VANTAGE TITAN 3T

K120487 · Toshibamedical Systems Corporation · LNH · May 23, 2012 · Radiology

Device Facts

• Record ID: K120487
• Device Name: VANTAGE TITAN 3T
• Applicant: Toshibamedical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: May 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of noncontrast enhanced imaging, such as MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are: - Proton density (PD) (also called hydrogen density) - Spin-lattice relaxation time (T1) - Spin-spin relaxation time (T2) - Flow dynamics - Chemical Shift - Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images vield information that can be useful in diagnosis.

Device Story

Vantage Titan 3T is a 3 Tesla MRI system. Subject device adds four software packages to existing platform: Positioning Assist for Cardiac (operator guidance for scan positioning); Diffusion Tensor Tractography (DTT) (visualizes central nerve bundles in 3D using diffusion anisotropy); Cardiac Function Analysis (generates cine images, wall motion abnormality evaluation, and bull's eye maps); and EM AIDR (image filter for ringing artifact reduction). System operates in clinical settings; used by trained physicians/technicians to acquire and interpret cross-sectional images. Output assists in clinical diagnosis by visualizing proton density, T1/T2 relaxation times, flow dynamics, and chemical shifts. Benefits include improved workflow, advanced nerve visualization, and enhanced image quality.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design control activities, risk management, and adherence to recognized consensus standards (IEC 60601 series, NEMA MS series).

Technological Characteristics

3T MRI system; software-based image processing and analysis. Connectivity via DICOM (NEMA PS 3.1-18). Complies with IEC 60601-1, 60601-2-33, and IEC 62304 (software lifecycle).

Indications for Use

Indicated for diagnostic imaging of head or body anatomic structures in patients requiring cross-sectional transaxial, coronal, sagittal, or oblique MRI, including non-contrast MRA. Contraindicated for use with contrast agents not approved for specific indications.

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

• Vantage Titan 3T (K113093)

Submission Summary (Full Text)

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Toshiba Vantage Titan 3T, v2.0, MRT-3010/A

## 510(k) SUMMARY AND EFFECTIVENESS

- 1. DEVICE NAME:
Generic Name: Model Name: Trade/ Proprietary Name:

Magnetic Resonance Diagnostic Device MRT-3010/A5 . Vantage Titan 3T

#### 2. ESTABLISHMENT REGISTRATION: 2020563

#### 3. U.S AGENT INFORMATION:

| U.S. Agent Name: | Paul Biggins<br>[phone] |
|---------------------------------|-----------------------------------------------------------------------------------------------------|
| Establishment Name and Address: | Toshiba America Medical Systems, Inc.<br>2441 Michelle Drive<br>Tustin, Ca. 92780 |
| 4. MANUFACTURING SITE: | Toshiba Medical Systems Corporation<br>1385 Shimoishigami<br>Otawara-shi, Tochigi 324-8550<br>Japan |
| 5. DATE OF SUBMISSION: | February 16, 2012 |

### 6. DEVICE DESCRIPTION:

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System(K113093). Four software packages (Positioning Assist for Cardiac, Diffusion Tensor Tractography (DTT) , Cardiac Function Analysis, and Image filter EM AIDR are added to Vantage Titan 3T.

## 6. SUMMARY OF MAJOR HARDWARE CHANGES Not applicable.

#### 7. SUMMARY OF MAJOR SOFTWARE CHANGES

Existing software (V1.35) packages are grouped by functions of software and pulse sequences. New software (V2.0) packages are added four application software as follows:

- a) Positioning Assist for Cardiac This function of software assists the operator to position for scanning for Cardiac imaging for easy operation. The operator shall confirm the patient position before
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starting the cardiac scanning and the operator can re-adjust the scanning position if needed.

- b) Diffusion Tensor Tractography (DTT)
- i. DTT represents direction of the central nerves by using anisotropy of diffusion coefficients calculated from the DTI map.
- ii. The central nerves are represented as bundle fibers in 3D volume.
- iii. DTT can visualize the fusion of SVR with cut-off plan. DTI maps and bundle of fibers in 3D view.
- a. SVR- is reconstructed Surface Volume Rendering image from anatomical images.
- iv. DTT can also visualize the fusion of cross sections, DTI maps and bundle of fibers
- c) Cardiac Function Analysis

This function of software makes cardiac cine image and visual evaluation of wall motion abnormality. This function shows the graphs and tables of the result of cardiac function analysis like Bull's eye map of wall thickening.

