Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes automated measurements based on user identification of nodules, not autonomous AI/ML detection or characterization.

Therapeutic

No.
The device is intended for the review and analysis of thoracic CT images to characterize lung nodules and aid in measuring them, which is a diagnostic function, not a therapeutic one.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" states that the device is for "characterizing nodules in the lung," which includes automatically performing measurements like "diameter, volume over time." This information is used to assess the nature and progression of lung nodules, which is a diagnostic purpose to aid in determining a patient's condition or disease prognosis.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Lung Analysis Software" and describes its function as analyzing and measuring lung nodules from CT images. There is no mention of accompanying hardware components being part of the device itself. The testing described focuses on software performance and image analysis.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: This device analyzes thoracic CT images. These are images generated by a medical imaging scanner, not samples taken from the body.
Intended Use: The intended use is for the review and analysis of these images to characterize lung nodules. This is an image analysis and measurement tool, not a diagnostic test performed on biological samples.

Therefore, while it's a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

Product codes

JAK, LLZ

Device Description

Lung Analysis aids in measuring and characterizing lung nodules. The interface and automated tools help to efficiently determine growth patterns and compose comparative reviews. Lung Analysis is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The Lung Analysis Software requires the user to identify a nodule and to determine whether it is a GGO or solid nodule in order to use the appropriate characterization tool.

Key features:
General Viewing:

Automated segmentation of lung and airways
Single click lung nodule segmentation tools to include solid nodules and ground glass opacity (GGO) nodules
Restore previously segmented nodules from prior studies for comparison
Evaluation of nodules with quantitative measurements
Dictation Table with Lung-RADS, Fleischner Criteria and option to export to Clipboard
Structured reporting available for export in the Viewer tab as well as the Reporting tab
Load three studies concurrently for temporal measurements
Select a nodule in a single time point and the tool will automatically find the nodule in the other studies loaded
Automatic nodule tracking of all measurements
Improved nodule management and numbering
Ability to export snapshots, CSV and copy to Clipboard features
- Available in Viewer and Report page

General Image Display, Manipulation, and Analysis Tools:

Automatic software calculation of the following measurements for each segmented nodule:
- Volume (mm³)
- Mean diameter (mm)
- Maximum diameter (mm) (RECIST)
- Short axis diameter (mm) (WHO)
- Average/minimum/maximum densities (HU)
- Manual edit of the nodule segmentation contour lines with automatic recalculation of all measurements post-editing
Manual specification of the following characteristics for each nodule:
- Lobe Location
- Shape
- Border
Comparison feature that allows establishing correspondence between nodules in two or three studies, and automatic calculation of the following temporal measurements between each follow-up scan and the previous scan:
- Elapsed time in days
- Doubling time in days
- Percent (%) growth in nodule volume

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

thoracic CT images

Anatomical Site

lung

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Radiologists, Technologist

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

Phantom Testing Dataset:

Source: Anthropomorphic lung phantoms with synthetic nodules.
Annotation Protocol: Not explicitly stated, but implies ground truth established by phantom construction.

Patient-based Dataset:

Source: Patient-based datasets.
Annotation Protocol: "User-edited GGOs" suggests manual annotation or refinement by users.

Summary of Performance Studies

Study Type: Non-clinical verification and validation tests, including phantom testing and external validation. No clinical studies were required or performed.

Phantom Testing:

Purpose: To verify that the Lung Analysis application generates reliable volumes and related linear and CT attenuation measurements of pulmonary ground glass opacifications (GGOs).
Sample Size: Not explicitly stated for the number of phantoms or nodules, but covers Siemens 64-CT, Philips 16-CT, and Toshiba AQ1 320-CT scanners.
Key Results: All phantom tests (Test 1.a, 1.b, 1.c, 3, 4) passed, indicating acceptable accuracy and precision for GGO volume, longest diameter, and mean CT attenuation measurements.
GGO Volume Accuracy and Precision (Toshiba scanner, 100mAs exposure):
- 5mm GGO Ref. diameter: Bias APE% 15.04%, Precision PRC% 24.74%
- 8mm GGO Ref. diameter: Bias APE% 16.15%, Precision PRC% 11.85%
- 10mm GGO Ref. diameter: Bias APE% 5.49%, Precision PRC% 3.24%
- 12mm GGO Ref. diameter: Bias APE% 2.98%, Precision PRC% 3.38%

Reproducibility (Patient-based dataset, User-edited GGOs):

Test 2: Evaluated intra-reader and inter-reader variability of GGO volume measurements.
Key Results: Intra-reader and inter-reader agreement were within acceptable ranges, measured by Concordance Correlation Coefficient (CCCinter), Total Deviation Index (TDI), and Coverage Probability (CV).

