XV Lung Ventilation Analysis Software

K193293 · 4Dx Limited · JAK · May 14, 2020 · Radiology

Device Facts

• Record ID: K193293
• Device Name: XV Lung Ventilation Analysis Software
• Applicant: 4Dx Limited
• Product Code: JAK · Radiology
• Decision Date: May 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The XV Ventilation Lung Analysis Software is software-based image processing technology that analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative of the patient's present lung envelope), to quantify ventilation of pulmonary tissue for use in adult patients. The XV Ventilation Lung Analysis Software provides reproducible quantification for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. For use by referral from a pulmonary specialist or equivalent, the Device can be used to provide the physician with additional clinical data in the diagnosis and documentation of inhomogeneties and defects in pulmonary ventilation. Quantification and statistics are provided in the form of a Report, including: - The tidal volume (i.e. total lung ventilation), presented as a single value; - Visualization of lung ventilation with color-defined specific ventilation ranges overlaid on the CT slices; - The heterogeneity of lung ventilation, presented as three values, which quantifies the regional variability of the ventilation: and - Ventilation graph/ histogram of the classified lung voxel's relative frequencies showing the frequency distribution of regional specific ventilation measured across the entire lung, including ventilation defect percentage which shows the volume of lung with low ventilation.

Device Story

Device processes cinefluorograph images and previously acquired CT scans to quantify 4D pulmonary tissue ventilation. Measures tissue motion at all lung locations and breath phases; calculates ventilation metrics; generates report with tidal volume, color-coded ventilation visualization, heterogeneity values, and ventilation histograms/defect percentages. Used by thoracic radiologists and pulmonologists in clinical settings to support diagnosis and follow-up. Provides quantitative data to assist clinical decision-making regarding lung function. Benefits patients by offering a lower-radiation alternative to repeated CT scans for longitudinal monitoring of lung health.

Clinical Evidence

Clinical study involved patients undergoing radiation therapy (breast or esophageal cancer) examined at four time-points over 13 months (twice pre- and twice post-radiation). Study validated consistency of device outputs against gold-standard measures (CT and PFT). Results demonstrated device sensitivity to changes in lung function over time.

Technological Characteristics

Software-based image processing technology. Inputs: cinefluorograph images and CT scans. Outputs: 4D ventilation quantification, tidal volume, heterogeneity metrics, and histograms. Connectivity: processes data from standard imaging modalities. Software lifecycle conforms to IEC 62304:2006. Risk management per ISO 14971:2007.

Indications for Use

Indicated for adult patients with pulmonary diseases and abnormalities to quantify pulmonary tissue ventilation. Used by referral from a pulmonary specialist or equivalent to provide clinical data for diagnosis and documentation of ventilation inhomogeneities and defects.

Regulatory Classification

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.

Predicate Devices

• Vitra CT Lung Density Analysis Software (K151919)
• Artis zee/zeego & Artis Q/Q.zen (K181407)

Submission Summary (Full Text)

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May 14, 2020

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4Dx Limited % Mr. Terrence Thiel Principal Consultant Level 5 Suite 3, 468 St Kilda Rd Melbourne, Victoria 3004 AUSTRALIA

Re: K193293

Trade/Device Name: XV Lung Ventilation Analysis Software System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: April 1, 2020 Received: April 17, 2020

Dear Mr. Thiel:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K193293

Device Name

XV Lung Ventilation Analysis Software System

### Indications for Use (Describe)

The XV Ventilation Lung Analysis Software is software-based image processing technology that analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative of the patient's present lung envelope), to quantify ventilation of pulmonary tissue for use in adult patients.

The XV Ventilation Lung Analysis Software provides reproducible quantification for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. For use by referral from a pulmonary specialist or equivalent, the Device can be used to provide the physician with additional clinical data in the diagnosis and documentation of inhomogeneties and defects in pulmonary ventilation. Quantification and statistics are provided in the form of a Report, including:

- · The tidal volume (i.e. total lung ventilation), presented as a single value;
- · Visualization of lung ventilation with color-defined specific ventilation ranges overlaid on the CT slices;
- · The heterogeneity of lung ventilation, presented as three values, which quantifies the regional variability of the ventilation: and

· Ventilation graph/ histogram of the classified lung voxel's relative frequencies showing the frequency distribution of regional specific ventilation measured across the entire lung, including ventilation defect percentage which shows the volume of lung with low ventilation.

