(241 days)
Not Found
Yes
The document explicitly states "Following functions are added as powered by Machine Learning - AutoPose (Knee, Shoulder, Spine) - AutoClip -Deep Learning Reconstruction (DLR)".
No.
The device is described as an imaging device intended for diagnosis determination by providing physiological and clinical information, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that the device provides "information that can be useful in diagnosis determination," indicating its role in the diagnostic process.
No
The device description explicitly states it is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design, which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is an "imaging device" that provides "physiological and clinical information" obtained "non-invasively." It produces images of the internal structure of the body.
- Device Description: The device is described as a "Magnetic Resonance Imaging System." MRI is an in-vivo imaging modality, not an in-vitro diagnostic method.
- Mechanism: The device works by utilizing magnetic resonance properties of protons within the body to create images. This is a physical process applied to the living subject, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to diagnose conditions.
In Vitro Diagnostics (IVDs) are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not fit that definition.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is listed as "Not Found."
Intended Use / Indications for Use
The ECHELON Synergy System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Product codes
LNH
Device Description
The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON OVAL V6.0A MRI system. The ECHELON Synergy has been designed to enhance clinical utility as compared to the ECHELON OVAL V6.0A by taking advantage of open architecture.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, Body, Spine, Extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, Certified Radiological Technologists
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
DLR Validation Study:
Data acquisition MRI system: ECHELON OVAL (1.5T MRI, FUJIFILM Healthcare Corporation), ECHELON Smart (1.5T MRI, FUJIFILM Healthcare Corporation), ECHELON Synergy (1.5T MRI, FUJIFILM Healthcare Corporation)
Data acquisition site: FUJIFILM Healthcare Corporation and clinical site
Subject type: Healthy volunteer and patient
Anatomical coverage: Head, Spine, Cardiac, Breast, Abdomen, Pelvis, Shoulder, Wrist, Knee, Ankle
Number of cases: 110
Annotation Protocol: A reader evaluation study was performed by three US certified radiologists. Readers compared pairs of DLR images and conventional images (without DLR) for each case to evaluate image quality of DLR images in terms of signal to noise ratio, sharpness, and lesion conspicuity. They also evaluated overall image quality and the influence of DLR on motion artifacts. An evaluation of DLR images with shorter scan time was also performed, and high-resolution DLR images were compared to low-resolution conventional images.
AutoClip Performance Comparison:
Data acquisition MRI system: ECHELON Synergy (1.5T MRI, FUJIFILM Healthcare Corporation)
Data acquisition site: FUJIFILM Healthcare Corporation
Subject type: Japanese healthy volunteers
Number of cases: 40
Anatomical coverage: Brain
Scan sequence: 3D TOF, 3D Soft TOF
Annotation Protocol: The performance comparison between AutoClip and the manual operation was conducted by certified radiological technologists.
AutoPose Spine, Shoulder, and Knee Performance Tests:
Data acquisition MRI system: ECHELON Synergy (1.5T MRI, FUJIFILM Healthcare Corporation)
Data acquisition site: FUJIFILM Healthcare Corporation
Subject type: Japanese healthy volunteers
Number of cases: Spine: 146, Shoulder: 48, Knee: 38
Annotation Protocol: The performance tests were conducted by certified radiological technologists. They evaluated that AutoPose Spine, Shoulder, and Knee were able to reduce the time and number of steps in slice positioning compared to manual slice positioning.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Image Evaluation (New Receiver Coils):
Study Type: Clinical image evaluation
Sample Size: Not explicitly stated, but clinical image examples were provided.
Key Results: The evaluation confirmed that the new features and the new receiver coils perform as intended for diagnostic use. A radiologist validated that the clinical images have acceptable image quality for clinical use.
Validation of Machine Learning Features (DLR, AutoClip, AutoPose):
Deep Learning Reconstruction (DLR):
Study Type: Reader evaluation study
Sample Size: 81 cases for SNR and sharpness, 45 cases for lesion conspicuity, 3 image pairs for motion artifacts, 18 cases for shorter scan time, and "all cases" for comparison of high-resolution DLR to low-resolution conventional images.
