Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description lists several image processing features like auto-segmentation, multi-planar reformatting, and fly-through, but none of these explicitly indicate the use of AI or ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No
The device is a software for processing CT images of the colon to aid in the examination of the lumen. It provides diagnostic assistance rather than direct therapeutic treatment.

Diagnostic

Yes

The device is intended for "locating and analyzing suspected polyps, masses and lesions" and facilitates "Polyp assessment using the C-RADS guidelines," which are activities related to diagnosis. While the last paragraph of the "Device Description" states "The software does not provide diagnosis or determine the recommended medical care," its functions directly support a physician in making a diagnosis.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as "Vitrea® CT Colon Analysis software" and its function is to process and display images generated from CT scans. The description focuses solely on software features and capabilities, and there is no mention of any accompanying hardware components that are part of the device itself. While it relies on CT data (generated by a separate hardware device), the device being cleared is the software for 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The described device is a software application that processes and visualizes medical images (CT scans) of the colon. It provides tools for examining the colon lumen, identifying potential abnormalities, and assisting in documentation.
Lack of Sample Analysis: The device does not analyze biological samples taken from the patient. Its input is image data, not biological material.
Intended Use: The intended use is to "closely examining the lumen of the colon" using image processing features. This is a diagnostic imaging tool, not an in vitro diagnostic test.
Device Description: The description focuses on image processing, visualization, and analysis features, not on the analysis of biological samples.
Statement in Description: The description explicitly states, "The software provides imaging information as an assistance to the physician. The software does not provide diagnosis or determine the recommended medical care." While IVDs also assist in diagnosis, their core function is the analysis of biological samples.

Therefore, this device falls under the category of medical image processing software, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.

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

LLZ

Device Description

Vitrea® CT Colon Analysis software generates 2D and 3D images of the colon to allow close examination of the lumen of the colon, thereby increasing the speed and ease of locating and analyzing suspected polyps, masses and lesions. Vitrea®CT Colon Analysis software has the following features:

. Auto-seqmentation of the colon
. Segmentation editing
. Axial imaging, multi-planar reformatting and 3D views
. Manual and automatic endoluminal fly-through of the colon
. Eye-based navigation for performing fly-through and target-based navigation for examining POI and Reverse View mode
MPR eye placement to adjust view direction down lumen
. Transparent wall view of the colon with a field-of-view cone to act as a reference during fly-through
. Dual Volume Viewer window format for side-by-side comparison of prone and supine studies
Ability to mark points in the colon with arrows; arrow are hidden from view when you fly too close
SPACE BAR to step through images containing arrows
Prone/supine registration .
. Polyp Probe tool to select and characterize polyps
Polyp assessment using the C-RADS guidelines
. Fly-through image batches and digital movies
Special report template that contains an anatomically-labeled diagram of the colon for . easier documentation of findings, as well as a C-RADS report template
. Fly-through keyboard shortcuts
. Automatic fluid/stool tagging and subtraction

Vitrea® CT Colon Analysis software deploys from the Vitrea® Platform, cleared under K150258, Vitrea®, Version 7.0 Medical Image Processing Software. The software provides imaging information as an assistance to the physician. The software does not provide diagnosis or determine the recommended medical care.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT

Anatomical Site

colon

Indicated Patient Age Range

Adult patients

Intended User / Care Setting

trained Radiologists, Clinicians or 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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical performance tests were conducted to demonstrate performance, safety, and effectiveness of the CT Colon Analysis Electronic Bowel Cleansing feature using datasets based on real patient data and phantoms. Verification and Validation activities were performed including: Risk Management, Requirements Reviews, Code Designs, Code Development Testing, Code Reviews, Design Reviews, Verification of the software that included performance and safety testing, and Validation of the software that included phantom testing and simulated usability testing by experienced professionals. The software validation team provided internal validation of Vitrea® CT Colon Analysis software, which included internal user acceptance testing using real scans as well as synthetic phantoms. Quantitative evaluation of polyp diameter accuracy using phantom datasets and run time performance evaluation were also part of the validation criteria. Experienced users evaluated auto-segmentation, axial imaging, multi-planar reformatting, fly-through viewing, simultaneous display of prone and supine images, and transparent wall view, and felt that the software meets user expectations and conforms to intended use.

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.

K052632

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.

K140920

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

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is positioned inside a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border.

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

March 16, 2016

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

Re: K160150 Trade/Device Name: Vitrea CT Colon Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 20, 2016 Received: January 21, 2016

Dear Ms. Erazo:

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. 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

1

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 D'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) K160150

Device Name Vitrea CT Colon Analysis

Indications for Use (Describe)

The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.