The clinical study used to validate the Device was limited to patients selected to undergo Radiation Therapy (most commonly for breast cancer and esophageal cancer). In this study these patients were examined using the Device at four time-points over a 13-month period (twice prior and twice following radiation therapy).

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary: XV Lung Ventilation Analysis Software System

#### 1. Submitter Information

2.

| Submitter: | 4Dx Limited<br>Level 5 Suite 3<br>468 St Kilda Rd<br>Melbourne, VIC 3004 AUSTRALIA |
|---------------------------|------------------------------------------------------------------------------------|
| Primary contact person: | Andreas Fouras<br>e-mail: [e-mail] |
| Secondary contact person: | Rachael Tenkaten<br>e-mail: [e-mail] |
| Date prepared: | November 22, 2019 |
| Subject Device | |
| 510(k) number: | K193293 |
| Name of Device: | XV Lung Ventilation Analysis Software System |
| Manufacturer: | 4Dx Limited |
| Regulation Number: | 21 CFR 892.1750 |
| Classification Name: | Computed Tomography X-ray System Class II |
| Classification Class: | JAK |
| Product Code: | JAK |

#### Legally Marketed Primary Predicate Device 3.

| Predicate 510(k) number: | K151919 |
|--------------------------|-----------------------------------------|
| Name of Device: | Vitra CT Lung Density Analysis Software |
| Manufacturer: | Vital Images, Inc. |
| Regulatory Number: | 21 CFR 892.1750 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Class: | Class II |
| Product Code: | JAK |
| Decision Date: | 10/10/2015 |

#### Legally Marketed Secondary Predicate Device 4.

| Predicate 510(k) number: | K181407 |
|--------------------------|------------------------------------|
| Name of Device: | Artis zee/zeego & Artis Q/Q.zen |
| Manufacturer: | Siemens Medical Solution USA, Inc. |

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Regulatory Number: Classification Name: Classification Class: Product Code: Decision Date:

21 CFR 892.1650 Image-intensified fluoroscopic X-ray system Class II OWB, IZI, JAA, JAK 08/15/2018

#### Device Description 5.

The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images in combination with a CT image to quantify ventilation of pulmonary tissue, thereby providing support to physicians in their assessment of patients with lung diseases.

The XV Lung Ventilation Analysis Software measures the tissue motion of the lung, at all locations throughout the lung, and at all phases of the breath. It uses these motion measurements to calculate the 4-dimensional (4D) ventilation of lung tissues. Quantification and statistics are provided in the form of a Report.

## The key outputs are:

- The tidal volume (i.e. total lung ventilation), presented as a single value;
- Visualization of lung ventilation with color-defined specific ventilation ranges; .
- The heterogeneity of lung ventilation, presented as three values; and .
- . Ventilation graph/ histogram of the classified lung voxel's relative frequencies including ventilation defect percentage.

#### Indications for use 6.

The XV Ventilation Lung Analysis Software is software-based image processing technology that analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative of the patient's present lung envelope), to quantify ventilation of pulmonary tissue for use in adult patients.

The XV Ventilation Lung Analysis Software provides reproducible quantification of ventilation for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. For use by referral from a pulmonary specialist or equivalent, the Device can be used to provide the physician with additional clinical data in the diagnosis and documentation of inhomogeneities and defects in pulmonary ventilation. Quantification and statistics are provided in the form of a Report, including:

- The tidal volume (i.e. total lung ventilation), presented as a single value;
- . Visualization of lung ventilation with color-defined specific ventilation ranges overlaid on the CT slices;

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Image /page/5/Picture/0 description: The image shows the logo for 4Dx. The logo consists of a geometric shape on the left, resembling a stylized flower or star, with varying shades of blue and teal. To the right of the geometric shape, the text "4Dx" is displayed in a bold, sans-serif font, with the number "4" and the letters "Dx" in black.

- The heterogeneity of lung ventilation, presented as three values, which quantifies the regional . variability of the ventilation; and
- . Ventilation graph/ histogram of the classified lung voxel's relative frequencies showing the frequency distribution of regional specific ventilation measured across the entire lung, including ventilation defect percentage which shows the volume of lung with low ventilation.

