(67 days)
Not Found
No
The summary describes image processing and quantitative analysis based on established methods (IDEAL, Couinaud/Brisbane terminology) and semi-automatic segmentation requiring operator input. There is no mention of AI, ML, deep learning, or any training/inference process indicative of such technologies. The performance studies compare results to radiologists (gold standard) and assess operator variability, which is typical for traditional image analysis software.
No.
The device is a post-processing medical device software that provides quantified metrics for assessment of liver health and supports surgical decision making, but it does not directly provide therapy or treatment.
Yes
The device processes medical image datasets to produce quantified metrics and anatomical models for assessing liver health and volume, which are used by clinicians to evaluate a patient's liver and support decision-making, fulfilling the role of a diagnostic device.
Yes
The device is explicitly described as a "standalone software device" and its function is to process and analyze existing medical image data to produce reports and visualizations. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device processes images of the human body (specifically, MR images of the liver).
- The intended use is to provide additional information for clinical evaluation and surgical decision making based on image analysis. It does not involve the analysis of biological samples.
- The device description focuses on image processing, visualization, and quantification of metrics derived from those images.
While the device provides quantitative metrics that contribute to the assessment of liver health, these metrics are derived from image analysis, not from the analysis of biological specimens. This places it outside the typical definition and scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health.
Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported.
Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.
Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
Hepatica v1 is a standalone software device. It is a post-processing medical device software that imports MR datasets encompassing the abdomen, including the liver. It provides visualization and display of T1-weighted MR data, allowing for analysis and the reporting of quantitative metrics of tissue characteristics and liver volume. The software uses image visualization and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica v1 can also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Quantified metrics and images derived from the analysis are collated into a report for evaluation and interpretation by a clinician. It allows for the 3D visualization of the liver and quantification of metrics (cT1, PDFF and volumetry) from liver tissue and exportation of results and images to a deliverable report. Operators are able to see live views of crosshair placements during landmarking across multiple image planes simultaneously and adjust contrast where required. Lesion segmentation is performed by navigating through axial slices using the crosshair tool and "painting in" the segment on each slice. The borders can be adjusted accordingly. Views of the segmented liver and lesions are updated in real-time and can be rotated in 3D space. Paint, eraser and zooming functionalities are also available. Where available, operators can review the position of cT1 and PDFF slices (derived from LMSv4) within the 3D view of the liver. The software runs on Mac OS.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance image datasets (MR data, MRI, T1-weighted MR data)
Anatomical Site
Abdomen, including the Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Device User: Trained Perspectum internal operator
Report User: An interpreting clinician or healthcare practitioner
Device Use Environment: Installation of Hepatica v1 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.
Clinical Setting: Hepatica v1 is a standalone software device that is intended to be installed on general use workstations at Perspectum's image analysis centres. The intended device users will log on to the workstations, access the device, and use the device on general-use HD monitors. Hepatica v1 is a post-processing software and the intended device users are trained Perspectum internal operators. Operators use Hepatica v1 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 Hepatica v1 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
Data Source: Previously acquired in-vivo volunteer data. "Volunteers participating in the performance testing were representative of the intended patient population."
Annotation Protocol / Gold Standard: Radiologists
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Performance Testing (Accuracy and Precision)
Sample Size: Not explicitly stated, but "previously acquired in-vivo volunteer data".
AUC, MRMC, Standalone performance: Not applicable.
Key Results:
Accuracy: Compared to the gold standard (radiologists) for volume, cT1, and PDFF in various liver segments and the whole liver, showing upper and lower limits of agreement.
Precision: Repeatability and Reproducibility for liver segment volume were assessed, showing upper and lower limits of agreement.
Inter and intra operator variability was also assessed.
The study concluded that:
- Metrics reported by Hepatica v1 (cT1, PDFF and volumetry in the whole liver and in each liver segment) are comparable to the gold standard (considered to be radiologists).
- Hepatica v1 measurements of volumetry are highly repeatable.
- Hepatica v1 measurements of volumetry are highly reproducible.
- The variation introduced by operator measurements are well within the acceptance criteria.
- cT1 and PDFF measurements reported by Hepatica v1 are within the acceptance criteria set for the predicate device.
