(154 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device and performance studies do not mention any AI/ML components or methodologies.
No
Explanation: The device is described as an "imaging device" and its purpose is to "provide the physician with physiological and clinical information" and "useful in diagnosis determination." It produces images that display internal body structures. There is no indication that it treats or cures a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the images, "When interpreted by a trained physician, provide information that can be useful in diagnosis determination." Additionally, "Performance Testing - Bench" confirms that new features "perform as intended for 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 beyond just software.
Based on the provided information, the OASIS MRI System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "imaging device" that provides "physiological and clinical information" through "non-invasive" means. It produces images of the internal structure of the body.
- Mechanism of Action: The device utilizes Magnetic Resonance Imaging (MRI) to create images based on the magnetic properties of protons within the body. This is a physical imaging technique, not a test performed on biological samples outside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The OASIS MRI System does not perform such tests on biological samples.
The OASIS MRI System is a medical imaging device used for diagnostic purposes, but it falls under a different regulatory category than IVDs.
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 (comma separated list FDA assigned to the subject device)
LNH
Device Description
The OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting maqnet in a qantry 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
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
New software functions were tested basically according to the documents which were described in Test Report for IEC 62304. In addition, tests for following new software functions were conducted, they include:
- Test Report: IP-Recon
- Test Report: IP-Scan
- Test Report: AutoPose Spine
- Test Report: AutoClip
Clinical images were collected and analyzed, to ensure that images from the new feature meet user needs. As a result of the analysis: Clinical image examples are provided for each applicable new feature, which are WIT Head/Neck Coil, WIT Head Attachment, WIT Head/Neck Attachment, WIT Neck Attachment and WIT Torso Coil A, WIT Torso Coil B and new software functions, and that we judged to be sufficient to evaluate clinical usability.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The OASIS MRI System was subjected to the following laboratory testing.
- NEMA MS-1-2008 (R2014), Determination of Signal-to-Noise Ratio (SNR) In Diagnostic Magnetic ● Resonance Imaging (All receiver coils)
- NEMA MS 3-2008 (R2014), Determination of Image Uniformity in Diagnostic Magnetic ● Resonance Images (All receiver coils)
- IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 ●
- 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 disturbances - 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 diaanosis
- IEC 62304 Ed.1.1:2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
The revisions to the OASIS MRI System and standards will have no effect on the standards tests, which were conducted on the OASIS MRI System (K202030) and included in the original submission. - NEMA MS 2-2008 (R2014), Determination of Two-Dimensional Geometric Distortion in ● Diagnostic Magnetic Resonance Images
- NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Resonance Imaging
- NEMA MS 8-2016, Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
New software functions were tested basically according to the documents which were described in Test Report for IEC 62304. In addition, tests for following new software functions were conducted, they include: - Test Report: IP-Recon
- Test Report: IP-Scan
- Test Report: AutoPose Spine
- Test Report: AutoClip
Clinical image examples are provided for each applicable new feature and or coil that we judged to be sufficient to evaluate clinical usability. Clinical image examples are provided for each applicable new feature, which are WIT Head/Neck Coil, WIT Head Attachment, WIT Head/Neck Attachment, WIT Neck Attachment and WIT Torso Coil A, WIT Torso Coil B and new software functions, and that we judged to be sufficient to evaluate clinical usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
October 7, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
Hitachi Healthcare Americas % Mr. Aaron Pierce Director, RA/QA 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K211406
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: August 25, 2021 Received: August 31, 2021
Dear Mr. Aaron 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/cfpmp/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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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,
For
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) K211406
Device Name OASIS MRI System Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
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 (T), 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) | |
| AAUWILIP ALL I APALRIFE BLARIP UPPREA |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
HITACHI
Inspire the 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: | April 23, 2021 |
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 (K202030) |
|---|---|
| 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 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 |
4
Image /page/4/Picture/0 description: The image shows the number 5-2 at the top. Below that is the Hitachi logo in bold black font. Underneath the logo is the text "Inspire the Next".
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 maqnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in maqnetic resonance imaging. When placed in a static maqnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events.
The emissions are used to develop a representation of the relaxation events in a threedimensional 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. In addition the OASIS MR system has the Function of measuring spectroscopy.
