(263 days)
Not Found
Yes
The device description explicitly states that LiverMultiScan v5 includes automatic processing functionality based on machine-learning.
No
The device is described as a "diagnostic device software application" and an "aid to diagnosis," providing information for clinicians but explicitly stating it is "not intended to replace established procedures" or make "treatment decisions."
Yes
The "Intended Use / Indications for Use" states that LMSv5 is a "magnetic resonance diagnostic device software application." Additionally, multiple sections mention that the device "may assist in diagnosis," is an "aid to diagnosis," and its metrics are intended to be "an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process."
Yes
The device description explicitly states "LiverMultiScan v5 (LMSv5) is a standalone software device." It processes existing DICOM image data and does not include any hardware components.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that LiverMultiScan v5 is a "magnetic resonance diagnostic device software application for noninvasive liver evaluation." It also mentions that the information derived from the images, when interpreted by a trained clinician, "may assist in diagnosis."
- Diagnostic Information: The device provides quantitative measurements (PDFF, T2*, LIC, cT1) derived from medical images. These measurements are intended to provide "additional diagnostic input to provide information to clinicians as part of a wider diagnostic process."
- Role in Diagnosis: While it's not a standalone diagnostic device and requires interpretation by a clinician, its purpose is to provide information that contributes to a diagnostic decision.
While the term "In Vitro Diagnostic" typically refers to tests performed on samples outside the body, the regulatory definition of IVD can encompass devices that provide diagnostic information, even if they are based on imaging and post-processing. The key is that the device is intended to be used in the diagnosis of disease or other conditions.
The fact that it processes medical images and provides quantitative data to aid in the diagnosis of liver conditions aligns with the broader concept of a diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The phrase "Control Plan Authorized (PCCP) and relevant text" is listed as "Not Found," indicating the absence of such information.
Intended Use / Indications for Use
LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
Product codes
LNH
Device Description
LiverMultiScan v5 (LMSv5) is a standalone software device. The LiverMultiScan v5 device is to assist a trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (a patient visit).
LiverMultiScan is a post-processing software device, a trained operator uses tools within the device interface to quantify liver tissue characteristics from parametric maps. LiverMultiScan v5 includes automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver. A summary report from the analysis conducted is generated for interpretation by a clinician.
LiverMultiScan v5 is not intended to replace the established procedures for the assessment of a patient's liver health by a clinician, providing many opportunities for competent human intervention in the clinical care of patients.
The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of clinical care, patients with clinical symptoms or risk factors which may indicate liver disease. The interpreting clinician needs to take into consideration the device's limitations and accuracy during clinical interpretation.
Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan v5 metrics, may contribute to a diagnostic decision.
LiverMultiScan v5 is not a computer-aided diagnostic device and can only present imaging information which must be interpreted by a qualified clinician. LiverMultiScan v5 is an aid to diagnosis and treatment decisions remain the responsibility of the clinician.
Mentions image processing
Yes
Mentions AI, DNN, or ML
LiverMultiScan v5 includes automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver.
Input Imaging Modality
Magnetic Resonance (MR) images / DICOM 3.0 compliant magnetic resonance image datasets
Anatomical Site
Abdomen, including the liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Perspectum internal operator.
Report User: An interpreting clinician or healthcare practitioner.
Clinical Setting: LiverMultiScan v5 is a standalone post-processing software device that is intended to be installed on general use workstations at Perspectum's image analysis centre. Operators use LMSv5 to conduct quantitative analysis of liver tissue characteristics to produce a report. The end-users for the output from the device, the report, are clinicians who receive and interpret LiverMultiScan (LMSv5) reports.
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)
Bench testing included functional verification to ensure software installation, licensing, labeling, and feature functionality all met design requirements. The accuracy and precision of device measurements was assessed using purpose-built phantoms containing vials with different relaxation times corresponding to the physiological ranges of tissue values expected to be seen in-vivo. To assess the precision of LiverMultiScan v5 measurements across supported scanners, in-vivo volunteer data was used. Volunteers participating in the performance testing were representative of the intended patient population. Inter and intra operator variability was also assessed.