No clinical investigations or studies were conducted during performance testing of Hepatica v1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Upper and Lower Limits of Agreement for Volume (% of total liver volume), cT1, and PDFF.
Precision: Upper and Lower limits of Agreement for Repeatability and Reproducibility of Liver Segment (% of total liver volume).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
January 12, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Perspectum Ltd. % Ioan Wigley Chief Compliance Officer 5520 John Smith Drive Oxford, Oxfordshire OX4 2LL UNITED KINGDOM
Re: K203280
Trade/Device Name: Hepatica (Hepatica v1) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: October 1, 2020 Received: November 16, 2020
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 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
1
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203280
Device Name Hepatica (Hepatica v1)
Indications for Use (Describe)
Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health.
Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported.
Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.
Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for Perspectum. The logo consists of the word "Perspectum" in a bold, sans-serif font, followed by a circular graphic made up of four different colored sections: yellow, blue, green, and pink. Below the logo is the text "K203280".
Date Prepared:
28th October 2020
1. Submitter Details
| Owner Address: | Perspectum Ltd
Gemini One,
5520 John Smith Drive,
Oxford Business Park,
Oxford,
OX4 2LL |
|------------------------------------|--------------------------------------------------------------------------------------------------------|
| Owner/Operator Number: | 10056574 |
| Establishment Registration Number: | 3014232555 |
| Contact Person: | Ioan Wigley |
ioan.wigley@perspectum.com +44 (0) 1865 655329
2. Subject and Predicate Device
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) number | K203280 | K202170 |
| Legal Manufacturer | Perspectum Ltd. | Perspectum Ltd. |
| Owner/Owner Operator | 10056574 | 10056574 |
| Device Name | Hepatica (Hepatica v1) | LiverMultiScan (LMSv4) |
| Proprietary/Common | Hepatica | LiverMultiScan |
| Panel | Radiology | Radiology |
| Regulation | 892.1000 | 892.1000 |
| Risk Class | Class II | Class II |
| Product Class code | LNH | LNH |
| Classification | System, Nuclear Magnetic | |
| Resonance Imaging | System, Nuclear Magnetic | |
| Resonance Imaging |
3. Subject Device Description
3.1. Intended Use
Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health.
Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported.
4
Image /page/4/Picture/1 description: The image shows the word "Perspectum" in a bold, dark gray font. To the right of the word is a circular logo with four different colored sections. The colors are yellow, blue, green, and pink. There is a registered trademark symbol in the upper right corner of the logo.
Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL method from multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.
Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient's liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient's liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica (Hepatica v1), may support surgical decision making.
3.2. Sterilization and Shelf Life
Hepatica v1 is a standalone software device thus it is non-contact, non-invasive and non-sterile. The shelf life of Hepatica v1 is indefinite as long as the manufacturer continues to support the device. Both sterilization and shelf life characteristics are equivalent of the predicate device.
3.3. Biocompatibility
Hepatica v1 is a standalone software device thus it is non-contact and non-invasive. No biocompatibility testing was deemed necessary to demonstrate the safety and effectiveness of Hepatica v1 does not consist of materials that differ from the predicate device.
3.4. Software
Hepatica v1 was successfully validated and verified against the requirements specification and its intended use. The results from the validation and verification activities, documented in this submission, corroborate that Hepatica v1 meets the product requirement specifications and intended use, which is deemed to be substantially equivalent to the predicate (see section below).
Validation and verification activities were conducted in a controlled environment and in compliance with IEC 62304:2006, ISO 13485:2016 and 21 CFR 820. Hepatica v1 is also in compliance with the DICOM standard.
3.5. Electromagnetic and Electrical Safety
Hepatica v1 is a standalone software device- there are no electrical safety risks associated with the direct use of the Hepatica v1 device. No electromagnetic or electrical safety testing was deemed necessary to demonstrate the safety and effectiveness of Hepatica v1.
5
Perspectu
4. Subject and Predicate Comparison
Subject and Predicate Device Comparison 4.1.