Performance Evaluation
The OASIS MRI System is equivalent to the OASIS MRI (K202030) with the following exceptions:
- Head Coil is no longer available.
- Breast Support Kit 2 is available for previously cleared Breast Coil as an accessory. ●
- WIT Spine Coil revision A which provides a MUX board which has a function to select elements.
- WIT Head/Neck Coil, WIT Head Attachment, WIT Head/Neck Attachment, WIT Neck . Attachment, WIT Torso Coil A and WIT Torso Coil B are added.
- . Application software is changed to V7.2E.
- IP-Recon, IP-Scan, AutoPose Spine, AutoExam and AutoClip are available. ●
5
Image /page/5/Picture/0 description: The image shows the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the word "HITACHI" is the phrase "Inspire the Next" in a smaller, black font. The letter "t" in "Next" has a red accent mark.
A rationale analysis was then conducted and the results are contained below.
| 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 or coil 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 is substantially equivalent to the OASIS MRI system (K202030). See tables below.
The technological characteristics in regards to hardware of the OASIS MRI system and the predicate are listed below:
| ITEM | OASIS (K202030) | OASIS | 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 open magnet, 1.2 Tesla | Super-conducting open magnet, 1.2 Tesla | No | |
| Resonant Frequency | 49.39MHz ± 98 kHz | 49.39MHz ± 98 kHz | No | |
| Gradient System | 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 | |
| Audible Noise (MCAN) | ||||
| Ambient | 63 dBA | 63 dBA | No | |
| Lpeak | 126.3 dBA | 126.3 dBA | No | |
| Leq | 119 dBA | 119 dBA | No | |
| RF System | Transmitter channels | 2 | 2 | No |
| Peak Envelop Power | 18 kW | 18 kW | No | |
| Duty Cycle | 85% (Gating max), 10% at full power | 85% (Gating max), 10% at full power | No | |
| RF receiver channel | 16 | 16 | No | |
| System Control | ||||
| Unit | Unit Type | IRCP | IRCP | No |
The hardware differences from the OASIS MRI system to the predicate device are analyzed in the table below:
Table 1 Hardware NSE 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 is no hardware difference. | | | |
| Significant
Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| HITACHI
Rationale
Statement | There is no change in the hardware. So, safety and effectiveness of the device are same as OASIS (K202030). | | | |
6
Image /page/6/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, with a red accent mark above the letter 't' in 'Next'. The logo is simple and modern.
The technological characteristics in regards to coils of the OASIS MRI system and the predicate are listed in the table below:
| ITEM | OASIS (K202030) | OASIS | DIFFERENCE | |
|---|---|---|---|---|
| RF Coils | Transmit Coil | T/R Body | T/R Body | No |
| Receiver Coils | Head Coil | - | See Table 2 | |
| Extremity Coil | Extremity Coil | No | ||
| Wrist Coil | Wrist Coil | No | ||
| Shoulder Coil | Shoulder Coil | No | ||
| Multipurpose Coil | Multipurpose Coil | No | ||
| Micro Coil | Micro Coil | No | ||
| Foot/Ankle Coil | Foot/Ankle Coil | No | ||
| Breast Coil | Breast Coil | No | ||
| Breast Support Kit 2 | See Table 2 | |||
| Large Flex Coil | Large Flex Coil | No | ||
| Extra Large Flex Coil | Extra Large Flex Coil | No | ||
| WIT Spine Coil | WIT Spine Coil (Rev.A) | See Table 2 | ||
| WIT Head/Neck Coil | See Table 2 | |||
| WIT Head Attachment | See Table 2 | |||
| WIT Head/Neck Attachment | See Table 2 | |||
| WIT Neck Attachment | See Table 2 | |||
| WIT Torso Coil A | See Table 2 | |||
| WIT Torso Coil B | See Table 2 |
The coil differences from the OASIS MRI system to the predicate device are analyzed in the table below:
| Table 2 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 | • Head Coil is no longer available. | |||
| • Breast Support Kit 2 is available for previously cleared Breast Coil as an accessory. | ||||
| • WIT Spine Coil revision A which provides a MUX board which has a function to select elements. | ||||
| • WIT Head/Neck Coil, WIT Head Attachment, WIT Head/Neck Attachment, WIT Neck Attachment, WIT Torso Coil A | ||||
| and WIT Torso Coil B are added. | ||||
| • WIT Torso Coil A and WIT Torso Coil B are added. | ||||
| Significant | ||||
| Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) | |
| HITACHI | ||||
| Rationale | ||||
| Statement | Additional or revised coils do not 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 (K202030). |
7
Image /page/7/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is written in large, bold, black letters. Below the word "HITACHI" is the phrase "Inspire the Next" in a smaller, black font. The letter "t" in the word "Next" has a red accent mark.
