Who is the manufacturer of ECHELON OVAL V6.0A MRI System?

Hitachi Healthcare Americas Corporation filed the 510(k) submission for ECHELON OVAL V6.0A MRI System (K172110).

What is the FDA product code for ECHELON OVAL V6.0A MRI System?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ECHELON OVAL V6.0A MRI System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ECHELON OVAL V6.0A MRI System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ECHELON OVAL V6.0A MRI System

Q: What are the predicate devices for ECHELON OVAL V6.0A MRI System?

ECHELON OVAL V5.1 MRI System (K153547).

K172110 · Hitachi Healthcare Americas Corporation · LNH · Jan 11, 2018 · Radiology

Device Facts

Record ID	K172110
Device Name	ECHELON OVAL V6.0A MRI System
Applicant	Hitachi Healthcare Americas Corporation
Product Code	LNH · Radiology
Decision Date	Jan 11, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended 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 (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.

Device Story

ECHELON OVAL V6.0A is a 1.5T superconducting MRI system; utilizes magnetic resonance principles to generate cross-sectional anatomical images. Input: proton resonance signals detected via RF coils; processed via gradient magnetic fields and RF excitation. Output: 2D/3D images reflecting proton density, T1/T2 relaxation, and flow. Used in clinical settings by trained physicians for diagnostic interpretation. New features include HiMAR (metal artifact reduction), QSM (quantitative susceptibility mapping), R2* map analysis, ASL-perfusion (GRASE), and computed DWI. System provides non-invasive physiological/clinical information without ionizing radiation. Benefits include improved image quality for implants, advanced abdominal imaging, and reduced acoustic noise via Soft Sound package.

Clinical Evidence

No formal clinical trials; performance evaluation based on bench testing of new features and clinical image validation. A radiologist reviewed clinical image examples for new/improved features (HiMAR, QSM, ASL-Perfusion, etc.) and confirmed acceptable image quality for clinical use.

Technological Characteristics

1.5 Tesla superconducting magnet; horizontal bore. Hardware and base software identical to predicate. Standards: NEMA MS 1-5, MS 8; IEC 60601-1, 60601-1-2, 60601-2-33, 62304. Connectivity: Networked. Sterilization: N/A (non-invasive). Software: Update to V6.0A including new pulse sequences (2D Soft GE, 2D Soft SARGE, 3D GRASE) and processing tasks (R2/R2* calculation, Computed DWI, volume flow).

Indications for Use

Indicated for diagnostic imaging of head, body, spine, and extremities using T1, T2, proton density weighted imaging, diffusion weighted imaging, MR angiography, image processing, spectroscopy, and whole-body imaging.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

ECHELON OVAL V5.1 MRI System (K153547)

