(343 days)
Not Found
No
The summary describes automated and semi-automated tools for image segmentation and measurement, but it does not explicitly mention the use of AI or ML algorithms. The performance study focuses on comparing semi-automated measurements to manual measurements, not on validating an AI/ML model's performance.
No
The device is a software-only post-processing application for analyzing medical images to aid in diagnosis and treatment planning, not to provide therapy itself.
Yes
VesselIQ Xpress is described as aiding physicians in diagnosis and determination of treatment paths, and for the purpose of cardiovascular and vascular disease assessment, which are diagnostic activities.
Yes
The device description explicitly states "This software-only device is designed to support physician assessment..." and describes it as a "software post-processing package" for existing hardware platforms (AW, CT scanners, PACS).
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "aiding physicians in diagnosis and determination of treatment paths" and is used for "cardiovascular and vascular disease assessment." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Input Data: The device processes "Computed Tomography (CT) Angiographic images," which are images of the internal structures of the body obtained using a medical imaging technique. While not a traditional "specimen" like blood or tissue, medical images derived from the human body are considered within the scope of IVD regulation when used for diagnostic purposes.
- Analysis of Biological Information: The software analyzes vascular anatomy, pathology, stenosis, plaque, and other features related to the patient's biological state, providing information relevant to diagnosis and treatment planning.
- Clinical Study: The presence of a clinical study evaluating the performance of the TAVI Analysis option in aiding measurements for aortic annulus assessment further supports its classification as an IVD, as clinical validation is a key aspect of demonstrating the diagnostic utility of such devices.
While the device is software-only and processes images rather than traditional biological samples, its intended use for diagnosis and assessment of disease based on data derived from the human body (CT angiographic images) places it within the regulatory framework of In Vitro Diagnostics.
N/A
Intended Use / 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 VesselIQ 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.
Product codes
JAK, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) Angiographic images
Anatomical Site
vascular anatomy, aorta, valves, branching vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in diagnosis and determination of treatment paths, interventional suite
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study. Sample size: 80 patients evaluated 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
High correlations for aortic annulus area, perimeter, minimum diameter and maximum diameter. Agreement between mean values of readers and reference standard.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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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Image /page/3/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a swirling pattern that resembles water or wind. 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 |
| Establishment Registration Number - 9611343 | |
| 283, rue de la Minière | |
| 78530 Buc, France | |
| Primary Contact Person: | Elizabeth Mathew |
| Senior Regulatory Affairs Manager | |
| Tel: 262-424-7774 | |
| Email: Elizabeth.Mathew@ge.com | |
| Secondary Contact Person: | John Jaeckle |
| Chief regulatory Affairs Strategist | |
| Tel: 262-424-9547 | |
| 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.
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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.
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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
Advanced
Vessel
Analysis II
(K060779) | Proposed
VesselIQ
Xpress | Comparison |
|---------------------------------|-------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aorta
Segmentation | Yes | Yes | Predicate device (AVA II) segmented the
aorta after user deposited points to identify
the desired vasculature. In proposed device,
the application can automatically initiate the
aorta segmentation and display the results in
a volume rendering model. |
| Aortic Valve Plane
Detection | No | Yes | Predicate device provided users with
oblique reformat tools to manually orientate
anatomy into off access orientations.
Proposed device offers an initial attempt to
orientating images to the aortic annular
plane and then prompts users to precisely
refine the auto-initiated orientation.
Additionally, the identical oblique tool that
was present in the predicate device is also
available for users in the proposed device to
use as a way to precisely refine the
orientation to the annular plane. |
| Aorta Angulation | No | Yes | Aorta angles, also referred to as cath angles
provide the perpendicular angles to the
aortic annulus plane. In the proposed
device, these perpendicular values are
graphically represented on the S-curve and
users are able to interactively move the
model by navigating along the S-Curve.
Additionally, users can display the angle
value between the annulus plane and the
horizontal plane. |
| Aortic
Measurements | Yes | Yes | Predicate device, provided individual tools
for distance measurements, free hand
contouring and spline contouring which
were available for contouring of any
anatomy. Proposed device offers a guided
workflow, stepping through the typical pre-
procedure measurements recommended for
TAVR work-ups and provides semi-
automation for a pre-defined list of
measurements. All measurements are based |
| | | | on user inputs for annular plane and annular
contour. |
| Calcification
Volume | No | Yes | In the predicate device the calcium volume
measurements were done manually by using
standard Volume Viewer tools. In the
proposed device, calcification quantification
with automated calcification segmentation
is provided. |
| Aorta Analysis | Yes | Yes | Aorta vessel tracking is present in the
predicate device. The advancement of the
aorta vessel tracking in the proposed device
is the automatic point deposit for the start
and end locations for the centerline to be
displayed automatically. Results are
displayed and the user can modify
immediately if not satisfied. |
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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.
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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.