Vision 2, EVARVision, TrackVision 2 and HeartVision 2 software applications are intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures.

Structures of interest and estimated dimensions can be overlaid on the radioscopic or radiographic images. Image processing can be applied to enhance the display of such images. This information is intended to assist the physician during interventional procedures.

The Stereo 3D option enables physicians to visualize and localize needles, points, and segments on a 3D model/space using a stereotactic reconstruction of radioscopic or radiographic images at a significantly lower dose than use of a full cone beam CT acquisition. This information is intended to assist the physician during interventional procedures.

Device Description

Vision Applications are a group of software applications called Vision 2, EVARVision, TrackVision 2 and HeartVision 2 that share the same core functionalities to target different clinical procedures.

Vision Applications load 3D datasets previously acquired from an acquisition modality (CT, MR or CBCT) and prepared with Volume Viewer application [K041521]. They overlay and register in real-time these 3D datasets with the 2D X-ray live images acquired from the GE Interventional X-ray system [K181403] (called IGS X-ray system in the rest of the document) to help support localization and guidance of catheters / devices during interventional procedures, in conjunction with primary images, native live 2D X-ray images.

Vision Applications help physicians to perform interventional procedures by providing enhanced image quality and additional 3D information instead of 2D X-ray live images alone.

Vision Applications operate on GE's Advantage Workstation (AW) [K110834] platform and communicates with the IGS X-ray system [K181403] for receiving the live X-ray images.

The subject device, Vision Applications were developed from modifications to the primary predicate device Innova Vision Applications [K092639], including the addition of new optional feature "Digital Pen". The Digital Pen option is what triggered this 510k and was modified from the reference device, GE's IGS X-ray systems [K181403] under the name Stenosis Analysis. The Vision Applications include also Stereo 3D option feature [K152352, secondary predicate].

The primary features/functionalities of the Vision Applications are:

. Digital Pen.
Overlay of 2D/3D images.
Reception and display of live 2D images and related information. ●
Loading of 3D datasets.
Review mode.
Film/Sequence/photo store.
. Display controls for Visualization of images: including Zoom/Roam, Rendering, Planning data display, Annotation display, Virtual Collimation, ECG Display, Calcification Visualization Enhancement, display adjustment tools.
Automatic Registration: including A priori registration and Registration based on Augmented Calibration.
Manual Registration.
Bi-view registration.
User Interface: control from AW and from Tableside.
. 2D Modes.
Send Angles: including EVAR Angles, Progress View/Bull's eye.
. Stereo 3D.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on your provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (How the device performed)
Dimension estimation accuracy of Digital Pen option	The test results met the predefined acceptance criteria. (No specific numerical metrics provided in the text)
Design Control Testing (Overall Software Quality)	Successfully completed per GE's quality system. No additional hazards, unexpected test results observed.
Compliance with NEMA PS 3.1 - 3.20 DICOM Standard	The proposed device complies with this standard.
Development under Quality System Regulations	Designed and manufactured under 21CFR 820 and ISO 13485.
Software Development Lifecycle Adherence	Adhered to Requirements Definition, Risk Analysis, Technical Design Reviews, Formal Design Reviews, Software Development Lifecycle.
Performance Testing (Verification, Validation)	Successfully completed.
System Testing (Verification, Validation)	Successfully completed.
Software Level of Concern	Moderate level of concern.
Safety and Effectiveness (Compared to Predicate)	No new questions of safety and effectiveness other than those already associated with predicate devices.

2. Sample Size for Test Set and Data Provenance

Sample Size: The text states "a phantom with series of known dimension." It does not provide a specific numerical sample size for the test set.
Data Provenance: The data was generated through "Engineering bench testing" using a "phantom." This indicates the data is prospective and simulated in a controlled environment, rather than from actual patient clinical data. The country of origin is not explicitly stated for this specific test, but the submitter is GE Medical Systems SCS, located in Buc, France.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: The document does not mention the use of experts to establish ground truth for this engineering bench testing. The ground truth for the dimension estimation was based on a "phantom with series of known dimension," implying a pre-defined, objective standard rather than expert consensus on images.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was based on a phantom with known dimensions, not on human interpretation requiring adjudication.

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

MRMC Study: No, an MRMC comparative effectiveness study was not performed. The text explicitly states, "The subject of this premarket submission, Vision Applications, did not require clinical studies to support substantial equivalence."

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes, the testing described appears to be a standalone performance study of the "Digital Pen option" specifically focusing on its "dimension estimation accuracy." This was performed using "engineering bench testing" with a "phantom," meaning the algorithm's performance was evaluated against known physical dimensions without human-in-the-loop assistance during the measurement evaluation. The overall device, however, is intended to assist human operators.

7. Type of Ground Truth Used

Type of Ground Truth: For the "Digital Pen option" dimension estimation testing, the ground truth was objective, pre-defined physical dimensions of a phantom ("a phantom with series of known dimension").