LiverMultiScan v5 underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that LiverMultiScan v5 is at least as safe and effective as the predicate devices.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
September 6, 2022
Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs Gemini One 5520 John Smith Drive Oxford, Oxfordshire OX 2LL UNITED KINGDOM
Re: K213960
Trade/Device Name: LiverMultiScan v5 (LMSv5) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: July 26, 2022 Received: July 26, 2022
Dear Ioan Wigley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 Magnetic Resonance and Nuclear Medicine Team 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
Enclosure
2
Indications for Use
510(k) Number (if known) K213960
Device Name LiverMultiScan v5
Indications for Use (Describe)
LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Dect
Date Prepared:
01 September 2022
Submitter Details
Owner Address:
Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL +44 (0) 1865 655329
| Owner/Operator Number: | 10056574 |
|---|---|
| Establishment Registration Number: | 3014232555 |
| Contact Person: | loan Wigley |
| loan.Wigley@perspectum.com | |
| +44 (0) 1865 655329 |
Subject and Predicate Devices
| Subject Device | Primary Predicate Device | Secondary Predicate Device | |
|---|---|---|---|
| 510(k) number | Not known | K202170 | K043271 |
| Legal Manufacturer | Perspectum Ltd. | Perspectum Ltd. | Inner Vision Biometrics Pty |
| Owner/Owner Operator | 10056574 | 10056574 | / |
| Device Name | LiverMultiScan v5.0.0 | LiverMultiScan v4.0.0 | R2-MRI Analysis System |
| (FerriScan) | |||
| Proprietary/Common | LiverMultiScan, LMSv5, LMS | LiverMultiScan, LMSv4, LMS | FerriScan |
| Panel | Radiology | Radiology | Radiology |
| Regulation | 892.1000 | 892.1000 | 892.1000 |
| Risk Class | Class II | Class II | Class II |
| Product Class code | LNH | LNH | LNH |
| Classification | System, Nuclear Magnetic | ||
| Resonance Imaging | System, Nuclear Magnetic | ||
| Resonance Imaging | System, Nuclear Magnetic | ||
| Resonance Imaging |
4
Subject Device
General Description
LiverMultiScan v5 (LMSv5) is a standalone software device. The LiverMultiScan v5 device is to assist a trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (a patient visit).
LiverMultiScan is a post-processing software device, a trained operator uses tools within the device interface to quantify liver tissue characteristics from parametric maps. LiverMultiScan v5 includes automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver. A summary report from the analysis conducted is generated for interpretation by a clinician.
LiverMultiScan v5 is not intended to replace the established procedures for the assessment of a patient's liver health by a clinician, providing many opportunities for competent human intervention in the clinical care of patients.
The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of clinical care, patients with clinical symptoms or risk factors which may indicate liver disease. The interpreting clinician needs to take into consideration the device's limitations and accuracy during clinical interpretation.
Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan v5 metrics, may contribute to a diagnostic decision.
LiverMultiScan v5 is not a computer-aided diagnostic device and can only present imaging information which must be interpreted by a qualified clinician. LiverMultiScan v5 is an aid to diagnosis and treatment decisions remain the responsibility of the clinician.
Intended Use and Indications for Use
LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LlC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
Indications and contraindications
LiverMultiScan is indicated for use where MRI is not contraindicated.
Contraindications
LiverMultiScan is indicated for use where MRI is not contraindicated.
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Intended Conditions
LiverMultiScan is not intended to be used for use on any specific disease or condition, but the information provided in the report, when interpreted by a licensed physician, may benefit the clinical management, including diagnosis and monitoring of patients.
Standalone Software
LiverMultiScan is a post-processing software device. All operations are directly controlled by the LiverMultiScan device. LiverMultiScan does not control other firmware or software outside of the device
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Subject and Predicate Comparison
The following characteristics were compared between the predicate device in order to demonstrate substantial equivalence.
| Characteristi
c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System
(FerriScan) (Secondary
Predicate) |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | LiverMultiScan v5 (LMSv5) is
indicated for use as a 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.
LMSv5 is designed to utilize DICOM
3.0 compliant magnetic resonance
image datasets, acquired from
compatible MR Systems, to display
the internal structure of the abdomen
including the liver. Other physical
parameters derived from the images
may also be produced. | LiverMultiScan (LMSv4) is indicated
for use as a 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.
