(104 days)
The ECHELON Oval 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 OVAL 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 MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.
This request is asking for a detailed breakdown of the acceptance criteria and the study used to validate the ECHELON Oval V5.0 MRI system, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a traditional table format for performance metrics. Instead, the acceptance is based on qualitative assessments and comparisons to the predicate device.
| Testing Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance Testing - Clinical | Acceptable image quality for clinical use. | "A radiologist validated that the clinical images have acceptable image quality for clinical use." |
| Performance Testing - Bench | New features perform as intended for diagnostic use. | "We confirmed that each new feature performs as intended for diagnostic use." Specifically for each new feature: - ASL-Perfusion: "Test results confirm ASL-Perfusion acquires perfusion images using labeled blood flowing into the brain tissue without Contrast-Enhanced both in phantom simulations and clinical results." - Beam Sat VASC-ASL: "Test results confirm Beam Sat improves the visibility of the portal vein in making MIP images both in phantom simulations and clinical results." - Breast MRS: "Test results from phantom simulations and clinical results confirm MRS (Magnetic Resonance Spectroscopy) acquires the magnetic resonance signal of in vivo metabolites through chemical shift phenomenon and can detect Choline as metabolite in the breast area." - Enhanced PC: "Test results from phantom simulations and clinical results indicate a reduction in scan time of phase contrast (PC) sequence in 2D and 3D by shorting the TR by optimizing velocity encode gradient and applied parallel imaging (RAPID). As a result of this improvement, we can shorten scan time of '4D flow' which is time-resolved (CINE) three-dimensional (3D) spatial encoding combined with three-directional velocityencoded phase contrast MRI." - Fat and water separation scan (FSE, RSSG, GE): "Test results from phantom simulations and clinical results indicate reliable and uniform fat suppression by utilizing the difference between resonant frequencies due to chemical shift of water protons and fat protons to obtain a water image and a fat image. The chemical shift of a water signal and a fat signal receives two echo signals at the timing which becomes an in-phase and an out-of-phase. By adding and subtracting it, a water image and a fat image are simultaneously acquirable." - k-RAPID: "Test results from phantom simulations and clinical results indicate that k-space parallel imaging technique accelerates the scan by acquiring k-space data with skipped phase encoding and skipped position which is filled with estimated data by the interpolation of neighboring data." - Multi b and DKI: "Test results from phantom simulations and clinical results confirm Multi b DKI images can be acquired in one scan utilizing Tensor 15 and Tensor 30 being added to the number of MPG Axes. Diffusion Kurtosis Imaging (DKI) is the diffusion-weighted imaging technique in restriction." - opFSE / opFIR: "Test results from phantom simulations and clinical results confirm by deriving opFSE and opFIR sequence from the primeFSE and primeFIR image quality is improved." - PBSG: "Test results from phantom simulations and clinical results confirm PBSG which is a sequence based on BASG sequence improves to mitigate the dark band artifact which is unique to BASG sequence. The PBSG sequence makes it possible to acquire BASG images under the condition of inhomogeneous magnetic field with less band artifact." - RADAR-GE/TOF: "Test results from phantom simulations and clinical results confirm the RADAR measurement feature is functioning with the GE and TOF sequence." - T2 RelaxMap:* "Test results from phantom simulations and clinical results confirm that T2* relaxation time can be mapped on morphological image in color by using T2* RelaxMap function. The T2* RelaxMap function consists of (a) acquisition of multi-echo images (up to 32) and (b) analysis of T2* relaxation time." |
| Substantial Equivalence | Hardware, coils, and functionality are substantially equivalent to the predicate device in design features, fundamental scientific technology, indications for use, and safety and effectiveness. | "based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed ECHELON Oval V5.0 MRI is considered substantially equivalent to the currently marketed predicate device (ECHELON Oval MRI System (K113145)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "Clinical images were collected and analyzed, to ensure that images from the new features meet user needs."
- "We provide clinical image examples for each new feature..."
However, the specific sample size (number of images or patients) used for the clinical test set is not provided in the document.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It only mentions "clinical images were collected," implying real patient data, but without further detail.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: "A radiologist" (singular) validated the clinical images.
- Qualifications of Experts: The document specifies "a radiologist." No further details on their experience (e.g., "10 years of experience") are provided.
