(58 days)
Yes
The predicate device explicitly mentions "AiCE Reconstruction Processing Unit for MR", which is a known AI/ML reconstruction technology from Canon Medical Systems. While the summary doesn't explicitly state the subject device includes AiCE, the predicate device's inclusion strongly suggests the technology is present or a similar AI/ML feature is incorporated in the new model.
No.
The device is indicated for use as a diagnostic imaging modality that produces images, which when interpreted by a trained physician, yield information useful in diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as a diagnostic imaging modality" and that, when interpreted by a trained physician, "these images yield information that can be useful in diagnosis."
No
The device description clearly states it is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware device. While it includes software components for image processing and potentially AI/ML features, it is fundamentally a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vantage Fortian 1.5T system is an MRI system. It produces images of the internal structures of the body using magnetic fields and radio waves. It does not analyze biological specimens taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This is consistent with an in vivo imaging device, not an in vitro diagnostic device.
- Input Modality: The input modality is Magnetic Resonance Imaging (MRI), which is an in vivo imaging technique.
While the device is used for diagnosis, it does so by imaging the body directly, not by analyzing samples taken from the body. Therefore, it falls under the category of an imaging device, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Vantage Fortian 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.
Product codes
LNH
Device Description
The Vantage Fortian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Fortian uses 1.4 m short and 4.1 tons light weight magnet. It includes the Canon Pianissimo™ Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Fortian provides the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/ WK, WM, WO, WQ 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 Fortian MRI System is comparable to the current 1.5T Vantage Orian MRI System (K211633), cleared July 22, 2021 with the following modifications.
Mentions image processing
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Mentions AI, DNN, or ML
LiverLine+: Machine Learning based detection technology for liver plane.
ProstateLine+: Machine Learning based detection technology for prostate plane.
W-SpineLine+: Machine Learning based detection technology for spine plane.
Input Imaging Modality
Not Found
Anatomical Site
head or body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
SureVOI Liver, LiverLine+, ProstateLine+, and W-SpineLine+ were evaluated using volunteer images. It was confirmed that these features worked as intended, the images were of diagnostic quality, and the test results met predetermined acceptance criteria.
IMC (Iterative Motion Correction) was evaluated using volunteer images. Testing confirmed that IMC is effective in reducing motion artifacts.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
SureVOI Liver, LiverLine+, ProstateLine+, and W-SpineLine+ were evaluated using volunteer images. It was confirmed that these features worked as intended, the images were of diagnostic quality, and the test results met predetermined acceptance criteria.
Exsper in FSE2D was evaluated utilizing phantom images. It was confirmed that Exsper reduces artifacts caused by unfolding errors, compared to traditional SPEEDER.
MR image quality metrics were performed, utilizing phantom images, to assess mART EXP. Testing verified mART EXP can reduce distortion artifacts in the readout direction like mART+ and can also reduce distortion artifacts in the slice direction more than mART+.
IMC (Iterative Motion Correction) was evaluated using volunteer images. Testing confirmed that IMC is effective in reducing motion artifacts.
RDC DWI was evaluated utilizing phantom images. It was confirmed that the distortion in phase encoding direction was reduced by RDC DWI as compared to conventional images without RDC DWI in SEEPI2D sequence.
pCASL (pseudo-continuous ASL) was evaluated utilizing phantom images. Testing confirmed CBF values via pCASL met predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Canon Medical Systems Corporation % Janine Reyes Senior Manager, Regulatory Affairs Canon Medical Systems U.S.A. Inc. 2441 Michelle Drive Tustin, California 92780
Re: K213305
Trade/Device Name: Vantage Fortian 1.5T, MRT-1550, V8.0 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: September 30, 2021 Received: October 4, 2021
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 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
December 1, 2021
1
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 (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
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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: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213305
Device Name
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
Indications for Use (Describe)
Vantage Fortian 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 nucle) 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) |
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:
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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 Fortian 1.5T, MRT-1550, V8.0 with AiCE 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
-
- MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED September 30, 2021
8. DEVICE NAME
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
9. TRADE NAME
Vantage Fortian 1.5T, MRT-1550, V8.0 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 : Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR (K211633)
Reference Device: Vantage Orian 1.5T, MRT-1550, V6.0 (K202210) and Vantage Elan 1.5T, MRT-2020, V6.0 (K210164)
| Subject Device | Predicate Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| System | Vantage Fortian 1.5T, | |||
| MRT-1550, V8.0 with | ||||
| AiCE Reconstruction | ||||
| Processing Unit for MR | Vantage Orian 1.5T, | |||
| MRT-1550, V7.0 with | ||||
| AiCE Reconstruction | ||||
| Processing Unit for MR | Vantage Orian 1.5T, | |||
| MRT-1550, V6.0 | Vantage Elan 1.5T, | |||
| MRT-2020, V6.0 | ||||
| Marketed | ||||
| By | Canon Medical Systems | |||
| USA, Inc. | Canon Medical Systems | |||
| USA, Inc. | Canon Medical Systems | |||
| USA, Inc. | Canon Medical Systems | |||
| USA, Inc. | ||||
| 510(k) | ||||
| Number | This Submission | K211633 | K202210 | K210164 |
| Clearance | ||||
| Date | July 22, 2021 | September 22, 2020 | March 10, 2021 |
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15. REASON FOR SUBMISSION
Modification of a cleared device
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. DEVICE DESCRIPTION
The Vantage Fortian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Fortian uses 1.4 m short and 4.1 tons light weight magnet. It includes the Canon Pianissimo™ Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Fortian provides the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/ WK, WM, WO, WQ 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 Fortian MRI System is comparable to the current 1.5T Vantage Orian MRI System (K211633), cleared July 22, 2021 with the following modifications.
