Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes image processing and quantitative analysis based on Hounsfield Units and segmentation, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The segmentation is described as "semi-automatic," which doesn't necessarily imply AI/ML.

Therapeutic

No.
The device is a software tool for quantitative analysis of CT thoracic datasets to support diagnosis and follow-up evaluation; it does not directly treat or prevent a disease or condition.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section states that the software offers "quantitative support for diagnosis and follow-up evaluation of lung tissue images."

SaMD (Software as a Medical Device)

Yes

The device is described as "Vitrea Lung Density Analysis software" and its description focuses entirely on software functionalities for analyzing CT images. There is no mention of accompanying hardware components or hardware-specific testing.

IVD (In Vitro Diagnostic)

Based on the provided information, the Vitrea Lung Density Analysis software is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens taken from the human body. The intended use and device description clearly state that this software analyzes CT thoracic datasets, which are medical images of the patient's body, not biological specimens like blood, urine, or tissue samples.
The analysis is performed on imaging data. The software processes and analyzes the information contained within the CT scans to provide quantitative data about lung density and volume. This is distinct from analyzing the chemical or biological properties of a specimen.
The output is quantitative data derived from images. The software provides CT values, volumes, density indices, and histograms based on the image data. This is different from providing a diagnostic result based on the analysis of a biological sample.

While the software provides "quantitative support for diagnosis and follow-up evaluation of lung tissue images," this support is based on the analysis of imaging data, not on the in vitro examination of a specimen.

Therefore, the Vitrea Lung Density Analysis software falls under the category of medical image processing software rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

JAK

Device Description

Vitrea CT Lung Density Analysis assists in analyzing lung densities and volumes. It semiautomatically segments lung tissues with quantifiable controls and renderings to aid communication with the pulmonologist.

The key features are:

Semi-automatic right lung, left lung, and airway segmentation .
Visualization of lung density with color-defined Hounsfield Unit (HU) ranges ●
. Lung density result quantification with HU density range, volume measurements, lunq density index, and the PD15% measurement
. Density graph/histogram of the classified lung voxels' relative frequencies
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

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT /CTA

Anatomical Site

pulmonary tissue (lungs)

Indicated Patient Age Range

Not Found

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 Vitrea CT Lung Density Analysis software was designed, developed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements.

The following design control measures were applied to the development of the Vitrea CT Lung Density Analysis software:

. Risk Management
Requirements Reviews ●
Code Designs .
Code Development Testing .
Code Reviews
Design Reviews
Verification of the software that included performance and safety testing ●
Validation of the software that included phantom testing and simulated usability testing . by experienced professionals.

Risk Management:
Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.

During the design review, the following conclusions were reached:

The medical benefits of the device outweigh the residual risk for each individual risk and ● all risks together
. The overall residual risk for the project is deemed acceptable

Verification:
The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.

Validation:
The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met.

Internal Validation (Phantom Testing):
The software validation team provided internal validation of Vitrea CT Lung Density Analysis software. Internal validation included internal user acceptance testing using various phantoms. Results of numerical quantities calculated by CT Lung Density Analysis were verified using CT semi-synthetic phantoms and patient based CT datasets.

External Validation:
During external validation of the CT Lung Density Analysis software, experienced users evaluated the visualization, axial plane location, quantification of density, and snapshots among other features. Each user felt that the Vitrea CT Lung Density Analysis software enables the user to assess and quantify lung density.

Summary of Clinical Tests:
The subject of this 510(k) notification, Vitrea CT Lung Density Analysis software, did not require clinical studies to support safety and effectiveness of the software.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K083227

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K043333

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2015

Vital Images, Inc. % Ms. Katie Ryan Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414

Re: K151919

Trade/Device Name: Vitrea® CT Lung Density Analysis Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 18, 2015 Received: September 21, 2015

Dear Ms. Ryan:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ocks

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K151919

Device Name

Vitrea® CT Lung Density Analysis Software

Indications for Use (Describe)

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, volumetric analysis, density evaluations and reporting tools are integrated in a specific workflow to offer the physician a quantitative support for diagnosis and followup evaluation of lung tissue images.

