(169 days)
Not Found
No
The summary describes image processing techniques to quantify lung ventilation based on tissue motion, but it does not mention or imply the use of AI or ML algorithms for this analysis.
No
The device provides quantitative support for diagnosis and follow-up examinations by analyzing images to quantify ventilation of pulmonary tissue, not to treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that 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" and provides "quantitative support for diagnosis and follow up examinations."
Yes
The device is explicitly described as "software-based image processing technology" and the description focuses solely on the software's function of analyzing existing image data (cinefluorograph and CT) to produce a report. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens derived from the human body. The XV Ventilation Lung Analysis Software analyzes medical images (cinefluorograph and CT) of the lung, which are not biological specimens like blood, urine, or tissue samples.
- The intended use is image analysis for diagnostic support. The software processes images to quantify lung ventilation and provide data to physicians for diagnosis and follow-up. This falls under the category of medical image analysis software, not IVD.
- The device description focuses on image processing and motion analysis. The core function is analyzing image data to derive quantitative measurements of lung ventilation.
While the software provides data that can be used in the diagnostic process, it does not perform a test on a biological specimen to determine the presence or absence of a disease or condition. Therefore, it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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).
Product codes
JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cinefluorograph images and CT
Anatomical Site
Pulmonary tissue / Lung
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Thoracic Radiologists and Pulmonologists
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 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)
| ☒ 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 Limited
Level 5 Suite 3
468 St Kilda Rd
Melbourne, VIC 3004 AUSTRALIA |
|---------------------------|------------------------------------------------------------------------------------|
| Primary contact person: | Andreas Fouras
e-mail: regulatory@4dx.com |
| Secondary contact person: | Rachael Tenkaten
e-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 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;
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.
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
Predicate Device | Comparison and
Comments |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | XV Ventilation
Lung Analysis
Software | Vitrea CT Lung
Density Analysis
Software | Artis Q / Q.zen | |
| Regulatory Comparison | | | | |
| Classification
name | Computed
Tomography X-ray
System | Computed
Tomography X-ray
System | Image-intensified
fluoroscopic X-ray
system | Identical (Primary)/
Similar (Secondary)
All three devices are
radiology devices. |
| Regulatory
number | 892.1750 | 892.1750 | 892.1650 | |
| Product Code | JAK | JAK | OWB, IZI, JAA,
JAK | Identical (Primary)/
Similar (Secondary)
All three devices can be
used for CT (JAK), the
secondary predicate
device is primarily a
fluoroscope |
| Classification | Class II | Class II | Class II | Identical (Primary)/
Identical (Secondary) |
| Review Panel | Radiology | Radiology | Radiology | Identical (Primary)/
Identical (Secondary) |
| Indications for Use Comparison | | | | |
| XV
Ventilation
Lung
Analysis
Software | 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
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 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. | |
| Vitrea CT | |
| Lung Density | |
| Analysis | |
| Software | The Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from CT |
| thoracic datasets. Three-dimensional (3D) segmentation of the left lung and right lung, volumetric | |
| analysis, density evaluations and reporting tools are integrated in a specific workflow to offer the | |
| 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. | |
| 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 | |
| and | |
| 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. |
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 | Secondary
Predicate Device | Comparison and
Comments |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | XV Ventilation
Lung Analysis
Software | Vitrea CT Lung
Density Analysis
Software | Artis Q / Q.zen | |
| Intended users | Thoracic
Radiologists and
Pulmonologists | Thoracic
Radiologists and
Pulmonologists | Radiologists
(including Thoracic
Radiologists) and
Physicians
(including
Pulmonologists) | Identical (Primary)/
Similar (Secondary)
All three devices can
be used by Thoracic
Radiologists, the
secondary predicate
device also has a
wider application
(whole body imaging
capability). |
| Patient population | Adult patients with
pulmonary diseases
and abnormalities | Patients with
pulmonary diseases
and abnormalities | All patients | Similar (Primary)/
Similar (Secondary)
The subject device
will initially have an
adult-only patient
population. Once 4Dx
has completed
additional clinical
trials (currently
under development)
4Dx will add
pediatric patients to
the IFU in a future
submission. |
| Input images | Cinefluorograph
images and CT | CT | 2D cinefluorograph
images are acquired
by the device. | Similar (Primary)/
Similar (Secondary) |
| Device
Description | The Device is a
software-based
image processing
technology that
analyzes
cinefluorograph
images to quantify
ventilation of
pulmonary tissue,
thereby providing
support to physicians
in their assessment of | Vitrea CT Lung
Density Analysis
assists in analyzing
lung densities and
volumes. It semi-
automatically
segments lung tissues
with quantifiable
controls and
renderings to aid
communication with
the pulmonologist. | The Artis Modular
Angiography
systems are
specialized
angiography
systems. In general,
they are equipped
with C-arm, stand,
flat panel detector,
x-ray tube, high
voltage generator,
patient table and
image post- | Similar (Primary)/
Similar (Secondary)
The primary
predicate utilizes CT
input images to
provide the end user
with 3D
measurements of lung
function.
The secondary
predicate utilizes |
| Characteristic | Subject Device | Predicate Device | Secondary
Predicate Device | Comparison and
Comments |
| | XV Ventilation
Lung Analysis
Software | Vitrea CT Lung
Density Analysis
Software | Artis Q / Q.zen | |
| | patients with lung
diseases.
The Device 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
ventilation of lung
tissues. | | processing
software.
Siemens will
provide new
software VD11D
for both, the Artis
zee/zeego and Artis
Q/Q.zen systems.
The new software
VD11D will
support the detector
Pixium 3040CV
(also known as
"40HDR") already
cleared with Artis
Q/Q.zen
(K123529).
