Vantage Titan 3T, MRT-3010/A7, M-Power GX by Toshiba Medical Systems Corporation, Japan

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 Description

The Vantage Titan (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K152371. This system is based upon the technology, software and materials of previously marketed Toshiba MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria, a study proving device conformance to those criteria, or details regarding the performance of the device against such criteria. The document is a 510(k) premarket notification for a Magnetic Resonance Imaging (MRI) system (Vantage Titan 3T, MRT-3010/A7, M-Power GX).

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices by outlining:

Device Description and Changes: The submission describes the MRI system and lists software functionalities being migrated from existing cleared devices (sequence enhancements, post-processing enhancements, R-wave detection improvement).
Safety Parameters: It compares safety parameters (static field strength, operational modes, SAR, dB/dt, emergency shutdown) of the subject device with the primary predicate device, noting they are the "Same."
Imaging Performance Parameters: It explicitly states "No change from the previous predicate submission, K152371," indicating that the imaging performance is considered equivalent to the cleared predicate and not re-evaluated with new acceptance criteria or studies.
Indications for Use: No changes to the previously cleared indications for use.
Design Control Activities: Mentions risk management activities for new software functionalities and pulse sequences, confirming the test methods are the same as those in previously cleared submissions and indicating conformity with design controls.
Safety and Standards Conformance: States the device is designed and manufactured under Quality System Regulations and ISO 13485, and conforms to applicable IEC and NEMA standards.
Software Documentation: References FDA guidance for software documentation for a moderate level of concern.
Conclusion: Concludes that "Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use."

Therefore, I cannot provide the requested table or detailed information on specific studies, sample sizes, expert qualifications, or adjudication methods related to specific acceptance criteria and device performance as this document addresses substantial equivalence rather than a new standalone performance evaluation against defined acceptance criteria. The "testing" mentioned is implicitly related to software validation and risk management applied to changes, assuming the underlying hardware and core imaging performance already met acceptance criteria in prior submissions.

Summary

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November 17, 2017

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Toshiba Medical Systems Corporation, Japan % Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, California 92780

Re: K172878

Trade/Device Name: Vantage Titan 3T, MRT-3010/A7, M-Power GX Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: September 20, 2017 Received: September 21, 2017

Dear Paul 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Ochs

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K172878

Device Name

Vantage Titan 3T, MRT-3010/A7, M-Power GX

Indications for Use (Describe)

· 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Made For life

K172878

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92

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, MRT-3010/A7,M-Power GX
Model Number:	MRT-3010/A7

2. SUBMITTER'S NAME

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

3. OFFICIAL CORRESPONDENT

Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance

4. CONTACT PERSON, U.S. AGENT and ADDRESS

Paul Biggins Director Regulatory Affairs pbiggins@tams.com (714) 669-7808 Toshiba America Medical Systems, Inc. 2441 Michelle Drive Tustin, CA 92780 Tel. (714) 730-5000 Fax. (714) 730-1310

5. MANUFACTURING SITE

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

1. ESTABLISHMENT REGISTRATION 9614698

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7. DATE PREPARED

September 20, 2017

8. DEVICE NAME

Vantage Titan 3T, MRT-3010/A7, M-Power GX

9. TRADE NAME

Vantage Titan 3T, MRT-3010/A7, M-Power GX

10. CLASSIFICATION NAME

Magnetic Resonance Diagnostic Device (MRDD)

11. CLASSIFICATION PANEL

Radiology

12. DEVICE CLASSIFICATION

Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)

13. PRODUCT CODE

90-LNH

14. PREDICATE DEVICE

Primary Predicate Device (system): Vantage Titan 3T, MRT-3010/A7, V3.5

Secondary Predicate Devices (added software functionalities): Vantage Galan 3T, MRT-3020, V4.0 and Vantage Titan 1.5T, MRT-1510, M-Power GX

	Subject	PrimaryPredicate	ReferencePredicate	ReferencePredicate
System	Vantage Titan 3T,MRT-3010/A7,M-Power GX	Vantage Titan 3T,MRT-3010,V3.5	Vantage Galan 3T,MRT-3020,V4.0	Vantage Titan 1.5T,MRT-1510,M-Power GX
	Marketed By	Toshiba America	Toshiba America	Toshiba America	Toshiba America
		Medical Systems	Medical Systems	Medical Systems	Medical Systems
510(k) Number	This Submission	K152371	K162183	K170412
Clearance Date		October 23, 2015	November 25, 2016	July 21, 2017

15. REASON FOR SUBMISSION

This submission is to add software items that were cleared previously via the reference predicate Toshiba MR systems listed above.

