(279 days)
Not Found
No
The document describes image processing and quantitative analysis software, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on accuracy, precision, and variability using phantoms and volunteer data, not on training or validation of AI/ML models.
No
CoverScan is a medical image management and processing software that aids in diagnosis and monitoring by quantifying metrics from MR data, but it does not directly treat or provide therapy to patients.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the metrics derived from CoverScan, when interpreted by a licensed physician, "yield information that may assist in diagnosis." This indicates that the device contributes to the diagnostic process.
Yes
The device is explicitly described as a "software package" and a "post-processing software system" that operates on acquired MR data. There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, CoverScan is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- CoverScan's Function: CoverScan processes and analyzes medical images (specifically MR data) acquired from within the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for the display, analysis, and postprocessing of medical images and MR data to derive metrics from organs. These metrics are then interpreted by a physician.
- Input: The input is DICOM compliant medical images and MR data, not biological specimens.
Therefore, CoverScan falls under the category of medical image processing software, not an IVD.
N/A
Intended Use / Indications for Use
CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data.
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).
These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients.
CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen.
Metrics produced by CoverScan can be used by licensed physicians in a clinical setting for the purposes of assessing multiple organs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR data, MRI, CT
Anatomical Site
Heart, lungs, liver, spleen, pancreas, kidney, blood vessels
Indicated Patient Age Range
Not restricted
Intended User / Care Setting
Intended Users: Trained Perspectum internal operators.
End-users for the report: clinicians who receive and interpret reports.
Care Setting: Installation of Modules 1-3 of CoverScan are installed on general purpose workstations at Perspectum's image analysis centre by specialist members of staff. Module 4-6 of CoverScan is hosted on Amazon Web Services (AWS) there is no user interface for these modules.
CoverScan is a software device that is intended to be installed on general workstations at Perspectum's image centre. The intended device users will log on to the workstations, access the device, and use the device on general-use HD monitors.
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
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 CoverScan v1 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance was assessed with purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for cT1, T1 and PDFF.
CoverScan 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 CoverScan v1 is at least as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K152602, K190017, K141480, K101342
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is the Department of Health & Human Services logo. The text is in blue, with "FDA" in a larger font size than the rest of the text.
Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs 5520 John Smith Drive Oxford. Oxfordshire OX4 2LL United Kingdom
Re: K212565
Trade/Device Name: CoverScan v1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 14, 2022 Received: April 15, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
May 19, 2022
1
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 (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 DHT8B: Division of Imaging Devices and Electronic Products 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) K212565
Device Name CoverScan v1
Indications for Use (Describe)
CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data.
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).
These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients.
CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
| 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 word "Perspectum" in a bold, dark gray font. To the right of the word is a circular logo that is divided into four colored sections: yellow, blue, green, and pink. The logo also has a small "R" in a circle in the upper right corner.
Date Prepared:
16th of May 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 |
| ioan.wigley@perspectum.com | |
| +44 (0) 1865 655329 |
Subject and Predicate Device
| Subject Device | Primary Predicate Device | Predicate Device | |||
|---|---|---|---|---|---|
| No. 2 | No. 3 | No. 4 | |||
| 510(k) number | Not known | K152602 | K190017 | K141480 | K101342 |
| Legal Manufacturer | Perspectum Ltd. | Olea Medical | Perspectum Ltd. | Circle | Pixmeo Sarl |
| Owner/Operator Number | 10056574 | Not known | 10056574 | 3007301305 | 3012516536 |
| Device Name | CoverScan v1 | Olea Sphere V3.0 | LiverMultiScan | ||
| (LMSv3) | Cvi42 v5.11 | Osirix MD | |||
| Proprietary/Common name | CoverScan | Olea Sphere V3.0 | LiverMultiScan | Cvi42 | Osirix MD v12.0 |
| 510k Review Panel | Radiology | Radiology | Radiology | Radiology | Radiology |
| Regulation Number | 892.2050 | 892.2050 | 892.1000 | 892.2050 | 892.2050 |
| Risk Class | Class II | Class II | Class II | Class II | Class II |
| Product Class code | LLZ | LLZ | LNH | LLZ | LLZ |
| Classification | Picture Archiving | ||||
| Communications | |||||
| System | Picture Archiving | ||||
| Communications | |||||
| System | System, Nuclear | ||||
| Magnetic Resonance | |||||
| Imaging | Picture Archiving | ||||
| Communications | |||||
| System | Picture Archiving | ||||
| Communications | |||||
| System |
4
Subject Device Description
Device Description
CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen.
