Vantage Titan 3T, MRT-3010, V2.5

K191128 · Canon Medical Systems Corporation · LNH · Jun 26, 2019 · Radiology

Device Facts

• Record ID: K191128
• Device Name: Vantage Titan 3T, MRT-3010, V2.5
• Applicant: Canon Medical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Jun 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Vantage Titan 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 - 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 Story

Vantage Titan 3T is a 3 Tesla MRI system; acquires cross-sectional images of head/body. New software features include mART (Metal Artifact Reduction Technique) and mART+ (mART with View Angle Tilting). System uses magnetic resonance principles to map proton density, T1/T2 relaxation, flow, and chemical shift. Operated by trained clinicians in clinical settings. Output is diagnostic MR images viewed by physicians to inform clinical decision-making. Benefits include improved image quality in presence of metal implants via artifact reduction.

Clinical Evidence

Bench testing only. Performance validated using phantom imaging and representative volunteer clinical images to demonstrate efficacy of mART and mART+ in reducing metal-related artifacts on MR images.

Technological Characteristics

3T MRI system; software-based metal artifact reduction (mART/mART+). Complies with IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-33, 60825-1, 62304, 62366; NEMA MS 1-5. Software version 2.50.

Indications for Use

Indicated for diagnostic imaging of head or body anatomic structures in patients requiring cross-sectional transaxial, coronal, sagittal, or oblique MRI, including non-contrast MRA.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Vantage Titan 3T, MRT-3010/A5, V2.50 (K143008)

Submission Summary (Full Text)

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Canon Medical Systems Corporation % Mr. Orlando Tadeo Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

June 26, 2019

#### Re: K191128

Trade/Device Name: Vantage Titan 3T, MRT-3010/A5, V2.50 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 26, 2019 Received: April 29, 2019

Dear Mr. Tadeo:

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

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

510(k) Number (if known) K191128

Device Name Vantage Titan 3T, MRT-3010/A5, V2.50

#### Indications for Use (Describe)

Vantage Titan 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
- ·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) | |
|---------------------------------------------------------------------------------------|--|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |
| <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *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 [e-mail]

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**Made For life**

## K191128

## 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 Titan 3T |
| Model Number: | MRT-3010/A5, V2.50 |

#### 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: [phone] Fax: [phone] E-mail: [e-mail]

#### Official Correspondent/U.S. Agent

Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: [phone] Fax: [phone] E-mail: [e-mail]

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# EDICAL SYSTEMS USA, INC.

*Made For life*

- 5. MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- 6. ESTABLISHMENT REGISTRATION 9614698
- 7. DATE PREPARED April 26, 2019
- 8. DEVICE NAME Vantage Titan 3T, MRT-3010/A5, V2.50
- 9. TRADE NAME

Vantage Titan 3T, MRT-3010/A5, V2.50

## 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 (system): Vantage Titan 3T, MRT-3010/A5, V2.50

| System | Subject | Predicate Device |
|----------------|--------------------------------------|--------------------------------------|
| | Vantage Titan 3T, MRT-3010/A5, V2.50 | Vantage Titan 3T, MRT-3010/A5, V2.50 |
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) Number | This Submission | K143008 |
| Clearance Date | | April 9th, 2015 |

#### 15. REASON FOR SUBMISSION

Modification of a cleared device

#### 16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

2441 Michelle Drive, Tustin, CA 92780 PHONE: [phone] https://us.medical.canon

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## CAL SYSTEMS USA, INC.

*Made For life*

## 17. DEVICE DESCRIPTION

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K143008. 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.

#### 18. SUMMARY OF CHANGE(S)

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

- mART: Metal Artifact Reduction Technique ●
- mART+: Metal Artifact Reduction Technique with the addition of View Angle Tilting (VAT) ●

#### 19. SAFETY PARAMETERS

| Item | Subject Device:<br>Vantage Titan 3T,<br>MRT-3010/A5, V2.50 | Predicate Device:<br>Vantage Titan 3T,<br>MRT-3010/A5, V2.50 | 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 access<br>requirements | Allows screen access to 1st level<br>operating mode | Allows screen access to 1st level<br>operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st operating<br>mode specified in IEC 60601-2-33:<br>2010 +A1:2013) | 4W/kg for whole body (1st operating<br>mode specified in IEC 60601-2-33:<br>2010 +A1:2013) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC<br>60601-2-33: 2010 +A1:2013 | 1st operating mode specified in IEC<br>60601-2-33: 2010 +A1:2013 | Same |
| Potential emergency<br>condition and means<br>provided for shutdown | Shutdown by Emergency Ramp Down<br>Unit for collision hazard for<br>ferromagnetic objects | Shutdown by Emergency Ramp<br>Down Unit for collision hazard for<br>ferromagnetic objects | Same |

#### 20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K143008.

#### 21. INDICATIONS FOR USE

Vantage Titan 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.

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## DICAL SYSTEMS USA, INC.

Made For life

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.

## 22. SUMMARY OF DESIGN CONTROL ACTIVITIES

Design controls for the software functionalities were conducted under K143008. The functionalities in this submission are embedded in software version 2.5. There are no new design control activities to report as part of this device modification.

## 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)

## 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, was included in K143008.

PHONE: [phone] Michelle Drive, Tustin, CA 92780 https://us.medical.canon

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**Made For life**

Bench testing utilizing both phantom and representative clinical images were obtained to demonstrate the subject device is capable of reducing metal related artifacts on MR images.

### 25. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the Vantage Titan 3T, MRT-3010/A5, V2.50 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Titan 3T, MRT-3010/A5, V2.50, referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Titan 3T, MRT-3010/A5, V2.50 are substantially equivalent to the previously cleared predicate device.

### 26. CONCLUSION

The implementation of mART and mART+ on the Vantage Titan 3T, MRT-3010/A5, V2.5 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.