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 3.8 tons light 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 55 x 50 cm. The Model MRT-1550/AC, AD, AG, AH includes the standard gradient system and Model MRT-2020/AK, AL, AO, AP includes the XGO gradient system.

AI/ML Overview

The provided text is a 510(k) summary for the Vantage Orian 1.5T, MRT-1550, V4.5 Magnetic Resonance Imaging (MRI) System. It details changes to an existing, cleared MRI system and asserts its substantial equivalence to predicate devices. However, this document does not describe a study that establishes acceptance criteria for specific device performance metrics in terms of diagnostic outcomes (e.g., sensitivity, specificity, accuracy) using a clinical test set with ground truth established by experts.

Instead, the document focuses on:

Hardware and Software Changes: It lists modifications made to the previous MRI system, such as new cover design, optional table, RF system changes, increased gradient strength, changes in maximum slew rate and rise time, and additional software functionalities (e.g., DSD filter, MultiBand SPEEDER, KneeLine+, k-t SPEEDER, R-wave Monitoring, SpineLine+, WFS DIXON, Quick Star, Fast 3D Mode, 2D-RMC for EPI).
Safety and Performance Parameters: It compares safety parameters (static field strength, operational modes, maximum SAR, maximum dB/dt, emergency shutdown) to the predicate device and states they are "Same." It also notes "No change from the previous predicate submission, K170412" for imaging performance parameters.
Compliance with Standards: It states that the device is designed and manufactured under Quality System Regulations (21 CFR § 820 and ISO 13485) and lists applicable IEC and NEMA standards.
Testing for Substantial Equivalence: It mentions that bench testing, phantom imaging, and volunteer clinical imaging were conducted to demonstrate that modifications result in performance "equal to or better than the predicate system" and to evaluate established PNS limits. It also states software validation and application of risk management and design controls were completed.
Intended Use: The indications for use are exactly the same as the predicate device, focusing on producing cross-sectional images of anatomic structures for diagnosis when interpreted by a trained physician.

Therefore, many of the requested categories cannot be directly addressed from the provided text because the study described is not a clinical performance study with predefined acceptance criteria for diagnostic accuracy metrics typically seen in AI/CAD device submissions.

However, based on the information provided, here's what can be extracted and inferred:

**No information available or directly applicable to the specific request for acceptance criteria and a study proving device performance in terms of diagnostic outcomes (e.g., sensitivity, specificity, accuracy) with a clinical test set, expert ground truth, and statistical analysis.**

The provided document describes a 510(k) submission for an MRI system, focusing on hardware and software modifications and demonstrating substantial equivalence to a predicate device through engineering and safety testing, not a clinical performance study measuring diagnostic accuracy against a ground truth.

Here's an attempt to populate the table and answer the questions based only on the provided content, explicitly stating when information is not available:

Table of acceptance criteria and the reported device performance

The document does not specify acceptance criteria in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for the overall device or its new functionalities, nor does it report performance against such criteria. The "performance" described is largely related to engineering specifications and compliance with safety standards, and comparative performance against the predicate is stated as "equal to or better than".

Acceptance Criteria (Diagnostic Performance) Reported Device Performance (Diagnostic Performance)
Not specified (for diagnostic performance) Not reported (for diagnostic performance)

However, for Safety Parameters, the acceptance criterion is effectively "Same as predicate" and the performance meets this:

Acceptance Criteria (Safety Parameters, e.g., Max SAR, Max dB/dt) Reported Device Performance (Safety Parameters)
Same as predicate (Vantage Titan 1.5T, K170412) Meets "Same as predicate"
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "A volunteer study was conducted to evaluate the established PNS limits" and "Sample clinical images were included in the determination of substantial equivalence."
- Test Set Sample Size: Not explicitly stated for specific imaging tasks/functionalities. The "volunteer study" sample size is not provided. The number of "sample clinical images" is not specified.
- Data Provenance: The country of origin and whether the data was retrospective or prospective are not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not mentioned. The document describes a general-purpose MRI system. "Ground truth" in the context of diagnostic accuracy established by expert consensus is not part of the described testing strategy in this 510(k) summary. The statement "When interpreted by a trained physician, these images yield information that can be useful in diagnosis" refers to the intended use of MRI generally, not a specific ground truth for the device's performance evaluation in this submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not mentioned, as there is no described clinical test set with expert-established ground truth.
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

