(84 days)
ECHELON Synergy V10.0 (K233687)
Not Found
No
The summary mentions "image processing" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The description of performance studies and lack of information on training/test sets for AI/ML models further supports this conclusion.
No
The device is described as an imaging device intended for diagnosis, not for treating any condition. Its purpose is to produce images that are useful in diagnosis determination.
Yes
The "Intended Use / Indications for Use" section states: "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." This explicitly indicates the device's role in diagnosis. The "Performance Testing - Bench" section also mentions "new feature perform as intended for diagnostic use."
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 IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The ECHELON Synergy System is an imaging device that uses Magnetic Resonance Imaging (MRI) to create images of the internal structure of the body without taking specimens. It provides physiological and clinical information directly from the patient.
The description clearly states it's an "imaging device" and obtains information "non-invasively and without the use of ionizing radiation." This aligns with the function of an MRI system, which is distinct from an IVD.
N/A
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, spinlattice relaxation time (TI), 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:
- · TI, T2, proton density weighted imaging
- · Diffusion weighted imaging
- · MR Angiography
- · Image processing
- · Spectroscopy
- · Whole Body
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design.
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 maqnetic 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 varving 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, Body, Spine, Extremities, Breast (specific to new coil)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
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
Clinical image examples are provided for applicable new feature 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Bench: Performance bench testing was conducted on the applicable new feature. Test data confirmed that new feature perform as intended for diagnostic use.
Performance Testing - Clinical: Clinical image examples are provided for applicable new feature and that we judged to be sufficient to evaluate clinical usability.
Clinical images were collected and analyzed, to ensure that images from the new feature meet user needs. As a result of the analysis: Clinical image examples are provided for applicable new feature 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ECHELON Synergy V10.0 (K233687)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 13, 2024
FUJIFILM Healthcare Corporation Chaitrali Kulkarni Sr. Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Ave Suite 300 Lexington, Massachusetts 02421
Re: K241429
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: May 21, 2024 Received: May 21, 2024
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" (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).
1
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 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-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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel M. Krainak, Ph.D. 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
2
Indications for Use
Submission Number (if known)
K241429
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, spinlattice relaxation time (TI), 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:
- · TI, 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
510(k) Summary
4
Submitter Information
| Submitter: | FUJIFILM Healthcare Corporation
2-1, Shintoyofuta
Kashiwa-shi, Chiba, 277-0804 Japan |
|-------------------|--------------------------------------------------------------------------------------------|
| Contact: | David Loeser
Regulatory Affairs Specialist |
| Telephone number: | 703-472-9452 |
| Telephone number: | HCUSRegulatoryAffairs@fujifilm.com |
| Data: | May 15, 2024 |
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 Synergy V10.0 (K233687) |
|---|---|
| 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
- MR Angiography
- Image processing
- Spectroscopy
- . Whole Body
5
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 ubiguitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static maqnetic 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 varving 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 MRI System is equivalent to the ECHELON Synergy V10.0 (K233687) with following exceptions:
- . Breast Coil 17 is added.
A rationale analysis was then conducted, and the results are contained in Table 1.
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Bench | Performance bench testing was conducted on the applicable new feature. |
| Test data confirmed that new feature perform as intended for diagnostic use. | |
| Performance Testing - | |
| Clinical | Clinical image examples are provided for applicable new feature and that we judged to be sufficient to evaluate clinical |
| usability. |
Table 1 Performance Analysis
6
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 is substantially equivalent to the ECHELON Synergy V10.0 (K233687). See tables below.
