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 vield 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 K203553. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

AI/ML Overview

This FDA 510(k) summary describes modifications to an existing device, the Vantage Galan 3T MRI system with AiCE Reconstruction Processing Unit, rather than a completely new device. Therefore, the "study" described focuses on validating that the changes do not negatively impact the device's performance or safety compared to the previously cleared predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format for performance metrics. Instead, it demonstrates through testing that the device modifications meet existing safety and image quality standards and are equivalent to the predicate device. The performance reports are qualitative confirmations that the changes do not degrade performance.

Parameter Tested	Acceptance Criteria (Implied)	Reported Device Performance
Image Quality: Image Homogeneity (Rx/Tx Correction Plus)	Improved homogeneity compared to images without intensity correction.	"Rx/Tx Correction Plus increases the homogeneity of the image compared to the image without intensity correction."
Image Quality: Distortion (Expanded SPEEDER)	Reduced distortion due to magnetic field inhomogeneity with increased acceleration factor.	"It was confirmed that the distortion due to magnetic field inhomogeneity was reduced by increasing the Exsper acceleration factor."
Image Quality: Low Contrast (Expanded SPEEDER)	Maintain acceptable low contrast performance.	Not explicitly quantified, but implied to be acceptable as part of overall performance validation and substantial equivalence.
Image Quality: SNR (Expanded SPEEDER)	Maintain acceptable Signal-to-Noise Ratio (SNR) performance.	Not explicitly quantified, but implied to be acceptable as part of overall performance validation and substantial equivalence.
Software Functionality (EPI, FSE 2D, FFE 2D/3D, Double Coverage Interleave)	All new/modified software features function as intended and meet system requirements.	"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 submission... A declaration of conformity with design controls is included in this submission."
Patient Belt Material Change	No adverse impact on patient safety or device function.	Implicitly covered by risk analysis and overall safety assessment.
Safety Parameters (Static field strength, Operational Modes, SAR, dB/dt, Emergency shutdown)	Match predicate device specifications.	All listed as "Same" as the predicate device.

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

Sample Size: The document mentions "phantom images" for image quality metrics and "volunteer clinical imaging" but does not specify numerical sample sizes for either.
Data Provenance: The document does not specify the country of origin of the data. It mentions "bench testing" and "volunteer clinical imaging" as testing methods, implying a prospective collection for the purpose of this submission, but no further details are given.

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

The document does not provide details on experts used to establish ground truth for the test set. For a device like an MRI system with software modifications, ground truth validation usually involves quantitative image quality metrics using phantoms, and potentially qualitative assessment by radiologists in clinical imaging, but this is not explicitly detailed here.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described in this document. The submission is for modifications to a cleared device and focuses on establishing substantial equivalence and safety, not on demonstrating improved diagnostic accuracy with human-AI assistance.

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

The focus of the testing mentioned (image homogeneity, distortion, SNR, low contrast, software functionality) primarily aligns with standalone algorithm performance as applied to image reconstruction and quality. The "AiCE Reconstruction Processing Unit" is an AI-powered reconstruction technology, and the tests would assess its direct impact on image characteristics. However, there isn't a specific section titled "standalone performance study" with detailed metrics outside of the general image quality evaluations.

7. The Type of Ground Truth Used

For image quality metrics (homogeneity, distortion, SNR, low contrast), the ground truth is often established via physical phantoms with known properties and computational models.
For software functionality, the ground truth is adherence to design specifications and system requirements.
For clinical imaging validation, the "ground truth" often refers to a consensus reading by expert radiologists, but details here are absent.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of this submission. The AiCE Reconstruction Processing Unit (which likely uses AI) was part of the predicate device (K203553). This submission is for modifications to the system around that already cleared AI component (e.g., new pulse sequences, increased acceleration factors). Therefore, details about the training data for AiCE itself would have been part of the K203553 submission, not this one.

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

As explained above, this submission focuses on modifications to a previously cleared device. Information regarding the training set and its ground truth for the AiCE Reconstruction Processing Unit would have been established during the development and clearance of the predicate device (K203553). This document does not provide those details.

Summary

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August 4, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is the Department of Health & Human Services logo. The text is in blue, with "FDA" in a larger font size than the rest of the text.

