(172 days)
Yes
The device description explicitly mentions "Deep Convolutional Neural Network methods" and "deep learning reconstruction" as part of the AiCE noise reduction algorithm.
No.
The device is indicated as a "diagnostic imaging modality" and its images are used "in diagnosis" by a "trained physician," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use as a diagnostic imaging modality" and that the images "yield information that can be useful in diagnosis."
No
The device description explicitly states, "This software and its associated hardware are used on Canon MRI systems." This indicates the device is not solely software but is integrated with and dependent on specific hardware components of an MRI system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Vantage Galan 3T system is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body using magnetic fields and radio waves. It does not analyze samples taken from the body.
- Intended Use: The intended use is described as a "diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This clearly describes an imaging device, not an in vitro test.
- Device Description: The description reinforces that it's an MRI system used to "acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body."
While the images produced by the MRI system are used for diagnosis, the system itself is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
No
The provided text states "Control Plan Authorized (PCCP) and relevant text Not Found", and there is no explicit statement that the FDA has reviewed and approved or cleared a PCCP for this device, nor does it mention section 515C(b)(1).
Intended Use / Indications for Use
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.
Product codes
LNH
Device Description
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K181593. 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.
AiCE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.
AiCE is designed to remove Gaussian distributed noise in MR images for reducing contributions of thermal noise. In order to train a DCNN that can learn a model that represents thermal noise, the training datasets are created by adding Gaussian noise of different amplitudes to high-SNR images acquired with large number of averages.
The device is targeted for Brain and knee regions.
This software and its associated hardware are used on Canon MRI systems that are designed to communicate with the AiCE Reconstruction Processing Unit for MR.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head or body, specifically Brain and knee regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
In order to train a DCNN that can learn a model that represents thermal noise, the training datasets are created by adding Gaussian noise of different amplitudes to high-SNR images acquired with large number of averages.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
AiCE deep learning reconstruction underwent both performance (bench testing) using a Model Observer study to determine that image Low Contrast Detectability was maintained or improved. Additionally a Human Observer study was conducted with 6 physicians and 160 images that demonstrated a statistical preference of AiCE when compared to other preferred filters. The results of the testing demonstrated that AiCE performed either at the same level or above the performance of commercially available predicate device.
Study type: Model Observer study (bench testing), Human Observer study
Sample size: 6 physicians, 160 images
Key results: Image Low Contrast Detectability was maintained or improved. Human Observer study demonstrated a statistical preference of AiCE when compared to other preferred filters. AiCE performed either at the same level or above the performance of commercially available predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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). 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.
March 9, 2020
Canon Medical Systems Corporation % Mr. Paul Biggins Senior Director, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780
Re: K192574
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: March 4, 2020 Received: March 5, 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
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 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) |
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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 |
|---|---|
| Classification | 90-LNH |
| Regulation Number: | 21 CFR § 892.1000 |
| Trade Proprietary Name: | Vantage Galan 3T, MRT-3020, V6.0 with |
| AiCE Reconstruction Processing 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
Paul Biggins Senior Director Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7808 Fax: (714) 730-1310 E-mail: pbiggins@us.medical.canon
4
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 pbiggins@us.medical.canon
5. MANUFACTURING SITE
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. ESTABLISHMENT REGISTRATION
9614698
7. DATE PREPARED
January 23, 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
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14. PREDICATE DEVICE
Predicate Device (system): Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593)
| System | Subject | Predicate Device |
|---|---|---|
| Vantage Galan 3T, | ||
| MRT-3020, V6.0 with | ||
| AiCE Reconstruction | ||
| Processing Unit for MR | Vantage Galan 3T, | |
| MRT-3020/A7, | ||
| V5.0 | ||
| Marketed By | Canon Medical Systems | |
| USA | Canon Medical Systems | |
| USA | ||
| 510(k) | ||
| Number | This Submission | K181593 |
| Clearance | ||
| Date | Aug 13, 2018 |
15. REASON FOR SUBMISSION
Modification of a cleared device
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 K181593. 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.
AiCE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.
AiCE is designed to remove Gaussian distributed noise in MR images for reducing contributions of thermal noise. In order to train a DCNN that can learn a model that represents thermal noise, the training datasets are created by adding Gaussian noise of different amplitudes to high-SNR images acquired with large number of averages.
The device is targeted for Brain and knee regions.
This software and its associated hardware are used on Canon MRI systems that are designed to communicate with the AiCE Reconstruction Processing Unit for MR.
6
18. SUMMARY OF CHANGE(S)
This submission is to report the following software functionalities have been added:
Summary of Hardware changes:
- AiCE Reconstruction Processing Unit for MR
Summary of Software Changes:
- •
AiCE is a newly-added optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods.
The device is targeted for Brain and knee regions and is MR system independent meaning that this software and its associated hardware are used on Canon MRI systems that are designed to communicate with the AiCE Reconstruction Processing Unit for MR.
19. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Galan 3T, MRT-3020,
V6.0 with AiCE Reconstruction
Processing Unit for MR | Predicate Device:
Vantage Galan 3.0T,
MRT-3020/A7, V5.0 | 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) | 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 | Same |
7
| Item | Subject Device:
Vantage Galan 3T, MRT-3020,
V6.0 with AiCE Reconstruction
Processing Unit for MR | Predicate Device:
Vantage Galan 3.0T,
MRT-3020/A7, V5.0 | Notes |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------|
| 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 |
20. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K181953.
21. INDICATIONS FOR USE
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.
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
Risk Management activities for new software functionalities are included in this submission. The test methods used are the same as those submitted in the previously cleared submissions of the predicate device, Vantage Galan 3T, MRT-3020/A7, V5.0 (K181953). A declaration of conformity with design controls is included in this submission.
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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 (when combining with Vantage Galan 3T, MRT-3020, V6.0)
- 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) ●
- IEC62304 (2006), Amd.1 (2015) ●
- 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
AiCE deep learning reconstruction underwent both performance (bench testing) using a Model Observer study to determine that image Low Contrast Detectability was maintained or improved. Additionally a Human Observer study was conducted with 6 physicians and 160 images that demonstrated a statistical preference of AiCE when compared to other preferred filters. The results of the testing demonstrated that AiCE performed either at the same level or above the performance of 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 referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020/A7, V5.0 are substantially equivalent to the previously cleared predicate devices.
9
26. CONCLUSION
The modifications incorporated into the Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR 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.