Metrics produced by CoverScan can be used by licensed physicians in a clinical setting for the purposes of assessing multiple organs.
Intended Use & Indications for Use
CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data.
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fractional area change on deep inspiration).
These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients.
CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
Contraindications
CoverScan is indicated for use where MRI is not contraindicated.
Intended Conditions
CoverScan 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
CoverScan is a post-processing software device. All operations and features are directly controlled by the CoverScan device. CoverScan does not control other firmware or software outside of the device.
5
Image /page/5/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 that is divided into four colored sections: yellow, blue, green, and pink. There is a small registered trademark symbol in the upper right corner of the logo.
Subject and Predicate Comparison
Subject and Predicate Device Comparison
The following characteristics were compared between the predicate devices in order to demonstrate substantial equivalence.
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| CoverScan (Subject device) | Sphere V3.0 (Primary | ||||
| Predicate) | LiverMultiScan (LMSv3) | ||||
| (Predicate Device No. 2) | Cvi42 (Predicate Device | ||||
| No. 3) | Osirix MD (Predicate | ||||
| Device No. 4) | |||||
| Product Code | LLZ | LLZ | LNH | LLZ | LLZ |
| Regulation Number | 892.2050 | 892.2050 | 892.1000 | 892.2050 | 892.2050 |
| Class | II | II | II | II | II |
| Intended Use & | |||||
| Indications for Use | CoverScan is a medical image | ||||
| management and processing | |||||
| software package that allows | |||||
| the display, analysis and post- | |||||
| processing of DICOM | |||||
| compliant medical images and | |||||
| MR data. | Olea Sphere V3.0 is an image | ||||
| processing software package | |||||
| to be used by trained | |||||
| professionals including but not | |||||
| limited to physicians and | |||||
| medical technicians. The | |||||
| software runs on a standard | |||||
| 'off-the-shelf' workstation and | |||||
| can be used to perform image | |||||
| viewing, processing, image | |||||
| collage and analysis of medical | |||||
| images. Data and images are | |||||
| acquired through DICOM | |||||
| compliant imaging devices and | |||||
| modalities. | LiverMultiScan (LMSv3) 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. | Cvi42 vascular analysis add- | ||||
| on is an image analysis | |||||
| software package add-on | |||||
| for evaluating CT and MR | |||||
| images of blood vessels. | Osirix MD is a software | ||||
| device intended for | |||||
| viewing of images | |||||
| acquired from CT, MR, | |||||
| CR, DR, US and other | |||||
| DICOM compliant | |||||
| medical imaging systems | |||||
| when installed on | |||||
| suitable commercial | |||||
| standard hardware. | |||||
| Images and data can be | |||||
| captured, stored, | |||||
| communicated, | |||||
| processed and displayed | |||||
| within the system and or | |||||
| across computer | |||||
| networks at distributed | |||||
| locations. |
6
Perspectum (
Characteristic
Subject and Predicate Device(s) Comparison
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
Olea Sphere V3.0 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (e.g., dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion weighted MRI data.
The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system
LiverMultiScan (LMSv3) 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.
7
| Characteristic | Subject and Predicate Device(s) Comparison | |
|---|---|---|
| The Dynamic Analysis Module | ||
| is used for visualization and | ||
| analysis of dynamic imaging | ||
| data, showing properties of | ||
| changes in contrast while | ||
| repeating acquisitions (e.g. | ||
| over time with or without | ||
| variable acquisition | ||
| parameters) where such | ||
| techniques are useful or | ||
| necessary. |
This functionality is referred to
as:
Perfusion Module – the
calculation of parameters
related to tissue flow
(perfusion) and tissue blood
volume. | |
| | Permeability Module – the
calculation of parameters
related to leakage of injected
contrast material from
intravascular to extracellular
space. | |
8
Perspectum
Characteristic
Subject and Predicate Device(s) Comparison
CoverScan provides measurements in different organs to be used for the assessment of fibrosis and/or inflammation of an organ (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and/or some metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).
Arterial Spin Labeling (ASL) Module – the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.
Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.
Metabolic Module – the calculation of parameters related to the fat signal fraction based on a MR technique using opposedphase imaging.
LiverMultiScan (LMSv3) 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 assessment of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or threepoint Dixon methodology.
Combining digital image process and visualisation tools such as multiplanar reconstruction (MRP)|, thin/thick maximum intensity projection (MIP) thin and thick, inverted thin and thick, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centreline calculation, lumen calculation stenosis calculation) and reporting tools (lesion location, lesion characteristics and key images), the software
9
Perspectum
Characteristic
Subject and Predicate Device(s) Comparison
These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
package is designed to support the physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesion.
