VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US

K122613 · Toshiba America Medical Systems, In.C · LNH · Dec 13, 2012 · Radiology

Device Facts

• Record ID: K122613
• Device Name: VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: LNH · Radiology
• Decision Date: Dec 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MRI system is 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. In addition, this system supports non-contrast 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 (MRT-1504/U5) is a 1.5T MRI system; utilizes proton density, T1/T2 relaxation, flow dynamics, and chemical shift to generate diagnostic images. System incorporates Helios gradient hardware (amplifier and coil) for modified gradient performance. Operated by trained clinicians in clinical settings to produce cross-sectional images of head/body. Output interpreted by physicians to aid diagnosis. System supports non-contrast MRA. Improvements include 3D Advanced Fourier Imaging (AFI), updated database software (Altibase), and new specialized coils (cardiac, head, spine, flexible SPEEDER). Safety features include SAR and dB/dt monitoring, emergency ramp-down unit, and compliance with IEC 60601-2-33. Device provides anatomical visualization to assist clinical decision-making.

Clinical Evidence

Bench testing only. Image quality metrics were evaluated using phantoms. System performance was verified in accordance with applicable IEC and NEMA standards for MRI safety and imaging performance. No clinical data provided.

Technological Characteristics

1.5T MRI system. Components: Helios gradient amplifier and coil. Connectivity: DICOM (NEMA PS 3.1-18). Standards: IEC 60601-1, IEC 60601-2-33, NEMA MS-1 through MS-5. Software: Altibase database. Features: 3D Advanced Fourier Imaging (AFI), wireless gating, and specialized coils (cardiac, head, spine, flexible SPEEDER).

Indications for Use

Indicated for diagnostic imaging of head or body anatomic structures in patients requiring cross-sectional transaxial, coronal, sagittal, or oblique MRI or 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, MRT-1504/U4 (K120638)
• Vantage Titan HSR, MRT-1504/A5 (K112003)

Submission Summary (Full Text)

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# ATTACHMENT G

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Vantage Titan, v2.1, MRT-1504/U5

# 510(k) SUMMARY AND EFFECTIVENESS

# DEC 1 3:2012

Page 1 of 5

# 1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.

- 2. ESTABLISHMENT REGISTRATION: 2020563
#### CONTACT PERSON AND U.S AGENT INFORMATION:

Charlemagne Chua Contact Person: [phone]

U.S. Agent Name:

Paul Biggins [phone]

2441 Michelle Drive Tustin, Ca. 92780

Establishment Name and Address:

## MANUFACTURING SITE

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

Toshiba America Medical Systems, Inc.

Japan

## 5. DATE OF SUBMISSION:

- 6. DEVICE NAME:
Generic Name: Model Name: Trade/ Proprietary Name: Magnetic Resonance Diagnostic Device MRT-1504/U5 Vantage Titan with Helios gradient

August 24, 2012 (Revised 11-5-2012)

## 7. CLASSIFICATION AND CLASS OF DEVICE

90-LNH, Class II per 21 CFR 892.1000

K122613-S1: Response to Al (10-9-12) Page 33 of 65

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#### PREDICATE DEVICE(S):

- K120638: Vantage Titan, MRT-1504/U4
- K112003: Vantage Titan HSR, MRT-1504/A5

#### REASON FOR SUMBISSION 9.

Modification of a cleared device

## 10. Submission Type Traditional 510(k)

#### 11. DEVICE DESCRIPTION

The Vantage Titan with Helios gradient (Model MRT-1504/U5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan with Helios gradient uses the same magnet as the Vantage Titan (K120638). The gradient performance was modified using. the same gradient amplifier and gradient coil as Vantage Titan HSR (K112003).

# 12. INTEDED USE

The MRI system is 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 : In addition, this system supports non-contrast 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 from the previous submission, K120638

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Page 3 of 5

#### 13. SUMMARY OF MAJOR HARDWARE CHANGES

- Gradient Amplifier
- Gradient Coil : b.
-

#### 14. SUMMARY OF MAJOR SOFTWARE CHANGES

- a. There are no software changes.
### 15. SUMMARY OF IMPROVEMENTS

- MRS Scan a.
- b. Altibase (Database SW), version upgrade

... ...