External Validation:

Description: Experienced medical professionals evaluated the application.
Key Results: All validators confirmed that the Lung Analysis software fulfills its intended uses.

Standalone Performance:

The software provides automated segmentation and measurement tools.

Key Metrics:

Accuracy (Phantom Tests): Absolute error (mm³), Absolute percentage normalized error %(APNE), Absolute error (mm), Absolute error (HU).
Precision (Phantom Tests): Percent Repeatability Coefficient (PRC), within-nodule standard deviation (wSD).
Reproducibility (Patient-based dataset): Intra-reader agreement, Inter-reader agreement, Concordance Correlation Coefficient (CCCinter), Total Deviation Index (TDI), Coverage Probability (CV).

Key Metrics

Bias: Absolute error (mm³), Absolute percentage normalized error %(APNE), Absolute error (mm), Absolute error (HU)
Precision: Percent Repeatability Coefficient (PRC), within-nodule standard deviation (wSD)
Intra-reader agreement: Concordance Correlation Coefficient (CCCinter), Total Deviation Index (TDI), Coverage Probability (CV)
Inter-reader agreement: Concordance Correlation Coefficient (CCCinter), Total Deviation Index (TDI), Coverage Probability (CV)

Predicate Device(s)

K043333

Reference Device(s)

K033374

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

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 30, 2015

Vital Images, Inc. % Mr. Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343

Re: K151283

Trade/Device Name: Lung Analysis Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: October 9, 2015 Received: October 13, 2015

Dear Mr. Shah:

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.

Michael O'Hara For

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) K151283

Device Name Lung Analysis

Indications for Use (Describe)

The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 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 word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

510(k) Summary

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

Purpose of Submission:	Vital Images, Inc. hereby submits this traditional 510(k) for changes that do not qualify for a Special 510(k) notification.
Submitter:	Vital Images, Inc.
5850 Opus Parkway
Suite 300
Minnetonka, MN, 55343-4414
Establishment Registration:	2134213
510(k) Submitter:	Parthiv Shah
Sr. Regulatory Affairs Specialist
Phone : 952-487-9574
Fax: 952-487-9510
E-mail: pshah@vitalimages.com
FDA Contact:	Vince Swenson
Sr. Director Quality and Regulatory Affairs
Phone : 952-487-9548
Fax: 952-487-9510
E-mail: vswenson@vitalimages.com
510(k) Type:	Traditional
Summary Date:	October 9, 2015
Device Trade Name:	Lung Analysis Software
Device Common Name:	Radiological Image Processing Software
Device Classification Name:	System, Image Processing, Radiological
Regulatory Description:	Picture Archiving and Communications System
Regulation Number:	21 CFR 892.1750
Product Code:	JAK
Regulatory Classification:	Class II

043_Updated_007_510k_Summary (21 CFR 807.92)

4

Image /page/4/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word, in smaller, red letters, is the phrase "A Toshiba Medical Systems Group Company". The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

Predicate Device:

Predicate Device	Manufacturer	FDA 510(k) number
Lung Analysis
(Legally Marketed Device)	Vital Images, Inc.	K043333

Reference Device:

Reference Device	Manufacturer	FDA 510(k) number
LungCARE CT
(Legally Marketed Device)	Siemens Medical Solutions,
Inc.	K033374

Device Description:

Lung Analysis aids in measuring and characterizing lung nodules. The interface and automated tools help to efficiently determine growth patterns and compose comparative reviews. Lung Analysis is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed. The Lung Analysis Software requires the user to identify a nodule and to determine whether it is a GGO or solid nodule in order to use the appropriate characterization tool.

