VesselIQ Xpress is an optional, non-invasive, optimized, post-processing application intended to provide images and tools to analyze vascular anatomy and pathology, aiding physicians in diagnosis and determination of treatment paths, from a set of Computed Tomography (CT) Angiographic images.

VesselIQ Xpress is an option for the Advantage Workstation (AW) platform, CT Scanner, and/or PACS, which can be used in the analysis of 2D and 3D CT Angiography images/data for the purpose of cardiovascular and vascular disease assessment. This software-only device is designed to support physician assessment for a wide variety of clinical uses such as stenosis analysis, pre/post stent planning, pre/post valve replacement planning, and directional vessel tortuosity visualization.

VesselIQ Xpress' automatic visualization tools provide users the capability to segment bony structures for accurate identification of the vessels. Additional tools enable analysis of the vascular anatomy including the aorta, valves, and branching vessels for: anatomical sizing; density and volume analysis of segmented vasculature and calcified / non-calcified plaque; and measurements of abnormalities

The TAVI Analysis option for VessellQ Xpress is a planning tool used for Trans Aortic Valve Implantation (TAVI) procedures. It automatically segments the aorta and displays the aortic valve in multiple views for measurements of anatomic structures commonly needed for aortic annulus replacement planning. TAVI Analysis provides guided workflow and semi-automated tools to aid in evaluation of appropriate access pathways for interventional procedure planning.

Device Description

VesselIQ Xpress:
CT Advanced vessel analysis is a post processing analysis software package designed to assist physicians in the evaluation and assessment of vascular anatomy.

VesselIQ Xpress is a software post-processing package for the Advantage. Workstation (AW) platform, CT scanners and PACS reading stations. It is an additional tool for the analysis of 2D & 3D CT angiographic images. It provides and facilitates generating a variety of displays, measurements and batch filming/archive features to study user-selected vasculature which include but are not limited to stenosis analysis, thrombus, pre/post stent planning procedures, pre/post valve planning procedures and directional vessel tortuosity visualization.

TAVI Analysis Option in VesselIQ Xpress:
TAVI Analysis is a post-processing software package for the Advantage Workstation (AW) and AW Server platforms. It is a planning tool used for Trans Aortic Valve Implantation (TAVI) procedures. It automatically segments the aorta and displays the aortic valve in multiple views for quick and easy measurements of anatomic structures commonly needed for aortic annulus replacement planning. TAVI Analysis provides guided workflow and semi-automated tools to help evaluate appropriate access pathways and can communicate directly with the interventional suite.

FlightPlan for EVAR Option in VesselIQ Xpress:
FlightPlan for EVAR is a post-processing software package for the Advantage Workstation (AW) and AW Server platforms. It is a planning tool used for Endovascular Aneurysm Repair (EVAR) procedures. The software helps to visualize the vascular anatomy, perform key anatomical measurements, choose the treatment strategy, size the endograft and save key information that can be used during the intervention.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for VesselIQ Xpress, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format for specific metrics. Instead, it relies on demonstrating high correlations and agreement with manual measurements, which is considered the "reference standard" or "current routine practice."

Metric / Comparison	Acceptance Criteria (Implicit)	Reported Device Performance
Aortic Annulus Area (TAVI software vs. Manual)	High correlation and agreement with manual measurements.	High correlations found. Agreement with reference standard.
Aortic Annulus Perimeter (TAVI software vs. Manual)	High correlation and agreement with manual measurements.	High correlations found. Agreement with reference standard.
Aortic Annulus Minimum Diameter (TAVI software vs. Manual)	High correlation and agreement with manual measurements.	High correlations found. Agreement with reference standard.
Aortic Annulus Maximum Diameter (TAVI software vs. Manual)	High correlation and agreement with manual measurements.	High correlations found. Agreement with reference standard.
Measurement Workflow Time	Improved (or at least non-inferior) time spent on tasks compared to manual methods.	Study compared "time spent on tasks among different operators with different experience in cardiovascular CT" (implying efficiency was a factor in the study design, though no specific improvement metric is reported here).

Study Details

2. Sample Size and Data Provenance for Test Set

Sample Size: 80 patients
Data Provenance: Retrospective, from patients who underwent successful TAVI procedures with pre-procedural CT exams. The document doesn't explicitly state the country of origin, but it references "the institution's TAVI planning," suggesting it's from a single clinical site.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Three qualified physicians.
Qualifications: "qualified physicians" and "different experience in cardiovascular CT." No further specific details like years of experience or subspecialty like "radiologist" are provided in the summary.

4. Adjudication Method for Test Set

The document refers to comparing "the mean values of all three readers and comparing to the reference standard" for assessing agreement. This implies some form of consensus or averaging among the three readers was used to establish the "reference standard" or against which the device was compared. It does not specify a formal 2+1 or 3+1 adjudication process where disagreements are resolved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: Yes, the study compared "manual measurements by the predicate" with "semi-automated measurements by TAVI software for aortic annulus assessment in terms of measurement agreement and time spent on tasks among different operators with different experience in cardiovascular CT."
Effect Size of Human Readers Improvement with AI vs Without AI: The document states that the study compared "time spent on tasks among different operators." While it implies efficiency was a factor evaluated, the summary does not report specific effect size or quantitative improvement in human reader performance with AI assistance (i.e., how much faster or more accurate humans were with the software). It focuses on the agreement and correlation of the measurements themselves.