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.

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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:

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Image /page/3/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 text is centered below the word "VITAL". The logo appears to be for a medical company.

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: | Vital Images, Inc. hereby submits this Traditional 510(k) to provide a
notification submission for proposed software changes in the already
510(k) cleared K052632 VITREA2 Version 3.8 (CT Colonography
Application). |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment
Registration: | 2134213 |
| Contact Person: | Alexis Erazo
Regulatory Affairs Specialist
Phone : 952-487-9774
Fax: 952—487—9510
E-mail: aerazo@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | January 20, 2016 |
| Device Trade Name: | Vitrea® CT Colon Analysis |
| Device Common
Name/ Regulatory
Description: | Radiological Image Processing Software |
| Device Classification
Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory
Classification: | Class II |
| Device Panel: | Radiology |

Predicate Device(s):

Predicate Device	Manufacturer	FDA 510(k) Number
VITREA2, Version 3.8
Medical Image Processing
System (CT Colonography)	Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN 55343	K052632

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

Reference Device(s):

Reference Device	Manufacturer	FDA 510(k) Number
syngo.CT Colonography	Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355	K140920

Device Description:

Vitrea® CT Colon Analysis software generates 2D and 3D images of the colon to allow close examination of the lumen of the colon, thereby increasing the speed and ease of locating and analyzing suspected polyps, masses and lesions. Vitrea®CT Colon Analysis software has the following features:

. Auto-seqmentation of the colon
. Segmentation editing
. Axial imaging, multi-planar reformatting and 3D views
. Manual and automatic endoluminal fly-through of the colon
. Eye-based navigation for performing fly-through and target-based navigation for examining POI and Reverse View mode
MPR eye placement to adjust view direction down lumen
. Transparent wall view of the colon with a field-of-view cone to act as a reference during fly-through
. Dual Volume Viewer window format for side-by-side comparison of prone and supine studies
Ability to mark points in the colon with arrows; arrow are hidden from view when you fly too close
SPACE BAR to step through images containing arrows
Prone/supine registration .
. Polyp Probe tool to select and characterize polyps
Polyp assessment using the C-RADS guidelines
. Fly-through image batches and digital movies
Special report template that contains an anatomically-labeled diagram of the colon for . easier documentation of findings, as well as a C-RADS report template
. Fly-through keyboard shortcuts
. Automatic fluid/stool tagging and subtraction

Vitrea® CT Colon Analysis software deploys from the Vitrea® Platform, cleared under K150258, Vitrea®, Version 7.0 Medical Image Processing Software. The software provides imaging information as an assistance to the physician. The software does not provide diagnosis or determine the recommended medical care.

Intended Use / Indications for Use:

The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, flythrough, simultaneous display of prone and supine images, and transparent wall view.

048 Updated 510(k) Summary

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Image /page/5/Picture/0 description: The image shows the word "VITAL" in black, with the "i" having a dot above it. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red. The text is centered and the font is sans-serif.

Intended for Disease / Condition / Patient Population:

The software provides trained Radiologists, Clinicians or Technologist with a robust dedicated suite of software tools to aid in the creation of evidence to support these physicians with their screening and assessment of adult patients with suspected colon pathologies (i.e. suspicious polyps, masses, and lesions).

Rationale for Additions and Enhancements to CT Colonography Software:

Vitrea users, require an intuitive, accurate, and efficient application to review, investigate, and problem solve their colonography exams in order to provide information for the referring clinicians. Many patients are unable to complete full evacuation of fecal material and residual liquids in the colon, which can obscure potential lesions and pathology. Vital customers have repeatedly requested to have functionality to electronically remove this residual material from the colon in order to fully evaluate the colon for any abnormalities. When viewing the colon in either 2D or 3D it is very important to see all aspects of the colon, so Vital is introducing "Bowel Cleansing" as a means to remove any residual materials that may inhibit a reader from fully visualizing all aspects of the colon interior. Vital customers will now be able to electronically remove any residual fecal material that has been tagged with a tagging agent.

Substantial Equivalence Comparison:

	Subject Device	Predicate Device
Characteristic	Vitrea® CT Colon
Analysis Software	VITREA2, Version
3.8 Medical Image
Processing System
(CT Colonography)
K052632	Comparison
Classification Name	System, Image
Processing,
Radiological	System, Image
Processing,
Radiological	Same
Regulatory Number	892.2050	892.2050	Same
Product Code	LLZ	LLZ	Same
Classification	Class II	Class II	Same
Review Panel	Radiology	Radiology	Same
Decision Date	Under Review	December 15, 2005	Predicate and
Reference
devices are
cleared

Regulatory Comparison:

6

Image /page/6/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller font size.

