OPART

K990260 · Toshiba America Mri, Inc. · LNH · Apr 15, 1999 · Radiology

Device Facts

• Record ID: K990260
• Device Name: OPART
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: Apr 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Head, body, extremity, spine, neck, TMJ, breast and heart Anatomical regions: Nuclei excited: Hydrogen Diagnostic imaging of the human body (including head, abdomen, breast, heart, pelvis, spine, blood vessels, limns, and extremities), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.

Device Story

The Accessorv MRT-600 (OPART) is an MRI system utilizing Version 2.5/V2.6 software (Performance Plus option) to facilitate acquisition and reconstruction of MR images. The system operates on SGI Indigo 2 and O2 workstations. It excites hydrogen nuclei to produce diagnostic images of various anatomical regions, including head, body, extremities, spine, neck, TMJ, breast, and heart. The device supports 2D/3D imaging, MR angiography, and MR fluoroscopy. It is intended for use by clinicians in a diagnostic setting. The software enhancements improve sequence acquisition and reconstruction, aiding healthcare providers in visualizing anatomy and pathology to support clinical decision-making.

Clinical Evidence

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

Technological Characteristics

Magnetic resonance diagnostic device; 0.35 Tesla static field; 19T/second rate of change; <0.4W/kg SAR; 98.4 dB(A) acoustic noise. Operates on SGI Indigo 2 and O2 workstations. Software-based sequence acquisition and reconstruction.

Indications for Use

Indicated for diagnostic imaging of the human body including head, abdomen, breast, heart, pelvis, spine, blood vessels, limbs, and extremities; includes fluid visualization, 2D/3D imaging, MR angiography, and MR fluoroscopy. 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

• OPART version 2 diagnostic resonance system (K981475)

Submission Summary (Full Text)

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APH 1 3

## 510(k) Premarket Notification

## Summary of Safety and Effectiveness

- Magnetic Resonance Diagnostic Device 1. DEVICE NAME: Accessorv MRT - 600 Model Number: OPART™ Trade/Proprietary Name: 293623 2. ESTABLISHMENT REGISTRATION: Toshiba America MRI. Inc. 3. U.S. AGENT Name and Address: 280 Utah Avenue South San Francisco, CA 94080 Bruce Clark Contact Person: [phone] Toshiba America MRI, Inc. 4. Manufacturing Site: 280 Utah Avenue South San Francisco, CA 94080 January 25, 1999 5. Date of Submission:
# 6. DEVICE DESCRIPTION:

Version 2.5/V2.6 software is a combination of modifications and the enhancement of sequences to the existing software, which facilitate the acquisition and reconstruction of This software will function on both SGI Indigo 2 and O2 computer MR images. workstations. The V2.6 software may also be identified as Performance Plus option.

#### 7. SAFETY PARAMETERS:

| Maximum static field strength: | 0.35 Tesla |
|-------------------------------------------------|-------------|
| Rate of change of magnetic field: | 19T/second |
| Maximum radio frequency power deposition (SAR): | <0.4Watt/kg |
| Acoustic noise levels (maximum): | 98.4 dB (A) |

Note: These safety parameters remain unchanged from previous submissions.

#### 8. IMAGING PERFORMANCE PARAMETERS:

| Specification volume: | Head: | 10cm |
|-----------------------|-------|------|
| | Body: | 20cm |

Sample phantom images and clinical images are presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing.

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#### 9. INTENTED USE

Head, body, extremity, spine, neck, TMJ, breast and heart Anatomical regions: Nuclei excited: Hydrogen Diagnostic imaging of the human body (including head, abdomen, Diagnostic use: breast, heart, pelvis, spine, blood vessels, limns, and extremities), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.

#### 10. EQUIVALENCY INFORMATION:

Toshiba America MRI, Inc., believes that the OPART™ version 2.5/2.6 software is substantially equivalent to the OPART™ version 2 diagnostic resonance system software accessories in that it consists of modifications that do not raise new questions of safety or efficacy. This software does not introduce any new indications for use from those cleared in the Premarket Notifications for OPART™ version 2 diagnostic resonance systems 510(k) number K981475.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of a bird-like figure with three lines representing its wings or feathers, and a human profile facing left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 15 1935

Bruce Clark QA Engineer Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 Re:

K990260

OPART™ (MRT-600) Dated: January 25, 1999 Received: January 27, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Clark:

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). 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 vour device is classified (see above) into either class III (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 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 requlatory 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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510(k) Number (if known):

K990260

Indications for Use:

Imaging of:

- The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR neok, Ywis, Hoard Broomy), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization ●
- 2D/3D Imaging .
- Mr Angiography/MR Vascular Imaging .

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| Concurrence of CDRH, Office of device Evaluation (ODE) | |
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| Perscription Use<br>(Per 21 CFR§801.109) | ✓ |
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OR

| Over-The-Counter Use<br>(Optional Format 1-2-96) | |
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CONFIDENTIAL

| (Division Sign-Off)<br>Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | |
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510(k) Number K940260