(135 days)
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.
The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The control and image processing hardware and the base elements of the system software are identical to the predicate device.
This document describes the ECHELON Synergy MRI system's acceptance criteria and the studies conducted to demonstrate its performance. The submission for FDA 510(k) clearance (K251386) references a predicate device, the ECHELON Synergy MRI System (K241429), and outlines modifications to hardware and software.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against which a numeric performance metric is listed for each new feature. Instead, it details that certain functionalities (DLR Symmetry and AutoPose) underwent performance evaluations. The "performance" reported is described qualitatively or comparatively to conventional methods.
| Feature/Metric | Acceptance Criteria (Implicit/Derived) | Reported Device Performance |
|---|---|---|
| DLR Symmetry - Artifact Reduction | Reduction of artifacts should be demonstrated. | Phantom testing demonstrated DLR Symmetry could reduce artifacts in the image using Normalized Root Mean Square Error (NRMSE). Clinical image review by radiologists indicated superior artifact reduction (p<0.05) compared to conventional images. |
| DLR Symmetry - Image Quality (SNR, Sharpness, Contrast, Lesion Conspicuity, Overall) | Should not degrade image quality compared to conventional methods. Images should be clinically acceptable. | Phantom Testing: Did not degrade image quality based on SNR, Relative Edge Sharpness, and Contrast Change Rate. Clinical Image Review: Radiologists reported superior SNR, image sharpness, lesion conspicuity, and overall image quality (p<0.05) in DLR Symmetry images. All DLR Symmetry images were evaluated as clinically acceptable. |
| AutoPose (Shoulder, Knee, HipJoint, Abdomen, Pelvis (male/female), Cardiac) - Automatic Slice Positioning | Should be able to set slice positions for a scan without manual adjustment in most cases. For remaining cases, user operation steps should be equivalent to manual positioning. | Evaluation by certified radiological technologists showed that "almost cases" were able to set slice positions without manual adjustment. The remaining cases required user operation steps equivalent to manual slice positioning. |
2. Sample Sizes Used for the Test Set and Data Provenance
- DLR Symmetry:
- Clinical Image Test Set: 89 unique subjects (patients and healthy subjects).
- Data Provenance: From U.S. and Japan.
- Data Type: Retrospective (clinical images collected).
- AutoPose:
- Shoulder: 60 cases
- Knee: 60 cases
- HipJoint: 65 cases
- Abdomen: 115 cases
- Pelvis for male: 60 cases
- Pelvis for female: 68 cases
- Cardiac: 126 cases
- Data Provenance: FUJIFILM Corp., FUJIFILM Healthcare Americas Corp., and clinical sites.
- Data Type: Subject type includes healthy volunteers and patients, implying a mix of prospective data collection for testing new features and potentially retrospective for some patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- DLR Symmetry:
- Number of Experts: Three US board certified radiologists.
- Qualifications: "US board certified radiologists." Specific years of experience are not mentioned.
- AutoPose:
- Number of Experts/Evaluators: Three certified radiological technologists.
- Qualifications: "Certified radiological technologists." Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
- DLR Symmetry: The document states that comparisons were made by "the reviewers" (plural) in terms of image quality metrics using a 3-point scale. It doesn't explicitly state an adjudication method like 2+1 or 3+1 if there were disagreements among the three radiologists. It implies a consensus or majority rule might have been used for the reported "superior" findings, but this isn't detailed.
- AutoPose: The evaluation results are simply described as "evaluation results showed," implying a summary of the technologists' findings. No specific adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- DLR Symmetry: A form of MRMC study was conducted where three US board-certified radiologists reviewed images reconstructed with DLR Symmetry versus conventional methods.
- Effect Size of Human Readers with AI vs. Without AI Assistance: The document indicates that images with DLR Symmetry (AI-assisted reconstruction) were "superior to those in the conventional images with statistically significant difference (p<0.05)" across various image quality metrics. This shows an improvement in the perceived image quality for human readers when using DLR Symmetry, but it does not quantify the "effect size of how much human readers improve with AI vs. without AI assistance" in terms of diagnostic performance (e.g., improved sensitivity/specificity for a given task). Instead, it focuses on the quality of the image presented to the reader.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- DLR Symmetry: Yes, in part. Phantom testing was conducted to evaluate artifact reduction (NRMSE), SNR, Relative Edge Sharpness, and Contrast Change Rate. This is an algorithmic performance evaluation independent of human interpretation of clinical images, although it assesses image characteristics rather than diagnostic output.
