(120 days)
Yes
The device description explicitly states that a new option, "AI Segmentation," was developed and includes two new algorithms powered by deep learning. The performance studies also mention the evaluation of these "Deep-Learning based algorithms."
No
The device is described as post-processing software intended for the planning phase of embolization procedures, explicitly stating it "is not intended to be used during therapy delivery." This indicates it's a diagnostic/planning tool, not a therapeutic one.
Yes
Explanation: The device is designed to aid physicians in visualizing vasculature and planning embolization procedures by analyzing 3D X-ray angiography images, which directly supports diagnosis and treatment planning.
Yes
The device description explicitly states "FlightPlan for Embolization is a post-processing, software-only application". While it operates on specific hardware platforms and uses input from a hardware device, the device being submitted for 510(k) is the software itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that FlightPlan for Embolization is a "post processing software package that helps the analysis of 3D X-ray angiography images." It is used "as an adjunct means to help visualize vasculature during the planning phase of embolization procedures." This describes a tool for image analysis and procedural planning, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The device is described as "a post-processing, software-only application using 3D X-ray angiography images (CBCT) as input." It operates on imaging workstations and servers. This further reinforces its role in image processing and visualization.
- Lack of Biological Sample Analysis: The entire process described involves the analysis of medical images (CBCT scans). There is no mention of collecting or analyzing biological samples (blood, urine, tissue, etc.), which is a defining characteristic of an IVD.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This software does not fit that definition. It is a medical image processing and planning tool.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery.
The output includes segmented vasculature, and selective display of proximal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, QIH
Device Description
FlightPlan for Embolization is a post-processing, software-only application using 3D X-ray angiography images (CBCT) as input. It helps clinicians visualize vasculature to aid in the planning of endovascular embolization procedures throughout the body.
A new option, called AI Segmentation, was developed from the modifications to the predicate device, GE HealthCare's FlightPlan for Embolization [K193261]. It includes two new algorithms. This Al Segmentation option is what triggered this 510(k) submission.
The software process 3D X-ray angiography images (CBCT) acquired from GE HealthCare's interventional X-ray system [K181403], operates on GEHC's Advantage Workstation (AW) [K110834] platform and AW Server (AWS) [K081985] platform, and is an extension to the GE HealthCare's Volume Viewer application [K041521].
FlightPlan for Embolization is intended to be used during the planning phase of embolization procedures. These procedures workflows are split into 5 main phases:
- (1) Planning, using DSA and CBCT to characterize the anatomy and identify injection point candidates.
- (2) Navigation, to position catheters under fluoroscopic guidance.
- (3) Decision, to confirm treatment point(s) using DSA and Selective CBCT.
- (4) Treatment, which consists into injection of embolization material from the confirmed treatment point(s).
- (5) Assessment, to assess the embolization procedure end-point.
The proposed device is only used as part of the phase (1) Planning.
The primary features/functions of the proposed software are:
- . Semi-automatic segmentation of vasculature from a starting point determined by the user, when AI Segmentation option is not activated;
- . Automatic segmentation of vasculature powered by a deep-learning algorithm, when Al Segmentation option is activated;
- Automatic definition of the root point powered by a deep-learning algorithm, when AI Segmentation option is activated;
- Selective display (Live Tracking) of proximal vessels from a point determined by the user's cursor;
- Ability to segment part of the selected vasculature;
- Ability to mark points of interest (POI) to store cursor position(s);
- Save results and optionally export them to other applications such as GEHC's Vision Applications ● [K092639] for 3D road-mapping.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
3D X-ray angiography images (CBCT)
Anatomical Site
Not Found
Indicated Patient Age Range
AI Segmentation option is validated for adult population only.
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
For both vessels extraction algorithm and root definition algorithm, contrast injected CBCT scans acquired from GE HealthCare's interventional X-ray system [K181403] were used for designing and qualifying the algorithms. A test set of 207 contrast injected scans was reserved, segregated, and used to evaluate both algorithms.
The segregated test set contained a mix of 207 contrast injected CBCT scans (each from a unique patient) acquired during the planning of embolization procedures from GE HealthCare's interventional X-ray system [K181403]. The scans were selected to be representative of the intended population in terms of anatomy (with a majority of cases from head, liver, and prostate), vessel contrast and type of CBCT acquisition.
For vessel extraction, the ground truth was produced by the consensus of 3 board certified radiologists. For root definition, the ground truth was performed by a GEHC advanced application specialist.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering bench testing:
- Sample size: 207 contrast injected CBCT scans (each from a unique patient).
- Results for automatic vessels extraction algorithm compared to best vessels segmentation with semi-automatic tool: success rate of 93.7% (acceptance criterion 90%).
- Results for root definition algorithm compared to acceptable area manually defined by annotator: success rate of 95.2% (acceptance criterion 90%).
- Subgroup analyses performed in the following areas: anatomy, vessel contrast, type of CBCT acquisition, and reconstruction filters.
Clinical Testing:
- Representative clinical sample images of 3D X-ray angiography from clinical sites were assessed by interventional radiologists using a 5-point Likert scale.