Key Results: DLR images were equivalent or better than conventional images in terms of signal to noise ratio (81 out of 81 cases), sharpness (80 out of 81 cases), and lesion conspicuity (45 out of 45 cases with pathology). Overall image quality of DLR images was equivalent or better than conventional images in all cases. DLR did not significantly change the appearance of motion artifacts. DLR images with shorter scan time were rated as acceptable for routine examinations in all cases. High-resolution DLR images were rated as better or equivalent image quality in all cases compared to low-resolution conventional images.
AutoClip:
Study Type: Performance comparison
Sample Size: 40 cases
Key Results: The performance of AutoClip was substantially equivalent to that of manual clipping.
AutoPose Spine, Shoulder, and Knee:
Study Type: Performance tests
Sample Size: Spine: 146 cases, Shoulder: 48 cases, Knee: 38 cases
Key Results: Many cases of AutoPose Spine, Shoulder, and Knee were able to reduce the time and number of steps in the slice positioning compared to manual slice positioning. The remaining cases showed the same time and number of steps as manual slice positioning.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Deep Learning Reconstruction (DLR):
- Signal-to-noise ratio: 81 out of 81 cases equivalent or better.
- Sharpness: 80 out of 81 cases equivalent or better.
- Lesion conspicuity: 45 out of 45 cases with pathology equivalent or better.
- Overall image quality: Equivalent or better in all cases.
Predicate Device(s)
ECHELON OVAL V6.0A MRI system (K172110)
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 13, 2023
FUJIFILM Healthcare Corporation % Kotei Aoki Manager, Regulatory Affairs FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421
Re: K223426
Trade/Device Name: ECHELON Synergy MRI system Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: June 2, 2023 Received: June 2, 2023
Dear Kotei Aoki:
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
1
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 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,
D
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K223426
Device Name ECHELON Synergy MRI system
Indications for Use (Describe)
The ECHELON Synergy System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
| Anatomical Region: | Head, Body, Spine, Extremities |
|---|---|
| Nucleus excited: | Proton |
| Diagnostic uses: | |
| • T1, T2, proton density weighted imaging | |
| • Diffusion weighted imaging |
- · MR Angiography
- · Image processing
- · Spectroscopy
- · Whole Body
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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3
ECHELON Synergy MRI system 510(k) Summary
Submitter Information
| Submitter: | FUJIFILM Healthcare Corporation
2-1, Shintoyofuta
Kashiwa-shi, Chiba, 277-0804 Japan |
|-------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Kotei Aoki
Manager, Regulatory Affairs |
| E-mail: | kotei.aoki@fujifilm.com |
| Telephone number: | 765-246-2931 |
| Date: | November 11, 2022 |
Subject Device Name
| Trade/Proprietary Name: | ECHELON Synergy MRI system |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |
Predicate Device Name
| Predicate Device(s): | ECHELON OVAL V6.0A MRI system (K172110) |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |
Device Intended Use
The ECHELON Synergy System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses:
- T1, T2, proton density weighted imaging
- Diffusion weighted imaging
4
- . MR Angiography
- . Image processing
- . Spectroscopy
- . Whole Body
Device Description
Function
The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON OVAL V6.0A MRI system. The ECHELON Synergy has been designed to enhance clinical utility as compared to the ECHELON OVAL V6.0A by taking advantage of open architecture.
Scientific Concepts
Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiguitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events.
The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Physical and Performance Characteristics
MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and T1 and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules. And MR system has the Function of measuring spectroscopy.
Device Technological Characteristics
The control and image processing hardware and the base elements of the system software are identical to the predicate device. The ECHELON Synergy MRI system software is substantially equivalent to the ECHELON OVAL V6.0A (K172110).
The technological characteristics in regard to hardware of the ECHELON Synergy MRI system and the predicate are listed in Table 1.
