HEPATIC VCAR

K133649 · GE Medical Systems SCS · JAK · Apr 22, 2014 · Radiology

Device Facts

• Record ID: K133649
• Device Name: HEPATIC VCAR
• Applicant: GE Medical Systems SCS
• Product Code: JAK · Radiology
• Decision Date: Apr 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 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, 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, vessel analysis, visualization, and quantitative analysis of liver anatomy. The user has the ability to adjust the contour and confirm the final segmentation.

Device Story

Hepatic VCAR is a CT image analysis software package used by clinicians to process, review, and quantify liver anatomy from DICOM 3.0 compliant CT scans. The device provides automated tools for 3D segmentation of the liver, liver lobes, liver segments, portal veins, and lesions. It features a 'Virtual Scalpel' for manual or semi-automated separation of liver partitions. The software operates on AW VolumeShare 5 workstations or AW Server platforms. Clinicians use the output—visualizations and quantitative measurements—to assess liver morphology and lesion progression. The user retains control by adjusting contours and confirming final segmentations. By automating initial segmentation and measurement, the device assists in clinical decision-making regarding liver anatomy and lesion management.

Clinical Evidence

Bench testing only. The device underwent rigorous verification and validation, including risk analysis, requirements reviews, design reviews, integration testing, and performance testing. Compliance with NEMA PS 3.1-3.20 (2011) DICOM standards was verified. No clinical data was required for this determination.

Technological Characteristics

Software-based CT image analysis tool. Operates on AW VolumeShare 5 and AW Server platforms. Utilizes DICOM 3.0 connectivity. Employs threshold and auto-select segmentation algorithms for liver, lobe, vessel, and lesion analysis. Includes Virtual Scalpel for manual/semi-automated partition separation. Software level of concern: Moderate.

Indications for Use

Indicated for clinicians to process, review, archive, print, and distribute liver CT studies for the assessment of liver morphology, including liver lesions (if distinct from surrounding tissue) and changes over time, in patients undergoing liver CT imaging.

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

• Volume Viewer Plus (K041521)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.

K133649

AFR 2 2 2014

# 510(k) Summary

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

| Date: | November 25, 2013 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems SCS |
| | 283, rue de la Minière |
| | 78530 Buc, France |
| Primary Contact Person: | Peter Uhlir |
| | Regulatory Affairs Leader |
| | Tel: [phone] |
| | Fax: [phone] |
| Secondary Contact Person: | Huy Doan |
| | Regulatory Affairs Director |
| | GE Healthcare |
| | Tel: [phone] |
| | Fax: [phone] |
| Device Trade Name: | Hepatic VCAR |
| Common/Usual Name: | Hepatic VCAR |
| Classification Names: | 21CFR 892.1750, Radiology |
| Product Code: | JAK |
| Predicate Device(s): | K041521 - Volume Viewer Plus |
| Device Description: | Hepatic VCAR is a CT image analysis software package that allows<br>the analysis and visualization of Liver CT data derived from DICOM<br>3.0 compliant CT scans. Hepatic VCAR is designed for the purpose<br>of assessing liver morphology, including liver lesion, provided the<br>lesion has different CT appearance from surrounding liver tissue;<br>and its change over time through automated tools for liver, liver<br>lobe, liver segments and liver lesion segmentation and<br>measurement. |
| | This software will assist the user by providing initial 3D<br>segmentation, vessel analysis, visualization, and quantitative<br>analysis of liver anatomy. The user has the ability to adjust the<br>contour and confirm the final segmentation.<br>Key functionalities of the Hepatic VCAR include:<br>a. Lesion segmentation |
| b. Liver segmentation<br>c. Portal vein segmentation<br>d. Segment Separation by Portal Vein Branches<br>e. Virtual Scalpel feature | |
| Hepatic VCAR is also made available as a standalone post<br>processing application on the AW VolumeShare 5 workstation and<br>the AW Server image processing platforms that host advanced<br>image processing applications. | |

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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. There are decorative swirls or flourishes around the outside of the circle, giving it a classic and recognizable appearance. The logo is in black and white.

| Indications for Use /<br>Intended Use: | Hepatic VCAR is a CT image analysis software package that<br>allows the analysis and visualization of Liver CT data derived<br>from DICOM 3.0 compliant CT scans. Hepatic VCAR is designed<br>for the purpose of assessing liver morphology, including liver<br>lesion, provided the lesion has different CT appearance from<br>surrounding liver tissue; and its change over time through<br>automated tools for liver, liver lobe, liver segments and liver<br>lesion segmentation and measurement. It is intended for use by<br>clinicians to process, review, archive, print and distribute liver CT<br>studies.<br><br>This software will assist the user by providing initial 3D<br>segmentation, vessel analysis, visualization, and quantitative<br>analysis of liver anatomy. The user has the ability to adjust the<br>contour and confirm the final segmentation. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology: | The Hepatic VCAR software employs the same fundamental<br>scientific technology as its predicate device. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The Hepatic VCAR software complies with NEMA PS 3.1 - 3.20<br>(2011) Digital Imaging and Communications in Medicine (DICOM)<br>Set (Radiology) standard.<br><br>The Hepatic VCAR software employs the same fundamental<br>scientific technology as its predicate device (Volume Viewer).<br>Hepatic VCAR SW uses the equivalent CT DICOM image data<br>input requirements. It has equivalent display, formatting,<br>archiving and visualization technologies compared to the<br>predicate device. Hepatic VCAR utilizes the enhanced<br>segmentation tools (threshold, auto-select) already found in<br>Volume Viewer and optimizes the segmentation algorithms for<br>lesion segmentation, liver segmentation, vessel (Portal Vein)<br>segmentation and liver lobe segmentation. The Virtual Scalpel<br>feature takes advantage of the existing enhanced visualization<br>capabilities and provides for an alternative way to virtually<br>separate liver partitions, independently of portal vein<br>segmentation. Thorough testing of these capabilities has not<br>raised any safety or effectiveness issues. |

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a stylized circle. The circle has small, rounded protrusions around its perimeter, giving it a textured appearance. The logo is presented in black against a white background.

| | The following quality assurance measures were applied to the<br>development of the system:<br>• Risk Analysis<br>• Requirements Reviews<br>• Design Reviews<br>• Integration testing (System verification)<br>• Performance testing (Bench testing, verification)<br>• Safety testing (Verification) |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The substantial equivalence determination is based on the<br>software documentation for a MODERATE level of concern<br>device. |
| Conclusion: | GE Healthcare considers the Hepatic VCAR software application<br>to be as safe, as effective, and performance is substantially<br>equivalent to the predicate device. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 22, 2014

GE Medical Systems SCS Huy Doan Director, Global Regulatory Affairs 3000 N. Grandview WAUKESHA WI 53188

Re: K133649

Trade/Device Name: Hepatic VCAR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 21, 2014 Received: March 24, 2014

Dear Mr. Doan:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adviseration. 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 your device 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 that I DA has made a sond regulations administered by other Federal agencies. You must of any I cach statutes and regarants, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK i at 607), laboring (21 CFR 803); good manufacturing practice requirements as set device-related adverse ovents) (2) CFR Part 820); and if applicable, the electronic forth in the quiant) 37001no (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Doan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smith 77)

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

# 510(k) Number (if known)

K133649

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)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Please do not write below this line – continue on a separate page if needed.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.p)

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