- c. . Scan parameter window -----
- ರ. Reconstruction speed
- e. Locator window operation
- Clinical application operability f.
- Autoview GUI g.
- Automatic map-scan h.
- Implementation of 3D Advanced Fourier Imaging (AFI) i.
- New coils (cardiac, Head, Spine and Flexible SPEEDER) i:

: : :

### <Next page>

K122613-S1: Response to AI (10-9-12) Page 35 of 65

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Toshiba America Medical Systems, Inc.
Pre-Market Notification 510(k) Vantage Titan, v2.1, MRT-1504/U5

#### 16. SAFETY PARAMETERS

| | Vantage Titan with<br>Helios gradient<br>(Subject device) | Vantage Titan<br>(K120638) | Vantage Titan HSR<br>(K112003) |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| a. Static field<br>strength: | 1.5T | 1.5T | 1.5T |
| b. Peak and A-<br>weighted acoustic<br>noise: | 112.0 dB (A-weighed)<br>122.9 dB(peak) | 106.2 dB (A-weighted)<br>115.4 dB (peak) | 113.0 dB (A-weighted)<br>121.6 dB (peak) |
| c. Operational<br>modes: | 1st operating mode | 1st operating mode | 1st operating mode |
| i. Safety<br>parameter<br>display: | SAR, dB/dt | SAR, dB/dt | SAR, dB/dt |
| ii. Operating<br>mode access<br>requirements: | Allows screen access to<br>1st level operating mode | Allows screen access to<br>1st level operating mode | Allows screen access to<br>1st level operating mode |
| d. Maximum SAR | 4W/kg for whole body (1st<br>operating mode specified<br>in IEC 60601-2-33 (2002)) | 4W/kg for whole body (1st<br>operating mode specified<br>in IEC 60601-2-33 (2002)) | 4W/kg for whole body (1st<br>operating mode specified<br>in IEC 60601-2-33 (2002)) |
| e. Maximum dB/dt | <1st operating mode<br>specified in IEC 60601-2-<br>33 (2002) | <1st operating mode<br>specified in IEC 60601-2-<br>33 (2002) | <1st operating mode<br>specified in IEC 60601-2-<br>33 (2002) |
| f. Potential<br>emergency<br>conditions and<br>means provided for<br>shutdown: | Shut down by Emergency<br>Ramp Down Unit for<br>collision hazard by<br>ferromagnetic objects | Shut down by Emergency<br>Ramp Down Unit for<br>collision hazard by<br>ferromagnetic objects | Shut down by Emergency<br>Ramp Down Unit for<br>collision hazard by<br>ferromagnetic objects |
| g. Biocompatibility<br>of materials | Confirmed for electrodes<br>and accessories for<br>wireless gating | Confirmed for electrodes<br>and accessories for<br>wireless gating | Confirmed for electrodes<br>and accessories for<br>wireless gating |

# 16. IMAGING PERFORMACE PARAMETERS

No change from the previous predicate submission (K120638).

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#### 17. DESIGN CHANGE

The Vantage Titan with Helios gradient MRI System is comparable to the existing 1.5T Vantage Titan MRI System (K120638), with the following modifications.

- Maximum gradient slew rate have been changed. a.
- Maximum gradient strength has been changed. b.

#### 18. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List for software and hardware changes have been is 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.

#### 19. TRUTHFUL AND ACCURACY CERTIFICATION

A certification of the truthfulness and accuracy of the Vantage Titan with Helios gradient described in this submission is provided in this submission.

#### 20. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan with Helios gradient (model MRT-1504/U5). 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

- IEC60601-1:1988, 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)

#### 21. TESTING

Image Quality metrics utilizing phantoms are provided in this submission. Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices.

#### 22. CONCLUSION :

The modifications incorporated into Vantage Titan with Helios Gradient (MRT-1504/U5), SW V2.20, do not affect the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications,

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 13, 2012

Toshiba Medical Systems Corporation C/O Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K122613

Trade/Device Name: Vantage Titan, MRT-1504/U5 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 5, 2012 Received: November 6, 2012

Dear Mr. Biggins:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollowed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreate) to togen. Jo togen. Januaries date of the Medical Device Amendments, or to conninered prior to May 20, sire) 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). and Cosmetic rice (110) that the novice, subject to the general controls provisions of the Act. The I ou may, dierelore, manol of the Act include requirements for annual registration, listing of general obliations provision 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 I lease be advised that I Dr o levice complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must or any I outlar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fart 607); mooning (DI CFR 803); good manufacturing practice requirements as set de rice-relation daverse overles) (1 CFR Part 820); and if applicable, the electronic forth in the quality of evelsions (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

# Janine M. Morris -S

Janine M. Morris 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):

Device Name:

Vantage Titan, MRT-1504/U5

Indications for Use:

The MRI system is 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. In addition, this system supports non-contrast 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),

K122613

- 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.

Over-The-Counter Use AND/OR Prescription Use × (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Janine M. Morris -S 2012.12.13 13:47:51 -05'00'

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

K122613 510(k) Number

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