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence.
| Comparison of Subject and Predicate Device | ||
|---|---|---|
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| Intended Use and | ||
| Indications for Use | "Hepatica (Hepatica v1) is a post-processing | |
| medical device software that presents | ||
| quantified metrics which may contribute to | ||
| the assessment of a patient's liver health. | "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. | ||
| Hepatica (Hepatica v1) uses image | ||
| visualisation and analysis tools to process | ||
| DICOM 3.0 compliant magnetic resonance | ||
| image datasets to produce semi-automatic | ||
| segmented 3D models of the liver based on | ||
| the work of Couinaud and the Brisbane 2000 | ||
| terminology. For each identified Couinaud | ||
| segment, volumetric data is determined and | ||
| reported. | 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. | ||
| Hepatica (Hepatica v1) may also report iron | ||
| corrected-T1 (cT1) and PDFF calculated using | ||
| the IDEAL method from multi-slice | ||
| acquisitions, on a per segment basis, over | ||
| the whole liver. Both metrics present | ||
| numerical values of different fundamental | ||
| liver tissue characteristics that can be used | ||
| as measures of liver tissue health. | 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. | ||
| Hepatica (Hepatica v1) provides trained | ||
| clinicians with additional information to | ||
| evaluate the volume and health of a patient's | ||
| liver on a segmental basis. It is not intended | ||
| to replace the established procedures for the | ||
| assessment of a patient's liver health. | ||
| However, information gathered through | ||
| existing diagnostic tests, clinical evaluation of | ||
| the patient, as well Hepatica (Hepatica v1), | ||
| may support surgical decision making." | These images and the physical parameters | |
| derived from the images, when interpreted | ||
| by a trained clinician, yield information that | ||
| may assist in diagnosis." | ||
| Target Population | Patients who are suitable to undergo an MRI | |
| scan and not contra-indicated for MRI. | ||
| Hepatica may benefit the clinical | ||
| management of patients who are being | ||
| considered for liver resection(s). | Patients suitable to undergo an MRI scan and | |
| not contra-indicated for MRI | ||
| Comparison of Subject and Predicate Device | ||
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| Device User | Trained Perspectum internal operator | Trained Perspectum internal operator |
| Report User | An interpreting clinician or healthcare | |
| practitioner | An interpreting clinician or healthcare | |
| practitioner | ||
| Device Use | ||
| Environment | Installation of Hepatica v1 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. | ||
| Clinical Setting | Hepatica v1 is a standalone software device | |
| that is intended to be installed on general | ||
| use workstations at Perspectum's image | ||
| analysis centres. The intended device users | ||
| will log on to the workstations, access the | ||
| device, and use the device on general-use | ||
| HD monitors. | ||
| Hepatica v1 is a post-processing software | ||
| and the intended device users are trained | LMSv4 is a standalone software device that is | |
| intended to be installed on general use | ||
| workstations at Perspectum's image analysis | ||
| centres. The intended device users will log | ||
| on to the workstations, access the device, | ||
| and use the device on general-use HD | ||
| monitors. | ||
| LMSv4 is a post-processing software and the | ||
| intended device users are trained | ||
| Perspectum internal operators. | ||
| Operators use Hepatica v1 to conduct | ||
| quantitative analysis of liver tissue | ||
| characteristics to produce a report. | ||
| The end-users for the output from the | Perspectum internal operators. | |
| 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 Hepatica v1 reports. | device, the report, are clinicians who receive | |
| and interpret LMSv4 reports. | ||
| Anatomical | ||
| Location | Abdomen, including the Liver | Abdomen, including the Liver |
| Energy | ||
| Considerations | Hepatica 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. | ||
| Design: Purpose | Hepatica is a standalone software application | |
| that imports MR datasets encompassing the | ||
| abdomen, including the liver. Visualisation | ||
| and display of T1-weighted MR data which | ||
| can be analysed, and quantitative metrics of | ||
| tissue characteristics and liver volume are | ||
| then reported. | ||
| Datasets imported into Hepatica are DICOM | ||
| 3.0 compliant and 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. | ||
| Design: Tools | Allows for the 3D visualisation of the liver | |
| and quantification of metrics (cT1, PDFF and | ||
| volumetry) from liver tissue and exportation | ||
| of results and 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 and images to a deliverable report. | ||