8. Sample Size for Training Set

Sample Size: The document does not provide information about the sample size used for the training set. This is common for submissions if the device is a modification of a predicate and primarily relies on engineering changes and validation rather than a completely new AI model.

9. How Ground Truth for Training Set was Established

How Ground Truth was Established: The document does not provide information on how ground truth was established for a training set. This suggests that the development likely leveraged existing algorithms or established principles from the predicate devices and the reference device's "Stenosis Analysis" functionality, rather than requiring a new, extensive labeled training dataset for novel AI model development.

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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

GE Medical Systems SCS % Ning Wen Regulatory Affairs Program Manager Associate 283 rue de la Miniere Buc. 78530 FRANCE

November 22, 2022

Re: K223152

Trade/Device Name: Vision 2, EVARVision, TrackVision 2, HeartVision 2 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, OWB Dated: October 4, 2022 Received: October 6, 2022

Dear Ning Wen:

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 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-reporting

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combination-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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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

510(k) Number (if known)

Device Name

Vision 2, EVARVision, TrackVision 2, HeartVision 2

Indications for Use (Describe)

Vision 2, Track Vision 2, EVARVision and Heart Vision 2 software applications are intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures.

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/1 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' in a stylized script inside. The letters are white and have a swirling design. The blue circle is surrounded by a white border, and there are also swirling white lines around the circle, giving the logo a dynamic and recognizable appearance. The logo is simple, yet elegant, and it is a well-known symbol of the General Electric company.

510(k) Summary of Safety and Effectiveness

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

Date:	October 4, 2022
Submitter:	GE Medical Systems SCSEstablishment Registration Number - 9611343283, rue de la Minière78530 Buc, France
Primary Contact:	Ning WEN
	Regulatory Affairs Program Manager Associate
	GE Healthcare, (GE Medical Systems SCS)
	Tel: +1 608 515 3077
	Email: ning.wen@ge.com
Secondary Contact	Camille VIDAL
	Senior Regulatory Affairs Director
	Tel: +1 410 948 3137
	Email: camille.vidal@ge.com
Device Trade Name:	Vision 2, EVARVision, TrackVision 2, HeartVision 2
Common/Usual Name:	Vision Applications
Primary Regulation Number:	21CFR 892.2050, Medical image management and processing system
Primary Product Code:	LLZ
Secondary Product Code:	OWB
Regulatory Class:	Class II
Primary Predicate Device:
Device Name:	Innova Vision Applications
Manufacturer:	GE Medical Systems SCS
510(k) number:	K092639
Regulation Number:	21CFR 892.2050, Medical image management and processing system
Product Code:	LLZ
Regulatory Class:	Class II
Secondary Predicate Device:
Device Name:	Stereo 3D option for Vision Applications
Manufacturer:	GE Medical Systems SCS
510(k) number:	K152352
Regulation Number:	21CFR 892.2050, Medical image management and processing system
Product Code:	LLZ, OWB
Regulatory Class:	Class II
Reference Device:
Device Name:	Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
Manufacturer:	GE Medical Systems SCS
510(k) number:	K181403
Regulation Number:	21CFR 892.1650, Image-intensified fluoroscopic x-ray system
Product Code:	OWB, JAA, IZI, OXO
Regulatory Class:	Class II

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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has a textured or patterned edge, giving it a slightly three-dimensional appearance.

Device Description and Marketed Devices:

Vision Applications are a group of software applications called Vision 2, EVARVision, TrackVision 2 and HeartVision 2 that share the same core functionalities to target different clinical procedures.

Vision Applications help physicians to perform interventional procedures by providing enhanced image quality and additional 3D information instead of 2D X-ray live images alone.

Vision Applications operate on GE's Advantage Workstation (AW) [K110834] platform and communicates with the IGS X-ray system [K181403] for receiving the live X-ray images.

The primary features/functionalities of the Vision Applications are:

. Digital Pen.
Overlay of 2D/3D images.
Reception and display of live 2D images and related information. ●
Loading of 3D datasets.
Review mode.
Film/Sequence/photo store.
. Display controls for Visualization of images: including Zoom/Roam, Rendering, Planning data display, Annotation display, Virtual Collimation, ECG Display, Calcification Visualization Enhancement, display adjustment tools.
Automatic Registration: including A priori registration and Registration based on Augmented Calibration.
Manual Registration.

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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has a stylized design with curved lines emanating from the top and bottom, resembling water droplets or stylized flames.

Bi-view registration.
User Interface: control from AW and from Tableside.
. 2D Modes.
Send Angles: including EVAR Angles, Progress View/Bull's eye.
. Stereo 3D.

Intended Use:

Indication for Use:

Vision 2, TrackVision 2, EVARVision and HeartVision 2 software applications are intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures.