5
| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | ||
|---|---|---|---|---|
| ECHELON OVAL V6.0A (K172110) | ECHELON Synergy | DIFFERENCE | ||
| System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, | ||
| IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, MS 14 | |||
| IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | Yes | |||
| Magnet and | ||||
| Gantry | Type and Field | |||
| Strength | Super-conducting magnet, horizontal bore, 1.5 Tesla | Super-conducting magnet, horizontal bore, 1.5 Tesla | No | |
| Resonant Frequency | 63.86 MHz | 63.86MHz | No | |
| Bore dimension | Oval shape with 74cm x 65cm | Circle shape with diameter 70cm | Yes | |
| Gradient System | Gradient Strength | 34mT/m | 33mT/m | Yes |
| Slew Rate | 150 T/m/sec | 130 T/m/sec | Yes | |
| Rise Time | 227 µsec to 34mT/m | 254µsec to 33mT/m | Yes | |
| Audible Noise (MCAN) | ||||
| Ambient | 58 dBA | 59.9 dBA | Yes | |
| Lpeak | 125 dBA | 122.7 dBA | Yes | |
| Leq | 117 dB | 116.5 dBA | Yes | |
| RF System | Transmitter channels | 2 | 1 | Yes |
| Peak Envelope Power | 40 kW | 18 kW | Yes | |
| Duty Cycle | 100% (Gating max), 12.5% at full power | 85% (Gating max), 10% at full power | Yes | |
| RF receiver channel | 16, 32 | 32 | Yes |
Table 1 Comparison: Hardware
The hardware differences from the predicate device to the ECHELON Synergy MRI System are analyzed in Table 2.
Table 2 Hardware Analysis
| FDA
Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and
effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness
(see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------|
| Device
Modification
Summary | Gantry bore dimension is changed from oval shape with 74cm x 65cm to circle shape with diameter 70cm. Gradient
field strength and slew rate, RF system Transmitter channels, Peak Envelop Power and Duty Cycle. Conformity to
NEMA MS 14. | | | |
| Significant
Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| FUJIFILM
Rationale
Statement | Modified specifications do not constitute a new intended use. There are no significant changes in technological
characteristics. For safety, gradient system and RF system is controlled according to same regulation as ECHELON
OVAL. So, safety and effectiveness of the device are same as ECHELON OVAL V6.0A(K172110). | | | |
The technological characteristics in regard to coils of the ECHELON Synergy MRI System and the predicate are listed in Table 3.
| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE | |
|---|---|---|---|---|
| ECHELON OVAL V6.0A (K172110) | ECHELON Synergy | |||
| RF Coils | Transmit Coil | T/R Body | T/R Body | No |
| Receiver Coils | WIT Posterior Head/Neck coil, WIT Anterior | |||
| Head attachment | ||||
| WIT Posterior Head/Neck coil B | FlexFit Neuro Coil | Yes | ||
| WIT Torso coil | ||||
| WIT Torso coil 12 | ||||
| WIT Torso coil 8 | FlexFit Blanket Coil A, | |||
| FlexFit Blanket Coil B | Yes | |||
| Extremity coil (Knee) | Extremity Coil | No | ||
| WIT Anterior Neck attachment | ||||
| WIT Anterior Neck attachment B | N/A | N/A | ||
| Hand/Wrist coil | Hand/Wrist Coil | No | ||
| WIT Anterior NV attachment | N/A | No | ||
| Breast | Breast Coil | |||
| Breast Support Kit 2 | Yes |
Table 3 Comparison: RF Coils
6
| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE |
|---|---|---|---|
| ECHELON OVAL V6.0A (K172110) | ECHELON Synergy | ||
| MP coil 140A, B | |||
| Micro coil (S) A, B | Micro Coil A, Micro Coil B | Yes | |
| Shoulder coil | |||
| Shoulder coil 8 | Shoulder Coil | No | |
| WIT Spine coil 12 | |||
| WIT Spine coil A | |||
| WIT Spine coil 8 | |||
| WIT Spine coil B | Spine Coil | Yes | |
| Foot/Ankle coil | Foot/Ankle Coil | No | |
| Flexible Extremity coil (Long Bone) | Flex M coil, Flex S Coil | Yes | |
| WIT Cardiac coil | N/A | N/A | |
| PV coil | N/A | N/A |
The Extremity Coil, Hand/Wrist Coil, Breast Coil, Micro Coil B, Shoulder Coil and Foot/Ankle Coil have an updated interface in order to connect with the ECHELON Synergy MRI system.