- The clinical assessment demonstrated that the proposed device FlightPlan for Embolization with Al Segmentation option met its pre-defined acceptance criteria and helps physicians in their analysis of 3D X-ray angiography images and in the planning of embolization procedures, including the selection of embolization injection points.
- This activity substantiated the performance of the two Deep-Learning based algorithms, for automatic segmentation of vessels and automatic root point definition.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Vessel extraction success rate: 93.7% (acceptance criterion 90%).
Root definition success rate: 95.2% (acceptance criterion 90%).
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.
K181403, K110834, K081985, K041521, K092639
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GE Medical Systems SCS % Ning Wen Regulatory Affairs Program Manager Associate 283, rue de la Miniere Buc. 78530 FRANCE
Re: K223490
March 21, 2023
Trade/Device Name: FlightPlan for Embolization Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: February 22, 2023 Received: February 22, 2023
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
1
801 and Part 809); 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-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 medical devices and radiation-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) K223490
Device Name
FlightPlan for Embolization
Indications for Use (Describe)
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery.
The output includes segmented vasculature, and selective display of proximal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains the logo for GE HealthCare. The logo consists of a circular emblem with the letters 'GE' intertwined in a stylized font, positioned to the left of the text 'GE HealthCare'. The color of the logo and text is a shade of purple.
510(k) Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92 the following summary of information is provided.
| Date: | March 20, 2023 |
|---|---|
| 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: +33 6 2324 6023 | |
| Email: ning.wen@ge.com | |
| Secondary Contact | Rachel Schandel |
| Senior Regulatory Affairs Leader | |
| Tel: +1 385 237 7519 | |
| Email: rachel.schandel@ge.com | |
| Device Trade Name: | |
| Common/Usual Name: | |
| Regulation Number: | |
| Product Code: | |
| Regulatory Class: | FlightPlan for Embolization |
| FlightPlan for Embolization, with AI Segmentation option | |
| 21CFR 892.2050, Medical image management and processing system | |
| QIH | |
| Class II | |
| Predicate Device: | |
| Device Name: | |
| Manufacturer: | |
| 510(k) number: | |
| Regulation Number: | |
| Product Code: | |
| Regulatory Class: | FlightPlan for Embolization |
| GE Medical Systems SCS | |
| K193261 | |
| 21CFR 892.2050, Medical image management and processing system | |
| LLZ | |
| Class II |
Device Description and Marketed Devices:
FlightPlan for Embolization is a post-processing, software-only application using 3D X-ray angiography images (CBCT) as input. It helps clinicians visualize vasculature to aid in the planning of endovascular embolization procedures throughout the body.
A new option, called AI Segmentation, was developed from the modifications to the predicate device, GE HealthCare's FlightPlan for Embolization [K193261]. It includes two new algorithms. This Al Segmentation option is what triggered this 510(k) submission.
4
Image /page/4/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a purple circular emblem with stylized letters on the left. To the right of the emblem is the text "GE HealthCare" in a simple, sans-serif font, also in purple. The logo is clean and modern, representing the company's brand identity.
The software process 3D X-ray angiography images (CBCT) acquired from GE HealthCare's interventional X-ray system [K181403], operates on GEHC's Advantage Workstation (AW) [K110834] platform and AW Server (AWS) [K081985] platform, and is an extension to the GE HealthCare's Volume Viewer application [K041521].
FlightPlan for Embolization is intended to be used during the planning phase of embolization procedures. These procedures workflows are split into 5 main phases:
- (1) Planning, using DSA and CBCT to characterize the anatomy and identify injection point candidates.
- (2) Navigation, to position catheters under fluoroscopic guidance.
- (3) Decision, to confirm treatment point(s) using DSA and Selective CBCT.
- (4) Treatment, which consists into injection of embolization material from the confirmed treatment point(s).
- (5) Assessment, to assess the embolization procedure end-point.
The proposed device is only used as part of the phase (1) Planning.
The primary features/functions of the proposed software are:
- . Semi-automatic segmentation of vasculature from a starting point determined by the user, when AI Segmentation option is not activated;
- . Automatic segmentation of vasculature powered by a deep-learning algorithm, when Al Segmentation option is activated;
- Automatic definition of the root point powered by a deep-learning algorithm, when AI Segmentation option is activated;
- Selective display (Live Tracking) of proximal vessels from a point determined by the user's cursor;
- Ability to segment part of the selected vasculature;
- Ability to mark points of interest (POI) to store cursor position(s);
- Save results and optionally export them to other applications such as GEHC's Vision Applications ● [K092639] for 3D road-mapping.
Intended Use:
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature.
Indication for Use:
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery.
The output includes segmented vasculature, and selective display of proximal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery.
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Image /page/5/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in purple, with "GE" in a slightly larger font size than "HealthCare".
Technology:
The proposed device FlightPlan for Embolization employs the same fundamental scientific technology as its predicate device FlightPlan for Embolization [K193261].
