Vantage Galan 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

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Device Description

The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K162183. 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 describes a 510(k) submission for the Vantage Galan 3T, MRT-3020, V4.6 Magnetic Resonance Imaging (MRI) System. This submission is for modifications to an already cleared device, including increased gradient strength and additional software functionalities (MultiBand SPEEDER, PSIR, MOLLI, V-TISP).

The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's diagnostic performance against specific acceptance criteria for a new clinical indication. Therefore, some of the requested information regarding clinical study specifics (e.g., sample size for test set, number of experts for ground truth, MRMC study effect size) is not explicitly detailed in the provided text, as this type of submission typically relies on equivalence to a previously cleared device's performance.

Here's a summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance or report specific performance metrics like sensitivity, specificity, or AUC as it would for a novel diagnostic algorithm. Instead, the "acceptance criteria" are related to safety, functionality, and demonstration of substantial equivalence to the predicate device.

Item	Acceptance Criteria (Implied by equivalence)	Reported Device Performance
Safety Parameters	Same safety parameters as predicate (Static field strength, Operational Modes, SAR, dB/dt, Emergency shutdown)	All safety parameters are "Same" as predicate (K162183)
Imaging Performance	No change in imaging performance from previous predicate submission (K162183)	"No change from the previous predicate submission, K162183."
New Software Functionality	Functionality of PSIR, MOLLI, V-TISP, MultiBand SPEEDER integrated and operating as intended, consistent with their function in the reference predicate (K172878).	Achieved through software validation and clinical imaging.
Intended Use/Indications	No change to previously cleared indication or intended use.	"No changes to the previously cleared indication, K162183."
Substantial Equivalence	The device is substantially equivalent to predicate devices.	Concluded based on bench testing, phantom imaging, volunteer clinical imaging, and software validation.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "volunteer clinical imaging" was performed. However, it does not specify the sample size for this clinical imaging, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature) for any test set specifically used to evaluate the new software functionalities. This type of information is often provided in a more detailed testing report, which is typically part of the full 510(k) submission but not fully included in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. As the submission focuses on modifications to an existing MRI system and demonstrating substantial equivalence, detailed diagnostic performance studies with adjudicated ground truth by experts are not typically the primary focus for this type of 510(k). The document states images are "interpreted by a trained physician," implying general clinical practice, not a specific expert panel for a study.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in this document. The device itself is an MRI scanner with enhanced sequences, not an AI-powered diagnostic aide designed to improve human reader performance directly.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes an MRI system with new pulse sequences and gradient capabilities. It is not an "algorithm only" device in the sense of a standalone diagnostic software that produces an output without human interaction. The system produces images that are then interpreted by a trained physician. Therefore, a standalone (algorithm only) performance assessment, as might be done for an AI diagnostic algorithm, is not applicable in this context and was not performed.

7. The Type of Ground Truth Used

For the "volunteer clinical imaging" and general assessment of the MRI system, the ground truth for image quality and diagnostic information is implicitly tied to clinical interpretation by a trained physician, as stated in the Indications for Use. For evaluating the technical performance and functionality of the new sequences (PSIR, MOLLI, V-TISP, MultiBand SPEEDER), the ground truth would be based on expected physical principles of MR imaging and technical image quality metrics. There is no mention of pathology or outcomes data as specific ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The new software functionalities (PSIR, MOLLI, V-TISP, MultiBand SPEEDER) are described as "techniques" or "sequence enhancements." They are not presented as machine learning algorithms that require a distinct training set for model development in the typical sense. These are likely based on established MR physics principles and refined through engineering and technical validation.

9. How the Ground Truth for the Training Set was Established

As no distinct "training set" for a machine learning algorithm is discussed, the concept of establishing ground truth for a training set is not applicable in this context. The "ground truth" for the development and validation of these MR sequences would be based on principles of physics, signal processing, and expected image characteristics, verified through phantom and volunteer studies.

Summary

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January 26, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.

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

Re: K173382

Trade/Device Name: Vantage Galan 3T, MRT-3020, V4.6 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 27, 2017 Received: October 31, 2017

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 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,

Michael D. 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

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Indications for Use

510(k) Number (if known)

K173382

Device Name

Vantage Galan 3T, MRT-3020, V4.6

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

Depending on the region of interest, contrast agents use may be used. 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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Image /page/3/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is stacked on top of the word "MEDICAL". Both words are in a bold, sans-serif font and are colored red. The logo is simple and clean, with a focus on the brand 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 Galan 3T, MRT-3020, V4.6
Model Number:	MRT-3020

2. SUBMITTER'S NAME

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

3. OFFICIAL CORRESPONDENT

Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance Toshiba Medical Systems Corporation

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

Contact Person

Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 jfreyes@tams.com

Official Correspondent/U.S. Agent

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

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Image /page/4/Picture/0 description: The image shows the words "TOSHIBA MEDICAL" stacked on top of each other. The words are 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. The background is white.

