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.

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 (T1, srT1, 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 images, when interpreted by a licensed physician, yield 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 and Siemens 3T MRI scanners.

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 healthcare professionals (HCPs) in a clinical setting for the purposes of assessing multiple organs.

CoverScan v1.1 is a new version of CoverScan that supports the use of Siemens 3T scan data to enable more scan sites to utilise CoverScan.

AI/ML Overview

The provided text is a summary of the FDA 510(k) clearance for CoverScan v1.1. It primarily focuses on demonstrating substantial equivalence to a predicate device (CoverScan v1.0) due to an expanded compatibility with Siemens 3T MRI scanners. The document outlines the device's intended use, functions, and the types of data it processes (T1, T2, PDFF, etc.).

However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance study specifics. It mentions "performance testing" and "extensive validation testing" but does not provide the specific metrics, sample sizes, ground truth establishment methods, or human reader study details you've asked for.

It states: "The change to add the Siemens 3T Scan data was made and performance testing using well established methods demonstrated equal performance between the subject and the predicate. In summary, CoverScan v1.1 is substantially equivalent to the predicate device CoverScan v1.0 (K212565)." This implies that the performance was compared to the predicate, but the specific performance results and acceptance criteria are not elaborated upon in this summary document.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.

Here's what can be extracted and what cannot:

What can be extracted:

Device Name: CoverScan (CoverScan v1.1)
Predicate Device: CoverScan v1.0 (K212565)
Purpose of the change (v1.0 to v1.1): To support Siemens 3T scan data.
General mention of testing: "Performance testing using well established methods demonstrated equal performance between the subject and the predicate." and "Internal verification and validation testing confirms that the product specifications are met."
Ground Truth Type (Inferred, not explicitly stated as "ground truth"): Device performance was assessed with "purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for sT1, cT1, T1 and PDFF." This suggests comparison against known phantom properties and physiological values, but the direct "ground truth" establishment method for patient data is not detailed.
Standards referenced: IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485.

What cannot be extracted (due to lack of information in the document):

Table of Acceptance Criteria and Reported Device Performance: No specific quantitative acceptance criteria or reported performance values are provided.
Sample sizes: No sample size is given for the test set or training set.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
Number of experts and qualifications for ground truth: Not mentioned.
Adjudication method: Not mentioned.
MRMC study: Not mentioned.
Standalone (algorithm only) performance: Not explicitly detailed with metrics.
How ground truth for the training set was established: Not mentioned.

In summary, the provided document is an FDA clearance letter focusing on substantial equivalence based on implied equivalent performance rather than a detailed performance study report with specific metrics and methodologies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

March 3, 2023

Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs Gemini One 5220 John Smith Drive Oxford, Oxfordshire OX4 2LL United Kingdom

Re: K230294

Trade/Device Name: CoverScan (CoverScan v1.1) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 28, 2022 Received: February 2, 2023

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.

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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 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.

Dghk

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K230294

Device Name

CoverScan (CoverScan v1.1)

Indications for Use (Describe)

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.

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 (T1. srT1. 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 images, when interpreted by a licensed physician, yield 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 and Siemens 3T 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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RA0913

Image /page/3/Picture/2 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in blue color. To the right of the word is a circular graphic divided into four colored sections: light blue, green, pink, and dark blue. The logo has a clean and modern design.

K230294

Date Prepared:	28 November 2022
----------------	------------------

Submitter Details

Owner Address: Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford. OX4 2LL

Perspectum Ltd

Contact Person:

loan Wigley

Subject and Predicate Device

	Predicate Device	Subject Device
510(k) number	K212565	Unknown
Legal Manufacturer	Perspectum Ltd.	Perspectum Ltd.
Owner/Operator Number	10056574	10056574
Device Name	CoverScan v1.0	CoverScan v1.1
Proprietary/Common name	CoverScan	CoverScan
510k Review Panel	Radiology	Radiology
Regulation Number	892.2050	892.2050
Risk Class	Class II	Class II
Product Class code	LLZ	LLZ
Classification	System, Image Processing, Radiological	System, Image Processing, Radiological

Device Name

Device Trade Name	Common Name
CoverScan v1.1	CoverScan, CoverScan v1

Device Description

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Image /page/4/Picture/1 description: The image shows the word "Perspectum" in a bold, sans-serif font. The word is colored in a dark blue. To the right of the word is a circular logo that is divided into four sections. The top three sections are colored light blue, green, and pink, while the bottom section is colored dark blue.

