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 K220192. 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 document (K222387) is a Special 510(k) Premarket Notification for a modification to an already cleared device: the Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR.

This means that the device itself was previously cleared (under K220192) and this submission is for a minor modification: an updated Iterative Motion Correction (IMC) for brain imaging. Therefore, the information provided focuses primarily on the safety and effectiveness of this specific software change relative to the predicate device.

Given this context, the document explicitly states:

Imaging Performance Parameters: "No change from the previous predicate submission, K220192."
Indications For Use: "No change from the previous predicate submission, K220192."

This indicates that a comprehensive de novo study proving the device meets all acceptance criteria for a new device was not performed for this specific submission. Instead, the focus is on demonstrating that the modification does not negatively impact existing performance and safety.

However, the document does mention "image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria" related to the IMC update. Unfortunately, the specific acceptance criteria and detailed performance from this testing are not explicitly provided in the given text.

Therefore, I cannot fully complete all sections of your request based solely on the provided text, as the detailed information on the original acceptance criteria and validating study for the core device (K220192) is not present here, and only limited information is given for the specific modification in K222387.

Based on the provided text for K222387, here is what can be extracted:

Acceptance Criteria and Study for K222387 (Modification to AiCE IMC)

The provided document (K222387) is a Special 510(k) for a modification to a previously cleared device. Therefore, the "acceptance criteria" and the "study" described here pertain to demonstrating that the modification (updated Iterative Motion Correction for brain imaging) does not compromise the safety and effectiveness of the device as previously cleared. A full, de novo study proving the entire device meets acceptance criteria is not presented, as that would have been part of the original clearance (K220192).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for IMC Modification)	Reported Device Performance (Summary from K222387)
No degradation in image quality after IMC update.	"image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria." Additionally, the purpose of the update was to "provide more consistent results in reducing motion artifacts."
Continued compliance with safety parameters (Static field strength, Operational Modes, SAR, dB/dt, Emergency Shutdown).	All safety parameters are "Same" as the predicate device and meet IEC standards (e.g., 4W/kg for whole body SAR).
Continued functionality of the device as a diagnostic imaging modality.	No change to the Indications for Use or intended use of the device.
Software validation requirements met.	"successful completion of software validation"
Risk management activities conducted.	"Risk analysis and verification/validation testing conducted through bench testing are included in this submission." "Risk management activities for this modification are included in this submission."

Important Note: The specific quantitative metrics for image quality acceptance (e.g., specific SNR values, resolution tests, or qualitative scores) are not detailed in this summary. It states "predetermined acceptance criteria" were met, but doesn't list them.

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

Test Set Sample Size: Not explicitly stated for the image quality testing related to the IMC update. The document mentions "bench testing" and "image quality testing." It does not specify human subject data for this particular modification.
Data Provenance: Not explicitly stated. Given it's a modification to an existing product by a Japanese company (Canon Medical Systems Corporation, Japan), the testing would likely have been done internally or with partners. It's unclear if this involved clinical data from specific countries or if it was purely technical/phantom-based testing for the IMC update. The submission type (Special 510(k)) often relies on substantial equivalence to the predicate, meaning extensive new clinical data is often not required for minor modifications.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
This information would be crucial for a de novo or comparative effectiveness study, but is not detailed for this type of special 510(k) where the primary focus is on the impact of a software change.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

MRMC Study: No, an MRMC comparative effectiveness study is not described in this document. The submission is for a modification to a reconstruction processing unit, not an AI-assisted diagnostic tool that directly aids human readers in interpretation, but rather a component of the image acquisition/processing chain aiming to improve image quality for diagnostic interpretation. Therefore, a study to measure human reader improvement with/without this AI feature is not applicable in the typical sense for this device.

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

Standalone Performance: The document states "image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria." This implies some form of standalone performance measurement (e.g., phantom studies, technical image quality metrics) was performed. However, the exact methodology and results are not detailed. The "AiCE Reconstruction Processing Unit" is an algorithm (Artificial intelligence Cleared Engine) that processes images. The IMC update is a part of this algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For "image quality testing" for a reconstruction algorithm, ground truth likely involved:
- Phantoms: Known physical targets with specific properties.
- Technical Metrics: Measurements like Signal-to-Noise Ratio (SNR), Contrast-to-Noise Ratio (CNR), spatial resolution, artifact suppression measured against theoretical ideals or established benchmarks.
- Qualitative Assessment: Visual assessment by experts based on predefined criteria, though a formal adjudication process is not described.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not provided in this document. The AiCE (Artificial intelligence Cleared Engine) is a deep learning reconstruction technology. Any training data for the neural network would have been used during the development phase of the original AiCE algorithm (K220192), not specifically detailed for this software update in K222387. This special 510(k) pertains to a modification to an existing algorithm, not the training of a new one.

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

Ground Truth for Training Set: Not applicable/Not provided in this document. As above, this pertains to the initial development of the AiCE algorithm which would have been covered in the K220192 submission.

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 along with the full name of the agency 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 the square.

August 31, 2022

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

Re: K222387

Trade/Device Name: Vantage Galan 3T, MRT-3020, V8.0 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: August 9, 2022 Received: August 10, 2022

Dear Janine 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.

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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 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 medical devices and radiation-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.

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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)

K222387

Device Name

Vantage Galan 3T, MRT-3020, V8.0, with AiCE Reconstruction Processing Unit for MR

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 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, V8.0 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. 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

August 5, 2022

8. DEVICE NAME

Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR

9. TRADE NAME

Vantage Galan 3T, MRT-3020, V8.0 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, V8.0 with AiCE Reconstruction Processing Unit for MR (K220192)

System	Predicate Device
	Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
Marketed By	Canon Medical Systems USA, Inc.
510(k) Number	K220192
Clearance Date	April 8, 2022

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Special 510(k) Premarket Notification

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17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

This submission is to report the following changes:

Summary of Software Changes:

Iterative Motion Correction (IMC): IMC as applied to brain imaging has been updated in order to provide more consistent results in reducing motion artifacts.

19. SAFETY PARAMETERS

Item	Subject Device:	Predicate Device:	Notes
	Vantage Galan 3T, MRT-3020, V8.0with AiCE Reconstruction	Vantage Galan 3T, MRT-3020, V8.0with AiCE Reconstruction
	Processing Unit for MR	Processing Unit for MR (K220192)
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, K220192.

21. INDICATIONS FOR USE

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Made For life

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, K220192.

22. SUMMARY OF DESIGN CONTROL ACTIVITIES

Risk Management activities for this modification 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, V8.0 with AiCE Reconstruction Processing Unit for MR (K220192). 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, 2014)
IEC62304 (2006), Amd.1 (2015) ●
IEC62366-1 (2020) ●
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.

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Made For life

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, V8.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR, is substantially equivalent to the previously cleared predicate device referenced in this submission.

Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020, V8.0, 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, V8.0, 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, 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.