EXCELART WITH PIANISSIMO

K993803 · Toshiba America Mri, Inc. · LNH · Feb 6, 2000 · Radiology

Device Facts

• Record ID: K993803
• Device Name: EXCELART WITH PIANISSIMO
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 6, 2000
• 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: Hvdrogen 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, Diffusion Imaging, [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac Tagging.]

Device Story

EXCELART with Pianissimo is a 1.5T MRI system; utilizes hydrogen nuclei excitation for diagnostic imaging. New features include Pianissimo gradient acoustic reduction system; various RF coils (QD Whole Body, Head, C/T/L Spine Array, Flex Body, Shoulder Array); 18.1" LCD monitor; increased SAR limit (<1.5 W/kg). Optional software packages (EPI Plus, Super FASE Plus, MRA Plus) enable advanced functions: perfusion, diffusion, fresh blood imaging (FBI), cardiac tagging, and dynamic scanning. Operated by trained clinicians in clinical settings. System processes RF signals to generate anatomical images; output viewed by physicians for diagnostic decision-making. Pianissimo reduces acoustic noise levels to 86.0 dB. Benefits include improved patient comfort via noise reduction and expanded diagnostic capabilities for vascular and cardiac applications.

Clinical Evidence

Bench testing only. Acoustic noise levels measured in accordance with NEMA guidelines. Imaging performance parameters (specification volumes) verified as identical to the previously cleared EXCELART system.

Technological Characteristics

1.5T static field strength; gradient acoustic reduction system (Pianissimo); RF coils (QD Whole Body, Head, Spine Array, Flex Body, Shoulder Array); 18.1" LCD monitor; SAR limit <1.5 W/kg; rate of change of magnetic field 19.35 T/sec. Software-based image processing for 2D/3D, MRA, BOLD, diffusion, perfusion, and cardiac tagging.

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. Includes fluid visualization, 2D/3D imaging, MR angiography, MR fluoroscopy, BOLD, diffusion, and perfusion 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

• EXCELART Magnetic Resonance System (K990620)
• MRT-150A QD Whole Body (K922798)
• VISART QD Spine Array (K965068)
• VISART QD Head (K961092)
• VISART GP Flex (K965068)
• MRT-150A Shoulder (K942609)

Reference Devices

• V4 software (K983110)

Submission Summary (Full Text)

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993803

# 510(k) Premarket Notification

# SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. | DEVICE NAME:<br>Model Number:<br>Trade/Proprietary Name: | Magnetic Resonance Diagnostic Device Accessory<br>MRT-1500 /P2<br>EXCELARTTM with Pianissimo | 7. SAFETY PARAMETERS: | EXCELART™ | EXCELART™<br>w/Pianissimo |
|----|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------|---------------------------|
| 2. | ESTABLISHMENT REGISTRATION: | 2636923 | Maximum static field strength: | 1.5T | 1.5T |
| 3. | U.S. AGENT NAME AND ADDRESS: | Toshiba America MRI, Inc.<br>280 Utah Avenue<br>South San Francisco, CA 94080 | Rate of change of magnetic field: | 19.5 T/sec. | 19.35 T/sec. |
| | CONTACT PERSON: | Ken Nehmer<br>[phone] ext. 6083 | Maximum radio frequency power | <1.0 W/kg | <1.5 W/kg |
| 4. | MANUFACTURING SITE: | Toshiba Corporation<br>1385 Shimoisigami<br>Otawara-shi, Tochigi-Ken<br>Japan 324 | Acoustic noise levels (maximum): | 110.8 dB | 86.0 dB |
| 5. | DATE OF SUBMISSION: | November 8, 1999 | | | |
| 6. | DEVICE DESCRIPTION: | This submission consists of a new Magnetic Resonance<br>Imaging system which is based primarily on the cleared<br>EXCELARTTM (K990620) with the following new functions<br>added to the standard system.<br>• Pianissimo: Gradient acoustic reduction system<br>• QD Whole Body coil<br>• QD Head coil<br>• QD C/T/L Spine Array coil<br>• 18.1" LCD flat screen monitor<br>• Increase of SAR limit from <1.0 Watts/Kg to < 1.5<br>Watts/Kg | | | |
| | | The following optional features are introduced in this<br>submission.<br>• Flexible Body Array coil<br>• Shoulder Array coil<br>• Storage Plus Package which includes:<br>* 8 GByte hard disk drive<br>* memory increase of 256 MBytes<br>• EPI Plus Package (see Appendix 15) which includes:<br>* extending Diffusion function<br>* adding Perfusion function<br>• Super FASE Plus Package (see Appendix 19) which<br>includes:<br>* ECG - Preparation<br>* Fresh Blood Imaging (FBI)<br>* Swap Phase Encode Extended Data acquisition | | | |

- (SPEED)
* Composite MIP

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· MRA Plus Package (see Appendix 23) which includes:

- * Visual Preparation
- * Moving Bed

* 3D Centric scan

* Sequential Target MIP Display (STAMD)

Acoustic noise data was measured in accordance with NEMA guidelines.

### IMAGING PERFORMANCE PARAMETERS: 8.

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

## * Same as previously cleared with initial EXCELART™ system (K990620).

### 9. INTENDED USE

Anatomical regions: Head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities

Nuclei excited: Hvdrogen

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, Diffusion Imaging, [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, 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™ with Pianissimo Magnetic Resonance Imaging (MRI) system is substantially equivalent to the EXCELART™ Magnetic Resonance System (K990620) cleared on May 14, 1999.

The new coils introduced are substantially equivalent to existing cleared RF coils as compared in the following table:

| New coil | Substantially equivalent to: |
|-----------------------------|-------------------------------------|
| EXCELART™ QD Whole Body | MRT-150A QD Whole Body<br>(K922798) |
| EXCELART™ C/T/L Spine Array | VISART QD Spine Array<br>(K965068) |
| EXCELART™ QD Head | VISART QD Head (K961092) |
| EXCELART™ Flex Body | VISART GP Flex (K965068) |
| EXCELART™ Shoulder Array | MRT-150A Shoulder<br>(K942609) |

The optional software packages (EPI Plus, SuperFASE Plus, MRA Plus) used for the EXCELART™ MRI system are based on the same software that was previously cleared as V4 (K983110).

The VISART/Ex MRI system (more powerful gradient system) described in the common Operation Manual located in Appendix 27 (pages S-4 and 6-41 through 6-45) is not part of this submission and will not be made available for sale in the United States of America.

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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 features a stylized depiction of an eagle or bird with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 2000

Ken Nehmer Manager Regulatory Affairs/Quality Systems Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080

Re: K993803 Pianissimo and Other Options for Excelart MRI System Dated: November 8, 1999 Received: November 9, 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 (Ad). 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 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 conceming 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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Page

510(k) Number (if known):

Device Name:

EXCELART™ with Pianissimo and options

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 Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]

Nº13893

Fluid Visualization

2D/3D Imaging

MR Angiography/MR Vascular Imaging

Blood Oxygenation Level Dependent (BOLD) Imaging

Diffusion Imaging

The EPI Plus optional package adds the following to the above indications: Perfusion Imaging

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

| Prescription Use<br>(Per 21 CFR§801.109) | <div style="display:inline-block; vertical-align:top;">✓</div> OR <div style="display:inline-block; vertical-align:top;">Over-The-Counter Use ______</div> |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K993803 |

Concurrence of CDRH, Office of Device Evaluation (ODE)