| Comparison of Subject and Predicate Device | ||
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| Hepatica v1 allows for: | LMSv4 allows for: | |
| Volumetry Reporting of whole liver and segmental volume Semi-automatic segmentation of the outer contour of the liver Semi-automatic segmentation of the liver into Couinaud segments via placed landmarks of anatomical areas of interest | cT1 Full segmentation of the outer liver contour and liver vasculature of the cT1 parametric map. IQR and median metrics are reported from the segmentation. ROI placed method on the cT1 map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. | |
| cT1 and PDFF metrics may be quantified and loaded from LMS when analysis has been conducted on the same patient. Datasets imported from LMS contain all image analysis warnings and cautions associated with the individual analysis and are included in the hepatica report. | T2* ROI placed method on the T2* map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. T2* parametric maps are calculated from the MOST method or the three-point DIXON method (1) | |
| PDFF Full liver segmentation of the PDFF parametric map where IQR and median metrics are reported from the segmentation. ROI placed method on the PDFF map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices PDFF parametric maps are calculated using the LMS IDEAL method (2) | ||
| Design: MR | ||
| Relaxometry | Hepatica v1 does not support quantification of metrics from MR relaxometry. If cT1 results are imported from LMS, cT1 may be reported for all individual Couinaud segments and for whole-liver analysis. Median T2* values are given from the cT1 quantification. | T1, iron- and fat- corrected T1 (cT1) and T2* mapping |
| Design: Liver Fat | ||
| Quantification | Liver fat quantification data is imported from the predicate device (LMSv4), where available. If PDFF results are imported from LMS, PDFF may be reported for all individual Couinaud segments as well as Whole-liver | Utilizes MR images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat using the LMS IDEAL method (2). |
| Comparison of Subject and Predicate Device | ||
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| contour. PDFF parametric maps are | ||
| calculated using the LMS IDEAL method (2). | ||
| Design: Liver | ||
| Segmentation | Hepatica v1 supports semi-automatic liver | |
| segmentation of T1-weighted volumetric | ||
| data. |
Liver segmentation in Hepatica v1 requires
the placement of anatomical landmarks to
define the outer contours of the liver and
can be adjusted by the operator, where
necessary.
Where available, whole liver and segmental
cT1 and PDFF quantitative metrics derived
from the predicate device may be presented
in the final report. | LMSv4 supports automatic multi-slice full
liver segmentation of the cT1 and PDFF
parametric maps. Use of this functionality is
at the discretion of the operator, instead or
in combination, with the ROI based method.
The cT1 segmented liver is presented in
colour level window, while the rest of the
cT1 image is presented in greyscale level
window with liver vasculature excluded from
the segmented volume. |
| Design: Regions of
Interest (ROI) | Does not support ROI functionality. | Median and interquartile range
measurements created from a cross
sectional slice of liver tissue. For each
parametric map, statistics from multiple
Regions of Interest (ROIs) - potentially
placed across multiple slices - are
summarised.
Also supports the display of 'Live' ROI
statistics when moving the ROI across the
parametric map. |
| Design: Parametric
Maps | Hepatica uses volumetric datasets to create
2D anatomical views from all supported
scanners.
Where available, cT1 and PDFF parametric
maps are derived from the predicate device. | Iron corrected T1 (cT1), T2* and Proton
Density Fat Fraction (PDFF) parametric maps
can be created from all supported scanners.
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 be
optionally be computed using either the
three-point DIXON method or the LMS MOST
method. |
| | Comparison of Subject and Predicate Device | |
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| Design:
Visualisation | Numerous views in the Hepatica v1 interface
can be used to assist analysis.
Operators are able to see live views of
crosshair placements during landmarking
across multiple image planes simultaneously
and adjust contrast where required.
Lesion segmentation will be performed by
navigating through the axial slices using the
crosshair tool and "painting in" the segment
on each slice.
Operators will be required to navigate
through the axial, sagittal and coronal planes
using the crosshair tool to confirm that the
delineation carried out by the device is
accurate. The borders can be adjusted
accordingly.
Views of the segmented liver and lesions are
updated in real-time and can be rotated in a
3D space. Paint, eraser and zooming
functionalities are also available to the
operator.
