(101 days)
Thoracic VCAR is a CT, non-invasive image analysis software package, which may be used in conjunction with CT lung images to aid in the assessment of thoracic disease diagnosis and management. The software will provide automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree. The software will provide quantification of Hounsfield units and display by color the thresholds within a segmented region.
Thoracic VCAR is a CT post-processing software for the GE Advantage Workstation (AW) platform. It is designed for the analysis and processing of volumetric CT chest data. It provides quantitative information to aid in the assessment of respiratory diseases. The primary features of the software are: lung and lobe segmentation to obtain threshold based volume measurements; bronchial tree segmentation and tracking to determine wall thickness measurements; lung maps based on HU values to help the physician in determining the location and extent of disease across both lungs as well as each lobe.
The provided document is a 510(k) Premarket Notification Summary for GE Healthcare's THORACIC VCAR, a CT post-processing software. The document explicitly states:
"Summary of Clinical Tests: The subject of this premarket submission, THORACIC VCAR, did not require clinical studies to support substantial equivalence."
Therefore, the document does not contain information regarding
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on non-clinical tests to establish substantial equivalence to predicate devices, including compliance with DICOM Standard NEMA PS 3.1 - 3.18(2008) and the application of quality assurance measures during development (Risk Analysis, Requirements Reviews, Design Reviews, Performance testing, Safety testing, Final acceptance testing).
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circle, and there are decorative swirls or flourishes around the outer edge of the circle.
な
: : GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 24, 2010 |
|---|---|
| Submitter: | GE Healthcare, (GE Medical Systems LLC)3000 Grandview BlvdWaukesha Wisconsin 53188 |
| Primary Contact Person: | Stephen G. Slavens, RACGlobal Regulatory Affairs DirectorGE Healthcare, (GE Medical Systems LLC)TEL: (262) 548-4992FAX: (262) 548-3884 |
| Secondary Contact Person: | Helen PengRegulatory Affairs LeaderGE Healthcare, (GE Medical Systems LLC)TEL: (262) 548-5091FAX: (262) 548-3884 |
| Device Trade Name: | THORACIC VCAR |
| Device Common Name: | THORACIC VCAR |
| Classification Names: | 21CFR 892.2050 Picture archiving and communications system |
| Product Code: | 90LLZ |
| Predicate Device(s): | K083227: Vida Pulmonary Workstation 2K071513: Syngo InSpace 4D |
| Device Description: | Thoracic VCAR is a CT post-processing software for the GEAdvantage Workstation (AW) platform. It is designed for theanalysis and processing of volumetric CT chest data.It provides quantitative information to aid in the assessment ofrespiratory diseases.The primary features of the software are: lung and lobesegmentation to obtain threshold based volume measurements;bronchial tree segmentation and tracking to determine wallthickness measurements; lung maps based on HU values to help thephysician in determining the location and extent of disease acrossboth lungs as well as each lobe. |
| Intended Use: | Thoracic VCAR is a CT, non-invasive image analysis softwarepackage, which may be used in conjunction with CT lung images toaid in the assessment of thoracic disease diagnosis and management.The software will provide automatic segmentation of the lungs andautomatic segmentation and tracking of the airway tree.The software will provide quantification of Hounsfield units anddisplay by color the thresholds within a segmented region. |
| Technology: | THORACIC VCAR provides same type of images and results as itspredicate devices. Main features include:lung and lobe segmentation lung and lobe volume measurements bronchial tree segmentation and tracking bronchial wall thickness measurements lung maps based on HU values The THORACIC VCAR employs the same fundamental scientifictechnology as its predicate devices. |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:THORACIC VCAR complies with DICOM Standard NEMA PS 3.1- 3.18(2008). The following quality assurance measures wereapplied to the development of the system:Risk Analysis Requirements Reviews Design Reviews Performance testing (Verification) Safety testing (Verification) Final acceptance testing (Validation) Summary of Clinical Tests:The subject of this premarket submission, THORACIC VCAR, didnot require clinical studies to support substantial equivalence. |
| Conclusion: | GE Healthcare considers THORACIC VCAR to be as safe, aseffective, and performance is substantially equivalent to thepredicate devices. |
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The letters are enclosed within a circle, and there are small, teardrop-shaped elements around the perimeter of the circle, adding a decorative touch to the design.
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510(k) Premarket Notification Submission
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Stephen Slavens Regulatory Affairs Director, MI & CT GE Medical Systems, LLC 3000 N. Grandview Blvd. WAUKESHA WI 53188
MAR - 7 2011
Re: K103480
Trade/Device Name: THORACIC VCAR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 21, 2011 Received: February 24, 2011
Dear Mr. Slavens:
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 adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mairy S Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K103480
Device Name: THORACIC VCAR
Indications for Use:
Thoracic VCAR is a CT, non-invasive image analysis software package, which may be used in conjunction with CT lung images to aid in the assessment of thoracic disease diagnosis and management. The software will provide automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree.
The software will provide quantification of Hounsfield units and display by color the thresholds within a segmented region.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Pastel
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
103480 510(k) Number
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).