4. Adjudication Method for the Test Set
The document mentions "a radiologist validated" the images. This suggests a single expert review. There is no mention of an adjudication method such as 2+1, 3+1, or any multi-reader consensus process for the clinical images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this submission. This submission is for a software update to an MRI system itself, not an AI-assisted diagnostic tool for readers. The "AI" features (like k-RAPID for image acceleration or certain processing tasks) are integrated into image acquisition and reconstruction, not designed to directly assist human interpretation in a comparative effectiveness study setting mentioned in the question.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "Performance Evaluation" section indicates that both "Performance Testing - Clinical" and "Performance Testing - Bench" were conducted for the new features.
- Bench tests involved "phantom simulations," which represents an algorithm-only evaluation for the technical performance of specific sequences.
- Clinical tests involved collecting and analyzing clinical images, and "a radiologist validated" them. While a human reviewed the output, the core algorithms for the new features (e.g., ASL-Perfusion generating perfusion images, T2* RelaxMap creating maps) operate in a standalone manner to produce these outputs before human interpretation.
Therefore, standalone performance tests were conducted for the new features on phantoms, and the resulting clinical images were then validated by a radiologist. The focus was on the technical and image quality output of the new algorithms, not diagnostic accuracy in a standalone AI context compared to a ground truth.
7. The Type of Ground Truth Used
- For the bench tests (phantom simulations), the "ground truth" would be the known physical properties and configurations of the phantom, allowing for objective measurement of parameters like signal-to-noise ratio, geometric distortion, etc.
- For the clinical validation, the ground truth appears to be expert consensus or opinion from "a radiologist" who validated the "acceptable image quality for clinical use." There is no mention of pathology, outcomes data, or a multi-expert consensus forming the ground truth.
8. The Sample Size for the Training Set
The document does not describe the development or training of new algorithms in a way that suggests a "training set" in the context of machine learning. The enhanced features are described as software updates and new pulse sequences. Therefore, there is no information provided regarding a training set size. This submission focuses on the performance verification and validation of the software update, not the development process of, for example, a deep learning model.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned in the context of machine learning algorithm development, this information is not applicable and not provided in the document. The document describes system updates and their performance validation.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2015
Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K151015
Trade/Device Name: ECHELON Oval V5.0 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and LNI Dated: July 1, 2015 Received: July 6, 2015
Dear Mr. Thistlethwaite:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K151015 |
|---|---|
| Device Name | ECHELON OVAL V5.0 MRI system |
Indications for Use (Describe)
The ECHELON Oval 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 imagingDiffusion weighted imagingMR AngiographyImage processingSpectroscopyWhole Body |
Type of Use (Select one or both, as applicable)
| </span> Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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Section 5
510(k) Summary
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| Submitter: | Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371 | ||
|---|---|---|---|
| Contact: | Douglas J. Thistlethwaite | ||
| Telephone number: | 330-425-1313 | ||
| Telephone number: | 330-963-0749 | ||
| E-mail: | thistlethwaited@hitachimed.com | ||
| Date: | April 13, 2015 | ||
| Device Name | |||
| Regulation Number: | 892.1000 | ||
| Requlation Name: | System, Nuclear Magnetic Resonance Imaging | ||
| Product Code | LNH | ||
| Class | 2 | ||
| Panel | Radiology | ||
| Trade/Proprietary Name: | ECHELON Oval V5.0 MRI System |
Submitter Information
Device Intended Use
The ECHELON Oval 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 crosssectional 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
Device Description
Function
The ECHELON OVAL 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 MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.
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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
Being the ECHELON Oval V5.0 MRI System is only a software update with new features, a clinical and performance evaluation was conducted on only the new features which include:
- . ASL-Perfusion
- . Beam Sat VASC-ASL
- Breast MRS ●
- Enhanced PC ●
- Fat and water separation scan (FSE, ● RSSG. GE)
- . k-RAPID
- Multi b and DKI ●
- opFSE / opFIR ●
- PBSG ●
- RADAR-GE/TOF
- T2* RelaxMap ●
A rationale analysis was then conducted and the results are contained in Table 1.
Table 1 Performance Analysis
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Clinical | We provide clinical image examples for each new feature and we judged to be sufficient to evaluate clinical usability. Inaddition, a radiologist validated that the clinical images have acceptable image quality for clinical use. |
| Performance Testing - Bench | We generated bench data for each of the new features.We confirmed that each new feature performs as intended for diagnostic use. |
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 OVAL includes V5.0 software is substantially equivalent to the ECHELON OVAL (K113145). See tables below.
