(246 days)
Not Found
No
The summary describes standard image processing and quantification tools for MR data, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is described as a diagnostic tool that assists in the evaluation and diagnosis of liver conditions by processing and displaying MR image data and deriving physical parameters, which are then interpreted by trained physicians. It does not provide any form of treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that LMS is "indicated for use as magnetic resonance diagnostic device software application" and that the generated information "may assist in diagnosis." Additionally, the "Device Description" states "LiverMultiScan is an aid to diagnosis."
Yes
The device is described as a "standalone software application" that runs on a workstation and processes existing MR image data. It does not include any hardware components for image acquisition or patient interaction beyond the standard workstation peripherals.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes. This examination is performed outside of the living body.
- Device Function: The description clearly states that LMS is a software application that processes and displays magnetic resonance medical image data acquired from a Siemens MAGNETOM Skyra MR Scanner. This data is generated from within the patient's body using a non-invasive imaging technique (MRI).
- Intended Use: The intended use is for non-invasive liver evaluation using MR image data and derived parameters. This is an in vivo diagnostic process, not an in vitro one.
- Specimen Type: The device works with image data, not biological specimens like blood or tissue.
Therefore, because the device operates on image data acquired in vivo and does not involve the examination of biological specimens in vitro, it does not fit the definition of an In Vitro Diagnostic device. It is a medical device used for image processing and analysis to aid in diagnosis, but it is not an IVD.
N/A
Intended Use / Indications for Use
[LMS is indicated for use as magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.
These images and the physical parameters derived from the images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes
LNH
Device Description
LiverMultiScan (LMS) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from Siemens MAGNETOM Skyra MR Scanners. LMS runs on a workstation with color monitor, keyboard and mouse.
LMS is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.
LMS allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver.
LMS provides a number of tools such as rulers and circular region of interest to be used for the assessment of regions of an image to support a clinical workflow.
LMS allows users to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.
LiverMultiScan (LMS) is intended to be used by trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists.
LiverMultiScan is an aid to diagnosis. When interpreted by a trained physician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.
LiverMultiScan offers:
- . Advanced visualization of MR data
- . Processing of MR data to quantify tissue characteristics including MR Relaxivity constants such as T2*, T1. cT1 and liver fat percentage
- . Circular Region of interest statistics
- Snapshot of images to include in a report
- Report to include region statistics, snapshot images and user-entered text
- Export of snapshot images and report to storage
- . Integration with Mirada DBx – a software module that maintains a local temporary cache of DICOM data and can interact with PACS, from which it can receive data
Mirada DBx is a medical device data system (MDDS, product code OUG, regulation number 880.6310) used for DICOM connectivity with other systems. - Ability to send data from Mirada DBx to PACS or other DICOM nodes for archive and distribution
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Abdomen, Liver
Indicated Patient Age Range
Any patient type who is suitable for an MRI scan
Intended User / Care Setting
Trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists.
Clinical/Hospital Environment
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)
LiverMultiScan is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that LiverMultiScan meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate devices.
Verification and Validation for LiverMultiScan has been carried out in compliance with the requirements of ISO 13485:2003, CFR 21 Part 820 and in adherence to the DICOM standard.
In conclusion, performance testing demonstrates that LiverMultiScan is substantially equivalent to, and performs at least as safely and effectively as the listed predicate device. LiverMultiScan meets requirements for safety and effectiveness and does not introduce any new potential safety risks.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2015
Mirada Medical, Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K143020
Trade/Device Name: LiverMultiScan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 9, 2015 Received: June 10, 2015
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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FDA Indications for Use Form
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143020 Device Name
LiverMultiScan
Indications for Use (Describe)
[LMS is indicated for use as magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.
These images and the physical parameters derived from the images, when interpreted by a trained physician, yield information that may assist in diagnosis.
| Type of Use (Select one or both, as applicable) | [X] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | |||
|---|---|---|---|
| ---------------------- | -- | -- | -- |
Services (201) 443-6740 EF PSC Polishing
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LiverMultiScan 510(k) Summary
| Date of summary: | 10 May 2015 |
|---|---|
| Submitter's name: | Mirada Medical Ltd |
| Submitter's address: | Oxford Centre for Innovation |
| New Road | |
| Oxford | |
| Oxfordshire | |
| OX1 1BY | |
| United Kingdom | |
| Submitter's contact: | Gwilym Owen |
| Telephone number: | +44 (0)1865 261410 |
| Device Proprietary Name: | LiverMultiScan |
| Device Common Name(s): | LiverMultiScan, LMS |
| Classification Name: | Class II: Magnetic Resonance Imaging System |
| (892.1000) Product Code: LNH |
LiverMultiScan is Substantially Equivalent to the following Legally Marketed devices:
Predicate Devices
| 510(k) Number | Trade Name | Manufacturer |
|---|---|---|
| K141977 | Software syngo MR E11A for the | |
| MAGNETOM systems Aera/Skyra | Siemens AG |
Intended Use
LMS is indicated for use as magnetic resonance diagnostic device standalone software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.