LiverMultiScan (LMSv4) is designed to
utilize DICOM 3.0 compliant magnetic
resonance image datasets, acquired
from compatible MR systems, to
display the internal structure of the
abdomen including the liver. Other
physical parameters derived from the
images may also be produced. | For the analysis of multi-
slice, spin-echo MRI data
sets of the liver for the
measurement of liver R2
and liver iron concentration. |
| Characteristi
c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System
(FerriScan) (Secondary
Predicate) |
| | LMSv5 provides several tools, such as
automated liver segmentation and
region of interest (ROI) placements,
to be used for the assessment of
selected regions of an image.
Quantitative assessment of selected
regions includes the determination of
triglyceride fat fraction in the liver
(PDFF), T2*, LIC (Liver Iron
Concentration) and iron corrected T1
(cT1) measurements. | LiverMultiScan (LMSv4) provides a
number of tools, such as automated
liver segmentation and region of
interest (ROI) placements, to be used
for the assessment of selected
regions of an image. Quantitative
assessments of selected regions
include the determination of
triglyceride fat fraction in the liver
(PDFF), T2* and iron-corrected T1
(cT1) measurements. T2* may be
optionally computed using the DIXON
or LMS MOST methods. | |
| | These images and the physical
parameters derived from the images,
when interpreted by a trained
clinician, yield information that may
assist in diagnosis. | These images and the physical
parameters derived from the images,
when interpreted by a trained
clinician, yield information that may
assist in diagnosis. | |
| Indications
for Use | Same as intended use | Same as intended use | The R2-MRI Analysis System
is an accessory diagnostic
device to MRI scanners and
is intended for diagnostic
use to present images that
reflect the magnetic
resonance spectra for the
determination of iron on the
liver. |
| Characteristi
c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System
(FerriScan) (Secondary
Predicate) |
| Target
Population | Patients suitable to undergo an MRI
scan and not contra-indicated for MRI | Patients suitable to undergo an MRI
scan and not contra-indicated for MRI | Patients suitable to undergo
an MRI scan and not contra-
indicated for MRI |
| Device User | Trained Perspectum internal operator | Trained Perspectum internal operator | Resonance Health's trained
analyst |
| Report User | An interpreting clinician or healthcare
practitioner | An interpreting clinician or healthcare
practitioner | An interpreting clinician or
healthcare practitioner |
| Device Use
Environment | Installation of LiverMultiScan v5 is
controlled and is installed on general
purpose workstations that meet the
minimum technical requirements at
Perspectum's image analysis centre
by specialist members of staff. | Installation of LMSv4 is controlled and
is installed on general purpose
workstations that meet the minimum
technical requirements at
Perspectum's image analysis centre
by specialist members of staff. | Image analysis and LIC
reporting is performed at a
central ISO 13485 certified
Service Centre. Hosting
platform is resonance
health's internal server. |
| Clinical
Setting | LiverMultiScan v5 is a standalone
post-processing software device that
is intended to be installed on general
use workstations at Perspectum's
image analysis centre.
Operators use LMSv5 to conduct
quantitative analysis of liver tissue
characteristics to produce a report.
The end-users for the output from
the device, the report, are clinicians
who receive and interpret
LiverMultiScan (LMSv5) reports. | LMSv4 is a standalone post-
processing software device that is
intended to be installed on general
use workstations at Perspectum's
image analysis centre.
Operators use LMS to conduct
quantitative analysis of liver tissue
characteristics to produce a report.
The end-users for the output from
the device, the report, are clinicians
who receive and interpret LMSv4
reports. | FerriScan is a standalone
software tool that is
intended to be used by
Resonance Health's trained
analyst, FerriScan is installed
and runs on the Resonance
Health's internal server.
The report result is overseen
by the radiologist and the
final decision for clinical
management of the patient
is made by their treating
clinician. |
| Anatomical
Location | Abdomen, including the liver | Abdomen, including the Liver | Abdomen, including the
Liver. |
| Characteristi
c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System
(FerriScan) (Secondary
Predicate) |
| Energy | LiverMultiScan v5 is a standalone
software application, it does not
deliver, monitor or depend on energy
delivered to or from patients. | LMS is a standalone software
application, it does not deliver,
monitor or depend on energy
delivered to or from patients. | FerriScan is a standalone
software application. It does
not deliver, monitor or
depend on energy delivered
to or from patients. |
| Design:
Purpose | LiverMultiScan v5 is a standalone
software application that imports MR
data sets encompassing the
abdomen, including the liver.
Visualisation and display of 2D multi-slice, spin-echo MR data can be
analysed and quantitative metrics of
tissue characteristics are then
reported.
