Liver Suite

K211180 · GE Medical Systems SCS · JAK · May 2, 2022 · Radiology

Device Facts

• Record ID: K211180
• Device Name: Liver Suite
• Applicant: GE Medical Systems SCS
• Product Code: JAK · Radiology
• Decision Date: May 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Liver Suite is a medical diagnostic software that provides the clinician with tools to efficiently process, analyze, review and communicate to peers findings from liver CT image data. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and patient management. Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.

Device Story

Liver Suite; medical software for multi-phase liver CT image review/analysis per LI-RADS v2018 guidelines. Input: phased contrast CT series. Operation: automatic phase identification (unenhanced, arterial, portal venous, delayed) via model-based algorithm; semi-automatic lesion contouring (leveraging Volume Viewer); automated computation of intensity metrics (APHE, washout, capsule) based on enhancement differences between lesion and parenchyma. Output: optimized series display, LI-RADS score calculation, and measurement table. Used in clinical settings by healthcare professionals on AW VolumeShare Workstations, AW Servers, or PACS. Clinician reviews output to assess major/ancillary features, edit contours, and finalize LI-RADS score. Benefits: standardized workflow for HCC assessment, improved efficiency in lesion characterization, and support for clinical decision-making.

Clinical Evidence

Bench testing only. Verification of phase identification algorithm demonstrated capability to identify two, three, or four phases on multi-phase CT images. APHE, washout, and capsule intensity metric calculations verified using synthetic images and validated by comparing metric distributions against expert-annotated lesion datasets.

Technological Characteristics

Software application embedded in Volume Viewer (K041521). Operates on AW VolumeShare Workstation (K110834) and AW Server (K081985). Complies with NEMA PS 3.1-3.20 (DICOM). Features model-based phase identification and semi-automatic lesion contouring. Software level of concern: Moderate.

Indications for Use

Indicated for healthcare professionals to review multi-phase liver CT images following LI-RADS® guidelines to analyze liver lesions in patients with known or suspected hepatocellular carcinoma (HCC).

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Hepatic VCAR (K193281)
• PROView (K193306)

Reference Devices

• Volume Viewer (K041521)
• AW VolumeShare Workstation (K110834)
• AW Server (K081985)

Submission Summary (Full Text)

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May 2, 2022

Image /page/0/Picture/1 description: The image shows 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

GE Medical Systems SCS % Peter Uhlir Regulatory Affairs Leader 283, rue de la Minière Buc. 78530 FRANCE

Re: K211180

Trade/Device Name: Liver Suite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: April 25, 2022 Received: April 26, 2022

Dear Peter Uhlir:

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

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801); 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 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,

Laurel Burk Assistant Director Diagnostic X-ray Systems Team DHT 8B: 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

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# Indications for Use

510(k) Number (if known)

K211180

Device Name

Liver Suite

Indications for Use (Describe)

Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# K211180

Image /page/3/Picture/2 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a decorative, swirling design around the letters, giving it a distinctive and recognizable appearance. The logo is simple, yet elegant, and is widely recognized as the symbol of the General Electric company.

# 510(k) Summary

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

| Date: | May 2, 2022 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems SCS<br>Establishment Registration Number - 9611343<br>283 rue de la Minière<br>78530 Buc, France |
| Primary Contact: | Peter Uhlir<br>Regulatory Affairs Leader<br>GE Healthcare, (GE Medical Systems SCS)<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact: | Camille Vidal<br>Director, Regulatory Strategy<br>Phone: [phone]<br>Email: [e-mail] |
| Proposed Device: | |
| Device Name: | Liver Suite |
| Common/Usual Name: | Liver Suite |
| Regulation number/ Product Code: | 21 CFR 892.1750 Computed tomography x-ray system / JAK<br>21 CFR 892.2050 Medical image management and processing system / LLZ |
| Classification: | Class II |
| Predicate Device: | |
| Device Name: | Hepatic VCAR |
| 510(k) number: | K193281 cleared on March 20, 2020 |
| Regulation number/ Product Code: | 21 CFR 892.1750 Computed tomography x-ray system / JAK<br>21 CFR 892.2050 Picture archiving and communication system / LLZ |
| Classification: | Class II |
| Manufacturer: | GE Medical Systems SCS |
| Device Name: | PROView |
| 510(k) number: | K193306 cleared on November 17, 2020 |
| Regulation number/ Product Code: | 21 CFR 892.2050 Picture archiving and communication system / LLZ |
| Classification: | Class II |
| Manufacturer: | GE Medical Systems SCS |

