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 vessel and distal 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 Description

FlightPlan for Embolization is a post processing software application which operates on the Advantage Workstation (AW) [K110834] platform and AW Server [K081985] platform. It is an extension to the Volume Viewer application [K041521] modified from FlightPlan for Liver (K121200) and is designed for processing 3D X-ray angiography images to help visualize vasculature

The primary features of the software are: semi-automatic segmentation of vascular tree from a starting point determined by the user; selective display (Live Tracking) of proximal vessel and distal vessels from a point determined by the user's cursor; ability to segment part of the vasculature; ability to mark points of interest (POI) to store cursor position; save results and export to other applications such as Vision Applications [K092639] for 3D road-mapping.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for FlightPlan for Embolization:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a dedicated section for "acceptance criteria." However, it describes validation activities that implicitly define the performance considered acceptable. Based on the "Summary of Non-Clinical Tests" and "Summary of Clinical Tests," the following can be inferred:

Acceptance Criteria (Inferred from Validation Activities)	Reported Device Performance
Non-Clinical:
Capability to automatically segment and selectively display vascular structures from a single user-defined point.	"FlightPlan for Embolization algorithms' capability to automatically segment and selectively display vascular structures from a single user defined point using a database of XACT exams... established satisfactory quality for FlightPlan for Embolization usage."
Compliance with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.	"The FlightPlan for Embolization complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard."
Adherence to design control testing per GE's quality system (21 CFR 820 and ISO 13485).	"FlightPlan for Embolization has successfully completed the required design control testing per GE's quality system. FlightPlan for Embolization was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485.• Risk Analysis• Requirements Reviews• Design Reviews• Performance testing (Verification, Validation)• Safety testing (Verification)"
Clinical:
Ability of the device to help physicians in the analysis of 3D X-ray angiography images and in the planning of embolization procedures, including the selection of embolization injection points.	"The assessment demonstrated that the proposed device (FlightPlan for Embolization) helps physicians in the analysis of 3D X-ray angiography images and in the planning of embolization procedures, including the selection of embolization injection points."

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical Test Set:
- Sample Size: A "database of XACT exams." The specific number of cases is not provided.
- Data Provenance: Not explicitly stated, but clinical scenarios are considered "representative" and include "consideration of acquisition parameters, image quality and anatomy." It can be inferred that these are existing clinical data, likely retrospective.
Clinical Test Set:
- Sample Size: "A sample of 3D X-ray angiography images representative of clinical practice." The specific number of cases is not provided.
- Data Provenance: Not explicitly stated, but described as "representative of clinical practice" and "most common anatomic regions where embolization procedures are performed." It can be inferred that these are retrospective clinical cases.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Clinical Test Set:
- Number of Experts: Four
- Qualifications: "board certified interventional radiologists." No information on years of experience is provided.

4. Adjudication Method for the Test Set

Clinical Test Set: The document states that the assessment was done "using a 5-point Likert scale." This implies an individual scoring system by each radiologist, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus). It sounds like individual assessments were performed and then aggregated or analyzed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not explicitly stated to have been done in the traditional sense of comparing human readers with AI vs. without AI assistance.
- The clinical study described is an assessment of the device's helpfulness by radiologists, rather than a comparative study measuring improvement in diagnostic accuracy or efficiency for humans using the AI vs. not using it. The statement "demonstrated that the proposed device (FlightPlan for Embolization) helps physicians" is an outcome of an assessment, not a quantitative effect size from an MRMC study comparing assisted vs. unassisted performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, a form of standalone performance was assessed in the "Summary of Non-Clinical Tests." The "Engineering...validated FlightPlan for Embolization algorithms' capability to automatically segment and selectively display vascular structures..." using a database of XACT exams. This implies an evaluation of the algorithm's output against some reference (likely manual segmentations or ground truth established by experts) without direct human interaction at the time of assessment.

7. The Type of Ground Truth Used

Non-Clinical Test Set: The ground truth for the non-clinical validation of segmentation and display capabilities is implicitly based on expert-defined correct segmentations or "satisfactory quality" as determined by engineering validation. The document does not explicitly state "expert consensus" or "pathology" for this.
Clinical Test Set: The ground truth for the clinical assessment relies on the judgment of "four board certified interventional radiologists" using a 5-point Likert scale to determine if the device "helps physicians." This is a form of expert assessment/opinion as ground truth regarding the device's utility/helpfulness.

8. The Sample Size for the Training Set

Not provided. The document does not disclose information about the training data used for the FlightPlan for Embolization algorithms.

9. How the Ground Truth for the Training Set was Established

Not provided. Since the training set details are not mentioned, how its ground truth was established is also not available in this document.

Summary

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FDA U.S. FOOD & DRUG
ADMINISTRATION

GE Medical Systems SCS c/o Ning Wen Regulatory Affairs Leader 283, rue de la Miniere BUC, 78530 FRANCE

January 24, 2020

Re: K193261

Trade/Device Name: FlightPlan for Embolization Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 25, 2019 Received: November 26, 2019

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

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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 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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193261

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.

