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

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. Canon Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780 # Re: K210340 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: February 4, 2021 Received: February 5, 2021 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 April 1, 2021 {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) 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) | | |--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 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<br>Reconstruction 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 ### 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}------------------------------------------------ ### 5. MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan # 6. ESTABLISHMENT REGISTRATION 9614698 - 7. DATE PREPARED February 4, 2021 ### 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 (system): Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR (K202767) ### TABLE No. 1: Predicate Device | | Subject Device | Predicate Device | |----------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | System | Vantage Orian 1.5T, MRT-1550, V6.0 with<br>AiCE Reconstruction Processing Unit for MR | Vantage Orian 1.5T, MRT-1550, V6.0 with<br>AiCE Reconstruction Processing Unit for MR | | Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. | | 510(k) Number | This Submission | K202767 | | Clearance Date | | January 15th, 2021 | ### 15. REASON FOR SUBMISSION Extension of the Compressed SPEEDER (2D) maximum acceleration factor of up to 4 with no changes to the cleared software and hardware. {5}------------------------------------------------ # 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. 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 (K202767), cleared January 15th, 2021. ### 18. SUMMARY OF CHANGE(S) Extension of the Compressed SPEEDER (2D) maximum acceleration factor: | Subject Device | Predicate Device (K202767) | |----------------|----------------------------| | Up to 4 | Up to 2.5 | # 19. SAFETY PARAMETERS (unchanged) | Item | Subject Device: | Predicate Device: | Notes | |---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------| | | Vantage Orian 1.5T, MRT-1550, V6.0, | Vantage Orian 1.5T, MRT-1550, V6.0, | | | | with AiCE Reconstruction Processing | with AiCE Reconstruction Processing | | | | Unit for MR | Unit for MR (K202767) | | | 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 | | Maximum SAR | 4W/kg for whole body (1st operating<br>mode specified in IEC 60601-2-33:<br>2010+A1:2013+A2:2015) | 4W/kg for whole body (1st operating<br>mode specified in IEC 60601-2-33:<br>2010+A1:2013+A2:2015) | Same | | Maximum dB/dt | 1st operating mode specified in IEC<br>60601-2-33: 2010+A1:2013+A2:2015 | 1st operating mode specified in IEC<br>60601-2-33: 2010+A1:2013+A2:2015 | 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 Down<br>Unit for collision hazard for<br>ferromagnetic objects | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is in red, and the rest of the text is in black. The text is left-aligned and the font is sans-serif. The logo is simple and professional. Made For life #### 20. IMAGING PERFORMANCE PARAMETERS No change from the previous predicate submission, K202767. #### 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, K202767. 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 extends the maximum acceleration factor of Compressed SPEEDER (2D). There are no changes to the software and hardware from the previous Pre-Market Notification 510(k) K202767. #### 24. TESTING Human observer study of the Compressed SPEEDER (2D) with the acceleration factor of 2.5, 3.0 and 4.0 was conducted with three board certified radiologists per anatomy and 34 studies that demonstrated no clinically-relevant difference in preference between the predicate Compressed SPEEDER (2D) images with acceleration factor of 2.5 when compared to the higher acceleration factor (shorter scan time) images. The results of the testing demonstrated that Compressed SPEEDER (2D) with the acceleration factors of 2.5, 3.0 and 4.0 performed at the equivalent performance level to the commercially available predicate device. {7}------------------------------------------------ ### 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 with AiCE Reconstruction Processing Unit for MR, 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 Compressed SPEEDER (2D) acceleration factors 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.