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.

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 K181593. 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

The provided text is a 510(k) summary for the Canon Medical Systems Corporation's Vantage Galan 3T, MRT-3020, V6.0 MRI System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, the requested information elements (1, 2, 3, 4, 5, 7, 8, 9) regarding acceptance criteria, sample sizes, expert qualifications, ground truth establishment, and MRMC effectiveness studies cannot be fully extracted from this document as it is not a study report for an AI device.

However, based on the information provided regarding the "Compressed SPEEDER" feature, which is a new software functionality, I can deduce some aspects related to its evaluation.

Here's a breakdown of what can be extracted or inferred, and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Inferred from conclusion)
SNR (related to image quality)	Compressed SPEEDER met all acceptance criteria.
Unfolding error artifacts (related to image quality)	Compressed SPEEDER met all acceptance criteria.
Performance in all phase encode directions (related to image quality)	Compressed SPEEDER met all acceptance criteria.
Diagnostic quality of images (clinical utility)	Images were of diagnostic quality.
Image degradation assessment (clinical utility)	Positive assessment, indicating no significant degradation.
Lesion conspicuity (clinical utility)	Positive assessment, indicating maintained or improved conspicuity.
Clinical utility (overall usefulness)	Positive assessment, indicating clinical utility.

2. Sample size used for the test set and the data provenance

Sample Size:
- For technical image quality metrics (SNR, unfolding error, phase encode performance): Phantoms and volunteer images were used. The exact number of phantoms or volunteers is not specified.
- For clinical image quality assessment by radiologists: Representative images were obtained using the subject device. The exact number of images or cases is not specified.
Data Provenance: Not explicitly stated, but given it's a medical device submission by a Japanese company with a U.S. agent, the volunteer imaging likely occurred either in Japan or the US. This was a prospective evaluation of the new software feature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not explicitly stated, but referred to as "American Board Certified Radiologists" (plural), indicating at least two.
Qualifications of experts: "American Board Certified Radiologists." No specific experience level (e.g., "10 years of experience") is provided.

4. Adjudication method for the test set

The document states that reviewers (radiologists) "provided detailed assessments." It does not specify an adjudication method (e.g., 2+1, 3+1, none) for reaching a consensus on the diagnostic quality or other assessments if multiple radiologists were involved. It simply says "reviewed by American Board Certified Radiologists."

5. 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 was not explicitly mentioned or performed in the context of human reader improvement with AI assistance. The evaluation focused on the diagnostic quality of images produced by the device's new "Compressed SPEEDER" and "T2 Map" features, reviewed by radiologists, rather than comparing human reader performance with and without AI assistance from these features. The device's features (Compressed SPEEDER) are about image acceleration and quality, not necessarily AI for diagnostic assistance to humans.

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

Yes, a standalone evaluation of the "Compressed SPEEDER" algorithm's technical performance was done using phantoms and volunteer images to assess SNR, unfolding error artifacts, and performance in all phase encode directions. The algorithm's output (images) was then assessed for diagnostic quality by radiologists. This refers to the algorithm generating the images, which are then interpreted.

7. The type of ground truth used

For the technical image quality metrics (SNR, unfolding error, phase encode performance), the ground truth was based on known phantom dimensions and electromagnetic properties, along with expected image characteristics from volunteer scans.
For the clinical assessment by radiologists, the ground truth was expert consensus (implied, as radiologists reviewed and confirmed diagnostic quality). No mention of pathology or outcomes data as ground truth is made.

8. The sample size for the training set

The document does not specify a training set size or methodology. It is a 510(k) summary for a software update to an MRI system, not a detailed algorithm development report. It is likely that the Compressed SPEEDER algorithm was developed and trained internally by Canon Medical Systems, but details are not provided here.

9. How the ground truth for the training set was established

As the training set itself is not mentioned, the method for establishing its ground truth is not provided in this document.

Summary

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Image /page/0/Picture/0 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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".

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

Re: K192506

Trade/Device Name: Vantage Galan 3T, MRT-3020, V6.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 21, 2020 Received: January 22, 2020

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

March 2, 2020

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K192506

Device Name Vantage Galan 3T, MRT-3020, V6.0

Indications for Use (Describe)

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.

·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.

