(111 days)
The ECHELON 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 the image appearance are proton density, spin-lattice 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.
The ECHELON OVAL V5.1 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 FDA 510(k) summary for the ECHELON Oval V5.1 MRI System does not contain acceptance criteria or a study proving the device meets acceptance criteria in the format often seen for AI/ML-driven devices. Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (ECHELON Oval V5.0 MRI System K151015).
In the context of a 510(k) for an MRI system, acceptance criteria are typically related to the physical and performance characteristics of the imaging system itself, rather than diagnostic accuracy like in AI/ML products. The 'studies' conducted here are primarily verification and validation tests to ensure the modified device meets established safety and performance standards equivalent to the predicate.
Given these limitations from the provided text, I will answer based on the information available and point out what is missing or not applicable.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in a table for diagnostic accuracy, as it's not an AI/ML diagnostic device with performance metrics like sensitivity/specificity.
However, the closest equivalent in this document would be the comparison of technical specifications against established standards and the predicate device. The "Performance Evaluation" section (Page 5) states: "There is no change from the previous predicate device that would affect performance." This implies that the performance of the ECHELON Oval V5.1 MRI System is expected to be equivalent to the ECHELON Oval V5.0 MRI System (K151015) which successfully met its own performance criteria (not detailed in this document).
The "Summary of Non-Clinical Testing" (Page 9) lists the standards that the device conforms to. These standards effectively act as the "acceptance criteria" for the MRI system's physical and technical performance. The "reported device performance" implicitly matches these standards by stating conformance.
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance (Implicitly Met) |
|---|---|
| NEMA MS 1-2008 (Signal-to-noise Ratio) | Conforming |
| NEMA MS 2-2008 (Two-Dimensional Geometric Distortion) | Conforming |
| NEMA MS 3-2008 (Image Uniformity) | Conforming |
| NEMA MS 4-2010 (Acoustic Noise Measurement) | Conforming (58 dBA, 125 dBA, 117 dBA) |
| NEMA MS 5-2010 (Slice Thickness) | Conforming |
| NEMA MS 8-2008 (Specific Absorption Rate) | Conforming |
| AAMI / ANSI ES60601-1:2005 (Basic Safety and Essential Performance) | Conforming |
| IEC 60601-1-2 Ed. 3:2007-03 (Electromagnetic Compatibility) | Conforming |
| IEC 60601-2-33 Ed. 3.1 2013-04 (Magnetic Resonance Equipment specific reqs) | Conforming |
| IEC 62304 Ed. 1 2006-05 (Medical Device Software - Life Cycle Processes) | Conforming |
| Soft Sound functionality (Acoustic sound pressure levels) | Test results confirm acoustic levels |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily focuses on technical comparisons and conformance to standards, not a clinical study on diagnostic performance with a test set of patient data.
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 and is not applicable in this context. Ground truth establishment by experts for specific diagnostic outcomes is typical for AI/ML device evaluations, not for demonstrating substantial equivalence of a new MRI system version. The "Indications for Use" mentions interpretation by a "trained physician," but this is general usage, not specific to a testing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for this type of submission.
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
An MRMC study was not done. This type of study is relevant for evaluating the clinical utility and impact of AI software on human reader performance, which is not the focus of this MRI system's 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of an algorithm was not done. This device is an MRI system, not an AI algorithm. Its performance is evaluated through its adherence to technical standards and demonstration of equivalence to its predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" (e.g., pathology, expert consensus) as used in AI/ML evaluations is not applicable here. The "ground truth" for an MRI system's performance revolves around its ability to accurately and safely generate images according to its technical specifications and relevant industry standards. The summary of non-clinical testing refers to conformance with NEMA and IEC standards, which define objective measures for image quality (SNR, geometric distortion, uniformity, slice thickness), safety (acoustic noise, SAR), and software processes.
8. The sample size for the training set
This information is not provided as this is an MRI system, not an AI/ML device trained on a dataset.
