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

K202767 · Canon Medical Systems Corporation · LNH · Jan 15, 2021 · Radiology

Device Facts

• Record ID: K202767
• Device Name: Vantage Orian 1.5T, MRT-1550, V6.0
• Applicant: Canon Medical Systems Corporation
• Product Code: LNH · Radiology
• Decision Date: Jan 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

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 Story

Vantage Orian 1.5T is a 1.5 Tesla MRI system utilizing Pianissimo scan noise reduction technology; features 1.4m short magnet; maximum field of view 55x50cm. Includes AiCE Reconstruction Processing Unit for MR, a deep learning-based image reconstruction algorithm. System acquires proton density, T1, T2, flow dynamics, and chemical shift data to produce cross-sectional images. Operated by trained clinicians/technicians in clinical settings. AiCE processes raw MR data to enhance image quality; output viewed by radiologists for diagnostic decision-making. Benefits include improved image quality and diagnostic confidence. This submission expands AiCE application to additional anatomical regions (spine, MSK, pelvis, abdomen, breast, cardiac) without hardware/software changes.

Clinical Evidence

Bench testing included a model observer study for low contrast detectability, SNR, and contrast performance. A human observer study involved 6 board-certified radiologists evaluating 55 studies, demonstrating a statistical preference for AiCE compared to standard performance filters. Results indicate performance is equivalent or superior to the predicate device.

Technological Characteristics

1.5T MRI system; 1.4m short magnet; 55x50cm FOV. Includes Pianissimo noise reduction. AiCE Reconstruction Processing Unit utilizes deep learning reconstruction. Complies with IEC 60601-2-33:2010+A1:2013+A2:2015 for SAR and dB/dt limits. Designed under 21 CFR 820 and ISO 13485.

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. Contraindications include presence of ferromagnetic objects or conditions incompatible with MRI.

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 Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K193097)

Reference Devices

• Vantage Orian 1.5T, MRT-1550, V6.0 (K193021)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Canon Medical Systems Corporation % Mr. Paul Biggins, Jr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

January 15, 2021

# Re: K202767

Trade/Device Name: Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: December 10, 2020 Received: December 11, 2020

Dear Mr. Biggins:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about 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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# Indications for Use

510(k) Number (if known) K2O2767

Device Name

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Made For life K202767

# 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 with AiCE Reconstruction<br>Processing Unit for MR |
| 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

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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- 5. MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- 6. ESTABLISHMENT REGISTRATION 9614698
- 7. DATE PREPARED September 14, 2020

# 8. DEVICE NAME

Vantage Oran 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

#### 9. TRADE NAME

Vantage Oran 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

#### 10. CLASSIFICATION NAME

Magnetic Resonance Diagnostic Device (MRDD)

#### 11. CLASSIFICATION PANEL

Radiology

#### 12. DEVICE CLASSIFICATION

Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)

#### 13. PRODUCT CODE

90-LNH

#### 14. PREDICATE DEVICE

Predicate Device (AiCE): Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K193097)

Reference Device (system): Vantage Orian 1.5T, MRT-1550, V6.0 (K193021)

TABLE No. 1: Primary Predicate Device

| System | Subject Device | Predicate Device |
|----------------|------------------------------------|----------------------------------------------------------------|
| | Vantage Orian 1.5T, MRT-1550, V6.0 | Predicate Device (AiCE): Vantage<br>Orian 1.5T, MRT-1550, V6.0 |
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) Number | This Submission | K193097 |
| Clearance Date | | July 14, 2020 |

#### 15. REASON FOR SUBMISSION

Addition of anatomical regions with no changes to the cleared software and hardware.

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## 16. SUBMISSION TYPE

Traditional 510(k) Premarket Notification

#### 17. 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 weight magnet. It includes the Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Orian 1.5T provides the maximum field of view of 55 x 50 cm. The Model MRT-1550/AC, AD, AG, AH includes the standard gradient system and Model MRT-1550/AK, AL, AO, AP includes the XGO gradient system. The AiCE Reconstruction Processing Unit for MR is included with this system for the processing of images for various anatomical regions.

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 3ºº, 2020.