Metrics produced by CoverScan can be used by healthcare professionals (HCPs) in a clinical setting for the purposes of assessing multiple organs.

CoverScan v1.1 is a new version of CoverScan that supports the use of Siemens 3T scan data to enable more scan sites to utilise CoverScan.

Intended 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.

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 (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 images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.

Indications for use

CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T and 3T MRI scanners.

Substantial equivalence

The modified CoverScan v1.1 device has the following similarities to the previously cleared CoverScan v1 device.

Characteristic	Subject and Predicate Device Comparison
	CoverScan v1.0 (Predicate device)	CoverScan v1.1 (Subject Device)
Product Code	LLZ	LLZ
RegulationNumber	892.2050	892.2050
Class	II	II
Intended Use &Indications forUse	CoverScan is a medical imagemanagement and processing softwarepackage that allows the display, analysisand postprocessing of DICOM compliantmedical images and MR data.CoverScan provides both viewing andanalysis capabilities to ascertain quantifiedmetrics of multiple organs such as theheart, lungs, liver, spleen, pancreas andkidney.CoverScan provides measurements indifferent organs to be used for theassessment of longitudinal and transversalrelaxation time and rate (T1, SR-T1, cT1, T2),fat content (proton density fat fraction orPDFF) and metrics of organ function (e.g.,left ventricular ejection fraction and lungfractional area change on deepinspiration).These metrics derived from the images,when interpreted by a licensed physician,yield information that may assist indiagnosis, clinical management andmonitoring of patients.	CoverScan is a medical imagemanagement and processingsoftware package that allows thedisplay, analysis and post-processingof DICOM compliant medical imagesand MR data.CoverScan provides both viewingand analysis capabilities to ascertainquantified metrics of multiple organssuch as the heart, lungs, liver, spleen,pancreas and kidney.CoverScan provides measurementsin different organs to be used for theassessment of longitudinal andtransversal relaxation time (T1, SR-T1,cT1, T2), fat content (proton densityfat fraction or PDFF) and metrics oforgan function (e.g., left ventricularejection fraction and lung fractionalarea change on deep inspiration).These metrics derived from theimages, when interpreted by alicensed physician, yield informationthat may assist in diagnosis, clinicalmanagement and monitoring ofpatients.
Indications foruse	CoverScan is not intended forasymptomatic screening. This device isintended for use with Siemens 1.5T MRIscanners	CoverScan is not intended forasymptomatic screening. This deviceis intended for use with Siemens 1.5Tand Siemens 3T MRI scanners.
The Subject device underwent additional performance testing to show that the performance was thesame as the predicate.
Limitations ofUse	Indicated where MRI is notcontraindicated.	Same as predicate
Device Users	Trained Perspectum internal operators.	Same as predicate
Use Environment	Installation of Modules 1-5 of CoverScanare installed on general purposeworkstations at Perspectum's image
	Module 6 of CoverScan is hosted onAmazon Web Services (AWS) there is nouser interface for these modules.
Clinical Setting	CoverScan is a software device that isintended to be installed on generalworkstations at Perspectum's imagecentre. The intended device users will logon to the workstations, access the device,and use the device on general-use HDmonitors.CoverScan is a post-processing software,the intended device users are trainedPerspectum internal operators. Operatorsuse CoverScan to conduct quantitativeanalysis of tissue characteristics andfunction to produce a quantitative report.The end-users for the output from thedevice, the report, are clinicians whoreceive and interpret reports.	Same as predicate
Principles ofOperation	CoverScan offers comprehensivefunctionality for image analysis andvisualisation, CoverScan contains multiplemodules for the quantitative analysis oftissue characteristics and function.Visualisation and quantification tools forimage analysis depend on the module.	Same as predicate
	Module 1 (Liver module)cT1Full segmentation of the outer livercontour and liver vasculature of the cT1parametric map.ROI placed method on the cT1 map withIQR and median metrics from the placedROIs potentially across multiple acquiredslices.PDFFFull liver segmentation of the PDFFparametric map where IQR and medianmetrics are reported from thesegmentation.ROI placed method on the PDFF map withIQR and median metrics from the placedROIs potentially across multiple acquiredslices	Same as predicate

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analysis centre by specialist members of staff. Workstations need to meet the minimum technical requirements.