Type of Use (Select one or both, as applicable)
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X 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/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a swirling pattern that resembles water or wind. The logo is simple and recognizable, and it is often used to represent the company's products and services.

510(k) Summary

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

Date:	November 22, 2019
Submitter:	GE Medical Systems SCSEstablishment Registration Number - 9611343283, rue de la Minière78530 Buc, France
Primary Contact Person:	Ning WENRegulatory Affairs LeaderGE Healthcare, (GE Medical Systems SCS)Tel: +33 1 3070 5668Email: ning.wen@ge.com
Secondary Contact Person:	Philip MalcaDirector - Regulatory Affairs, Interventional & SurgeryGE Healthcare, (GE Medical Systems SCS)Tel: +33 6 4637 3852Email: philip.malca@ge.com
Device Trade Name:	FlightPlan for Embolization
Common/Usual Name:	Picture Archiving and Communications System
Classification Names:	21CFR 892.2050, Class II
Product Code:	LLZ
Predicate Device(s):	K121200, FlightPlan for Liver
Device Description:	FlightPlan for Embolization is a post processing software application which operates on the Advantage Workstation (AW) [K110834] platform and AW Server [K081985] platform. It is an extension to the Volume Viewer application [K041521] modified from FlightPlan for Liver (K121200) and is designed for processing 3D X-ray angiography images to help visualize vasculature
The primary features of the software are:	semi-automatic segmentation of vascular tree from a starting point determined by the user; selective display (Live Tracking) of proximal vessel and distal vessels from a point determined by the user's cursor; ability to segment part of the vasculature; ability to mark points of interest (POI) to store cursor position; save results and export to other applications such as 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 vessel and distal 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.
Technology:	The proposed device (FlightPlan for Embolization) employs the same fundamental scientific technology as its predicate device (FlightPlan for Liver).The proposed device (FlightPlan for Embolization) is a selective display tool helping user's visualization of vascular structures.

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Image /page/4/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 font in the center. The circle is surrounded by a series of white swirls, which give the impression of movement or energy. The blue color is a medium shade, and the white swirls provide a contrast.

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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue, and the border has a water droplet design.

Comparison:	The table below summarizes the feature/technological comparison between the predicate device and the proposed device:
	Specification	Predicate Device:	Proposed Device:
		FlightPlan for Liver[K121200]	FlightPlan forEmbolization
	Segmentation ofthe vasculature	Yes, Semi-automatic	Yes, Semi-automatic
	Segmentationand selectivedisplay of part ofthe vasculature	Yes, using targetdefined by user	Yes, using tool forlive tracking ofvessels
	Identification ofPoints of interest	Yes	Yes
	Save and Export	Yes	Yes
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:Engineering has validated FlightPlan for Embolization algorithms' capability to automatically segment and selectively display vascular structures from a single user defined point using a database of XACT exams. This database of exams is considered representative of the clinical scenarios where FlightPlan for Embolization is intended to be used, with consideration of acquisition parameters, image quality and anatomy. The result of the algorithms' validation established satisfactory quality for FlightPlan for Embolization usage.The FlightPlan for Embolization complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.FlightPlan for Embolization has successfully completed the required design control testing per GE's quality system. FlightPlan for Embolization 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:• Risk Analysis

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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, cursive font, enclosed within a circular shape. The logo is colored in a bright blue hue, and the circular border around the letters has a wave-like design.

Requirements Reviews Design Reviews Performance testing (Verification, Validation) Safety testing (Verification) The substantial equivalence determination is also based on thesoftware documentation for a MODERATE level of concerndevice.Summary of Clinical Tests:A sample of 3D X-ray angiography images representative ofclinical practice was assessed by four board certifiedinterventional radiologists using a 5-point Likert scale. Thesedatasets represent the most common anatomic regions whereembolization procedures are performed. The assessmentdemonstrated that the proposed device (FlightPlan forEmbolization) helps physicians in the analysis of 3D X-rayangiography images and in the planning of embolizationprocedures, including the selection of embolization injectionpoints.
Conclusion: GE Healthcare considers the FlightPlan for Embolization to be assafe, as effective, and performance is substantially equivalent tothe predicate device.

Requirements Reviews Design Reviews Performance testing (Verification, Validation) Safety testing (Verification) The substantial equivalence determination is also based on thesoftware documentation for a MODERATE level of concerndevice.Summary of Clinical Tests:A sample of 3D X-ray angiography images representative ofclinical practice was assessed by four board certifiedinterventional radiologists using a 5-point Likert scale. Thesedatasets represent the most common anatomic regions whereembolization procedures are performed. The assessmentdemonstrated that the proposed device (FlightPlan forEmbolization) helps physicians in the analysis of 3D X-rayangiography images and in the planning of embolizationprocedures, including the selection of embolization injectionpoints.

Conclusion: GE Healthcare considers the FlightPlan for Embolization to be assafe, as effective, and performance is substantially equivalent tothe predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).