(130 days)
Not Found
No
The summary describes image analysis software with features like segmentation, tracking, and quantification based on Hounsfield units and iodine attenuation. While these are advanced image processing techniques, the summary does not mention or imply the use of AI, ML, deep learning, or any related terms. The performance studies described are based on phantom testing and clinical assessment by radiologists, not on training or testing of an AI/ML model.
No
The device is a software package for image analysis and processing that aids in diagnosis and assessment of thoracic diseases, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "may be used in conjunction with CT lung images to aid in the assessment of thoracic disease" and "It is intended to be used as an adjunct to current standard methods... to aid in identifying segments of relative perfusion differences which may be useful in assessing thoracic disease." These statements indicate the device provides information to assist in the identification and assessment of medical conditions.
Yes
The device is described as a "software analysis package" and its function is image analysis and processing of CT data. It does not mention any accompanying hardware components that are part of the device itself, only the platforms it runs on (AW platform, CT Scanner, Cloud, PACS stations).
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: Thoracic VCAR is a software package that analyzes medical images (CT scans). It processes existing images to provide quantitative and visual information to aid in the assessment of thoracic disease. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's an "image analysis software package" used "in conjunction with CT lung images."
- Device Description: The description reinforces that it's a "software analysis package" for analyzing and processing "volumetric CT chest data."
Therefore, Thoracic VCAR falls under the category of medical image analysis software, not in vitro diagnostics.
N/A
Intended Use / 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. The software provides automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree. Thoracic VCAR also provides quantification of Hounsfield units and display by color of thresholds within a segmented region.
Thoracic VCAR also supports Gemstone Spectral Imaging (GSI) acquisitions for the evaluation of pulmonary perfusion. It provides additional information to aid in visualization of variations of perfusion within the lungs and to quantitatively assess lung volumes. It is intended to be used as an adjunct to current standard methods utilizing color coded displays of iodine attenuation differences in the lungs to aid in identifying segments of relative perfusion differences which may be useful in assessing thoracic disease. Thoracic diseases that may be associated with changes in perfusion include pulmonary embolism and COPD.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, JAK
Device Description
Thoracic VCAR is a software analysis package for the Advantage Workstation (AW) platform, CT Scanner, Cloud or PACS stations which can be used in the analysis of CT images. It is designed for the analysis and processing of volumetric CT chest data. It provides quantitative information to aid in the assessment of thoracic 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 a well as each lobe. Additionally, GSI datasets can be used for the evaluation of relative perfusion within the lungs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Thoracic, lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
A representative clinical sample image set of 15 CT cases were assessed by three board certified radiologists using 5 point Likert scale. This data is representative of routine clinical imaging from thoracic acquisition perspective, in which such a tool is most likely to be utilized.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
Engineering has validated the algorithm for Thoracic VCAR with GSI Pulmonary Perfusion in order to prove the capabilities of the algorithm for the evaluation of relative perfusion within the lungs.
In order to demonstrate the effectiveness of the algorithm in identifying and separating the iodine(water) distributions within the lungs we designed a phantom test with a test setup that simulates regions of relative perfused and non-perfused volumes inside of a commercially available anthropomorphic lung phantom. This simulated bench testing demonstrates that the algorithm correctly segmented/thresholded the modeled lung regions that had relative perfusion differences (Iodine concentrations).
The Thoracic VCAR with GSI Pulmonary Perfusion software complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
Thoracic VCAR with GSI Pulmonary Perfusion has successfully completed the required design control testing per GE's quality system. Thoracic VCAR with GSI Pulmonary Perfusion was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485.
The following quality assurance measures were applied to the development of the system:
■ Risk Analysis
■ Requirements Reviews
■ Design Reviews
■ Performance testing (Verification, validation)
■ Safety testing (Verification)
The substantial equivalence determination is also based on the software documentation for a MODERATE level of concern device.
Summary of Clinical tests:
A representative clinical sample image set of 15 CT cases were assessed by three board certified radiologists using 5 point Likert scale. This data is representative of routine clinical imaging from thoracic acquisition perspective, in which such a tool is most likely to be utilized. The assessment demonstrated the proposed device improves diagnostic value, reader confidence and efficiency in evaluating relative distribution of iodine within the lungs such as in the presence of pulmonary emboli.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym followed by the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue.
