(119 days)
The TRILLIUM Oval MRI 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 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
The TRILLIUM OVAL is a Magnetic Resonance Imaging System that utilizes a 2.9 Tesla superconducting magnet in a gantry design. The TRILLIUM OVAL has been designed to enhance clinical utility as compared to the ECHELON Oval by taking advantage of the stronger magnetic field and stronger gradient field and slew rate. There is no change in the system composition from the predicate device.
The document you provided is a 510(k) premarket notification for the Hitachi TRILLIUM Oval V5.1 MRI System. It describes a software update to an existing MRI system (TRILLIUM OVAL, K142734) and therefore focuses on demonstrating substantial equivalence to the predicate device, rather than proving that the device meets specific acceptance criteria through a standalone study with defined performance thresholds.
The "acceptance criteria" discussed in this document are primarily compliance with international and national standards for medical electrical equipment and MRI devices, and the demonstration that new software features perform as intended without compromising safety or effectiveness.
Here's an analysis based on the information provided, framed to address your questions as closely as possible, while noting where specific answers are not available due to the nature of a 510(k) for a software update:
1. A table of acceptance criteria and the reported device performance
For a software update to an existing MRI system, the "acceptance criteria" are generally about maintaining compliance with safety and performance standards established for the predicate device and confirming the intended function of new features.
| Acceptance Criteria (Standards Compliance & Functional Performance) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| General Safety and Essential Performance: Adherence to IEC 60601-1 (general medical electrical equipment safety) and IEC 60601-2-33 (specific MRI safety). | The device conforms to AAMI / ANSI ES60601-1:2005/(R)2012 and IEC 60601-2-33 Edition 3.1 2013-04. SAR and dB/dt management methods comply with these standards. |
| Electromagnetic Compatibility: Compliance with IEC 60601-1-2. | Conforms to IEC 60601-1-2 Edition 3:2007-03. |
| Software Life Cycle Processes: Compliance with IEC 62304. | Conforms to IEC 62304 First edition 2006-05. |
| Image Quality (Specific NEMA Standards): Signal-to-noise ratio (SNR), geometric distortion, image uniformity, slice thickness. | The revisions to the software have "no effect on the standards tests which were conducted on the TRILLIUM OVAL MRI System (K142734)." Implies predicate device's performance is maintained. |
| Acoustic Noise: Compliance with NEMA MS 4. | Audible Noise (MCAN) values changed slightly (e.g., LAeq from 118.8 dBA to 124.3 dBA) due to parameter changes to improve image quality. Measurement method (NEMA MS 4:2010) and risk analysis remain the same as the predicate. Considered safe. |
| SAR Characterization: Compliance with NEMA MS 8. | SAR management modified to improve accuracy (coil loss coefficient from measured Q values). SAR monitor upgraded for precision. SAR is limited by IEC 60601-2-33. Conforms to NEMA MS 8-2008. |
| Multi-b and DKI: Ability to acquire multi-b DKI images in one scan. Diffusion Kurtosis Imaging performs as expected. | Test results from phantom simulations and volunteer studies confirm Multi b DKI images can be acquired utilizing Tensor 15 and Tensor 30. |
| k-Space Parallel Imaging: Accelerate scan time by acquiring k-space data with skipped phase encoding/position and filling with estimated data. Reduces wrap artifacts. | Test results from phantom simulations and volunteer studies indicate that k-space parallel imaging technique accelerates the scan and reduces wrap artifacts. |
| T2 RelaxMap:* Ability to map T2* relaxation time on morphological images in color, using multi-echo images and T2* analysis. | Test results from phantom simulations and volunteer studies confirm T2* relaxation time can be mapped. |
| Vivid Image: Enhancement of overall SNR in 2D processing tasks. | Test results from phantom simulations and volunteer studies confirm improvement of overall SNR. |
| RADAR-GE/TOF: RADAR motion correction feature functions with GE and TOF sequences. | Test results from phantom simulations and volunteer studies confirm the RADAR measurement feature is functioning. |
| ASL-Perfusion: Acquire non-contrast brain perfusion images using labeled blood. | Test results confirm ASL-Perfusion acquires perfusion images both in phantom simulations and volunteer studies. |
| Breast MRS: Acquire MR signal of in vivo metabolites (e.g., Choline) in the breast area. | Test results from phantom simulations and volunteer studies confirm MRS can detect Choline as metabolite in the breast area. |
| Enhanced PC: Reduce scan time of phase contrast (PC) sequence in 2D and 3D by shortening TR. | Test results from phantom simulations and volunteer studies indicate a reduction in scan time. |
| PBSG: Improve mitigation of dark band artifact unique to BASG sequence, allowing BASG images under inhomogeneous magnetic field with less artifact. | Test results from phantom simulations and volunteer studies confirm PBSG improves to mitigate the dark band artifact. |
| Volume RF Shimming: Improve B1 uniformity. | Test results and volunteer studies confirm that Volume RF shimming improves B1 uniformity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical testing involving phantom simulations and volunteer studies. It does not specify a quantitative "test set" in terms of patient data or detailed sample sizes.