These images and the physical parameters derived from the images, when interpreted by a trained physician, yield information that may assist in diagnosis.
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Device Description
LiverMultiScan (LMS) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from Siemens MAGNETOM Skyra MR Scanners. LMS runs on a workstation with color monitor, keyboard and mouse.
LMS is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.
LMS allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver.
LMS provides a number of tools such as rulers and circular region of interest to be used for the assessment of regions of an image to support a clinical workflow.
LMS allows users to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.
LiverMultiScan (LMS) is intended to be used by trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists.
LiverMultiScan is an aid to diagnosis. When interpreted by a trained physician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.
LiverMultiScan offers:
- . Advanced visualization of MR data
- . Processing of MR data to quantify tissue characteristics including MR Relaxivity constants such as T2*, T1. cT1 and liver fat percentage
- . Circular Region of interest statistics
- Snapshot of images to include in a report
- Report to include region statistics, snapshot images and user-entered text
- Export of snapshot images and report to storage
- . Integration with Mirada DBx – a software module that maintains a local temporary cache of DICOM data and can interact with PACS, from which it can receive data
Mirada DBx is a medical device data system (MDDS, product code OUG, regulation number 880.6310) used for DICOM connectivity with other systems.
- Ability to send data from Mirada DBx to PACS or other DICOM nodes for archive and distribution
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Testing
LiverMultiScan is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that LiverMultiScan meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate devices.
Verification and Validation for LiverMultiScan has been carried out in compliance with the requirements of ISO 13485:2003, CFR 21 Part 820 and in adherence to the DICOM standard.
In conclusion, performance testing demonstrates that LiverMultiScan is substantially equivalent to, and performs at least as safely and effectively as the listed predicate device. LiverMultiScan meets requirements for safety and effectiveness and does not introduce any new potential safety risks.
Comparison to Predicate Devices
The proposed device is substantially equivalent to the predicate device image processing applications.
Although the proposed device does not contain software for image acquisition, the proposed device and predicate device support multi-slice MR data acquired using the same specific acquisition protocols, from the same scanner type and acquisition software to acquire the input data.
The proposed and predicate device include software applications which utilize MR data to visualize and enable quantify physiological characteristics in the liver to provide measurements which may be used to aid diagnosis.
The proposed device and both predicate device are software applications to facilitate the import and visualization of MR data sets.
Both the proposed device and the predicate device include applications to facilitate the import and visualization of MR data sets and include tools to enable the manipulation of the views and to enable the quantification and analysis of tissue characteristics in the liver from the MR data.
The proposed device and the predicate enable the quantification of analysis of tissue characteristics in the liver from the MR data.
The proposed device and the predicate device both support region of interest measurements derived from MR images and parametric maps of tissue characteristics.
The proposed device and predicate device facilitate the creation of a medical report containing the images and data analysis derived from quantification of liver tissue parameters.
The proposed device and predicate device reports all include tabular display of quantification statistics, parametric map images and include normal range references.
In conclusion, the proposed device (LiverMultiScan) does not result in any new potential safety risk and performs in accordance with its intended use as well as comparatively with the intended use of the chosen predicate.
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We conclude that the LiverMultiScan device is as safe and effective as the predicate devices and poses no unanswered questions with regard to safety and efficacy.
The key similarities and differences are highlighted in the following summary table.
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Device Comparison Table
| Characteristic | LiverMultiScan | Software syngo MR E11A for the MAGNETOM systems Aera/Skyra | |
|---|---|---|---|
| 510(k) number | Not known | K141977 | |
| Classification | Class II. 892.1000 LNH | Class II. 892.1000 LNH | |
| Intended Use | LMS is indicated for use as magnetic resonance diagnostic | ||
| device software application for non-invasive liver evaluation | |||
| that enables the generation, display and review of 2D magnetic | |||
| resonance medical image data and pixel maps for MR relaxation | |||
| times. | The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] are | ||
| indicated for use as a magnetic resonance diagnostic device (MRDD) that | |||
| produces transverse, sagittal, coronal and oblique cross sectional images, | |||
| spectroscopic images and/or spectra, and that displays the internal structure | |||
| and/or function of the head, body, or extremities. | |||
| LMS is designed to utilize DICOM 3.0 compliant magnetic | |||
| resonance image datasets, acquired from Siemens MAGNETOM | |||
| Skyra MR Scanners, to display the internal structure of the | |||
| abdomen including the liver. Other physical parameters derived | |||
| from the images may also be produced. | Other physical parameters derived from the images and/or spectra may also be produced. |
Depending on the region of interest, contrast agents may be used. These images
and/or spectra and the physical parameters derived from the images and/or
spectra, when interpreted by a trained physician, yield information that may
assist in diagnosis.
