OASIS MRI System

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February 21, 2020 Hitachi Healthcare Americas % Mr. Aaron Pierce Director, RA/QA 1959 Summit Commerce Park TWINSBURG OH 44087 Re: K192851 Trade/Device Name: OASIS MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 22, 2020 Received: January 24, 2020 Dear Mr. Pierce: 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). 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Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use #### 510(k) Number (if known) K192851 Device Name OASIS MRI system ### Indications for Use (Describe) The OASIS 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) | |-------------------------------------------------| |-------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the company name is the slogan "Inspire the Next" in a smaller font, also in black, except for a small red accent mark above the letter 't' in "Next." # Section 5 510(k) Statement or Summary ## Submitter Information | Submitter: | Hitachi Healthcare Americas<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44087-2371 | |-------------------|----------------------------------------------------------------------------------------| | Contact: | Aaron Pierce | | Telephone number: | 330-425-1313 | | Telephone number: | 330-963-0749 | | E-mail: | piercea@hitachihealthcare.com | | Date: | January 18, 2019 | ## Subject Device Name | Trade/Proprietary Name: | OASIS MRI system | |-------------------------|--------------------------------------------| | Regulation Number: | 21 CFR 892.1000 | | Regulation Name: | System, Nuclear Magnetic Resonance Imaging | | Product Code | LNH | | Class | II | | Panel | Radiology | | | | ## Predicate Device Name | Predicate Device(s): | OASIS MRI System (K093044) | |----------------------|--------------------------------------------| | Regulation Number: | 21 CFR 892.1000 | | Regulation Name: | System, Nuclear Magnetic Resonance Imaging | | Product Code | LNH | | Class | II | | Panel | Radiology | ## Indications for Use The OASIS 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 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 diaqnosis 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 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is in bold, black letters on the top line. The words "Inspire the Next" are in a smaller font below the word "HITACHI." ## Device Description ### Function The OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting maqnet in a qantry design. ### Scientific Concepts Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the 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. In addition the OASIS MR system has the Function of measuring spectroscopy. ### Performance Evaluation The OASIS MRI system w/V6.0F is equivalent to the OASIS MRI (K093044) with the following exceptions, which were added to the product specification: - . Micro coil (S) and Foot/Ankle coils - Windows 7 and 10 IoT in Operating System - Xeon 3.5GHz in CPU platform ● - V6.0F Application software ● {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is in large, bold, black letters. Below it, in a smaller font, is the phrase "Inspire the Next" in black, except for a small red accent mark above the letter 't' in 'Next'. The logo is simple and modern. 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 features.<br>Test data confirmed that each new feature perform as intended for diagnostic use. | | Performance Testing -<br>Clinical | Clinical image examples are provided for each applicable new feature and that we judged to be sufficient to evaluate clinical usability. | ## Device Technological Characteristics The control and image processing hardware and the base elements of the system software are identical to the predicate device. The OASIS MRI system w/V6.0F software is substantially equivalent to the OASIS (K093044). See tables below. The technological characteristics in regards to hardware of the OASIS MRI system w/V6.0F and the predicate are listed in Table 2. | ITEM | | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE | |--------------------|----------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------| | | | OASIS (K093044) | OASIS V6.0F | | | System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS7, MS 8,<br>IEC: 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-33 | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS 8,<br>IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | See Table 3 | | | Magnet and<br>Gantry | Type and Field<br>Strength | Super-conducting open magnet, 1.2 Tesla | Super-conducting open magnet, 1.2 Tesla | | Resonant Frequency | | 49.39MHz ±100 kHz | 49.39MHz ±100 kHz | No | | Gradient Strength | | 33mT/m | 33mT/m | No | | Slew Rate | | 100 T/m/sec | 100 T/m/sec | No | | Rise Time | | 300µsec to 30mT/m | 300µsec to 30mT/m | No | | Gradient System | Audible Noise (MCAN) | | | | | | Ambient | 63 dBA | 63 dBA | No | | | Lpeak | 108.3 dBA | 126.3 dBA | See Table 3 | | | Leq | 106.2 dB | 119 dBA | See Table 3 | | RF System | Transmitter channels | 2 | 2 | No | | | Peak Envelop Power | 18 kW | 18 kW | No | | | Duty Cycle | 60% (Gating max), 10% at full power | 60% (Gating max), 10% at full power | No | | | RF receiver channel | 8 | 8 | No | #### Table 2 Comparison: Hardware The hardware differences from the OASIS MRI system w/V6.0F to the predicate device are analyzed in Table 3. #### Table 3 Hardware Comparison Analysis | FDA<br>Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not<br>constitute a new intended use; and any differences in technological characteristics are