The clinical study used to validate the Device was limited to patients selected to undergo Radiation Therapy (most commonly for breast cancer and esophageal cancer). In this study these patients were examined using the Device at four time-points over a 13-month period (twice prior and twice following radiation therapy).

| Characteristic | Subject Device | Predicate Device | Secondary<br>Predicate Device | Comparison and<br>Comments |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | XV Ventilation<br>Lung Analysis<br>Software | Vitrea CT Lung<br>Density Analysis<br>Software | Artis Q / Q.zen | |
| Regulatory Comparison | | | | |
| Classification<br>name | Computed<br>Tomography X-ray<br>System | Computed<br>Tomography X-ray<br>System | Image-intensified<br>fluoroscopic X-ray<br>system | Identical (Primary)/<br>Similar (Secondary)<br>All three devices are<br>radiology devices. |
| Regulatory<br>number | 892.1750 | 892.1750 | 892.1650 | |
| Product Code | JAK | JAK | OWB, IZI, JAA,<br>JAK | Identical (Primary)/<br>Similar (Secondary)<br>All three devices can be<br>used for CT (JAK), the<br>secondary predicate<br>device is primarily a<br>fluoroscope |
| Classification | Class II | Class II | Class II | Identical (Primary)/<br>Identical (Secondary) |
| Review Panel | Radiology | Radiology | Radiology | Identical (Primary)/<br>Identical (Secondary) |
| Indications for Use Comparison | | | | |
| XV<br>Ventilation<br>Lung<br>Analysis<br>Software | The XV Ventilation Lung Analysis Software is software-based image processing technology that<br>analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative<br>of the patient's present lung envelope), to quantify ventilation of pulmonary tissue for use in<br>adult patients.<br>The XV Ventilation Lung Analysis Software provides reproducible quantification of ventilation<br>for pulmonary tissue, which is essential for providing quantitative support for diagnosis and<br>follow up examinations. For use by referral from a pulmonary specialist or equivalent, the Device | | | |

can be used to provide the physician with additional clinical data in the diagnosis and

#### 7. Substantial Equivalence

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Image /page/6/Picture/0 description: The image shows the logo for 4Dx. The logo consists of a geometric shape on the left and the text "4Dx" on the right. The geometric shape is made up of several triangles in shades of blue and green. The text "4Dx" is in a bold, sans-serif font and is black.

| | documentation of inhomogeneities and defects in pulmonary ventilation. Quantification and |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | statistics are provided in the form of a Report, including: |
| | <b>•</b> The tidal volume (i.e. total lung ventilation), presented as a single value;<br><b>•</b> Visualization of lung ventilation with color-defined specific ventilation ranges overlaid on the<br>CT slices; |
| | <b>•</b> The heterogeneity of lung ventilation, presented as three values, which quantifies the regional<br>variability of the ventilation; and |
| | <b>•</b> Ventilation graph/ histogram of the classified lung voxel's relative frequencies showing the<br>frequency distribution of regional specific ventilation measured across the entire lung,<br>including ventilation defect percentage which shows the volume of lung with low ventilation. |
| Vitrea CT<br>Lung Density<br>Analysis<br>Software | The Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from CT<br>thoracic datasets. Three-dimensional (3D) segmentation of the left lung and right lung, volumetric<br>analysis, density evaluations and reporting tools are integrated in a specific workflow to offer the<br>physician a quantitative support for diagnosis and follow-up evaluation of lung tissue images. |
| Artis Q / | Artis is a family of dedicated angiography systems developed for single and biplane diagnostic |
| Q.zen | imaging and interventional procedures. |
| | Procedures that can be performed with the Artis family include cardiac angiography, neuro- |
| | angiography, general angiography, rotational angiography, multipurpose angiography and whole |
| | body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient |
| | extremities. |
| | The examination table as an integrated part of the system can be used for X-ray imaging, surgery |
| | and interventions.<br>Artis can also support the acquisition of position triggered imaging for spatial data synthesis. |
| | |
| | The Artis systems include also the software option DynaCT with following IFU: |
| | DynaCT is an x-ray imaging software option, which allows the reconstruction of two- |
| | dimensional images acquired with a standard angiographic C-arm device into a three-dimensional |
| | image format. |
| | DynaCT is intended for imaging both hard and soft tissues as well as other internal body |
| | structures for diagnosis, surgical planning, interventional procedures and treatment follow-up. |
| | |
| Comparison<br>and<br>Comments | Similar (Primary Predicate) / Similar (Secondary Predicate) |
| | These devices are all intended to support physicians in diagnosis and treatment follow-up by |
| | providing three-dimensional (3D) information of the lungs. |
| | The primary predicate measures density and the subject device measures ventilation. Ventilation |
| | is a commonly used concept in CT-based lung diagnostics, with similarities to the nomenclature |
| | of the Device outputs. Pulmonologists often use the concept of controlled ventilation when |
| | performing CT scans. Surrogate measurements of ventilation, such as density (which is often |
| | referred to as aeration) are routinely used in 3D CT, inspiratory/expiratory CT and V/Q scans, |
| | for diagnostic purposes. Measurement of lung density, expressed in Hounsfield Units (HU), is a |
| | common output of the predicate device. With the aid of careful calibration, and the knowledge of |
| | the relationship between X-ray attenuation and material density, the local lung density can be |
| | derived from the voxel intensities. In lung tissue, density is almost universally used as a surrogate |
| | of aeration. Similarly, in some CT studies, aeration has been used as a surrogate for ventilation |
| | output, ventilation which is output by the subject Device. |
| | The secondary predicate device utilizes fluoroscopy in combination with tomographic reconstruction to generate 3D data, similar to the subject device. |