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The technological characteristics in regards to hardware of the ECHELON Oval V5.0 MRI System and the predicate are listed in Table 2.
| ITEM | ECHELON OVAL (K113145)PREDICATE | ECHELON OVAL V 5.0 | DIFFERENCEANALYSIS | |
|---|---|---|---|---|
| System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4, MS5, MS 8,IEC: 60601-1, 60601-1-1, 60601-1-2,60601-1-4, 60601-2-33, 62304 | NEMA: MS 1, MS 2, MS 3, MS 4,MS 5, MS 8,IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | No |
| Magnet andGantry | Type and FieldStrength | Super-conducting magnet, horizontalbore, 1.5 Tesla | Super-conducting magnet,horizontal bore, 1.5 Tesla | No |
| ResonantFrequency | 63.86 MHz | 63.86MHz | No | |
| GradientSystem | Gradient Strength | 34mT/m | 34mT/m | No |
| Slew Rate | 150 T/m/sec | 150 T/m/sec | No | |
| Rise Time | 227µsec to 34mT/m | 227 µsec to 34mT/m | No | |
| Audible Noise (MCAN) | ||||
| Ambient | 56 dBA | 58 dBA | See Table 3 | |
| Lpeak | 121 dBA | 125 dBA | See Table 3 | |
| Leq | 119 dB | 117 dBA | See Table 3 | |
| RF System | Transmitterchannels | 2 | 2 | No |
| Peak EnvelopPower | 40 kW | 40 kW | No | |
| Duty Cycle | 100% (Gating max), 12.5% at fullpower | 100% (Gating max), 12.5% at fullpower | No | |
| RF receiverchannel | 16 | 16 | No |
| Table 2 Comparison: Hardware | |
|---|---|
The hardware differences from the ECHELON Oval V5.0 MRI System to the predicate device are analyzed in Table 3.
| 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 (seesection 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | |||
|---|---|---|---|---|
| DeviceModificationSummary | There are no significant hardware changes that affect technological characteristics and safety. | |||
| SignificantChanges | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance |
| ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) | |
| HITACHIRationaleStatement | Modified specification 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 OVAL (K113145). So,safety and effectively of the device are same as ECHELON OVAL (K113145) |
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The technological characteristics in regards to coils of the ECHELON Oval V5.0 MRI System and the predicate are listed in Table 4.
| ITEM | ECHELON OVAL (K113145)PREDICATE | ECHELON OVAL V 5.0 | DIFFERENCEANALYSIS | |
|---|---|---|---|---|
| RF Coils | Transmit Coil | T/R Body | T/R Body | No |
| Receiver Coils | RAPID Posterior/Anterior Head | WIT Posterior Head/Neck coil,WIT Anterior Head attachment | See Table 5 | |
| RAPID Anterior Body | WIT Torso coil | See Table 5 | ||
| RAPID Extremity (Knee) | Extremity coil (Knee) | See Table 5 | ||
| RAPID Anterior Neck | WIT Anterior Neck attachment | See Table 5 | ||
| RAPID Extremity(S) (Hand/Wrist) | Hand/Wrist coil | See Table 5 | ||
| RAPID Anterior NV | WIT Anterior NV attachment | See Table 5 | ||
| RAPID Breast | Breast | See Table 5 | ||
| Multi-purpose | MP coil 140A, B | See Table 5 | ||
| RAPID Shoulder | Shoulder | See Table 5 | ||
| RAPID Back A | WIT Spine coil 12 | See Table 5 | ||
| RAPID Back B | WIT Spine coil 8 | See Table 5 | ||
| RAPID Foot/Ankle | Foot/Ankle | See Table 5 | ||
| RAPID Long Bone | Flexible Extremity (Long Bone) | See Table 5 | ||
| RAPID Cardiac | WIT Cardiac | See Table 5 | ||
| RAPID PV | PV | See Table 5 |
| Table 4 Comparison: RF Coils | ||
|---|---|---|
The coil differences from the ECHELON Oval V5.0 MRI System to the predicate device are analyzed in Table 5.