Systems, Artis
zee/zeego, and Artis
Q/Q.zen use the
cleared AEC
(Automatic
Exposure Control)
functionality. | acquired
cinefluorograph
images to provide the
end user with 3D
images.
The subject device
utilizes
cinefluorograph
images and a CT
image to provide the
end user with 3D
measurements of lung
function. |
| Device Output -
Lung Volume | The tidal volume (i.e.
total lung
ventilation),
presented as a single
value | Semi-automatic right
lung, left lung and
airway segmentation | NA | The subject device
and predicate device
both support Lung
Volume measurement. |
| Device Output -
Lung
Visualization | Visualization of lung
ventilation with
color-defined
specific ventilation
ranges | Visualization of lung
density with color-
defined Hounsfield
Unit (HU) ranges | The systems include
a software which
allows the
reconstruction of
2D images acquired
with a standard
angiographic C-arm
device into a 3D
image format. | The subject device
and predicate device
both support
visualizations of
lungs utilizing a
color-defined range.
The subject device
and the second
predicate both
reconstruct
cinefluorograph 2D
images into 3D
images. |
| Device Output -
Lung Analysis | The heterogeneity of
lung ventilation,
presented as three
values. | Lung density result
quantification with
HU density range,
volume | NA | The subject device
and predicate device
both support:
• Region (Voxel by
voxel) |
| Characteristic | Subject Device | Predicate Device | Secondary
Predicate Device | Comparison and
Comments |
| | XV Ventilation
Lung Analysis
Software | Vitrea CT Lung
Density Analysis
Software | Artis Q / Q.zen | |
| | | measurements, lung
density index and the
PD15% measurement | | characterization of
lung tissue
• Quantification of
pulmonary tissue
ventilation
• Lung analysis;
deriving further
analysis metrics
from the voxel
characteristics and
frequency
distribution
histogram
characteristics. |
| Device Output -
Lung Voxels | Ventilation graph/
histogram of the
classified lung
voxel's relative
frequencies including
ventilation defect
percentage. | Density
graph/histogram of
the classified lung
voxels' relative
frequencies. | NA | The subject device
and predicate device
both support
histograms of the
classified lung voxels'
relative frequencies. |
| Device Output -
Reporting | This data is provided
in the form of a
Report. | Comparison of upper
and lower lung
density index ratios.
Adjustable density
thresholds for
refining and
optimizing HU
ranges.
Overlay of density
quantification results
and density graph
histogram for
reporting.
Export of density
values and curves to
CSV tables or copy
to clipboard for
insertion into a
report. | NA (does not
produce a report) | All devices support
data to the end user,
the subject device and
primary predicate
device support
reporting. |
| Technology Comparison | | | | |
| Characteristic | Subject Device | Predicate Device | Secondary
Predicate Device | Comparison and
Comments |
| | XV Ventilation
Lung Analysis
Software | Vitrea CT Lung
Density Analysis
Software | Artis Q / Q.zen | |
| Modality | Cinefluorograph
images and CT | CT | Cinefluorograph
images | Substantially
equivalent |
| Lung Volume
measurement | Measures Tidal
Volume. | Measures left and
right lung volume | NA | Substantially
equivalent |
| Visualization
representation | Visualization of lung
ventilation with
color-defined
specific ventilation
ranges. | Visualization of lung
density with color-
defined Hounsfield
Unit (HU) ranges. | NA | Substantially
equivalent |
| Voxel by voxel
measure of lung
characteristics | Measures ventilation
in each lung voxel. | Measures HU in each
lung voxel. | NA | Substantially
equivalent |
| Quantification of
pulmonary tissue
ventilation | Analyzing ventilation
at all voxels
throughout the lung,
and at all phases of
the breath. | Analyzing densities
and volumes of
pulmonary tissue. | NA | Substantially
equivalent |
| Lung analysis
support | Analyzes voxel
characteristics to
provide metrics
derived from
ventilation, i.e.
regional ventilation. | Analyzes voxel
characteristics to
provide metrics
derived from density,
i.e. density indices as
a function of both
HU range (low/
medium) and
location
(right/left/both
lungs). | NA | Substantially
equivalent |
| Statistical
measures derived
from voxel
characteristics | The heterogeneity of
lung ventilation
derived from
frequency
distribution
histograms of
specific ventilation. | PD15 measurement
derived from
frequency
distribution
histograms of HU in
a given lung region
(15% of voxels have
a lower HU unit in
right/left/both lungs). | NA | Substantially
equivalent |
| Generate
frequency
distribution
histograms | Frequency
distribution
histograms of
specific ventilation. | Frequency
distribution
histograms of HU. | NA | Substantially
equivalent |
| Analyzed data
export | Ability to export
outputs in a report. | Ability to export
outputs to support
reporting. | Ability to export 3D
data from 2D
images. | Substantially
equivalent |
| Characteristic | Subject Device | Predicate Device | Secondary
Predicate Device | Comparison and
Comments |
| | XV Ventilation
Lung Analysis
Software | Vitrea CT Lung
Density Analysis
Software | Artis Q / Q.zen | |
| Approximate
effective radiation
dose | For a patient with an
existing thoracic CT
scan on file; the
radiation dose is
approximately 3%
the dose of a thoracic
CT. | Radiation dose of a
thoracic CT. | Radiation dose for
3D image is
comparable to a
thoracic CT (dose is
dependent on
procedure) | Significant
Improvement
The subject device
can use a previously
acquired CT and
therefore the effective
radiation dose is
significantly less than
both of the predicate
devices providing a
considerable benefit
to 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.