1. MANUFACTURING SITE Toshiba Medical Systems Corporation 1385 Shimoishigami
  Otawara-shi, Tochigi 324-8550, Japan
1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED November 3rd, 2017
1. DEVICE NAME Vantage Galan 3T, MRT-3020, V4.6
1. TRADE NAME

Vantage Galan 3T, MRT-3020, V4.6

10. CLASSIFICATION NAME

Magnetic Resonance Diagnostic Device (MRDD)

11. CLASSIFICATION PANEL

Radiology

1. DEVICE CLASSIFICATION
  Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)

13. PRODUCT CODE

90-LNH

14. PREDICATE DEVICE

Predicate Device (system): Vantage Galan 3T, MRT-3020, V4.0

Reference Predicate Device (added software functionalities): Vantage Titan 3T, MRT-3010/A7, M-Power GX

	Subject	Primary Predicate	Reference Predicate
System	Vantage Galan 3T,MRT-3020,V4.6	Vantage Galan 3T,MRT-3020,V4.0	Vantage Titan 3T,MRT-3010/A7,M-Power GX
Marketed By	Toshiba AmericaMedical Systems	Toshiba AmericaMedical Systems	Toshiba AmericaMedical Systems
510(k) Number	This Submission	K162183	K172878
Clearance Date		November 25, 2016	November 17, 2017

15. REASON FOR SUBMISSION

Modification of a cleared device

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Image /page/5/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the second line. Both words are in a bold, sans-serif font and are colored red. The logo is simple and clean, with a focus on the company name.

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

This submission is to report the following changes. Additional software functionalities PSIR, MOLLI and V-TISP are being migrated from the listed reference predicate device (K172878):

XG option with increased gradient strength of 45mT/m ●
Additional Software Functionalities: ●
- oMultiBand SPEEDER: MultiBand SPEEDER is a technique to acquire multiple slices at one time by using simultaneous multiband excitation RF pulses. MultiBand SPEEDER technique can be used to reduce acquisition time.
- o Sequence Enhancements:
  - PSIR: Phase Sensitive Inversion Recovery
  - · MOLLI: Modified Look Locker Inversion recovery
  - V-TISP: Variable TI1 and TS2 Prep (*1 inversion recovery time / * saturation recovery time)

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Galan 3T,MRT-3020, V4.6	Predicate Device:Vantage Galan 3T,MRT-3020, V4.0	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 accessrequirements	Allows screen access to 1st leveloperating mode	Allows screen access to 1st leveloperating mode	Same
Maximum SAR	4W/kg for whole body (1st operatingmode specified in IEC 60601-2-33:2010+A1:2013)	4W/kg for whole body (1st operatingmode specified in IEC 60601-2-33:2010)	Same
Maximum dB/dt	1st operating mode specified in IEC60601-2-33: 2010+A1:2013	1st operating mode specified in IEC60601-2-33: 2010	Same
Potential emergencycondition and meansprovided for shutdown	Shutdown by Emergency Ramp DownUnit for collision hazard forferromagnetic objects	Shutdown by Emergency RampDown Unit for collision hazard forferromagnetic objects	Same

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Image /page/6/Picture/0 description: The image shows the words "TOSHIBA MEDICAL" stacked on top of each other. The words are 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 second line.

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K162183.

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

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

*NOTE: No changes to the previously cleared indication, K162183.

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 Galan 3T, MRT-3020, V4.0 (K162183), and the reference predicate device, Vantage Titan 3T, MRT-3010/A7, M-Power GX (K172878). 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.

This device is based upon the same technologies, materials and software as the predicate device. Risk activities were conducted in concurrence with established medical device development standards and guidance. Additionally, testing was done in accordance with applicable recognized consensus standards published by the International Electrotechnical Commission (IEC) for medical devices and the National Electrical Manufacturers Association (NEMA):

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LIST OF APPLICABLE STANDARDS

IEC60601-1 (2005), Amd.1 (2012) ●
IEC60601-1-2 (2007)
IEC60601-1-8 (2006), Amd.1 (2012) ●
IEC60601-2-33 (2010), Amd.1 (2013) ●
. IEC60825-1 (2007)
IEC62304 (2006) ●
IEC62366 (2007), Amd.1 (2014) ●
NEMA MS 1 (2008) ●
NEMA MS 2 (2008) ●
NEMA MS 3 (2008) ●
. NEMA MS 4 (2010)
NEMA MS 5 (2010) ●

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 Galan 3T, MRT-3020, V4.6 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 Galan 3T, MRT-3020, V4.6 are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Galan 3T, MRT-3020, V4.6 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.