The coil differences from the predicate device to the ECHELON Synergy MRI system are analyzed in Table 4.
| FDA
Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and
effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness
(see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|------------|--------------------------------|
| Device
Modification
Summary | FlexFit Neuro Coil is changed from ECHELON OVAL WIT Posterior Head/Neck coil, WIT Anterior Head
attachment, WIT Posterior Head/Neck coil B, WIT Anterior Neck attachment and WIT Anterior Neck attachment
B.
FlexFit Blanket Coil A and FlexFit Blanket Coil B are changed from ECHELON OVAL WIT Torso coil, WIT Torso
coil 12 and WIT Torso coil 8.
Spine Coil is changed from ECHELON OVAL WIT Spine coil 12, WIT Spine coil A, WIT Spine coil 8 and WIT
Spine coil B.
Flex M Coil and Flex S Coil are changed from ECHELON OVAL Flexible Extremity coil (Long Bone).
Breast Support Kit 2 is available for Breast Coil as the accessories. | | | |
| Significant
Changes | Manufacturing Process | Labeling | Technology | Performance |
| | Engineering | Materials | Others | None (See rationale statement) |
| FUJIFILM
Rationale
Statement | Revised coils do not constitute a new intended use. There are no significant changes in technological characteristics
During transmitter coil operation, RF Coils are de-resonated for the safety function by same scheme as ECHELON
OVAL(K172110) | | | |
Table 4 Coil Comparison Analysis
The technological characteristics in regard to changes in functionality of the ECHELON Synergy MRI System as compared to the predicate are listed in Table 5.
Table 5 Comparison: Functionality
| ITEM | DIFFERENCES | ANALYSIS |
|---|---|---|
| Operating System | Going from Windows 7 to Windows 10 IoT | See Table 6 |
| CPU Platform | Xeon E3-1275 v6 3.8GHz, Xeon Silver 4210 2CPU, Core i5-7440EQ | See Table 6 |
| Application Software | Going from V6.0A to V9.0A | See Table 6 |
| Scan Tasks | Following positioning application of Scan Tasks are added in Auto Pose. | |
| -Knee, Shoulder, Spine | See Table 6 | |
| 2D Processing Tasks | Add the parameter R1 in Parameter Analysis | See Table 6 |
| 3D Processing Tasks | Following 3D Processing Tasks are added. |
- Auto VR
- Auto Clip | See Table 6 |
| Analysis Tasks | None | No |
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| ITEM | DIFFERENCES | ANALYSIS |
|---|---|---|
| Maintenance Tasks | None | No |
| Viewport Tools | None | No |
| Film, Archive Tools | None | No |
| Network Tools | None | No |
| Protocol Enhancements | Following protocol enhancement are added. |
- HiMAR Advanced
- Double-IR isoFSE
- AutoExam
- Auto Table Centering
- IP-Recon
- IP-Scan
- MSDE
- Golden Random Sampling
- Deep Learning Reconstruction (DLR)
- IterativeRAPID
- Dynamic slice count per study changes 4096 to 200.
- Presaturation pulses changes 8 to 6.
- 2D opFSE, 2D opFIR, 2D/3D Prime FSE and 2D/3D Prime FIR are integrated to FSE or FIR in
"RADAR" category. - 3D Soft RSSG and 3D Soft RSSG EPI are added in "Soft Sound" category. | See Table 6 |
| Pulse Sequences | Following Pulse sequence are added. - 3D RF Spoiled SARGE (3D Soft RSSG)
- 3D RF Spoiled SARGE Echo Planar Imaging (3D Soft RSSG EPI)
- 2D T1Map Sequence (2D T1Map)
- 2D Phase Sensitive Inversion Recovery (2D PSIR)
- 2D IR sequence is integrated to SE using with IR-pulse.
- 2D opFSE, 2D opFIR, 2D/3D Prime FSE and 2D/3D Prime FIR are integrated to FSE or FIR.
- 2D Time Reversed SARGE (2D TRSG) is not available.
