Hepatic VCAR

K193281 · GE Medical Systems SCS · JAK · Mar 20, 2020 · Radiology

Device Facts

• Record ID: K193281
• Device Name: Hepatic VCAR
• Applicant: GE Medical Systems SCS
• Product Code: JAK · Radiology
• Decision Date: Mar 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

Hepatic VCAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data derived from DICOM 3.0 compliant CT scans. Hepatic VCAR is designed for the purpose of assessing liver morphology, including liver lesion, provided the lesion has different CT appearance from surrounding liver tissue; and its change over time through automated tools for liver lobe, liver segments and liver lesion segmentation and measurement. It is intended for use by clinicians to process, review, archive, print and distribute liver CT studies. This software will assist the user by providing initial 3D segmentation, visualization, and quantitative analysis of liver anatomy. The user has the ability to adjust the contour and confirm the final segmentation.

Device Story

Software package for analysis/visualization of DICOM 3.0 liver CT data; processes images to provide 3D segmentation, vessel analysis, and quantitative measurements of liver, lobes, segments, and lesions. Operates on Advantage Workstation (AW), AW Server, CT scanners, and PACS/cloud. Clinicians use automated tools to generate initial segmentations, which are then reviewed and manually refined/confirmed by the user. Incorporates two deep learning convolutional neural networks: one for liver contour segmentation and one for hepatic artery segmentation (based on initial user input point). Assists in assessing liver morphology and lesion changes over time. Benefits include standardized, efficient anatomical quantification and visualization to support clinical decision-making.

Clinical Evidence

Bench testing compared deep learning algorithm outputs against expert-annotated ground truth. Clinical assessment involved 3 board-certified radiologists evaluating a representative set of clinical sample images using a 5-point Likert scale, confirming the capability of the liver and hepatic artery segmentation algorithms.

Technological Characteristics

Software-based CT image analysis; utilizes two deep learning convolutional neural networks for automated segmentation. Deployed on AW/AW Server platforms. Compliant with DICOM 3.0. Software level of concern: Moderate.

Indications for Use

Indicated for clinicians to perform 3D segmentation, visualization, and quantitative analysis of liver anatomy, including liver morphology and lesions, using DICOM 3.0 compliant CT scans.

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 (K133649)

Reference Devices

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

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol that appears to be a stylized representation of human figures or faces. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in a bold, blue font, with the word 'ADMINISTRATION' appearing below in a smaller font size.

GE Medical Systems SCS % Lifeng Wang Regulatory Affairs Manager 283 rue de la Miniere 78530 Buc FRANCE

March 20, 2020

## Re: K193281

Trade/Device Name: Hepatic VCAR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray System Regulatory Class: Class II Product Code: JAK, LLZ Dated: February 19, 2020 Received: February 20, 2020

Dear Lifeng Wang:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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.

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)

Device Name

Hepatic VCAR

Indications for Use (Describe)

Hepatic VCAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data derived from DICOM 3.0 compliant CT scans. Hepatic VCAR is designed for the purpose of assessing liver morphology, including liver lesion, provided the lesion has different CT appearance from surrounding liver tissue; and its change over time through automated tools for liver lobe, liver segments and liver lesion segmentation and measurement. It is intended for use by clinicians to process, review, archive, print and distribute liver CT studies.

This software will assist the user by providing initial 3D segmentation, visualization, and quantitative analysis of liver anatomy. The user has the ability to adjust the contour and confirm the final segmentation.

| Type of Use (Select one or both, as applicable) | |
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| | <label><span style="font-size: 10pt;"></span></label> |

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## 510(k) Summary

K193281

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

| Date: | Nov 26, 2019 | | | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Submitter: | GE Medical Systems SCS (Establishment Registration Number – 9611343) | | | | |
| | 283 rue de la Miniere | | | | |
| | 78530 Buc, France | | | | |
| Primary Contact<br>Person: | Lifeng Wang | | | | |
| | Regulatory Affairs Manager | | | | |
| | GE Healthcare | | | | |
| | Phone: [phone] | | | | |
| | Email: [e-mail] | | | | |
| Secondary Contact<br>Person: | Elizabeth Mathew | | | | |
| | Senior Regulatory Affairs Manager | | | | |
| | GE Healthcare | | | | |
| | Phone: [phone] | | | | |
| | Email: [e-mail] | | | | |
| Proposed Device | > Device Name: Hepatic VCAR | | | | |
| | > Regulation number/ Product Code: 21 CFR 892.1750 Computed tomography<br>x-ray system / JAK | | | | |
| | > Secondary Regulation number/ Product Code: 21 CFR 892.2050 Picture<br>archiving and communications system/ LLZ | | | | |
| | > Classification: Class II | | | | |
| Predicate Device: | > Device Name: Hepatic VCAR | | | | |
| | > 510(k) number: K133649 | | | | |
| | > Regulation number/ Product Code: 21 CFR 892.1750 Computed tomography<br>x-ray system / JAK | | | | |
| | > Secondary Regulation number/ Product Code: 21 CFR 892.2050 Picture<br>archiving and communications system/ LLZ | | | | |
| | > Classification: Class II | | | | |
| Device Description | Hepatic VCAR is a CT image analysis software package that allows the analysis<br>and visualization of Liver CT data derived from DICOM 3.0 compliant CT scans.<br>Hepatic VCAR was designed for the purpose of assessing liver morphology,<br>including liver lesion, provided the lesion has different CT appearance from<br>surrounding liver tissue; and its change over time through automated tools for<br>liver, liver lobe, liver segments and liver lesion segmentation and measurement. | | | | |
| | Hepatic VCAR is a post processing software medical device built on the Volume<br>Viewer (K041521) platform, and can be deployed on the Advantage Workstation | | | | |