Datasets imported into
LiverMultiScan (LMSv5) are DICOM
3.0 compliant, reported metrics are
independent of the MRI equipment
vendor. | LMS is a standalone software
application that imports MR data sets
encompassing the abdomen,
including the liver. Visualisation and
display of 2D multi-slice, spin-echo
MR data can be analysed and
quantitative metrics of tissue
characteristics are then reported.
Datasets imported into LMS are
DICOM 3.0 compliant, reported
metrics are independent of the MRI
equipment vendor. | FerriScan is intended for:
• Supporting clinical
diagnoses about the
status of liver iron
concentration.
• Supporting the
subsequent clinical
decision-making
processes.
• Supporting the use in
clinical research trials,
directed at studying
changes in liver iron
concentration as a
result of interventions.
• It contains an image
viewer for importing
DICOM images,
browsing through
patient datasets,
viewing images and
performing region of
interest analysis |
| Characteristi | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System |
| c | | | (FerriScan) (Secondary
Predicate) |
| Design: Tools | Allows for the visualisation via
parametric maps and quantification
of metrics (cT1, LIC and PDFF) from
liver tissue and exportation of results
& images to a deliverable report. | Allows for the visualisation via
parametric maps and quantification
of metrics (cT1, T2* and PDFF) from
liver tissue and exportation of results
& images to a deliverable report. | Allows for the visualisation
of images that reflect the
magnetic resonance spectra
for the determination of
iron on the liver. It contains |
| | Quantification is through either full
segmentation of the outer liver
contour and liver vasculature or
manual placement of ROI's on the
parametric maps. IQR and median
metrics are reported from the
segmentation/ROI quantification.
automatically detects artefacts on the
and are delineated on the parametric
map computed images as well as
recommends slices to be used as the | Quantification is through either full
segmentation of the outer liver
contour and liver vasculature or
manual placement of ROI's on the
parametric maps. IQR and median
metrics are reported from the
segmentation/ROI quantification. | an image viewer for
• importing DICOM
images,
• browsing through
patient datasets,
• viewing images and
performing ROI analysis. |
| Design: MR
Relaxometry | quantitative output of the device.
T1, iron corrected T1 (cT1) mapping
and LIC | T1, iron corrected T1 (cT1) and T2*
mapping | R2 (Signal Decay Rate)
mapping |
| Design: Liver
Fat
Quantificatio
n | Utilizes MR images that exploit the
difference in resonance frequencies
between hydrogen nuclei in water
and triglyceride fat using the
LiverMultiScan v5 IDEAL method. | Utilizes MR images that exploit the
difference in resonance frequencies
between hydrogen nuclei in water
and triglyceride fat using the LMS
IDEAL method. | N/A |
| Design:
Parametric
Maps | Iron corrected T1 (cT1), Proton
Density Fat Fraction (PDFF) and LIC
parametric maps can be created from
all supported scanners. | Iron corrected T1 (cT1), T2* and
Proton Density Fat Fraction (PDFF)
parametric maps can be created from
all supported scanners. | FerriScan calculates the
signal decay rate (R2) that is
used to characterise iron
loading in the liver. It
produces an output report |
| Characteristic | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System
(FerriScan) (Secondary
Predicate) |
| | It is possible to use the LIC maps and
knowledge of the measurements and
the scanner field strength to correct
for signal changes related to iron
deposits, producing a cT1 map. The
cT1 map eliminates the effects of
elevated iron from the T1
measurement (3) and standardizes
for the fat signal across scanner
manufacturers.
PDFF is quantified using the LMS
IDEAL method. Parametric maps of
LIC are quantified using the LMS
MOST method.
LMSv5 uses the measured T2* value
and uses them to characterise iron
loading in the liver which is then
transformed by a defined calibration
curve to provide a quantitative
measure of liver iron concentration in
vivo. LMSv5 presents images that
reflect the magnetic resonance
spectra for iron determination on the
liver. | It is possible to use the T2* and PDFF
maps and knowledge of the T2* and
PDFF measurements and the scanner
field strength to correct for signal
changes related to iron deposits,
producing a cT1 map. The cT1 map
eliminates the effects of elevated iron
from the T1 measurement (3) and
standardizes for the fat signal across
scanner manufacturers.
