(57 days)
No
The summary describes an estimation algorithm (2D Multi-Modality Direct Inversion (MMDI) algorithm) for calculating tissue stiffness, but does not mention or imply the use of AI or ML techniques. The performance studies focus on traditional statistical analysis (linear regression, Bland Altman) of measured vs. reference values.
No.
The device obtains an image that reflects tissue stiffness; it does not treat or alleviate a medical condition.
Yes
The device obtains an image that reflects the stiffness of body tissue (in kPa), and can output a stiffness image. This information is used for diagnostic purposes.
No
The device description explicitly states that the MR Elastography package includes hardware components such as an Acoustic Driver System (Active Driver, Passive Driver, QA Phantom, Other parts) and a TTL trigger converter (including AC adaptor), in addition to the software license.
Based on the provided information, 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. They are used to examine these samples outside of the body.
- Device Function: This device is an optional package for an MRI system. It works by applying vibrations to the body during an MRI scan and then processing the resulting images to determine tissue stiffness. This is an in vivo (within the living body) measurement, not an in vitro test on a sample.
- Intended Use: The intended use is to obtain an image that reflects the stiffness of body tissue such as liver and muscle. This is a measurement taken directly from the patient's body.
Therefore, while this device provides diagnostic information, it does so through an in vivo imaging technique, not an in vitro test.
N/A
Intended Use / Indications for Use
MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) systems. This option allows the user to obtain an image that reflects the stiffness, in kPa, of body tissue such as liver and muscle.
Product codes
LNH
Device Description
MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) system. This option allows the user to obtain an image that reflects the stiffness of body tissue.
MR Elastography consists of Acoustic Driver System including Active Driver, Passive Driver, QA Phantom and Other parts,TTL trigger converter includes AC adaptor, Manuals and Software (License).
By MRI scanning while applying vibration from the Acoustic Driver System, it is possible to obtain an image that reflects the stiffness of the body tissue in kPa. The sequence to be used with Acoustic Driver System is FE2D or SE-EPI2D. The MRI scanner outputs the following images from the acquired phase image and magnitude image.
- · Wave image
- · Stiffness image (capable of registration and display in color image format)
- · Confidence image (capable of superimposing confidence image on the stiffness image)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Body tissue such as liver and muscle.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 Elastography (MRE) performance testing (bench testing), using three Resoundant-provided calibration phantoms having known stiffness values representing the expected clinical range, was conducted to measure tissue stiffness, based on the 2D Multi-Modality Direct Inversion (MMDI) algorithm. The phantoms were scanned 5 times per day, multiple days per scanner, on 2 different 1.5T and 2 different 3T scanners by FE2D and SE-EPI2D techniques.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MR Elastography (MRE) performance testing (bench testing), using three Resoundant-provided calibration phantoms having known stiffness values representing the expected clinical range, was conducted to measure tissue stiffness, based on the 2D Multi-Modality Direct Inversion (MMDI) algorithm. The phantoms were scanned 5 times per day, multiple days per scanner, on 2 different 1.5T and 2 different 3T scanners by FE2D and SE-EPI2D techniques. Results of the study demonstrated that a calculated slope of measured stiffness mean value and reference stiffness value by linear regression analysis as well as a 95% confidence limit of measured vs. reference value, by Bland Altman analysis were within the acceptance criteria of 1.0±0.1 (slope) and 95% confidence limits within ±10%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Calculated slope of measured stiffness mean value and reference stiffness value by linear regression analysis within the acceptance criteria of 1.0±0.1. 95% confidence limit of measured vs. reference value, by Bland Altman analysis within ±10%.
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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March 3, 2022
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Canon Medical Systems Corporation % Mr. Paul Biggins Sr. Dir. Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780
Re: K220018
Trade/Device Name: MR Elastography; MZEK-001A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: December 29, 2021 Received: January 5, 2022
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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 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
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Indications for Use
510(k) Number (if known)
Device Name
MR Elastography; MZEK-001A
Indications for Use (Describe)
MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) systems. This option allows the user to obtain an image that reflects the stiffness, in kPa, of body tissue such as liver and muscle.
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 |
|---|---|
| Regulation Number: | 90-LNH (Per 21 CFR § 892.1000) |
| Trade Proprietary Name: | MR Elastography |
| Model Number: | MZEK-001A |
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/ 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
5. MANUFACTURING SITE
Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
6. ESTABLISHMENT REGISTRATION 9614698
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DICAL SYSTEMS USA, INC.
Made For life
7. DATE PREPARED
December 29, 2021
8. DEVICE NAME
MR Elastography, MZEK-001A
9. TRADE NAME
MR Elastography, MZEK-001A
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:
- . MR Elastography (K140666)
Reference Devices:
- . Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215)
- . MR Elastography, Resoundant (K201389)
| System | Subject Device | Predicate Device | Reference Device | Reference Device |
|---|---|---|---|---|
| MR Elastography | MR Elastography | Achieva, Intera, Ingenia, | ||
| Ingenia CX, Ingenia Elition, | ||||
| and Ingenia Ambition MR | ||||
| Systems | MR Elastography | |||
| Marketed By | Canon Medical Systems USA, Inc. | Philips | Philips | Resoundant |
| 510(k) Number | This Submission | K140666 | K193215 | |
| (Referred to MR Elastography | ||||
| extension) | K201389 | |||
| Clearance Date | June 13, 2014 | April 10, 2020 | July 10, 2020 |
15. REASON FOR SUBMISSION
Modification of a cleared device
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Image /page/5/Picture/0 description: The image shows the logo for Canon Medical Systems USA, Inc. The word "Canon" is written in red, with the rest of the text in black. The text is simple and easy to read, with a focus on the company name.