Related Devices

K151015 — ECHELON Oval V 5.0 MRI System · Hitachi Medical Systems America, Inc. · Jul 29, 2015
K153547 — ECHELON Oval V 5.1 MRI System · Hitachi Medical Systems America, Inc. · Mar 31, 2016
K233687 — ECHELON Synergy V10.0 · FUJIFILM Healthcare Americas Corporation · May 3, 2024
K160152 — Trillium Oval V 5.1 MRI System · Hitachi Medical Systems America, Inc. · May 20, 2016
K060003 — EXCELART VANTAGE ZGV · Toshibamedical Systems Corporation · Jan 18, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 11, 2018 Hitachi Healthcare Americas Corporation Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park Twinsburg, Ohio 44087 Re: K172110 Trade/Device Name: ECHELON OVAL V6.0A MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: November 30, 2017 Received: December 01 2017 Dear Doug 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 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); {1}------------------------------------------------ ## Page 2 - Doug Thistlethwaite and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert A. 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 510(k) Number (if known) K172110 Device Name ECHELON OVAL V6.0A 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 (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) | | |-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | <div>☒ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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 Healthcare Americas 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@HitachiHealthcare.com | | Date: | June 14, 2017 | ## Subject Device Name | Trade/Proprietary Name: | ECHELON OVAL V6.0A MRI system | |-------------------------|--------------------------------------------| | Regulation Number: | 21 CFR 892.1000 | | Regulation Name: | System, Nuclear Magnetic Resonance Imaging | | Product Code: | LNH | | Class: | 2 | | Panel: | Radiology | ## Predicate Device Name | Predicate Device(s): | ECHELON OVAL V5.1 MRI System (K153547) | |----------------------|--------------------------------------------| | Regulation Number: | 21 CFR 892.1000 | | Regulation Name: | System, Nuclear Magnetic Resonance Imaging | | Product Code | LNH | | Class | 2 | | Panel | Radiology | ## Device Intended Use The ECHELON Oval System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton Diagnostic uses: T1, T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Image processing Spectroscopy Whole Body {5}------------------------------------------------ ## Device Description ## Function The ECHELON OVAL is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture. ### Scientific Concepts Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adiacent 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 The ECHELON OVAL V6.0A MRI System is only a software update with new and improved features. Therefore, a clinical and performance evaluation was conducted on the new features which include: - . Computed DWI HiMAR . QSM . HiMAR can be used for reduction of metal artifacts around passive MR Conditional implants. In addition, a clinical and performance evaluation was conducted on the improved features which include: - Soft Sound Package - R2* Map Analysis o - Advanced contrast enhanced abdominal imaging ● - ASL-Perfusion (GRASE) ● - Cine-PC Analysis {6}------------------------------------------------ #### A rationale analysis was then conducted and the results are contained in Table 1. Table 1 Performance Analysis | Testing Type | Rationale Analysis | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Testing - Bench | Performance bench testing was conducted on the applicable new and improved features. Test data confirmed that each new and improved feature perform as intended for diagnostic use. | | Performance Testing - Clinical | Clinical image examples are provided for each applicable new and improved feature and that we judged to be sufficient to evaluate clinical usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use. | ## 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 V6.0A MRI system software is substantially equivalent to the ECHELON OVAL V5.1 (K153547). See tables below. The technological characteristics in regards to hardware of the ECHELON OVAL V6.0A MRI system and the predicate are listed in Table 2. | | ITEM | PREDICATE DEVICE ECHELON OVAL V5.1 (K153547) | SUBJECT DEVICE ECHELON OVAL V6.0A | DIFFERENCE | |----------------------|-------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------| | 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 | Super-conducting magnet, horizontal bore, 1.5 Tesla | Super-conducting magnet, horizontal bore, 1.5 Tesla | No | | Gradient System | Resonant Frequency | 63.86 MHz | 63.86MHz | No | | | Gradient Strength | 34mT/m | 34mT/m | No | | | Slew Rate | 150 T/m/sec | 150 T/m/sec | No | | | Rise Time | 227µsec to 34mT/m | 227µsec to 34mT/m | No | | Audible Noise (MCAN) | Ambient | 58 dBA | 58 dBA | No | | | Lpeak | 125 dBA | 125 dBA | No | | | Leq | 117 dB | 117 dBA | No | | RF System | Transmitter channels | 2 | 2 | No | | | Peak Envelop Power | 40 kW | 40 kW | No | | | Duty Cycle | 100% (Gating max), 12.5% at full power | 100% (Gating max), 12.5% at full power | No | | | RF receiver channel | 16, 32 | 16, 32 | No | Table 2 Comparison: Hardware The hardware differences from the ECHELON OVAL V6.0A MRI system to the predicate device are analyzed in Table 3. ## Table 3 Hardware Comparison Analysis | FDA Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not constitute a new intended use; and any differences in technological characteristics are accompanied by information that demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------| | Device Modification Summary | There are no significant hardware changes that affect technological characteristics and safety. | | | | | 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 V5.1 (K153547). So, safety and effectively of the device are same as ECHELON Oval V5.1 (K153547) | | | | {7}------------------------------------------------ The technological characteristics in regards to coils of the ECHELON OVAL V6.0A MRI system and the predicate are listed in Table 4. | ITEM | | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE | |----------|----------------|---------------------------------------------------------------|---------------------------------------------------------------|-------------| | | | ECHELON OVAL V5.1 (K153547) | ECHELON OVAL V6.0A | | | 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 Posterior Head/Neck coil B | See Table 5 | | | | WIT Torso