GE Medical Systems SCS % Ms. Helen Peng Director, Regulatory Affairs Leader, MICT & AW GE Medical Systems, LLC 3000 North Grandview Blvd. WAUKESHA WI 53188
March 29, 2019
Re: K183210
Trade/Device Name: Thoracic VCAR with GSI Pulmonary Perfusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK Dated: March 19, 2019 Received: March 20, 2019
Dear Ms. Peng:
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183210
Device Name
Thoracic VCAR with GSI Pulmonary Perfusion
Indications for Use (Describe)
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. The software provides automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree. Thoracic VCAR also provides quantification of Hounsfield units and display by color of thresholds within a segmented region.
Thoracic VCAR also supports Gemstone Spectral Imaging (GSI) acquisitions for the evaluation of pulmonary perfusion. It provides additional information to aid in visualization of variations of perfusion within the lungs and to quantitatively assess lung volumes. It is intended to be used as an adjunct to current standard methods utilizing color coded displays of iodine attenuation differences in the lungs to aid in identifying segments of relative perfusion differences which may be useful in assessing thoracic disease. Thoracic diseases that may be associated with changes in perfusion include pulmonary embolism and COPD.
| 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) |
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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. There are also white swirls around the letters, adding a dynamic element to the design.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | November 16, 2018 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Establishment Registration Number - 9611343 | |
| 283, rue de la Minière | |
| 78530 Buc, France | |
| Primary Contact Person: | Peter Uhlir |
| Regulatory Affairs Leader | |
| Tel: 00 36 1 4793318 | |
| Email: Peter.Uhlir@ge.com | |
| Secondary Contact Person: | Helen Peng |
| Director, Regulatory Affairs Leader, MICT & AW | |
| Tel: (262) 424-8222 | |
| Email: Hong.Peng@ge.com | |
| Device Trade Name: | Thoracic VCAR with GSI Pulmonary Perfusion |
| Common/Usual Name: | Thoracic VCAR |
| Proposed Device: | |
| Primary Regulation Number/ | 21CFR 892.2050, Picture archiving and communications |
| Primary Product Code: | System/LLZ |
| Secondary Product Code: | JAK |
| Classification Panel: | Radiology |
| Regulatory Class: | Class II |
| Predicate Device: | Thoracic VCAR |
| 510(k) number | K103480, cleared on March 7, 2011 |
| Regulation Number/ | 21CFR 892.2050, Picture archiving and communications |
| Product Code: | system/LLZ |
| Classification Panel: | Radiology |
| Regulatory Class: | Class II |
| Manufacturer: | GE Healthcare (GE Medical Systems LLC) |
| Device Description: | Thoracic VCAR is a software analysis package for the Advantage |
| Workstation (AW) platform, CT Scanner, Cloud or PACS stations | |
| which can be used in the analysis of CT images. It is designed for | |
| the analysis and processing of volumetric CT chest data. It | |
| provides quantitative information to aid in the assessment of | |
| thoracic 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 a well as each lobe. Additionally, GSI datasets
can be used for the evaluation of relative perfusion within the
lungs. |
| Intended 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. |
| 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. 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 also supports Gemstone Spectral Imaging (GSI)
acquisitions for the evaluation of pulmonary perfusion. It
provides additional information to aid in visualization of
variations of perfusion within the lungs and to quantitatively
assess lung volumes. It is intended to be used as an adjunct to
current standard methods utilizing color coded displays of
iodine attenuation differences in the lungs to aid in identifying
segments of relative perfusion differences which may be
useful in assessing thoracic disease. Thoracic diseases that
may be associated with changes in perfusion include
pulmonary embolism and COPD. |
| Technology: | The Thoracic VCAR with GSI Pulmonary Perfusion software
employs the same fundamental scientific technology as its
predicate device.
The GSI Pulmonary Perfusion protocol relies on the predicate
device's capability to provide tools to review thoracic datasets. It
uses the lungs and lung vessels segmentation already present in |
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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 script, enclosed within a blue circle. There are several droplet-like shapes surrounding the circle, giving it a dynamic and fluid appearance. The logo is simple, recognizable, and represents the brand identity of General Electric.