- AutoPose: The evaluation by certified radiological technologists focuses on the algorithm's ability to set slice positions automatically, which is a standalone performance metric for the automation function.
7. The Type of Ground Truth Used
- DLR Symmetry:
- For phantom testing: "Ground truth" refers to the known characteristics of the phantom and metrics like NRMSE, SNR, etc.
- For clinical image review: The ground truth was established by expert consensus or individual assessment of the "clinical acceptability" of the images and comparative judgment (superiority) of image quality metrics by three US board-certified radiologists. This isn't pathology or outcomes data, but rather expert radiological opinion on image quality and clinical utility.
- AutoPose: The "ground truth" was whether the automated positioning successfully set the slice positions without manual adjustment, as evaluated by certified radiological technologists.
8. The Sample Size for the Training Set
The document explicitly states regarding DLR Symmetry: "The test dataset was independent of the training and validation datasets." However, it does not provide the sample size or details for the training set (or validation set) for DLR Symmetry or AutoPose.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set was established for either DLR Symmetry or AutoPose, as the training set details are not included in the provided text.
FDA 510(k) Clearance Letter - ECHELON Synergy
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
September 17, 2025
Fujifilm Corporation
℅ Chaitrali Kulkarni
Sr. Regulatory Affairs Specialist
Fujifilm Healthcare Americas Corporation
81 Hartwell Ave, Suite 300
Lexington, Massachusetts 02421
Re: K251386
Trade/Device Name: ECHELON Synergy
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic Resonance Diagnostic Device
Regulatory Class: Class II
Product Code: LNH
Dated: September 3, 2025
Received: September 3, 2025
Dear Chaitrali Kulkarni:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K251386 - Chaitrali Kulkarni Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K251386 - Chaitrali Kulkarni Page 3
Sincerely,
NINGZHI LI -S Digitally signed by NINGZHI LI -S
for
Daniel M. Krainak, PhD
Assistant Director
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K251386
Please provide the device trade name(s).
ECHELON Synergy
Please provide your Indications for Use below.
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
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
ECHELON Synergy
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510(k) Summary
©2025 FUJIFILM Corporation ECHELON Synergy Page 1 of 10
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510(k) Summary
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Submitter Information
| Field | Information |
|---|---|
| Submitter: | FUJIFILM Corporation26-30, Nishiazabu 2-ChomeMinato-ku, Tokyo, 106-8620 Japan |
| Contact: | Ms. Chaitrali KulkarniSr. Regulatory Affairs Specialist |
| Telephone number: | 704-517-4886 |
| E-mail: | HCUSRegulatoryAffairs@fujifilm.com |
| Data: | April 30, 2025 |
Subject Device Name
| Field | Information |
|---|---|
| Trade/Proprietary Name: | ECHELON Synergy |
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |
Predicate Device Name
| Field | Information |
|---|---|
| Predicate Device(s): | ECHELON Synergy MRI System (K241429) |
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |
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.
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
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Device Description
Function
The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design.
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 ubiquitous 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.
Performance Evaluation
The ECHELON Synergy is equivalent to the ECHELON Synergy MRI System (K241429) with following exceptions:
- Alternative super-conducting magnet (also called as "ZeroHelium") and units related to alternative super-conducting magnet are added.
- Alternative patient table (also called as "dockable patient table") and units related to alternative patient table are added.
- Alternative approved PMM monitor (K152330) is added.
- Spine Coil B applicable for the dockable patient table is added as the alternative of Spine Coil.
- Application software is changed to V11.0A.
A rationale analysis was then conducted, and the results are contained in Table 1.
Table 1 Performance Analysis
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Bench | Performance bench testing was conducted on the applicable new feature. |
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| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Clinical | Clinical image examples are provided for applicable new feature and that we judged to be sufficient to evaluate clinical usability. |
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 is substantially equivalent to the ECHELON Synergy MRI System (K241429). See tables below.
The technological characteristics in regard to software of the ECHELON Synergy and the predicate are listed in Table 2.