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. Cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cvi42 is not restricted, however, image acquisition by a cardiac CT or MR scanner may limit the use
Lossy compressed mammographic images and digitised film screen images must not be viewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the users responsibility to ensure monitor quality, ambient light conditions, and image compression
10
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| CoverScan is not intended for | |||||
| asymptomatic screening. This | |||||
| device is intended for use with | |||||
| Siemens 1.5T MRI scanners. | of the device for certain | ||||
| sectors of the general | |||||
| public. | ratios are consistent with | ||||
| the clinical application. | |||||
| Limitations of Use | Indicated where MRI is not | ||||
| contraindicated. | Lossy compressed | ||||
| mammographic images and | |||||
| digitized film screen images | |||||
| must not be reviewed for | |||||
| primary image interpretations. | Indicated where MRI is not | ||||
| contraindicated. | Patients suitable to | ||||
| undergo an MRI or CT scan | |||||
| not contra-indicated for | |||||
| MRI or CT. | Lossy compressed | ||||
| mammographic images | |||||
| and digitised film screen | |||||
| images must not be | |||||
| viewed for primary | |||||
| diagnosis or image | |||||
| interpretation. For | |||||
| primary diagnosis, post | |||||
| process DICOM “for | |||||
| presentation” images | |||||
| must be used. | |||||
| Mammographic images | |||||
| should only be viewed | |||||
| with a monitor approved | |||||
| by FDA for viewing | |||||
| mammographic images. | |||||
| It is the users | |||||
| responsibility to ensure | |||||
| monitor quality, ambient | |||||
| light conditions, and | |||||
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| ratios are consistent with | |||||
| the clinical application. | |||||
| Device Users | Trained Perspectum internal | ||||
| operators. | The main users of the program | ||||
| are medical imaging | |||||
| professionals who need to | |||||
| visualize and analyse images | |||||
| acquired primarily with MRI or | |||||
| CT systems. | Trained Perspectum internal | ||||
| operator. | Qualified medical | ||||
| professionals, experienced | |||||
| in examining and evaluating | |||||
| cardiovascular CT or MR | |||||
| images | No restriction on users. | ||||
| Osirix MD is distributed | |||||
| directly from the | |||||
| company website. | |||||
| Use Environment | Installation of Modules 1-3 of | ||||
| CoverScan are installed on | |||||
| general purpose workstations | |||||
| at Perspectum's image | |||||
| analysis centre by specialist | |||||
| members of staff. | |||||
| Workstations need to meet | |||||
| the minimum technical | |||||
| requirements. | Olea Sphere is for use in | ||||
| hospitals, imaging centres, | |||||
| radiologist reading practices | |||||
| by a professional who requires | |||||
| and is granted access to | |||||
| patient image, demographic | |||||
| and report information. | Installation of LMSv3 is | ||||
| controlled and is installed on | |||||
| general purpose workstations. | |||||
| Workstations need to meet | |||||
| the minimum technical | |||||
| requirements. LMSv3 is | |||||
| installed on workstations at | |||||
| Perspectum's image analysis | |||||
| centre by specialist members | |||||
| of staff. | Cvi42 is a software | ||||
| application that can be | |||||
| used as a stand-alone | |||||
| product or in a networked | |||||
| environment. | Installation of Osirix MD | ||||
| is controlled and is | |||||
| installed on general | |||||
| purpose workstations or | |||||
| in a networked | |||||
| environment. | |||||
| Workstations need to | |||||
| meet the minimum | |||||
| technical requirements. | |||||
| Module 4-6 of CoverScan is | |||||
| hosted on Amazon Web | |||||
| Services (AWS) there is no | |||||
| user interface for these | |||||
| modules. | |||||
| Clinical Setting | CoverScan is a software device | ||||
| that is intended to be installed | |||||
| on general workstations at | Installed on PC's at the clinical | ||||
| site. | LMSv3 is a standalone | ||||
| software device that is | |||||
