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).

Device Description

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.

AI/ML Overview

The provided document, a 510(k) premarket notification, describes the XV Lung Ventilation Analysis Software System. While it discusses the device's intended use, its comparison to predicate devices, and general safety and effectiveness concerns, it does not contain the specific details of acceptance criteria for performance metrics or a detailed clinical study demonstrating the device meets those criteria, as typically found in clinical trial reports.

The document refers to a "clinical study" but only provides a high-level summary and its overall conclusion regarding safety and efficacy, not the quantitative results against pre-defined acceptance criteria. Therefore, I cannot generate a table of acceptance criteria and reported device performance from the provided text.

Here is a breakdown of the information that cannot be extracted from the provided text, based on your request:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The document states "Testing for verification and validation of the device supports that all software specifications have met the acceptance criteria" in section 9, and in section 10, "it is considered that the XV Lung Ventilation Analysis Software presents no unacceptable clinical risks, is safe for clinical usage as indicated by the manufacturer and meets the manufacturer's intended performance criteria." However, the actual criteria and the quantitative performance measured against them are not provided.
Sample size used for the test set and the data provenance: The document states, "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)." It mentions "Data from all four time points was analyzed," referring to four time points over a 13-month period. However, the exact sample size (number of patients or cases) for the test set is not specified. Data provenance (country of origin, retrospective/prospective) is also not specified, beyond the implication of a prospective study given the description of follow-up time points.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. The document mentions the study "validated the consistency of outputs with gold-standard measures (CT and PFT)," implying these were used as a form of ground truth or reference, but it doesn't describe the process of establishing ground truth by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided. The document describes the device as a "software-based image processing technology" to quantify ventilation, implying it's a tool providing data to a physician, but there is no mention of a comparative effectiveness study involving human readers with and without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document doesn't explicitly state "standalone performance." It validates "consistency of outputs with gold-standard measures (CT and PFT)," which implies a comparison of the algorithm's output to these measures. However, the specifics of how this comparison was quantified or what metrics were used are not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document mentions "consistency of outputs with gold-standard measures (CT and PFT)." This suggests that quantitative data from CT and Pulmonary Function Tests (PFTs) were used as references. It does not explicitly state expert consensus or pathology data as ground truth.
The sample size for the training set: This information is not provided. The document only details the clinical study used for validation, not the development or training of the AI model.
How the ground truth for the training set was established: This information is not provided.

Summary

{0}------------------------------------------------

May 14, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193293

Device Name

XV Lung Ventilation Analysis Software System

Indications for Use (Describe)

· 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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/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 teal. The text "4Dx" is in a bold, sans-serif font and is black.

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

1. Submitter Information

Submitter:	4Dx LimitedLevel 5 Suite 3468 St Kilda RdMelbourne, VIC 3004 AUSTRALIA
Primary contact person:	Andreas Fourase-mail: regulatory@4dx.com
Secondary contact person:	Rachael Tenkatene-mail: rtenkaten@4dx.com
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.

{4}------------------------------------------------

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 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 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;

{5}------------------------------------------------

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.

Characteristic	Subject Device	Predicate Device	SecondaryPredicate Device	Comparison andComments
	XV VentilationLung AnalysisSoftware	Vitrea CT LungDensity AnalysisSoftware	Artis Q / Q.zen
Regulatory Comparison
Classificationname	ComputedTomography X-raySystem	ComputedTomography X-raySystem	Image-intensifiedfluoroscopic X-raysystem	Identical (Primary)/Similar (Secondary)All three devices areradiology devices.
Regulatorynumber	892.1750	892.1750	892.1650
Product Code	JAK	JAK	OWB, IZI, JAA,JAK	Identical (Primary)/Similar (Secondary)All three devices can beused for CT (JAK), thesecondary predicatedevice is primarily afluoroscope
Classification	Class II	Class II	Class II	Identical (Primary)/Identical (Secondary)
Review Panel	Radiology	Radiology	Radiology	Identical (Primary)/Identical (Secondary)
Indications for Use Comparison
XVVentilationLungAnalysisSoftware	The XV Ventilation Lung Analysis Software is software-based image processing technology thatanalyzes cinefluorograph images and a CT (can be a previously acquired CT that is representativeof the patient's present lung envelope), to quantify ventilation of pulmonary tissue for use inadult patients.The XV Ventilation Lung Analysis Software provides reproducible quantification of ventilationfor pulmonary tissue, which is essential for providing quantitative support for diagnosis andfollow 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