accompanied by information that<br>demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and<br>effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see<br>section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------|---------------------------------| | Device<br>Modification<br>Summary | There are no significant hardware changes that affect technological characteristics and safety. | | | | | Significant<br>Changes | □Manufacturing Process | □Labeling | □Technology | □Performance | | | □Engineering | □Materials | □Others | ☑None (See rationale statement) | | HITACHI<br>Rationale<br>Statement | Modified specification doesn't constitute a new intended use. There are no significant changes in technological<br>characteristics. For safety, gradient system and RF system is controlled according to same regulation as OASIS<br>(K093044). So, safety and effectively of the device are same as OASIS (K093044) | | | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font size, also in black, with a red accent mark over the letter 'e' in 'Next'. The technological characteristics in regards to coils of the OASIS MRI system w/V6.0F and the predicate are listed in Table 4. | Table 4 Comparison: RF Coils | | | | | |------------------------------|----------------|-------------------------------------|-------------------------------|-------------| | ITEM | | PREDICATE DEVICE<br>OASIS (K093044) | SUBJECT DEVICE<br>OASIS V6.0F | DIFFERENCE | | RF Coils | Transmit Coil | T/R Body | T/R Body | No | | | Receiver Coils | QD Head | N/A | See Table 5 | | | | Rapid Head | Rapid Head | No | | | | Rapid Body | Rapid Body | No | | | | Rapid Knee | Rapid Knee | No | | | | Rapid C-spine | Rapid C-spine | No | | | | Rapid Wrist | Rapid Wrist | No | | | | Rapid Shoulder | Rapid Shoulder | No | | | | N/A | Micro coil (S) | See Table 5 | | | | N/A | Foot/Ankle coil | See Table 5 | | | | Large Joint | Large Joint | No | The coil differences from the OASIS MRI system w/V6.0F 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<br>not constitute a new intended use; and any differences in technological characteristics are accompanied by<br>information that demonstrates the device is as safe and effective as the predicate and do not raise different questions<br>of safety and effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety<br>and effectiveness (see section 513(i)(1)(A) of the FD&C Act and<br>21 CFR 807.87(f)). | | | | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------|--------------------------------| | Device Modification<br>Summary | Micro coil (S) and Foot/Ankle coil are added and the QD Head coil is deleted. The performance and technological<br>characteristics of the coils are the same as OASIS (K093044). | | | | | Significant Changes | □ Manufacturing Process | □ Labeling | □Technology | □Performance | | | □Engineering | □Materials | □ Others | None (See rationale statement) | | HITACHI Rationale<br>Statement | Modified functions don't constitute a new intended use. There are no significant changes in technological<br>characteristics. During transmitter coil operation, RF Coils are de-resonated by same scheme as OASIS (K093044). | | | | The technological characteristics in regards to changes in functionality of the OASIS MRI System as compared to the predicate are listed in Table 6. | ITEM | DIFFERENCES | ANALYSIS | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Operating System | Going from Windows XP to Windows 7 and 10 loT | See Table 7 | | CPU Platform | Going from Dual Xeon 2.8GHz to Xeon 3.5GHz | See Table 7 | | Application Software | Going from V2.1B to V6.0F | See Table 7 | | Scan Tasks | Auto Pose is available | See Table 7 | | 2D Processing Tasks | Image Division, R2/R2* calculation and VIVID image are available. | See Table 7 | | 3D Processing Tasks | None | No | | Analysis Tasks | Color FA, AD, RD, Computed DWI and volume flow analysis are available. | See Table 7 | | Maintenance Tasks | None | No | | Viewport Tools | SIR Map is available | See Table 7 | | Film, Archive Tools | None | No | | Network Tools | None | No | | Protocol Enhancements | BSI, ADAGE, Multi-b measurement, k-RAPID, T2* Relax Map, RADAR (2D GE, 3D GE, 2D TOF, 3D<br>TOF, 2D Soft GE, 2D Soft FSE, 2D Soft FIR, 2D Soft SE, and 3D Soft TOF), Enhanced PC,Soft Sound<br>Package (2D Soft SE, 2D Soft FSE, 2D Soft FIR, 3D Soft TOF, 2D Soft GE, and 2D Soft SARGE),<br>Advanced contrast enhanced abdominal imaging, and BeamNavi are available. | See Table 7 | | Pulse Sequences | 3D RSSG EPI, T2 RELAXMAP, 3D isoFSE, 2D FatSepFSE, 2D FatSepRSSG, 3D FatSepRSSG, 2D FatSepFSE, 2D<br>opFSE, 2D opFIR, 3D opFSE, 2D PBSG, 3D PBSG, 2D Soft SE, 2D Soft FSE, 2D Soft FIR, 3D Soft TOF,<br>2D Soft GE, and 2D Soft SARGE are available | See Table 7 | #### Table 6 Comparison: Functionality {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Hitachi. The word "HITACHI" is in large, bold, black letters. Below it, in a smaller font, is the phrase "Inspire the Next" in black, except for a small red accent mark above the letter 't' in 'Next'. The functionality differences from the OASIS MRI System to the predicate device are analyzed in Table 7. Features have been added since the predicate device through the Memo to File process. | Table 7 Functionality Comparison Analysis | | | | | | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|---------------------------------|--| | FDA<br>Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not<br>constitute a new intended use; and any differences in technological characteristics are accompanied by information that<br>demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and<br>effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see<br>section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | | | | Device<br>Modification<br>Summary | • Windows 7 and 10 IoT in Operating System are added to product specification.