P3, MRT-1503/P2) (K032490 ) cleared on August 21, 2003.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2006

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K060003 Trade/Device Name: Excelart Vantage™ ZGV Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 29, 2005 Received: January 3, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brigdon

Nanev C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Attachment 1

# Indications for Use

510(k) Number (if known):

Device Name: EXCELART Vantage™ ZGV

Indications for Use:

Imaging of:

- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, t t neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
- Fluid Visualization .
- . 2D / 3D Imaging
- MR Angiography / MR Vascular Imaging .
- Blood Oxygenation Level Dependent (BOLD) imaging ●
- Perfusion / Diffusion Imaging .
- Proton Spectroscopy .

Prescription Use
(Part 21 CFR 801Subpart D)

OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Seymour

(Division Sign-Off) Division of Reproductive, Abdon and Parlicipal Devices 510K, NUMBER ______________