Table 2 Comparison: Hardware
| ITEM | PREDICATE DEVICEECHELON Synergy MRI System (K241429) | SUBJECT DEVICEECHELON Synergy | DIFFERENCE |
|---|---|---|---|
| System | |||
| Standards Met | 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 | 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 | No |
| 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 | 63.86MHz | 63.86MHz | No |
| Bore dimension | Circle shape with diameter 70cm | Circle shape with diameter 70cm | No |
| Gradient System | |||
| Gradient Strength | 33mT/m | 33mT/m | No |
| Slew Rate | 130 T/m/sec | 130 T/m/sec | No |
| Rise Time | 254μsec to 33mT/m | 254μsec to 33mT/m | No |
| Audible Noise (MCAN) | |||
| Ambient | 59.9 dBA | 59.9 dBA | No |
| Lpeak | 122.7 dBA | 122.7 dBA | No |
| Leq | 116.5 dBA | 116.5 dBA | No |
| RF System | |||
| Transmitter channels | 1 | 1 | No |
| Peak Envelop Power | 18 kW | 18 kW | No |
| Duty Cycle | 85% (Gating max), 10% at full power | 85% (Gating max), 10% at full power | No |
| RF receiver channel | 32 | 32 | No |
| PMM | Internal Type Name: EM-7 | Internal Type Name: EM-7 or EM-7A | No |
| Patient table | Fixed table | Fixed table or Dockable table | Yes |
The hardware differences from the predicate device to the ECHELON Synergy are analyzed in Table 3.
Table 3 Hardware 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 | Alternative super-conducting magnet (ZeroHelium) and units related to alternative super-conducting magnet are added.Alternative patient table (dockable patient table) and units related to alternative patient table are added.Alternative approved PMM monitor (K152330) is added.These devices have changed but there are no significant changes in technology, engineering and performance. |
| Significant Changes | ☐ Manufacturing Process ☐ Labeling ☐ Technology ☐ Performance☐ Engineering ☐ Materials ☐ Others ☑ None (See rationale statement) |
| FUJIFILM Rationale Statement | There are no significant changes in technological characteristics.For safety, gradient system, RF system, PMM and Patient table is controlled according to same regulation as ECHELON Synergy MRI system (K241429). So, safety and effectively of the device are same as ECHELON Synergy MRI System (K241429). |
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The technological characteristics in regards to coils of the ECHELON Synergy and the predicate are listed in Table 4.
Table 4 Comparison: RF Coils
| ITEM | PREDICATE DEVICEECHELON Synergy MRI System (K241429) | SUBJECT DEVICEECHELON Synergy | DIFFERENCE |
|---|---|---|---|
| RF Coils | |||
| Transmit Coil | T/R Body | T/R Body | No |
| Receiver Coils | FlexFit Neuro Coil | FlexFit Neuro Coil | No |
| FlexFit Blanket Coil A,FlexFit Blanket Coil B | FlexFit Blanket Coil A,FlexFit Blanket Coil B | No | |
| Extremity Coil | Extremity Coil | No | |
| Hand/Wrist Coil | Hand/Wrist Coil | No | |
| Breast CoilBreast Support Kit 2Breast Coil 17Breast Support Holder | Breast CoilBreast Support Kit 2Breast Coil 17Breast Support Holder | No | |
| Micro Coil A,Micro Coil B | Micro Coil A,Micro Coil B | No | |
| Shoulder Coil | Shoulder Coil | No | |
| Spine Coil | Spine Coil,Spine Coil B | Yes | |
| Foot/Ankle Coil | Foot/Ankle Coil | No | |
| Flex M Coil, Flex S Coil | Flex M Coil, Flex S Coil | No |
The coil differences from the predicate device to the ECHELON Synergy are analyzed in Table 5.
Table 5 Coil 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 | Spine Coil B applicable for the dockable patient table is added as the alternative of Spine Coil.These devices have changed but there are no significant changes in technology, engineering and performance. |
| Significant Changes | ☐ Manufacturing Process ☐ Labeling ☐ Technology ☐ Performance☐ Engineering ☐ Materials ☐ Others ☑ None (See rationale statement) |
| FUJIFILM Rationale Statement | There are no significant changes in technological characteristics. Therefore, safety, intended use and effectively of the RF coils are same as ECHELON Synergy MRI System (K241429). |
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The technological characteristics in regard to changes in functionality of the ECHELON Synergy as compared to the predicate are listed in Table 6.