<br>• Xeon 3.5GHz in CPU platform is added to product specification.<br>• Auto Pose in the Scan Tasks is added to product specification<br>• Image Division, R2/R2* calculation of Parameter Analysis, and VIVID image in the 2D Processing Tasks are added to<br>product specification.<br>• Color FA, Ad, RD, Computed DWI of DWI Analysis and volume flow of Velocity Analysis in the Analysis Tasks category<br>are added to product specification.<br>• SIR Map in the Viewport Tools is added to product specification.<br>• 2D GE, 3D GE, 2D TOF, 3D TOF, 2D Soft GE, 2D Soft FSE, 2D Soft FIR, 2D Soft SE, and 3D Soft TOF of RADAR in<br>the Protocol Enhancements category are added to product specification.<br>• 2D Soft SE, 2D Soft FSE, 2D Soft FIR, 3D Soft TOF, 2D Soft GE, and 2D Soft SARGE of Soft Sound Package in the<br>Protocol Enhancements category are added to product specification.<br>• BSI, ADAGE, Multi-b measurement, k-RAPID, T2* Relax Map, Enhanced PC, Soft Sound Package, Advanced contrast<br>enhanced abdominal imaging, and BeamNavi in the Protocol Enhancements category are added to product<br>specification.<br>• 3D RSSG EPI, T2 RELAXMAP, 3D isoFSE, 2D FatSepRSSG, 3D FatSepRSSG, 2D FatSepFSE, 2D opFSE, 3D<br>opFSE, 2D PBSG, 3D PBSG, 2D Soft SE, 2D Soft FSE, 2D soft FIR, 3D Soft TOF, 2D Soft GE, and 2D Soft SARGE in<br>pulse sequences category are added to functional specification. | | | | | | Significant<br>Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance | | | | □ Engineering | □ Materials | □ Others | ☑None (See rationale statement) | | | HITACHI<br>Rationale<br>Statement | Modified functions do not constitute a new intended use. There are no significant changes in technological characteristics.<br>For safety, pulse sequences are controlled according to same safety limits as OASIS (K093044). So safety and effectivity<br>of the device are equivalent to the OASIS (K093044). | | | | | ## Substantial Equivalence A summary decision was based on analysis of Table 8. | Table 8 Rationale Analysis: OASIS MRI vs. Predicate | |-----------------------------------------------------| |-----------------------------------------------------| | ITEM | Overall Rationale Analysis | |---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Hardware | Different specifications do not constitute a new intended use. There are no significant changes in technological<br>characteristics, safety and effectiveness. | | Coils | Modified functions don't constitute a new intended use. There are no significant changes in technological characteristics,<br>safety and effectiveness. | | Functionality | Enhanced features do not constitute a new intended use. There are no significant changes in technological<br>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 OASIS MRI is considered substantially equivalent to the currently marketed predicate device (OASIS MRI System (K093044)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is written in large, bold, black letters. Below it, in a smaller font, is the phrase "Inspire the Next" in black, except for a small red accent mark above the letter 't' in "Next." ## Summary of Non-Clinical Testing The OASIS MRI System at the original submission (K072279) was subjected to the following laboratory standards testing. - NEMA MS 2-2008 (R2014), Determination of Two-Dimensional Geometric Distortion in . Diagnostic Magnetic Resonance Images - 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 Hitachi determined the revisions to the subject system have no effect on these standards tests and therefore, would not need to be repeated. During the V4.8 release, the OASIS MRI System was subjected to the following laboratory testing: - . NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices Hitachi determined the revisions to the subject system have no effect on this standard test and therefore, would not need to be repeated. The predicate coils at the time of their clearance were subject to the following laboratory testing: - NEMA MS 1-2008 (R2014), Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic . Resonance Images (Micro coil. Foot/Ankle coil only) - NEMA MS 3-2008 (R2014), Determination of Image Uniformity in Diagnostic Magnetic ● Resonance Images (Micro coil, Foot/Ankle coil only) Hitachi determined only the new Micro coil and Foot/Ankle coil would need to be tested. In addition, Hitachi conducted the following standards tests on the subject system: - . 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 4.0 2014-02, 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 Ed. 3.2 b:2015, medical electrical equipment Part 2-33: particular requirements ● for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic. - IEC 62304 Ed.1.0:2006, medical device software software life cycle processes. . ## Summary of Clinical Testing Clinical images were collected and analyzed, to ensure that images from the new feature meet user needs. As a result of the analysis: | Testing Type | Rationale Analysis | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Performance Testing -<br>Clinical | Clinical image examples are provided for each applicable new feature and that we judged to be sufficient to evaluate<br>clinical usability. | ## Conclusions It is the opinion of Hitachi, the OASIS MRI system w/V6.0F is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the OASIS MRI System (K093044).