- 3D Time Reversed SARGE (3D TRSG) is not available. | See Table 6 |
| Powered by Machine
Learning | Following functions are added as powered by Machine Learning - AutoPose (Knee, Shoulder, Spine)
- AutoClip
-Deep Learning Reconstruction (DLR) | See Table 6 |
The functionality differences from the predicate device from the ECHELON Synergy MRI System are analyzed in Table 6.
Table 6 Functionality Comparison Analysis
| FDA
Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and
effectiveness than the predicate), affect safety or effectiveness, or raise different questions of safety and effectiveness
(see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Modification
Summary | Application software is changed in V9.0A.
Add the parameter R1 in Parameter Analysis as 2D Processing.
Following variation of Scan Tasks are added in Auto Pose:
-Knee, Shoulder, Spine
Following 3D Processing Tasks are added:
- Auto VR
- Auto Clip
Following protocol enhancement are added: - HiMAR Advanced
- Double-IR isoFSE
- AutoExam
- Auto Table Centering |
8
| - IP-Recon | |||||
|---|---|---|---|---|---|
| - IP-Scan | |||||
| - MSDE | |||||
| - Golden Random Sampling | |||||
| - Deep Learning Reconstruction (DLR) | |||||
| - IterativeRAPID | |||||
| Following Pulse sequence are added: | |||||
| - 3D RF Spoiled SARGE (3D Soft RSSG) | |||||
| - 3D RF Spoiled SARGE Echo Planar Imaging (3D Soft RSSG EPI) | |||||
| - 2D T1Map Sequence (2D T1Map) | |||||
| - 2D Phase Sensitive Inversion Recovery (2D PSIR) | |||||
| Significant | |||||
| Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance | |
| □ Engineering | □ Materials | □ Others | ✓ None (See rationale statement) | ||
| FUJIFILM | |||||
| Rationale | |||||
| Statement | Modified functions do not constitute a new intended use. There are no significant changes in technological | ||||
| characteristics. For safety, pulse sequences are controlled according to the same safety limits as ECHELON Oval V6.0 | |||||
| (K172110) Therefore, safety and effectiveness of the device are the same as ECHELON OVAL V6.0A(K172110). |
Substantial Equivalence
A summary decision was based on analysis of Table 7.
| Table 7 Rationale Analysis: ECHELON Synergy vs. Predicate | |
|---|---|
| ITEM | Overall Rationale Analysis |
|---|---|
| Hardware | Modified specifications do not constitute a new intended use. There are no significant changes in technological |
| characteristics. For safety, gradient system and RF system is controlled according to same regulation as ECHELON | |
| OVAL. So, safety and effectiveness of the device are same as ECHELON OVAL V6.0A(K172110). | |
| Coils | Revised coils do not constitute a new intended use. There are no significant changes in technological characteristics. |
| During transmitter coil operation, RF Coils are de-resonated for the safety function by same scheme as ECHELON | |
| OVAL(K172110) | |
| Functionality | Modified functions do not constitute a new intended use. There are no significant changes in technological characteristics. |
| For safety, pulse sequences are controlled according to the same safety limits as ECHELON Oval V6.0 (K172110) | |
| Therefore, safety and effectiveness of the device are the same as ECHELON OVAL V6.0A(K172110). |
Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed ECHELON Synergy is considered substantially equivalent to the currently marketed predicate device (ECHELON OVAL V6.0A MRI System (K172110)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Summary of Non-Clinical Testing
The ECHELON Synergy MRI System was evaluated for software and electrical safety according to the following recognized standards:
- ANSI / AAMI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(r) 2012 and A2:2010/(R) 2012 . (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (IEC 60601-1:2005, mod).
- IEC 60601-1-2 Edition 4.0:2014, medical electrical equipment part 1-2: general requirements for . basic safety and essential performance - collateral standard: electromagnetic disturbances requirements and tests.
- . IEC 60601-2-33 Edition 3.2 b:2015, medical electrical equipment - part 2-33: particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic.
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- . IEC 60825-1:2014, safety of laser products – part 1: equipment classification and requirements.
- . IEC 62304 Edition 1.1 2015-06, CONSOLIDATED VERSION medical device software - software life cycle processes.