PDFF is quantified using the LMS
IDEAL method. Parametric maps of
T2* may optionally be computed
using either the three-point DIXON
method or the LMS MOST method. | comprising R2 which is
transformed by a defined
calibration curve into a
quantitative measure of liver
iron concentration in vivo.
FerriScan presents images
that reflect the magnetic
resonance spectra for iron
determination on the liver. |
| Design:
Visualisation | Numerous views within the
LiverMultiScan v5 interface can be
used to assist in analysis of Iron
corrected T1 (cT1), triglyceride fat
(also known as Proton Density Fat
Fraction (PDFF)) and LIC parametric | Numerous views within the LMSv4
interface can be used to assist in
analysis, Iron-corrected T1 (cT1), T2*
and triglyceride fat (also known as
Proton Density Fat Fraction (PDFF))
parametric maps can be created from | Visualisation of multi-slice,
spin-echo MRI data sets
encompassing the
abdomen.
Software tool calculates the
signal decay rate (R2) that is |
| Characteristi
c | LMSv5 (Subject device) | LMSv4 (Primary Predicate Device) | R2-MRI Analysis System
(FerriScan) (Secondary
Predicate) |
| | maps can be created from all
supported scanners.
Parametric maps displayed using the
LMSv5 colourmap, designed to have
maximum contrast on liver
parenchymal tissue. | all supported scanners. R2 maps can
also be utilised to assess the quality
of the map fitting.
Iron- corrected T1 (cT1) displayed
using LMSv4 colourmap, designed to
have maximum contrast on liver
parenchymal tissue. | used to characterise iron
loading in the liver, which is
then transformed by a
defined calibration curve to
provide a quantitative
measure of liver iron
concentration in vivo.
LIC is displayed on a map
and histogram within the
FerriScan LIC report. |
| Design:
Supported
Modalities | DICOM 3.0 compliant MR data from | DICOM 3.0 compliant MR data from | DICOM Image Format.
Functionality independent
of MRI equipment vendor. |
| | supported MRI scanners. | supported MRI scanners. | |
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Differences between subject and predicate devices
- The LMSv5 device offers additional quantification tools in its interface that are not available in the primary . predicate device, LMSv4. LMSv5 automatically detects artefacts on the and are delineated on the parametric map computed images as well as recommends slices to be used as the quantitative output of the device. Artefact areas are overlayed on the parametric maps to assist in quantification and interpretation.
- . LMSv5 uses the measured T2* values to characterise iron loading in the liver which is transformed by a defined calibration curve to provide a quantitative measure of liver iron concentration (LIC) in vivo. LMSv5 presents images that reflect the magnetic resonance spectra for iron determination on the liver. The primary predicate device does not offer quantification of LIC. However, the secondary predicate, R2-MRI Analysis System (FerriScan) also produces an outputted report comprising measured R2 values that are transformed by a defined calibration curve into a quantitative measure of liver iron concentration.
Software and Performance Testing
All product specifications were verified and the overall ability of the product to meet user needs was validated. Testing was performed according to internal company procedures. Software testing and validation were conducted according to written test protocols established before testing was conducted. Software verification and validation testing were conducted, and documentation was provided as detailed in FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." The software level of concern for LiverMultiScan v5 is Moderate, as per FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This device does not control a life supporting or life-sustaining device, nor does it control the delivery of a potentially harmful energy. This device does not control the delivery of treatment, and it does not provide diagnostic information, nor does it provide any vital signs monitoring. The hazard analysis identifies the potential software-related risks of using the device, and the mitigations implemented.
Bench testing included functional verification to ensure software installation, licensing, labeling, and feature functionality all met design requirements. The accuracy and precision of device measurements was assessed using purpose-built phantoms containing vials with different relaxation times corresponding to the physiological ranges of tissue values expected to be seen in-vivo. To assess the precision of LiverMultiScan v5 measurements across supported scanners, in-vivo volunteer data was used. Volunteers participating in the performance testing were representative of the intended patient population. Inter and intra operator variability was also assessed.
LiverMultiScan v5 underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that LiverMultiScan v5 is at least as safe and effective as the predicate devices.
Conclusion
LiverMultiScan v5 has the same intended use and similar technological characteristics as the predicate devices, LiverMultiScan v4 and Ferriscan. Software and Performance testing corroborate the differences between the subject device and the predicates do not result in a new intended use and do not raise any questions of safety and effectiveness. It can be concluded that LiverMultiScan v5 is substantially equivalent to the listed predicate devices.