Vantage Titan 3T

K152371 · Toshibamedical Systems Corporation · LNH · Oct 23, 2015 · Radiology

Device Facts

• Record ID: K152371
• Device Name: Vantage Titan 3T
• Applicant: Toshibamedical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Oct 23, 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 (T1, T2, proton density, flow dynamics, chemical shift) to generate cross-sectional images. Operated by trained clinicians in clinical settings. New software features include pulse sequences (UTE, MP-RAGE, T2:mEcho, T2*:mEcho), improved MRS, multi b-value DWI, and automated positioning/planning tools (SpineLine+, NeuroLine+, SureVOI). Includes 2D real-time motion correction and eFSBB phase-enhanced filtering. Output images interpreted by physicians to aid diagnosis. Benefits include enhanced imaging capabilities and workflow automation for patient positioning and planning.

Clinical Evidence

Bench testing, phantom image studies, and sample clinical images provided. No formal clinical trial data reported. Testing performed in accordance with IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-33, 60825-1, 62304, and 62366.

Technological Characteristics

3 Tesla MRI system. Hardware unchanged from K143008. Software-based pulse sequences and automated planning algorithms. Complies with IEC 60601-2-33 (2010) for SAR and dB/dt limits. Connectivity via standard medical imaging interfaces.

Indications for Use

Indicated for diagnostic imaging of head or body anatomic structures; produces cross-sectional transaxial, coronal, sagittal, and oblique images; capable of non-contrast enhanced imaging (e.g., MRA). No specific age or gender restrictions; contrast use restricted to 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 (K143008)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

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

October 23, 2015

Toshiba Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K152371

Trade/Device Name: Vantage Titan 3T (MRT-3010) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 18, 2015 Received: August 21, 2015

Dear Ms. Reyes:

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.

{1}------------------------------------------------

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 O'Hara

For

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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K152371

Device Name Vantage Titan 3T, MRT-3010

Indications for Use (Describe)

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.

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

| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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 |

### 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:

#### Contact Person

Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780 [phone]

### 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:

August 11th, 2015

{4}------------------------------------------------

# 7. DEVICE DESCRIPTION:

The Vantage Titan 3T (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K143008. This submission will include the following software functionalities: UTE (Ultra Short TE), MP-RAGE, T2:mEcho, T2*:mEcho, Improvements to MRS, Multi b-value DWI, SpineLine+, SureVOI, 2D Real-time Motion Correction (2D-RMC) and eFSBB.

# 7.1 SUMMARY OF HARDWARE CHANGES

No change from previous predicate submission, K143008.

# 7.2 SUMMARY OF SOFTWARE CHANGES

- a. UTE (Ultra Short TE) pulse sequence
- b. MP-RAGE pulse sequence
- c. T2:mEcho pulse sequence
- d. T2*:mEcho pulse sequence
- e. Improvements to MRS
- f. Multi b-value DWI
- g. SpineLine (automatic positioning assistance for spine)
- h. NeuroLine+ (automatic positioning assistance for neuro)
- i. SureVOI (automatic cardiac planning assistance)
- j. 2D Real-time Motion Correction (2D-RMC)
- k. eFSBB (new phase-enhanced filter)

# 8. SAFETY PARAMETERS

| Item | Vantage Titan 3T, V3.5<br>(Subject Device) | Vantage Titan 3T, V2.50 K143008<br>(Predicate Device) | Notes |
|----------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | Normal and 1st Operating Mode | Normal and 1st Operating Mode | Same |
| i. Safety parameter display | SAR dB/dt | SAR dB/dt | Same |
| ii. Operating mode access requirements | Allows screen access to 1st level operating mode | Allows screen access to 1st level operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st operating mode specified in<br>IEC 60601-2-33(2010)) | 4W/kg for whole body (1st operating mode specified in<br>IEC 60601-2-33(2010)) | Same |
| Maximum dB/dt | <1st operating mode specified in<br>IEC 60601-2-33 (2010) | <1st operating mode specified in<br>IEC 60601-2-33 (2010) | Same |

{5}------------------------------------------------

| Item | Vantage Titan 3T, V3.5<br>(Subject Device) | Vantage Titan 3T, V2.50<br>K143008<br>(Predicate Device) | Notes |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------|
| 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 |

# 8. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K143008).

# 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 (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 (K143008).

# 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 (K143008). 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-

{6}------------------------------------------------

3010) 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

Based upon bench testing, phantom image studies and sample clinical images 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.