Vantage Titan 3T

K143008 · Toshibamedical Systems Corporation · LNH · Apr 9, 2015 · Radiology

Device Facts

• Record ID: K143008
• Device Name: Vantage Titan 3T
• Applicant: Toshibamedical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Apr 9, 2015
• 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 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 3T is a 3 Tesla MRI system; utilizes nuclear magnetic resonance properties (proton density, T1, T2, flow dynamics, chemical shift) to generate cross-sectional images. Input: RF signals from body tissues/fluids; Output: cross-sectional transaxial, coronal, sagittal, oblique images, and MRA. Operated by trained clinicians in clinical settings. New features include Water Fat Separation (WFS) software for water/fat dominant imaging and Saturn Gradient Option (45mT/m). Physician interprets images to aid diagnosis. Benefits include improved workflow and diagnostic visualization of anatomic structures.

Clinical Evidence

Bench testing only. Performance of WFS pulse sequence and software functionality validated using phantom studies and representative volunteer images. No clinical trials conducted.

Technological Characteristics

3T MRI system; Saturn Gradient Option (45mT/m). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-33, IEC 60825-1, IEC 62304, IEC 62366, NEMA MS-1 through MS-5, NEMA PS 3.1-20. Connectivity: DICOM (NEMA PS 3.1-20).

Indications for Use

Indicated for diagnostic imaging of head or body anatomy 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

• Vantage Titan 3T (K132160)

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

April 9, 2015

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

Re: K143008

Trade/Device Name: Vantage Titan 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: April 6, 2015 Received: April 7, 2015

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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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/Resourcesfor You/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.

Michael D'Hara

for

Robert Ochs, Ph.D. Acting 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)

K143008

#### Device Name

MRT-3010/A5, Vantage Titan 3T

#### Indications for Use (Describe)

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 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 maqnetic 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 aqent use is restricted to the approved druq indications. When interpreted by a trained physician, these imaqes yield information that can be useful in diagnosis.

Type of Use (Select one or both, as applicable)

ك Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 3T |
| Model Number: | MRT-3010/A5 |

### 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:

October 17, 2014

## 7. DEVICE DESCRIPTION:

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K132160. This submission includes WFS (Water Fat Separation) software functionality and the optional subsystem, Saturn Gradient Option.

### 7.1 SUMMARY OF HARDWARE CHANGES

Saturn Gradient Option with increased gradient field strength of 45mT/m.

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# 7.2 SUMMARY OF SOFTWARE CHANGES

a. WFS (Water Fat Separation) to provide water dominant images and fat dominant images.

## 8. SAFETY PARAMETERS

| ltem | Vantage Titan 3T, V2.50 | Vantage Titan 3T, V2.30 | Notes |
|------------------------|---------------------------|---------------------------|-------|
| | | K132160 | |
| | (subject device) | (Predicate Device) | |
| Static field strength | 3T | 3T | Same |
| Operational Modes | Normal and 1st Operating | Normal and 1st Operating | Same |
| | Mode | Mode | |
| i.<br>Safety parameter | SAR dB/dt | SAR dB/dt | Same |
| display | | | |
| ii. Operating mode | Allows screen access to | Allows screen access to | Same |
| access | 1st level operating mode | 1st level operating mode | |
| requirements | | | |
| Maximum SAR | 4W/kg for whole body (1st | 4W/kg for whole body (1st | Same |
| | operating mode specified | operating mode specified | |
| | in | in | |
| | IEC 60601-2-33(2010) | IEC 60601-2-33(2010) | |
| Maximum dB/dt | <1st operating mode | <1st operating mode | Same |
| | specified in | specified in | |
| | IEC 60601-2-33 (2010) | IEC 60601-2-33 (2010) | |
| Potential | Shut down by Emergency | Shut down by Emergency | Same |
| emergency | Ramp Down Unit for | Ramp Down Unit for | |
| condition and | collision hazard for | collision hazard for | |
| means provided for | ferromagnetic objects | ferromagnetic objects | |
| shutdown | | | |

## 8. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K132160).

## 9. 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 non-contrast enhanced imaging, such as MRA.

MRI (maqnetic 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:

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- 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 (K132160).

# 10. 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 (K132160). A declaration of conformity with design controls is included in this submission.

## 11. 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.

# 12. 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
- · NEMA MS-1:2008
- NEMA MS-2:2008
- · NEMA MS-3:2008
- NEMA MS-4:2010
- NEMA MS-5:2010
- · NEMA PS 3.1-20 (2011)

Additional testing for WFS (Water Fat Separation) pulse sequence and software functionality included both phantom studies and representative volunteer images. This testing demonstrated that the software performed as specified and did not raise new issues of safety and effectiveness. The additional software packages are work flow improvements and their performance was demonstrated to be equal to or better than the current methods for obtaining the same results.