Vantage Titan 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-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K160632. This system is based upon the technology 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

This document is a 510(k) summary for the Toshiba Vantage Titan 1.5T MRI system, model MRT-1510, with V4.0 software. It details the modifications to a previously cleared device and asserts substantial equivalence to predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Acceptance Criteria and Device Performance

The document does not explicitly state specific acceptance criteria (performance targets/thresholds) for the new software functionalities. Instead, it focuses on demonstrating that the modified device remains safe and effective for its intended use, which is to produce diagnostic MRI images. The testing outlined aims to show that the new functionalities perform as expected and do not compromise the device's safety or the quality of the diagnostic images compared to the predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria are not provided, this table will reflect the types of tests performed and the general conclusions rather than specific numerical targets.

Acceptance Criterion (Implicit)	Reported Device Performance
Maintenance of imaging performance parameters (e.g., image quality, resolution, contrast)	"No change from the previous predicate submission, K160632" regarding Imaging Performance Parameters. (This implies performance is maintained at the level of the predicate device).
Proper functioning of new software functionalities (FFE3D, mUTE, mUTE 4D-MRA, 2D-RMC, MP2RAGE, FSE2D mEcho, FFE2D mEcho, mASTAR, FASE DWI, PSIR, MOLLI, V-TISP, enhanced SPEEDER, improved surfECG R-wave detection)	Demonstrated through:Bench testingPhantom imagingVolunteer clinical imagingSuccessful completion of software validationConclusion: "It is concluded that the subject device is safe and effective for its intended use" and "does not change the indications for use or the intended use of the device."
Continued compliance with safety parameters (SAR, dB/dt, operational modes, emergency shutdown)	"No change from the previous predicate submission, K160632" and "hardware and related safety considerations remain unchanged." Tabulated safety parameters (Static field strength, Operational Modes, Safety parameter display, Operating mode access, Maximum SAR, Maximum dB/dt, Potential emergency condition) are identical to the predicate.
Conformity to applicable consensus standards (IEC 60601-1, IEC 60601-2-33, IEC 60601-1-2, IEC 60601-1-8, IEC 60825-1, IEC 62304, IEC 62366)	"This device is in conformance with the applicable parts of the following consensus standards..."
Software documentation for moderate level of concern	"Software Documentation for a Moderate Level of Concern... is also included as part of this submission."

Study Details

The document describes the testing performed to support the substantial equivalence claim, primarily focusing on general types of testing rather than a specific clinical study with detailed methodology as one might expect for a novel diagnostic algorithm.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "volunteer clinical imaging" but does not specify the number of volunteers or cases.
- Data Provenance: The document implies testing was conducted by Toshiba Medical Systems Corporation (TMSC) in Japan and/or Toshiba America Medical Systems (TAMS) in the USA, as these are the manufacturing and applicant/US agent locations. The data would likely be prospective as it involves "volunteer clinical imaging" and phantom/bench testing of the new V4.0 software.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document states "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." However, it does not detail the number or qualifications of physicians involved specifically in establishing ground truth for the testing described in this submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study is not mentioned in this document. The submission is for a modification to an MRI system's software adding new pulse sequences and functionalities, not for an AI diagnostic algorithm that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The term "standalone performance" isn't directly applicable in the context of an MRI system's pulse sequences. The performances described (bench testing, phantom imaging, volunteer clinical imaging) are for the imaging capabilities of the device itself, which generates images for human interpretation. The algorithms are part of the image generation process, not a separate diagnostic tool. The document focuses on the system's performance rather than a specific AI algorithm's diagnostic accuracy in isolation.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not explicitly stated. Given the nature of MRI system validation, ground truth would typically be established by expert radiologists interpreting the images from "volunteer clinical imaging" and comparing them to expected anatomical structures or known pathological conditions (if applicable to the volunteers). For phantom imaging, the 'ground truth' is the known physical properties and configurations of the phantom.
The sample size for the training set:
- Not applicable / Not specified. This submission is for an MRI system's software update, introducing new pulse sequences and image processing enhancements. It does not describe a machine learning algorithm that requires a "training set" in the conventional sense for a diagnostic AI. The software development and validation process would involve iterative testing and refinement, but not a distinct "training set" for an AI model as typically understood in AI/ML submissions.
How the ground truth for the training set was established:
- Not applicable / Not specified. As there is no mention of a "training set" for an AI model, this question does not apply.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

June 7, 2017

TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS DIRECTOR REGULATORY AFFAIRS 2441 MICHELLE DRIVE TUSTIN CA 92780

Re: K170412

Trade/Device Name: Vantage Titan 1.5T. MRT-1510. M-Power GX Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 16, 2017 Received: May 17, 2017

Dear Mr. 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 (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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

Robert A. Ochs. PhD 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)

K170412

Device Name Vantage Titan 1.5T, MRT-1510, 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)

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 PRAStaff@fda.hhs.gov

"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."