Not applicable. This is an MRI system, not an AI/CAD-assisted diagnostic device where human reader improvement with AI would typically be evaluated. The "improvements" mentioned are technical enhancements of the MRI system for image acquisition (e.g., speed, noise reduction, motion correction) and workflow (e.g., automatic positioning), not AI assistance for diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an imaging modality. Its output (images) is intended to be interpreted by a human physician, not to provide a standalone diagnostic interpretation. Some software functionalities mentioned (like SpineLine+ or surevol Knee) do involve automated processing to aid workflow but are not standalone diagnostic algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No formal clinical ground truth (like expert consensus, pathology, or outcomes data) for diagnostic accuracy metrics is described as being used in the performance evaluation presented in this 510(k) summary. The evaluation focuses on technical performance and safety.
The sample size for the training set

Not applicable/Not mentioned. The document does not describe a machine learning algorithm that would require a distinct "training set" for diagnostic performance evaluation. The software enhancements are integrated features of the MRI system, and their development likely involved internal data for quality assurance and algorithm development, but this is not termed a "training set" in the context of a performance study shown here.
How the ground truth for the training set was established

Not applicable/Not mentioned, as no training set for a diagnostic algorithm is described.

Acceptance Criteria (Diagnostic Performance)	Reported Device Performance (Diagnostic Performance)
Not specified (for diagnostic performance)	Not reported (for diagnostic performance)

Acceptance Criteria (Safety Parameters, e.g., Max SAR, Max dB/dt)	Reported Device Performance (Safety Parameters)
Same as predicate (Vantage Titan 1.5T, K170412)	Meets "Same as predicate"

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 19, 2018

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

Re: K182282

Trade/Device Name: Vantage Orian 1.5T, MRT-1550, V4.5 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: August 21, 2018 Received: August 23, 2018

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 mav, 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 avare 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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.

Michael D. O'Hara For

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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)

K182282

Device Name

Vantage Orian 1.5T, MRT-1550, V4.5

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, V4.5
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 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 21, 2018
1. DEVICE NAME Vantage Orian 1.5T, MRT-1550, V4.5
1. TRADE NAME Vantage Orian 1.5T, MRT-1550, V4.5

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)
1. PRODUCT CODE
  90-LNH

14. PREDICATE DEVICE

Primary Predicate Device (system): Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412) Reference Predicate Device (software/sequences): Vantage Galan 3T, MRT-3020, V5.0 (K181593)

System	Subject	Primary Predicate Device	Reference Predicate Device
	Vantage Orian, MRT-1550,V4.5	Vantage Titan 1.5T, MRT-1510, M-Power GX	Vantage Galan 3T, MRT-3020,V5.0
Marketed By	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.	Canon Medical Systems USA, Inc.
510(k)	This Submission	K170412	K181593
Clearance		June 7th, 2017	August 13th, 2018

15. REASON FOR SUBMISSION

New medical device

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16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

17. DEVICE DESCRIPTION

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 Titan MRI System (K170412), cleared June 7, 2017 with the following modifications.

18. SUMMARY OF CHANGE(S)

This submission is to report the following changes:

Summary of Hardware Changes:

New Cover Design ●
Optional Dockable/Detachable Table ●
RF System: ●
- o Number of transmission channel was changed from 1ch to 2ch
- o Maximum power of RF amplifier was changed from 20kW(1ch) to 30kW(2ch)
Maximum gradient amplitude (per axis) in T/m, rise time (ms), and maximum slew rate (T/m/s) changes:

System	Vantage Orian 1.5T, MRT-1550, V4.5Subject Device		Vantage Titan 1.5T, MRT-1510, M-Power GXPredicate DeviceK170412
Model	MRT-1550/ACMRT-1550/ADMRT-1550/AGMRT-1550/AH	MRT-1550/AKMRT-1550/ALMRT-1550/AOMRT-1550/AP	MRT-1510
Maximum GradientAmplitude	34mT/m	45 mT/m	34mT/m
Rise time	0.220 ms	0.225 ms	0.230 ms
Maximum Slew Rate	155T/m/s	200T/m/s	148T/m/s

Increase Gradient Strength: increased gradient strength of 45mT/m for models MRT-O 1550/AK, MRT-1550/AL, MRT-1550/AO, MRT-1550/AP
Maximum Slew Rate Change: maximum slew rate of gradient field was changed from o 148mT/m/ms to:
- 155 mT/m/ms for MRT-1550/AC, MRT-1550/AD, MRT-1550/AG, MRT-1550/AH I
- 200 mT/m/ms for MRT-1550/AK, MRT-1550/AL, MRT-1550/AO, MRT-1550/AP I

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Made For life

Rise Time Change: rise time changed from 0.230 ms to:
- 0.22 ms for MRT-1550/AC, MRT-1550/AD, MRT-1550/AG, MRT-1550/AH I
- I 0.225 ms for MRT-1550/AK, MRT-1550/AL, MRT-1550/AO, MRT-1550/AP