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

17. DEVICE DESCRIPTION

The Vantage Titan (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K152371. This system is based upon the technology, software and

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Made For life

materials of previously marketed Toshiba MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

18. SUMMARY OF CHANGE(S)

This submission is to report the following software functionalities that are being migrated from the listed Secondary Predicate devices:

Sequence Enhancements:
o FFE3D:
SPAIR: Pre-pulse for fat suppression
T2Prep: Pre-pulse for T2 contrast
mUTE: Ultra short TE T1 weighted sequence with reduced acoustic noise
mUTE 4D-MRA: Ultra short TE time resolved MR angiography with reduced acoustic noise
2D-RMC: Two dimensional real-time motion correction

o MP2RAGE: Images with multiple TI (Inversion time) to create T1 map o FSE2D mEcho: Images with multiple TE (Echo time) to create T2 map

o FFE2D mEcho: Images with multiple TE (Echo time) to create T2* map

omASTAR: Multiple phase ASL (Arterial Spin Labeling)
oFASE DWI: Spin Echo based Diffusion Weighted Imaging with reduced acoustic noise
o PSIR: Phase Sensitive Inversion Recovery
o MOLLI: Modified Look Locker Inversion recovery
o V-TISP: Variable TI*1 and TS 2 Prep (*1 inversion recovery time time)
Enhancement of SPEEDER post-processing
EasyTech Cardiac: SUREVOI and CardioLine+ ●
Improvement of SUREECG R-wave detection ●
●

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Titan 3T,MRT-3010/A7, M-Power GX	Predicate Device:Vantage Titan 3T ,MRT-3010, V3.5	Notes
Static field strength	3T	3T	Same
Operational Modes	Normal and 1st OperatingMode	Normal and 1st OperatingMode	Same
i. Safety parameterdisplay	SAR, dB/dt	SAR, dB/dt	Same

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Item	Subject Device:Vantage Titan 3T,MRT-3010/A7, M-Power GX	Predicate Device:Vantage Titan 3T ,MRT-3010, V3.5	Notes
ii. Operating modeaccess requirements	Allows screen access to 1stlevel operating mode	Allows screen access to 1stlevel operating mode	Same
Maximum SAR	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33: 2010)	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33: 2010)	Same
Maximum dB/dt	1st operating mode specifiedin IEC 60601-2-33: 2010	1st operating mode specifiedin IEC 60601-2-33: 2010	Same
Potential emergencycondition and meansprovided forshutdown	Shutdown by EmergencyRamp Down Unit for collisionhazard for ferromagneticobjects	Shutdown by EmergencyRamp Down Unit for collisionhazard for ferromagneticobjects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K152371.

21. INDICATIONS FOR USE

. 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.

NOTE No changes to the previously cleared indication, K152371.

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Image /page/7/Picture/3 description: The image shows the words "TOSHIBA MEDICAL" stacked on top of each other. The words are written in a bold, sans-serif font and are colored red. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the bottom line.

22. SUMMARY OF DESIGN CONTROL ACTIVITIES

Risk Management activities for new software functionalities and pulse sequences are included in this submission. The test methods used are the same as those submitted in the previously cleared submissions of the primary predicate device, Vantage Titan 3T, MRT-3010, V3.5 (K152371), and the reference predicate devices, Vantage Galan 3T, MRT-3020, V4.0 (K162183) and Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412). A declaration of conformity with design controls is included in this submission.

23. SAFETY

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. The changes to this device are limited to the application software that is being presented for review. As the hardware and related safety considerations remain unchanged from the previous submission no information related to these aspects are presented for the determination of safety. Performance and/or clinical testing are being provided to demonstrate the safety and effectiveness of the application software.

This device is in conformance with the applicable parts of the following consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA).

LIST OF APPLICABLE STANDARDS

. IEC 60601-1:2005
. IEC 60601-2-33:2010
IEC 60601-1-2:2007
. IEC 60601-1-8:2006
IEC 60825-1:2007
. IEC 62304:2006
. IEC 62366:2007

24. TESTING

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

25. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan 3T, MRT-3010/A7, M-Power GX Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device referenced in this submission. Toshiba Medical Systems Corporation believes that the changes incorporated into the Vantage Titan 3T, MRT-3010/A7, M-Power GX software are substantially equivalent to the previously cleared predicate devices.

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26. CONCLUSION

The modifications incorporated into the Vantage Titan 3T, MRT-3010/A7, M-Power GX software do not change the indications for use or the intended use of the device. Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.

TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

2441 Michelle Drive, Tustin, CA 92780 / 714.730.5000 / medical.toshiba.com

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.