Bench performance testing was conducted on the ECHELON Synergy MRI System according to the following recognized standards:
- NEMA MS 1-2008, Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic . Resonance Images
- . NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnostic Resonance . Imaging Devices
- . NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Resonance Imaging
- . NEMA MS 8-2016, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- . NEMA MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Summary of Clinical Testing
Clinical image evaluation was performed on the new receiver coils to ensure that user needs were met. The evaluation confirmed that the new features and the new receiver coils perform as intended for diagnostic use.
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - | |
| Clinical | Clinical image examples are provided for applicable new features and coils and that we judged to be sufficient to |
| evaluate clinical usability. In addition, a radiologist validated that the clinical images have acceptable image quality for | |
| clinical use. |
The validation results of the new features using machine learning (DLR, AutoClip, AutoPose Spine, AutoPose Shoulder, and AutoPose Knee) were described below.
A reader evaluation study was performed by three US certified radiologists on DLR images acquired across a variety of pulse sequences and anatomies. Readers compared pairs of DLR images and conventional images (without DLR) for each case to evaluate image quality of DLR images. The results confirmed that the DLR images were equivalent or better than the conventional images in terms of signal to noise ratio (81 out of 81 cases), sharpness (80 out of 81 cases). Iesion conspicuity (45 out of 45 cases with pathology). The radiologists also indicated that the overall image quality of the DLR images was equivalent or better than that of the conventional images in all cases.
The influences of DLR on the motion artifacts were also evaluated by using three image pairs with motion artifacts. The DLR images were rated as better or equivalent image quality in all image pairs and indicated that DLR did not significantly change the appearance of the motion artifacts.
Readers also evaluated the image quality of the DLR images taken with shorter scan time was also performed in 18 cases. Despite of shorter scan time, DLR images were rated as acceptable for routine examinations in all cases.
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Additionally, readers compared pairs of high resolution DLR images and low-resolution conventional images. The high resolution DLR images were rated as better or equivalent image quality in all cases.
The information about the data in the above evaluations is shown below.
| Data acquisition MRI system | ECHELON OVAL
(1.5T MRI, FUJIFILM Healthcare Corporation)
ECHELON Smart
(1.5T MRI, FUJIFILM Healthcare Corporation)
ECHELON Synergy
(1.5T MRI, FUJIFILM Healthcare Corporation) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Data acquisition site | FUJIFILM Healthcare Corporation and clinical site |
| Subject type | Healthy volunteer and patient |
| Anatomical coverage | Head, Spine, Cardiac, Breast, Abdomen, Pelvis,
Shoulder, Wrist, Knee, Ankle |
| Number of cases | 110 |
The performance comparison between AutoClip and the manual operation was conducted by the certified radiological technologists. The results confirmed that the performance of AutoClip was substantially equivalent to that of manual clipping. The information about the comparison data is shown below.
| Data acquisition MRI system | ECHELON Synergy
(1.5T MRI, FUJIFILM Healthcare Corporation) | |
|-----------------------------|----------------------------------------------------------------|--|
| Data acquisition site | FUJIFILM Healthcare Corporation | |
| Subject type | Japanese healthy volunteers | |
| Number of cases | 40 | |
| Anatomical coverage | Brain | |
| Scan sequence | 3D TOF, 3D Soft TOF | |
The performance tests of AutoPose Spine, Shoulder and Knee, were conducted by the certified radiological technologists. They evaluated that many cases of AutoPose Spine, Shoulder, and Knee were able to reduce the time and number of steps in the slice positioning compared to the manual slice positioning. They also evaluated that the remaining cases of AutoPose Spine, Shoulder, and Knee were able to show the same time and number of steps as the manual slice positioning. The information about the data in the above tests is shown below.
| Spine | Shoulder | Knee | |
|---|---|---|---|
| Data acquisition MRI system | ECHELON Synergy | ||
| (1.5T MRI, FUJIFILM Healthcare Corporation) | |||
| Data acquisition site | FUJIFILM Healthcare Corporation | ||
| Subject type | Japanese healthy volunteers | ||
| Number of cases | 146 | 48 | 38 |
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Conclusions
The ECHELON Synergy MRI system is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECHELON OVAL V6.0A MRI System (K172110).