{6}------------------------------------------------

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:
	• 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 theCT slices;
	• The heterogeneity of lung ventilation, presented as three values, which quantifies the regionalvariability of the ventilation; and
	• Ventilation graph/ histogram of the classified lung voxel's relative frequencies showing thefrequency distribution of regional specific ventilation measured across the entire lung,including ventilation defect percentage which shows the volume of lung with low ventilation.
Vitrea CTLung DensityAnalysisSoftware	The Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from CTthoracic datasets. Three-dimensional (3D) segmentation of the left lung and right lung, volumetricanalysis, density evaluations and reporting tools are integrated in a specific workflow to offer thephysician 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.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.

ComparisonandComments	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.

{7}------------------------------------------------

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	SecondaryPredicate Device	Comparison andComments
	XV VentilationLung AnalysisSoftware	Vitrea CT LungDensity AnalysisSoftware	Artis Q / Q.zen
Intended users	ThoracicRadiologists andPulmonologists	ThoracicRadiologists andPulmonologists	Radiologists(including ThoracicRadiologists) andPhysicians(includingPulmonologists)	Identical (Primary)/Similar (Secondary)All three devices canbe used by ThoracicRadiologists, thesecondary predicatedevice also has awider application(whole body imagingcapability).
Patient population	Adult patients withpulmonary diseasesand abnormalities	Patients withpulmonary diseasesand abnormalities	All patients	Similar (Primary)/Similar (Secondary)The subject devicewill initially have anadult-only patientpopulation. Once 4Dxhas completedadditional clinicaltrials (currentlyunder development)4Dx will addpediatric patients tothe IFU in a futuresubmission.
Input images	Cinefluorographimages and CT	CT	2D cinefluorographimages are acquiredby the device.	Similar (Primary)/Similar (Secondary)
DeviceDescription	The Device is asoftware-basedimage processingtechnology thatanalyzescinefluorographimages to quantifyventilation ofpulmonary tissue,thereby providingsupport to physiciansin their assessment of	Vitrea CT LungDensity Analysisassists in analyzinglung densities andvolumes. It semi-automaticallysegments lung tissueswith quantifiablecontrols andrenderings to aidcommunication withthe pulmonologist.	The Artis ModularAngiographysystems arespecializedangiographysystems. In general,they are equippedwith C-arm, stand,flat panel detector,x-ray tube, highvoltage generator,patient table andimage post-	Similar (Primary)/Similar (Secondary)The primarypredicate utilizes CTinput images toprovide the end userwith 3Dmeasurements of lungfunction.The secondarypredicate utilizes
Characteristic	Subject Device	Predicate Device	SecondaryPredicate Device	Comparison andComments
	XV VentilationLung AnalysisSoftware	Vitrea CT LungDensity AnalysisSoftware	Artis Q / Q.zen
	patients with lungdiseases.The Device measuresthe tissue motion ofthe lung, at alllocations throughoutthe lung, and at allphases of the breath.It uses these motionmeasurements tocalculate the 4-dimensionalventilation of lungtissues.		processingsoftware.Siemens willprovide newsoftware VD11Dfor both, the Artiszee/zeego and ArtisQ/Q.zen systems.The new softwareVD11D willsupport the detectorPixium 3040CV(also known as"40HDR") alreadycleared with ArtisQ/Q.zen(K123529).Systems, Artiszee/zeego, and ArtisQ/Q.zen use thecleared AEC(AutomaticExposure Control)functionality.	acquiredcinefluorographimages to provide theend user with 3Dimages.The subject deviceutilizescinefluorographimages and a CTimage to provide theend user with 3Dmeasurements of lungfunction.
Device Output -Lung Volume	The tidal volume (i.e.total lungventilation),presented as a singlevalue	Semi-automatic rightlung, left lung andairway segmentation	NA	The subject deviceand predicate deviceboth support LungVolume measurement.
Device Output -LungVisualization	Visualization of lungventilation withcolor-definedspecific ventilationranges	Visualization of lungdensity with color-defined HounsfieldUnit (HU) ranges	The systems includea software whichallows thereconstruction of2D images acquiredwith a standardangiographic C-armdevice into a 3Dimage format.	The subject deviceand predicate deviceboth supportvisualizations oflungs utilizing acolor-defined range.The subject deviceand the secondpredicate bothreconstructcinefluorograph 2Dimages into 3Dimages.
