(241 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 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.
The provided document, K223426, is a 510(k) premarket notification for the FUJIFILM Healthcare Corporation's ECHELON Synergy MRI system. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (ECHELON OVAL V6.0A MRI system, K172110) rather than presenting a detailed performance study with explicit acceptance criteria for an AI/ML powered device as typically required for novel AI products.
However, the document mentions several new features powered by Machine Learning (ML), specifically Deep Learning Reconstruction (DLR), AutoClip, AutoPose Spine, AutoPose Shoulder, and AutoPose Knee. For DLR, some form of evaluation was performed. For AutoClip and AutoPose functions, performance comparisons were made against manual operations.
Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as one would expect for a dedicated AI/ML device approval, is not explicitly stated with numerical thresholds. The evaluations are largely qualitative or comparative to existing methods.
Below is an attempt to extract the closest information to your request, specifically focusing on the DLR, AutoClip, and AutoPose functions, as they are the only "AI/ML powered" components mentioned with specific evaluations.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit numerical acceptance criteria are not provided for the AI/ML components, the table below consolidates the stated evaluative goals and findings from the "Summary of Clinical Testing" section.
| Feature (AI/ML Powered) | Acceptance Criteria (Implicit from study goals) | Reported Device Performance |
|---|---|---|
| Deep Learning Reconstruction (DLR) | Image Quality Equivalence/Improvement: DLR images should be "equivalent or better" than conventional images in terms of SNR, sharpness, lesion conspicuity, and overall image quality. Motion Artifact Handling: DLR should not "significantly change the appearance of motion artifacts." Shorter Scan Time Efficacy: DLR images taken with shorter scan times should be "acceptable for routine examinations." Resolution Improvement: High-resolution DLR images should be "better or equivalent" to low-resolution conventional images. | Image Quality Equivalence/Improvement: - SNR: Equivalent or better in 81 out of 81 cases. - Sharpness: Equivalent or better in 80 out of 81 cases. - Lesion Conspicuity: Equivalent or better in 45 out of 45 cases (with pathology). - Overall Image Quality: Equivalent or better in all cases. Motion Artifact Handling: Rated as better or equivalent image quality in all 3 image pairs with motion artifacts, indicating DLR did not significantly change their appearance. Shorter Scan Time Efficacy: DLR images with shorter scan times were rated "acceptable for routine examinations" in all 18 cases. Resolution Improvement: High-resolution DLR images were rated "better or equivalent" image quality in all cases compared to low-resolution conventional images. |
| AutoClip | Performance Equivalence: Performance should be "substantially equivalent" to manual clipping. | Confirmed that the performance of AutoClip was "substantially equivalent to that of manual clipping." |
| AutoPose (Spine, Shoulder, Knee) | Efficiency Improvement/Equivalence: Should reduce time and number of steps in slice positioning compared to manual, or at least show the "same time and number of steps." | Spine, Shoulder, and Knee: - Many cases were able to reduce the time and number of steps in slice positioning compared to manual. - Remaining cases showed the same time and number of steps as manual slice positioning. |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Deep Learning Reconstruction (DLR):
- Number of cases: 110 cases for DLR image quality evaluation (including 81 cases for SNR/sharpness/overall IQ, 45 cases with pathology for lesion conspicuity, 3 cases for motion artifacts, and 18 cases for shorter scan time evaluation). The exact breakdown per sub-analysis is specified.
- Data Provenance: ECHELON OVAL, ECHELON Smart, and ECHELON Synergy MRI systems (all FUJIFILM Healthcare Corporation 1.5T MRI systems). Data acquired at "FUJIFILM Healthcare Corporation and clinical site."
- Subject Type: Healthy volunteer and patient.
- Anatomical Coverage: Head, Spine, Cardiac, Breast, Abdomen, Pelvis, Shoulder, Wrist, Knee, Ankle.
-
AutoClip:
- Number of cases: 40 cases.
- Data Provenance: ECHELON Synergy MRI system (FUJIFILM Healthcare Corporation 1.5T MRI system). Data acquired at "FUJIFILM Healthcare Corporation."
- Subject Type: Japanese healthy volunteers.
- Anatomical Coverage: Brain (using 3D TOF, 3D Soft TOF scan sequences).
-
AutoPose (Spine, Shoulder, Knee):
- Number of cases: Spine (146 cases), Shoulder (48 cases), Knee (38 cases).