The MAGNETOM systems may also be used for imaging during interventional
procedures when performed with MR compatible devices such as in-room display
and MR-Safe biopsy needles. | |
| | LMS provides a number of quantification tools such as rulers
and region of interest to be used for the assessment of regions
of an image to support existing clinical workflows.
These images and the physical parameters derived from the
images, when interpreted by a trained physician, yield
information that may assist in diagnosis. | | |
| Device
Description | LMS is a standalone software application for displaying 2D
Magnetic Resonance medical image data acquired from
Siemens MAGNETOM Skyra MR Scanners. LMS runs on a | The subject device, software syngo MR E11A for MAGNETOM Aera and
MAGNETOM Skyra offers two new applications, LiverLab (an application of non-
invasive liver evaluation) and MyoMaps (an application designed to provide a
means to generate pixel maps for myocardial MR relaxation times). In addition, | |
| software syngo MR E11A makes the Dot Cockpit available for the user to modify
workstation with color monitor, keyboard and mouse.
and create Siemens Dot Engine workflows in a very intuitive way which
LMS is designed to allow the review of DICOM 3.0 compliant
MR E11A also includes new and modified sequences as well as minor
datasets stored on the workstation and the user may also
modifications of already existing features. In addition, three additional coils are
create, display, print, store and distribute reports resulting from
interpretation of the datasets.
offered and some hardware components have been modified.
Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera and
LMS allows the display and comparison of combinations of
MAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11A
magnetic resonance images and provides a number of tools for
offers additional capabilities with respect to the predicate device, the
the quantification of magnetic resonance images, including the
MAGNETOM Aera and MAGNETOM Skyra have the same technological
determination of triglyceride fat fraction in the liver.
characteristics as the predicate device (K121434; Cleared November, 5, 2012).
LMS provides a number of tools such as rulers and circular
Furthermore, Siemens Medical Solutions, USA Inc., intends to market a new
region of interest to be used for the assessment of regions of an
configuration of the MAGNETOM Skyra with 24 receive channels with software
image to support a clinical workflow.
syngo MR E11A.
LMS allows users to create relaxometry parameter maps of the
The MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (new
abdomen which can be used by clinicians to help determine
production) as well as in-field upgrades for the currently installed MAGNETOM
different tissue characteristics to support a clinical workflow.
Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configuration
Examples of such workflows include, but are not limited to, the
with 24 receive channels will be offered as an ex-factory option (new
evaluation of the presence or absence of liver fat.
production).
The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] are
Indications for
LMS is indicated for use as magnetic resonance diagnostic
device software application for non-invasive liver evaluation
indicated for use as a magnetic resonance diagnostic device (MRDD) that
Use
that enables the generation, display and review of 2D magnetic
produces transverse, sagittal, coronal and oblique cross sectional images,
resonance medical image data and pixel maps for MR relaxation
spectroscopic images and/or spectra, and that displays the internal structure
and/or function of the head, body, or extremities.