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Image /page/7/Picture/0 description: The image shows the logo for 4Dx. The logo consists of a geometric shape on the left and the text "4Dx" on the right. The geometric shape is made up of several triangles in shades of blue and green. The text "4Dx" is in a bold, sans-serif font and is black.

| Characteristic | Subject Device | Predicate Device | Secondary<br>Predicate Device | Comparison and<br>Comments |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | XV Ventilation<br>Lung Analysis<br>Software | Vitrea CT Lung<br>Density Analysis<br>Software | Artis Q / Q.zen | |
| Intended users | Thoracic<br>Radiologists and<br>Pulmonologists | Thoracic<br>Radiologists and<br>Pulmonologists | Radiologists<br>(including Thoracic<br>Radiologists) and<br>Physicians<br>(including<br>Pulmonologists) | Identical (Primary)/<br>Similar (Secondary)<br>All three devices can<br>be used by Thoracic<br>Radiologists, the<br>secondary predicate<br>device also has a<br>wider application<br>(whole body imaging<br>capability). |
| Patient population | Adult patients with<br>pulmonary diseases<br>and abnormalities | Patients with<br>pulmonary diseases<br>and abnormalities | All patients | Similar (Primary)/<br>Similar (Secondary)<br>The subject device<br>will initially have an<br>adult-only patient<br>population. Once 4Dx<br>has completed<br>additional clinical<br>trials (currently<br>under development)<br>4Dx will add<br>pediatric patients to<br>the IFU in a future<br>submission. |
| Input images | Cinefluorograph<br>images and CT | CT | 2D cinefluorograph<br>images are acquired<br>by the device. | Similar (Primary)/<br>Similar (Secondary) |
| Device<br>Description | The Device is a<br>software-based<br>image processing<br>technology that<br>analyzes<br>cinefluorograph<br>images to quantify<br>ventilation of<br>pulmonary tissue,<br>thereby providing<br>support to physicians<br>in their assessment of | Vitrea CT Lung<br>Density Analysis<br>assists in analyzing<br>lung densities and<br>volumes. It semi-<br>automatically<br>segments lung tissues<br>with quantifiable<br>controls and<br>renderings to aid<br>communication with<br>the pulmonologist. | The Artis Modular<br>Angiography<br>systems are<br>specialized<br>angiography<br>systems. In general,<br>they are equipped<br>with C-arm, stand,<br>flat panel detector,<br>x-ray tube, high<br>voltage generator,<br>patient table and<br>image post- | Similar (Primary)/<br>Similar (Secondary)<br>The primary<br>predicate utilizes CT<br>input images to<br>provide the end user<br>with 3D<br>measurements of lung<br>function.<br>The secondary<br>predicate utilizes |
| Characteristic | Subject Device | Predicate Device | Secondary<br>Predicate Device | Comparison and<br>Comments |
| | XV Ventilation<br>Lung Analysis<br>Software | Vitrea CT Lung<br>Density Analysis<br>Software | Artis Q / Q.zen | |
| | patients with lung<br>diseases.<br>The Device measures<br>the tissue motion of<br>the lung, at all<br>locations throughout<br>the lung, and at all<br>phases of the breath.<br>It uses these motion<br>measurements to<br>calculate the 4-<br>dimensional<br>ventilation of lung<br>tissues. | | processing<br>software.<br>Siemens will<br>provide new<br>software VD11D<br>for both, the Artis<br>zee/zeego and Artis<br>Q/Q.zen systems.<br>The new software<br>VD11D will<br>support the detector<br>Pixium 3040CV<br>(also known as<br>"40HDR") already<br>cleared with Artis<br>Q/Q.zen<br>(K123529).<br>Systems, Artis<br>zee/zeego, and Artis<br>Q/Q.zen use the<br>cleared AEC<br>(Automatic<br>Exposure Control)<br>functionality. | acquired<br>cinefluorograph<br>images to provide the<br>end user with 3D<br>images.<br>The subject device<br>utilizes<br>cinefluorograph<br>images and a CT<br>image to provide the<br>end user with 3D<br>measurements of lung<br>function. |