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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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, V6.0
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. Reyes 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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1. MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED September 10th, 2019
1. DEVICE NAME Vantage Galan 3T, MRT-3020, V6.0
1. TRADE NAME Vantage Galan 3T, MRT-3020, V6.0

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/A7, V5.0 (K181593) Reference Device (system): Vantage Galan 3T, MRT-3020 (K162183), Vantage Galan 3T, MRT-3020/A9 (K183657), Vantage Orian 1.5T, MRT-1550 (K182282)

System	Subject Device	Predicate Device	Reference Device	Reference Device	Reference Device
	Vantage Galan3T, MRT-3020,V6.0	Vantage Galan 3T,MRT-3020/A7,V5.0	Vantage Galan 3T,MRT-3020,V4.0	Vantage Galan 3T,MRT-3020/A9,V5.0	Vantage Orian1.5T, MRT-1550,V4.5
MarketedBy	Canon MedicalSystems USA, Inc.	Canon MedicalSystems USA, Inc.	Canon MedicalSystems USA, Inc.	Canon MedicalSystems USA, Inc.	Canon MedicalSystems USA, Inc.
510(k)Number	This Submission	K181593	K162183	K183657	K182282
ClearanceDate		August 13, 2018	November 25, 2016	March 15, 2019	October 19, 2018

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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 software functionalities have been added:

Summary of Hardware Changes:

New Cover Design
Optional Dockable/Detachable Table

Summary of Software Changes:

New SAR: New calculation method is applied.
Compressed SPEEDER (Compressed Sensing)*: ●
- This application allows accelerated fast scan of the brain, cervical spine, thoracic . spine, lumbar spine, shoulder, knee, foot, ankle, elbow and wrist. Compressed SPEEDER combines parallel imaging by using multi-sensitivity map and compressed sensing.
- . Compressed SPEEDER feature allows acceleration factors for shorter scan times or higher resolution in FSE2D imaging based upon the principle of Compressed Sensing in combination with parallel imaging.
T2 Map Using Pre-Contrast Pulses: ECG gating or peripheral pulse gating is used in scanning with FFE2D sequences, and different Pre-contrast pulses are used to obtain multiple TEeff images.
CP Mode (quadrature transmit mode): has been added. ●

Labeling Changes:

Adaptive Scan Mode: The function name of "Limited Scan Mode" has been changed to "Adaptive Scan Mode".
*Note: Compressed SPEEDER should not be used for contrast-agent-enhanced imaging.

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Made For life

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Galan 3T,MRT-3020, V6.0	Predicate Device:Vantage Galan 3.0T, MRT-3020/A7, V5.0	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+A2:2015)	4W/kg for whole body (1stoperating mode specified in IEC60601-2-33: 2010+A1:2013)	Same
Maximum dB/dt	1st operating mode specified inIEC 60601-2-33:2010+A1:2013+A2:2015	1st operating mode specified inIEC 60601-2-33: 2010+A1:2013	Same
Potential emergencycondition and meansprovided for shutdown	Shutdown by Emergency RampDown Unit for collision hazard forferromagnetic objects	Shutdown by Emergency RampDown Unit for collision hazardfor ferromagnetic objects	Same

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K181593.

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.

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Made For life

22. SUMMARY OF DESIGN CONTROL ACTIVITIES

Risk Management activities for new software functionalities and hardware changes 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/A7, V5.0 (K181593). 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 phantoms and volunteer images, to assess Compressed SPEEDER with regards to SNR, unfolding error artifacts and performance in all the phase encode directions. It was concluded that Compressed SPEEDER met all acceptance criteria.

Additionally, representative images, reviewed by American Board Certified Radiologists, were obtained using the subject device. Reviewers provided detailed assessments of image degradation, diagnostic performance, lesion conspicuity, and clinical utility. It was confirmed that Compressed SPEEDER images were of diagnostic quality.

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Image /page/8/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in red, and the rest of the text is in black. The text is left-aligned and the font is sans-serif. The logo is simple and professional.

Made For life

T2 Map Using Pre-Contrast Pulses was evaluated utilizing phantom and volunteer images. It was concluded that T2 maps can be generated using the data acquired using pre-contrast pulses.

New SAR calculation method was evaluated by imaging and modeling a phantom of known dimension and electromagnetic properties in combination with volunteer imaging. It was concluded that the new SAR calculation method is substantially equivalent to the predicate device as demonstrated by the results of the above 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

Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020, V6.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020/A7, V5.0, referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020, V6.0 are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Galan 3T, MRT-3020, V6.0 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.