- Data Provenance: ECHELON Synergy MRI system (FUJIFILM Healthcare Corporation 1.5T MRI system). Data acquired at "FUJIFILM Healthcare Corporation."
- Subject Type: Japanese healthy volunteers.
- Anatomical Coverage: Spine, Shoulder, Knee.
Note: The document does not explicitly state if the data was retrospective or prospective. Given the nature of performance testing within a company and potentially a clinical site, it could be a mix or internal prospective collection, but it's not specified. The country of origin for the "clinical site" data is also not explicitly stated beyond "Japanese healthy volunteers" for AutoClip/AutoPose, implying at least part of the data is from Japan for those features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
-
Deep Learning Reconstruction (DLR):
- Number of Experts: Three (3) US certified radiologists.
- Qualifications: "US certified radiologists." No specific years of experience or subspecialty are provided, beyond their certification.
-
AutoClip & AutoPose (Spine, Shoulder, Knee):
- Number of Experts: Not specified as "experts" establishing ground truth, but rather "certified radiological technologists" performed the performance comparison/evaluation. The ground truth for performance was implicitly "manual operation" by these technologists. Their qualifications are listed as "certified radiological technologists."
4. Adjudication Method for the Test Set
-
Deep Learning Reconstruction (DLR): The document states "Readers compared pairs of DLR images and conventional images (without DLR) for each case to evaluate image quality of DLR images." It does not specify an explicit adjudication method (e.g., 2+1, 3+1). It merely presents the results as derived from the collective evaluation of the three radiologists. It's unclear if consensus was required, or if individual ratings were aggregated.
-
AutoClip & AutoPose: The evaluation was done by "certified radiological technologists" comparing against manual operation. No formal adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
-
Deep Learning Reconstruction (DLR): A study involving multiple readers (3 US certified radiologists) and multiple cases (110 cases in total for DLR evaluation) was performed, which aligns with the spirit of an MRMC study. However, it's not explicitly labeled as such, and the methodology primarily focuses on qualitative comparison of image quality between DLR and conventional images rather than a comparative effectiveness study of human reader diagnostic performance with vs. without AI assistance for a specific diagnostic task.
- Effect Size of Human Reader Improvement: This type of effect size (e.g., AUC uplift) is not reported. The study focused on assessing image quality attributes and acceptability for routine examinations from the DLR images themselves, as perceived by radiologists, not on how DLR assistance changes a radiologist's diagnostic accuracy or efficiency on a specific clinical task. The evaluation was primarily about the AI's impact on image characteristics, not human diagnostic performance.
-
AutoClip & AutoPose: These evaluations were focused on the efficiency and equivalence of the automated process compared to manual operation, as assessed by technologists. They were not MRMC studies designed to measure impact on human readers' diagnostic effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- The document implies a standalone assessment of the DLR output quality (SNR, sharpness, etc.) against conventional images, as rated by radiologists. The AutoClip and AutoPose functions are also inherently standalone algorithms that automate tasks, with their performance evaluated against manual methods. However, no formal "standalone performance study" with typical metrics like sensitivity, specificity, or AUC for a diagnostic task is presented for these AI/ML components in isolation. The evaluation focuses on product-level performance and usability.
7. The Type of Ground Truth Used
-
Deep Learning Reconstruction (DLR): The ground truth for evaluation was expert consensus/opinion (or individual expert assessment) of the image quality attributes (SNR, sharpness, lesion conspicuity, overall image quality) when comparing DLR images to conventional images. The underlying "ground truth" for the cases themselves (e.g., presence of pathology) would presumably come from standard clinical diagnostic reports or other confirmed findings, but the DLR study's focus was on image quality as assessed by experts.
-
AutoClip & AutoPose: The ground truth for these functions was the manual operation by certified radiological technologists. The evaluation aimed to determine if the automated function delivered equivalent or better performance (in terms of results and/or efficiency) compared to the human-performed task.
8. The Sample Size for the Training Set
- The document does not provide any details on the sample size used for the training set for DLR, AutoClip, or AutoPose. This information is typically proprietary and not included in 510(k) summaries unless specifically requested by the FDA or deemed critical for demonstrating substantial equivalence for a novel AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Similar to the training set sample size, the document does not provide any details on how the ground truth for the training set was established for DLR, AutoClip, or AutoPose.