Device Output -Lung Analysis	The heterogeneity oflung ventilation,presented as threevalues.	Lung density resultquantification withHU density range,volume	NA	The subject deviceand predicate deviceboth support:• Region (Voxel byvoxel)
Characteristic	Subject Device	Predicate Device	SecondaryPredicate Device	Comparison andComments
	XV VentilationLung AnalysisSoftware	Vitrea CT LungDensity AnalysisSoftware	Artis Q / Q.zen
		measurements, lungdensity index and thePD15% measurement		characterization oflung tissue• Quantification ofpulmonary tissueventilation• Lung analysis;deriving furtheranalysis metricsfrom the voxelcharacteristics andfrequencydistributionhistogramcharacteristics.
Device Output -Lung Voxels	Ventilation graph/histogram of theclassified lungvoxel's relativefrequencies includingventilation defectpercentage.	Densitygraph/histogram ofthe classified lungvoxels' relativefrequencies.	NA	The subject deviceand predicate deviceboth supporthistograms of theclassified lung voxels'relative frequencies.
Device Output -Reporting	This data is providedin the form of aReport.	Comparison of upperand lower lungdensity index ratios.Adjustable densitythresholds forrefining andoptimizing HUranges.Overlay of densityquantification resultsand density graphhistogram forreporting.Export of densityvalues and curves toCSV tables or copyto clipboard forinsertion into areport.	NA (does notproduce a report)	All devices supportdata to the end user,the subject device andprimary predicatedevice supportreporting.
Technology Comparison
Characteristic	Subject Device	Predicate Device	SecondaryPredicate Device	Comparison andComments
	XV VentilationLung AnalysisSoftware	Vitrea CT LungDensity AnalysisSoftware	Artis Q / Q.zen
Modality	Cinefluorographimages and CT	CT	Cinefluorographimages	Substantiallyequivalent
Lung Volumemeasurement	Measures TidalVolume.	Measures left andright lung volume	NA	Substantiallyequivalent
Visualizationrepresentation	Visualization of lungventilation withcolor-definedspecific ventilationranges.	Visualization of lungdensity with color-defined HounsfieldUnit (HU) ranges.	NA	Substantiallyequivalent
Voxel by voxelmeasure of lungcharacteristics	Measures ventilationin each lung voxel.	Measures HU in eachlung voxel.	NA	Substantiallyequivalent
Quantification ofpulmonary tissueventilation	Analyzing ventilationat all voxelsthroughout the lung,and at all phases ofthe breath.	Analyzing densitiesand volumes ofpulmonary tissue.	NA	Substantiallyequivalent
Lung analysissupport	Analyzes voxelcharacteristics toprovide metricsderived fromventilation, i.e.regional ventilation.	Analyzes voxelcharacteristics toprovide metricsderived from density,i.e. density indices asa function of bothHU range (low/medium) andlocation(right/left/bothlungs).	NA	Substantiallyequivalent
Statisticalmeasures derivedfrom voxelcharacteristics	The heterogeneity oflung ventilationderived fromfrequencydistributionhistograms ofspecific ventilation.	PD15 measurementderived fromfrequencydistributionhistograms of HU ina given lung region(15% of voxels havea lower HU unit inright/left/both lungs).	NA	Substantiallyequivalent
Generatefrequencydistributionhistograms	Frequencydistributionhistograms ofspecific ventilation.	Frequencydistributionhistograms of HU.	NA	Substantiallyequivalent
Analyzed dataexport	Ability to exportoutputs in a report.	Ability to exportoutputs to supportreporting.	Ability to export 3Ddata from 2Dimages.	Substantiallyequivalent
Characteristic	Subject Device	Predicate Device	SecondaryPredicate Device	Comparison andComments
	XV VentilationLung AnalysisSoftware	Vitrea CT LungDensity AnalysisSoftware	Artis Q / Q.zen
Approximateeffective radiationdose	For a patient with anexisting thoracic CTscan on file; theradiation dose isapproximately 3%the dose of a thoracicCT.	Radiation dose of athoracic CT.	Radiation dose for3D image iscomparable to athoracic CT (dose isdependent onprocedure)	SignificantImprovementThe subject devicecan use a previouslyacquired CT andtherefore the effectiveradiation dose issignificantly less thanboth of the predicatedevices providing aconsiderable benefitto the patient.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the logo for 4Dx. The logo consists of a geometric shape on the left, resembling a stylized crystal or multifaceted object, colored in shades of teal and blue. To the right of the geometric shape, the text "4Dx" is displayed in a bold, sans-serif font, with the letters appearing in black.