- Sample Size for Test Set: Not explicitly stated as a number of cases/patients for each feature. The studies involved "phantom simulations and volunteer studies." This suggests a small, controlled set of healthy volunteers rather than a large patient cohort.
- Data Provenance: Not specified. "Volunteer studies" typically implies prospective data collection. Country of origin is not mentioned. Given Hitachi Medical Systems America, Inc. is the submitter, the studies could be internal or conducted in an associated facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For non-clinical performance evaluations of MRI system features, "ground truth" might be established through:
- Physical measurements on phantoms.
- Physiological parameters measured during volunteer studies.
- Comparison to established imaging techniques or qualitative assessment by experienced MR physicists or radiologists, but specifics are absent here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of a software update for an MRI system demonstrating substantial equivalence, formal adjudication methods (common in AI/CADe studies) are generally not performed or required for these types of submissions. The evaluations are more focused on technical performance and image quality by MR physicists and system engineers, potentially with clinical input from radiologists for qualitative assessment of 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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed and is not described for this submission. This is because the device is an MRI system itself and its software, not an AI/CADe product intended to assist human readers. The document focuses on the technical performance of the MRI system's new sequences and processing capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire performance evaluation described is essentially "standalone" in the sense that it assesses the technical capabilities of the MRI system and its new software features directly (e.g., confirming acquisition, mapping, or reduction of scan time). It's not an "algorithm-only" performance as one might describe an AI model, but rather the performance of the full integrated imaging system. The "test results from phantom simulations and volunteer studies" for all the new features (Multi-b and DKI, k-Space Parallel Imaging, T2* RelaxMap, etc.) represent the demonstrated performance of the system directly, without explicitly quantifying 'human-in-the-loop' interaction in terms of diagnostic performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the new features, the "ground truth" likely refers to:
- Physical measurements/known properties of phantoms: For features like SNR, geometric distortion, T2* relaxation times in phantoms, or artifact reduction.
- Physiological measurements/expected outcomes in volunteers: For features like ASL-Perfusion (labeled blood flow), or the detection of metabolites in Breast MRS.
- Qualitative assessment of image quality and feature functionality: By qualified personnel (e.g., MR physicists, radiologists) for aspects like "improvement of overall SNR," "reduction of scan time," or "mitigation of dark band artifact."
No mention of pathology or outcomes data is made, which is typical for demonstrating substantial equivalence of an imaging system software update.
