(43 days)
Yes
The document explicitly states that the device incorporates an "AI algorithm and learning condition of DLR Rise".
No.
The device is described as an "imaging device" intended to provide "physiological and clinical information" and for "diagnosis determination" through images, rather than for treatment or therapy.
Yes
The intended use explicitly states that "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination," and the document lists "Diagnostic uses" such as T1, T2, proton density weighted imaging, diffusion weighted imaging, MR Angiography, Image processing, Spectroscopy, and Whole Body.
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 text, the OASIS MRI System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "imaging device" that provides "physiological and clinical information, obtained non-invasively and without the use of ionizing radiation." It produces images of the internal structure of the body.
- Mechanism of Action: The device description explains that it uses magnetic resonance imaging (MRI) to create images based on the properties of atomic nuclei (specifically protons). This is a physical imaging technique, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens (like blood, urine, tissue, etc.) or the detection of specific analytes or markers within those specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The OASIS MRI System is an imaging modality that visualizes internal structures directly within the body.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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 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
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The OASIS MRI System is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting magnet in a gantry design.
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.
MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and T1 and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules. And MR system has the Function of measuring spectroscopy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
The Al algorithm and learning condition of DLR Rise in the subject device are the same as those of DLR Rise in the reference device (K223426).
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, Body, Spine, Extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained 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
The 71 unique subjects (patients and volunteers) from U.S. and Japan (Male: 38. Female: 33. Age: 21 - 91 years. BMI:15.2 - 55.1) were scanned in the anatomical regions from brain to ankle in order to provide the test datasets separately from the training and validation datasets using FUJIFILM 1.2T MRI Scanners (OASIS Velocity). The total of 124 images in multiple orientations (axial, sagittal and coronal), multiple dimensions (2D and 3D), and various contrast weightings (T1-T2-T2-JPD-weighted image with/without Fat saturation, FLAIR, DWI, MRA, MRCP, STIR, and Cine) were obtained for the test dataset by pulse sequences of SE, GE, FSE, FIR, BASG, RSSG, EPI, TOF, and PC.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Image testing: Three US board certified radiologists, who had at least 5 years' experience since residency, reviewed the image quality with DLR Rise. The images reconstructed with either the conventional method or DLR Rise were randomized, blinded to the reviewers, and compared by the reviewers in terms of image quality metrics (SNR, sharpness, lesion conspicuity, and overall image quality). All images used for this comparison were also evaluated by the reviewers in terms of clinical acceptability. After each radiologist reviews, the combination of three radiologists' answers was obtained by majority decision, and the combined answers were used for this evaluation. The review results indicated that SNR, sharpness, lesion conspicuity, and overall image quality in the images with DLR Rise were superior to those in the conventional images with statistically significant difference (p
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows 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.
April 12, 2024
Fujifilm Healthcare Corporation Chaitrali Kulkarni Sr. Regulatory Affairs Specialist 2-1, Shintoyofuta Kashiwa-shi. Chiba 277-0804 Japan
Re: K240571
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: February 29, 2024 Received: February 29, 2024
Dear Chaitrali Kulkarni:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
K240571
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 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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Whole Body
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K240571
4
| Submitter: | FUJIFILM Healthcare Corporation
2-1, Shintoyofuta
Kashiwa-Shi, Chiba JP 277-0804 |
|-------------------|----------------------------------------------------------------------------------------|
| Contact: | David Loeser
Regulatory Affairs Specialist |
| Telephone number: | 703-472-9452 |
| E-mail: | HCUSRegulatoryAffairs@fujifilm.com |
| Date: | February 29, 2024 |
Submitter Information
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 | 2 |
| Panel | Radiology |
Predicate Device Name
| Predicate Device(s): | OASIS MRI System (K211406) |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |
Reference Device Name
| Reference Device(s): | ECHELON Synergy MRI system (K223426) |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |
Device Intended 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
5
Nucleus excited: Proton
Diagnostic uses:
- . T1, T2, proton density weighted imaging
- . Diffusion weighted imaging
- . MR Angiography
- Image processing .
