(141 days)
No
The document describes a standard MRI system and its intended use, focusing on the physical principles of MRI and image interpretation by a physician. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as an "imaging device" intended to provide "physiological and clinical information" and produce "images" useful in "diagnosis determination," rather than for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "When interpreted by a trained physician. these images provide information that can be useful in diagnosis determination." Additionally, the "Summary of Performance Studies" mentions "diagnostic use."
No
The device description explicitly states it is a "Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting magnet in a gantry design," indicating it includes significant 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- OASIS MRI System Function: The description clearly states the OASIS MRI System is an imaging device that produces images of the internal structure of the head, body, or extremities non-invasively. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to provide physiological and clinical information through imaging, not through the analysis of biological samples.
Therefore, based on the provided information, the OASIS MRI System falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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.
Product codes
LNH
Device Description
The OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting magnet in a gantry design.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, Body, Spine, Extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician (trained), Not Found
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)
Performance Testing - Bench: Performance bench testing was conducted on the applicable new features. Test data confirmed that each new feature perform as intended for diagnostic use.
Performance Testing - Clinical: Clinical image examples are provided for each applicable new feature and that we judged to be sufficient to evaluate clinical usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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.
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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. 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)
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3
Image /page/3/Picture/1 description: The image shows 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, 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
1959 Summit Commerce Park
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 |
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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 ●
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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. |
| Test data confirmed that each new feature perform as intended for diagnostic use. | |
| Performance Testing - | |
| 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, | ||
| 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, | |||
| IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | See Table 3 | |||
| Magnet and | ||||
| Gantry | Type and Field | |||
| 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
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 OASIS
(K093044). So, safety and effectively of the device are same as OASIS (K093044) | | | |
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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 | |||
| OASIS (K093044) | SUBJECT DEVICE | |||
| 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
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 | Micro coil (S) and Foot/Ankle coil are added and the QD Head coil is deleted. The performance and technological
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
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 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 | |
| TOF, 2D Soft GE, 2D Soft FSE, 2D Soft FIR, 2D Soft SE, and 3D Soft TOF), Enhanced PC,Soft Sound | ||
| Package (2D Soft SE, 2D Soft FSE, 2D Soft FIR, 3D Soft TOF, 2D Soft GE, and 2D Soft SARGE), | ||
| 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 | |
| opFSE, 2D opFIR, 3D opFSE, 2D PBSG, 3D PBSG, 2D Soft SE, 2D Soft FSE, 2D Soft FIR, 3D Soft TOF, | ||
| 2D Soft GE, and 2D Soft SARGE are available | See Table 7 |
Table 6 Comparison: Functionality
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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 | |||||
| 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 | • Windows 7 and 10 IoT in Operating System are added to product specification. | ||||
| • Xeon 3.5GHz in CPU platform is added to product specification. | |||||
| • Auto Pose in the Scan Tasks is added to product specification | |||||
| • Image Division, R2/R2* calculation of Parameter Analysis, and VIVID image in the 2D Processing Tasks are added to | |||||
| product specification. | |||||
| • Color FA, Ad, RD, Computed DWI of DWI Analysis and volume flow of Velocity Analysis in the Analysis Tasks category | |||||
| are added to product specification. | |||||
| • SIR Map in the Viewport Tools is added to product specification. | |||||
| • 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 | |||||
| the Protocol Enhancements category are added to product specification. | |||||
| • 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 | |||||
| Protocol Enhancements category are added to product specification. | |||||
| • BSI, ADAGE, Multi-b measurement, k-RAPID, T2* Relax Map, Enhanced PC, Soft Sound Package, Advanced contrast | |||||
| enhanced abdominal imaging, and BeamNavi in the Protocol Enhancements category are added to product | |||||
| specification. | |||||
| • 3D RSSG EPI, T2 RELAXMAP, 3D isoFSE, 2D FatSepRSSG, 3D FatSepRSSG, 2D FatSepFSE, 2D opFSE, 3D | |||||
| 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 | |||||
| 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 OASIS (K093044). So safety and effectivity | |||||
| 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 |
| 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 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.
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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 - | |
| Clinical | Clinical image examples are provided for each applicable new feature and that we judged to be sufficient to evaluate |
| 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).