times. | Characteristic | LiverMultiScan | Software syngo MR E11A for the MAGNETOM systems Aera/Skyra |
| | | | |
| | | | supplements some of the support of an application specialist. The software syngo |
| | | | |
| | | | |
| | | | |
| | | | |
| LMS is designed to utilize DICOM 3.0 compliant magnetic
Other physical parameters derived from the images and/or spectra may also be | | | |
| Characteristic | LiverMultiScan | Software syngo MR E11A for the MAGNETOM systems Aera/Skyra | |
| | resonance image datasets, acquired from Siemens MAGNETOM
Skyra MR Scanners, to display the internal structure of the
abdomen including the liver. Other physical parameters derived
from the images may also be produced. | produced. | |
| | LMS provides a number of quantification tools such as rulers
and region of interest to be used for the assessment of regions
of an image to support existing clinical workflows. | Depending on the region of interest, contrast agents may be used. These images
and/or spectra and the physical parameters derived from the images and/or
spectra, when interpreted by a trained physician, yield information that may
assist in diagnosis. | |
| | These images and the physical parameters derived from the
images, when interpreted by a trained physician, yield
information that may assist in diagnosis. | The MAGNETOM systems may also be used for imaging during interventional
procedures when performed with MR compatible devices such as in-room display
and MR-Safe biopsy needles. | |
| Target Population | Any patient type who is suitable for an MRI scan | Any patient type who is suitable for an MRI scan | |
| Where used | Clinical/Hospital Environment | Clinical/Hospital Environment | |
| Anatomical Site | Abdomen, Liver | Abdomen, Liver, Heart, various other anatomical sites | |
| Energy Used
and/or Delivered | None – software only application. The software application
does not deliver or depend on energy delivered to or from
patients | When used in conjunction with MAGNETOM MR Scanners, the scanner delivers
electromagnetic energy. The software applications do not deliver or depend on
energy delivered to or from patients | |
| Human factors | Designed to be used by trained clinicians | Designed to be used by trained clinicians | |
| Design Purpose | Standalone software application to facilitate the import and
visualization of MR data sets encompassing the abdomen,
including the liver with functionality independent of the MRI
equipment vendor | Software tool used as an accessory to an MR scanning machine, to facilitate the
import and visualization of multi-slice, spin-echo MR data sets. Includes an
application for visualization of Cardiac MR datasets and an application for MR
datasets encompassing the abdomen for visualization of the Liver | |
| Design: Data
visualization | Software application intended to display and visualize 2D multi-
slice, spin-echo MR data sets encompassing the abdomen. The
user may process, and review DICOM 3.0 compliant datasets
within the system and/or across computer networks | software application for visualization of DICOM 3.0 compliant multi-slice, spin-
echo MR data sets encompassing the abdomen and chest | |
| Design: MR
relaxometry | T1, cT1 & T2* Mapping | T1, T2 & T2* Mapping | |
| Characteristic | LiverMultiScan | Software syngo MR E11A for the MAGNETOM systems Aera/Skyra | |
| mapping | | | |
| Design: Liver Fat
quantification | Utilizes magnetic resonance images that exploit the difference
in resonance frequencies between hydrogen nuclei in water
and triglyceride fat using DIXON method | Utilizes magnetic resonance images that exploit the difference in resonance
frequencies between hydrogen nuclei in water and triglyceride fat using DIXON
method | |
| Design: Region of
Interest
measurements | Mean, Median, Standard deviation, Interquartile range
measurements created from a cross sectional slice of liver
tissue | Mean, Standard deviation, Histogram. | |
| Design:
Supported
modalities | DICOM 3.0 compliant MR data from GRE Echo & Molli
acquisition protocols. | DICOM 3.0 compliant MR data from GRE Echo & Molli acquisition protocols. | |
| Design: Reporting | Liver quantification images and analysis collated in a report. | Liver quantification images and analysis collated in a report. Cardiac
quantification images and analysis collated in a report | |
| Performance | Validated with volunteer and phantom scans | Validated with volunteer and phantom scans and synthetic raw data | |
| Standards met | IEC 62304, DICOM 3.0 | IEC 62304, DICOM 3.0 | |
| Materials | Software product only | Not applicable to software component of this device. | |
| Biocompatibility | N/A, Software product only | N/A, Not applicable to software component of this device. | |
| Compatibility
with the | Compatible with data from Siemens Skyra 3T MR scanners. | Compatible with data from Siemens Aera 1.5T & Skyra 3T MR scanners | |
| environment and
other devices | Compatible with Microsoft windows | Compatible with Microsoft windows | |
| Sterility | N/A, Software product only | Not applicable to software component of this device. | |
| Electrical Safety | N/A, Software product only | Not applicable to software component of this device. | |
| Mechanical
Safety | N/A, Software product only | Not applicable to software component of this device. | |
| Chemical Safety | N/A, Software product only | Not applicable to software component of this device. | |
| Thermal Safety | N/A, Software product only | Not applicable to software component of this device. | |
| Radiation Safety | N/A, Software product only | Not applicable to software component of this device. | |
| Operating System | Microsoft Windows | Microsoft Windows | |
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Conclusion
In conclusion, the proposed device (LiverMultiScan) does not result in any new potential safety risk and performs in accordance with its intended use as well as comparatively with the intended use of the chosen predicates.
We conclude that the LiverMultiScan device is as safe and effective as the predicate devices and poses no unanswered questions with regard to safety and efficacy.