Thoracic VCAR with GSI Pulmonary Perfusion

K183210 · GE Medical Systems SCS · LLZ · Mar 29, 2019 · Radiology

Device Facts

• Record ID: K183210
• Device Name: Thoracic VCAR with GSI Pulmonary Perfusion
• Applicant: GE Medical Systems SCS
• Product Code: LLZ · Radiology
• Decision Date: Mar 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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. 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.

Device Story

Software analysis package for CT chest data; operates on Advantage Workstation (AW), CT scanner, cloud, or PACS. Inputs: CT chest images, including Gemstone Spectral Imaging (GSI) datasets. Processing: automatic segmentation of lungs, lobes, and airway tree; quantification of Hounsfield units; mapping of iodine attenuation differences in GSI datasets to visualize relative pulmonary perfusion. Outputs: color-coded perfusion maps and quantitative lung volume measurements. Used by radiologists to identify perfusion deficits; aids in assessment of thoracic diseases like pulmonary embolism and COPD. Benefits: improved diagnostic value, reader confidence, and efficiency in evaluating lung perfusion.

Clinical Evidence

Clinical assessment of 15 representative CT cases by three board-certified radiologists using a 5-point Likert scale. Results demonstrated improved diagnostic value, reader confidence, and efficiency in evaluating relative iodine distribution in the lungs, particularly for pulmonary emboli.

Technological Characteristics

Software-based image analysis package. Complies with NEMA PS 3.1-3.20 (2016) DICOM standards. Operates on CT datasets, including GSI material density images. Features include automatic segmentation (lungs, lobes, airway tree), threshold-based volume measurement, and color-coded perfusion mapping. Developed under 21 CFR 820 and ISO 13485 quality systems.

