(250 days)
Yes
The device description explicitly mentions "AiCE is an optional noise reduction algorithm that improves image quality and reduces thermal noise by employing Deep Convolutional Neural Network methods." and describes the training of a DCNN.
No.
This device is described as a diagnostic imaging modality used to produce images of anatomic structures, and the output is used for diagnosis, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Vantage Orian 1.5T systems are indicated for use as a diagnostic imaging modality". It also mentions that "these images yield information that can be useful in diagnosis."
No
The device description explicitly states that the Vantage Orian is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, which is a hardware device. While it includes software components like the AiCE algorithm, it is not solely software.
Based on the provided text, 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 treatment.
- Device Function: The Vantage Orian 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 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 imaging device, not an IVD.
- Device Description: The description details the physical components of an MRI machine (magnet, gradient coil, etc.) and software for image processing. It does not mention any components for handling or analyzing biological specimens.
The device is a diagnostic imaging system, which is a different category of medical device than an In Vitro Diagnostic.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. It states "Not Found" for "Control Plan Authorized (PCCP) and relevant text".
Intended Use / Indications for Use
Vantage Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
·Proton density (PD) (also called hydrogen density)
- ·Spin-lattice relaxation time (T1)
- ·Spin-spin relaxation time (T2)
- ·Flow dynamics
- ·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Product codes
LNH
Device Description
The Vantage Orian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 3.8 tons light weight magnet. It includes the Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Orian 1.5T provides the maximum field of view of 55 x 50 cm. The Model MRT-1550/AC, AD, AG, AH includes the standard gradient system and Model MRT-1550/AK, AL, AO, AP includes the XGO gradient system.
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.
This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR is comparable to the current 1.5T Vantage Orian MRI System (K193021), cleared June 3rd, 2020 with the following modifications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
MRI
Anatomical Site
head or body, Brain, knee regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
AiCE deep learning reconstruction underwent 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 board certified radiologists and 160 image data sets 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.
In order to quantify the increase in SNR with AiCE over standard protocols, SNR measurements of sample clinical brain and knee images were obtained. Additionally, contrast was measured using the absolute signal intensity differences between two tissues. The resting demonstrated that AiCE both increased SNR and maintained contrast.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
low contrast detectability, SNR, contrast
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
Canon Medical Systems Corporation % Ms. Janine F. Reyes Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780
Re: K193097
Trade/Device Name: Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: June 3, 2020 Received: June 5, 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
July 14, 2020
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
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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: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K193097
Device Name
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Indications for Use (Describe)
Vantage Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
·Proton density (PD) (also called hydrogen density)
- ·Spin-lattice relaxation time (T1)
- ·Spin-spin relaxation time (T2)
- ·Flow dynamics
- ·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| 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."
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Image /page/3/Picture/1 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.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
1. CLASSIFICATION and DEVICE NAME
| Classification Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| Regulation Number: | 90-LNH (Per 21 CFR § 892.1000) |
| Trade Proprietary Name: | Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE 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
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5. MANUFACTURING SITE
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. ESTABLISHMENT REGISTRATION 9614698
-
- DATE PREPARED November 6th, 2019
8. DEVICE NAME
Vantage Oran 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
9. TRADE NAME
Vantage Oran 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
10. CLASSIFICATION NAME
Magnetic Resonance Diagnostic Device (MRDD)
11. CLASSIFICATION PANEL
Radiology
12. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1000, Magnetic Resonance Diagnostic Device)
13. PRODUCT CODE
90-LNH
14. PREDICATE DEVICE
Predicate Device: Vantage Orian 1.5T, MRT-1550, V6.0 (K193021)
Reference Device: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574)
TABLE No. 1: Predicate Device
| Subject Device | Predicate Device | |
|---|---|---|
| System | Vantage Orian 1.5T, MRT-1550, V6.0 | Vantage Orian 1.5T, MRT-1550, V6.0 |
| Marketed By | Canon Medical Systems USA, Inc. | Canon Medical Systems USA, Inc. |
| 510(k) Number | This Submission | K193021 |
| Clearance Date | June 3, 2020 |
15. REASON FOR SUBMISSION
Modification of a cleared device
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16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. DEVICE DESCRIPTION
The Vantage Orian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 3.8 tons light weight magnet. It includes the Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Orian 1.5T provides the maximum field of view of 55 x 50 cm. The Model MRT-1550/AC, AD, AG, AH includes the standard gradient system and Model MRT-1550/AK, AL, AO, AP includes the XGO gradient system.
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.
This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR is comparable to the current 1.5T Vantage Orian MRI System (K193021), cleared June 3rd, 2020 with the following modifications.
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: Advanced Intelligent Clear-IQ Engine (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.
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YSTEMS USA. INC.
19. SAFETY PARAMETERS
| Item | Subject Device:
Vantage Orian 1.5T, MRT-1550, V6.0
with AiCE Reconstruction Processing
Unit for MR | Predicate Device:
Vantage Orian 1.5T,
MRT-1550, V6.0 (K193021) | 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 |
20. IMAGING PERFORMANCE PARAMETERS
No change from the previous predicate submission, K193021.
21. INDICATIONS FOR USE
Vantage Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and obligue 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 submission of the predicate device, Vantage Orian 1.5T, MRT-1550, V6.0 (K193021). A declaration of conformity with design controls is included in this submission.
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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 written in a bold, red font. Below the word "Canon" is the text "CANON MEDICAL SYSTEMS USA, INC." in a smaller, black font. The logo is simple and clean, and it is likely used on the company's website, marketing materials, and products.
Made For life
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
AiCE deep learning reconstruction underwent 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 board certified radiologists and 160 image data sets 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.
In order to quantify the increase in SNR with AiCE over standard protocols, SNR measurements of sample clinical brain and knee images were obtained. Additionally, contrast was measured using the absolute signal intensity differences between two tissues. The resting demonstrated that AiCE both increased SNR and maintained contrast.
25. SUBSTANTIAL EQUIVALENCE
Canon Medical Systems Corporation believes that the Vantage Orian 1.5T, MRT-1550, V6.0, Magnetic Resonance Imaging (MRI) System with AiCE Reconstruction Processing Unit for MR is substantially equivalent to the previously cleared predicate device, Vantage Orian 1.5T, MRT-1550, V6.0, referenced in this submission. Canon Medical Systems Corporation believes that the changes incorporated into the Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR are substantially equivalent to the previously cleared predicate device.
26. CONCLUSION
The modifications incorporated into the Vantage Orian 1.5T, MRT-1550, 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.