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

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is white.

510K Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c).

| Basis for the
Submission: | To obtain 510k clearance for Vital's software preset Vitrea CT Lung
Density Analysis which is substantially equivalent to the cleared
VIDA Pulmonary Workstation 2 (PW2) manufactured by VIDA
Diagnostics. | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414 | |
| Establishment
Registration: | 2134213 | |
| Contact Person: | Katie Ryan
Regulatory Affairs Specialist
Phone : 952-487-9793
Fax: 952-487-9510
E-mail: kryan@vitalimages.com | |
| 510(k) Type: | Traditional | |
| Summary Date: | July 20, 2015 | |
| Device Trade Name: | Vitrea® CT Lung Density Analysis Software | |
| Device Common
Name/ Regulatory
Description: | Computed Tomography X-ray System | |
| Device Classification
Name: | System, X-ray, Tomography, Computed | |
| Regulation Number: | 21 CFR 892.1750 | |
| Product Code: | JAK | |
| Regulatory
Classification: | Class II | |
| Device Panel: | Radiology | |

Predicate Device(s):

Predicate Device	Manufacturer	FDA 510(k) Number
VIDA Pulmonary
Workstation 2 (PW2)	VIDA Diagnostics
100 Oakdale Campus, Suite 225 Tic
lowa City, IA 55242	K083227

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Image /page/4/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters of "VITAL" are spaced apart, and the dot of the "i" is a perfect circle.

Reference Device(s):

Reference Device	Manufacturer	FDA 510(k) Number
VITREA2, Version 3.7
Medical Image Processing
System (Lung Analysis)	Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN 55343	K043333

Device Description:

Vitrea CT Lung Density Analysis assists in analyzing lung densities and volumes. It semiautomatically segments lung tissues with quantifiable controls and renderings to aid communication with the pulmonologist.

The key features are:

Semi-automatic right lung, left lung, and airway segmentation .
Visualization of lung density with color-defined Hounsfield Unit (HU) ranges ●
. Lung density result quantification with HU density range, volume measurements, lunq density index, and the PD15% measurement
. Density graph/histogram of the classified lung voxels' relative frequencies
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

Intended Use / Indications for Use:

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.

Intended for Disease / Condition / Patient Population:

The software provides Thoracic Radiologists and Pulmonologists with a robust dedicated suite of software tools to aid in the creation of evidence to support these physicians with their assessment of patients with chest diseases.

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Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company information serving as a secondary detail.

Substantial Equivalence Comparison:

Regulatory Comparison

	Subject Device	Predicate Device
Characteristic	Vitrea CT Lung
Density Analysis
Software	VIDA Pulmonary
Workstation 2
(PW2)	Comparison
Classification Name	Computed
Tomography X-ray
System.	Computed
Tomography X-
ray System.	None
Regulatory Number	892.1750	892.1750	None
Product Code	JAK	JAK	None
Classification	Class II	Class II	None
Review Panel	Radiology	Radiology	None
Decision Date	Under Review	November 8,
2008	Predicate and
Reference
devices are
cleared

Intended Use Comparison with Predicate Device:

| Criteria | Subject Device
Vitrea CT Lung
Density Analysis
Software | Predicate Device
VIDA Pulmonary
Workstation 2 (PW2) | Comparison |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | The VIDA Pulmonary
Workstation 2 (PW2)
software provides
reproducible CT values
for pulmonary tissue,
which is essential for
providing quantitative
support for diagnosis and
follow up examinations.
The PW2 can be used to
support the physician in
the diagnosis and
documentation of
pulmonary tissue images
(e.g., abnormalities) from
CT thoracic datasets.
Three-D segmentation
and isolation of sub-
compartments, volumetric
analysis, density
evaluations, low density
cluster analysis and
reporting tools are | The support for low
density cluster analysis
is not part of the subject
device's indications for
use. |

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Image /page/6/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters of the word "VITAL" are spaced apart from each other.