Key features:

General Viewing:

. Automated segmentation of lung and airways
Single click lung nodule segmentation tools to include solid nodules and ground glass opacity (GGO) nodules
Restore previously segmented nodules from prior studies for comparison ●
Evaluation of nodules with quantitative measurements .
Dictation Table with Lung-RADS, Fleischner Criteria and option to export to Clipboard
Structured reporting available for export in the Viewer tab as well as the Reporting tab .
Load three studies concurrently for temporal measurements .
. Select a nodule in a single time point and the tool will automatically find the nodule in the other studies loaded
Automatic nodule tracking of all measurements
Improved nodule management and numbering ●
Ability to export snapshots, CSV and copy to Clipboard features
- Available in Viewer and Report page o

General Image Display, Manipulation, and Analysis Tools:

. Automatic software calculation of the following measurements for each segmented nodule:
- Volume (mm³) o
- Mean diameter (mm) O

043_Updated_007_510k_Summary (21 CFR 807.92)

5

Image /page/5/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 above the "i" is a perfect circle.

Maximum diameter (mm) (RECIST) o
O Short axis diameter (mm) (WHO)
Average/minimum/maximum densities (HU) o
Manual edit of the nodule segmentation contour lines with automatic recalculation of all measurements post-editing
. Manual specification of the following characteristics for each nodule:
- o Lobe Location
- Shape o
- O Border
. Comparison feature that allows establishing correspondence between nodules in two or three studies, and automatic calculation of the following temporal measurements between each follow-up scan and the previous scan:
- o Elapsed time in days
- Doubling time in days o
- Percent (%) growth in nodule volume O

Intended Use / Indications for Use:

The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

Changes from the last 510(k) clearance K043333:

No.	Change(s)	Rationale for Changes
1	Change-1: Support of Ground Glass Opacity
(GGO) Nodule
Provides the ability to probe and segment a
GGO type lung nodule. In addition, this feature
includes the ability to use 2nd Maximum
Diameter to measure the solid portion of a GGO
nodule and enabling solid nodules to be
segmented prior to GGO nodules.	Extend the capabilities and
functionality of the previously cleared
Lung Analysis software to provide
physicians the ability to examine and
report on GGO nodules which can
be cancerous.
2	Change-2: Lung Analysis Performance
Enhancements
Improvements to enhance the overall
performance of Lung Analysis.	Enhance performance to include
improved execution and workflow for
better user experience and function.
3	Change-3: Nodule Numbering Enhancement
Updated nodule numbering to automatically
update numbering to the next sequential
number, specifically after deletion of a previously
numbered nodule.	Provide continuous numbering
during probing and matching of
nodules for better user experience.

6

Image /page/6/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word, in a smaller, red font, is the text "A Toshiba Medical Systems Group Company". The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

No.	Change(s)	Rationale for Changes
4	Change-4: Dictation Table Addition
Added a dictation table with the ability to enable
L-Rad and Fleischner criteria.	Add the functionality of dictation
table with L-RAD and Fleischner
criteria as these are standard criteria
for reporting on lung cancer
screenings and diagnosis.
5	Change-5: Replaced Current Editing Feature
The previous editing configuration was replaced
with a Lung Region editing functionality.	Replaced with Region editing to
increase the lung field which is to be
examined for more precise nodule
segmentation.
6	Change-6: Replaced Effective Diameter
Measurement Function
The previous measurement function “effective
diameter” was replaced with “mean diameter.”	Replaced for enhanced performance
and usability as mean diameter
provides a more accurate
measurement.

Intended for Disease / Condition / Patient Population:

The software provides Radiologists, Technologist, with a robust application to locate, identify, segment, measure and create reports on solid and GGO nodules. This application allows for the preparation of nodule comparison studies.

Substantial Equivalence Comparison:

● Regulatory Comparison with the Predicate Device

Criteria	Predicate Device	Subject Device	Comparison
	Lung Analysis (K043333)	Lung Analysis
(Modified Lung
Analysis Software)
Device Type /
Classification Name	System, Image Processing,
Radiological	System, Image
Processing,
Radiological	Same
Common Name	Radiological Image Processing
Software	Radiological Image
Processing Software	Same
Regulation /
Classification Number	21 CFR 892.2050	21 CFR 892.1750	Similar
Product Code	LLZ	JAK	Similar
Classification	Class II	Class II	Same
Review Panel	Radiology	Radiology	Same

043_Updated_007_510k_Summary (21 CFR 807.92)

Page: 043-4 (of 14)

7

Image /page/7/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word, in a smaller, red font, is the text "A Toshiba Medical Systems Group Company". The text below "VITAL" appears to be a descriptor of the company.

