Vantage Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

·Proton density (PD) (also called hydrogen density)

·Spin-lattice relaxation time (T1)
·Spin-spin relaxation time (T2)

·Flow dynamics

·Chemical Shift

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

Device Description

The Vantage Orian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 4.1 tons light weight magnet. It includes the Canon Pianissimo™ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Orian provides the maximum field of view of 55 x 50 cm. The Model MRT-1550/A3, A4, A7, A8 includes the standard gradient system.

This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Orian MRI System is comparable to the current 1.5T Vantage Orian MRI System (K193021), cleared June 3, 2020 with the following modifications.

AI/ML Overview

The provided document is a 510(k) summary for the Vantage Orian 1.5T, MRT-1550, V6.0 MRI System. This submission is for modifications to an already cleared device (K193021) and primarily focuses on safety and performance parameters typical for an MRI system, rather than AI/algorithm-driven diagnostic performance.

The document states:

"No change from the previous predicate submission, K193021." regarding "IMAGING PERFORMANCE PARAMETERS".
"image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria. Image quality metrics were performed to assess signal-to-noise ratio, two-dimensional geometric distortion, image uniformity, and slice thickness."

Therefore, the acceptance criteria and study detailed below relate to physical device performance and image quality, not an AI algorithm's diagnostic accuracy or effectiveness in clinical interpretation. Since this is an MRI system and not an AI-powered diagnostic device, many of the requested elements for AI/algorithm studies (like sample size for test sets and training sets, AI effect size on human readers, adjudication methods, number of experts for ground truth, etc.) are not applicable in the context of this 510(k) submission.

Here is the information directly applicable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Metric)	Reported Device Performance (Summary)
Signal-to-noise ratio (SNR)	Meets predetermined acceptance criteria (exact values not provided in this summary)
Two-dimensional geometric distortion	Meets predetermined acceptance criteria (exact values not provided in this summary)
Image uniformity	Meets predetermined acceptance criteria (exact values not provided in this summary)
Slice thickness	Meets predetermined acceptance criteria (exact values not provided in this summary)

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

The document does not specify a "test set" in the context of patient data or clinical images for evaluating diagnostic performance. The tests described are "bench testing" and "image quality testing." These likely refer to tests conducted on phantoms or test objects, not human patient data. Therefore, details like data provenance or sample size of patient cases are not provided as they are not relevant to the type of testing performed for this device modification.

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

Not applicable. The "ground truth" here would relate to physical image quality measurements from phantoms or engineering specifications, not expert diagnostic consensus on patient images.

4. Adjudication Method

Not applicable. No expert adjudication process is described for the image quality testing details provided.

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

Not performed/Not applicable. This is a 510(k) for an MRI system modification, not an AI diagnostic algorithm. The document makes no mention of studies involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device (MRI system), not an AI algorithm. The performance evaluation is for the system's ability to acquire images, not interpret them.

7. Type of Ground Truth Used

The ground truth for the image quality testing would be based on physical phantom measurements and engineering specifications for parameters like SNR, geometric distortion, uniformity, and slice thickness.

8. Sample Size for the Training Set

Not applicable. This is a hardware modification submission for an MRI system, not an AI algorithm requiring a training set.

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

Not applicable. As there's no AI algorithm training set, there's no ground truth established for it.

Summary

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September 22, 2020

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

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

Re: K202210

Trade/Device Name: Vantage Orian 1.5T, MRT-1550, V6.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: August 20, 2020 Received: August 24, 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

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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 (OS) 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,

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

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

510(k) Number (if known) K202210

Device Name Vantage Orian 1.5T, MRT-1550, V6.0

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 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 Orian 1.5T, MRT-1550, V6.0
Model Number:	MRT-1550

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 Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 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 pbiggins@us.medical.canon

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5. MANUFACTURING SITE

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

1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED August 5, 2020
1. DEVICE NAME Vantage Orian 1.5T, MRT-1550, V6.0

9. TRADE NAME

Vantage Orian 1.5T, MRT-1550, 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 Orian 1.5T, MRT-1550, V6.0 (K193021) Reference Device (magnet): Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412)

	Subject Device	Predicate Device	Reference Device
System	Vantage Orian 1.5T, MRT-1550, V6.0	Vantage Orian 1.5T, MRT-1550, V6.0	Vantage Titan 1.5T, MRT-1510, M-Power GX
Marketed By	Canon Medical Systems USA	Canon Medical Systems USA	Canon Medical Systems USA
510(k) Number	This Submission	K193021	K170412
Clearance Date	This Submission	June 3, 2020	June 7, 2017

15. REASON FOR SUBMISSION

Modification of a cleared device

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16. SUBMISSION TYPE

Special 510(k) Premarket Notification

17. DEVICE DESCRIPTION

18. SUMMARY OF CHANGE(S)

Magnet (for MRT-1550/A3, MRT-1550/A4, MRT-1550/A7, MRT-1550/A8): The Vantage Orian 1.5T, MRT-1550/A3, MRT-1550/A4, MRT-1550/A7, and MRT-1550/A8 utilize a 1.5T magnet (TN150), the same magnet used with the Vantage Titan, MRT-1510, M-Power GX (K170412) cleared June 7, 2017.
. IR pulse can be used in MultiBand SPEEDER: Added combination of MultiBand SPEEDER and IR pulse on SEEPI2D sequence.
. RMC (Real Time Motion Correction) can be used in QuickStar: Added combination of QuickStar and RMC on SSFP3D sequence.

Item	Subject Device:Vantage Orian 1.5T, MRT-1550, V6.0	Predicate Device:Vantage Orian 1.5T, MRT-1550, V6.0K193021	Notes
Static field strength	1.5T	1.5T	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 (1st operatingmode specified in IEC 60601-2-33:2010+A1:2013+A2:2015)	Same

19. SAFETY PARAMETERS

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Item	Subject Device:	Predicate Device:	Notes
	Vantage Orian 1.5T, MRT-1550, V6.0	Vantage Orian 1.5T, MRT-1550, V6.0
		K193021
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, K193021.

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.

22. SUMMARY OF DESIGN CONTROL ACTIVITIES

Hazard analysis has been performed and documentation is included in this submission. The test methods used are the same as those submitted in the previously cleared submissions of the predicate device, Vantage Orian 1.5T, MRT-1550, V6.0 (K193021). 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

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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)
IIEC60601-1-6 (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)

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. Image quality metrics were performed to assess signal-to-noise ratio, twodimensional geometric distortion, image uniformity, and slice thickness.

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 Orian 1.5T, MRT-1550, V6.0 Magnetic Resonance Imaging (MRI) System 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 Orian 1.5T, MRT-1550, V6.0 are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Orian 1.5T, MRT-1550, V6.0 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.