- d) Image filter EM AIDR
This is an image filter which can reduce the ringing artifact especially in low resolution images.

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 3T, v2.0, MRT-3010/A5

#### 8. SAFETY PARAMETERS

| Item | Vantage Titan 3T<br>(subject device) | Vantage Titan 3T<br>K113093<br>(Predicate Device) | Notes |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | 1st Operating Mode | 1st Operating Mode | Same |
| i. Safety parameter display | SAR dB/dt | SAR dB/dt | Same |
| ii. Operating mode access<br>requirements | Allows screen access to<br>1st level operating mode | Allows screen access to<br>1st level operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st<br>operating mode specified<br>in<br>IEC 60601-2-33(2002)) | 4W/kg for whole body (1st<br>operating mode specified<br>in<br>IEC 60601-2-33(2002)) | Same |
| Maximum dB/dt | <1st operating mode<br>specified in<br>IEC 60601-2-33 (2002) | <1st operating mode<br>specified in<br>IEC 60601-2-33 (2002) | Same |
| Potential emergency<br>condition and<br>means provided for<br>shutdown | Shut down by Emergency<br>Ramp Down Unit for<br>collision hazard for<br>ferromagnetic objects | Shut down by Emergency<br>Ramp Down Unit for<br>collision hazard for<br>ferromagnetic objects | Same |

#### 10. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K113093).

### 11. INTEDED USE

Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of noncontrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

- . Proton density (PD) (also called hydrogen density)
- Spin-lattice relaxation time (T1) .
- . Spin-spin relaxation time (T2)
- . Flow dynamics
- Chemical Shift .

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- Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images vield information that can be useful in diagnosis.
No changes to the previously cleared indication (K113093).

### 12. DESIGN CHANGE

Following software package addition to Vantage Titan 3T (K113093).

- a) Positioning Assist for Cardiac
- b) Diffusion Tensor Tractography (DTT)
- c) Cardiac Function Analysis
- d) Image filter EM AIDR (Development name is "EMTONE")

### 13. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software of changing packages is included in this submission. The test methods used are the same as those submitted in the previously cleared submissions (K113093). A declaration of conformity with design controls is included in this submission.

#### 14. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the Vantage Titan 3T described in this submission is provided in this submission.

#### 15. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan 3T (model MRT-3010/A5) Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate devices referenced in this submission.

Testing was done in accordance with applicable recognized consensus standards as listed below.

#### List of Applicable Standards

- · IEC60601-1:1988, Amd.1:1991, Amd.2:1995
- · IEC60601-1-1:2000
- · IEC60601-1-2:2001, Amd.1:2004
- · IEC60601-1-4:1996, Amd.1:1999
- · IEC60601-1-6:2006
- · IEC60601-1-8:2003,Amd.1:2006
- · IEC60601-2-33:2002, Amd.1:2005, Amd.2:2007
- · IEC60825-1: 2007
- · IEC62304:2006
- · IEC62366:2007
- · NEMA MS-1:2008
- · NEMA MS-2:2003
- · NEMA MS-3:2008
- · NEMA MS-4:2006
- · NEMA MS-5:2003
- · NEMA PS 3.1-18 (2008)

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Image /page/4/Picture/0 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 in flight, rendered in black. The bird is composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird, with the words following the curve of the circle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY 2 3 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Toshiba Medical Systems Corporation % Mr. Paul Biggins Regulatory Affairs Director Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K120487

Trade/Device Name: MRT-3010/A5, Vantage Titan 3T, v2.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH . Dated: April 12, 2012 Received: April 13, 2012

## Dear Mr. Biggins:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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## Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan 3T, v2.0, MRT-3010/A5

## Indications for Use

510(k) Number (if known):

Device Name:

## MRT-3010/A5, Vantage Titan 3T, v2.0

Indications for Use:

Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

- Proton density (PD) (also called hydrogen density) .
- . Spin-lattice relaxation time (T1)
- Spin-spin relaxation time (T2) .
- . Flow dynamics
- . Chemical Shift

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images vield information that can be useful in diagnosis

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Aushurf O'thun

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number Kla0487

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Indication for Use Page 1 of 1

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