(153 days)
No
The document describes image processing techniques for 3D reconstruction and object identification, including an "Automatic Mode for needles," but it does not explicitly mention the use of AI or ML algorithms for these functions. The description of the automatic mode suggests a rule-based or algorithmic approach rather than a learned model.
No.
This device is for real-time visualization and guidance during interventional procedures, not directly for treating a disease or condition.
No
The device is intended to enable users to load 3D datasets and overlay and register them with radioscopic or radiographic images to support catheter/device guidance during interventional procedures, assisting in visualizing needles, points, and segments. It is for guidance and localization, not for diagnosing a condition or disease.
Yes
The device is described as "software applications" and the description focuses entirely on the software's functionality, data processing, and workflow. While it interacts with imaging hardware (X-ray, CT, MR), the submission describes the device itself as the software that processes and displays this data. There is no mention of hardware components being part of the device being submitted.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a software application that processes and fuses medical images (radioscopic, radiographic, CT, MR) to assist physicians during interventional procedures by providing guidance and visualizing anatomical structures and devices in 3D. It works with images acquired from the patient's body, not on specimens taken from the body.
- Intended Use: The intended use clearly states it's for "support catheter/device guidance during interventional procedures" and "assist the physician during interventional procedures." This is an image-guided intervention tool, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of medical imaging software or image-guided surgery/intervention systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Vision 2, 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.
The Stereo 3D option enables physicians to visualize 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.
Type of Use: Prescription Use (Part 21 CFR 801 Subpart D)
Product codes
LLZ, OWB
Device Description
Vision Applications (K092639) includes Vision 2, TrackVision 2 and HeartVision 2 applications. Vision Applications can load and dynamically fuse in real-time live 2D X-ray images from the X-ray system with 3D models from X-Ray (DICOM 3D XA), CT or MR system.
Stereo 3D is a new option and the subject of this submission. The Stereo 3D option is designed to be used with the Vision 2 and TrackVision 2 applications which are part of Vision Applications. The Stereo 3D option enables the user to reconstruct 3D objects from radioscopic or radiographic images.
The Stereo 3D option intends to provide an alternative to intra operative CBCT (cone beam CT) usually performed for the same purpose: to localize needles and markers within the 3D anatomy. The Stereo 3D option provides a method to reconstruct 3D contrasted objects (point and segments) from a pair of 2D X-ray images, e.g. acquisition of fluoroscopic images from different C-arm positions (2 different projections). The 3D object reconstruction is then fused in the 3D space with the 3D model used at the fusion of the x-ray image.
Stereo 3D has a workflow that is significantly guided, to support clear and easy use of the reconstruction procedure. The workflow contains the following 4 high level steps:
Image acquisition and registration adjustment Automatic or manual object identification Quality assessment of 3D reconstruction Display of the reconstructed point(s) and segment(s) on a cross section of the 3D model. The second step (object identification) can be done manually or automatically:
Manual point(s) or segment(s) identification:
After the acquisition and registration of the two x-ray images acquired at two different C-arm positions, the user has to manually select points on the two x-ray images which correspond to the object to reconstruct (e.g. endograph markers and needles).
Automatic Mode for needles (only with Trackvision 2):
The user first selects a planned trajectory with a needle inserted
After the acquisition of the two X-ray images, and the registration adjustment phase, the needle will automatically be detected and reconstructed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radioscopic or radiographic images, X-ray (DICOM 3D XA), CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
The Stereo 3D option for Vision Applications comply with NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set and with voluntary standards IEC 62304 (2006) and IEC 62366 (2007).
The following quality management measures were applied to the development of the software application:
Product verification ensures the software conforms to its requirements including hazard mitigations risk management requirements. The verification tests confirmed that design output meets design input requirements. The tests were executed at component, software subsystems, and system levels. Functional testing and performance testing are part of system level verification. Performance has been confirmed with bench testingSimulated Use Testing ensured the system conforms to user needs and intended uses through simulated clinical workflows using step-by step procedures that would be performed for representative clinical applications.Usability validation testing is conducted to confirm that the product can be used safely and effectively. The participants used for this testing were licensed and/or clinically trained healthcare providers or users.Additional bench testing was performed to substantiate Stereo 3D's product claims.