| intended to be installed on | Cvi42 is a software | ||||
| application that can be | |||||
| used as a stand-alone | Installation of Osirix MD | ||||
| is controlled and is | |||||
| installed on general |
11
12
| Characteristic | Subject and Predicate Device(s) Comparison | ||
|---|---|---|---|
| Perspectum's image centre. | |||
| The intended device users will | |||
| log on to the workstations, | |||
| access the device, and use the | |||
| device on general-use HD | |||
| monitors. | general use workstations at | ||
| Perspectum's image analysis | |||
| centre. The intended device | |||
| users will log on to the | |||
| workstations, access the | |||
| device, and use the device on | |||
| general-use HD monitors. | |||
| CoverScan is a post-processing | |||
| software, the intended device | |||
| users are trained Perspectum | |||
| internal operators. Operators | |||
| use CoverScan to conduct | |||
| quantitative analysis of tissue | |||
| characteristics and function to | |||
| produce a quantitative report. | LMSv3 is a post-processing | ||
| software, the intended device | |||
| users are trained Perspectum | |||
| internal operators. Operators | |||
| use LMSv3 to conduct | |||
| quantitative analysis of liver | |||
| tissue characteristics to | |||
| produce a report. | Cvi42 is a post-processing | ||
| software, intended device | |||
| users are qualified medical | |||
| professionals. Users use | |||
| may use cvi42 to conduct | |||
| quantitative analysis to | |||
| produce a clinical report. | Osirix MD is a post- | ||
| processing software. | |||
| Images and data can be | |||
| captured, stored, | |||
| communicated, | |||
| processed and displayed | |||
| within the system or in a | |||
| networked environment. | |||
| Osirix MD can export | |||
| DICOM files to CD/DVD | |||
| or USB sticks, including a | |||
| stand-alone cross- | |||
| platform viewer to | |||
| display the images. | |||
| It is possible to print | |||
| directly from DICOM | |||
| printers images derived | |||
| from Osirix MD. | |||
| The end-users for the output | |||
| from the device, the report, | |||
| are clinicians who receive and | |||
| interpret reports. | The end-users for the output | ||
| from the device, the report, | |||
| are clinicians who receive and | |||
| interpret LMSv3 reports. | The end-users for the | ||
| output from the device, the | |||
| report, are clinicians who | |||
| receive and interpret | |||
| reports. |
13
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| Principles of | |||||
| Operation | CoverScan offers | ||||
| comprehensive functionality | |||||
| for image analysis and | |||||
| visualisation, CoverScan | |||||
| contains multiple modules for | |||||
| the quantitative analysis of | |||||
| tissue characteristics and | |||||
| function. Visualisation and | |||||
| quantification tools for image | |||||
| analysis depend on the | |||||
| module. |
Module 1 (Liver module)
cT1
Full segmentation of the
outer liver contour and
liver vasculature of the
cT1 parametric map. ROI placed method on the
cT1 map with IQR and
median metrics from the
placed ROIs potentially
across multiple acquired
slices. | The Olea Sphere software
offers comprehensive
functionality for dynamic
image analysis and
visualization, where signal
changes over time are
analysed to determine various
modality dependent
functional parameters.
Olea Sphere provides both
viewing and analysis
capabilities of functional and
dynamic imaging datasets
acquired with MRI or other
relevant modalities, including
diffusion weighted MRI (DWI)
/ fiber tracking, and dynamic
analysis (e.g. dynamic
exogenous or endogenous
contrast enhanced imaging
data for MRI and CT).
DWI / Fiber Tracking Module:
Diffusion analysis is used to
visualize local water diffusion | 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.
LMSv3 allows for:
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 | Cvi42 contains multiple
modules for the analysis of
blood vessels derived from
CT and MR images.
Visualisation and
quantification tools for
image analysis depend on
the use case. When used
for the analysis of cardiac
images the following
modules are available: | Osirix MD is a post-
processing software.