The Stereo 3D option enables physicians to visualize and localize needles, points, and segments on a 3D model/space using a stereotaction of radioscopic or radiographic images at a significantly lower dose than use of a full cone beam CT acquisition. This information is intended to assist the physician during interventional procedures.

Technology:

The proposed device Vision Applications employ the same fundamental scientific technology as its predicate devices Innova Vision Applications and Stereo 3D.

In addition, the proposed device Vision Applications include Digital Pen option. The Digital Pen option provides the ability to draw objects on the Viewer and to perform dimension estimations on 2D X-ray images, based on the same technology employed in the cleared Stenosis Analysis option from the reference device, GE's IGS X-ray systems [K181403].

Device Modification Overview

The table below summarizes the substantive feature/technological differences and similarities between the predicate devices and the proposed device:

Specification	Primary Predicate Device:Innova Vision Applications[K092639]	Proposed Device:Vision Applications
Digital Pen	No, user can draw objects andperform dimension estimation	Yes, user can draw objects andperform dimension estimation
	by using separate StenosisAnalysis feature cleared inreference device [K181403]	by using directly Digital Penoptional feature embedded inVision Applications
Overlay of 2D/3D images	Identical	Identical
Reception and display of live 2Dimages and related information	Yes	Yes
Loading of 3D datasets	Identical	Identical
Review mode	Yes	Yes
Film / Sequence / photo store	Identical	Identical
Zoom / Roam	Identical	Identical
Rendering	Yes	Yes
Planning data display	Yes	Yes
Virtual Collimation	No, Virtual Collimation exists inIGS X-ray system [K181403]	Yes, Virtual Collimationinformation is duplicated inVision Applications
ECG Display	Identical	Identical
Calcification VisualizationEnhancement	No, moving /contrastedstructures are visible on live X-ray, but without visualizationenhancement.	Yes, enhanced visualization ofmoving contrasted structures isoptionally available.
Display adjustment tools	Yes	Yes
A priori registration	Identical	Identical
Registration based onAugmented Calibration	Yes	Yes
Manual Registration	Yes	Yes
Bi-view registration	No, only manual single-viewregistration	Yes, Bi-view registration
User Interface	Yes, from Advantage Workstationand Tableside	Yes, from Advantage Workstationand Tableside
2D Modes	Yes	Yes
Send Angles	Yes	Yes
Progress View / Bull's eye	Identical	Identical
Specification	Secondary Predicate Device:Stereo 3D option for VisionApplications [K152352]	Proposed Device:Vision Applications
Stereo 3D	Identical	Identical

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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 circle has a white border with a swirling pattern, giving it a dynamic and recognizable appearance.

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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' in a stylized script, enclosed within a circular shape. The circular shape has a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The logo is presented in a blue color.

Determination of Substantial Equivalence:

Summary of Non-Clinical, Design Control Testing

The proposed device, Vision Applications, has successfully completed the design control testing per GE's quality system. No additional hazards were identified, and no unexpected test results were observed. The proposed device complies with NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.

The proposed device, Vision Applications, has successfully completed the required design control testing per GE Healthcare Quality Management System. It was designed and manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485.

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

· Requirements Definition
Risk Analysis
Technical Design Reviews
· Formal Design Reviews
Software Development Lifecycle
· Performance testing (Verification, Validation)
· System Testing (Verification, Validation)

The proposed device, Vision Applications, has been successfully verified on the AW VolumeShare workstation [K110834] together with the IGS X-ray systems [K181403]. All of the testing and results did not raise new or different questions of safety and effectiveness other than those already associated with predicate devices.

Software documentation for a MODERATE level of concern.

Additional Non-Clinical Testing

Engineering bench testing was used to support substantial equivalence and demonstrate performance.

Engineering has validated the dimension estimation accuracy of Digital Pen option using a phantom with series of known dimension and simulated use conditions.

The variety of test conditions in the evaluations is representative of the clinical scenarios where Digital Pen option of Vision Applications is intended to be used. The test results met the predefined acceptance criteria.

Summary of Clinical Testing

The subject of this premarket submission, Vision Applications, did not require clinical studies to support substantial equivalence.

Substantial Equivalence Conclusion

The changes to predicate device cleared in 2009 do not create a new Intended Use. Vision Applications with the Digital Pen option has identical or equivalent technological characteristics as its predicate devices and reference device.

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Image /page/8/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The circle has a double border, with the inner border being slightly thicker than the outer border. The logo is simple and recognizable, and it is associated with a well-known company.

GE's quality system's design, verification, and risk management processes did not identify any new questions of safety or effectiveness, hazards, unexpected results, or adverse effects stemming from the changes to the predicates.

Based on development under GE Healthcare's quality system, successful design verification, software documentation for a "Moderate" level of concern, along with engineering bench testing demonstrate that the proposed Vision Applications with the Digital Pen option is substantially equivalent to, and hence as safe and as effective for its Intended Use as the legally marketed predicate devices.

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).