| Device Output -<br>Lung Volume | The tidal volume (i.e.<br>total lung<br>ventilation),<br>presented as a single<br>value | Semi-automatic right<br>lung, left lung and<br>airway segmentation | NA | The subject device<br>and predicate device<br>both support Lung<br>Volume measurement. |
| Device Output -<br>Lung<br>Visualization | Visualization of lung<br>ventilation with<br>color-defined<br>specific ventilation<br>ranges | Visualization of lung<br>density with color-<br>defined Hounsfield<br>Unit (HU) ranges | The systems include<br>a software which<br>allows the<br>reconstruction of<br>2D images acquired<br>with a standard<br>angiographic C-arm<br>device into a 3D<br>image format. | The subject device<br>and predicate device<br>both support<br>visualizations of<br>lungs utilizing a<br>color-defined range.<br>The subject device<br>and the second<br>predicate both<br>reconstruct<br>cinefluorograph 2D<br>images into 3D<br>images. |
| Device Output -<br>Lung Analysis | The heterogeneity of<br>lung ventilation,<br>presented as three<br>values. | Lung density result<br>quantification with<br>HU density range,<br>volume | NA | The subject device<br>and predicate device<br>both support:<br>• Region (Voxel by<br>voxel) |
| Characteristic | Subject Device | Predicate Device | Secondary<br>Predicate Device | Comparison and<br>Comments |
| | XV Ventilation<br>Lung Analysis<br>Software | Vitrea CT Lung<br>Density Analysis<br>Software | Artis Q / Q.zen | |
| | | measurements, lung<br>density index and the<br>PD15% measurement | | characterization of<br>lung tissue<br>• Quantification of<br>pulmonary tissue<br>ventilation<br>• Lung analysis;<br>deriving further<br>analysis metrics<br>from the voxel<br>characteristics and<br>frequency<br>distribution<br>histogram<br>characteristics. |
| Device Output -<br>Lung Voxels | Ventilation graph/<br>histogram of the<br>classified lung<br>voxel's relative<br>frequencies including<br>ventilation defect<br>percentage. | Density<br>graph/histogram of<br>the classified lung<br>voxels' relative<br>frequencies. | NA | The subject device<br>and predicate device<br>both support<br>histograms of the<br>classified lung voxels'<br>relative frequencies. |
| Device Output -<br>Reporting | This data is provided<br>in the form of a<br>Report. | Comparison of upper<br>and lower lung<br>density index ratios.<br>Adjustable density<br>thresholds for<br>refining and<br>optimizing HU<br>ranges.<br>Overlay of density<br>quantification results<br>and density graph<br>histogram for<br>reporting.<br>Export of density<br>values and curves to<br>CSV tables or copy<br>to clipboard for<br>insertion into a<br>report. | NA (does not<br>produce a report) | All devices support<br>data to the end user,<br>the subject device and<br>primary predicate<br>device support<br>reporting. |
| Technology Comparison | | | | |
| Characteristic | Subject Device | Predicate Device | Secondary<br>Predicate Device | Comparison and<br>Comments |
| | XV Ventilation<br>Lung Analysis<br>Software | Vitrea CT Lung<br>Density Analysis<br>Software | Artis Q / Q.zen | |
| Modality | Cinefluorograph<br>images and CT | CT | Cinefluorograph<br>images | Substantially<br>equivalent |
| Lung Volume<br>measurement | Measures Tidal<br>Volume. | Measures left and<br>right lung volume | NA | Substantially<br>equivalent |
| Visualization<br>representation | Visualization of lung<br>ventilation with<br>color-defined<br>specific ventilation<br>ranges. | Visualization of lung<br>density with color-<br>defined Hounsfield<br>Unit (HU) ranges. | NA | Substantially<br>equivalent |
| Voxel by voxel<br>measure of lung<br>characteristics | Measures ventilation<br>in each lung voxel. | Measures HU in each<br>lung voxel. | NA | Substantially<br>equivalent |
| Quantification of<br>pulmonary tissue<br>ventilation | Analyzing ventilation<br>at all voxels<br>throughout the lung,<br>and at all phases of<br>the breath. | Analyzing densities<br>and volumes of<br>pulmonary tissue. | NA…