Indications for Use Comparison with Predicate Device:

	Subject Device	Predicate Device
Criteria	Vitrea® CT Colon Analysis
Software	VITREA2, Version 3.8
Medical Image
Processing System (CT
Colonography) K052632	Comparison
Indications for
Use	The separately-licensed CT
Colonography option is
intended for closely
examining the lumen of the
colon using features such as
auto-segmentation, axial
imaging, multi-planar
reformatting, fly-through,
simultaneous display of
prone and supine images,
and transparent wall view.	The separately-licensed CT
Colonography option is
intended for closely
examining the lumen of the
colon using features such
as auto-segmentation, axial
imaging, multi-planar
reformatting, fly-through,
simultaneous display of
prone and supine images,
and transparent wall view.	Same
Intended Users	Radiologists, Clinicians or
Technologist	Radiologists, Clinicians or
Technologist	Same
Patient
Population	Adult patients with
suspected colon pathologies	Patients with suspected
colon pathologies	Similar
	Subject Device	Predicate Device
Criteria/Feature	Vitrea® CT Colon
Analysis Software	VITREA2, Version 3.8
Medical Image
Processing System (CT
Colonography)
K052632	Comparison
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
2D Imaging
Real-time window
level, zoom and
pan	Yes	Yes	Same
3D Imaging
Volume rendering
with window-level,
rotate, zoom an
pan	Yes	Yes	Same
Features and Capabilities
3D Measurements
Manual contour
volumes and
diameter	Yes	Yes	Same
2D Measurements
Ruler and ROI
tools with statistics	Yes	Yes	Same
3D/Axial Review	Yes	Yes	Same
Dual Volume Viewer	Yes	Yes	Same
Endoluminal Fly-
Through	Yes	Yes	Same
	Subject Device	Predicate Device
Criteria/Feature	Vitrea® CT Colon
Analysis Software	VITREA2, Version 3.8
Medical Image
Processing System (CT
Colonography)
K052632	Comparison
Target-based
navigation for
examining a POI	Yes	Yes	Same
Eye-based navigation
for performing fly-
throughs	Yes	Yes	Same
Assisted navigation	Yes	Yes	Same
Reverse view mode	Yes	Yes	Same
Fly-through images
batches and digital
movies	Yes	Yes	Same
Viewer auto rotation
to keep gravity	Yes	Yes	Same
MPR eye placement
to adjust view
direction down lumen	Yes	Yes	Same
Multi-planner
reformatting
Any user defined
linear plane, MIP
and average	Yes	Yes	Same
Auto-cine	Yes	Yes	Same
Save workflow
Restorable state
from user
snapshots,
including multiple
volume sessions	Yes	Yes	Same
Printing
Printing to
standard windows
printers	Yes	Yes	Same
	Subject Device	Predicate Device
Criteria/Feature	Vitrea® CT Colon
Analysis Software	VITREA2, Version 3.8
Medical Image
Processing System (CT
Colonography)
K052632	Comparison
Ease of use
Visualization presets for typical image review procedures Click-Drag-Click ruler interaction When In fly Though, click on tissue rotates to look at the crosshair "decoupled" eye and crosshair	Yes	Yes	Same
Viewers
Ability to not update MPRs while flying, only updates when you stop flying Lock MPR Cine Displays x, y, z, value for crosshair position to lower right of viewers	Yes	Yes	Same
Viewing capacities
MPR viewing of candidates Endoluminal viewing of candidates with	Yes	Yes	Same
	Subject Device	Predicate Device
Criteria/Feature	Vitrea® CT Colon
Analysis Software	VITREA2, Version 3.8
Medical Image
Processing System (CT
Colonography)
K052632	Comparison
viewing"
technology
Hardware
Requirements	Identical to the Vitrea®
Platform	Identical to the Vitrea®
Platform	Same
Software
Requirements	Identical to the Vitrea®
Platform	Identical to the Vitrea®
Platform	Same
Performance Testing
Nonclinical Testing
Safety and
Performance
Standards	Yes.
The subject device is
designed to fulfill the
requirements of the
following standards
DICOM, IEC 62304, and
ISO 14971.	Yes.
The CT Colonography
software within VITREA2,
Version 3.8 was designed
to fulfill the requirements
of the following standards
DICOM, IEC 62304, and
ISO 14971.	Same.
Software Verification
and Validation	Yes.
Vital has completed and
provided Software
Documentation for a
Moderate Level of
Concern software per
FDA's Guidance
Document "Guidance for
the Content of Premarket
Submissions for Software
Contained in Medical
Devices" issued on May
11, 2005	Yes.
The K052632 Submission
contained Software
Documentation for a
Moderate Level of
Concern software per
FDA's Guidance
Document "Guidance for
the Content of Premarket
Submissions for Software
Contained in Medical
Devices" issued on May
11, 2005	Same.
Please
reference
Attachments_03
5-043 for more
details.
Clinical Testing	Yes.
Clinical performance tests
were conducted to
demonstrate
performance, safety, and
effectiveness of the CT
Colon Analysis Electronic
Bowel Cleansing feature
using datasets based on	Yes.
Clinical performance tests
were conducted to
demonstrate performance,
safety, and effectiveness
of the CT Colonography
software within VITREA2,
Version 3.8.	Same.
Please
reference
Attachment_036
VLC-08319 A
Colon Electronic
Bowel Cleansing
Algorithm
Verification and
Validation and
Attachment_039
	Subject Device	Predicate Device
Criteria/Feature	Vitrea® CT Colon
Analysis Software	VITREA2, Version 3.8
Medical Image
Processing System (CT
Colonography)
K052632	Comparison
	real patient data and
phantoms.		VLC-08836 A
Vitrea CT Colon
EBC Verification
and Validation
Summary for
more details.