Canon Medical Systems Corporation % Ms. Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K212056

Trade/Device Name: Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: July 1, 2021 Received: July 2, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212056

Device Name

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

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 may be used. When interpreted by a trained physician, these images vield 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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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, V7.0 with AiCE ReconstructionProcessing Unit for MR
Model Number:	MRT-3020

2. SUBMITTER'S NAME

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

3. OFFICIAL CORRESPONDENT

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

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

Contact Person

Janine F. Reves Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 E-mail: jfreyes@us.medical.canon

Official Correspondent/U.S. Agent

Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon

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5. MANUFACTURING SITE

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

6. ESTABLISHMENT REGISTRATION 9614698

7. DATE PREPARED

June 29, 2021

8. DEVICE NAME

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

9. TRADE NAME

Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR

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

Predicate Device: Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K203553)

	Subject Device	Predicate Device
System	Vantage Galan 3T, MRT-3020, V7.0 withAiCE Reconstruction Processing Unit for MR	Vantage Galan 3T, MRT-3020, V7.0 withAiCE Reconstruction Processing Unit for MR
Marketed By	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.
510(k) Number	This Submission	K203553
Clearance Date		February 2, 2021

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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 changes:

Summary of Software Changes:

EPI:
Exsper (Expanded SPEEDER): The number of maximum acceleration factor changes to 6 (subject modification).
FSE 2D: ●
- Compressed SPEEDER: Extension of the Compressed SPEEDER (2D) maximum acceleration factor of up to 4 (K211037).
FFE 2D/3D: ●
- o Min. TR / Min. TE: Min. TR and Min. TE in Matrix 64 on STD gradient system change to 1.0[ms] and 0.29[ms], respectively (subject modification).
Double Coverage Interleave: The planned slices are divided into coverages at intervals of N-1 ● slices, where N is the number of coverages, and then the coverages are excited sequentially. In addition, Interleave acquisition is applied in each coverage (subject modification).

Summary of Accessory Changes:

Patient Belt: material change. ●

Summary of Labeling Changes:

M-Power: "M-Power" marketing name is removed (subject modification). ●

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19. SAFETY PARAMETERS

Item	Subject Device:Vantage Galan 3T, MRT-3020, V7.0with AiCE ReconstructionProcessing Unit for MR	Predicate Device:Vantage Galan 3T, MRT-3020, V7.0with AiCE ReconstructionProcessing Unit for MR (K203553)	Notes
Static field strength	3T	3T	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 in IEC60601-2-33:2010+A1:2013+A2:2015)	4W/kg for whole body (1stoperating mode specified in IEC60601-2-33:2010+A1:2013+A2:2015)	Same
Maximum dB/dt	1st operating mode specified in IEC60601-2-33:2010+A1:2013+A2:2015	1st operating mode specified in IEC60601-2-33:2010+A1:2013+A2:2015	Same
Potential emergencycondition and meansprovided for shutdown	Shutdown by Emergency RampDown Unit for collision hazard forferromagnetic objects	Shutdown by Emergency RampDown Unit for collision hazard forferromagnetic objects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K203553.

21. INDICATIONS FOR USE

Vantage Galan 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.

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 change from the previous predicate submission, K203553.

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Made For life

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 submission of the predicate device, Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR (K203553). 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):

LIST OF APPLICABLE STANDARDS

ANSI AAMI ES60601-1:2005/(R)2012 ● and A1:2012
IEC60601-1-2 (2014)
IEC60601-1-6 (2010), Amd.1 (2013)
IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015)
. IEC60825-1 (2007)
IEC62304 (2006), Amd.1 (2015) ●
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

Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrate that the system requirements have been met. Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria.

MR image quality metrics were performed, utilizing phantom images, to assess Rx/Tx Correction Plus with regards to image homogeneity. It was concluded that Rx/Tx Correction Plus increases the homogeneity of the image compared to the image without intensity correction.

MR image quality metrics were performed, utilizing phantom images, to assess Exper (expanded SPEEDER) maximum acceleration factor of up to six with regards to image distortion, homogeneity, low contrast and SNR. It was confirmed that the distortion due to magnetic field inhomogeneity was reduced by increasing the Exsper acceleration factor.

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

Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020, V7.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020, V7.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, referenced in this submission.

Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020, V7.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Galan 3T, MRT-3020, V7.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR do not change the indications for use or the intended use of the device. Based upon bench testing, 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.