Criteria	Predicate Device	Subject Device	Comparison
	Lung Analysis
(K043333)	Lung Analysis
(Modified Lung
Analysis Software)
Indications for Use	The separately-
licensed Lung
Analysis option is
intended for the
review and analysis
of thoracic CT
images for the
purposes of
characterizing
nodules in the lung in
a single study, or
over the time course
of several thoracic
studies.
Characterizations
include diameter,
volume and volume
over time. The
system automatically
performs the
measurements,
allowing lung nodules
and measurements to
be displayed.	The separately-
licensed Lung
Analysis option is
intended for the
review and analysis
of thoracic CT
images for the
purposes of
characterizing
nodules in the lung in
a single study, or
over the time course
of several thoracic
studies.
Characterizations
include diameter,
volume and volume
over time. The
system automatically
performs the
measurements,
allowing lung nodules
and measurements to
be displayed.	Same

Intended Use Comparison with the Predicate Device ●

Technology Comparison with the Predicate Device ●

Criteria	Predicate Device	Subject Device	Comparison
	Lung Analysis
(K043333)	Lung Analysis
(Modified Lung
Analysis Software)
Image
Communication
Standard: DICOM	Yes	Yes	Same
2D Image Review	Yes	Yes	Same
3D Image Review	Yes	Yes	Same
Criteria	Predicate Device	Subject Device	Comparison
	Lung Analysis
(K043333)	Lung Analysis
(Modified Lung
Analysis Software)
2D and 3D
Comparative Review	Yes	Yes	Same
3D Lung map	Yes	Yes	Same
2D Measurements	Line and ROI tools
with statistics
Area	Line and ROI tools
with statistics
Area	Same
Density
Measurements	Minimum, Maximum
and Average HU	Minimum, Maximum
and Average HU	Same
Temporal
Measurements	Elapsed Time
% Growth in Volume
Doubling Time	Elapsed Time
% Growth in Volume
Doubling Time	Same
Workflow	Point-and-click
detection
Automated contouring
Automated
measurements
Manual correction	Point-and-click
detection
Automated
contouring
Automated
measurements
Manual correction	Same
Multi-planar
reformatting	MPR in any user-
defined linear plane,
MIP and average	MPR in any user-
defined linear plane,
MIP and average	Same
Auto-cine	Yes	Yes	Same
Save workflow	Restorable state from
user snapshots	Restorable state from
user snapshots	Same
Reporting	Detailed tabular report
with auto-population of
user-defined key
images	Detailed tabular
report with auto-
population of user-
defined key images	Same
Printing	Printing to standard
windows printers	Printing to standard
windows printers	Same
Criteria	Predicate Device	Subject Device	Comparison
	Lung Analysis
(K043333)	Lung Analysis
(Modified Lung
Analysis Software)
Ease of Use	Visualization presets
and semi-automated
steps for typical image
review procedures	Visualization presets
and semi-automated
steps for typical
image review
procedures	Same

8

Image /page/8/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 text appears to be a logo or branding for a company.

9

Image /page/9/Picture/0 description: The image shows the word "VITAL" in black, with a red subtitle that reads "A Toshiba Medical Systems Group Company". The font is sans-serif and the letters are bold. The dot on the "i" is a circle.

. Technology Comparison with the Reference Device

Criteria	Reference Device	Subject Device	Comparison
	LungCARE CT
(K033374)	Lung Analysis
(Modified Lung
Analysis Software)
Feature: Support of
GGO lung nodule

The GGO lung
nodule feature
allows for detection,
segmentation and
tracking over time of
GGO nodules. | Yes | Yes | Same

Note: The added
GGO lung nodule
feature is similar to
the feature on the
already cleared
Siemens Medical
Solutions, Inc.,
LungCARE CT
("Reference Device")
software package by
K033374. Therefore,
the added feature
does not raise new
questions of safety
and effectiveness. |

10

Image /page/10/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 word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

Criteria	Predicate Device	Subject Device	Comparison
	Lung Analysis
(K043333)	Lung Analysis
(Modified Lung Analysis Software)
Feature: Support
of Ground Glass
Opacity (GGO)
Nodule and 2nd
Maximum
Diameter Rulers
Provides the ability
to probe and
segment a GGO
type lung nodule. In
addition, this
feature includes the
ability to use 2nd
Maximum Diameter
to measure the
solid portion of a
GGO nodule and
enabling solid
nodules to be
segmented prior to
GGO nodules.	No	Yes	The added features
do not affect the
intended use or
fundamental scientific
technology of the
already cleared Lung
Analysis software
(K043333).