- . Spectroscopy
- Whole Body .
Device Description
Function
The OASIS MRI System is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting magnet in a gantry 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. And MR system has the Function of measuring spectroscopy.
Performance Evaluation
The OASIS MRI System is equivalent to the OASIS MRI System (K211406) with following exceptions:
- Application software is changed to V9.0E. .
6
- DLR Rise, IterativeRAPID, and DIR are available.
- IP-Recon and IP-Scan are modified. ●
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 feature. |
| Test data confirmed that new feature perform as intended for diagnostic use. | |
| Performance Testing - Clinical | Clinical image examples are provided for 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 software is substantially equivalent to the OASIS MRI System (K211406). See tables below.
The technological characteristics in regard to hardware of the OASIS MRI system and the predicate are listed in Table 2.
| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE | |
|---|---|---|---|---|
| OASIS MRI System (K211406) | OASIS MRI System | |||
| 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 |
| Console | Storage type | HDD | SSD | Yes |
| Memory capacity | 16GB | 32GB | Yes | |
| IRCP Unit | Storage | HDD | SSD | Yes |
| Memory capacity | 16GB | 32GB | Yes |
Table 2 Comparison: Hardware
The hardware differences from the predicate device to the OASIS MRI System 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 | • The storage type of the console is changed from HDD to SSD, and the memory capacity is changed from 16GB to 32GB.
• The storage type of the IRCP unit is changed from HDD to SSD, and the memory capacity is changed from 32GB to 64GB. | | | |
| Significant
Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
7
| FUJIFILM | Modified specification doesn't constitute a new intended use. There are no significant changes in technological |
|---|---|
| Rationale | characteristics. For safety, gradient system and RF system is controlled according to same regulation as OASIS MRI |
| Statement | System. |
8
| Table 4 Comparison: RF Coils | ||||
|---|---|---|---|---|
| ITEM | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE | |
| RF Coils | Transmit Coil | OASIS MRI System (K211406) | OASIS MRI System | No |
| Receiver Coils | 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 | Breast Support Kit 2 | No | ||
| Large Flex Coil | Large Flex Coil | No | ||
| Extra Large Flex Coil | Extra Large Flex Coil | No | ||
| WIT Spine Coil (Rev.A) | WIT Spine Coil (Rev.A) | No | ||
| WIT Head/Neck Coil | WIT Head/Neck Coil | No | ||
| WIT Head Attachment | WIT Head Attachment | No | ||
| WIT Head/Neck Attachment | WIT Head/Neck Attachment | No | ||
| WIT Neck Attachment | WIT Neck Attachment | No | ||
| WIT Torso Coil A | WIT Torso Coil A | No | ||
| WIT Torso Coil B | WIT Torso Coil B | No |
The technological characteristics in regard to coils of the OASIS MRI System and the predicate are listed in Table 4.
The coil differences from the predicate device to the OASIS MRI system 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 | There are no differences from the predicate device. | | | |
| Significant
Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| FUJIFILM
Rationale
Statement | There are no significant changes in technological characteristics. Therefore, safety, intended use and effectively of the RF
coils are same as OASIS MRI System (K211406). | | | |
9
| Table 6 Comparison: Functionality | ||
|---|---|---|
| ITEM | DIFFERENCES | ANALYSIS |
| Operating System | None | None |
| CPU Platform | None | None |
| Application Software | Going from V7.2E to V9.0E | See Table 7 |
| Scan Tasks | None | None |
| 2D Processing Tasks | None | None |
| 3D Processing Tasks | None | None |
| Analysis Tasks | None | None |
| Maintenance Tasks | None | None |
| Viewport Tools | None | None |
| Film, Archive Tools | None | None |
| Network Tools | None | None |
| Imaging Functions | Following functions are added. |
- DLR Rise
- IterativeRAPID
- DIR (Double-IR isoFSE)
Following functions are modified. - IP-Recon
- IP-Scan | See Table 7 |
| Pulse Sequences | None | None |
The technological characteristics in regard to changes in functionality of the OASIS MRI System as compared to the predicate are listed in Table 6.
