(172 days)
No
The document does not mention AI, ML, or related terms, and the performance studies focus on traditional image quality metrics and SAR calculations.
No.
The device is indicated for use as a diagnostic imaging modality to produce images useful in diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging modality" and that, when interpreted by a trained physician, the images "yield information that can be useful in diagnosis."
No
The device description explicitly states it is a "3 Tesla Magnetic Resonance Imaging (MRI) System," which is a hardware device. While it likely includes software for operation and image processing, it is not solely software.
No, 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 Galan 3T system is a Magnetic Resonance Imaging (MRI) system. It produces images of the internal structures of the body by using magnetic fields and radio waves. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states that it "produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body." This is an in vivo (within the living body) imaging technique, not an in vitro diagnostic test.
- Input: The input is the patient's body within the MRI scanner, not a biological specimen.
Therefore, based on the provided information, the Vantage Galan 3T system is an in vivo diagnostic imaging device, not an IVD.
N/A
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 (comma separated list FDA assigned to the subject device)
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 crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head or body
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
MR image quality metrics were performed, utilizing phantoms and volunteer images, to assess Compressed SPEEDER with regards to SNR, unfolding error artifacts and performance in all the phase encode directions. It was concluded that Compressed SPEEDER met all acceptance criteria.
Additionally, representative images, reviewed by American Board Certified Radiologists, were obtained using the subject device. Reviewers provided detailed assessments of image degradation, diagnostic performance, lesion conspicuity, and clinical utility. It was confirmed that Compressed SPEEDER images were of diagnostic quality.
T2 Map Using Pre-Contrast Pulses was evaluated utilizing phantom and volunteer images. It was concluded that T2 maps can be generated using the data acquired using pre-contrast pulses.
New SAR calculation method was evaluated by imaging and modeling a phantom of known dimension and electromagnetic properties in combination with volunteer imaging. It was concluded that the new SAR calculation method is substantially equivalent to the predicate device as demonstrated by the results of the above testing.
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.
MR image quality metrics were performed, utilizing phantoms and volunteer images, to assess Compressed SPEEDER with regards to SNR, unfolding error artifacts and performance in all the phase encode directions. It was concluded that Compressed SPEEDER met all acceptance criteria.
Additionally, representative images, reviewed by American Board Certified Radiologists, were obtained using the subject device. Reviewers provided detailed assessments of image degradation, diagnostic performance, lesion conspicuity, and clinical utility. It was confirmed that Compressed SPEEDER images were of diagnostic quality.
T2 Map Using Pre-Contrast Pulses was evaluated utilizing phantom and volunteer images. It was concluded that T2 maps can be generated using the data acquired using pre-contrast pulses.
New SAR calculation method was evaluated by imaging and modeling a phantom of known dimension and electromagnetic properties in combination with volunteer imaging. It was concluded that the new SAR calculation method is substantially equivalent to the predicate device as demonstrated by the results of the above testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".
Canon Medical Systems Corporation % Ms. Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K192506
Trade/Device Name: Vantage Galan 3T, MRT-3020, V6.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 21, 2020 Received: January 22, 2020
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
March 2, 2020
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K192506
Device Name Vantage Galan 3T, MRT-3020, V6.0
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.