Te technological characteristics in regard to software of the ECHELON Synergy MRI System and the predicate are listed in Table 2.
| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE | |
|---|---|---|---|---|
| ECHELON Synergy V10.0 (K233687) | ECHELON Synergy MRI System | |||
| 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 |
Table 2 Comparison: Hardware
The hardware differences from the predicate device to the ECHELON Synergy MRI System 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 | The new receiver coil named Breast coil 17 is added to ECHELON Synergy MRI system. 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 | Added coil doesn't 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 Synergy V10.0
(K233687). So, safety and effectively of the device are same as ECHELON Synergy V10.0 (K233687). | | | | |
7
The technological characteristics in regards to coils of the ECHELON Synergy MRI System and the predicate are listed in Table 4.
| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | 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 Coil | Breast Coil | Yes | ||
| Breast Support Kit 2 | Breast Support Kit 2 | |||
| Breast Coil 17 | ||||
| Breast Support Holder | ||||
| Micro Coil A, | ||||
| Micro Coil B | Micro Coil A, | |||
| Micro Coil B | No | |||
| Shoulder Coil | Shoulder Coil | No | ||
| Spine Coil | Spine Coil | No | ||
| Foot/Ankle Coil | Foot/Ankle Coil | No | ||
| Flex M Coil, Flex S Coil | Flex M Coil, Flex S Coil | No |
| Table 4 Comparison: RF Coils | ||||
|---|---|---|---|---|
| -- | -- | ------------------------------ | -- | -- |
The coil differences from the predicate device to the ECHELON Synergy MRI System 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 | Breast coil 17 is added to ECHELON synergy MRI system. | | | |
| Significant
Changes | Manufacturing Process | Labeling | Technology | Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| FUJIFILM
Rationale
Statement | | | | Added coil doesn't constitute a new intended use. There are no significant changes in technological characteristics.
Therefore, safety, intended use and effectively of the RF coils are same as ECHELON Synergy V10.0 (K233687). |
8
The technological characteristics in regard to changes in functionality of the ECHELON Synergy MRI System 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 | None | No |
| Scan Tasks | None | No |
| 2D Processing Tasks | None | No |
| 3D Processing Tasks | None | No |
| Analysis Tasks | None | No |
| Maintenance Tasks | None | No |
| Viewport Tools | None | No |
| Film, Archive Tools | None | No |
| Network Tools | None | No |
| Protocol Enhancements | None | No |
| Pulse Sequences | None | No |
| Monitoring Tools | None | No |
The functionality differences from the predicate device to the ECHELON Synergy MRI System 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 | There are no differences from the predicate device. | |||
| 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 V10.0 | ||||
| (K233687). Therefore, safety and effectiveness of the device are the same as ECHELON Synergy V10.0 (K233687). |
9
Substantial Equivalence
A summary decision was based on analysis of Table 8.
Table 8 Rationale Analysis: ECHELON Synergy MRI System vs. Predicate
| ITEM | Overall Rationale Analysis |
|---|---|
| Hardware | There are no differences regarding hardware units. |
| Coils | Added coil doesn't 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 Synergy V10.0 | |
| (K233687). So, safety and effectively of the device are same as ECHELON Synergy V10.0 (K233687). | |
| Functionality | There are no differences regarding software functionality. |
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 MRI System is considered substantially equivalent to the currently marketed predicate device (ECHELON Synergy V10.0 (K233687)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
10
Summary of Non-Clinical Testing
The ECHELON Synergy MRI System 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 MRI System will have no effect on the standards tests, which were conducted on the ECHELON Synergy V10.0 (K233687) and included in the original submission.
Therefore, ECHELON Synergy MRI System 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 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 Edition 2.0 2007-03, Safety of laser products - Part 1 : Equipment classification and requirements [including : Technical Corrigendum 1 (2008) interpretation Sheet 1 (2007) Interpretaion Sheet 2 (2007)]
Summary of Clinical Testing
Clinical images were collected and analyzed, to ensure that images from the new feature meet user needs.
As a result of the analysis:
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing – | Clinical image examples are provided for applicable new feature and that we judged to be sufficient to evaluate clinical |
| Clinical | usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use. |
Conclusions
The ECHELON Synergy MRI System is substantially equivalent with respect to hardware, software, safety, effectiveness, and functionality to the ECHELON Synergy V10.0 (K233687).