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Image /page/7/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 dot on the "i" in "VITAL" is a circle.

Similarities in Technology with Predicate Device:

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Image /page/8/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 dot on the "i" in "VITAL" is a circle.

9

Image /page/9/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 letters of the word "VITAL" are black, and the dot on the "i" is white.

10

Image /page/10/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 dot on the "i" in "VITAL" is a circle.

11

Image /page/11/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 logo is simple and professional, likely representing a company or organization.

Differences in Technology with the Predicate Device:

Criteria	Subject Device	Predicate Device
	Vitrea® CT Colon
Analysis Software	VITREA2, Version
3.8 Medical Image
Processing System
(CT Colonography)
K052632	Comparison
Electronic Bowel
Cleansing	Yes	No	Predicate device does
not contain the
automatic fluid/stool
tagging and subtraction
feature.

The added feature does
not affect the intended
use, indications for use,
or fundamental scientific
technology of the
already cleared CT
Colonography K052632. |

Similarities in Technology with the Reference Device:

The Electronic Bowel Cleansing enhancement features, subject of this 510(k) Submission, are highlighted in yellow color.

Feature/Criteria	Subject Device	Reference Device	Comparison
Modality	Vitrea® CT Colon
Analysis Software	syngo.CT Colonography
(K140920)
CT	Yes	Yes	Same
	Subject Device	Reference Device	Comparison
Feature/Criteria	Vitrea® CT Colon
Analysis Software	syngo.CT Colonography
(K140920)
Data Loading
DICOM	Yes	Yes	Same
Data Viewing Support
2D Imaging	Yes	Yes	Same
3D Imaging	Yes	Yes	Same
Features and Capabilities
Flythrough View	Yes	Yes
Panoramic Endoluminal
View	Same
Stool Tagging	Yes	Yes	Same
Filet View	Yes	Yes
Virtual Dissection	Same
Cube View	Yes	Yes.
Polyp Lens	Same
Electronic Bowl
Cleansing	Yes	Yes
Stool Subtraction	Same
Paging	Yes	Yes
Navigation through the CT
Volume Data Sets	Same
Semi-Automatic
Measurements	Yes	Yes	Same
Movie Reporting	Yes	Yes	Same
Volume Rendering	Yes	Yes
Volume Rendering
Technique (VRT)	Same
Size measurements
of polyps	Yes	Yes	Same
Segmentation in
Global View	Yes	Yes	Same
Feature/Criteria	Subject Device
Vitrea® CT Colon
Analysis Software	Reference Device
syngo.CT Colonography
(K140920)	Comparison
Flythrough Cut Plane	Yes	Yes
Polyp Enhanced Viewing
(PEV)	Same
Multiplanar
Reconstruction
(MPR)	Yes	Yes	Same
Flythrough	Yes	Yes
Virtual Flight	Same
Performance Testing
Nonclinical Testing	Yes.	Yes.	Same.
Safety and
Performance
Standards	The subject device is
designed to fulfill the
requirements of the
following standards
DICOM, IEC 62304, and
ISO 14971.	The syngo.CT
Colonography was
designed to fulfill the
requirements of the
following standards
DICOM, IEC 62304, and
ISO 14971.	Same.
Software Verification
and Validation	Yes.
Vital has completed and
provided Software
Documentation for a
Moderate Level of
Concern software per
FDA's Guidance
Document "Guidance for
the Content of Premarket
Submissions for Software
Contained in Medical
Devices" issued on May
11, 2005	Yes.
The K140920 Submission
contained Software
Documentation for a
Moderate Level of
Concern software per
FDA's Guidance
Document "Guidance for
the Content of Premarket
Submissions for Software
Contained in Medical
Devices" issued on May
11, 2005	Same.
Please
reference
Attachments_03
5-043 for more
details.
Clinical Testing	Yes.
Clinical performance tests
were conducted to
demonstrate
performance, safety, and
effectiveness of the CT
Colon Analysis Electronic
Bowel Cleansing feature
using datasets based on	Yes.
Clinical performance tests
were conducted to
demonstrate performance,
safety, and effectiveness
of syngo.CT
Colonography. Testing
was provided to cover a
variety of clinical situations
that would be seen in daily	Similar.
Please
reference
Attachment_036
VLC-08319 A
Colon Electronic
Bowel Cleansing
Algorithm
Verification and
Validation and
Feature/Criteria	Subject Device
Vitrea® CT Colon
Analysis Software	Reference Device
syngo.CT Colonography
(K140920)	Comparison
	real patient data and
phantoms.	clinical use of the subject
device.	Attachment_039
VLC-08836 A
Vitrea CT Colon
EBC Verification
and Validation
Summary for
more details.