The functionality differences from the predicate device to the OASIS MRI System are analyzed in Table 7.
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 | Application software is changed to V9.0E.
DLR Rise, IterativeRAPID, and DIR are added.
The Al algorithm and learning condition of DLR Rise in the subject device are the same as those of
DLR Rise in the reference device (K223426).
The pulse sequence and architecture of DIR function of the subject device are completely the same as
those of DIR function of the reference device (K223426).
The algorithm and parameter of IterativeRAPID of the subject device are completely the same as
IterativeRAPID in the reference device (K223426).
IP-Recon and IP-Scan are modified. | | | |
| Significant Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| FUJIFILM Rationale Statement | Modified specification doesn't constitute a new intended use. There are no significant changes in
technological characteristics. So, safety and effectively of the device are same as OASIS MRI System
(K211406). | | | |
10
Substantial Equivalence
A summary decision was based on analysis of Table 8.
Table 8 Rationale Analysis: OASIS MRI System vs. Predicate
| ITEM | Overall Rationale Analysis |
|---|---|
| Hardware | 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 MRI System (K211406). So, | |
| safety and effectively of the device are same as OASIS MRI System (K211406). | |
| Coils | There are no significant changes in technological characteristics. Therefore, safety, intended use and effectively of the RF |
| coils are same as OASIS MRI System (K211406). | |
| 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 OASIS MRI System (K211406) |
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 System is considered substantially equivalent to the currently marketed predicate device (OASIS MRI System (K211406)) 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.
- ANSI / AAMI 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 60601-2-33 Edition 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 Edition 1.1 2015-06. CONSOLIDATED VERSION medical device software software . life cycle processes.
The revisions to the OASIS MRI System will have no effect on the standards tests, which were conducted on the OASIS MRI System (K211406) and included in the original submission. Therefore, OASIS MRI System is in conformance with the applicable parts of the following standards:
- NEMA MS 1-2008, Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic . Resonance Images
- . NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images ●
- NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnostic 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 for Magnetic Resonance . Imaging Systems
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, medical electrical equipment -. part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests.
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- IEC 60825-1 Edition 2.0 2007-03. Safety of laser products Part 1: Equipment classification and . requirements [Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]
Summary of Clinical Testing
Clinical images were collected and analyzed, to ensure that images from the new feature meet user needs.
DLR Rise: Three US board certified radiologists, who had at least 5 years' experience since residency, reviewed the image quality with DLR Rise. The images reconstructed with either the conventional method or DLR Rise were randomized, blinded to the reviewers, and compared by the reviewers in terms of image quality metrics (SNR, sharpness, lesion conspicuity, and overall image quality). All images used for this comparison were also evaluated by the reviewers in terms of clinical acceptability. After each radiologist reviews, the combination of three radiologists' answers was obtained by majority decision, and the combined answers were used for this evaluation. The 71 unique subjects (patients and volunteers) from U.S. and Japan (Male: 38. Female: 33. Age: 21 - 91 years. BMI:15.2 - 55.1) were scanned in the anatomical regions from brain to ankle in order to provide the test datasets separately from the training and validation datasets using FUJIFILM 1.2T MRI Scanners (OASIS Velocity). The total of 124 images in multiple orientations (axial, sagittal and coronal), multiple dimensions (2D and 3D), and various contrast weightings (T1-T2-T2-JPD-weighted image with/without Fat saturation, FLAIR, DWI, MRA, MRCP, STIR, and Cine) were obtained for the test dataset by pulse sequences of SE, GE, FSE, FIR, BASG, RSSG, EPI, TOF, and PC. The review results indicated that SNR, sharpness, lesion conspicuity, and overall image quality in the images with DLR Rise were superior to those in the conventional images with statistically significant difference (p