{9}------------------------------------------------

Image /page/9/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 teal. The text "4Dx" is in a bold, sans-serif font and is black.

{10}------------------------------------------------

Image /page/10/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.

{11}------------------------------------------------

Image /page/11/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 teal. The text "4Dx" is in a bold, sans-serif font and is black.

General safety and Effectives concerns 8.

The device is designed and manufactured under the Ouality System Regulations as outlined in 21 CFR §820. The device labelling contains instructions for use and any necessary cautions and warnings for safe and effective use of the device. Risk management is ensured via a risk analysis, and risk control(s) have been implemented to mitigate identified potential hazards (conforming with "ISO 14971:2007 Medical devices -Application of risk management to medical devices"). Testing for verification and validation of the device supports that all software specifications have met the acceptance criteria.

9. Verification

The software level of concern for the XV Lung Ventilation Analysis Software is Moderate as per FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005. The performance data demonstrates conformance with "IEC 62304: 2006 Medical device software life cycle processes". Software testing was completed using a combination of automatic testing (unit, integration, coverage and performance) and manual component level testing to ensure the software operates in according to defined requirements.

{12}------------------------------------------------

Image /page/12/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 teal. The text "4Dx" is in a bold, sans-serif font and is black.

10. Summary of Clinical Study

The clinical performance of the XV Lung Ventilation Analysis Software was assessed in a clinical study involving patients undergoing radiation therapy. The clinical study involves the patients using the Device at four timepoints (twice prior and twice following radiation therapy). The cohort typically had breast cancer or esophageal cancer, (i.e. patients at the first two timepoints represent a very broad cross-section of lung health in the community). Data from all four time points was analyzed, with the two timepoints after radiation therapy being used to demonstrate the sensitivity of the Device to changes in the lung over time.

The study validated the consistency of outputs with gold-standard measures (CT and PFT). Based upon:

consideration of the Device design:
consideration of the intended clinical usage; and
a review of the literature on current clinical practice in use of similar devices,

it is considered that the XV Lung Ventilation Analysis Software presents no unacceptable clinical risks, is safe for clinical usage as indicated by the manufacturer and meets the manufacturer's intended performance criteria.

11. Conclusion as to Substantial Equivalence

The XV Lung Ventilation Analysis Software application has the same intended use and similar target patient population, indications for use, principle of operation, and technical characteristics as the legally marketed Vitrea CT Lung Density Analysis Software from Vital Images (K151919). The subject Device and the Artis Q / O.zen (K181407) share similar functionality of producing 3D data from cinefluorographs.

Based on the close similarities between XV Lung Ventilation Analysis Software device and the predicates, the similar technological characteristics and as the proposed Device has no additional considerations impacting safety or effectiveness, it is believed the Vitrea CT Lung software is substantially equivalent to the subject Device.

Regulation Number and Section

§ 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.