8. The sample size for the training set
The document describes software updates and performance validation for an MRI system. It does not mention "training sets" in the context of machine learning or AI models. The software features are likely based on established MR physics principles and algorithms, rather than being data-driven machine learning models that require training sets. Therefore, this question is not applicable in the context of this submission.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for machine learning, this question is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Hitachi Medical Systems America, Inc. % Mr. Douglas Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
May 20, 2016
Re: K160152
Trade/Device Name: Trillium Oval V5.1 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 18, 2016 Received: April 19, 2016
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. 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 Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name TRILLIUM Oval V5.1 MRI system
Indications for Use (Describe)
The TRILLIUM Oval MRI 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 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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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: | December 4, 2015 |
| Device Name | |
| Regulation Number: | 892.1000 |
| Regulation Name: | Magnetic resonance diagnostic device |
| Product Code | 90LNH |
| Class | 2 |
| Panel | Radiology |
| Trade/Proprietary Name: | TRILLIUM Oval V5.1 MRI System |
Submitter Information
Device Intended Use
The TRILLIUM 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 Reqion: 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 TRILLIUM OVAL is a Magnetic Resonance Imaging System that utilizes a 2.9 Tesla superconducting magnet in a gantry design. The TRILLIUM OVAL has been designed to enhance clinical utility as compared to the ECHELON Oval by taking advantage of the stronger magnetic field and stronger gradient field and slew rate. There is no change in the system composition from the predicate device.
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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 maqnetic 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 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 TRILLIUM OVAL V5.1 MRI System is only a software update with new features, quality assurance measures was conducted on only the new features which include:
- . Multi-b measurement
- Kspace parallel imaging ●
- T2*Relax MAP ●
- Vivid Image ●
- RADAR Enhancement ●
- . DKI
- . ASL-Perfusion
- . Breast MRS
- Enhanced PC (improvement of Cine PC)
- PBSG for MRH ●
- . Volume RF shimming
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Device Technological Characteristics
The control and image processing hardware and the base elements of the system software are identical to the predicate device. The TRILLIUM OVAL includes V5.1 software is substantially equivalent to the TRILLIUM OVAL (K142734). See tables below.
The technological characteristics in regards to hardware of the TRILLIUM OVAL V5.1 MRI System and the predicate are listed in Table 2.
| ITEM | TRILLIUM OVAL (K142734) | TRILLIUM OVAL | DIFFERENCE ANALYSIS | |
|---|---|---|---|---|
| System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, 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, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-33, 62304 | No |
| Magnet andGantry | Type and FieldStrength | Super-conducting magnet, horizontalbore, 3 Tesla | Super-conducting magnet, horizontalbore, 3 Tesla | No |
| ResonantFrequency | 123.47 MHz | 123.47 MHz | No | |
| GradientSystem | Gradient Strength | 40mT/m | 40mT/m | No |
| Slew Rate | 200 T/m/sec | 200 T/m/sec | No | |
| Rise Time | 200µsec to 40mT/m | 200µsec to 40mT/m | No | |
| Audible Noise (MCAN) | ||||
| Ambient | 69.7 dBA | 62.9 dBA | See table 3 | |
| Lpeak | 126.9 dB | 133.4 dB | See table 3 | |
| LAeq | 118.8 dBA | 124.3 dBA | See table 3 | |
| RF System | Transmitterchannels | 4 | 4 | No |
| Peak EnvelopPower | 40 kW | 40 kW | No | |
| Duty Cycle | 60% (Gating max), 100ms at fullpower | 60% (Gating max), 100ms at fullpower | No | |
| RF receiverchannel | 16/32 | 16/32 | No |
Table 2 Comparison: Hardware
The hardware differences from the TRILLIUM OVAL V5.1 MRI System to the predicate device are analyzed in Table 3.
Table 3 Hardware NSE 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)).21 CFR 807.87(f)). | |||
|---|---|---|---|---|
| DeviceModificationSummary | Audible Noise (MCAN) is changed (from 118.8 dBA to 124.3 dBA of LAeq), because pulse sequence parameter limitation(BASG (TR), and on GEEPI (IET)) is changed to improve image quality. (see table 7 and 8)Audible Noise (MCAN) measurement method (NEMA MS 4:2010) and risk analysis method performed is same asTRILLIUM OVAL (K142734) | |||
| SignificantChanges | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance |
| ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationalestatement) | |
| 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 TRILLIUM OVAL (K142734). So,safety and effectively of the device are same as TRILLIUM OVAL (K142734) |
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The technological characteristics in regards to RF coils of the TRILIUM OVAL V5.1 MRI System and the predicate are listed in Table 4.