Same as predicate.

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PDFF parametric maps are calculatedusing the LMS IDEAL method (1)
Module 2 (Pancreas module)sT1
ROI placed method on the T1 map with IQRand median metrics from the placed ROIspotentially across multiple acquired slicesPDFFROI placed method on the PDFF map withIQR and median metrics from the placedROIs potentially across multiple acquiredslicesPDFF parametric maps are calculatedusing the LMS IDEAL method (1)	Same as predicate
Module 3 (Kidney module)T1ROI placed method on the T1 map with IQRand median metrics from the placed ROIspotentially across multiple acquired slices	Same as predicate
Module 4 (Cardiac function module)Operators may use modules withinCoverScan to analyse and quantify cardiacimages with the below capabilities:Left Ventricular functionEjection fractionEnd Diastolic Volume – left ventricleEnd Systolic Volume - left ventricle	Same as predicate

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Image /page/8/Picture/1 description: The image shows the word "Perspectum" in a bold, dark blue font. To the right of the word is a circular logo that is divided into four sections. The top three sections are colored light blue, green, and pink, while the bottom section is dark blue. The logo is meant to represent a global perspective.

	Stroke VolumeLeft Ventricle Muscle MassLeft Ventricular Wall ThicknessGlobal and regional LV function andvolume analysisGlobal RV function analysisT1 mapping ModuleAssessment of native and post contrast T1Relaxation times T1, T1*and R2 maps withcustomizable color LUT and polar mapdisplayAssessment of ECV % per slice andsegment including polar map display andmap generation with customizable colorLUTT2 Mapping ModuleGlobal and Regional Segmental T2 times
	Module 5 (Lung)Basic calculations to determine thepercentage change in area frominspiration to expiration from datasetsexported from analysis conducted in OsirixMD.	Same as predicate
	Module 6 (Metric consolidation)A compiled clinical report containingmetrics from modules 1-5, rounding ofthese numbers along with a referencerange. Basic logic algorithm applied todetermine if there is evidence of heartimpairment from cardiac metrics exportedfrom analysis conducted.	Same as predicate
PerformanceFeatures	Main software features:Post-processing, display and allowmanipulation of medical MR imagesImage loading and savingSession file loading and savingImage viewingImage manipulationImage analysisImage processingRelaxometry post-processingFat fraction postprocessingSegmentation of regions of interest	Same as predicate
Design: MRRelaxometry	Relaxometry post-processing (T1, T2 andT2*). And subsequently cT1 and sT1.	Same as predicate
Design: Liver FatQuantification	Fat fraction postprocessing (PDFF)	Same as predicate
Design:Parametric Maps	An operator can use modules 1-3 ofCoverScan to generate T2, T2 and T1relaxometry maps fitted from anappropriate set of MR Inversion Recoveryimages which are Gradient Echo (GRE) andMOLLI acquisition protocols respectively.Modules within CoverScan may also beused to generate fat signal fraction (PDFF)maps calculated from an appropriate set ofMR GRE images using the IDEAL (iterativedecomposition of water and fat with echoasymmetric and least-squares estimation)methodology (13).Module 5 within CoverScan can be used tocalculate percentage change in area frominspiration to expiration change using theinterface that offers tools:3D rendering tools, such as MultiplanarReconstructions, Curved Reconstructions,3D Volume Rendering, 3D SurfaceRendering, 3D Endoscopy3D sculpting toolsMeasure distance in 3D VolumeRendering, 3D Curved-MPR or 3DOrthogonal MultiPlanar3D rigid registrationModule 4 within CoverScan can be used toanalyse and calculate cardiac metrics toreport:Left Ventricular functionEjection fractionEnd Diastolic Volume – left ventricleEnd Systolic Volume – left ventricleStroke VolumeLeft Ventricle Muscle MassLeft Ventricular Wall ThicknessGlobal and regional LV function andvolume analysisGlobal RV function analysisAssessment of native and post contrast T1Relaxation times T1, T1 and R2	Same as predicate