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Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background. The logo is simple, recognizable, and represents the brand identity of General Electric.

### Reference Device:

Liver Suite is a medical software that offers a guided workflow for the review and Device Description: assessment of multi-phase CT liver exams per LI-RADS® v2018 guidelines. It is designed to help analyze liver lesions in patients with known or suspected hepatocellular carcinoma (HCC) by providing optimized image display and assessment of intensity metrics related to the 3 major imaging features for LI-RADS scoring.

> Liver Suite takes phased contrast CT series as input. It only processes one exam at a time (no longitudinal analysis).

Liver Suite guided workflow includes:

- Automatic phase identification of the four hepatic imaging phases: unenhanced, arterial, portal venous and delayed
- Semi-automatic lesion contouring based on an initial deposition from the user, user selects applicable appropriate score (LRNC, LR-TIV, LR-1, LR-2 or LR-M) based on image review
- -A user interface to guide the user in the application of LI-RADS scoring guidelines v2018
- -User sets the features - non-rim APHE (Yes/No), Enhancing Capsule (Yes/No), Non-peripheral washout (Yes/No), Threshold growth (Yes/No/Not Applicable), Ancillary Features
- Automated computation of intensity metrics to help characterize Arterial Phase -Hyper Enhancement (APHE), Washout and Capsule
- Automated calculation of LI-RADS score (per LI-RADS v2018 guidelines) from user assessment of major and ancillary features
- Display of all measurements in a table for review and export

Identification of hepatic phases is based on a model-based algorithm or can be set manually by the user. Semi-automatic contouring of the lesion is based on the Auto Contour feature and user input. The Auto Contour feature is already part of Volume Viewer (K041521).

User sets LI-RADS major and ancillary features and compute associated LI-RADS score. To assist with the assessment of Arterial Phase Hyper Enhancement (APHE), Washout and Capsule, intensity metrics based on enhancement characteristics around the lesion are automatically computed.

LI-RADS score is computed based on LI-RADS features using LI-RADS diagnostic table. User can edit the major features, add ancillary features or manually choose a different score.

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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' in a stylized, cursive font, enclosed within a circular border. There are three water droplet-like shapes evenly spaced around the outside of the circle. The logo is colored in a light blue hue.

- Liver Suite is a medical diagnostic software that provides the clinician with tools to Intended Use: efficiently process, analyze, review and communicate to peers findings from liver CT image data. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide the referring physician with clinically relevant information that may aid in diagnosis and patient management.
- Indication for Use: Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.
- Technology: Liver Suite software provides a workflow to assess hepatocellular carcinoma following LI-RADS guidelines using multi-phase liver CT images which are routine acquisitions, systematically done by the clinician for liver cancer assessment in case of hepatocellular carcinoma, as it is part of LI-RADS guidelines.

