(112 days)
Vantage Galan 3T 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.
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K192574. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The AiCE Reconstruction Processing Unit for MR is included with this system for the processing of images for various anatomical regions.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image low contrast detectability maintained or improved compared to other performance filters | Demonstrated to be maintained or improved through a model observer study. |
| Image quality (SNR and contrast performance) maintained or improved | Demonstrated to be maintained or improved through bench testing. |
| Statistical preference for AiCE reconstructions compared to other performance filters by human observers. | Demonstrated statistical preference for AiCE by 15 board-certified radiologists/cardiologists. |
2. Sample Size Used for the Test Set and Data Provenance
The human observer study included 60 subjects and a total of 348 scans. The provenance of this data (e.g., country of origin, retrospective or prospective) is not specified in the provided document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The human observer study involved 15 board-certified radiologists/cardiologists. The document does not explicitly state that these experts established "ground truth" for the test set, but rather that they evaluated the images and demonstrated a statistical preference for AiCE. Their qualifications are listed as "board certified radiologists / cardiologists." No further details on their experience (e.g., 10 years of experience) are provided.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (such as 2+1 or 3+1) for the human observer study. It only states that 15 radiologists/cardiologists provided evaluations leading to a statistical preference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Yes, a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. The study involved 15 board-certified radiologists/cardiologists evaluating images from 60 subjects and 348 scans.
The effect size of how much human readers improve with AI vs. without AI assistance is not explicitly quantified in terms of a specific numerical improvement in accuracy or efficiency. Instead, the study "demonstrated a statistical preference of AiCE when compared to other performance filters," indicating improved perception or diagnostic confidence with AiCE, but without detailing the magnitude of this improvement or the specific metrics used for "preference."
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The document states that "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." This indicates an assessment of the algorithm's intrinsic image quality improvement without direct human interaction at that stage.
7. Type of Ground Truth Used
For the model observer study and bench testing, the ground truth appears to be based on objective image quality metrics such as "low contrast detectability," "SNR," and "contrast performance." These are inherent properties of the reconstructed images.
For the human observer study, the "ground truth" or reference for comparison was the performance of "other performance filters" (implicitly, the images reconstructed with these filters). The observers then indicated a "statistical preference" for AiCE, which served as the outcome measure. It isn't explicitly stated that the cases had a confirmatory diagnostic "ground truth" (e.g., pathology or outcomes data) that the radiologists were evaluating for accuracy. Rather, it focuses on the radiologists' perception and preference for the AiCE reconstructed images.
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set of the AiCE deep learning model.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established for the AiCE deep learning model.
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March 4, 2021
Image /page/0/Picture/1 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
Canon Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K203323
Trade/Device Name: Vantage Galan 3T, MRT-3020, 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 17, 2021 Received: February 23, 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
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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 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) K203323
Device Name
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Indications for Use (Describe)
Vantage Galan 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)
| 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! *
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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 Galan 3T, MRT-3020, V6.0 with AiCE ReconstructionProcessing Unit for MR |
| Model Number: | MRT-3020 |
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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-
- MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- ESTABLISHMENT REGISTRATION 6. 9614698
-
- DATE PREPARED November 10, 2020
8. DEVICE NAME
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
9. TRADE NAME
Vantage Galan 3T, MRT-3020, 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 Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574)
Reference Device (system): Vantage Galan 3T, MRT-3020, V6.0 (K192506)
TABLE No. 1: Predicate Device
| Subject Device | Predicate Device | |
|---|---|---|
| System | Vantage Galan 3T, MRT-3020, V6.0 withAiCE Reconstruction Processing Unit for MR | Vantage Galan 3T, MRT-3020, V6.0 with AiCEReconstruction Processing Unit for MR |
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) Number | This Submission | K192574 |
| Clearance Date | March 9th, 2020 |
15. REASON FOR SUBMISSION
Addition of anatomical regions with no changes to the cleared software and hardware.
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Made For life
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. DEVICE DESCRIPTION
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K192574. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The AiCE Reconstruction Processing Unit for MR is included with this system for the processing of images for various anatomical regions.
18. SUMMARY OF CHANGE(S)
Addition of the following anatomical regions:
| Subject Device | Predicate Device (K192574) | |
|---|---|---|
| Anatomical Region | Sub-categories | |
| Head | Brain | Yes |
| MSK | Knee | Yes |
| Spine | Cervical, Lumbar, Thoracic | New |
| MSK | Shoulder, Hip, Elbow, Wrist/Hand, Foot/Ankle | New |
| 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
| Item | Subject Device:Vantage Galan 3T, MRT-3020, V6.0with AiCE Reconstruction ProcessingUnit for MR | Predicate Device:Vantage Galan 3T, MRT-3020, V6.0with AiCE Reconstruction ProcessingUnit for MR (K192574) | 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 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 |
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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.
| Item | Subject Device:Vantage Galan 3T, MRT-3020, V6.0with AiCE Reconstruction ProcessingUnit for MR | Predicate Device:Vantage Galan 3T, MRT-3020, V6.0with AiCE Reconstruction ProcessingUnit for MR (K192574) | Notes |
|---|---|---|---|
| Potential emergencycondition and meansprovided forshutdown | Shutdown by Emergency Ramp DownUnit 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, K192574.
21. INDICATIONS FOR USE
Vantage Galan 3T 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 vield information that can be useful in diagnosis.
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
No change from the previous predicate submission, K192574. 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) K192574.
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 15 board certified radiologists / cardiologists and a total of 60 subjects and 348 scans
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Image /page/7/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
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 Galan 3T, MRT-3020, V6.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020, 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 Galan 3T, MRT-3020, 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.
§ 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.