Table 6 Comparison: Functionality
| ITEM | DIFFERENCES | ANALYSIS |
|---|---|---|
| Operating System | None | No |
| CPU Platform | None | No |
| Application Software | Going from V10.0A from V11.0A | See Table 7 |
| Scan Tasks | Following positioning applications are added.- AutoPose Abdomen, AutoPose Pelvis for male, AutoPose Pelvis for female, AutoPose CardiacFollowing positioning applications are modified.- AutoPose Knee, AutoPose Shoulder, AutoPose HipJoint | See Table 7 |
| 2D Processing Tasks | None | No |
| 3D Processing Tasks | Following function is modified.- Multiplanar Reformatting (MPR) | See Table 7 |
| Analysis Tasks | None | No |
| Maintenance Tasks | None | No |
| Viewport Tools | None | No |
| Film, Archive Tools | None | No |
| Network Tools | Following function is modified.-AutoProtocol | See Table 7 |
| Protocol Enhancements | Following Protocol Enhancements are modified.- Gating: cardiac, peripheral pulse (with multi-gate delay parameter and SSFP capability), Respiratory Gating- Echo Planar, Diffusion Weighted Imaging- Beam Navi- Enhanced PC (improvement of Cine PC)- AutoExam- Navigated StillShot, Visual StillShot- IQ RetouchFollowing Protocol Enhancements are enhanced.- k-RAPID- IP-Scan | See Table 7 |
| Pulse Sequences | Following changes are added in Pulse Sequences.- 2D GE, 2D RSSG, 3D RSSG, 2D GE EPI, 2D DW EPI, 2D Soft GE"DLR Symmetry" is added. | See Table 7 |
| Monitoring Tools | Following function is modified.- Synergy Vision | No |
The functionality differences from the predicate device to the ECHELON Synergy are analyzed in Table 7.
Table 7 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 to V11.0A.• Following positioning applications are added in Scan Tasks.- AutoPose Abdomen, AutoPose Pelvis for male, AutoPose Pelvis for female, AutoPose Cardiac• Following positioning applications are modified in Scan Tasks.- AutoPose Knee, AutoPose Shoulder, AutoPose HipJoint• Following function is modified in 3D Processing Tasks.- Multiplanar Reformatting (MPR)• Following function is modified in Network Tools.- AutoProtocol• Following functions of Protocol Enhancements are modified. |
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- Gating: cardiac, peripheral pulse (with multi-gate delay parameter and SSFP capability), Respiratory Gating
- Echo Planar, Diffusion Weighted Imaging
- Beam Navi
- Enhanced PC (improvement of Cine PC)
- AutoExam
- Navigated StillShot, Visual StillShot
- IQ Retouch
• Following functions of Protocol Enhancements are enhanced. - k-RAPID
- IP-Scan
• Following changes are added in Pulse Sequences. - 2D GE, 2D RSSG, 3D RSSG, 2D GE EPI, 2D DW EPI, 2D Soft GE
"DLR Symmetry" is added.
• Following function is modified in Monitoring Tools. - Synergy Vision
| Significant Changes | ☐ Manufacturing Process ☐ Labeling ☐ Technology ☐ Performance☐ Engineering ☐ Materials ☐ Others ☑ None (See rationale statement) |
|---|---|
| FUJIFILM Rationale Statement | There are no significant changes in technological characteristics.For safety, pulse sequences are controlled according to the same safety limits as ECHELON Synergy MRI System (K241429). Therefore, safety and effectiveness of the device are the same as ECHELON Synergy MRI System (K241429). |
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Substantial Equivalence
A summary decision was based on analysis of Table 8.
Table 8 Rationale Analysis: ECHELON Synergy vs. Predicate
| ITEM | Overall Rationale Analysis |
|---|---|
| Hardware | Some alternative hardware are added but there are no significant changes in technological characteristics. So, safety and effectively of the device are same as ECHELON Synergy MRI System (K241429). |
| Coils | Alternative coil is added but there are no significant changes in technological characteristics.For safety, gradient system and RF system is controlled according to same regulation as ECHELON Synergy MRI System (K241429). So, safety and effectively of the device are same as ECHELON Synergy MRI System (K241429). |
| Functionality | Additional functions do not constitute a new intended use. There are no significant changes in technological characteristics. So, safety and effectivity of the device are equivalent to ECHELON Synergy MRI System (K241429). |
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 Synergy MRI System (K241429)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
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Summary of Non-Clinical Testing
The ECHELON Synergy was subjected to the following laboratory testing.
- 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 60601-2-33 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.
- IEC 62304 Edition 1.1 2015-06, CONSOLIDATED VERSION medical device software - software life cycle processes.