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

Addition of the following anatomical regions;

| Subject Device | | Predicate Device (K193097) |
|-------------------|----------------------------------------|----------------------------|
| Anatomical Region | Sub-categories | |
| Head | Brain | Yes |
| MSK | Knee | Yes |
| Spine | Cervical, Lumbar, Thoracic | New |
| MSK | Shoulder, Hip, Elbow, Wrist/Hand, | New |
| | Foot/Ankle | |
| Pelvis | Female, Pelvis (soft tissue), Prostate | New |
| Abdomen | Liver, Renal, Pancreas | New |
| Breast | No Sub-category | New |
| Cardiac | No Sub-category | New |

#### 19. SAFETY PARAMETERS (unchanged)

| Item | Subject Device:<br>Vantage Orian 1.5T,<br>MRT-1550, V6.0 | Predicate Device:<br>Vantage Orian 1.5T,<br>MRT-1550, V6.0 | Notes |
|-------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|-------|
| Static field strength | 1.5T | 1.5T | Same |
| Operational Modes | Normal and 1st Operating Mode | Normal and 1st Operating Mode | Same |
| i. Safety parameter<br>display | SAR, dB/dt | SAR, dB/dt | Same |
| ii. Operating mode<br>access requirements | Allows screen access to 1st level<br>operating mode | Allows screen access to 1st level<br>operating mode | Same |

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# TEMS USA. INC.

| Item | Subject Device:<br>Vantage Orian 1.5T,<br>MRT-1550, V6.0 | Predicate Device:<br>Vantage Orian 1.5T,<br>MRT-1550, V6.0 | Notes |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------|
| Maximum SAR | 4W/kg for whole body (1st<br>operating mode specified in IEC<br>60601-2-33:<br>2010+A1:2013+A2:2015) | 4W/kg for whole body (1st<br>operating mode specified in IEC<br>60601-2-33:<br>2010+A1:2013+A2:2015) | Same |
| Maximum dB/dt | 1st operating mode specified in<br>IEC 60601-2-33:<br>2010+A1:2013+A2:2015 | 1st operating mode specified in<br>IEC 60601-2-33:<br>2010+A1:2013+A2:2015 | Same |
| Potential emergency<br>condition and means<br>provided for shutdown | Shutdown by Emergency Ramp<br>Down Unit for collision hazard<br>for ferromagnetic objects | Shutdown by Emergency Ramp<br>Down Unit for collision hazard<br>for ferromagnetic objects | Same |

#### 20. IMAGING PERFORMANCE PARAMETERS

No change from the previous predicate submission, K193021.

#### 21. INDICATIONS FOR USE

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

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

- Proton density (PD) (also called hydrogen density)
- Spin-lattice relaxation time (T1)
- Spin-spin relaxation time (T2)
- Flow dynamics
- Chemical Shift

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

#### 22. SUMMARY OF DESIGN CONTROL ACTIVITIES

No change from the previous predicate submission, 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 submission is a modification that expands the clinical regions for the AiCE Deep Learning Reconstruction. There are no changes to the software and hardware from the previous Pre-Market Notification 510(k) K193021.

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## 24. TESTING

AiCE deep learning reconstruction underwent performance (bench testing) using a model observer study to determine that image low contrast detectability was maintained or improved, accompanied with other bench testing of SNR and contrast performance. Additionally, a human observer study was conducted with 6 board certified radiologists and 55 studies that demonstrated a statistical preference of AiCE when compared to other performance filters. The results of the testing demonstrated that AiCE performed either at the same level or above the performance of the commercially available predicate device.

### 25. SUBSTANTIAL EQUIVALENCE

Canon Medical Systems Corporation believes that the Vantage Orian 1.5T, MRT-1550, V6.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR is substantially equivalent to the previously cleared predicate device, Vantage Orian 1.5T, MRT-1550, V6.0, As there is no change to the hardware and software of the predicate device. Additionally, the testing conducted demonstrates that the device performance is equivalent to the predicate device for the anatomical regions that are stated above.

#### 26. CONCLUSION

The Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR does not have any change for the indications for use or the intended use of the device. Bench testing and volunteer clinical imaging additionally conducted does not change the conclusion that the subject device is safe and effective for its intended use.