(111 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on standard MRI technology and a new "Soft Sound" feature.
No
The device is described as an "imaging device" and "Magnetic Resonance Imaging System" intended for diagnosis determination by providing "physiological and clinical information" and "images." It does not mention any therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device provides "physiological and clinical information" and that the images produced "provide information that can be useful in diagnosis determination." This indicates its role in the diagnostic process.
No
The device description explicitly states it is a Magnetic Resonance Imaging System utilizing a 1.5 Tesla superconducting magnet in a gantry design, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Description: The ECHELON Oval MRI System is an imaging device that uses magnetic resonance to create images of the internal structure of the body. It obtains information non-invasively and without the use of ionizing radiation.
- Intended Use: The intended use describes the device as providing physiological and clinical information through imaging, which is interpreted by a physician for diagnosis determination. This process does not involve testing samples taken from the body.
Therefore, based on the provided information, the ECHELON Oval MRI System is an imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Head, Body, Spine, Extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Testing:
There is no change from the previous predicate device that would affect clinical performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 5
510(k) Summary
4
| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, 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.
5
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.
6
Device Technological Characteristics
The control and image processing hardware and the base elements of the system software are identical to the predicate device. The ECHELON 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 | DIFFERENCE
ANALYSIS |
|----------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------|
| 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 and
Gantry | Type and Field
Strength
Resonant Frequency | Super-conducting magnet,
horizontal bore, 1.5 Tesla
63.86 MHz | Super-conducting magnet,
horizontal bore, 1.5 Tesla
63.86MHz | No
No |
| Gradient
System | Gradient Strength
Slew Rate
Rise Time | 34mT/m
150 T/m/sec
227µsec to 34mT/m | 34mT/m
150 T/m/sec
227µsec to 34mT/m | No
No
No |
| | Audible Noise (MCAN)
Ambient
Lpeak
Leq | 58 dBA
125 dBA
117 dB | 58 dBA
125 dBA
117 dBA | No
No
No |
| RF System | Transmitter channels
Peak Envelop Power
Duty Cycle | 2
40 kW
100% (Gating max), 12.5% at full
power | 2
40 kW
100% (Gating max), 12.5% at full
power | No
No
No |
| | 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
| FDA
Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and
effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see
section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------|
| Device
Modification
Summary | 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. | | | |
| Significant
Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| HITACHI
Rationale
Statement | 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) | | | |
7
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 | 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 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 | ||||
|---|---|---|---|---|
| FDA | ||||
| Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not constitute a new intended use; and any differences in technological characteristics are accompanied by information that demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | |||
| Device | ||||
| Modification | ||||
| Summary | The performance and technological characteristics of the coils are the same as ECHELON Oval V5.0 (K151015). | |||
| Significant | ||||
| Changes | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance |
| ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) |
8
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
| FDA
Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and
effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see
section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------|--|
| Device
Modification
Summary | • Soft FSE, Soft FIR, Soft SE and Soft TOF, which are used for the Protocol Enhancements of Soft Sound, in pulse
sequences 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 to
product specification. | | | | |
| Significant
Changes | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance | |
| | ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) | |
| HITACHI
Rationale
Statement | Modified functions do not constitute a new intended use. There are no significant changes in technological characteristics. For
safety, pulse sequences are controlled according to same safety limits as ECHELON Oval V5.0 (K151015). So safety and
effectivity of the device are equivalent to the ECHELON Oval V5.0 (K151015). | | | | |
Table 6 Functionality Comparison Analysis
9
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 technological |
| characteristics, 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.
10
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).