| Criteria | Subject Device
Vitrea CT Lung
Density Analysis
Software | Predicate Device
VIDA Pulmonary
Workstation 2 (PW2) | Comparison |
|-----------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | combined with a
dedicated workflow. The
VIDA Pulmonary
Workstation 2 (PW2)
software package is also
intended to be a real-time
interactive evaluation in
space and time for CT
volume data sets that
provides the
reconstruction of two-
dimensional images into
a three-dimensional
image format. | |
| Intended Users | Thoracic Radiologists
and Pulmonologists | Thoracic Radiologists
and Pulmonologists | None |
| Patient
Population | Patients with
pulmonary diseases
and abnormalities | Patients with chest
diseases, e.g. when
examining the pulmonary
tissue (i.e. lung
parenchyma) in CT
thoracic datasets | Similar |
| Modality
Support | CT /CTA | CT /CTA | None |

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Image /page/7/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot above the "i" in "VITAL" is white.

Subiect Device Predicate Device Comparison VIDA Pulmonary Workstation 2 Vitrea CT Lung Density Analysis Software (PW2) VIDA Pulmonary Workstation 2 (PW2) Vitrea CT Lung Density Analysis The support for low assists in analyzing lung densities is a self-contained image analysis density cluster and volumes. It semi-automatically software package. This real-time analysis is not part of the subject device interactive evaluation in space and time segments lung tissues with quantifiable controls and renderings for CT volume data sets provides the description. to aid communication with the reconstruction of two-dimensional pulmonologist. images into a three-dimensional image format. VIDA Pulmonary Workstation 2 The key features are: (PW2) can be used to support the physician in the diagnosis and · Semi-automatic right lung, left documentation of chest diseases, e.g. lung and airway segmentation when examining the pulmonary tissue • Visualization of lung density with (i.e. lung parenchyma) in CT thoracic color-defined Hounsfield Unit datasets. Evaluation tools (3D (HU) ranges segmentation & isolation of subcompartments, volumetric analysis, · Lung density result quantification density evaluations, and low density with HU density range, volume cluster analysis) and reporting tools are measurements. Jung density combined with a dedicated workflow. index and the PD15% measurement The PW2 is designed to analyze pulmonary CT slice data and display · Density graph/histogram of the analysis results. Each voxel of the scan classified lung voxels' relative is measured by Hounsfield units (HU), a frequencies measurement of x-ray attenuation that is applied to each volume element in • Comparison of upper and lower three-dimensional space ("voxel"). The lung density index ratios HU are utilized to distinquish between • Adjustable density thresholds for air, water, tissue and bone, such refining and optimizing HU distinction is common in the industry. ranges PW2 provides computed tomography · Overlay of density quantification (CT) viewing, airway analysis, and results and density graph parenchymal density analysis in one histogram for reporting application. PW2 provides imaging of bronchial airwavs that can be used to • Export of density values and assess therapy effectiveness based on curves to CSV tables or copy to CT scan data. PW2 reconstructs clipboard for insertion into a multiple cross-section images from CT report data into a computer model displaying complex bronchial branches. PW2 does not interface directly with any CT or data collection equipment; instead PW2 imports data files previously generated by such equipment. PW2 provides quantitative measurements and tabulates quantitative properties. PW2 focuses on what is visible to the eye and applies volumetric methods that might otherwise be too tedious to use. The software does not perform any function

Device Description Comparison with Predicate Device:

064 510(k) Summary S001

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Subject Device	Predicate Device	Comparison
Vitrea CT Lung Density
Analysis Software	VIDA Pulmonary Workstation 2
(PW2)

which cannot be accomplished by a
trained user utilizing manual tracing
methods; the intent of the software is to
save time and automate potential error
prone manual tasks.