9. How the ground truth for the training set was established
This information is not provided as this is an MRI system, not an AI/ML device.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K153547
Trade/Device Name: ECHELON Oval V 5.1 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 2, 2016 Received: March 3, 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.
Robert Ocks
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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4-1
510(k) Number (if known) K153547
Device Name ECHELON OVAL V5.1 MRI system
Indications for Use (Describe)
The ECHELON 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 the image appearance are proton density, spin-lattice 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: | 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)
[X] 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: | November 30, 2015 |
| Device Name | |
| Regulation Number: | 892.1000 |
| Regulation Name: | Magnetic resonance diagnostic device |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |
| Trade/Proprietary Name: | ECHELON Oval V5.1 MRI System |
Submitter Information
Device Intended Use
The ECHELON Oval V5.1 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
Device Description
Function
The ECHELON OVAL V5.1 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 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
There is no change from the previous predicate device that would affect performance.
The ECHELON OVAL V5.1 MRL is equivalent to the ECHELON OVAL V5.0 MRJ (K151015) with the following exceptions:
- 32ch in RF receiver channel is added to product specification.
- Xeon 3.5GHz in CPU platform is added to product specification.
- Reconstruction configuration hardware is changed to from the TIP to the FARCON. ●
- Coil mode of Spine coil is added for over 16ch receiver channels.
- The Soft Sound function in pulse sequences is added to functional specification.
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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 ECHELON OVAL includes V5.1 software is substantially equivalent to the ECHELON OVAL V5.0 (K151015). See tables below.
The technological characteristics in regards to hardware of the ECHELON Oval MRI System and the predicate are listed in Table 1.
| ITEM | ECHELON OVAL V5.0 (K151015)PREDICATE | ECHELON OVAL V5.1 | DIFFERENCEANALYSIS | |
|---|---|---|---|---|
| System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4,MS 5, MS 8,IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | NEMA: MS 1, MS 2, MS 3, MS 4,MS 5, MS 8,IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | No |
| Magnet andGantry | Type and FieldStrengthResonant Frequency | Super-conducting magnet,horizontal bore, 1.5 Tesla63.86 MHz | Super-conducting magnet,horizontal bore, 1.5 Tesla63.86MHz | NoNo |
| GradientSystem | Gradient StrengthSlew RateRise Time | 34mT/m150 T/m/sec227µsec to 34mT/m | 34mT/m150 T/m/sec227µsec to 34mT/m | NoNoNo |
| Audible Noise (MCAN)AmbientLpeakLeq | 58 dBA125 dBA117 dB | 58 dBA125 dBA117 dBA | NoNoNo | |
| RF System | Transmitter channelsPeak Envelop PowerDuty Cycle | 240 kW100% (Gating max), 12.5% at fullpower | 240 kW100% (Gating max), 12.5% at fullpower | NoNoNo |
| RF receiver channel | 16 | 16, 32 | See Table 2 |
Table 1 Comparison: Hardware
The hardware differences from the ECHELON Oval MRI System to the predicate device are analyzed in Table 2.
Table 2 Hardware 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 | 32ch in RF receiver channel is added to product specification.Xeon 3.5GHz in CPU platform is added to product specification.Reconstruction configuration hardware is changed to from the TIP and 1 PC to the FARCON and 2 PCs. | |||
| 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 V5.0 (K151015). So, safety and effectively of the device are same as ECHELON Oval V5.0 (K151015) |
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The technological characteristics in regards to coils of the ECHELON Oval MRI System and the predicate are listed in Table 3.