- IEC 60601-1-2 Edition 4.1:2020-09, CONSOLIDATED VERSION medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests.
The revisions to the ECHELON Synergy will have no effect on the standards tests, which were conducted on the ECHELON Synergy MRI System (K241429) and included in the original submission.
Therefore, ECHELON Synergy is in conformance with the applicable parts of the following 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 Magnetic Resonance Imaging Devices
- NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
- NEMA MS 8-2016, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- NEMA Standards Publication MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
- IEC 60825-1:2014, safety of laser products – part 1: equipment classification and requirements.
Summary of Clinical Testing
Clinical images were collected and analyzed, to ensure that images from the new feature meet user needs.
The validation results of the new features using machine learning (DLR Symmetry and AutoPose) were described below.
Performance tests of DLR Symmetry were conducted by using phantoms in terms of artifact reduction, SNR, image sharpness, and image contrast. The phantom testing demonstrated that DLR Symmetry could reduce artifacts in the image by using the metric of Normalized Root Mean Square Error (NRMSE). The phantom testing also demonstrated that DLR Symmetry did not degrade the image quality by using the metrics of SNR, Relative Edge Sharpness, and Contrast Change Rate. In addition, three US board certified radiologists reviewed the image quality in clinical image with DLR Symmetry in terms of the artifact reduction, SNR, image sharpness, lesion conspicuity, and overall image quality. The images reconstructed with either the conventional method or DLR Symmetry were randomized, blinded to the reviewers, and
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compared by the reviewers in terms of image quality metrics (artifact reduction, SNR, image sharpness, lesion conspicuity, and overall image quality) using 3-point scale. All images used for this comparison were also evaluated by the reviewers in terms of clinical acceptability. The 89 unique subjects (patients and healthy subjects) from U.S. and Japan (Male: 58, Female:31, Age: 14 - 90 years old, BMI:16.3 – 49.6) were scanned in the anatomical regions that DLR Symmetry supported to provide the test datasets using FUJIFILM 1.5T MRI Scanners (ECHELON Smart, ECHELON OVAL, and ECHELON Synergy). The total of 178 images in multiple orientations (axial, sagittal and coronal), and various contrast weightings (T1-/T2*-weighted image, DWI) were obtained for the test dataset by pulse sequences of GE, Soft GE, RSSG (2D/3D), DW EPI, GE EPI. The test dataset was independent of the training and validation datasets. The review results indicated that the artifact reduction, SNR, image sharpness, lesion conspicuity, and overall image quality in the images with DLR Symmetry were superior to those in the conventional images with statistically significant difference (p<0.05). All of images with DLR Symmetry were evaluated as clinically acceptable by the reviewers. In conclusion, the phantom testing and the clinical Image testing demonstrated that DLR Symmetry could reduce the artifact in the image and did not degrade the image quality compared to the conventional methods.
The performance tests of AutoPose Shoulder, Knee, HipJoint, Abdomen, Pelvis for male, Pelvis for female and Cardiac were conducted by the three certified radiological technologists.
The evaluation results showed that the almost cases in AutoPose Shoulder, Knee, HipJoint, Abdomen, Pelvis for male, Pelvis for female and Cardiac were able to set the slice positions for a scan without manual adjustment. The evaluation results also showed that the remaining cases were the same user operation steps as the manual slice positioning as without using AutoPose.
The information on the data in the single evaluations is shown below.
| Shoulder | Knee | HipJoint | Abdomen | Pelvis for male | Pelvis for female | Cardiac | |
|---|---|---|---|---|---|---|---|
| Number of cases | 60 | 60 | 65 | 115 | 60 | 68 | 126 |
| Data acquisition site | FUJIFILM Corp., FUJIFILM Healthcare Americas Corp., clinical sites | FUJIFILM Corp., clinical site | FUJIFILM Corp., FUJIFILM Healthcare Americas Corp., clinical site | ||||
| Subject Type | Healthy volunteer and patients |
As a result of the analysis:
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing – Clinical | Clinical image examples are provided for applicable new feature and that we judged to be sufficient to evaluate clinical usability. In addition, radiologists validated that the clinical images have acceptable image quality for clinical use. |
Conclusions
It is the opinion of FUJIFILM, the ECHELON Synergy is substantially equivalent with respect to hardware, software, safety, effectiveness, and functionality to the ECHELON Synergy MRI System (K241429).
§ 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.