Summary of Clinical Tests:
The Stereo 3D option for Vision Applications did not require clinical studies to assess safety and effectiveness and, thus, to establish the substantial equivalence.
Stereo 3D is based on established GE technology which enabled use of our "typical” verification and validation testing methods. Additionally, engineering bench testing was able to be performed using existing phantoms, methods, and performance metrics. The requirements were met and there were not any unexpected results.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that appears to be three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
GE Medical Systems, SCS % Mr. John Jaeckle Regulatory Affairs Leader 283 rue de la MINIERE Buc 78530 FRANCE
Re: K152352
Trade/Device Name: Stereo 3D option for Vision Applications Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, OWB Dated: December 11, 2015 Received: December 14, 2015
Dear Mr. Jaeckle:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oolo
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152352
Device Name Stereo 3D option for Vision Applications
Indications for Use (Describe)
Vision 2, 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.
The Stereo 3D option enables physicians to visualize 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.
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. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle is surrounded by a series of white, wave-like shapes, giving the impression of motion or energy emanating from the center.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 11-December-2015 |
|---|---|
| Submitter: | GE Healthcare, (GE Medical Systems SCS) |
| 283 rue de la MINIERE | |
| 78530 Buc, France | |
| Primary Contact | |
| Person: | Ning WEN |
| Regulatory Affairs Leader | |
| GE Healthcare, (GE Medical Systems SCS) | |
| Tel: (+33)-1-3070-5668 | |
| Email: ning.wen@ge.com | |
| Secondary Contact | |
| Persons: | Michel GENUER |
| Regulatory Affairs Program Manager | |
| GE Healthcare, (GE Medical Systems SCS) | |
| Tel: (+33)-1-3070-4741 | |
| Email: michel.genuer@ge.com |
John Jaeckle
Chief Regulatory Affairs Strategist
GE Healthcare
Tel: (262) 424-9547
Email: John.Jaeckle@ge.com |
| Device Trade Name: | Stereo 3D option for Vision Applications |
| Common/Usual Name: | Stereo 3D option for Vision Applications |
| Classification Names: | Picture archiving and communications system
Image-intensified fluoroscopic x-ray system |
| Product Code: | LLZ - 21CFR 892.2050
OWB - 21CFR 892.1650 |
| Class: | II |
| Primary Predicate
Device(s): | K092639, Innova Vision Applications (from GE Healthcare)
Product code: LLZ; Regulation number: 892.2050. |
| Second Predicate
Device(s): | K052412, Innova 3D (from GE Healthcare)
Product code: OWB, JAA; Regulation number : 892.1650. |
| Device Description: | Vision Applications (K092639) includes Vision 2, TrackVision 2 and HeartVision 2 applications. Vision Applications can load and dynamically fuse in real-time live 2D X-ray images from the X-ray system with 3D models from X-Ray (DICOM 3D XA), CT or MR system.
Stereo 3D is a new option and the subject of this submission. The Stereo 3D option is designed to be used with the Vision 2 and TrackVision 2 applications which are part of Vision Applications. The Stereo 3D option enables the user to reconstruct 3D objects from radioscopic or radiographic images.
The Stereo 3D option intends to provide an alternative to intra operative CBCT (cone beam CT) usually performed for the same purpose: to localize needles and markers within the 3D anatomy. The Stereo 3D option provides a method to reconstruct 3D contrasted objects (point and segments) from a pair of 2D X-ray images, e.g. acquisition of fluoroscopic images from different C-arm positions (2 different projections). The 3D object reconstruction is then fused in the 3D space with the 3D model used at the fusion of the x-ray image.
Stereo 3D has a workflow that is significantly guided, to support clear and easy use of the reconstruction procedure. The workflow contains the following 4 high level steps:
Image acquisition and registration adjustment Automatic or manual object identification Quality assessment of 3D reconstruction Display of the reconstructed point(s) and segment(s) on a cross section of the 3D model. The second step (object identification) can be done manually or automatically:
Manual point(s) or segment(s) identification:
After the acquisition and registration of the two x-ray images acquired at two different C-arm positions, the user has to manually select points on the two x-ray images which correspond to the object to reconstruct (e.g. endograph markers and needles).