Liver Suite is a post processing application option that is intended for the analysis of CT liver images. It is embedded in Volume Viewer (K041521). Volume Viewer is a platform of 3D applications that provides at the same time an autonomous set of layouts, protocols and tools for the user and common framework to build other specialty 3D applications on top of Volume Viewer, such as proposed application Liver Suite. Liver Suite and Volume Viewer run on AW VolumeShare Workstation (K110834) and AW Server (K081985) platforms, Cloud or PACS stations

- The table below summarizes the feature/technological comparison between the predicate Comparison: device and the proposed device:

| Specification | Predicate Device:<br>Hepatic VCAR (K193281) | Proposed Device:<br>Liver Suite |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Targeted clinical<br>condition,<br>anatomy and<br>imaging<br>modality | Clinical condition: patient<br>with suspected or known<br>liver lesions. Anatomy:<br>Liver; Imaging modality:<br>CT | Clinical condition: patient with<br>suspected or known HCCs,<br>which are a type of liver<br>lesions. Anatomy: Liver;<br>Imaging modality: CT |
| Lesion<br>characterization | Automatic characterization<br>of the lesion volume based<br>on maximum 2D diameter<br>given manually by the user. | Automatic characterization of<br>the lesion volume based on<br>maximum 2D diameter given<br>manually by the user. |
| | User can review and edit<br>the contour. Once accepted,<br>the following statistics are<br>available: | User can review and edit the<br>contour. Once accepted, the<br>following statistics are<br>available: |
| | - lesion volume | - lesion volume |
| | - lesion 2D max and short<br>axis | |

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Image /page/6/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. There are three white swirls around the outside of the circle. The logo is simple and recognizable.

| - lesion HU values (min,<br>max, average, standard<br>deviation) | - lesion 2D max and short axis<br>- lesion HU values (min, max,<br>average, standard deviation)<br>- 3 intensity metrics: Arterial<br>Phase Hyper Enhancement<br>(APHE), Washout and Capsule<br>based on analysis of intensity<br>enhancement differences<br>between the lesion and<br>adjacent parenchyma.<br>User sets LI-RADS major and<br>ancillary features in workflow<br>panel to enable computation of<br>the associated LI-RADS score. | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automatic phase<br>identification | Automatic detection of portal<br>phase based on image<br>information.<br>User can modify series<br>display if needed. | Automatic detection of<br>uncontrasted, arterial, portal and<br>delayed phase based on a<br>statistical model using image<br>and acquisition information.<br>User can modify series display if<br>needed. |
| Summary Report<br>Content | Organ type bookmarks:<br>• Liver<br>• Portal Vein<br>• Hepatic Artery<br>• Segment<br>Lesion type bookmarks:<br>• Lesion | For each lesion Observation<br>Analysis finding:<br>• Observation size<br>• Observation major<br>features<br>• Observation ancillary<br>features<br>• Observation LI-RADS<br>score |

| Specification | Reference Device:<br>PROView (K193306) | Proposed Device:<br>Liver Suite |
|------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Computation of<br>PI/LI-RADS score | Based on user input on<br>location and assessment<br><br>Following PI-RADS™ v2.1<br>guidelines | Based on user input on major<br>and ancillary features<br><br>Following LI-RADS® v2018<br>guidelines |

## Determination of

Substantial Equivalence:

The proposed device, Liver Suite, has successfully completed the required design control testing per GE Healthcare Quality Management System. Liver Suite was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO

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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has small, white, droplet-like shapes around its perimeter, giving it a dynamic and fluid appearance.

13485:2016. The proposed device complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.

The following quality assurance measures have been applied to the development of the system:

- . Risk Analysis
- . Required Reviews
- . Design Reviews
- . Software Development Lifecycle
- Performance testing (Verification)
- . Safety testing (Verification)
- Algorithm Qualification (Validation)

Liver Suite has been verified on AW workstation (K110834) and AW Server (K081985) platforms. The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.

Engineering bench testing for the Liver Suite Phase Identification algorithm demonstrated the capabilities to identify automatically the two, three or four phases acquired on multi-phases CT images for LI-RADS scoring.

APHE. Washout and Capsule intensity metric calculation was verified through testing on synthetic images and validated by comparing intensity metric distribution on a set of expert-annotated lesions.

- Conclusion: GE Healthcare considers the Liver Suite software application to be as safe, as effective, and performance is substantially equivalent to the predicate device.