Images and data can be
captured, stored,
communicated,
processed and displayed
within the system or in a
networked environment |
14
| Characteristic | Subject and Predicate Device(s) Comparison | |
|---|---|---|
| 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 ROIs potentially across multiple acquired slices PDFF parametric maps are calculated using the LMS IDEAL method (1) | diffusion weighted MRI data. | |
| Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system. |
Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging, showing properties of changes in contrast while repeating acquisitions (e.g. over time with or without variable acquisition parameters) where such techniques are useful or necessary. | 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 or DIXON method (1). |
| Module 2 (Pancreas module)
SR-T1 ROI placed method on the T1 map with IQR and median metrics from the placed ROIs potentially | This functionality includes dedicated analysis methods and visualization tools for dynamic contrast enhanced imaging data (from MRI or CT) where a bolus injection of a contrast agent material results | T2* ROI placed method on the T2* map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. |
15
| Characteristic | Subject and Predicate Device(s) Comparison | |||
|---|---|---|---|---|
| across multiple acquired slices The calculation of pancreas T1 maps using the MultiScan module uses the signal from supported scanners and MRI field strengths to simulate the data as it would be acquired on the reference scanner, providing improved reproducibility. The SR-T1 pipeline maps MRI-system dependent T1 images to MRI-system independent SR-T1 images and that allows comparison of SR-T1 values over a wide variety of MRI systems | in a temporal change in the signal intensity. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow (perfusion) and tissue blood volume as well as leakage (due to capillary permeability) of the injected contrast material from the intravascular to the extracellular space. | |||
| This functionality is referred to as: | ||||
| Perfusion Module: Calculation of parameters related to tissue flow (perfusion) and tissue blood volume. | T2* parametric maps are calculated from the DIXON method (2) | |||
| PDFF ROI placed method on the PDFF map with IQR and median metrics from the placed ROIs potentially | Permeability Module: | |||
| Calculation of parameters related to leakage of injected contrast material from | ||||
| Characteristic | Subject and Predicate Device(s) Comparison | |||
| across multiple acquired slices | ||||
| PDFF parametric maps are calculated using the LMS IDEAL method (1) Module 3 (Kidney module) | intravascular to extracellular space. | |||
| T1 ROI placed method on the T1 map with IQR and median metrics from the placed ROIs potentially across multiple acquired slices | This functionality also includes dedicated analysis methods and visualization tools for MR technique using the water in arterial blood as endogenous tracer to visualize tissue perfusion and evaluate blood flow non-invasively. This functionality is referred to as: | |||
| Arterial Spin Labelling (ASL) Module – the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion. | ||||
| This functionality also includes dedicated analysis methods and visualization tools for MR technique using intrinsic tissue properties to visualize and evaluate tissue relaxation times and fat signal fraction. This functionality is referred to as: |
16
17
| Characteristic | Subject and Predicate Device(s) Comparison | |
|---|---|---|
| Relaxometry Module – the | ||
| calculation of parameters | ||
| related to the MR longitudinal | ||
| and transversal relaxation | ||
| time and rate |
Metabolic Module – the
calculation of parameters
related to the fat signal
fraction based on a MR
technique using opposed-
phase imaging. | Short Axis 3D Module |
| Module 4 (Cardiac function
module)
Operators may use modules
within CoverScan to analyse
and quantify cardiac images
with the below capabilities:
Left Ventricular function
• Ejection fraction
• End Diastolic Volume – left
ventricle
• End Systolic Volume – left
ventricle
• Stroke Volume
• Left Ventricle Muscle Mass | | Left Ventricular function
• Ejection fraction
• End Diastolic Volume –
left ventricle
• End Systolic Volume – left
ventricle
• Stroke Volume
• Left Ventricle Muscle
Mass
• Left Ventricular Wall
Thickness
• Global and regional LV
function and volume
analysis |
| Characteristic | Subject and Predicate Device(s) Comparison | |
| • Left Ventricular Wall
Thickness
T1 mapping Module
Assessment of native T1
Relaxation times T1, T1and R2
maps with customizable color
LUT and polar map display | • Global RV function
analysis
T1 mapping Module
• Assessment of native and
post contrast T1
Relaxation times T1,
T1and R2 maps with
customizable colour LUT
and polar map display
• Assessment of ECV % per
slice and segment
including polar map
display and map
generation with
customizable colour LUT | |
| T2 Mapping Module
Assessment of segmental T2
times. | T2 Mapping Module
Global and Regional
Segmental T2 times | |
| Module 5 (Lung)
Basic calculations to
determine the percentage | Viewing
• Zooming, rotating,
panning and scrolling | |
| Characteristic | Subject and Predicate Device(s) Comparison | |
| change in area from inspiration to expiration from datasets exported from analysis conducted in Osirix MD. | ROI (Region-Of-Interests) tools are available to measure angles, surfaces, distances, densities, SUV, Cobb angle, volumes Extract statistical data on 2D or 3D ROI Image fusion for reviewing PET-CT, PET-MR and SPECT-CT Ejection Fraction calculation, Growing Region tool Post-processing 3D rendering tools, such as Multiplanar Reconstructions, Curved Reconstructions, 3D Volume Rendering, 3D Surface Rendering 3D sculpting tools Measure distance in 3D Volume Rendering, 3D Curved-MPR or 3D Orthogonal MultiPlanar | |
18
19
20
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| Module 6 (Metric | |||||
| consolidation) | |||||
| A compiled clinical report | |||||
