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

Flow dynamics
Chemical Shift

•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/A9) 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 cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

AI/ML Overview

The provided text describes a 510(k) submission for a modified MRI system, the Vantage Galan 3T, MRT-3020/A9, V5.0. It aims to demonstrate substantial equivalence to a previously cleared device. However, the document primarily focuses on system modifications, safety parameters, and regulatory compliance, and does not contain explicit acceptance criteria or detailed results from a study proving the device meets specific performance criteria in the way a diagnostic AI/CADe would.

The document states: "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." The performance is generally evaluated in terms of image quality and safety, implying that the images produced by the new system should be diagnostically equivalent to those from the predicate device.

Given the information available, I can construct a table for "Acceptance Criteria" based on the safety and imaging performance claims made. The "Reported Device Performance" for this specific submission is mainly comparative to the predicate device, emphasizing that the new features do not negatively impact safety or general image quality for diagnostic purposes.

Here's an attempt to extract and present the requested information, with caveats where specific details are not provided in the document:

Acceptance Criteria and Study for Vantage Galan 3T, MRT-3020/A9, V5.0

The provided 510(k) summary for the Vantage Galan 3T, MRT-3020/A9, V5.0 concerns a modified Magnetic Resonance Imaging (MRI) system. The acceptance criteria for this type of device are primarily related to safety, image quality, and functional equivalence to its predicate device, rather than specific diagnostic accuracy metrics typically seen with AI/CADe devices. The study demonstrating compliance is implicitly the collection of verification and validation testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (based on predicate equivalence and safety)	Reported Device Performance (as stated in the document)
I. Safety Parameters
Static Field Strength	Maintain 3T static field strength.	3T
Operational Modes	Maintain Normal and 1st Operating Mode.	Normal and 1st Operating Mode
Safety Parameter Display	Display SAR, dB/dt.	SAR, dB/dt
Operating Mode Access	Allow screen access to 1st level operating mode.	Allows screen access to 1st level operating mode
Maximum SAR (Whole Body)	≤ 4W/kg (1st operating mode per IEC 60601-2-33).	4W/kg (1st operating mode per IEC 60601-2-33)
Maximum dB/dt	Adhere to 1st operating mode per IEC 60601-2-33.	1st operating mode per IEC 60601-2-33
Emergency Shutdown	Provide means for shutdown for collision hazard.	Shutdown by Emergency Ramp Down Unit
II. Imaging Performance
Image Quality	Provide diagnostically equivalent cross-sectional images.	"No change from the previous predicate submission, K181593." Implies equivalent diagnostic image quality.
III. Indications for Use
Diagnostic Modality	Function as a diagnostic imaging modality for anatomical structures.	"No changes to the previously cleared indication, K181593." – Maintains
same indications.
Non-contrast enhanced imaging	Capable of non-contrast enhanced imaging (e.g., MRA).	Maintains capability for non-contrast enhanced imaging.
NMR Properties (PD, T1, T2, Flow, Chemical Shift)	Utilize these properties for image formation.	Maintains utilization of these properties.
IV. Compliance
Design Control/Risk Mgmt	Compliance with Quality System Regulations (21 CFR § 820, ISO 13485) and risk management for changes.	Risk management activities performed. Declaration of conformity with design controls included.
Applicable Standards	Compliance with relevant IEC and NEMA standards.	Compliance with listed IEC and NEMA standards.
Software Documentation	Documentation for Moderate Level of Concern per FDA guidance.	Documentation included.

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

The document mentions "volunteer clinical imaging" as part of the testing. However, it does not specify the sample size for this clinical imaging, nor does it provide details on the country of origin or whether the data was retrospective or prospective. It is likely the imaging was conducted specifically for the verification of the modified system's performance.

3. Number of Experts and Qualifications for Ground Truth

The document states, "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." However, it does not specify the number of experts used to establish ground truth for any test set or their specific qualifications. For an MRI system, the "ground truth" for image quality assessment is often implicitly based on the ability of trained radiologists to make a diagnosis from the images without specific expert adjudication for a fixed dataset, assuming the image quality is acceptable.

4. Adjudication Method

The document does not describe an adjudication method (e.g., 2+1, 3+1). This level of detail is typically not required for an MRI system 510(k) submission unless there's a specific diagnostic accuracy claim being made (e.g., for a CADe device integrated into the MRI).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention an MRMC comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. This is expected as the device is an MRI scanner itself, not an AI/CADe diagnostic aid for interpretation.