Where available, operators can review the
position of cT1 and PDFF slices (derived from
LMSv4) within the 3D view of the liver. | 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 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. |
| Design: Supported
Modalities | DICOM 3.0 compliant MR data from
supported MRI scanners. | DICOM 3.0 compliant MR data from
supported MRI scanners. |
| Design: Report | Quantified metrics and images derived from
the analysis of liver volume and tissue
characteristics are collated into a report for
evaluation and interpretation by a clinician.
Images
Images of the whole liver divided into
Couinaud segments are presented in
greyscale in the report.
Where available, cT1 and PDFF slices are also
presented from the imported LMSv4
analysis.
Values
Whole and segmental liver volume metrics
calculated during analysis are provided in the
report. | Quantified metrics and images derived from
the analysis of liver tissue characteristic on
parametric maps are collated into a report
for evaluation and interpretation by a
clinician.
When segmentation analysis is used a
representative pie- chart is provided based
on the confirmed segmentation contour
from the PDFF map. The voxels within the
segmentation are separated into 5
categories (66%) to give
proportions based on PDFF. These categories
were chosen based on the work of Kleiner et
al (3) and Satkunasingham et al (4) on the
grading of histological features presented in
Non-Alcoholic Fatty Liver Disease. |
| Comparison of Subject and Predicate Device | | |
| Characteristic | Hepatica v1 (Subject device) | LMSv4 (Predicate device) |
| | Where available, whole liver segmental cT1
and PDFF values are provided. For each
metric, the median, IQR and a 'reference
range' are provided. | Based on the placed ROIs, for each metric
the median and IQR are given as well as a
'reference range'. |
| Compatibility with
the environment | Installation of Hepatica v1 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. |
| Performance | Device performance was assessed with
previously acquired in-vivo data from healthy
and non-healthy volunteers. | Device performance was assessed with
purpose-built phantoms and in-vivo acquired
data from volunteers covering a range of
physiological values for cT1, T2* and PDFF. |
| Human Factors | Assessed in accordance with IEC 62366 and
FDA guidance document 'Applying Human
Factors and Usability Engineering to Medical
Devices.' | Assessed in accordance with IEC 62366 and
FDA guidance document 'Applying Human
Factors and Usability Engineering to Medical
Devices.' |
| Supported MRI
Systems | Validated across all listed supported
manufacturers and field strengths. | Validated across all listed supported
manufacturers and field strengths. |
| Standards | IEC 62304, IEC 62366, DICOM 3.0, ISO 14971,
ISO 13485 | IEC 62304, IEC 62366, DICOM 3.0, ISO 14971,
ISO 13485 |
| System/Operating
System | Mac OS | Mac OS |
| Materials | Not applicable, standalone software | Not applicable, standalone software |
| Biocompatibility | Not applicable, standalone software | Not applicable, standalone software |
| Sterility | Not applicable, standalone software | Not applicable, standalone software |
| Electrical Safety | Not applicable, standalone software | Not applicable, standalone software |
| Mechanical Safety | Not applicable, standalone software | Not applicable, standalone software |
| Chemical Safety | Not applicable, standalone software | Not applicable, standalone software |
| Thermal Safety | Not applicable, standalone software | Not applicable, standalone software |
| Radiation Safety | Not applicable, standalone software | Not applicable, standalone software |
6
7
8
9
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Table 1. Comparison of similar characteristics between the subject and predicate device.
In conclusion, the subject device does not result in any new potential safety risk when compared to the chosen predicate device and performs in accordance with its use characteristics and intended use.
5. Performance Testing
Hepatica v1 underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that Hepatica v1 is at least as safe and effective as the predicate device and does not introduce any new risks.