| Table 5 Coil 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 (seesection 513(i)(1)(A) of the FD&C Act and21 CFR 807.87(f)). | |||
| DeviceModificationSummary | Some coil names are changed. The performance and technological characteristics of the coils are the same as ECHELONOVAL (K113145). | |||
| SignificantChanges | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) | |
| HITACHIRationaleStatement | Modified functions don't constitute a new intended use. There are no significant changes in technological characteristics.During transmitter coil operation, RF Coils are de-resonated by same scheme as ECHELON OVAL (K113145). |
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The technological characteristics in regards to changes in functionality of the ECHELON Oval V5.0 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 | Going from V4.0A to V5.0A | See Table 7 |
| Scan Tasks | None | No |
| 2D Processing Tasks | Only difference is T2* calculation is now available on ECHELON Oval V5.0. | See Table 7 |
| 3D Processing Tasks | None | No |
| Analysis Tasks | Only change is DEC-FA, AD, RD, MK, AK, RK, and FAK Maps with DWI Analysis are now available onECHELON Oval V5.0. | See Table 7 |
| Maintenance Tasks | None | No |
| Viewport Tools | None | No |
| Film, Archive Tools | None | No |
| Network Tools | None | No |
| Protocol Enhancements | Only change is Multi-b measurement, k-RAPID, T2* Relax Map, BeamSat VASC-ASL, RADAR (2DGE,3D GE, 2D TOF, and 3D TOF), ASL-Perfusion, Enhanced PC (improvement of Cine PC), and BreastMRS are now available on ECHELON Oval V5.0. | See Table 7 |
| Pulse Sequences | Only change is 2D Spoiled SARGE Fat Water Separation (2D FATSEPRSSG), 3D Spoiled SARGE FatWater Separation (3D FATSEPRSSG), 2D Fast Spin Echo Fat Water Separation (2D FATSEPFSE),2D Gradient Echo Fat Water Separation (2D FATSEPGE), 3D Gradient Echo Fat Water Separation(3D FATSEPGE), 2D Fast Spin Echo (2D opFSE), 2D Fast Spin Echo (2D opFIR), 2D Phase BalancedSARGE (2D PBSG), and 3D Phase Balanced SARGE (3D PBSG) are now available on ECHELONOval V5.0. | See Table 7 |
The functionality differences from the ECHELON Oval V5.0 MRI System to the predicate device are analyzed in
Table 7 Functionality Comparison Analysis
| Table 7 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 (seesection 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). |
| DeviceModificationSummary | 2D Processing TasksT2* Calculation - Adds the ability to obtain T2* maps as opposed to previous software. Benefits areas such as liver andcartilage imaging.Analysis TasksDWI Analysis- New Maps are added and allow for advanced evaluation of diffusion tensor and diffusion kurtosis imaging.Protocol Enhancementsk-RAPID - K-space based parallel imaging. Reduces the occurrence of wrap artifacts.T2* RelaxMap - Adds the ability to obtain T2* maps as opposed to previous software. Benefits areas such as liver andcartilage imaging.BeamSat VASC-ASL - Cylindrical preset pulse added to current VASC-ASL sequence. Benefit is to selectively saturate atarget vascular structure.ASL-Perfusion - Non-contrast brain perfusion. pASL based gradient echo EPI sequence.Enhanced PC - Reduces minimum TR/TE and adds RAPID capability.Breast MRS - Added single voxel breast spectroscopyMulti-b measurement - Gives the ability to acquire more than one B factor in one scan which saves time with no change inimage quality.RADAR - 2D/3D GE and 2D/3D TOF pulse sequences can now use RADAR motion correction. |
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| Pulse Sequences | |||||
|---|---|---|---|---|---|
| 2D/3D FatSepRSSG - TE can be adjusted as opposed to a fixed TE in the previous software. Single 2pt. was added whichgives the benefit of higher resolution scans. | |||||
| 2D FatSepFSE - Inner Echo time is now adjustable as opposed to the previous version of software. Single 2pt. was addedwhich gives the benefit of higher resolution scans. | |||||
| 2D/3D FatSepGE - New, allows for T2* weighted imaging. | |||||
| 2D opFSE - Improved SNR, less artifacts, makes images less grainy than conventional FSE.2D opFIR - Improved SNR, less artifacts, makes images less grainy than conventional FIR. | |||||
| 2D/3D PBSG - BASG sequence acquired at two different RF phases, resulting in decreased banding artifacts. | |||||
| SignificantChanges | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance | |
| ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) | ||
| HITACHIRationaleStatement | Modified functions do not constitute a new intended use. There are no significant changes in technological characteristics. Forsafety, pulse sequences are controlled according to same safety limits as ECHELON OVAL (K113145). So safety andeffectivity of the device are equivalent to the ECHELON OVAL (K113145). |
Substantial Equivalence
A summary decision was based on analysis of Table 8.