| containing metrics from | |||||
| modules 1-5, rounding of | |||||
| these numbers along with a | |||||
| reference range. | Reporting Module | ||||
| • Viewing of compiled | |||||
| clinical report | |||||
| • Send and/or save report | • 3D rigid registration | ||||
| Post-processing | |||||
| techniques such as | |||||
| MPR (Multiplanar | |||||
| Reconstruction), 3D | |||||
| Rendering (MIP, | |||||
| Volume Rendering and | |||||
| Surface Rendering). | |||||
| Performance | |||||
| Features | Main software features: | ||||
| • Post-processing, display | |||||
| and allow manipulation of | |||||
| medical MR images | |||||
| • Image loading and saving | |||||
| • Session file loading and | |||||
| saving | |||||
| • Image viewing | |||||
| • Image manipulation | |||||
| • Image analysis | |||||
| • Image processing | Main software features: | ||||
| • Image Loading & Saving | |||||
| • Image Viewing | |||||
| • Image Manipulation | |||||
| • Image Analysis | |||||
| • Imaging Processing | |||||
| • Perfusion post-processing | |||||
| • Permeability post- | |||||
| processing | |||||
| • Kinetics post-processing | |||||
| • Arterial spin labelling | Main software features: | ||||
| • Image loading and saving | |||||
| • Session file loading and | |||||
| saving | |||||
| • Image viewing | |||||
| • Image manipulation | |||||
| • Image analysis | |||||
| • Image processing | |||||
| • Relaxometry post- | |||||
| processing | Main software features: | ||||
| • Receive, store, transmit, | |||||
| post process, display | |||||
| and allow manipulation | |||||
| of medical MR and CT | |||||
| images | |||||
| • Clinical server | |||||
| functionality | |||||
| • Visualisation in 2D, 3D | |||||
| and 4D of single or | |||||
| multiple datasets | Main software features: | ||||
| • Image Loading & | |||||
| Saving | |||||
| • Image Viewing | |||||
| • Image Manipulation | |||||
| • Image Analysis | |||||
| • Imaging Processing | |||||
| Characteristic | Relaxometry post-processing Fat fraction post-processing Segmentation of regions of interest | Diffusion Weighted Imaging / Tensor Imaging postprocessing / Intra-Voxel Incoherent Motion Fiber Tracking post-processing Collage (composing) Relaxometry post-processing Metabolic postprocessing | Fat-fraction post-processing Segmentation of regions of interest | Define and edit paths through structures such as centrelines Analysis of cross references of structures Fly-through visualisation Segmentation of regions of interest Quantitative analysis including, distance, angle, volume, histogram, and tracking quantities over time Derive metadata or new images from input image sets Creating/forwarding DICOM images DICOM compliant | |
| Design: MR Relaxometry | Relaxometry post-processing (T1, T2 and T2*), and subsequently cT1 and SR-T1. | Relaxometry (for MR imaging) - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate. | Relaxometry post-processing (cT1 and T2*) | Relaxometry post-processing (T1*, T1 and T2) | N/A |
| Design: Liver Fat Quantification | Fat fraction postprocessing (PDFF) | Metabolic (for MR imaging) - the calculation of parameters related to the fat signal fraction based on a MR | Fat fraction post-processing (PDFF) | N/A | N/A |
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| technique using opposed-phase imaging (otherwise known as PDFF). | |||||
| Design: Parametric Maps | An operator can use modules 1-3 of CoverScan to generate T2*, T2 and T1 relaxometry maps fitted from an appropriate set of MR Inversion Recovery images which are Gradient Echo (GRE) and MOLLI acquisition protocols respectively. Modules within CoverScan may also be used to generate fat signal fraction (PDFF) maps calculated from an appropriate set of MR GRE images using the IDEAL (iterative decomposition of water and fat with echo asymmetric and least-squares estimation) methodology (13). Module 5 within CoverScan can be used to calculate percentage change in area from inspiration to expiration | Olea Sphere V3.0 allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. Depending on the purpose of the imaging, the following optional plug-in are used by the software: | |||
| • Metabolic (for MR imaging) - the calculation of parameters related to the fat signal fraction based on a MR technique | An operator can use LMSv3 to generate T1 maps fitted from an appropriate set of MR Inversion Recovery images which are Gradient Echo (GRE) and MOLLI acquisition protocols, acquired from supported MR Systems. The T1 mapping uses a model of MR physics shown in (3). Multiple image signal measurements are for a number of different inversion times. Fitting the model to these measurements on a pixel-by-pixel basis allows an estimation of the pixel-wise T1 values. The three-parameter model fitting is performed using a Nelder-Mead Simplex algorithm (4). LMSv3 utilizes magnetic resonance images that exploit | Cvi42 can be used to receive, store, transmit, post process, display and allow manipulation of medical MR and CT images. An operator may use cvi42 to generate T1 maps fitted from an appropriate set of) acquisition protocols, acquired from MR and CT Systems. Depending on the purpose of the imaging, the following optional plug-in can be used in the software: | Osirix MD is a post-processing software. Images and data can be captured, stored, communicated, processed and displayed. Image maps may be processed using the following tools and capabilities: |
Post-processing
• 3D rendering tools, such as Multiplanar Reconstructions, |
| Characteristic | | Subject and Predicate Device(s) Comparison | | | |
| change using the interface
that offers tools:
3D rendering tools, such as
Multiplanar
Reconstructions, Curved
Reconstructions, 3D
Volume Rendering, 3D
Surface Rendering, 3D
Endoscopy 3D sculpting tools Measure distance in 3D
Volume Rendering, 3D
Curved-MPR or 3D
Orthogonal MultiPlanar 3D rigid registration Module 4 within CoverScan
can be used to analyse and
calculate cardiac metrics to
report:
Left Ventricular function | using opposed-phase
imaging.