The software has functions for loading,
analyzing, saving datasets and will
generate screen displays, computations
and aggregate statistics. | |

Similarities in Technology with Predicate Device:

Criteria	Subject Device	Predicate Device	Comparison
	Vitrea CT Lung
Density Analysis
Software	VIDA Pulmonary
Workstation 2
(PW2)
Modality
CT	Yes	Yes	Same
Data Loading
DICOM	Yes	Yes	Same
Ability to load one or two
series of chest CT exam	Yes	Yes	Same
Data Viewing Support
MPR	Yes	Yes	Same
3D	Yes	Yes	Same
Segmentation
Provides 3D Segmentation
tool	Yes	Yes	Same
Provide Left Lung
Segmentation	Yes	Yes	Same
Provides Right Lung
Segmentation	Yes	Yes	Same
Provides airways
segmentation (trachea,
main bronchi, and some
larger bronchioles)	Yes	Yes	Same
Criteria	Subject Device	Predicate Device	Comparison
	Vitrea CT Lung
Density Analysis
Software	VIDA Pulmonary
Workstation 2
(PW2)
User can manually edit
segmentation provided by
the software	Yes	Yes	Same
Lung Volume Analysis Support
Ability to measure and
view Left Lung volume	Yes	Yes	Same
Ability to measure and
view Right Lung volume	Yes	Yes	Same
Lung Density Analysis Support
Low (ml) Volume for
Right Lung:
Ability to measure volume
of Right lung voxels in the
lowest HU density range
as defined by the density
thresholds	Yes	Yes	Same
Low (ml) Volume for Left
Lung:
Ability to measure volume
of Left lung voxels in the
lowest HU density range
as defined by the density
thresholds	Yes	Yes	Same
Low (ml) Volume for
Both Lungs:
Ability to measure addition
of volumes of both lungs
voxels in the lowest HU
density range as defined
by the density thresholds	Yes	Yes	Same
Medium (ml) Volume for
Right Lung:
Ability to measure volume
of Right lung voxels in the
middle HU density range
as defined by the density
thresholds	Yes	Yes	Same
Medium (ml) Volume for
Left Lung:	Yes	Yes	Same
Criteria	Subject Device	Predicate Device	Comparison
	Vitrea CT Lung
Density Analysis
Software	VIDA Pulmonary
Workstation 2
(PW2)
Ability to measure volume
of Left lung voxels in the
middle HU density range
as defined by the density
thresholds	Yes
Medium (ml) Volume for
Both Lungs:
Ability to measure addition
of volumes of both lungs
voxels in the middle HU
density range as defined
by the density thresholds	Yes	Yes	Same
High (ml) Volume for
Right Lung:
Ability to measure volume
of Right lung voxels in the
highest HU density range
(such as vessels) as
defined by the density
thresholds	Yes	Yes	Same
High (ml) Volume for
Left Lung:
Ability to measure volume
of Left lung voxels in the
highest HU density range
(such as vessels) as
defined by the density
thresholds	Yes	Yes	Same
High (ml) Volume for
Both Lungs:
Ability to measure addition
of volumes of both lungs
voxels in the highest HU
density range (such as
vessels) as defined by the
density thresholds	Yes	Yes	Same
Right Lung (ml) Volume:
Ability to provide Right
lung volume including only
the voxels designated as
Low and Medium Right	Yes	Yes	Same
Criteria	Subject Device	Predicate Device	Comparison
	Vitrea CT Lung
Density Analysis
Software	VIDA Pulmonary
Workstation 2
(PW2)
lung tissues
Left Lung (ml) Volume:
Ability to provide Left lung
volume including only the
voxels designated as Low
and Medium Left lung
tissues	Yes	Yes	Same
Lung (ml) Volume:
Ability to provide addition
of both lungs volumes
including only the voxels
designated as Low and
Medium Right and Left
lung tissues	Yes	Yes	Same
Low Density (LD) Index
(%) for Right Lung:
$Low RightLung volume(Low RightLung volume+Medium RightLung volume)$	Yes	Yes	Same
Low Density (LD) Index
(%) for Left Lung:
$Low LeftLung volume(Low LeftLung volume+Medium LeftLung volume)$	Yes	Yes	Same
Low Density (LD) Index
(%) for Both Lungs:	Yes	Yes	Same
Criteria	Subject Device
Vitrea CT Lung
Density Analysis
Software	Predicate Device
VIDA Pulmonary
Workstation 2
(PW2)	Comparison
Addition of Left
and Right Lungs
Low volumes
(Addition of Left
and Right Lungs
Low volumes

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Image /page/10/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, and the dot above the "i" is a solid black circle. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.