Made For life
16. SUBMISSION TYPE
Traditional 510(k) Premarket Notification
17. DEVICE DESCRIPTION
MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) system. This option allows the user to obtain an image that reflects the stiffness of body tissue.
MR Elastography consists of Acoustic Driver System including Active Driver, Passive Driver, QA Phantom and Other parts, TTL trigger converter includes AC adaptor, Manuals and Software (License).
By MRI scanning while applying vibration from the Acoustic Driver System, it is possible to obtain an image that reflects the stiffness of the body tissue in kPa. The sequence to be used with Acoustic Driver System is FE2D or SE-EPI2D. The MRI scanner outputs the following images from the acquired phase image and magnitude image.
- · Wave image
- · Stiffness image (capable of registration and display in color image format)
- · Confidence image (capable of superimposing confidence image on the stiffness image)
18. SUMMARY OF CHANGE(S)
This submission is to report the following functionalities have been added:
Summary of Hardware Changes:
- . MR Elastography:
MR Elastography consists of Acoustic Driver System including Active Driver, Passive Driver, QA Phantom and Other parts, TTL converter includes AC adaptor.
Summary of Software Changes:
● MR Elastography:
MR Elastography is a newly added optional package that allows the user to obtain an image that reflects the stiffness of body tissue.
By MRI scanning while applying vibration from the Acoustic Driver System, it is possible to obtain an image that reflects the stiffness of the body tissue in kPa. The sequence to be used with Acoustic Driver System is FE2D or SE-EPI2D. The MRI scanner outputs the following images from the acquired phase image and magnitude image.
- · Wave image
- · Stiffness image (capable of registration and display in color image format)
- · Confidence image (capable of superimposing confidence image on the stiffness image)
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19. INDICATIONS FOR USE
MR Elastography is an optional package for Canon Medical Systems magnetic resonance imaging (MRI) systems. This option allows the user to obtain an image that reflects the stiffness, in kPa, of body tissue such as liver and muscle.
20. SUMMARY OF DESIGN CONTROL ACTIVITIES
Risk Management activities for new software functionality is included in this submission. A declaration of conformity with design controls is included in this submission.
21. SAFETY
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards.
This modification is based upon the same technologies, materials, and software as the target Canon MRI systems. Risk activities were conducted in concurrence with established medical device development standards and guidance.
22. TECHNOLOGICAL CHARACTERISTICS:
MR Elastography contains both hardware and software elements. The hardware elements are supplied by Resoundant, Inc. (K201389) and consist of an active driver positioned outside the magnet room and a passive driver positioned on the scan subject. The MR Elastography software postprocessing package was based on an estimation algorithm provided by the Mayo Clinic and Resoundant, Inc. and the final MR Elastography software was developed in conjunction with The Mayo Clinic and Resoundant, Inc. The Philips MR Elastography (K140666) and Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215) contain the same hardware elements provided by Resoundant, Inc. and used the same estimation algorithm and worked in conjunction with the Mayo Clinic and Resoundant, Inc. to develop the final software. The GE IDEAL IQ SOFTWARE OPTION (K103411) and MR-TOUCH OPTION (K083421), and the SIEMENS SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO (K121434) and MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL (K141977) are as well.
The phase contrast imaging sequences to be used for the MR Elastography data process are substantially equivalent to the existing phase contrast imaging sequences which was previously cleared Vantage Orian 1.5T, MRT-1550, V7.0 (K211633, K203053) and Vantage Galan 3T, MRT-3020, V7.0 (K212056). The acquisition, processing and output images are substantially equivalent to the previously cleared predicate, Philips MR Elastography (K140666) and Achieva, Intera, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215). As with the above predicate, the MR Elastography option provides for a sensitive phase-contrast acquisition synchronized with the vibration supplied by the Resoundant hardware. This captures images of the tissue displacements, which are then input to an algorithm to estimate tissue stiffness.
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23. TESTING
MR Elastography (MRE) performance testing (bench testing), using three Resoundant-provided calibration phantoms having known stiffness values representing the expected clinical range, was conducted to measure tissue stiffness, based on the 2D Multi-Modality Direct Inversion (MMDI) algorithm. The phantoms were scanned 5 times per day, multiple days per scanner, on 2 different 1.5T and 2 different 3T scanners by FE2D and SE-EPI2D techniques. Results of the study demonstrated that a calculated slope of measured stiffness mean value and reference stiffness value by linear regression analysis as well as a 95% confidence limit of measured vs. reference value, by Bland Altman analysis were within the acceptance criteria of 1.0±0.1 (slope) and 95% confidence limits within ±10%.
24. SUBSTANTIAL EQUIVALENCE
Canon Medical Systems Corporation believes that the MR Elastography is substantially equivalent to the previously cleared predicate device, MR Elastography (K140666), MR Elastography of Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215), using with Canon MRI systems, referenced in this submission.
Canon Medical Systems Corporation believes that the MR Elastography option added to Canon MRI systems are substantially equivalent to the previously cleared predicate device.
25. CONCLUSION
The MR Elastography indications for use along with, technological characteristics, safety and performance testing, verifies that the subject device meets the requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate and reference devices.