Indications for Use

Indicated for patients undergoing CT lung imaging to aid in the assessment of thoracic disease, including pulmonary embolism and COPD. Used for automatic segmentation of lungs and airway tree, quantification of Hounsfield units, and evaluation of pulmonary perfusion via GSI acquisitions.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Thoracic VCAR (K103480)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: [phone] |
| | Email: [e-mail] |
| Secondary Contact Person: | Helen Peng |
| | Director, Regulatory Affairs Leader, MICT & AW |
| | Tel: [phone] |
| | Email: [e-mail] |
| 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<br>Workstation (AW) platform, CT Scanner, Cloud or PACS stations<br>which can be used in the analysis of CT images. It is designed for<br>the analysis and processing of volumetric CT chest data. It<br>provides quantitative information to aid in the assessment of<br>thoracic diseases.<br><br>The primary features of the software are: lung and lobe<br>segmentation to obtain threshold-based volume measurements;<br>bronchial tree segmentation and tracking to determine wall<br>thickness measurements; lung maps based on HU values to help<br>the physician in determining the location and extent of disease<br>across both lungs a well as each lobe. Additionally, GSI datasets<br>can be used for the evaluation of relative perfusion within the<br>lungs. |
| Intended Use: | Thoracic VCAR is a CT, non-invasive image analysis software<br>package, which may be used in conjunction with CT lung images<br>to aid in the assessment of thoracic disease diagnosis and<br>management. |
| Indications for Use: | Thoracic VCAR is a CT, non-invasive image analysis software<br>package, which may be used in conjunction with CT lung images<br>to aid in the assessment of thoracic disease. The software will<br>provide automatic segmentation of the lungs and automatic<br>segmentation and tracking of the airway tree. The software will<br>provide quantification of Hounsfield units and display by color<br>the thresholds within a segmented region.<br><br>Thoracic VCAR also supports Gemstone Spectral Imaging (GSI)<br>acquisitions for the evaluation of pulmonary perfusion. It<br>provides additional information to aid in visualization of<br>variations of perfusion within the lungs and to quantitatively<br>assess lung volumes. It is intended to be used as an adjunct to<br>current standard methods utilizing color coded displays of<br>iodine attenuation differences in the lungs to aid in identifying<br>segments of relative perfusion differences which may be<br>useful in assessing thoracic disease. Thoracic diseases that<br>may be associated with changes in perfusion include<br>pulmonary embolism and COPD. |
| Technology: | The Thoracic VCAR with GSI Pulmonary Perfusion software<br>employs the same fundamental scientific technology as its<br>predicate device.<br><br>The GSI Pulmonary Perfusion protocol relies on the predicate<br>device's capability to provide tools to review thoracic datasets. It<br>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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| Thoracic VCAR, applied to GSI datasets and combines the<br>segmentation to GSI material density (MD) images. | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------|
| Comparison: The most notable change in Thoracic VCAR with GSI Pulmonary<br>Perfusion as compared to Thoracic VCAR is that it allows to use<br>GSI datasets for the evaluation of relative perfusion within the<br>lungs.<br>The table below summarizes the feature/technological<br>comparison between the predicate device and the proposed<br>device: | | |
| Specification | Predicate Device<br>Thoracic VCAR<br>(K103480) | Proposed<br>Thoracic VCAR<br>with GSI<br>Pulmonary<br>Perfusion |
| Modality images<br>supported | CT chest dataset | Same +<br>GSI CT chest<br>dataset |
| Automatic lungs,<br>Lobe, Airway tree<br>segmentation | Yes | Yes |
| Manual editing of<br>segmentation<br>results | Yes | Yes |
| Relative perfusion<br>deficit map in the<br>lung parenchyma<br>regions with GSI<br>Pulmonary<br>Perfusion protocol | No | Yes |
| Summary Table<br>automatically<br>displays total<br>volume of<br>segmented lungs<br>as well as relative<br>hypo-perfusion<br>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<br>Equivalence: | Summary of Non-Clinical Tests: |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Engineering has validated the algorithm for Thoracic VCAR with<br>GSI Pulmonary Perfusion in order to prove the capabilities of the<br>algorithm for the evaluation of relative perfusion within the<br>lungs. |
| | In order to demonstrate the effectiveness of the algorithm in<br>identifying and separating the iodine(water) distributions within<br>the lungs we designed a phantom test with a test setup that<br>simulates regions of relative perfused and non-perfused volumes<br>inside of a commercially available anthropomorphic lung<br>phantom. This simulated bench testing demonstrates that the<br>algorithm correctly segmented/thresholded the modeled lung<br>regions that had relative perfusion differences (lodine<br>concentrations). |
| | The Thoracic VCAR with GSI Pulmonary Perfusion software<br>complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and<br>Communications in Medicine (DICOM) Set (Radiology) standard. |
| | Thoracic VCAR with GSI Pulmonary Perfusion has successfully<br>completed the required design control testing per GE's quality<br>system. Thoracic VCAR with GSI Pulmonary Perfusion was<br>designed and will be manufactured under the Quality System<br>Regulations of 21CFR 820 and ISO 13485. |
| | The following quality assurance measures were applied to the<br>development of the system:<br>■ Risk Analysis<br>■ Requirements Reviews<br>■ Design Reviews<br>■ Performance testing (Verification, validation)<br>■ Safety testing (Verification) |
| | The substantial equivalence determination is also based on the<br>software documentation for a MODERATE level of concern<br>device. |
| | Summary of Clinical tests: |
| | A representative clinical sample image set of 15 CT cases were<br>assessed by three board certified radiologists using 5 point Likert<br>scale. This data is representative of routine clinical imaging from<br>thoracic acquisition perspective, in which such a tool is most<br>likely to be utilized. The assessment demonstrated the proposed<br>device improves diagnostic value, reader confidence and<br>efficiency in evaluating relative distribution of iodine within the<br>lungs such as in the presence of pulmonary emboli. |
| Conclusion: | GE Healthcare considers the Thoracic VCAR with GSI Pulmonary<br>Perfusion software application to be as safe, as effective, and<br>performance is substantially equivalent to the predicate device. |