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Image /page/11/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot above the "i" in "VITAL" is a solid black circle.

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Image /page/12/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is in black, and the dot above the "i" is a perfect circle.

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Differences in Technology with the Predicate Device:

	Subject Device	Predicate Device
Criteria	Vitrea CT Lung Density Analysis Software	VIDA Pulmonary Workstation 2 (PW2)	Comparison
Low density
cluster analysis	No	Yes	The support for low
density cluster
analysis is not part of
the subject device.

Similarities in Technology with the Reference Device:

	Subject Device	Reference Device	Comparison
Criteria	Vitrea CT Lung
Density Analysis
Software	VITREA2, Version 3.7
Medical Image
Processing System
(Lung Analysis)
Segmentation	Yes	Yes	Similar

Note: The Lung Analysis preset shows lung segmentation as a single region while the CT Lung Density Analysis preset provides left and right lung regions. The sum of left and right lung regions in the Lung Density Analysis preset is equivalent to the lung region in Lung Analysis preset. |

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Summary of Non-Clinical Tests:

The Vitrea CT Lung Density Analysis software was designed, developed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements.

The following design control measures were applied to the development of the Vitrea CT Lung Density Analysis software:

. Risk Management
Requirements Reviews ●
Code Designs .
Code Development Testing .
Code Reviews
Design Reviews
Verification of the software that included performance and safety testing ●
Validation of the software that included phantom testing and simulated usability testing . by experienced professionals.

Risk Management:

Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.

During the design review, the following conclusions were reached:

The medical benefits of the device outweigh the residual risk for each individual risk and ● all risks together
. The overall residual risk for the project is deemed acceptable

Verification:

The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.

Validation:

The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met.

Internal Validation (Phantom Testing):

The software validation team provided internal validation of Vitrea CT Lung Density Analysis software. Internal validation included internal user acceptance testing using various phantoms. Results of numerical quantities calculated by CT Lung Density Analysis were verified using CT semi-synthetic phantoms and patient based CT datasets.

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Image /page/15/Picture/0 description: The image shows the word "VITAL" in bold, black letters. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font.

External Validation:

During external validation of the CT Lung Density Analysis software, experienced users evaluated the visualization, axial plane location, quantification of density, and snapshots among other features. Each user felt that the Vitrea CT Lung Density Analysis software enables the user to assess and quantify lung density.

Summary of Clinical Tests:

The subject of this 510(k) notification, Vitrea CT Lung Density Analysis software, did not require clinical studies to support safety and effectiveness of the software.

Cyber and Information Security:

Confidentiality

The Vitrea platform (K071331) relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.

Integrity

The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. New DICOM produced by Vitrea is identified as such with the appropriate manufacturer tags per the DICOM standard.

Availability

The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.

Accountability

The Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.

Performance Standards:

The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.

| Standard No. | Standards
Organization | Standard Title | Version | Date |
|-------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| PS 3.1- 3.20 (2011)
(Recognition
Number 12-238) | NEMA | Digital Imaging and
Communications in Medicine
(DICOM) Set (Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007
(Recognition
Number 5-70) | AAMI / ANSI
/ ISO | Medical Devices -
Applications of Risk
Management to Medical
Devices | 2007 | 03/16/2012 |
| IEC 62304:2006
(Recognition
Number 13-32) | AAMI / ANSI
/ IEC | Medical Device Software -
Software Life Cycle
Processes (Software /
Informatics) | 2006 | 08/20/2012 |

The Vitrea software complies with the following voluntary recognized consensus standards:

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Image /page/16/Picture/0 description: The image shows the word "VITAL" in all capital letters. The letters are black and bolded. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font.

Substantial Equivalence Analysis Conclusion:

Vital Images believes the CT Lung Density Analysis software application has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed VIDA Pulmonary Workstation 2 software (K083227). In addition, the segmentation algorithm is similar to the algorithm available on already cleared CT Lung Analysis software (K043333).

Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed tests demonstrate the safety and efficacy of the subject device. Based on the comparison information provided above, Vital Images believes the subject device should be found substantially equivalent to the predicate device.