Who is the manufacturer of FlightPlan for Embolization?

GE Medical Systems SCS filed the 510(k) submission for FlightPlan for Embolization (K223490).

What is the FDA product code for FlightPlan for Embolization?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for FlightPlan for Embolization?

510(k) clearance (submission type: Traditional).

Does FlightPlan for Embolization use AI or machine learning?

Yes. FlightPlan for Embolization (K223490) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like FlightPlan for Embolization?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like FlightPlan for Embolization get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

FlightPlan for Embolization

Q: What are the predicate devices for FlightPlan for Embolization?

FlightPlan for Embolization (K193261).

K223490 · GE Medical Systems SCS · LLZ · Mar 21, 2023 · Radiology

Device Facts

Record ID	K223490
Device Name	FlightPlan for Embolization
Applicant	GE Medical Systems SCS
Product Code	LLZ · Radiology
Decision Date	Mar 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

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 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.

Device Story

FlightPlan for Embolization is a post-processing software application for 3D X-ray angiography (CBCT) images. It aids physicians in planning endovascular embolization procedures by segmenting vasculature and defining root points. The device operates on GE HealthCare's Advantage Workstation (AW) and AW Server platforms. It features an 'AI Segmentation' option utilizing deep-learning algorithms for automatic vessel extraction and root point definition. Physicians use the output to visualize anatomy and identify injection points; results can be exported for 3D road-mapping. The device is used in clinical settings during the planning phase; it does not perform therapy delivery. By automating segmentation and root definition, the device streamlines procedure planning, potentially improving workflow efficiency and accuracy in identifying treatment targets.

Clinical Evidence

Clinical assessment involved interventional radiologists evaluating representative 3D X-ray angiography images using a 5-point Likert scale. The assessment confirmed the device met pre-defined acceptance criteria for assisting in embolization planning and injection point selection. Additionally, engineering bench testing on 207 contrast-injected CBCT scans validated the deep-learning algorithms against ground truth (consensus of 3 radiologists for vessel extraction; advanced application specialist for root definition), achieving success rates of 93.7% and 95.2% respectively, exceeding the 90% acceptance criterion.

Technological Characteristics

Software-only post-processing application. Operates on GE AW/AWS platforms. Integrates with interventional X-ray systems. Employs deep-learning algorithms for automatic vessel segmentation and root point definition. Complies with NEMA PS 3.1-3.20 (DICOM). Manufactured under ISO 13485 and 21 CFR 820. Software level of concern: Moderate.

Indications for Use

Indicated for adult patients undergoing embolization procedures. Used by physicians as an adjunct for visualizing vasculature during the planning phase. Not for use during therapy delivery. Injection points must be independently confirmed.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

FlightPlan for Embolization (K193261)

Reference Devices

GE HealthCare interventional X-ray system (K181403)
Advantage Workstation (AW) (K110834)
AW Server (AWS) (K081985)
Volume Viewer application (K041521)
Vision Applications (K092639)

Related Devices

K210807 — FlightPlan for Liver · GE Medical Systems SCS · Oct 22, 2021
K193261 — FlightPlan for Embolization · GE Medical Systems SCS · Jan 24, 2020
K121200 — FLIGHTPLAN FOR LIVER · GE Healthcare · Nov 2, 2012
K213838 — AneuGuide · ArteryFlow Technology Co., Ltd. · Jun 1, 2022
K250045 — uWS-Angio Pro · Shanghai United Imaging Healthcare Co., Ltd. · Sep 24, 2025

Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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. {5}------------------------------------------------ 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 | {6}------------------------------------------------ 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%. {7}------------------------------------------------ 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.