| ITEM | TRILLIUM OVAL (K142734) | TRILLIUM OVAL | DIFFERENCE ANALYSIS | |
|---|---|---|---|---|
| RF Coils | Transmit Coil | T/R Body | T/R Body | No |
| Receiver Coils | WIT Posterior Head/Neck coil, WIT Anterior Head attachment | WIT Posterior Head/Neck coil, WIT Anterior Head attachment | No | |
| WIT Anterior NV attachment | WIT Anterior NV attachment | No | ||
| WIT Anterior Neck attachment | WIT Anterior Neck attachment | No | ||
| WIT Spine coil 12 | WIT Spine coil 12 | No | ||
| WIT Spine coil 8 | WIT Spine coil 8 | No | ||
| WIT Torso coil 12 | WIT Torso coil 12 | No | ||
| Extremity coil | Extremity coil | No | ||
| Shoulder coil | Shoulder coil | No | ||
| Flexible Extremity coil | Flexible Extremity coil | No | ||
| Foot/Ankle coil | Foot/Ankle coil | No | ||
| Head/Wrist coil | Head/Wrist coil | No | ||
| Breast coil | Breast coil | No | ||
| Micro coil A | Micro coil A | No | ||
| Micro coil B | Micro coil B | No | ||
| WIT Torso coil 8 | WIT Torso coil 8 | No |
| Table 4 Comparison: RF Coils | ||
|---|---|---|
The coil differences from the TRILLIUM OVAL V5.1 MRI System to the predicate device are analyzed in Table 5.
Table 5 RF coils NSE 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 and effectivenessthan the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see section513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)).21 CFR 807.87(f)). | |||
|---|---|---|---|---|
| DeviceModificationSummary | The performance and technological characteristics of coil is same as TRILLIUM OVAL (K142734) | |||
| SignificantChanges | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance |
| ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) | |
| HITACHIRationaleStatement | There is no new intended use. There are no changes in technological characteristics. |
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The technological characteristics in regards to changes in functionality of TRILLIUM OVAL V5.1 MRI System as compared to the predicate are listed in Table 6.
| ITEM | DIFFERENCES | ANALYSIS |
|---|---|---|
| Operating System | None | No |
| CPU Platform | None | No |
| Application Software | Going from V4.6B to V5.1B | See Table 7 |
| Scan Tasks | None | No |
| 2D Processing Tasks | T2* calculation, Vivid Image | See Table 7 |
| 3D Processing Tasks | None | No |
| Analysis Tasks | DWI analysis (AD, RD, MK, AK, RK, and FAK Maps(*)) are now available on TRILLIUM OVAL V5.1. | See Table 7 |
| SAR and dB/dt Management | SAR management is modified.dB/dt calculation on TRILLIUM OVAL V5.1 is modified. | See Table 7 |
| Maintenance Tasks | None | No |
| Viewport Tools | None | No |
| Film, Archive Tools | None | No |
| Network Tools | None | No |
| Protocol Enhancements | RF shimming is modified.Multi-b measurement, k-space parallel imaging, T2* Relax Map, RADAR (2DGE, 3D GE, 2D TOF,and 3D TOF), ASL-Perfusion, Enhanced PC(improvement of Cine PC), and Breast MRS are nowavailable on TRILLIUM OVAL V5.1. | See Table 7 |
| Pulse Sequences | 2D GEEPI and 2D/3D BASG is changed in sequence parameter,2D/3D Phase Balanced SARGE (2D PBSG) are now available on TRILLIUM OVAL V5.1. | See Table 7 |
Table 6 Comparison: Functionality
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The functionality differences from the TRILLIUM OVAL V5.1 MRI System to the predicate device are analyzed in Table 7.