coil | WIT Torso coil | No | | | | | WIT Torso coil 12 | See Table 5 | | | | | WIT Torso coil 8 | See Table 5 | | | | Extremity coil (Knee) | Extremity coil (Knee) | No | | | | WIT Anterior Neck attachment | WIT Anterior Neck attachment | No | | | | | WIT Anterior Neck attachment B | 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 | | | | | Micro coil (S) A, B | See Table 5 | | | | Shoulder | Shoulder | No | | | | | Shoulder coil 8 | See Table 5 | | | | WIT Spine coil 12 | WIT Spine coil 12 | No | | | | | WIT Spine coil A | See Table 5 | | | | WIT Spine coil 8 | WIT Spine coil 8 | No | | | | | WIT Spine coil B | See Table 5 | | | | Foot/Ankle | Foot/Ankle | No | | | | Flexible Extremity (Long Bone) | Flexible Extremity (Long Bone) | No | | | | WIT Cardiac | WIT Cardiac | No | | | | PV | PV | No | #### Table 4 Comparison: RF Coils The coil differences from the ECHELON OVAL V6.0A MRI system to the predicate device are analyzed in Table 5. #### Table 5 Coil Comparison Analysis | FDA Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not constitute a new intended use; and any differences in technological characteristics are accompanied by information that demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------| | Device Modification Summary | WIT Posterior Head/Neck coil B, WIT Anterior Neck attachment B, WIT Spine coil A, WIT Spine coil B, Micro coil (S) A, B, Shoulder coil 8, WIT Torso coil 12 and WIT Torso coil 8 are added. The performance or safety and effectiveness are the same as WIT Posterior Head/Neck coil, WIT Anterior Neck attachment, WIT Spine coil 12, MP coil 140A, B, Shoulder and WIT Torso coil for ECHELON Oval V5.1 (K153547). | | | | | Significant Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance | | | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) | | HITACHI Rationale Statement | Modified functions don't constitute a new intended use. There are no significant changes in technological characteristics. During transmitter coil operation, RF Coils are de-resonated by same scheme as ECHELON Oval V5.1 (K153547). | | | | {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 6. Table 6 Comparison: Functionality | ITEM | DIFFERENCES | ANALYSIS | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Operating System | None | No | | CPU Platform | None | No | | Application Software | Going from V5.1A to V6.0A | See Table 7 | | Scan Tasks | RAPID capability is changed to 4.0 per a direction (16.0 per 2 dir.) | See Table 7 | | 2D Processing Tasks | Image Division, and R2/R2* calculation are available. | See Table 7 | | 3D Processing Tasks | None | No | | Analysis Tasks | Computed DWI and volume flow analysis are available. | See Table 7 | | Maintenance Tasks | None | No | | Viewport Tools | None | No | | Film, Archive Tools | None | No | | Network Tools | None | No | | Protocol Enhancements | RADAR (2D Soft GE, 2D Soft FSE, 2D Soft FIR, 2D Soft SE, and 3D Soft TOF), Soft Sound (2D Soft FSE (Rephase: off), 2D Soft FSE (Rephase:Slice), 2D Soft FSE (RADAR), 2D Soft FIR (RADAR), 2D Soft SE (RADAR), 3D Soft TOF (RADAR), 2D Soft GE, 2D Soft GE (RADAR), and 2D Soft SARGE), ASL-Perfusion (GRASE), Advanced contrast enhanced abdominal imaging, HiMAR, and QSM are available. | See Table 7 | | Pulse Sequences | 2D Soft GE, 2D Soft SARGE, and 3D GRASE are available. | See Table 7 | #### The functionality differences from the ECHELON Oval MRI System to the predicate device are analyzed in #### Table 7 Functionality Comparison Analysis | FDA Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not constitute a new intended use; and any differences in technological characteristics are accompanied by information that demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------| | Device Modification Summary | Image Division, and R2/R2* calculation of Parameter Analysis in the 2D Processing Tasks are added to product specification. Computed DWI of DWI Analysis and volume flow of Velocity Analysis in the Analysis Tasks category are added to product specification. 2D Soft GE, 2D Soft FSE, 2D Soft FIR, 2D Soft SE, and 3D Soft TOF of RADAR in the Protocol Enhancements category are added to product specification. 2D Soft FSE (Rephase: off), 2D Soft FSE (Rephase:Slice), 2D Soft FSE (RADAR), 2D Soft FIR (RADAR), 2D Soft SE (RADAR), 3D Soft TOF (RADAR), 2D Soft GE, 2D Soft GE (RADAR), and 2D Soft SARGE of Soft Sound in the Protocol Enhancements category are added to product specification. ASL-Perfusion (GRASE), Advanced contrast enhanced abdominal imaging, HiMAR, and QSM in the Protocol Enhancements category are added to product specification. Soft GE and Soft SARGE, which are used for the Protocol Enhancements of Soft Sound, and GRASE, which are used for the Protocol Enhancements of ASL-Perfusion (GRASE) in pulse sequences category are added to functional 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 V5.1 (K153547). So safety and effectivity of the device are equivalent to the ECHELON Oval V5.1 (K153547). | | | | {9}------------------------------------------------ ## Substantial Equivalence A summary decision was based on analysis of Table 8. Table 8 Rationale Analysis: ECHELON Oval 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 V5.1 MRI System (K153547)) 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 MRI System software will have no effect on the standards tests which were conducted on the ECHELON Oval V5.1 MRI System (K153547) 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. ● {10}------------------------------------------------ In addition, tests were conducted on the new and improved features of the ECHELON OVAL V6.0A MRI system, they include: - Test Report: ASL-Perfusion (GRASE) ● - Test Report: Advanced contrast enhanced abdominal imaging - Test Report: Cine-PC Analysis - Test Report: Computed DWI ● - Test Report: HiMAR . - Test Report: QSM . - Test Report: R2* Map Analysis . - Test Report: Soft Sound Package o ## Summary of Clinical Testing Clinical images were collected and analyzed, to ensure that images from the new features meet user needs. As a result of the analysis: | Testing Type | Rationale Analysis | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Testing - Clinical | Clinical image examples are provided for each applicable new and improved feature and that we judged to be sufficient to evaluate clinical usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use. | ## Conclusions It is the opinion of Hitachi, the ECHELON OVAL V6.0A MRI system is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECHELON Oval V5.1 MRI System (K153547).