VANTAGE TITAN 3T

K132160 · Toshibamedical Systems Corporation · LNH · Oct 16, 2013 · Radiology

Device Facts

• Record ID: K132160
• Device Name: VANTAGE TITAN 3T
• Applicant: Toshibamedical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Oct 16, 2013
• 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 yield information that can be useful in diagnosis.

Device Story

Vantage Titan 3T is a 3 Tesla MRI system. This update (v2.30) adds five software functionalities: updated SAR calculation for increased slice flexibility; 3D Arterial Spin Labeling (ASL) for volumetric imaging; Advanced Moving Bed (AMB) for station-specific scan settings; 3D MR Spectroscopy (MRS) for multi-voxel proton data acquisition; and distortion correction for 3D volumes. Operated by trained clinicians in clinical settings. System processes proton density, T1, T2, flow, and chemical shift data to generate diagnostic images. Output interpreted by physicians to aid diagnosis. Benefits include improved scan efficiency, volumetric imaging capabilities, and reduced image distortion.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance verified through adherence to recognized consensus standards (IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-33, 60825-1, 62304, 62366) and internal design control risk assessments.

Technological Characteristics

3T MRI system. Software-based enhancements: SAR calculation, 3D ASL, AMB, 3D MRS, and 3D volume distortion correction. Compliance with IEC 60601-2-33:2010. Connectivity: Standard MRI system architecture. Sterilization: N/A (non-invasive diagnostic imaging).

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. Contraindications include standard MRI safety exclusions (e.g., incompatible implants).

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 (K120487)

Submission Summary (Full Text)

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K132160

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

#### 510(k) SUMMARY AND EFFECTIVENESS

### 1. CLASSIFICATION and DEVICE NAME:

| Classification Name: | Magnetic Resonance Diagnostic Device |
|-------------------------|--------------------------------------|
| Regulation Number: | 21 CFR 892.1000 |
| Product Code: | LNH |
| Trade Proprietary Name: | Vantage Titan 3T |
| Model Number: | MRT-3010/A5 |

#### 2. ESTABLISHMENT REGISTRATION: 2020563

#### 3. CONTACT PERSON, U.S AGENT and ADDRESS:

Contact Person Charlemagne Chua Manager, Regulatory Affairs [phone]

OCT 16 2013

U.S. Agent Name: Paul Biggins Director, Regulatory Affairs [phone]

#### Establishment Name and Address:

Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780

#### 4. MANUFACTURING SITE:

Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

#### 5. DATE OF SUBMISSION:

July 10, 2013

#### 6. DEVICE DESCRIPTION:

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K120487. This submission will include the following

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five software functionalities: Changes in the SAR calculation method, 3D ASL (3 dimensional Arterial Spin Labeling), Advanced Moving Bed (AMB), 3D MRS (3 dimensional MR Spectroscopy) and Distortion correction for entire volume are added to Vantage Titan 3T.

# 7. SUMMARY OF HARDWARE CHANGES

There are no major hardware changes associated with the software change.

# 8. SUMMARY OF SOFTWARE CHANGES

Existing software packages are grouped by functions of software and pulse sequences. New software (V2.30) packages (four software functionalities) as follows:

# a) Changes in the SAR calculation method

The new calculation method provides more flexibility in setting scan parameters, which enables scan with increased number of slices per unit time etc.

# b) 3D ASL (3 dimensional Arterial Spin Labeling)

This function of software adds a new feature for current ASL imaging so that images can be acquired from 3D volume instead of 2D slice.

# c) Advanced Moving Bed (AMB)

AMB enables individual scan settings for each station when Moving Bed is used. It allows acquisition of images with the most appropriate settings for each station.

# d) 3D MRS (3 dimensional MR Spectroscopy)

This function of software enables the acquisition of proton spectroscopic data from multiple voxel in a 3 dimensional volume of an object by applying phase encode aradients in three orthogonal directions.

# e) Distortion correction for entire volume

This function of software performs correction of image distortion due to gradient magnetic field non-linearity for entire 3D volume including slice direction.

# 9. SAFETY PARAMETERS

| Item | Vantage Titan 3T with<br>new application software<br>package<br>(subject device) | Vantage Titan 3T ,<br>K120487<br>(Predicate Device) | Notes |
|-----------------------|----------------------------------------------------------------------------------|-----------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | 1st Operating Mode | 1st Operating Mode | Same |

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

| i. Safety parameter<br>display | SAR dB/dt | SAR dB/dt | Same |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------|
| ii. Operating mode<br>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(2010)) | 4W/kg for whole body (1st<br>operating mode specified<br>in<br>IEC 60601-2-33(2002)) | Change* |
| Maximum dB/dt | <1st operating mode<br>specified in<br>IEC 60601-2-33 (2010) | <1st operating mode<br>specified in<br>IEC 60601-2-33 (2002) | Change* |
| Potential<br>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 |

*Note: The difference between predicate and subject device is due to the conformance of the subject device to IEC 60601-2-33 (2010)

#### 10. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K120487).

#### 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

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

No changes to the previously cleared indication (K120487).

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### 12. DESIGN CHANGE

Following software package addition to Vantage Titan 3T (K120487).

- a) Changes in the SAR calculation method
- b) 3D ASL (3 dimensional Arterial Spin Labeling)
- c) Advanced Moving Bed (AMB)
- d) 3D MRS (3 dimensional MR Spectroscopy)
- e) Distortion correction for entire volume

### 13. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software of changing packages are attached. The test methods used are the same as those submitted in the previously cleared submissions (K120487).

### 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

- · IEC60601-1:2005
- · IEC60601-1-2:2007
- · IEC60601-1-8:2003,Amd.1:2006
- · IEC60601-2-33:2010
- · IEC60825-1: 2007
- · IEC62304:2006
- · IEC62366:2007

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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-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 16, 2013

TOSHIBA MEDICAL SYSTEMS CORPORATION % Mr. PAUL BIGGINS DIRECTOR REGULATORY AFFAIRS 2441 MICHELLE DRIVE TUSTIN CA 92780

Re: K132160

Trade/Device Name: Vantage Titan 3T, MRT-3010/A5 v2.30 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 6, 2013 Received: September 9, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Biggins

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Michael D. O'Hara

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

l'or

Enclosure

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# Indications for Use

510(k) Number (if known):

K132160

Device Name:

Vantage Titan 3T, v2.30 (MRT-3010/A5)

Indications for Use:

Vantaqe Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display analomic 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 mağnetic 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 yield information that can be useful in diagnosis.

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

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

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Michael D. O'Hara

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