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Image /page/4/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 blue circle. There are three white teardrop shapes surrounding the circle, positioned at the top and on either side.

| | (AW) (K110834) and AW Server (K081985) platforms, CT Scanners, and PACS<br>stations or cloud in the future.<br>This software will assist the user by providing initial 3D segmentation, vessel<br>analysis, visualization, and quantitative analysis of liver anatomy. The user has<br>the ability to adjust the contour and confirm the final segmentation.<br>In the proposed device, two new algorithms utilizing deep learning technology<br>were introduced. One such algorithm segments the liver producing a liver contour<br>editable by the user; another algorithm segments the hepatic artery based on an<br>initial user input point. The hepatic artery segmentation is also editable by the<br>user. | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | This software will assist the user by providing initial 3D segmentation, vessel<br>analysis, visualization, and quantitative analysis of liver anatomy. The user has<br>the ability to adjust the contour and confirm the final segmentation. | | |
| Intended Use/<br>Indication for Use: | Hepatic VCAR is a CT image analysis software package that allows the analysis<br>and visualization of Liver CT data derived from DICOM 3.0 compliant CT scans.<br>Hepatic VCAR is designed for the purpose of assessing liver morphology,<br>including liver lesion, provided the lesion has different CT appearance from<br>surrounding liver tissue; and its change over time through automated tools for<br>liver, liver lobe, liver segments and liver lesion segmentation and measurement. It<br>is intended for use by clinicians to process, review, archive, print and distribute<br>liver CT studies. | | |
| | This software will assist the user by providing initial 3D segmentation, vessel<br>analysis, visualization, and quantitative analysis of liver anatomy. The user has<br>the ability to adjust the contour and confirm the final segmentation. | | |
| Technology: | The modified Hepatic VCAR employs two deep learning convolutional neural<br>networks to segment the liver contour and the hepatic artery on CT liver exams<br>while the predicate device uses a traditional deterministic method to segment the<br>liver and manual tools to segment the vascular structure including the hepatic<br>artery. These changes do not change the Indications for Use from the predicate,<br>and represent equivalent technological characteristics, with no impact on control<br>mechanism, and operating principle.<br>The table below summarizes the feature/technological comparison between the<br>predicate device and the proposed device: | | |
| | Specification | Predicate Device:<br>Hepatic VCAR (K133649) | Proposed Device:<br>Hepatic VCAR |
| | Liver<br>segmentation | Atlas algorithm based<br>segmentation | Deep Learning algorithm<br>based segmentation |
| | Hepatic artery<br>segmentation | Manual segmentation tools<br>("autoselect" and scalpel) | Semi-automatic segmentation<br>workflow based on deep<br>learning segmentation of the<br>hepatic artery and edition |
| | | | tools to correct/refine the<br>result. |
| Determination of<br>Substantial<br>Equivalence: | Verification and validation including risk mitigations have been executed with<br>results demonstrating Hepatic VCAR met the design inputs and user needs with<br>no unexpected results or risks. | | |
| | Hepatic VCAR was designed and will be manufactured under the Quality System<br>Regulations of 21CFR 820 and ISO 13485. The following quality assurance<br>measures have been applied to the development of the device: | | |
| | Risk Analysis Requirements Reviews Design Reviews Performance testing (Verification, Validation) Safety testing (Verification) | | |
| | Bench tests that compare the output of the two new algorithms with ground truth<br>annotated by qualified experts show that the algorithms performed as expected. | | |
| | A representative set of clinical sample images was assessed by 3 board certified<br>radiologists using 5-point Likert scale. The assessment demonstrated that<br>capability of liver segmentation and hepatic artery segmentation utilizing the deep<br>learning algorithm by Hepatic VCAR. | | |
| | The substantial equivalence was also based on software documentation for a<br>"Moderate" level of concern device. | | |
| Conclusion: | GE Healthcare considers proposed device Hepatic VCAR to be as safe, as<br>effective, and performance is substantially equivalent to the predicate device. | | |

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Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are three white, teardrop-shaped elements surrounding the circle, positioned at the top, left, and right sides. The logo is simple and recognizable, representing the company's brand identity.