6. Standalone Performance (Algorithm Only)

The study assessed "semi-automated measurements by TAVI software." This indicates that the software plays a significant role in generating these measurements, potentially with some user interaction for refinement (as implied by "semi-automated"). Therefore, it represents the device's performance in a semi-standalone capacity where it generates the initial measurements that are then compared to manual methods. It's not a purely "algorithm-only" performance if any human input in the measurement process was still involved, but it does evaluate the algorithm's direct output. The summary focuses on comparing the software's measurements to manual ones, rather than comparing human performance assisted by AI versus unassisted human performance, although the latter was implied to be part of the MRMC study.

7. Type of Ground Truth Used

The ground truth was established by expert consensus/manual measurements (manual measurements by the predicate device, which is "routinely used during the institution's TAVI planning"). This is referred to as the "reference standard" against which the TAVI software's measurements were compared.

8. Sample Size for Training Set

The document does not provide information regarding the sample size for the training set. It only describes the clinical study for evaluation of the device.

9. How Ground Truth for Training Set Was Established

The document does not provide information on how the ground truth for any training set (if one was used for model development) was established. It only describes the ground truth for the test set used in the clinical study.

Summary

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GE Medical Systems SCS % Elizabeth Mathew Senior Regulatory Affairs Manager 283 rue de la Miniere Buc. Yvelines 78530 FRANCE

Re: K200626

Trade/Device Name: VesselIQ Xpress Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK, LLZ Dated: January 13, 2021 Received: January 14, 2021

Dear Elizabeth Mathew:

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

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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.

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

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Indications for Use

510(k) Number (if known) K200626

Device Name

VesselIQ Xpress

Indications for Use (Describe)

VessellQ Xpress is an optional, non-invasive, optimized, post-processing application intended to provide images and tools to analyze vascular anatomy and pathology, aiding physicians in diagnosis and determination of treatment paths, from a set of Computed Tomography (CT) Angiographic images.

VessellQ Xpress is an option for the Advantage Workstation (AW) platform, CT Scanner, and/or PACS, which can be used in the analysis of 2D and 3D CT Angiography images/data for the purpose of cardiovascular disease assessment. This software-only device is designed to support physician assessment for a wide variety of clinical uses such as stenosis analysis, pre/post stent planning, pre/post valve replacement planning, and directional vessel tortuosity visualization.

VessellQ Xpress' automatic visualization tools provide users the capability to segment bony structures for accurate identification of the vessels. Additional tools enable analysis of the vascular anatomy including the aorta, valves, and branching vessels for: anatomical sizing; density and volume analysis of segmented vasculature and calcified / noncalcified plaque; and measurements of abnormalities.

The TAVI Analysis option for VesselIQ Xpress is a planning tool used for Trans Aortic Valve Implantation (TAVI) procedures. It automatically segments the aortic valve in multiple views for measurements of anatomic structures commonly needed for aortic annulus replacement planning. TAVI Analysis provides guided workflow and semi-automated tools to aid in evaluation of appropriate access pathways for interventional procedure planning.

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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510(k) Summary or 510(k) Statement

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	February 15, 2021
Submitter:	GE Medical Systems SCSEstablishment Registration Number - 9611343283, rue de la Minière78530 Buc, France
Primary Contact Person:	Elizabeth MathewSenior Regulatory Affairs ManagerTel: 262-424-7774Email: Elizabeth.Mathew@ge.com
Secondary Contact Person:	John JaeckleChief regulatory Affairs StrategistTel: 262-424-9547Email: John.Jaeckle@ge.com
Device Trade Name:	VesselIQ Xpress
Common/Usual Name:	VesselIQ, AVA
Proposed Device:
Primary Regulation Number:	21CFR 892.1750, Computed Tomography X-Ray System
Primary Product Code:	JAK
Secondary Product Code:	LLZ
Classification Panel:	Radiology
Regulatory Class:	Class II
Predicate Device 1:	Advanced Vessel Analysis II
510(k) number	K060779, cleared on April 5, 2006
Regulation Number:	21CFR 892.1750, Computed Tomography X-Ray System
Product Code:	JAK
Classification Panel:	Radiology
Regulatory Class:	Class II
Manufacturer:	GE Healthcare (GE Medical Systems)
Device Description:

VesselIQ Xpress:

CT Advanced vessel analysis is a post processing analysis software package designed to assist physicians in the evaluation and assessment of vascular anatomy.

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TAVI Analysis Option in VesselIQ Xpress:

TAVI Analysis is a post-processing software package for the Advantage Workstation (AW) and AW Server platforms. It is a planning tool used for Trans Aortic Valve Implantation (TAVI) procedures. It automatically segments the aorta and displays the aortic valve in multiple views for quick and easy measurements of anatomic structures commonly needed for aortic annulus replacement planning. TAVI Analysis provides guided workflow and semi-automated tools to help evaluate appropriate access pathways and can communicate directly with the interventional suite.