	Assessment of ECV % per slice andsegmentGlobal and Regional Segmental T2 times
Design:Visualisation	Offers numerous views within modules 1-5of the CoverScan interface can be used toassist in analysis, T1, T2* and ProtonDensity Fat Fraction (PDFF)) parametricmaps can be created from all supportedscanners. R2 maps can also be utilised toassess the quality of the map fitting.Colormaps in the parametric maps aredesigned to have maximum contrast onorgan tissue.	Same as predicate
Design:Outputted data	Quantified metrics and images derivedfrom the analysis of liver tissuecharacteristic on parametric maps arecollated into a datafile that maysubsequently be assembled into a reportfor evaluation and interpretation by aclinician.Based on the placed ROI's (during analysisin Modules 1-3), for each metric the medianand IQR are given as well as a 'referencerange'.	Same as predicate
Design:SupportedModalities	DICOM 3.0 compliant MR data fromsupported MRI scanners.	Same as predicate
PerformanceTesting	Perspectum has conducted extensivevalidation testing of CoverScan, a medicalimage management and processingsystem (MIMPS), that is capable ofproviding reliable post-processing anddisplay of images for instantaneous multi-parametric analysis.Internal verification and validation testingconfirms that the product specificationsare met.All of the different components of theCoverScan software have been stresstested to ensure that the system as awhole provides all the capabilitiesnecessary to operate according to itsintended use.The main groups of tests performedinclude:Product Risk AssessmentSoftware modules verification testsSoftware validation testDevice performance was assessed withpurpose-built phantoms and in-vivoacquired data from volunteers covering arange of physiological values for sT1, cT1,T1 and PDFF.	Same as predicate
Human Factors	Assessed in accordance with IEC 62366and FDA guidance document 'ApplyingHumanFactors and Usability Engineering toMedical Devices'	Same as predicate
Standards	IEC 62304, IEC 62366, DICOM 3.0, ISO14971, ISO 13485	Same as predicate
System/Operating System	Mac OS	Same as predicate
Materials	Not applicable, post-processing software	Not applicable, post-processingsoftware
Energy Source	Not applicable, post-processing software	Not applicable, post-processingsoftware
Biocompatibility	Not applicable, post-processing software	Not applicable, post-processingsoftware
Sterility	Not applicable, post-processing software	Not applicable, post-processingsoftware
Electrical Safety	Not applicable, post-processing software	Not applicable, post-processingsoftware
Thermal Safety	Not applicable, post-processing software	Not applicable, post-processingsoftware
MechanicalSafety	Not applicable, post-processing software	Not applicable, post-processingsoftware
Radiation Safety	Not applicable, post-processing software	Not applicable, post-processingsoftware
Chemical Safety	Not applicable, post-processing software	Not applicable, post-processingsoftware

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RA0913

Image /page/9/Picture/2 description: The image shows the word "Perspectum" in a bold, blue font. To the right of the word is a circular logo. The logo is divided into four sections, with the top three sections colored light blue, green, and pink, respectively, and the bottom section colored dark blue.

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RA0913

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The change to add the Siemens 3T Scan data was made and performance testing using well established methods demonstrated equal performance between the subject and the predicate. In summary, CoverScan v1.1 is substantially equivalent to the predicate device CoverScan v1.0 (K212565).

Conclusion

The subject device does not result in any new potential safety risk when compared to the chosen predicate device and it performs in accordance with its use characteristics and intended use. Based upon comparison of devices and performance testing results CoverScan v1.1 is substantially equivalent to the listed predicate device.

Regulation Number and Section

§ 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).