EXCELART

K990620 · Toshiba America Mri, Inc. · LNH · May 14, 1999 · Radiology

Device Facts

• Record ID: K990620
• Device Name: EXCELART
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: May 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Anatomical regions: Head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities 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, Blood Oxygenation Level Dependent (BOLD) Imaging. [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac Tagging.}

Device Story

EXCELART is a 1.5T magnetic resonance imaging (MRI) system; utilizes hydrogen nuclei excitation for whole-body diagnostic imaging. System features a short-bore magnet and gantry design. Operated by trained clinicians in clinical settings. Inputs include magnetic resonance signals; system transforms these into 2D/3D anatomical images, vascular maps, and functional data (BOLD). Output displayed for physician review to assist in clinical diagnosis and patient management. Benefits include non-invasive visualization of internal structures and physiological processes. System incorporates software V4 for image processing and control.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and bench testing of safety parameters, including magnetic field strength, rate of change, RF power, and acoustic noise levels measured per NEMA guidelines.

Technological Characteristics

1.5T MRI system; short-bore magnet and gantry design. Maximum static field strength 1.5T; rate of change 19.35 T/sec; RF power <1.0 W/kg. Acoustic noise level 110.8 dB. Software V4. Connectivity and specific material standards not detailed.

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. Applicable for 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

• VISART™/Hyper (K965068)

Reference Devices

• V4 software (K983110)

Submission Summary (Full Text)

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MAY 1 4 1999

# K990620

### 510(k) Premarket Notification

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. | DEVICE NAME:<br>Model Number: | Magnetic Resonance Diagnostic Device Accessory<br>MRT-150 /V2 (EXCELART) | | |
|----|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--|
| | Trade/Proprietary Name: | EXCELART | | |
| 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: | February 24, 1999 | | |
| 6. | DEVICE DESCRIPTION: | This submission consists of a new Magnetic Resonance<br>Imaging system which is based primarily on the cleared<br>VISART™/Hyper system (K965068) with modifications<br>including a short bore magnet and gantry design. The<br>software used with the EXCELART MRI system is V4<br>(K983110). All other technology used for the EXCELART<br>system is the same as that of the cleared VISART™/Hyper<br>system. | | |
| 7. | SAFETY PARAMETERS:<br>Maximum static field strength: | VISART™/Hyper<br>1.5T | EXCELART<br>1.5T | |

| Rate of change of magnetic field: | 19.5 T/sec. | 19.35 T/sec. |
|-----------------------------------|-------------|--------------|
| Maximum radio frequency power | <1.0 W/kg | <1.0 W/kg |
| Acoustic noise levels (maximum): | 105.1 dB | 110.8 dB |

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

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### 8. IMAGING PERFORMANCE PARAMETERS:

| Specification volume: Head: | VISART™/Hyper<br>16cm dsv | EXCELART<br>16cm dsv |
|-----------------------------|---------------------------|----------------------|
| Body: | 28cm dsv | 28cm dsv |

#### 9. INTENDED USE

Anatomical regions: Head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities 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, Blood Oxygenation Level Dependent (BOLD) Imaging. [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 EXCELART Magnetic Resonance Imaging (MRI) system is substantially equivalent to the VISART™/Hyper Magnetic Resonance System (K965068) cleared on 7/15/1997. The software used for the EXCELART MRI system is the same as V4 (K983110). The short bore magnet and short gantry do not raise new questions of safety or efficacy.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 1999

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

K990620 EXCELART MRI System Dated: February 24, 1999 Received: February 25, 1999 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 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). 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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/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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K990620 510(k) Number (if known): EXCELART MRI System __________________________________________________________________________________________________________________________________________________________ Device Name: Indications for Use:

Imaging of:

- The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, . spine, blood vessels , limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), 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 .

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K990620 |

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

CONFIDENTIAL