18. SUMMARY OF CHANGE(S)
This submission is to report the following changes:
Summary of Hardware Changes:
- Gantry color change.
- RF System:
- O Number of transmission channel was changed from 2ch to 1ch.
- O Maximum power of RF amplifier was changed from 30kW(2ch) to 24kW(1ch).
- Maximum gradient amplitude (per axis) [mT/m], maximum slew rate [mT/m/ms], and rise ● time [ms] changes:
| | Subject Device | Predicate Device
K211633 | Reference Device
K202210 |
|-------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------|
| System | Vantage Fortian 1.5T,
MRT-1550, V8.0 with AiCE
Reconstruction Processing
Unit for MR | Vantage Orian 1.5T,
MRT-1550, V7.0 with AiCE
Reconstruction Processing
Unit for MR | Vantage Orian 1.5T,
MRT-1550, V6.0 |
| Maximum Gradient
Amplitude | 35 [mT/m] | 45 [mT/m] | 34 [mT/m] |
| Rise Time | 0.226 [ms] | 0.225 [ms] | 0.220 [ms] |
| Maximum Slew Rate | 155 [mT/m/ms] | 200 [mT/m/ms] | 155 [mT/m/ms] |
- . New Gradient coil: Changed to another vender.
- WB coil changed: Number of rung changed. ●
6
Made For life
- . Canon Pianissimo™ Σ: Pianissimo Σ technology dramatically reduces the level of acoustic gradient noise, thus substantially enhancing patient comfort, especially during scanning with fast sequences (K210164).
- Water cooling system: Branch of cooling water by cooling cabinet to RFA, GPS, Refrigerator Compressor. For Gradient coil, cooling water is supplied by Heat Exchanger. Eco cooling system is not available.
Summary of Software Changes:
- Artifacts Suppression Techniques:
- o mART EXP: mART EXP is 3D method to resolve in-plane and through-plane distortion artifact induced by susceptibility. Each slice is 3D phase-encoded to resolve distortion in slice dimension. In addition, VAT method is combined to resolve in-plane distortion. In the reconstruction, the data of each slice which is encoded in the slice direction is combined and corrected, and finally the images are registered as 2D multi-slice images like normal FSE2D. In addition, this application can be used in combination with Compressed SPEEDER application to reduce scan time.
- o RDC DWI: RDC DWI is the method to reduce distortion in phase encoding direction for SEEPI2D sequence. The direction of distortion described above can be reversed by reversing the phase encoding polarity. Hence, the pair of the data that have reversed phase encoding polarity each other is acquired, and then the distortion in reconstructed images can be reduced by estimating displacements between them. In addition, this application can be used in combination with SPEEDER or Exsper.
- . pCASL (pseudo-continuous ASL): pCASL is one of the arterial spin labeling (ASL) techniques which can provide perfusion-weighted images without contrast media by subtracting the tag image from the control image. Unlike ASTAR based on pulsed ASL (PASL) technique which asymmetrically applies single tag and control IR pulse on the upper and lower sides of the imaging slab, pCASL uses a train of very short RF pulses with thinner thickness than ASTAR for both tag and control applied upstream of the inflow artery with respect to the imaging slab.
- . lterative Motion Correction (IMC): IMC reduces motion artifact by correcting k-space data based on detecting the amount of motion during scan.
- . sureVOI Liver: 500€ VOI Liver automatically detects liver area and plan scan position for shimming scan, map scan, axial scan, coronal scan, probe scan for Real-time Motion Correction (RMC), and VisualPrep scan. The positions of the detected planes can be adjusted using functions provided in the Scan Plan window.
- . LiverLine+: Machine Learning based detection technology for liver plane. Using 2D images as the input, two kinds of MRCP scan plan (MRCP 3D and MRCP 2D) are automatically detected and set for the scan positioning ROIs. The orientations and positions of the detected basic planes can be adjusted using functions provided in the Scan Plan window.