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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
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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
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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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ECHELON Synergy MRI system 510(k) Summary
Submitter Information
| Submitter: | FUJIFILM Healthcare Corporation2-1, ShintoyofutaKashiwa-shi, Chiba, 277-0804 Japan |
|---|---|
| Contact Person: | Kotei AokiManager, 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
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- . 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.
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| 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 14IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | Yes |
| Magnet andGantry | Type and FieldStrength | 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
| FDARequirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does notconstitute a new intended use; and any differences in technological characteristics are accompanied by information thatdemonstrates the device is as safe and effective as the predicate and do not raise different questions of safety andeffectiveness 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)). | |||
|---|---|---|---|---|
| DeviceModificationSummary | Gantry bore dimension is changed from oval shape with 74cm x 65cm to circle shape with diameter 70cm. Gradientfield strength and slew rate, RF system Transmitter channels, Peak Envelop Power and Duty Cycle. Conformity toNEMA MS 14. | |||
| SignificantChanges | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) | |
| FUJIFILMRationaleStatement | Modified specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics. For safety, gradient system and RF system is controlled according to same regulation as ECHELONOVAL. 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 AnteriorHead attachmentWIT Posterior Head/Neck coil B | FlexFit Neuro Coil | Yes | |
| WIT Torso coilWIT Torso coil 12WIT Torso coil 8 | FlexFit Blanket Coil A,FlexFit Blanket Coil B | Yes | ||
| Extremity coil (Knee) | Extremity Coil | No | ||
| WIT Anterior Neck attachmentWIT Anterior Neck attachment B | N/A | N/A | ||
| Hand/Wrist coil | Hand/Wrist Coil | No | ||
| WIT Anterior NV attachment | N/A | No | ||
| Breast | Breast CoilBreast Support Kit 2 | Yes |
Table 3 Comparison: RF Coils
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| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE |
|---|---|---|---|
| ECHELON OVAL V6.0A (K172110) | ECHELON Synergy | ||
| MP coil 140A, BMicro coil (S) A, B | Micro Coil A, Micro Coil B | Yes | |
| Shoulder coilShoulder coil 8 | Shoulder Coil | No | |
| WIT Spine coil 12WIT Spine coil AWIT Spine coil 8WIT 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.
| FDARequirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does notconstitute a new intended use; and any differences in technological characteristics are accompanied by information thatdemonstrates the device is as safe and effective as the predicate and do not raise different questions of safety andeffectiveness 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)). | |||
|---|---|---|---|---|
| DeviceModificationSummary | FlexFit Neuro Coil is changed from ECHELON OVAL WIT Posterior Head/Neck coil, WIT Anterior Headattachment, WIT Posterior Head/Neck coil B, WIT Anterior Neck attachment and WIT Anterior Neck attachmentB.FlexFit Blanket Coil A and FlexFit Blanket Coil B are changed from ECHELON OVAL WIT Torso coil, WIT Torsocoil 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 WITSpine 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. | |||
| SignificantChanges | Manufacturing Process | Labeling | Technology | Performance |
| Engineering | Materials | Others | None (See rationale statement) | |
| FUJIFILMRationaleStatement | Revised coils do not constitute a new intended use. There are no significant changes in technological characteristicsDuring transmitter coil operation, RF Coils are de-resonated for the safety function by same scheme as ECHELONOVAL(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 MachineLearning | 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
| FDARequirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does notconstitute a new intended use; and any differences in technological characteristics are accompanied by information thatdemonstrates the device is as safe and effective as the predicate and do not raise different questions of safety andeffectiveness 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)). |
|---|---|
| DeviceModificationSummary | 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, SpineFollowing 3D Processing Tasks are added:- Auto VR- Auto ClipFollowing protocol enhancement are added:- HiMAR Advanced- Double-IR isoFSE- AutoExam- Auto Table Centering |
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| - 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) | |||||
| SignificantChanges | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance | |
| □ Engineering | □ Materials | □ Others | ✓ None (See rationale statement) | ||
| FUJIFILMRationaleStatement | Modified functions do not constitute a new intended use. There are no significant changes in technologicalcharacteristics. 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 technologicalcharacteristics. For safety, gradient system and RF system is controlled according to same regulation as ECHELONOVAL. 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 ECHELONOVAL(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 toevaluate clinical usability. In addition, a radiologist validated that the clinical images have acceptable image quality forclinical 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).
§ 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.