VANTAGE TITAN 3T

K113093 · Toshibamedical Systems Corporation · LNH · Jan 13, 2012 · Radiology

Device Facts

• Record ID: K113093
• Device Name: VANTAGE TITAN 3T
• Applicant: Toshibamedical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Jan 13, 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 yield information that can be useful in diagnosis.

Device Story

Vantage Titan 3T (MRT-3010/A5) is a 3 Tesla MRI system. Device acquires NMR signals from protons in body tissues/fluids to produce cross-sectional images. New software (V1.35) adds mCardiovascular, mBreast, and mBody application packages to existing platform. System operated by trained professionals in clinical settings. Output consists of diagnostic images interpreted by physicians to assess anatomy and pathology. Benefits include non-invasive visualization of internal structures and flow dynamics. Hardware remains unchanged from predicate; software updates reorganize imaging targets and pulse sequences.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance verified through design control activities, risk management, and adherence to consensus standards (IEC/NEMA).

Technological Characteristics

3T MRI system. Hardware unchanged from K102489. Software V1.35 includes application-specific packages (Cardiovascular, Breast, Body). Connectivity includes DICOM (NEMA PS 3.1-18). Complies with IEC 60601-1, 60601-1-2, 60601-2-33, and NEMA MS series standards. Usability standard updated to IEC 60601-1-6:2006.

Indications for Use

Indicated for diagnostic imaging of head or body anatomic structures via cross-sectional transaxial, coronal, sagittal, and oblique images; includes non-contrast enhanced MRA. Applicable to patients requiring MRI for visualization of proton density, T1, T2, flow dynamics, and chemical shift. Contrast use restricted to approved drug indications. For use by trained physicians.

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 (K102489)

Reference Devices

• Vantage Titan 1.5T MRI (K080038)

Submission Summary (Full Text)

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JAN 1 3 2012

511301.

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

# 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 [phone]

2441 Michelle Drive Tustin, Ca. 92780

Establishment Name and Address:

4. MANUFACTURING SITE:

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

Toshiba America Medical Systems, Inc.

October 17, 2011 5. DATE OF SUBMISSION:

#### 6. DEVICE DESCRIPTION:

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System (K102489). MRA (MR Angio) software package which functions are same as the MRA package of existing 1.5T MRI Vantage Titan (K080038) is added to Vantage Titan 3T.

# 7. SUMMARY OF MAJOR HARDWARE CHANGES Not applicable.

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# 8. SUMMARY OF MAJOR SOFTWARE CHANGES

Existing software (V1.20) packages are grouped by functions of softwares and pulse sequences. New software (V1.35) packages are changed the configuration of imaging targets (for example Body package, Breast package etc.). Three software packages which use V1.20 MRA package are added to Vantage Titan 3T.

- a) mCardiovascular package
- b) mBreast package
- c) mBody package

# 9. SAFETY PARAMETERS

| Item | Vantage Titan 3T with new<br>application software package<br>(subject device) | Vantage Titan 3T , K102489<br>(Predicate Device) | Notes |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------|
| Static field strength | 3T | 3T | Same |
| Operational Modes | 1st Operating Mode | 1st Operating Mode | Same |
| i.<br>Safety parameter<br>display | SAR dB/dt | SAR dB/dt | Same |
| ii. Operating mode<br>access requirements | Allows screen access to 1st level<br>operating mode | Allows screen access to 1st level<br>operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st<br>operating mode specified in<br>IEC 60601-2-33(2002)) | 4W/kg for whole body (1st<br>operating mode specified in<br>IEC 60601-2-33(2002)) | Same |
| Maximum dB/dt | <1st operating mode specified in<br>IEC 60601-2-33 (2002) | <1st operating mode specified in<br>IEC 60601-2-33 (2002) | Same |
| Potential emergency<br>condition and means<br>provided for<br>shutdown | Shut down by Emergency Ramp<br>Down Unit for collision hazard<br>for ferromagnetic objects | Shut down by Emergency Ramp<br>Down Unit for collision hazard for<br>ferromagnetic objects | Same |

# 10. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K102489).

#### 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) .

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- 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 (K102489).

# 12. DESIGN CHANGE

Following software package addition to Vantage Titan 3T (K102489).

- a) mCardiovascular package
- b) mBreast package
- c) mBody package

# 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 (K102489). 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.

The version of applicable standard of IEC60601-1-6 (standard of usability) is changed from IEC60601-1-6:2004 to IEC60601-1-6:2006.

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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side and top of the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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 Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

JAN 1 3 2012

Re: K113093

Trade/Device Name: MRT-3010/A5, Vantage Titan 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 5, 2012 Received: January 6, 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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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,

Mary S Patel

Mary S. Pastel, Sc.D. 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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# Indications for Use

510(k) Number (if known):

K113093

Device Name:

MRT-3010/A5, Vantage Titan 3T

Indications for Use:

Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces crosssectional 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 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 us 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)

Mary S. Patel

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

510(k) Number K113093

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