(47 days)
No
The summary describes image processing and registration techniques, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test data for such models. The performance studies focus on traditional engineering bench testing and phantom studies.
No
Explanation: The device is a software application intended to support catheter/device guidance during interventional procedures by providing enhanced image quality and additional 3D information. It assists the physician but does not directly treat or diagnose a disease or condition.
No
Explanation: The software applications are intended to support catheter/device guidance during interventional procedures by overlaying and registering 3D datasets with real-time radioscopic/radiographic images. They assist physicians in performing procedures by providing enhanced image quality and additional 3D information, but they do not provide a diagnosis.
No
The device is described as software applications that operate on a specific hardware platform (GE's Advantage Workstation) and communicate with a specific hardware system (GE Interventional X-ray system) for receiving live images. While the submission focuses on the software, its functionality is intrinsically tied to and dependent on these hardware components, making it a component of a larger system rather than a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vision Applications software is designed to process and display medical images (CT, MR, CBCT, and X-ray) to assist physicians in guiding catheters and devices during interventional procedures. It overlays and registers 3D datasets with real-time 2D images of the patient's anatomy.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. Its function is entirely focused on image processing and visualization for procedural guidance.
Therefore, the intended use and device description clearly indicate that this is a medical imaging software used for procedural guidance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, OWB
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR or CBCT (for 3D datasets); 2D X-ray (live images)
Anatomical Site
Same anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician during interventional procedures.
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
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 Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
The subject of this premarket submission, Vision Applications, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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.
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.
| 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 SCS |
| Establishment Registration Number - 9611343 | |
| 283, rue de la Minière | |
| 78530 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 |
4
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 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.
5
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:
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.
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.
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 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 and
perform dimension estimation | Yes, user can draw objects and
perform dimension estimation |
| | by using separate Stenosis
Analysis feature cleared in
reference device [K181403] | by using directly Digital Pen
optional feature embedded in
Vision Applications |
| Overlay of 2D/3D images | Identical | Identical |
| Reception and display of live 2D
images 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 in
IGS X-ray system [K181403] | Yes, Virtual Collimation
information is duplicated in
Vision Applications |
| ECG Display | Identical | Identical |
| Calcification Visualization
Enhancement | No, moving /contrasted
structures are visible on live X-
ray, but without visualization
enhancement. | Yes, enhanced visualization of
moving contrasted structures is
optionally available. |
| Display adjustment tools | Yes | Yes |
| A priori registration | Identical | Identical |
| Registration based on
Augmented Calibration | Yes | Yes |
| Manual Registration | Yes | Yes |
| Bi-view registration | No, only manual single-view
registration | Yes, Bi-view registration |
| User Interface | Yes, from Advantage Workstation
and Tableside | Yes, from Advantage Workstation
and Tableside |
| 2D Modes | Yes | Yes |
| Send Angles | Yes | Yes |
| Progress View / Bull's eye | Identical | Identical |
| Specification | Secondary Predicate Device:
Stereo 3D option for Vision
Applications [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.
7
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.
8
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.