- ProstateLine+: Machine Learning based detection technology for prostate plane. Using 3D images as the input, five planes (axial, coronal, sagittal, oblique axial, and oblique coronal) of
7
the prostate are automatically detected and set for the scan positioning ROIs. The orientations and positions of the detected planes can be adjusted using functions provided in the Scan Plan window.
- . W-SpineLine+: Machine Learning based detection technology for spine plane. Using 3D images of multiple stations covered whole spine region as the input, three planes (sagittal, coronal, and spinal disc planes) conforming to the curvature of the spine are automatically detected and set for the scan positioning ROIs. The orientations and positions of the detected basic planes can be adjusted using functions provided in the Scan Plan window. It is also possible to label to detected spinal discs and can be adjusted using functions provided in the W-SpineLine+ window.
- . Exsper Sequence Expansion: Exsper is available in FSE2D in addition to SE-EPI(DWI)
Summary of Accessory Changes:
- Ceiling Camera: The ceiling camera, in combination with the intelligent monitor, provides the operator with real-time coil positioning and patient centering assistance.
- Apps for Tablet UX: The application, installed on a tablet, allows the operator to prepare for the next patient study and monitor examination progress. This option allows to install an application for the Tablet UX to tablet from Host PC of the MRI system via web browser on a tablet.
| Item | Subject Device:
Vantage Fortian 1.5T, MRT-1550, V8.0 | Predicate Device:
Vantage Orian 1.5T, MRT-1550, V7.0
K211633 | 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
display | SAR, dB/dt | SAR, dB/dt | Same |
| ii. Operating mode
access requirements | Allows screen access to 1st level
operating mode | Allows screen access to 1st level
operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st operating
mode specified in IEC 60601-2-33:
2010+A1:2013+A2:2015) | 4W/kg for whole body (1st operating
mode specified in IEC 60601-2-33:
2010+A1:2013+A2:2015) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015 | 1st operating mode specified in IEC
60601-2-33:
2010+A1:2013+A2:2015 | Same |
| Potential emergency
condition and means
provided for
shutdown | Shutdown by Emergency Ramp Down
Unit for collision hazard for
ferromagnetic objects | Shutdown by Emergency Ramp Down
Unit for collision hazard for
ferromagnetic objects | Same |
19. SAFETY PARAMETERS
20. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K211633.
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21. INDICATIONS FOR USE
Vantage Fortian 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.
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 submission of the predicate device, Vantage Orian 1.5T, MRT-1550, V7.0 (K211633). 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
- ANSI AAMI ES60601-1:2005 / (R)2012 ● and A1:2012
- IEC60601-1-2 (2014)
- IEC60601-1-6 (2010), Amd.1 (2013) ●
- IEC60601-2-33 (2010), Amd.1 (2013), Amd.2 (2015)
- IEC60825-1 (2007, 2014)
- IEC62304 (2006), Amd.1 (2015) ●
- IEC62366-1 (2020) ●
- NEMA MS 1 (2008)
- NEMA MS 2 (2008) ●
- NEMA MS 3 (2008) ●
- NEMA MS 4 (2010)
- NEMA MS 5 (2018) ●
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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.
SureVOI Liver, LiverLine+, ProstateLine+, and W-SpineLine+ were evaluated using volunteer images. It was confirmed that these features worked as intended, the images were of diagnostic quality, and the test results met predetermined acceptance criteria.
Exsper in FSE2D was evaluated utilizing phantom images. It was confirmed that Exsper reduces artifacts caused by unfolding errors, compared to traditional SPEEDER.
MR image quality metrics were performed, utilizing phantom images, to assess mART EXP. Testing verified mART EXP can reduce distortion artifacts in the readout direction like mART+ and can also reduce distortion artifacts in the slice direction more than mART+.
IMC (Iterative Motion Correction) was evaluated using volunteer images. Testing confirmed that IMC is effective in reducing motion artifacts.
RDC DWI was evaluated utilizing phantom images. It was confirmed that the distortion in phase encoding direction was reduced by RDC DWI as compared to conventional images without RDC DWI in SEEPI2D sequence.
pCASL (pseudo-continuous ASL) was evaluated utilizing phantom images. Testing confirmed CBF values via pCASL met predetermined acceptance criteria.
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 Fortian 1.5T, MRT-1550, V8.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Orian 1.5T, MRT-1550, V7.0, referenced in this submission.
Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Fortian 1.5T, MRT-1550, V8.0 are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The modifications incorporated into the Vantage Fortian 1.5T, MRT-1550, V8.0 do not change the indications for use or the intended use of the device. Based on the indications for use, technological characteristics, and safety and performance testing, the subject device meets the requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate device.