VesselIQ Xpress

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text. 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. 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Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use ### 510(k) Number (if known) 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) | <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------| | <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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The logo is simple and recognizable, and it is often used to represent the company's products and services. # 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 SCS<br>Establishment Registration Number - 9611343<br>283, rue de la Minière<br>78530 Buc, France | | Primary Contact Person: | Elizabeth Mathew<br>Senior Regulatory Affairs Manager<br>Tel: 262-424-7774<br>Email: Elizabeth.Mathew@ge.com | | Secondary Contact Person: | John Jaeckle<br>Chief regulatory Affairs Strategist<br>Tel: 262-424-9547<br>Email: 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. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular shape. The circle has a break at the top and bottom, with small, curved lines extending outward from these breaks, giving the impression of motion or energy. 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. ### 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: 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular frame. The logo is colored in blue and has a white background. ### 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 | Predicate<br>Advanced<br>Vessel<br>Analysis II<br>(K060779) | Proposed<br>VesselIQ<br>Xpress | Comparison | |---------------------------------|-------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aorta<br>Segmentation | Yes | Yes | Predicate device (AVA II) segmented the<br>aorta after user deposited points to identify<br>the desired vasculature. In proposed device,<br>the application can automatically initiate the<br>aorta segmentation and display the results in<br>a volume rendering model. | | Aortic Valve Plane<br>Detection | No | Yes | Predicate device provided users with<br>oblique reformat tools to manually orientate<br>anatomy into off access orientations.<br>Proposed device offers an initial attempt to<br>orientating images to the aortic annular<br>plane and then prompts users to precisely<br>refine the auto-initiated orientation.<br>Additionally, the identical oblique tool that<br>was present in the predicate device is also<br>available for users in the proposed device to<br>use as a way to precisely refine the<br>orientation to the annular plane. | | Aorta Angulation | No | Yes | Aorta angles, also referred to as cath angles<br>provide the perpendicular angles to the<br>aortic annulus plane. In the proposed<br>device, these perpendicular values are<br>graphically represented on the S-curve and<br>users are able to interactively move the<br>model by navigating along the S-Curve.<br>Additionally, users can display the angle<br>value between the annulus plane and the<br>horizontal plane. | | Aortic<br>Measurements | Yes | Yes | Predicate device, provided individual tools<br>for distance measurements, free hand<br>contouring and spline contouring which<br>were available for contouring of any<br>anatomy. Proposed device offers a guided<br>workflow, stepping through the typical pre-<br>procedure measurements recommended for<br>TAVR work-ups and provides semi-<br>automation for a pre-defined list of<br>measurements. All measurements are based | | | | | on user inputs for annular plane and annular<br>contour. | | Calcification<br>Volume | No | Yes | In the predicate device the calcium volume<br>measurements were done manually by using<br>standard Volume Viewer tools. In the<br>proposed device, calcification quantification<br>with automated calcification segmentation<br>is provided. | | Aorta Analysis | Yes | Yes | Aorta vessel tracking is present in the<br>predicate device. The advancement of the<br>aorta vessel tracking in the proposed device<br>is the automatic point deposit for the start<br>and end locations for the centerline to be<br>displayed automatically. Results are<br>displayed and the user can modify<br>immediately if not satisfied. | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The script is white, creating a contrast against the blue background. The logo is simple and recognizable, representing the brand identity of General Electric. 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. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a blue circle. The circle has a wavy or swirling design around the letters, giving it a dynamic and recognizable appearance. 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.