5.1. Performance Testing - Clinical
To assess the accuracy and precision of Hepatica v1 measurements across supported scanners, previously acquired invivo 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. The results of which are summarized below:
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Accuracy
| Metric | Volume (% of total liver
volume) | cT1 | PDFF |
|---------------|----------------------------------------|----------------------------------------|----------------------------------------|
| Liver Segment | Upper and Lower Limits of
Agreement | Upper and Lower Limits
of Agreement | Upper and Lower Limits
of Agreement |
| Segment 1 | -0.49% to 0.95% | -1.13% to 0.61% | -0.26% to 0.21% |
| Segment 2 | -3.09% to 5.06% | -2.38% to 1.56% | -0.33% to 0.38% |
| Segment 3 | -5.01% to 3.9% | -1.51% to 1.31% | -0.16% to 0.17% |
| Segment 4a | -4.60% to 4.26% | -0.77% to 1.10% | -0.30% to 0.23% |
| Segment 4b | -5.50% to 2.56% | -1.32% to 1.13% | -0.16% to 0.14% |
| Segment 5 | -1.54% to 3.38% | -1.11% to 0.87% | -0.16% to 0.18% |
| Segment 6 | -4.34% to 4.29% | -1.00% to 0.83% | -0.16% to 0.26% |
| Segment 7 | -3.30% to 1.79% | -0.88% to 0.64% | -0.12% to 0.18% |
| Segment 8 | -3.86% to 5.54% | -0.91% to 1.09% | -0.24% to 0.32% |
| Whole liver | -4.16% to 0.54% | 0.00% to 0.00% | -0.02% to 0.02% |
Table 2: Performance testing results for Hepatica v1 accuracy when compared to the gold standard (radiologists)
Precision
| Liver Segment (% of total liver
| volume) | Repeatability | Reproducibility |
|---|---|---|
| Upper and Lower limits of Agreement | Upper and Lower Limits of Agreement | |
| Segment 1 | -0.72% to 0.65% | -1.39% to 0.90% |
| Segment 2 | -3.06% to 3.24% | -3.10% to 3.15% |
| Segment 3 | -2.67% to 3.13% | -2.41% to 2.06% |
| Segment 4a | -2.48% to 2.43% | -2.54% to 2.58% |
| Segment 4b | -1.82% to 1.96% | -1.70% to 1.74% |
| Segment 5 | -4.45% to 4.45% | -4.97% to 5.94% |
| Segment 6 | -3.60% to 4.10% | -3.69% to 5.40% |
| Segment 7 | -3.32% to 3.33% | -4.39% to 3.59% |
| Segment 8 | -4.99% to 3.81% | -6.23% to 5.04% |
| Whole liver | -6.15% to 3.78% | -16.6% to 6.95% |
Table 3: Pooled performance testing results for Hepatica v1 precision
Performance testing of Hepatica v1 demonstrates that:
- . Metrics reported by Hepatica v1 (cT1, PDFF and volumetry in the whole liver and in each liver segment) are comparable to the gold standard (considered to be radiologists)
- Hepatica v1 measurements of volumetry are highly repeatable ●
- Hepatica v1 measurements of volumetry are highly reproducible
- The variation introduced by operator measurements are well within the acceptance criteria ●
- cT1 and PDFF measurements reported by Hepatica v1 are within the acceptance criteria set for the predicate device. ●
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Image /page/12/Picture/1 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, dark gray font. To the right of the word is a circular logo with four colored sections: yellow, blue, green, and pink.
5.2. Clinical Investigation
No clinical investigations or studies were conducted during performance testing of Hepatica v1.
6. Conclusion
The subject device is substantially equivalent to the predicate device, and is based on the following observations:
- The indications for use and intended use of the subject device fall within the general tool-type claims of the predicate device.
- The subject device and predicate device both support multi-slice MR data acquired using the specific acquisition protocols, from supported MR systems, to acquire the input data.
- The subject and predicate devices include software applications which utilise MR data to visualise and enable quantification of physiological characteristics in the liver to provide measurements which may be used to assess liver health.
- Both the subject 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 subject and predicate device are both standalone software applications to facilitate the import and visualization of MR data sets.
- The subject and predicate devices enable the quantification of analysis of tissue characteristics in the liver from the MR data.
- The subject and predicate device facilitate the creation of a medical report containing the images and analysis output derived from quantification of liver tissue parameters intended to be interpreted by a trained clinician.
- The subject and predicate device reports all include tabular display of quantification statistics, parametric map images and include normal range references.
- Both the subject and predicate devices are designed to run on general-purpose computing hardware. ●
- Both the subject and predicate device are intended to be used in the same use environment and by trained Perspectum operators.
- Performance testing demonstrates that the subject device performs at least as safely and effectively as the proposed predicate device.
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