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:
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 Galan 3T, MRT-3020, V6.0 |
| 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
4
-
- MANUFACTURING SITE Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED September 10th, 2019
-
- DEVICE NAME Vantage Galan 3T, MRT-3020, V6.0
-
- TRADE NAME Vantage Galan 3T, MRT-3020, V6.0
10. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
11. CLASSIFICATION PANEL
Radiology
-
- DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
- DEVICE CLASSIFICATION
13. PRODUCT CODE
90-LNH
14. PREDICATE DEVICE
Predicate Device (system): Vantage Galan 3T, MRT-3020/A7, V5.0 (K181593) Reference Device (system): Vantage Galan 3T, MRT-3020 (K162183), Vantage Galan 3T, MRT-3020/A9 (K183657), Vantage Orian 1.5T, MRT-1550 (K182282)
| System | Subject Device | Predicate Device | Reference Device | Reference Device | Reference Device |
|---|---|---|---|---|---|
| Vantage Galan | |||||
| 3T, MRT-3020, | |||||
| V6.0 | Vantage Galan 3T, | ||||
| MRT-3020/A7, | |||||
| V5.0 | Vantage Galan 3T, | ||||
| MRT-3020, | |||||
| V4.0 | Vantage Galan 3T, | ||||
| MRT-3020/A9, | |||||
| V5.0 | Vantage Orian | ||||
| 1.5T, MRT-1550, | |||||
| V4.5 | |||||
| Marketed | |||||
| By | Canon Medical | ||||
| Systems USA, Inc. | 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 | K181593 | K162183 | K183657 | K182282 |
| Clearance | |||||
| Date | August 13, 2018 | November 25, 2016 | March 15, 2019 | October 19, 2018 |
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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 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 crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
18. SUMMARY OF CHANGE(S)
This submission is to report the following software functionalities have been added:
Summary of Hardware Changes:
- New Cover Design
- Optional Dockable/Detachable Table
Summary of Software Changes:
- New SAR: New calculation method is applied.
- Compressed SPEEDER (Compressed Sensing)*: ●
- This application allows accelerated fast scan of the brain, cervical spine, thoracic . spine, lumbar spine, shoulder, knee, foot, ankle, elbow and wrist. Compressed SPEEDER combines parallel imaging by using multi-sensitivity map and compressed sensing.
- . Compressed SPEEDER feature allows acceleration factors for shorter scan times or higher resolution in FSE2D imaging based upon the principle of Compressed Sensing in combination with parallel imaging.
- T2 Map Using Pre-Contrast Pulses: ECG gating or peripheral pulse gating is used in scanning with FFE2D sequences, and different Pre-contrast pulses are used to obtain multiple TEeff images.
- CP Mode (quadrature transmit mode): has been added. ●
Labeling Changes:
- Adaptive Scan Mode: The function name of "Limited Scan Mode" has been changed to "Adaptive Scan Mode".
*Note: Compressed SPEEDER should not be used for contrast-agent-enhanced imaging.
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Made For life
19. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Galan 3T,
MRT-3020, V6.0 | 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 |
| 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, K181593.
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 yield information that can be useful in diagnosis.
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Made For life
22. SUMMARY OF DESIGN CONTROL ACTIVITIES
Risk Management activities for new software functionalities and hardware changes 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 Galan 3T, MRT-3020/A7, V5.0 (K181593). 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)
- 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
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.
MR image quality metrics were performed, utilizing phantoms and volunteer images, to assess Compressed SPEEDER with regards to SNR, unfolding error artifacts and performance in all the phase encode directions. It was concluded that Compressed SPEEDER met all acceptance criteria.
Additionally, representative images, reviewed by American Board Certified Radiologists, were obtained using the subject device. Reviewers provided detailed assessments of image degradation, diagnostic performance, lesion conspicuity, and clinical utility. It was confirmed that Compressed SPEEDER images were of diagnostic quality.
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Made For life
T2 Map Using Pre-Contrast Pulses was evaluated utilizing phantom and volunteer images. It was concluded that T2 maps can be generated using the data acquired using pre-contrast pulses.
New SAR calculation method was evaluated by imaging and modeling a phantom of known dimension and electromagnetic properties in combination with volunteer imaging. It was concluded that the new SAR calculation method is substantially equivalent to the predicate device as demonstrated by the results of the above testing.
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 Galan 3T, MRT-3020, V6.0 Magnetic Resonance Imaging (MRI) System is substantially equivalent to the previously cleared predicate device, Vantage Galan 3T, MRT-3020/A7, V5.0, referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Galan 3T, MRT-3020, V6.0 are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The modifications incorporated into the Vantage Galan 3T, MRT-3020, V6.0 do not change the indications for use or the intended use of the device. Based upon bench testing, 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.