Note: The added
GGO lung nodule
feature is similar to
the feature on the
already cleared
Siemens Medical
Solutions, Inc.,
LungCARE CT
("Reference Device")
software package by
K033374. Therefore,
the added feature
does not raise new
questions of safety
and effectiveness. |
| Enhancement:
Lung Analysis
Performance
Improvements to
enhance the overall
performance of
Lung Analysis. | No | Yes | The added
performance
enhancements do not
affect the intended
use or fundamental
scientific technology
of the already cleared
Lung Analysis
software (K043333). |
| Criteria | Predicate Device | Subject Device | Comparison |
| | Lung Analysis
(K043333) | Lung Analysis
(Modified Lung
Analysis Software) | |
| Enhancement:
Nodule
Numbering
Updated nodule
numbering to
automatically
update numbering
to the next
sequential number,
specifically after
deletion of a
previously
numbered nodule. | No | Yes | This enhancement
does not affect the
intended use or
fundamental scientific
technology of the
already cleared Lung
Analysis software
(K043333). |
| Enhancement:
Dictation Table
Added a dictation
table with the ability
to enable L-Rad
and Fleischner
criteria. | No | Yes | This enhancement
does not affect the
intended use or
fundamental scientific
technology of the
already cleared Lung
Analysis software
(K043333). |
| Change: Replaced
Current Editing
Feature
The previous
editing
configuration was
replaced with a
Lung Region
editing functionality. | No | Yes | This change does not
affect the intended
use or fundamental
scientific technology
of the already cleared
Lung Analysis
software (K043333). |
| Change: Replaced
Effective Diameter
Measurement
Function
The previous
measurement
function "effective
diameter" was
replaced with
"mean diameter." | No | Yes | This change does not
affect the intended
use or fundamental
scientific technology
of the already cleared
Lung Analysis
software (K043333). |

● Differences in Technology with the Predicate Device

11

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 text appears to be a logo or branding for a company.

12

Image /page/12/Picture/0 description: The image shows the word "VITAL" in large, 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 affiliation provided as additional context.

. Substantial Equivalence Analysis

The enhancements in the software do not affect the intended use or alter the fundamental scientific technology of the legally marketed Lung Analysis software (K043333). The modified Lung Analysis software has the same indications for use, principle of operation, and performs the same technological functions as the already cleared Lung Analysis software - K043333 (Predicate Device). The added GGO lung nodule feature is similar to the already cleared Siemens Medical Solutions, Inc., LungCARE CT (K033374) (Reference Device). The modifications are not consequential from the standpoint of device operation, safety, effectiveness or intended use. Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, and the performed verification and validation tests demonstrate the safety and efficacy of the device is equivalent to the predicate device. Based on the comparison data and test data, Vital Images believes the subject device should be found substantially equivalent to the predicate device.

Summary of Non-Clinical Tests:

The changes to the software were designed, developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new features operate according to their requirements.

Testing included verification, validation, and evaluation on previously acquired medical images. The following quality assurance measures were applied to the development:

Risk Management ●
. Requirements reviews
Code designs .
Code reviews
. Design reviews
. Verification of the software - that included performance and safety testing
. Validation of the software – that included simulated usability testing by independent experienced medical professionals.

Risk Management:

Each risk pertaining to this feature has 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 at least "Remote". All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Based on the post market information contained in our Clinical Evaluation Report, injury or death is very rare for our product and products similar to ours. Because of this history and 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:

All risks were reduced as low as possible ●
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

13

Image /page/13/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The dot of the "i" is a perfect circle. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo is simple and modern.

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.