Automatic Mode for needles (only with Trackvision 2):
The user first selects a planned trajectory with a needle inserted |
| | After the acquisition of the two X-ray images, and the registration
adjustment phase, the needle will automatically be detected and
reconstructed. |
| Intended Use: | Vision 2, 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 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
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. |
| Technology: | Vision Applications are software applications that execute on the
Advantage Workstation (AW) review workstation [K110834]. |
| | The live fluoroscopic images, as well as the necessary exam data,
are transmitted from the Interventional fluoroscopic X-ray system
to the AW through a dedicated link. The 3D datasets previously
acquired (from XA only for TrackVision 2, and from XA, CT and MR
for Vision 2 and HeartVision 2) are loaded from the AW database. |
| | The 3D-2D fusion and the user interface of the application are
displayed on the AW main screen, which is distributed identically in
both the Control and Exam Rooms, The most frequently used
functions are available from the Central Touch Screen at table side
in the exam room. This user interface is controlled by the
application through the Interventional fluoroscopic X-ray system
Ethernet network. |
| | The Vision Applications employ the same fundamental scientific
technology as its primary predicate devices. |
| | The new Stereo 3D option is an embedded software component of
the Vision 2 and/or TrackVision 2 components of Vision
Applications. This option is designed to reconstruct 3D object(s).
Stereo 3D contains the algorithms used to detect the 2D needles
on the image and to reconstruct points, needles and segments in
3D from fluoroscopic images. Stereo 3D option is based on the 3D
reconstruction technology of “Innova 3D” [K052412] that is second
predicate device and also runs on AW platforms. |
| | The reconstructed 3D objects can be displayed by Vision Applications on the initial 3D model (fused with live 2D), and exported to Volume Viewer [K041521].
All causes of hazard relative to the introduction of Stereo 3D option have been identified and mitigated. |
| Determination of Substantial Equivalence: | The following testing was used to assess safety and effectiveness and, thus, to establish the substantial equivalence with the predicate devices. |
| | Summary of Non-Clinical Tests: |
| | The Stereo 3D option for Vision Applications comply with NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set and with voluntary standards IEC 62304 (2006) and IEC 62366 (2007). |
| | The following quality management measures were applied to the development of the software application:
Product verification ensures the software conforms to its requirements including hazard mitigations risk management requirements. The verification tests confirmed that design output meets design input requirements. The tests were executed at component, software subsystems, and system levels. Functional testing and performance testing are part of system level verification. Performance has been confirmed with bench testingSimulated Use Testing ensured the system conforms to user needs and intended uses through simulated clinical workflows using step-by step procedures that would be performed for representative clinical applications.Usability validation testing is conducted to confirm that the product can be used safely and effectively. The participants used for this testing were licensed and/or clinically trained healthcare providers or users.Additional bench testing was performed to substantiate Stereo 3D's product claims. |
| | Summary of Clinical Tests: |
| | The Stereo 3D option for Vision Applications did not require clinical studies to assess safety and effectiveness and, thus, to establish the substantial equivalence. |
| | Stereo 3D is based on established GE technology which enabled use of our "typical” verification and validation testing methods. Additionally, engineering bench testing was able to be performed using existing phantoms, methods, and performance metrics. The |
| | requirements were met and there were not any unexpected results. |
| Conclusion: | GE Healthcare considers the Stereo 3D Option for Vision Applications to be as safe and as effective and substantially equivalent to the predicate devices. |
| | This conclusion is based on:
Verification and Validation testing has demonstrated that the design inputs, user requirements, and risk mitigations have been met. Bench testing has demonstrated the performance and substantiated the claims of Stereo 3D. The results of design validation did not raise new issues of safety and effectiveness. The successful completion of the above testing was sufficient to assess safety and effectiveness and, thus, to establish the substantial equivalence. The Stereo 3D Option for Vision Applications does not raise new issues of safety and effectiveness. The Stereo 3D Option for Vision Applications does not introduce new fundamental scientific technology. |
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Image /page/4/Picture/0 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 circular shape. The circular shape has four wave-like elements extending outward from the circle at the top, bottom, left, and right.
GE Healthcare 510(k) Premarket Notification Submission
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GE Healthcare 510(k) Premarket Notification Submission
6
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.