Table 8 Rationale Analysis: ECHELON Oval V5.0 MRI vs. Predicate
| ITEM | Overall Rationale Analysis |
|---|---|
| Hardware | Different specifications do not constitute a new intended use. There are no significant changes in technologicalcharacteristics, safety and effectiveness. |
| Coils | Modified functions don't constitute a new intended use. There are no significant changes in technological characteristics,safety and effectiveness. |
| Functionality | Enhanced features do not constitute a new intended use. There are no significant changes in technological characteristics,safety and effectiveness. The feature set of the device is generally equivalent to the Predicate. |
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 Oval V5.0 MRI is considered substantially equivalent to the currently marketed predicate device (ECHELON Oval MRI System (K113145)) 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 revisions to the ECHELON Oval V5.0 MRI System software will have no effect on the standards tests which were conducted on the ECHELON Oval MRI System (K113145) and included in the original submission.
Therefore, ECHELON Oval V5.0 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 5-2010, Determination of Slice Thickness in Diagnostic Resonance Imaging ●
- . NEMA MS 8-2008. Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- AAMI / ANSI 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 3:2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests.
- IEC 60601-2-33 Edition 3.1 2013-04, medical electrical equipment part 2-33: particular . requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic.
- IEC 62304 First edition 2006-05, medical device software software life cycle processes. .
In addition, tests were conducted on the new features of the ECHELON Oval V5.0 MRI System, they include:
ASL-Perfusion .
Test results confirm ASL-Perfusion acquires perfusion images using labeled blood flowing into the brain tissue without Contrast-Enhanced both in phantom simulations and clinical results.
Beam Sat VASC-ASL ●
Test results confirm Beam Sat improves the visibility of the portal vein in making MIP images both in phantom simulations and clinical results.
Breast MRS ●
Test results from phantom simulations and clinical results confirm MRS (Magnetic Resonance Spectroscopy) acquires the magnetic resonance signal of in vivo metabolites through chemical shift phenomenon and can detect Choline as metabolite in the breast area.
● Enhanced PC
Test results from phantom simulations and clinical results indicate a reduction in scan time of phase contrast (PC) sequence in 2D and 3D by shorting the TR by optimizing velocity encode gradient and applied parallel imaging (RAPID). As a result of this improvement, we can shorten scan time of "4D flow" which is time-resolved (CINE) three-dimensional (3D) spatial encoding combined with three-directional velocityencoded phase contrast MRI.
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Fat and water separation scan (FSE, RSSG, GE) ●
Test results from phantom simulations and clinical results indicate reliable and uniform fat suppression by utilizing the difference between resonant frequencies due to chemical shift of water protons and fat protons to obtain a water image and a fat image. The chemical shift of a water signal and a fat signal receives two echo signals at the timing which becomes an in-phase and an out-of-phase. By adding and subtracting it, a water image and a fat image are simultaneously acquirable.
k-RAPID .
Test results from phantom simulations and clinical results indicate that k-space parallel imaging technique accelerates the scan by acquiring k-space data with skipped phase encoding and skipped position which is filled with estimated data by the interpolation of neighboring data.
Multi b and DKI .
Test results from phantom simulations and clinical results confirm Multi b DKI images can be acquired in one scan utilizing Tensor 15 and Tensor 30 being added to the number of MPG Axes. Diffusion Kurtosis Imaging (DKI) is the diffusion-weighted imaging technique in restriction.
opFSE / opFIR .
Test results from phantom simulations and clinical results confirm by deriving opFSE and opFIR sequence from the primeFSE and primeFIR image quality is improved.
- PBSG .
Test results from phantom simulations and clinical results confirm PBSG which is a sequence based on BASG sequence improves to mitigate the dark band artifact which is unique to BASG sequence. The PBSG sequence makes it possible to acquire BASG images under the condition of inhomogeneous magnetic field with less band artifact.
RADAR-GE/TOF .
Test results from phantom simulations and clinical results confirm the RADAR measurement feature is functioning with the GE and TOF sequence.
T2* RelaxMap .
Test results from phantom simulations and clinical results confirm that T2* relaxation time can be mapped on morphological image in color by using T2* RelaxMap function. The T2* RelaxMap function consists of (a) acquisition of multi-echo images (up to 32) and (b) analysis of T2* relaxation time.
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Summary of Clinical Testing
Clinical images were collected and analyzed, to ensure that images from the new features meet user needs.
As a result of the analysis:
| Testing Type | Rationale Analysis |
|---|---|
| Performance Testing - Clinical | We provide clinical image examples for each new feature and we judged to be sufficient to evaluate clinical usability. Inaddition, a radiologist validated that the clinical images have acceptable image quality for clinical use. |
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. the ECHELON Oval V5.0 MRI System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECHELON Oval MRI System (K113145).
§ 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.