| 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 | T2* Calculation (T2RelaxMap) - Adds the ability to obtain T2 values of tissues as opposed to previous software. Benefitsareas such as liver and cartilage imaging. (same function as one equipped on ECHELON OVAL V5.0A K151015)Vivid Image- Enhances image quality in the 2D processing tasks.DWI Analysis- New Maps are added and allow for advanced evaluation of diffusion tensor and diffusion kurtosis imaging.(same function as one equipped on ECHELON OVAL V5.0A K151015)SAR Management- Coil loss coefficient is determined from measured Q values at each subject to improve SARmeasurement accuracy. SAR monitor is upgraded to improve precision SAR is limited by IEC 60601-2-33 as same asTRILLIUM OVAL (K142734).dB/dt Calculation- To handle the peripheral nerve stimulation (PNS) threshold level more accurate, Directly determinedlimits as specified IEC60601-2-33 is used for TRILLIUM OVAL V5.1B system instead of Default values as also specifiedIEC60601-2-33. We refer 201.12.4.105.1 Direct determination of the limits of the PNS OUTPUT for the measurement.RF Shimming- RF shimming parameter of predefined mode is changed to improve B₁ uniformity. Volume RF shimmingmode is added to improve B₁ uniformity. Safety evaluation with using the improved RF shimming function is done with sameSAR evaluation method as TRILLIUM OVAL (K142734) that shows safety of the device are same as TRILLIUM OVAL(K142734)Multi-b Measurement - Gives the ability to acquire more than one b factor in one scan which saves time with no change inimage quality. (same function as one equipped on ECHELON OVAL V5.0A K151015)k-Space Parallel Imaging - k-Space based parallel imaging. Reduces the occurrence of wrap artifacts.RADAR - 2D/3D GE and 2D/3D TOF pulse sequences can now use RADAR motion correction.ASL-Perfusion - Non-contrast brain perfusion. pASL based gradient echo EPI sequence. Benefits areas such as brainimaging.Enhanced PC (improvement of Cine PC) - Reduces minimum TR/TE and adds RAPID(*) capability. Benefits areas suchas artery imaging.Breast MRS - Added single voxel breast spectroscopy (same function as one equipped on ECHELON OVAL V5.0AK151015)2D GEEPI and 2D/3D BASG -2D GEEPI is changed at minimum inter echo time to improve image quality. 2D/3D BASG ischanged at minimum TR to improve image quality. Acoustic noise evaluation is performed as same as TRILLIUM OVAL(K142734). (see table 2)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, SAR and dB/dt is managed according to IEC60601-2-33, and pulse sequences are controlled according to IEC60601-2-33 as same as TRILLIUM OVAL (K142734). |
Table 7 Functionality Comparison Analysis
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Substantial Equivalence
A summary decision was based on analysis of Table 8.
| Table 8 Rationale Analysis: TRILLIUM OVAL V5.1 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 | The performance and technological characteristics of coil is same as TRILLIUM OVAL (K142734) |
| 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 TRILLIUM OVAL V5.1 MRI is considered substantially equivalent to the currently marketed predicate device (TRILLIUM OVAL MRI System (K142734)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Summary of Non-Clinical Testing
The revisions to the TRILLIUM OVAL V5.1 MRI System software will have no effect on the standards tests which were conducted on the TRILLIUM OVAL MRI System (K142734) and included in the original submission.
Therefore, TRILLIUM OVAL V5.1 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.
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In addition, quality assurance measures were conducted on the new features of the TRILLIUM V5.1 MRI System, they include:
. Multi b and DKI
Test results from phantom simulations and volunteer studies 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.
k-Space Parallel Imaging .
Test results from phantom simulations and volunteer studies indicate that k-space parallel imaqinq 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.
. T2* RelaxMap
Test results from phantom simulations and volunteer studies 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.
Vivid Image .
Test results from phantom simulations and volunteer studies confirm improvement of overall SNR.
RADAR-GE/TOF .
Test results from phantom simulations and volunteer studies confirm the RADAR measurement feature is functioning with the GE and TOF sequence.
. 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 volunteer studies.
● Breast MRS
Test results from phantom simulations and volunteer studies 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 volunteer studies 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 velocity encoded phase contrast MRI.
PBSG .
Test results from phantom simulations and volunteer studies 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.
Volume RF Shimming .
Test results and volunteer studies confirm that Volume RF shimming improves B1 uniformity.
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Summary of Clinical Testing
The modification to the software to include the new features did not require clinical testing.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. the TRILLIUM OVAL V5.1 MRI System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the TRILLIUM OVAL MRI System (K142734).
§ 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.