Summary of Software Changes:

Additional Software Functionalities and Improvements:
- New SAR: New calculation method is applied. O
- DSD (Dynamic Shrinkage Denoise) Filter: The DSD (Dynamic Shrinkage Denoise) Filter O noise removal technique is based on principal component analysis and shrinkage. Components determined to be noise are removed, making it possible to provide images with optimal smoothness and sharpness at the same time.
- MultiBand SPEEDER: MultiBand SPEEDER is a technique to acquire multiple slices at o one time by using simultaneous multiband excitation RF pulses. MultiBand SPEEDER technique can be used to reduce acquisition time.
- O Limited Scan Mode: Operator can set SAR operating mode and upper limit of B1+rms. Scan parameters are calculated so that SAR and B1+rms do not exceed set limits.
- KneeLine+: When the basic planes of the knee are to be scanned, this application O makes it possible to set the slice plane more easily than before. After a 3D image is acquired, it is used to obtain the three planes (sagittal, axial and coronal) after adjusting the angle of the knee. The obtained images can be used to set the plane of the positioning ROI. If necessary, the orientation and position of the detected basic planes can be adjusted by scan positioning operation in the Scan Plan (Locator) window.
- surevol Knee: Using a 3D image as an input, the region of the knee is determined and O the VOI for shimming scan, map scan, or presaturation is detected. The detected VOI can be used for knee scan positioning. If necessary, the VOI can be checked and the orientation and position of the VOI can be adjusted in the Scan Plan (Locator) window.
- k-t SPEEDER: Estimated sensitivity data is calculated using the sensitivity data for each O coil obtained during scanning, and the folded image obtained by skipped image acquisition is unfolded. A speedup factor of 2 to 8 can be achieved depending on the skipping ratio.
- R-wave Monitoring: The range of the R-R intervals for data acquisition can be O determined. If the R-R intervals at the time of data acquisition is out of range, data acquisition is performed again.
- SpineLine+ (Spinal Scan Positioning Support Function): provides automatic positioning O assistance for spine imaging. SpineLine was previously cleared under K152371. As compared to SpineLine, SpineLine+ offers improved detection of the axial plane along the intervertebral space.
Sequence Enhancements:
- O WFS DIXON (Water Fat Separation): WFS option previously applicable to FE3D sequences is added to FSE2D sequences.

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O Quick Star: Data acquisition is started from the center of the k-space in a radial pattern in the in-plane direction in the k-space and in a Cartesian pattern in the slice direction. Because the data near the center of the k-space is acquired repeatedly, data acquisition with Quick Star is relatively unaffected by motion.
o Fast 3D Mode: Fast 3D mode can be used to increase imaging efficiency. Two types of Fast 3D mode (Multiple and Wheel) are available. Multiple is technique for acquiring two parallel SE lines continuously in a single shot. Wheel is technique for acquiring signals at the center of the k-space in a deformed wheel pattern in the PE-SE plane.
2D-RMC (Real Time Motion Correction) for EPI: 2D Real-time Motion Correction is O available for Diffusion Weighted Imaging to mitigate respiratory motion artifacts during abdominal examinations. 2D-RMC option is newly applied to EPI sequences (previously applicable to FASE3D and FFE3D).

19. SAFETY PARAMETERS

Item	Subject Device:Vantage Orian 1.5T, MRT-1550,V4.5	Predicate Device:Vantage Titan 1.5T, MRT-1550, M-Power GX (K170412)	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 modeaccessrequirements	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
Potentialemergencycondition andmeans provided forshutdown	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, K170412.

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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

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 submissions Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412) and the Vantage Galan 3T, MRT-3020, 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)
IEC60601-1-8 (2006), Amd.1 (2012)
IEC60601-2-33 (2010), Amd.1 (2013)
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) ●

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24. TESTING

This submission contains test data that demonstrates the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and in accordance with the FDA Guidance, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issues on November 18, 2016.

Risk analysis and verification/validation testing, conducted through bench testing, are included in this submission which demonstrate that the system requirements have been met. A volunteer study was conducted to evaluate the established PNS limits. Sample clinical images were included in the determination of substantial equivalence.

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, V4.5 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Titan 1.5T, MRT-1550, M-Power GX (K170412), referenced in this submission.

Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Orian 1.5T, MRT-1550, V4.5 are substantially equivalent to the previously cleared predicate device.

26. CONCLUSION

The modifications incorporated into the Vantage Orian 1.5T, MRT-1550, V4.5 software do not change the indications for use or the intended use of the device. Based upon bench testing, phantom imaging, 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.