FLEXART V3.5 SOFTWARE

K970573 · Toshiba America Mri, Inc. · LNH · Jul 21, 1997 · Radiology

Device Facts

• Record ID: K970573
• Device Name: FLEXART V3.5 SOFTWARE
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jul 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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

Device Story

FLEXART™/FLEXART™/Hyper V3.5 is an MRI system upgrade. Inputs: hydrogen nuclei signals captured via phased array coils. Transformation: V3.5 software processes signals to generate 2D/3D anatomical images, MR angiography, and cine imaging. Operation: performed by trained clinicians in clinical settings. Output: diagnostic images for physician review to assess anatomy and pathology. Benefits: improved image quality and performance over V3.1 software; expanded diagnostic capabilities via new phased array coils. System maintains static field strength and safety parameters consistent with predicate.

Clinical Evidence

Bench testing only. Sample phantom images and clinical images were presented to demonstrate conformance with consensus standards for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing.

Technological Characteristics

1.5T static field strength; phased array coils; hydrogen nuclei excitation. Software upgrade V3.5. Acoustic noise levels 100.2 (98.5) dB. Conforms to NEMA guidelines for acoustic noise and consensus standards for imaging performance.

Indications for Use

Indicated for whole body MRI imaging including head, abdomen, pelvis, limbs, extremities, joints, spine, neck, TMJ, heart, blood vessels, and breast. Includes MRCP, MR Urography, MR Myelography, SAS, dynamic scanning, and cine imaging. Prescription use only.

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™ V3.1 (K962138)

Submission Summary (Full Text)

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K970573

TOSHIBA

TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

2441 MICHELLE DRIVE, P.O. BOX 2068,

TUSTIN, CA 92781

PHONE: [phone]

# 510(k) Summary

JUL 21 1997

## SUMMARY OF SAFETY AND EFFECTIVENESS

1. Model Name: MRT-50GP/E2 and MRT-50GP/H2
Device Name: Magnetic Resonance Device
Trade/Proprietary Name: FLEXART™/FLEXART™/Hyper V3.5

2. Establishment Registration: 2936923

3. U.S. Agent Name and Address: TOSHIBA AMERICA MRI, INC.
280 Utah Ave.
South San Francisco, CA 94080

Contact Person: Steven M. Kay
[phone]

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

5. DATE OF SUBMISSION: February 12, 1997

6. DEVICE DESCRIPTION
This submission consists of two upgrades to the MRT-50GP/E2 (FLEXART™) and MRT-50GP/H2 (FLEXART™/Hyper) system. The first is the V3.5 software, which is an upgrade over the V3.1 software. The second is the introduction of phased array coils into the coil lineup. More detailed descriptions appear below.

7. SAFETY PARAMETERS [( ): FLEXART™/Hyper]
| | V3.1 | V3.5 |
| --- | --- | --- |
| Maximum static field strength: | 1.5T | Same |
| Rate of change of magnetic field (τ = 1000ms): | 11 (13.3)T/sec, | 11 (13.3)T/sec. |
| Max. Radio frequency power deposition: | <0.34W/kg | <0.4W/kg |
| Acoustic Noise levels: | 100.2 (98.5) dB | 100.2 (98.5) dB |
| | Maximum | Maximum |

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

A1

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A2

# 8. IMAGING PERFORMANCE PARAMETERS

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

Sample phantom images and clinical images were presented for new sequences and optional coils, 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. Equivalency Information

Toshiba America MRI, Inc. (TAMI) believes the FLEXART™ V3.5 software is substantially equivalent to the FLEXART™ V3.1 software because it consists of software upgrades that improve the image quality and performance of the FLEXART™, without introducing new questions of safety or efficacy. The FLEXART™ V3.1 was cleared by K962138. Although the new coils expand the indications for use, they do not change the intended use of the FLEXART™ system. Good Manufacturing Practices requirements are unchanged from those already in effect for V3.1 and the FLEXART™.

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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: K970573
FLEXART™/FLEXART™/Hyper V3.5
Software
Dated: February 12, 1997
Received: February 14, 1997
Regulatory class: II
21 CFR 892.1000/Procode: 90 LNH

JUL 21 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,


Lillian Yin, Ph.D.
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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510(k) Number (if known): K970573

Device Name: Flexart™ (MRT-50GP) Version 3.5 Software

Indications for Use:

Imaging of:

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

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970573

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

CONFIDENTIAL - 10