In addition, the proposed device FlightPlan for Embolization includes an Al Segmentation option. The Al Segmentation option enabling both automatic segmentation of vasculature and automatic definition of the root point is based on two new algorithms: Deep-Learning based automatic vessels extraction algorithm and Deep-Learning based root definition algorithm.
For both vessels extraction algorithm and root definition algorithm, contrast injected CBCT scans acquired from GE HealthCare's interventional X-ray system [K181403] were used for designing and qualifying the algorithms. A test set of 207 contrast injected scans was reserved, segregated, and used to evaluate both algorithms.
Device Modification Overview:
The table below summarizes the substantive feature/technological differences and similarities between the predicate device and the proposed device:
| Specification | Predicate Device:
FlightPlan for Embolization
[K193261] | Proposed Device:
FlightPlan for Embolization
[K223490] |
|-----------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Indication for Use | Identical | Identical |
| Patient Population | No limitations on the patient
population. | AI Segmentation option is validated
for adult population only. |
| Semi-automatic segmentation
of vasculature | Identical | Identical |
| Automatic segmentation of
vasculature | No, segmentation of
vasculature can only be done
semi-automatically | Yes, automatic segmentation of
vasculature powered by Deep-
Learning based algorithm |
| Automatic definition of the root
point | No, definition of the root
point can only be done
manually | Yes, automatic definition of the
root point powered by Deep-
Learning based on algorithm |
| Selective display (Live Tracking) | Identical | Identical |
| Segment part of the vasculature | Yes | Yes |
| Mark points of interest (POI) | Yes | Yes |
| Save and Export | Yes | Yes |
| General features | Identical | Identical |
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Image /page/6/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a purple circular emblem with the letters "GE" intertwined inside. To the right of the emblem, the words "GE HealthCare" are written in purple, with "GE" slightly larger than "HealthCare".
Determination of Substantial Equivalence:
Summary of Non-Clinical, Design Control Testing
The proposed device, FlightPlan for Embolization, has successfully completed the required design control testing per GE HealthCare Quality Management 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. It was designed and will be 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 FlightPlan for Embolization has been successfully verified on the AW VolumeShare workstation [K110834] and AW Server [K081985] platforms. All of the testing and results did not raise new or different questions of safety and effectiveness other than those already associated with predicate device.
The substantial equivalence determination is also based on the software documentation for a MODERATE level of concern device.
Additional Non-Clinical Testing
Engineering bench testing of the two new algorithms for the Al Segmentation option demonstrated the new algorithms' capabilities to automatically segment vasculature and to automatically define root point using CBCT scans.
The segregated test set contained a mix of 207 contrast injected CBCT scans (each from a unique patient) acquired during the planning of embolization procedures from GE HealthCare's interventional X-ray system [K181403]. The scans were selected to be representative of the intended population in terms of anatomy (with a majority of cases from head, liver, and prostate), vessel contrast and type of CBCT acquisition.
For vessel extraction, the ground truth was produced by the consensus of 3 board certified radiologists. For root definition, the ground truth was performed by a GEHC advanced application specialist.
The test set was used to evaluate the performance of the automatic vessels extraction algorithm compared to the best vessels segmentation result obtained with the semi-automatic tool in the predicate device; the success rate is 93.7% with acceptance criterion 90%. The same test set was used to evaluate the performance of the root definition algorithm compared to the acceptable area manually defined by the annotator; the success rate is 95.2% with acceptance criterion 90%.
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Image /page/7/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem is the text "GE HealthCare" in a matching purple color. The text is in a sans-serif font and is aligned horizontally with the emblem.
Subgroup analyses were performed in the following areas: anatomy, vessel contrast, type of CBCT acquisition, and reconstruction filters. Since the critical input data for the algorithms are high contrast images of vessels with an intra-arterial injection acquired only on GE HealthCare interventional C-arms with similar acquisition protocol in all sites, and since there is minimal variation in this vessel anatomy across race/gender, standard sub-groups such as imaging device manufacturer, site, race, gender, are not relevant. The test results of both algorithms, including the subgroup analyses, support the acceptable performance of the algorithms in the intended population and indications for use.
Summary of Clinical Testing
Representative clinical sample images of 3D X-ray angiography from clinical sites were assessed by interventional radiologists using a 5-point Likert scale. The clinical assessment demonstrated that the proposed device FlightPlan for Embolization with Al Segmentation option met its pre-defined acceptance criteria and helps physicians in their analysis of 3D X-ray angiography images and in the planning of embolization procedures, including the selection of embolization injection points. As well, this activity substantiated the performance of the two Deep-Learning based algorithms, for automatic segmentation of vessels and automatic root point definition.
Substantial Equivalence Conclusion
The changes to predicate device FlightPlan for Embolization cleared in 2020 do not create new Intended Use nor Indication for Use. The proposed device FlightPlan for Embolization has identical or equivalent technological characteristics as its predicate device.
GE HealthCare'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 predicate.
Based on development under GE HealthCare's quality system, successful design verification, software documentation for a "Moderate" level of concern, along with the engineering bench testing and the clinical evaluation demonstrate that the proposed FlightPlan is substantially equivalent to, and hence as safe and as effective for its Intended Use as the legally marketed predicate device.