5-5
The technological characteristics in regards to changes in functionality of the OASIS MRI System as compared to the predicate are listed in the table below:
| ITEM | DIFFERENCES | ANALYSIS |
|---|---|---|
| Operating System | None. | No |
| CPU Platform | None. | No |
| Application Software | Going from V7.0D to V7.2E. | See Table 3 |
| Scan Tasks | AutoPose Spine is available. | See Table 3 |
| 2D Processing Tasks | None. | No |
| 3D Processing Tasks | AutoClip is available. | See Table 3 |
| Analysis Tasks | None. | No |
| Maintenance Tasks | None. | No |
| Viewport Tools | None. | No |
| Film, Archive Tools | None. | No |
| Network Tools | None. | No |
| Protocol Enhancements | IP-Recon, IP-Scan and AutoExam are available. | See Table 3 |
| Pulse Sequences | None. | No |
The functionality differences from the OASIS MRI System to the predicate device are analyzed in the table below. Features have been added since the predicate device through the Memo to File process.
| Table 3 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 | Application software is changed to V7.2E. IP-Recon, IP-Scan, AutoPose Spine, AutoExam and AutoClip are available. | ||||||||
| Significant | |||||||||
| Changes | □ Manufacturing Process □ Labeling □ Technology □ Performance □ Engineering □ Materials □ Others ☑ None (See rationale statement) | ||||||||
| HITACHI | |||||||||
| Rationale | |||||||||
| Statement | Additional functions do not constitute a new intended use. There are no significant changes in technological characteristics. | ||||||||
| So, safety and effectivity of the device are equivalent to the OASIS (K202030). |
8
Substantial Equivalence
A summary decision was based on analysis of results in the table below:
| Table 4 Rationale Analysis: OASIS MRI vs. Predicate | |
|---|---|
| ITEM | Overall Rationale Analysis |
| Hardware | There is no change in the hardware. So, safety and effectively of the device are same as OASIS (K202030). |
| Coils | Additional or revised coils do not 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 (K202030). | |
| Functionality | Additional functions do not constitute a new intended use. There are no significant changes in technological characteristics. |
| So, safety and effectivity of the device are equivalent to the OASIS (K202030). |
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 in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Summary of Non-Clinical Testing
The OASIS MRI System was subjected to the following laboratory testing.
- NEMA MS-1-2008 (R2014), Determination of Signal-to-Noise Ratio (SNR) In Diagnostic Magnetic ● Resonance Imaging (All receiver coils)
- NEMA MS 3-2008 (R2014), Determination of Image Uniformity in Diagnostic Magnetic ● Resonance Images (All receiver coils)
- IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 ●
- 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 disturbances - 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 diaanosis
- . IEC 62304 Ed.1.1:2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes
The revisions to the OASIS MRI System and standards will have no effect on the standards tests, which were conducted on the OASIS MRI System (K202030) and included in the original submission.
- NEMA MS 2-2008 (R2014), Determination of Two-Dimensional Geometric Distortion in ● Diagnostic Magnetic Resonance Images
- . NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- . NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Resonance Imaging
- . NEMA MS 8-2016, Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
New software functions were tested basically according to the documents which were described in Test Report for IEC 62304. In addition, tests for following new software functions were conducted, they include:
- . Test Report: IP-Recon
- . Test Report: IP-Scan
- Test Report: AutoPose Spine ●
- . Test Report: AutoClip
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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, which are WIT Head/Neck Coil, WIT Head Attachment, WIT Head/Neck Attachment, WIT Neck Attachment and WIT Torso Coil A, WIT Torso Coil B and new software functions, and that we judged to be sufficient to evaluate clinical usability. |
Conclusions
It is the opinion of Hitachi, the OASIS MRI system is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the OASIS MRI System (K202030).