Phantom Testing:

The phantom tests were performed is to verify that the Lung Analysis application generates reliable volumes and related linear and CT attenuation measurements of pulmonary ground glass opacifications (GGOs). The validation of the GGO measurements is based on anthropomorphic lung phantoms with synthetic nodules. Moreover, accuracy, intra-reader variability and interreader variability are assessed using patient-based datasets. In summary the following tests were performed:

1. GGO volume accuracy and precision: the accuracy and the precision of the GGO volume measurements after semi-automatic segmentation and before manual editing are within acceptable.
1. GGO volume reproducibility: the intra-reader and inter-reader agreement for the GGO volume measurements (patient-based dataset - after manual editing) are within acceptable ranges.
GGO diameters accuracy and precision: the accuracy and the precision of the GGO 3. longest nodule diameter measurements after semi-automatic segmentation and before manual editing are within acceptable ranges.
GGO mean CT attenuation accuracy and precision: the accuracy and the precision of 4. the GGO mean CT attenuation (HU) measurements after semi-automatic segmentation and before manual editing are within acceptable ranges.

ID	Test Case Name	Parameters	Type	Status
Test 1.a	Evaluate the accuracy and
precision of the GGO volume
measurement for Siemens 64-CT
scanner.	GGO volume
Bias: Absolute error (mm3)
Absolute percentage normalized
error %(APNE)

Precision: Percent Repeatability
Coefficient (PRC) | Phantom
dataset | Passed |
| ID | Test Case Name | Parameters | Type | Status |
| Test 1.b | Evaluate the accuracy and
precision of the GGO volume
measurement for Philips 16-CT
scanner. | GGO volume
Bias: Absolute error (mm3)
Absolute percentage normalized
error %(APNE)
Precision: Percent Repeatability
Coefficient (PRC) | Phantom
dataset | Passed |
| Test 1.c | Evaluate the accuracy and
precision of the GGO volume
measurement for Toshiba AQ1
320-CT scanner | GGO volume
Bias: Absolute error (mm3)
Absolute percentage normalized
error %(APNE)
Precision: Percent Repeatability
Coefficient (PRC) | Phantom
dataset | Passed |
| Test 2 | Evaluate the intra-reader and
inter-reader variability of GGO
volume measurements on
patient-based datasets. | Intra-reader agreement and
Inter-reader agreement:
Concordance Correlation
Coefficient (CCCinter, Total
Deviation Index (TDI), Coverage
Probability (CV) | Patient-
based
dataset
User-edited
GGOs | Passed |
| Test 3 | Evaluate the accuracy and
precision of the GGO longest
diameter measurement for
Toshiba AQ1 320-CT scanner. | Longest diameter (mm)
Bias: Absolute error (mm)
Absolute percentage normalized
error %(APNE)
Precision: within-nodule standard
deviation (wSD). | Phantom
dataset | Passed |
| Test 4 | Evaluate the accuracy and
precision of the GGO mean
attenuation measurement for
Toshiba AQ-One CT scanner. | Mean attenuation (HU)
Bias: Absolute error (HU) Absolute
percentage normalized error
%(APNE)
Precision: within-nodule standard
deviation (wSD). | Phantom
dataset | Passed |

The following table summarize the performed phantom tests:

14

Image /page/14/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 also black. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.

15

Measurement Accuracy:

The following table summarize accuracy i.e. average bias (APE %) and precision (PRC %) for lung GGO volume measurement performed on Toshiba scanner with 100mAs exposure.

GGO Ref. diameter	Bias APE%	Precision PRC%
5mm	15.04%	24.74%
8mm	16.15%	11.85%
10mm	5.49%	3.24%
12mm	2.98%	3.38%

The accuracy and precision results of the GGO volume measurements may vary for other CT scanner types or CT manufacturers and for other acquisition conditions involving tube current, slice thickness, reconstruction filters, etc.

External Validation:

During external validation of Lung Analysis software, experienced medical professionals evaluated the application. All validators confirmed that the Lung Analysis software fulfills its intended uses.

Summary of Clinical Tests:

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

Cyber and Information Security:

Confidentiality ●
The Vitrea platform (K150258) 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.

● Intearity

The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances.

● 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 tracks authenticated and authorized user operations along with information on what data was 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.

16

Image /page/16/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

The Lung Analysis software complies with the following voluntary recognized consensus standards:

| 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 |

Conclusion:

Vital Images believes that the Lung Analysis software application has the same intended use and indications and similar principle of operation, and technological characteristics as the predicate and reference devices. Any minor differences noted have been explained and do not raise any new 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 device in comparison to the predicate device. Based on the comparison data and test data, Vital Images believes the subject device should be found substantially equivalent to the predicate device. The Lung Analysis software device is as safe and effective as the predicate device.