FlightPlan for EVAR Option in VesselIQ Xpress:

FlightPlan for EVAR is a post-processing software package for the Advantage Workstation (AW) and AW Server platforms. It is a planning tool used for Endovascular Aneurysm Repair (EVAR) procedures. The software helps to visualize the vascular anatomy, perform key anatomical measurements, choose the treatment strategy, size the endograft and save key information that can be used during the intervention.

Intended Use:

VesselIQ Xpress is a non-invasive, optimized, post-processing application intended to provide images and tools to analyze vascular anatomy and pathology aiding physicians in assessment, diagnosis, and determination of treatment paths for cardiovascular disease, from a set of Computed Tomography Angiographic images.

Indications for Use:

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Technology:

The VessellQ Xpress software employs the same fundamental scientific technology as its predicate device.

Comparison:

The table below summarizes the feature/technological comparison between the predicate device and the proposed device:

Specification	PredicateAdvancedVesselAnalysis II(K060779)	ProposedVesselIQXpress	Comparison
AortaSegmentation	Yes	Yes	Predicate device (AVA II) segmented theaorta after user deposited points to identifythe desired vasculature. In proposed device,the application can automatically initiate theaorta segmentation and display the results ina volume rendering model.
Aortic Valve PlaneDetection	No	Yes	Predicate device provided users withoblique reformat tools to manually orientateanatomy into off access orientations.Proposed device offers an initial attempt toorientating images to the aortic annularplane and then prompts users to preciselyrefine the auto-initiated orientation.Additionally, the identical oblique tool thatwas present in the predicate device is alsoavailable for users in the proposed device touse as a way to precisely refine theorientation to the annular plane.
Aorta Angulation	No	Yes	Aorta angles, also referred to as cath anglesprovide the perpendicular angles to theaortic annulus plane. In the proposeddevice, these perpendicular values aregraphically represented on the S-curve andusers are able to interactively move themodel by navigating along the S-Curve.Additionally, users can display the anglevalue between the annulus plane and thehorizontal plane.
AorticMeasurements	Yes	Yes	Predicate device, provided individual toolsfor distance measurements, free handcontouring and spline contouring whichwere available for contouring of anyanatomy. Proposed device offers a guidedworkflow, stepping through the typical pre-procedure measurements recommended forTAVR work-ups and provides semi-automation for a pre-defined list ofmeasurements. All measurements are based
			on user inputs for annular plane and annularcontour.
CalcificationVolume	No	Yes	In the predicate device the calcium volumemeasurements were done manually by usingstandard Volume Viewer tools. In theproposed device, calcification quantificationwith automated calcification segmentationis provided.
Aorta Analysis	Yes	Yes	Aorta vessel tracking is present in thepredicate device. The advancement of theaorta vessel tracking in the proposed deviceis the automatic point deposit for the startand end locations for the centerline to bedisplayed automatically. Results aredisplayed and the user can modifyimmediately if not satisfied.

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Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The subject device VessellQ Xpress was designed under the Quality System Regulations of 21CFR 820 and ISO 13485. It has successfully completed the design control testing per our quality system with no unexpected test results observed. The device modifications to VesselIQ Xpress product as compared to the predicate device do not change intended use from the predicate.

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The following quality assurance measures were applied to the development of the system:

Risk Analysis
" Requirements Reviews
· Design Reviews
Performance testing (Verification, validation)
Safety testing (Verification)

All the testing and results did not raise new questions of safety and effectiveness from those associated with predicate device and demonstrated that VessellQ Xpress performs substantially equivalent to the predicate device.

The substantial equivalence determination is also based on the software documentation for a MODERATE level of concern device.

Summary of Clinical Testing

An independent clinical study of 80 patients that underwent successful TAVI procedure with pre procedural CT exams were retrospectively selected for evaluation by three qualified physicians.

The study compared manual measurements by the predicate, which is routinely used during the institution's TAVI planning, and semi-automated measurements by TAVI software for aortic annulus assessment in terms of measurement agreement and time spent on tasks among different operators with different experience in cardiovascular CT.

High correlations were found between manual and TAVI software aided measurements for aortic annulus area, perimeter, minimum diameter and maximum diameter in comparison with standard measurements for the 3 readers.

The result also shows agreement when taking the mean values of all three readers and comparing to the reference standard, demonstrating equivalent performance of the TAVI software to the standard manual measurements.

Substantial Equivalence Conclusion:

The device modifications to VessellQ Xpress product as compared to the predicate device do not change intended use from the predicate.

VesselIQ Xpress was developed under GE Healthcare's quality system. The subject device's design, verification & validation, and risk management processes did not identify any additional hazards, unexpected results, or adverse effects stemming from the changes to the predicate. Design verification and validation, including clinical testing provided in this submission demonstrates that VesselIO Xpress is substantially equivalent and hence as safe and as effective as the legally marketed predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.