Relaxometry (for MR
imaging) - the calculation
of parameters related to
the MR longitudinal and
transversal relaxation
time and rate. | the difference in resonance
frequencies between
Hydrogen nuclei in water and
triglyceride fat. An operator
can use LMSv3 to generate
PDFF maps calculated from an
appropriate set of MR GRE
images using the IDEAL
(iterative decomposition of
water and fat with echo
asymmetric and least-squares
estimation) or three-point
DIXON methodology (13).
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*
measurements and the
scanner field strength to
correct for signal changes | Short Axis 3D Module
Left Ventricular function | Curved
Reconstructions, 3D
Volume Rendering,
3D Surface
Rendering, 3D
Endoscopy 3D sculpting tools Measure distance in
3D Volume
Rendering, 3D
Curved-MPR or 3D
Orthogonal
MultiPlanar 3D rigid registration Post-processing
techniques such as
MPR (Multiplanar
Reconstruction), 3D
Rendering (MIP,
Volume Rendering
and Surface
Rendering). | |
| Left Ventricular function Ejection fraction End Diastolic Volume – left
ventricle End Systolic Volume – left
ventricle | | | Ejection fraction End Diastolic Volume –
left ventricle End Systolic Volume – left
ventricle Stroke Volume Left Ventricle Muscle
Mass | | |
| Characteristic | | Subject and Predicate Device(s) Comparison | | | |
| | Stroke Volume Left Ventricle Muscle Mass Maximum Left Ventricular
Wall Thickness Regional segmental T1
times Regional Segmental T2
times
T2 Mapping Module
Segmental T2 times | related to iron deposits,
producing a cT1
map. The cT1 map eliminates
the effects of elevated iron
from the T1 measurement (4)
PDFF is quantified using the
LMS IDEAL or DIXON method.
Parametric maps of T2* is
computed using the DIXON
method. | Left Ventricular Wall
Thickness Global and regional LV
function and volume
analysis Global RV function
analysis
T1 mapping Module Assessment of native and
post contrast T1
Relaxation times T1, T1*
and R² maps with
customizable colour LUT
and polar map display Assessment of ECV % per
slice and segment
including polar map
display and map
generation with
customizable colour LUT
T2 Mapping Module
Global and Regional
Segmental T2 times | | |
| Design:
Visualisation | Offers numerous views within
modules 1-5 of the CoverScan
interface can be used to assist | Offers numerous views,
dependent on the purpose of
the imaging, in the interface | Offers numerous views within
the LMSv3 interface can be
used to assist in analysis, Iron- | Offers numerous views,
dependant on the purpose
of the imaging, in the | Osirix MD offers the 2D,
3D and 4D viewing of
medical images read |
| Characteristic | Subject and Predicate Device(s) Comparison | | | | |
| | in analysis, T1, T2* and 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. Colormaps in
the parametric maps are
designed to have maximum
contrast on organ tissue. | that can be used to assist in
analysis of relaxometry and
metabolic post-processing. | corrected T1 (cT1), T2* and
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 LMSv3 colormap,
designed to have maximum
contrast on liver parenchymal
tissue. | interface that can be used
to receive, store, transmit,
post process, display and
allow manipulation of
medical MR and CT images.
The interface allows for the
visualisation in 2D, 3D and
4D of single or multiple
datasets. | from all types of DICOM
files, produced by
medical imaging
modalities, including
images produced by
scanners, MRI,
ultrasounds, or standard
X-rays. |
| Design: Outputted
data | Quantified metrics and images
derived from the analysis of
tissue characteristics and
organ function from
parametric maps that are
collated into a report for
evaluation and interpretation
by a licensed physician.
