Vantage Titan 1.5T, V3.1, MRT-1510

K150427 · Toshibamedical Systems Corporation · LNH · Apr 17, 2015 · Radiology

Device Facts

• Record ID: K150427
• Device Name: Vantage Titan 1.5T, V3.1, MRT-1510
• Applicant: Toshibamedical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Apr 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Vantage Titan 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 yield information that can be useful in diagnosis.

Device Story

Vantage Titan 1.5T is a magnetic resonance imaging (MRI) system; utilizes 1.5T magnet to capture proton density, T1, T2, flow dynamics, and chemical shift signals. Transforms signals into cross-sectional images (transaxial, coronal, sagittal, oblique) of head/body. Operated by trained clinicians in clinical settings. Includes Pianissimo scan noise reduction technology. Output interpreted by physicians for diagnostic decision-making. Modifications from predicate include updated magnet (TN150/OR200), expanded power requirements, Windows 7 OS, and Water Fat Separation (WFS) software. Benefits include diagnostic visualization of internal anatomy without ionizing radiation.

Clinical Evidence

Bench testing only. Evidence includes phantom image studies and analysis of archived clinical images to validate hardware and software modifications. Conformance to recognized consensus standards (IEC 60601 series, NEMA MS series) was documented. No prospective clinical trials were conducted.

Technological Characteristics

1.5T MRI system; 1.4m short magnet; 55x55x50 cm max FOV. Power: 380/400/415/480 V. Software: Windows 7 OS, WFS (Water Fat Separation). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-33 (2010), IEC 60825-1, IEC 62304, IEC 62366, NEMA MS-1 through MS-5.

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 outside of approved drug 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

• 1.5T EXCELART Vantage Titan (K120638)
• Vantage Elan 1.5 T (K141472)
• Vantage Titan 3T, V2.50 Software (K143008)

Submission Summary (Full Text)

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

September 10, 2015

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

Re: K150427

Trade/Device Name: Vantage Titan 1.5T, MRT-1510 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: February 18, 2015 Received: February 19, 2015

Dear Mr. Biggins:

This letter corrects our substantially equivalent letter of April 17, 2015.

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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oolo

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K150427

Device Name

Vantage Titan 1.5T, MRT-1510

Indications for Use (Describe)

Vantage Titan 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 yield information that can be useful in diagnosis.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. CLASSIFICATION and DEVICE NAME:

| Classification Name: | Magnetic Resonance Diagnostic Device |
|-------------------------|--------------------------------------|
| Regulation Number: | 90-LNH (Per 21 CFR 892.1000) |
| Trade Proprietary Name: | Vantage Titan 1.5T |
| Model Number: | MRT-1510 |

## 2. ESTABLISHMENT REGISTRATION: 9614698

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

## 4. Contact Person, U.S AGENT and ADDRESS:

#### U.S. Agent Name:

Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780 [phone]

## 5. MANUFACTURING SITE:

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

## 6. DATE OF SUBMISSION:

February 18th, 2015

## 7. DEVICE DESCRIPTION:

The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm. The Vantage Titan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.

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## 7.1 SUMMARY OF HARDWARE CHANGES

- a. Main magnet has been changed from OR76 to TN150 (MRT-1510/1A) or OR200 (MRT-1510/2A).
- b. System power requirements has been changed from 200V and 400V to 380/400/415/480 V.

## 7.2 SUMMARY OF SOFTWARE CHANGES

- a. New Operating System (Windows 7)
- b. WFS (Water Fat Separation) to provide water dominant images and fat dominant images.

## 8. SAFETY PARAMETERS

#### Table 1: Primary Predicate Device

| Item | Vantage Titan<br>(subject device) | Vantage Titan K120638<br>(Predicate Device) | Notes |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------|
| Static field strength | 1.5T | 1.5T | Same |
| Operational Modes<br>i. Safety parameter display | 1st Operating Mode<br>SAR dB/dt | 1st Operating Mode<br>SAR dB/dt | Same |
| ii. Operating mode<br>access requirements | Allows screen<br>access to 1st level<br>operating mode | Allows screen<br>access to 1st level<br>operating mode | Same |
| Maximum SAR | 4W/kg for whole<br>body (1st operating<br>mode specified in<br>IEC 60601-2-<br>33(2010)) | 4W/kg for whole<br>body (1st operating<br>mode specified in<br>IEC 60601-2-<br>33(2002)) | Change* |
| Maximum dB/dt | 1st operating mode<br>specified in<br>IEC 60601-2-33<br>(2010) | 1st operating mode<br>specified in<br>IEC 60601-2-33<br>(2002) | Change* |
| Potential emergency<br>condition and means<br>provided for<br>shutdown | Shut down by<br>Emergency Ramp<br>Down Unit for<br>collision hazard for<br>ferromagnetic<br>objects | Shut down by<br>Emergency Ramp<br>Down Unit for<br>collision hazard for<br>ferromagnetic<br>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)

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## 9. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K120638).

## 10. INTENDED USE

Vantage Titan 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 (K120638).

## 11. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for system and software are included in this submission. The test methods used are the same as those submitted in the previously cleared submissions (K120638). A declaration of conformity with design controls is included in this submission.

## 12. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the Vantage Titan 1.5T described in this submission is provided in this submission.

## 13. SUBSTANTIAL EQUIVALENCE

This device is substantially equivalent to the 1.5T EXCELART Vantage Titan MRI System (K120638), marketed by Toshiba America Medical Systems. Vantage Titan 1.5T, V3.1. MRT 1510 includes additional software features. The additional software features have the same intended use as the secondary predicate device, listed below in table one. Testing was performed using archived clinical images, simulation testing and bench (phantom) testing. This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device.

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Toshiba Medical Systems Corporation believes that the Vantage Titan 1.5T (model MRT-1510) Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate devices referenced in this submission.

| 510 (k) Number | Clearance Date | Device Name | Manufacturer |
|-------------------------------------------------------|------------------|-------------------------------------|------------------------------------|
| K120638<br>Primary Predicate<br>(System) | 06/01/2012 | 1.5T EXCELART<br>Vantage Titan | Toshiba America<br>Medical Systems |
| K141472<br>Secondary Predicate<br>(Magnet) | 09/19/2014 | Vantage Elan 1.5 T | Toshiba America<br>Medical Systems |
| K143008<br>Secondary Predicate<br>(Software Features) | RTA - 10/31/2014 | Vantage Titan 3T,<br>V2.50 Software | Toshiba America<br>Medical Systems |

## Table 2: Primary and Secondary Predicate Device

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
- NEMA MS-1:2008
- NEMA MS-2:2008
- · NEMA MS-3:2008
- · NEMA MS-4:2010
- · NEMA MS-5:2010

Based upon bench testing and phantom image studies Toshiba Medical Systems Corporation believes this system has characteristics that are compatible with currently marketed devices and has proven substantively that this system performed as specified and did not raise new issues of safety and effectiveness. Furthermore, this system does not offer new intended or indicated use when compared to the predicate. Based upon this information, Toshiba believes that it has established substantial equivalence to this device and the predicate.

April 6th, 2015