(146 days)
Not Found
No
The summary describes automated segmentation and measurement tools, but does not explicitly mention AI or ML, nor does it provide details about training or test sets typically associated with such technologies. The description focuses on optimizing existing algorithms from the predicate device.
No
The device is described as image analysis software for assessing liver morphology and its changes over time, intended to process, review, archive, print, and distribute liver CT studies. It does not provide any form of treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the software is for "assessing liver morphology, including liver lesion" and its "change over time." This involves analyzing medical images to identify and characterize medical conditions, which falls under the definition of a diagnostic device. While it states it "will assist the user," the primary purpose is obtaining information for diagnosis.
Yes
The device is described as a "CT image analysis software package" and its functionalities are purely software-based (segmentation, visualization, measurement). While it processes data from CT scans and is available on specific workstations/servers, the device itself is the software, not the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: Hepatic VCAR is a software package that analyzes and visualizes CT images of the liver. It processes existing medical images, not biological samples.
- Intended Use: The intended use describes the analysis and visualization of liver morphology and lesions based on CT data. This is image analysis, not laboratory testing of biological specimens.
The device is clearly described as a CT image analysis software package used by clinicians to process and review medical images. This falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
JAK
Device Description
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.
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.
Key functionalities of the Hepatic VCAR include:
a. Lesion segmentation
b. Liver segmentation
c. Portal vein segmentation
d. Segment Separation by Portal Vein Branches
e. Virtual Scalpel feature
Hepatic VCAR is also made available as a standalone post processing application on the AW VolumeShare 5 workstation and the AW Server image processing platforms that host advanced image processing applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Hepatic VCAR software complies with NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
Thorough testing of these capabilities has not raised any safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041521 - Volume Viewer Plus
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
ﺮ ﻣ
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.
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: 00 36 23 410121 | |
| Fax: (262) 364 2506 | |
| Secondary Contact Person: | Huy Doan |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Tel: (414) 581-8553 | |
| Fax: (262) 364 2506 | |
| 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 |
| 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. | |
| 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. | |
| Key functionalities of the Hepatic VCAR include: | |
| a. Lesion segmentation | |
| b. Liver segmentation | |
| c. Portal vein segmentation | |
| d. Segment Separation by Portal Vein Branches | |
| e. Virtual Scalpel feature | |
| Hepatic VCAR is also made available as a standalone post | |
| processing application on the AW VolumeShare 5 workstation and | |
| the AW Server image processing platforms that host advanced | |
| image processing applications. |
1
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 /
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. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology: | The Hepatic VCAR software employs the same fundamental
scientific technology as its predicate device. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The Hepatic VCAR software complies with NEMA PS 3.1 - 3.20
(2011) Digital Imaging and Communications in Medicine (DICOM)
Set (Radiology) standard.
The Hepatic VCAR software employs the same fundamental
scientific technology as its predicate device (Volume Viewer).
Hepatic VCAR SW uses the equivalent CT DICOM image data
input requirements. It has equivalent display, formatting,
archiving and visualization technologies compared to the
predicate device. Hepatic VCAR utilizes the enhanced
segmentation tools (threshold, auto-select) already found in
Volume Viewer and optimizes the segmentation algorithms for
lesion segmentation, liver segmentation, vessel (Portal Vein)
segmentation and liver lobe segmentation. The Virtual Scalpel
feature takes advantage of the existing enhanced visualization
capabilities and provides for an alternative way to virtually
separate liver partitions, independently of portal vein
segmentation. Thorough testing of these capabilities has not
raised any safety or effectiveness issues. |
2
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
development of the system:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Integration testing (System verification)
• Performance testing (Bench testing, verification)
• Safety testing (Verification) |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The substantial equivalence determination is based on the
software documentation for a MODERATE level of concern
device. |
| Conclusion: | GE Healthcare considers the Hepatic VCAR software application
to be as safe, as effective, and performance is substantially
equivalent to the predicate device. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars extending from the top of the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
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.
4
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
5
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)
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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