Quantification is based on the
placement of ROI's (during
analysis in Modules 1-3), for
each metric. The median and
IQR are given as well as a
'reference range'. | Information not given. | 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 | Quantified metrics and
images derived from the
analysis are collated into a
report for evaluation and
interpretation by a clinician. | Osirix MD can export
DICOM files to CD/DVD
or USB sticks, including a
stand-alone cross-
platform viewer to
display the images.
It is possible to print
directly from DICOM
printers images derived
from Osirix MD. |
| Characteristic | | Subject and Predicate Device(s) Comparison | | | |
| | | 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. Based on
the placed ROI's, for each
metric the median and IQR are
given as well as a 'reference
range'. | | | |
| Design: Supported
Modalities | DICOM 3.0 compliant MR data
from supported MRI scanners. | Supports compliant data from
both CT and MRI. | DICOM 3.0 compliant MR data
from supported MRI scanners. | Supports compliant data
from both CT and MRI. | Supports all types of
DICOM files, produced
by medical imaging
modalities, including
images produced by
scanners, MRI,
ultrasounds, or standard
X-rays. |
| Characteristic | Subject and Predicate Device(s) Comparison | | | | |
| Performance
Testing | Perspectum has conducted
extensive validation testing of
CoverScan, a medical image
management and processing
system (MIMPS), that is
capable of providing reliable
post-processing and display of
images for multi-parametric
analysis.
Internal verification and
validation testing confirms
that the product specifications
are met.
All of the different
components of the CoverScan
software have been stress
tested to ensure that the
system as a whole provides all
the capabilities necessary to
operate according to its
intended use. | Olea Medical has conducted
extensive validation testing of
the Olea Sphere V3.0 system,
as a PACS that is capable of
providing reliable post-
processing and display of
images for instantaneous
multi-parametric analysis.
Internal verification and
validation testing confirms
that the product specifications
are met, in support of the
substantial equivalence of the
intended use and
technological characteristic as
the predicate devices.
All of the different
components of the Olea
Sphere V3.0 software have
been stress tested to ensure
that the system as a whole
provides all the capabilities
necessary to operate
according to its intended use. | Internal verification and
validation testing confirms
that the product specifications
are met.
All of the different
components of the LMSv3
software have been stress
tested to ensure that the
system as a whole provides all
the capabilities necessary to
operate according to its
intended use. | Not given | Not given |
21
22
23
24
25
26
27
28
| Characteristic | Subject and Predicate Device(s) Comparison | |
|---|---|---|
| The main groups of tests performed include: |
Product Risk Assessment Software modules verification tests Software validation test Device performance was assessed with purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for cT1, T1 and PDFF. | The main groups of tests performed include:
Product Risk Assessment Software modules verification tests Software validation test 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.' |
| Standards | IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485 | IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485 |
29
Perspectum
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| System/Operating System | Mac OS | Windows or Linux | Mac OS | Windows or Mac OS | Windows or Mac OS |
| Materials | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Energy Source | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Biocompatibility | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Sterility | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Electrical Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Thermal Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Mechanical Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Radiation Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Chemical Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
In conclusion, the subject device does not result in an compared to the chosen predicate device and it performs in acordance with its use characteristics and intended use.
30
Image /page/30/Picture/1 description: The image shows the word "Perspectum" in a bold, dark gray font. To the right of the word is a colorful circular logo. The logo is divided into four sections, with the top section being yellow, the right section being green, the bottom section being pink, and the left section being blue.
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 CoverScan v1 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 CoverScan v1 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.
CoverScan 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 CoverScan v1 is at least as safe and effective as the predicate devices.
Conclusion
CoverScan v1 has the same intended use and similar technological characteristics as the primary predicate's devices, Olea Sphere v3.0. CoverScan is comprised of several modules for the multi-organ quantification of metrics derived from tissue and organ characteristics. Additionally, further predicates are used (LiverMultiScan manufactured by Perspectum Ltd, Osirix MD manufactured by Pixmeo SARL, cvi42 manufactured by Circle Cardiovascular Imaging Inc) to corroborate those differences between the devices do not result in a new intended use for CoverScan and do not raise any questions of safety and effectiveness. It can be concluded that CoverScan is substantially equivalent to the listed predicate devices.
31
Image /page/31/Picture/1 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in dark gray. To the right of the word is a circular graphic divided into four colored sections: yellow, blue, green, and pink. There is a registered trademark symbol above and to the right of the yellow section.
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