6. Standalone (Algorithm only) Performance

The device is an MRI system, not a standalone diagnostic algorithm. Therefore, no standalone (algorithm-only) performance was conducted or reported in this context. The performance is inherently tied to the system's ability to acquire images for human interpretation.

7. Type of Ground Truth Used

For an MRI system, the "ground truth" for evaluating image quality and diagnostic utility is typically based on:

Clinical usability/diagnostic interpretability by trained physicians: Images are evaluated for clarity, resolution, contrast, and freedom from artifacts, allowing for accurate anatomical visualization and diagnosis.
Physical phantom measurements: Used to verify technical performance metrics like signal-to-noise ratio, spatial resolution, and geometric accuracy.
Volunteer clinical imaging: Utilized to ensure the system performs as expected in a human subject, producing images suitable for diagnostic purposes.

The document implicitly refers to these types of evaluations.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. This is because the device is an MRI system, not an AI/ML algorithm that requires a "training set" in the conventional sense for diagnostic performance. Its development involves engineering design, safety testing, and image quality optimization.

9. How Ground Truth for the Training Set Was Established

Since there is no "training set" in the AI/ML context for this MRI system, the concept of establishing ground truth for a training set does not apply as described. Development and validation of the MRI system rely on established engineering principles, physics, phantom testing, and clinical evaluations for diagnostic image quality.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA 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 Department of Health & Human Services logo features a stylized human figure. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

March 15, 2019

Re: K183657

Trade/Device Name: Vantage Galan 3T, MRT-3020/A9, V5.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: February 26, 2019 Received: February 27, 2019

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

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

Hol. 2. Mild

Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

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)

K183657

Device Name Vantage Galan 3T, MRT-3020/A9, V5.0

Indications for Use (Describe)

·Proton density (PD) (also called hydrogen density) •Spin-lattice relaxation time (T1)

·Spin-spin relaxation time (T2)

·Flow dynamics

Flow dynamics
Chemical Shift

•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."

{3}------------------------------------------------

510(k) SUMMARY

K183657

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/A9, V5.0
Model Number:	MRT-3020/A9

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

{4}------------------------------------------------

1. MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED December 21, 2018
1. DEVICE NAME Vantage Galan 3T, MRT-3020/A9, V5.0
1. TRADE NAME Vantage Galan 3T, MRT-3020/A9, V5.0

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)

1. PRODUCT CODE
  90-LNH

14. PREDICATE DEVICE

Predicate Device (system): Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593)

System	Subject	Predicate Device
	Vantage Galan 3T, MRT-3020/A9, V5.0	Vantage Galan 3T, MRT-3020/A7, V5.0
Marketed By	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.
510(k) Number	This Submission	K181593
Clearance Date		August 13, 2018

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

{5}------------------------------------------------

17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

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

Summary of Hardware Changes:

Maximum gradient field strength has been changed from 45mT/m to 100mT/m.
Patient aperture size has been changed from 71 cm to 63 cm.
Gradient coil and QD whole body transmit coil have been changed.

Summary of Software Changes:

CP mode (quadrature transmit mode) has been added.
No other changes from the previously cleared indication (K181593).

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Galan 3T,MRT-3020/A9, V5.0	Predicate Device:Vantage Galan 3T,MRT-3020, V4.6	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 +A1:2013)	Same
Maximum dB/dt	1st operating mode specified in IEC60601-2-33: 2010 +A1:2013	1st operating mode specified in IEC60601-2-33: 2010 +A1:2013	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

20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K181593.

21. INDICATIONS FOR USE

{6}------------------------------------------------

CAL SYSTEMS USA, INC.

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 vield information that can be useful in diagnosis.

No changes to the previously cleared indication, K181593.

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

IEC60601-1 (2005), Amd.1 (2012)
IEC60601-1-2 (2007), (2014)
IEC60601-1-8 (2006), Amd.1 (2012) ●
o IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015)
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.

{7}------------------------------------------------

25. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the Vantage Galan 3T, MRT-3020/A9, V5.0 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/A9, V5.0 are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Galan 3T, MRT-3020/A9, V5.0 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.