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Image /page/3/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in large, bold, red letters on the top line. Below it, the word "MEDICAL" is written in the same font and color, but slightly smaller. The logo is simple and clean, with a focus on the company name.

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 1.5T
Model Number:	MRT-1510

2. SUBMITTER'S NAME

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

3. OFFICIAL CORRESPONDENT

Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance

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

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

5. MANUFACTURING SITE

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

1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED February 6, 2017
1. DEVICE NAME Vantage Titan 1.5T, MRT-1510, V4.0 Software

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9. TRADE NAME

Vantage Titan 1.5T

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 1.5T, MRT-1510, V3.6

Reference Predicate Device (added software functionalities): Vantage Galan 3T, MRT-3020, V4.0

	Subject	Primary Predicate	Reference Predicate
System	Vantage Titan 1.5T,MRT-1510, V4.0	Vantage Titan 1.5T,MRT-1510, V3.6	Vantage Galan 3T,MRT-3020, V4.0
Marketed By	Toshiba AmericaMedical Systems	Toshiba America MedicalSystems	Toshiba AmericaMedical Systems
510(k) Number	This Submission	K160632	K162183
Clearance Date		August 23, 2016	November 25, 2016

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

This submission is to report the following software functionalities have been added:

. FFE3D:
- o mUTE: Ultra short TE T1 weighted sequence with reduced acoustic noise o mUTE 4D-MRA: Ultra short TE time resolved MR angiography with reduced acoustic noise
- o 2D-RMC: Two dimensional real-time motion correction
MP2RAGE: Images with multiple TI (Inversion time) to create T1 map ●

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Image /page/5/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in large, bold, red letters on top of the word "MEDICAL", which is also written in large, bold, red letters. The logo is simple and clean, with a focus on the company name.

Made For life

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
mASTAR: Multi Phase ASL (Arterial Spin Labeling)
FASE DWI: Spin Echo based Diffusion Weighted Imaging with reduced acoustic noise
PSIR: Phase Sensitive Inversion Recovery
MOLLI: Modified Look Locker Inversion recovery
V-TISP: Variable Ti1 and TS2 Prep (*1 inversion recovery time; *2 saturation recovery time)
o Enhancement of SPEEDER post-processing: Improvement of SPEEDER algorithm
Improvement of surfECG R-wave detection: Morphology-matching based R-wave detection.

Item	Subject Device: Vantage Titan1.5T, V4.0	Predicate Device: Vantage Titan1.5T, V3.6 (K160632)	Notes
Static field strength	1.5T	1.5T	Same
Operational Modes	Normal and 1st Operating Mode	Normal and 1st Operating Mode	Same
i. Safety parameterdisplay	SAR dB/dt	SAR dB/dt	Same
ii. Operating modeaccess requirements	Allows screen access to 1st leveloperating mode	Allows screen access to 1st leveloperating mode	Same
Maximum SAR	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33:2010+Amd.1:2013)	4W/kg for whole body (1stoperating mode specified inIEC 60601-2-33(2010))	Same
Maximum dB/dt	<1st operating mode specified inIEC60601-2-33(2010)+Amd.1:2013	<1st operating mode specified inIEC 60601-2-33 (2010)	Same
Potential emergency conditionand means provided for shutdown	Shut down by Emergency RampDown Unit for collision hazardfor ferromagnetic objects	Shut down by Emergency RampDown Unit for collision hazardfor ferromagnetic objects	Same

19. SAFETY PARAMETERS

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K160632.

21. INDICATIONS FOR USE

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. Proton density (PD) (also called hydrogen density)
Spin-lattice relaxation time (T1)
o 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 vield information that can be useful in diagnosis.

No changes to the previously cleared indication, K160632.

22. SUMMARY OF DESIGN CONTROL ACTIVITIES

PS Risk List 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 1.5T, MRT-1510, V3.6 (K160632), and the reference predicate device, Vantage Galan 3T, MRT-3020, V4.0 (K162183). 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 +Amd.1:2012 ●
IEC 60601-2-33:2010 +Amd.1:2013 .
IEC 60601-1-2:2007 o
IEC 60601-1-8:2006 +Amd.1:2012
. IEC 60825-1:2007
IEC 62304:2006 ●
IEC 62366:2007 +Amd.1:2014 ●

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.

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25. SUBSTANTIAL EQUIVALENCE

Toshiba Medical Systems Corporation believes that the Vantage Titan 1.5T, MRT-1510, V4.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate devices referenced in this submission. Toshiba Medical Systems Corporation believes that the changes incorporated into the Vantage Titan 1.5T, MRT-1510, V4.0 software are substantially equivalent to the previously cleared predicate devices.

26. CONCLUSION

The modifications incorporated into the Vantage Titan 1.5T, MRT-1510, V4.0 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.

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.