| Table 3 Comparison: RF Coils | ||||
|---|---|---|---|---|
| ITEM | ECHELON OVAL V5.0 (K151015)PREDICATE | ECHELON OVAL | DIFFERENCEANALYSIS | |
| RF Coils | Transmit Coil | T/R Body | T/R Body | No |
| Receiver Coils | WIT Posterior Head/Neck coil, WITAnterior Head attachment | WIT Posterior Head/Neck coil,WIT Anterior Head attachment | No | |
| WIT Torso coil | WIT Torso coil | No | ||
| Extremity coil (Knee) | Extremity coil (Knee) | No | ||
| WIT Anterior Neck attachment | WIT Anterior Neck attachment | No | ||
| Hand/Wrist coil | Hand/Wrist coil | No | ||
| WIT Anterior NV attachment | WIT Anterior NV attachment | No | ||
| Breast | Breast | No | ||
| MP coil 140A, B | MP coil 140A, B | No | ||
| Shoulder | Shoulder | No | ||
| WIT Spine coil 12 | WIT Spine coil 12 | No | ||
| WIT Spine coil 8 | WIT Spine coil 8 | No | ||
| Foot/Ankle | Foot/Ankle | No | ||
| Flexible Extremity (Long Bone) | Flexible Extremity (Long Bone) | No | ||
| WIT Cardiac | WIT Cardiac | No | ||
| PV | PV | No |
The coil differences from the ECHELON Oval MRI System to the predicate device are analyzed
| Table 4 Coil Comparison Analysis | ||||
|---|---|---|---|---|
| FDARequirements | 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)). | |||
| DeviceModificationSummary | The performance and technological characteristics of the coils are the same as ECHELON Oval V5.0 (K151015). | |||
| SignificantChanges | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance |
| ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) |
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The technological characteristics in regards to changes in functionality of the ECHELON Oval MRI System as compared to the predicate are listed in Table 5.
| ITEM | DIFFERENCES | ANALYSIS |
|---|---|---|
| Operating System | None | No |
| CPU Platform | Core i3 3.5GHz in CPU platform is also available on ECHELON Oval V5.1 | See Table 6 |
| Application Software | Going from V5.0A to V5.1A | See Table 6 |
| Scan Tasks | None | No |
| 2D Processing Tasks | Vivid Image is available | See Table 6 |
| 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 | ASL perfusion (pCASL) is available, NCC function is available. | See Table 6 |
| Pulse Sequences | 2D Soft FSE, 2D Soft FIR, 2D Soft SE, 3D Soft TOF is available | See Table 6 |
Table 5 Comparison: Functionality
The functionality differences from the ECHELON Oval MRI System to the predicate device are analyzed in
| 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 | • Soft FSE, Soft FIR, Soft SE and Soft TOF, which are used for the Protocol Enhancements of Soft Sound, in pulsesequences category are added to functional specification.• Xeon 3.5GHz in CPU platform is added to product specification.• ASL Perfusion (pCASL) in the protocol enhancement is added to product specification.• VIVID image which enhances image quality in the 2D processing tasks is added to product specification.• NCC function for improvement of MAC coil reconstruction image quality in the protocol enhancements is added toproduct specification. | ||||
| 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 V5.0 (K151015). So safety andeffectivity of the device are equivalent to the ECHELON Oval V5.0 (K151015). |
Table 6 Functionality Comparison Analysis
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Substantial Equivalence
A summary decision was based on analysis of Table 7.
Table 7 Rationale Analysis: ECHELON 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 | 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 MRI is considered substantially equivalent to the currently marketed predicate device (ECHELON Oval V5.0 MRI System (K151015)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Summary of Non-Clinical Testing
The revisions to the ECHELON Oval V5.1 MRI System software will have no effect on the standards tests which were conducted on the ECHELON Oval V5.0 MRI System (K151015) and included in the original submission.
Therefore, ECHELON Oval 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 feature of the ECHELON Oval V5.1 MRI System. they include:
● Soft Sound
Test results confirm the acoustic sound pressure levels of conventional sequences and soft sound sequences.
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Summary of Clinical Testing
There is no change from the previous predicate device that would affect clinical performance.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. the ECHELON Oval V5.1 MRI System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECHELON Oval V5.0 MRI System (K151015).
§ 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.