FlightPlan for Embolization

K193261 · GE Medical Systems SCS · LLZ · Jan 24, 2020 · Radiology

Device Facts

• Record ID: K193261
• Device Name: FlightPlan for Embolization
• Applicant: GE Medical Systems SCS
• Product Code: LLZ · Radiology
• Decision Date: Jan 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 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 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 Story

Post-processing software for 3D X-ray angiography images; operates on Advantage Workstation (AW) and AW Server platforms. Inputs: 3D X-ray angiography images. Processing: semi-automatic segmentation of vascular tree; selective display (Live Tracking) of proximal/distal vessels from user-defined reference point; marking points of interest (POI). Outputs: segmented vasculature, POI data, and exportable data for 3D road-mapping. Used in clinical settings by interventional radiologists/physicians for procedure planning. Output serves as adjunct visualization tool; injection points require independent confirmation. Benefits: assists in planning embolization procedures by identifying vascular structures and injection points.

Clinical Evidence

Non-clinical bench testing validated algorithms using a database of XACT exams representative of clinical scenarios. Clinical assessment involved four board-certified interventional radiologists evaluating 3D X-ray angiography images across common embolization anatomic regions using a 5-point Likert scale. Results demonstrated the device assists in image analysis and planning, including selection of injection points.

Technological Characteristics

Post-processing software application; runs on AW/AW Server platforms. Features semi-automatic vascular segmentation and selective display algorithms. Complies with NEMA PS 3.1-3.20 (2016) DICOM standards. Developed under 21 CFR 820 and ISO 13485 quality systems. Software level of concern: Moderate.

Indications for Use

Indicated for physicians to analyze 3D X-ray angiography images for visualizing vasculature during the planning phase of embolization procedures. Not for use during therapy delivery.

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 Liver (K121200)

Reference Devices

• Advantage Workstation (AW) (K110834)
• AW Server (K081985)
• Volume Viewer (K041521)
• Vision Applications (K092639)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## 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.

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.

| 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/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 SCS<br>Establishment Registration Number - 9611343<br>283, rue de la Minière<br>78530 Buc, France |
| Primary Contact Person: | Ning WEN<br>Regulatory Affairs Leader<br>GE Healthcare, (GE Medical Systems SCS)<br>Tel: [phone]<br>Email: [e-mail] |
| Secondary Contact Person: | Philip Malca<br>Director - Regulatory Affairs, Interventional & Surgery<br>GE Healthcare, (GE Medical Systems SCS)<br>Tel: [phone]<br>Email: [e-mail] |
| 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.<br><br>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).<br><br>The proposed device (FlightPlan for Embolization) is a selective display tool helping user's visualization of vascular structures. |

{4}------------------------------------------------

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.

{5}------------------------------------------------

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<br>[K121200] | FlightPlan for<br>Embolization |
| | Segmentation of<br>the vasculature | Yes, Semi-<br>automatic | Yes, Semi-<br>automatic |
| | Segmentation<br>and selective<br>display of part of<br>the vasculature | Yes, using target<br>defined by user | Yes, using tool for<br>live tracking of<br>vessels |
| | Identification of<br>Points of interest | Yes | Yes |
| | Save and Export | Yes | Yes |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>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.<br>The FlightPlan for Embolization complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.<br>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.<br>The following quality assurance measures were applied to the development of the device:<br>• Risk Analysis | | |

{6}------------------------------------------------

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 the<br>software documentation for a MODERATE level of concern<br>device.<br>Summary of Clinical Tests:<br>A sample of 3D X-ray angiography images representative of<br>clinical practice was assessed by four board certified<br>interventional radiologists using a 5-point Likert scale. These<br>datasets represent the most common anatomic regions where<br>embolization procedures are performed. The assessment<br>demonstrated that the proposed device (FlightPlan for<br>Embolization) helps physicians in the analysis of 3D X-ray<br>angiography images and in the planning of embolization<br>procedures, including the selection of embolization injection<br>points. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Conclusion:</b> GE Healthcare considers the FlightPlan for Embolization to be as<br>safe, as effective, and performance is substantially equivalent to<br>the predicate device. |