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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" written in a stylized script, enclosed within a blue circle. The circle has a white outline and a few white curved lines emanating from the top and bottom, giving the impression of movement or energy.
| Thoracic VCAR, applied to GSI datasets and combines the
| segmentation to GSI material density (MD) images. | ||
|---|---|---|
| Comparison: The most notable change in Thoracic VCAR with GSI Pulmonary | ||
| Perfusion as compared to Thoracic VCAR is that it allows to use | ||
| GSI datasets for the evaluation of relative perfusion within the | ||
| lungs. | ||
| The table below summarizes the feature/technological | ||
| comparison between the predicate device and the proposed | ||
| device: | ||
| Specification | Predicate Device | |
| Thoracic VCAR | ||
| (K103480) | Proposed | |
| Thoracic VCAR | ||
| with GSI | ||
| Pulmonary | ||
| Perfusion | ||
| Modality images | ||
| supported | CT chest dataset | Same + |
| GSI CT chest | ||
| dataset | ||
| Automatic lungs, | ||
| Lobe, Airway tree | ||
| segmentation | Yes | Yes |
| Manual editing of | ||
| segmentation | ||
| results | Yes | Yes |
| Relative perfusion | ||
| deficit map in the | ||
| lung parenchyma | ||
| regions with GSI | ||
| Pulmonary | ||
| Perfusion protocol | No | Yes |
| Summary Table | ||
| automatically | ||
| displays total | ||
| volume of | ||
| segmented lungs | ||
| as well as relative | ||
| hypo-perfusion | ||
| volumes | No | Yes |
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Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a blue circle. The letters are stylized with curved lines, giving them a flowing appearance. The circle is also blue and has a white outline, creating a clean and recognizable design.
| Determination of Substantial
| Equivalence: | Summary of Non-Clinical Tests: |
|---|---|
| Engineering has validated the algorithm for Thoracic VCAR with | |
| GSI Pulmonary Perfusion in order to prove the capabilities of the | |
| algorithm for the evaluation of relative perfusion within the | |
| lungs. | |
| In order to demonstrate the effectiveness of the algorithm in | |
| identifying and separating the iodine(water) distributions within | |
| the lungs we designed a phantom test with a test setup that | |
| simulates regions of relative perfused and non-perfused volumes | |
| inside of a commercially available anthropomorphic lung | |
| phantom. This simulated bench testing demonstrates that the | |
| algorithm correctly segmented/thresholded the modeled lung | |
| regions that had relative perfusion differences (lodine | |
| concentrations). | |
| The Thoracic VCAR with GSI Pulmonary Perfusion software | |
| complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and | |
| Communications in Medicine (DICOM) Set (Radiology) standard. | |
| Thoracic VCAR with GSI Pulmonary Perfusion has successfully | |
| completed the required design control testing per GE's quality | |
| system. Thoracic VCAR with GSI Pulmonary Perfusion was | |
| designed and will be manufactured under the Quality System | |
| Regulations of 21CFR 820 and ISO 13485. | |
| The following quality assurance measures were applied to the | |
| development of the system: | |
| ■ Risk Analysis | |
| ■ Requirements Reviews | |
| ■ Design Reviews | |
| ■ Performance testing (Verification, validation) | |
| ■ Safety testing (Verification) | |
| The substantial equivalence determination is also based on the | |
| software documentation for a MODERATE level of concern | |
| device. | |
| Summary of Clinical tests: | |
| A representative clinical sample image set of 15 CT cases were | |
| assessed by three board certified radiologists using 5 point Likert | |
| scale. This data is representative of routine clinical imaging from | |
| thoracic acquisition perspective, in which such a tool is most | |
| likely to be utilized. The assessment demonstrated the proposed | |
| device improves diagnostic value, reader confidence and | |
| efficiency in evaluating relative distribution of iodine within the | |
| lungs such as in the presence of pulmonary emboli. | |
| Conclusion: | GE Healthcare considers the Thoracic VCAR with GSI Pulmonary |
| Perfusion software application to be as safe, as effective, and | |
| performance is substantially equivalent to the predicate device. |