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Summary of Non-Clinical Tests:

The Vitrea® CT Colon Analysis software was designed, 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 Colon Analysis software:

Risk Management ●
Requirements Reviews ●
. Code Designs
Code Development Testing
. Code Reviews
Desian 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 the Electronic Bowel Cleansing 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 "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
. All risks have been reduced as low as possible
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

048_Updated 510(k) Summary

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and monitored the Requirements Traceability Matrix (RTM) to ensure coverage of the items within the RTM. Reference Attachment 013 Summary of Performed Verification Tests with results.

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 properly to conform to the intended use. Reference Attachment 015 Summary of Performed Validation Tests with results.

Internal Validation and Phantom Testing:

The software validation team provided internal validation of Vitrea® CT Colon Analysis software. Internal validation included internal user acceptance testing using real scans as well as synthetic phantoms. The validation criteria covered image qualitative comparison of segmentation to previous releases, quantitative evaluation of polyp diameter accuracy using phantom datasets, and run time performance evaluation. Reference Attachment_014 Summary of Performed Phantom Tests with results.

External Validation:

During external validation of the CT Colon Analysis software, experienced users evaluated the auto-segmentation, axial imaging, multi-planar reformatting, fly-through viewing, simultaneous display of prone and supine images, and transparent wall view among other features. Each user felt that the Vitrea® CT Colon Analysis software meets the users' expectations and conforms to the intended use. Reference Attachment 015 Summary of Performed Validation Tests with results.

Summary of Clinical Tests:

The subject of this 510(k) notification, Vitrea® CT Colon 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.

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.

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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® CT Colon Analysis software complies with the following voluntary recognized consensus standards:

Substantial Equivalence Analysis Conclusion:

Vital Images believes that the Electronic Bowel Cleansing feature is only an enhancement to the predicate device, as the predicate (CT Colonography software cleared within K052632 VITREA2, Version 3.8) already contained the capability to identify and review visible polyps in different views. The basic workflow hasn't changed due to this enhancement. The predicate allowed the user to navigate through the colon and interrogate polyps in 2D and 3D viewers. This enhancement is an optional tool, which now allows the tagged material to allow the user to see the polyps more clearly (the ones that were covered by tagged material). It is important to note that the tagged material will not be necessarily hidden in all viewers because the user has the capability to control when or if they want it hidden. The user can toggle tagged material on or off in 2D and 3D views so it is up to the user to have it hidden in both, hidden in 3D only or visible in both. The risk of incorrectly removing polyps when hiding tagged material in 3D (which was observed 0% of the time during our validation) has been mitigated because the polyps can still be seen in 2D. Therefore, Vital believes this enhancement does not alter the fundamental scientific technology, safety or intended use of the device.

Furthermore, the verification and validation testing performed demonstrated the modified device is as safe and effective as the predicate device and does not raise different questions of safety

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and effectiveness than the predicate device (CT Colonography software within K052632 VITREA2, Version 3.8).

Vital Images believes the Vitrea® CT Colon Analysis software application has the same intended use, indications for use, principle of operation, and technological characteristics as the legally marketed predicate device K052632 VITREA2, Version 3.8 Medical Image Processing System (CT Colonography). The addition of the Electronic Bowel Cleansing feature is similar to the already cleared reference device Siemen's syngo.CT Colonography (K140920).

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 verification 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.