(146 days)
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.
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.
Here's an analysis of the provided text regarding the Hepatic VCAR device, focusing on its acceptance criteria and the study proving its performance.
Note: The provided document is a 510(k) summary and FDA letter, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific performance metrics and acceptance criteria as might be found in a full scientific publication or clinical trial report. As such, some information (especially quantitative acceptance criteria and detailed study results) is not explicitly present.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the device's acceptance criteria are framed in terms of substantial equivalence to its predicate device, Volume Viewer Plus (K041521). The summary asserts that Hepatic VCAR is "as safe, as effective, and performance is substantially equivalent to the predicate device."
Specific, quantitative acceptance criteria for performance metrics (such as accuracy, sensitivity, or specificity for lesion detection or segmentation) are not explicitly stated in this document. The "reported device performance" is primarily qualitative, asserting equivalence to the predicate and highlighting optimized algorithms.
| Acceptance Criteria (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Safety and Effectiveness: "as safe, as effective" as predicate. | Hepatic VCAR is considered "as safe, as effective, and performance is substantially equivalent to the predicate device." |
| Functional Equivalence: Same fundamental scientific technology. | Employs the "same fundamental scientific technology" as the predicate device (Volume Viewer Plus). Utilizes "equivalent CT DICOM image data input requirements." Has "equivalent display, formatting, archiving and visualization technologies." |
| Algorithm Optimization & Functionality: Improved segmentation. | Optimizes the segmentation algorithms for lesion segmentation, liver segmentation, vessel (Portal Vein) segmentation, and liver lobe segmentation. Incorporates a "Virtual Scalpel feature" that takes advantage of existing visualization capabilities for virtual liver partition separation. "Thorough testing of these capabilities has not raised any safety or effectiveness issues." |
| Compliance: Adherence to relevant standards. | Complies with NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard. |
| Risk Mitigation: Development process quality assurance. | Quality assurance measures applied: Risk Analysis, Requirements Reviews, Design Reviews, Integration testing (System verification), Performance testing (Bench testing, verification), Safety testing (Verification). Substantial equivalence based on software documentation for a MODERATE level of concern device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set in terms of number of cases or patients examined for clinical performance. The focus is on technical equivalence and functionality rather than a specific clinical validation study with a defined cohort.
The data provenance (e.g., country of origin, retrospective/prospective) for any internal testing is also not specified in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given 510(k) summary. Since detailed clinical performance metrics for a test set are not discussed, the establishment of ground truth by experts is not described.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for a test set, as a specific clinical performance test set with expert ground truth validation is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described or presented in this 510(k) summary. The document does not discuss human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is described as "assisting the user by providing initial 3D segmentation" and explicitly states "The user has the ability to adjust the contour and confirm the final segmentation." This indicates that the device is intended for human-in-the-loop use.
While "Performance testing (Bench testing, verification)" is mentioned, the summary does not detail a standalone algorithm-only performance study where the algorithm's output is evaluated without human interaction or adjustment in a clinical context. The claim of "optimized segmentation algorithms" implies some level of internal evaluation, but specifics are absent.
7. The Type of Ground Truth Used
Given the nature of the 510(k) summary and its focus on substantial equivalence based on technical aspects and functionality, a formal "ground truth" (such as pathology or long-term outcomes data) for clinical performance validation is not explicitly mentioned or described as being used in a reported study.
The closest to "ground truth" implied would be expert assessment of the "thorough testing of these capabilities" which "has not raised any safety or effectiveness issues," but the details of this assessment are not provided.
8. The Sample Size for the Training Set
The 510(k) summary does not disclose any information regarding the sample size used for training the algorithms within Hepatic VCAR.
9. How the Ground Truth for the Training Set Was Established
Similarly, the document does not provide details on how ground truth was established for any training data used in the development of Hepatic VCAR's algorithms.
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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.
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 allowsthe analysis and visualization of Liver CT data derived from DICOM3.0 compliant CT scans. Hepatic VCAR is designed for the purposeof assessing liver morphology, including liver lesion, provided thelesion has different CT appearance from surrounding liver tissue;and its change over time through automated tools for liver, liverlobe, liver segments and liver lesion segmentation andmeasurement. |
| This software will assist the user by providing initial 3Dsegmentation, vessel analysis, visualization, and quantitativeanalysis of liver anatomy. The user has the ability to adjust thecontour and confirm the final segmentation.Key functionalities of the Hepatic VCAR include:a. Lesion segmentation | |
| b. Liver segmentationc. Portal vein segmentationd. Segment Separation by Portal Vein Branchese. Virtual Scalpel feature | |
| Hepatic VCAR is also made available as a standalone postprocessing application on the AW VolumeShare 5 workstation andthe AW Server image processing platforms that host advancedimage 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 /Intended Use: | Hepatic VCAR is a CT image analysis software package thatallows the analysis and visualization of Liver CT data derivedfrom DICOM 3.0 compliant CT scans. Hepatic VCAR is designedfor the purpose of assessing liver morphology, including liverlesion, provided the lesion has different CT appearance fromsurrounding liver tissue; and its change over time throughautomated tools for liver, liver lobe, liver segments and liverlesion segmentation and measurement. It is intended for use byclinicians to process, review, archive, print and distribute liver CTstudies.This software will assist the user by providing initial 3Dsegmentation, vessel analysis, visualization, and quantitativeanalysis of liver anatomy. The user has the ability to adjust thecontour and confirm the final segmentation. |
|---|---|
| Technology: | The Hepatic VCAR software employs the same fundamentalscientific technology as its predicate device. |
| Determination ofSubstantial 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 fundamentalscientific technology as its predicate device (Volume Viewer).Hepatic VCAR SW uses the equivalent CT DICOM image datainput requirements. It has equivalent display, formatting,archiving and visualization technologies compared to thepredicate device. Hepatic VCAR utilizes the enhancedsegmentation tools (threshold, auto-select) already found inVolume Viewer and optimizes the segmentation algorithms forlesion segmentation, liver segmentation, vessel (Portal Vein)segmentation and liver lobe segmentation. The Virtual Scalpelfeature takes advantage of the existing enhanced visualizationcapabilities and provides for an alternative way to virtuallyseparate liver partitions, independently of portal veinsegmentation. Thorough testing of these capabilities has notraised 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 thedevelopment 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 thesoftware documentation for a MODERATE level of concerndevice. | |
| Conclusion: | GE Healthcare considers the Hepatic VCAR software applicationto be as safe, as effective, and performance is substantiallyequivalent 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 (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
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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)
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)
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§ 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.