VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM

K043333 · Vital Images, Inc. · LLZ · Dec 15, 2004 · Radiology

Device Facts

• Record ID: K043333
• Device Name: VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
• Applicant: Vital Images, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 15, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

Vitrea™ 2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images. Vitrea 2, Version 3.7 has the following additional indications: CT Colonography The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, simultaneous display of prone and supine images, and transparent wall view. CT Cardiac The separately-licensed CT Cardiac option contains two components: Coronary Artery Analysis and Cardiac Functional Analysis. The Vital Images CT Cardiac provides a variety of tools and views for working with clinical CT images of the coronary arteries, heart, and surrounding tissue. Coronary Artery Analysis The Coronary Artery Analysis component of the Vitrea CT Cardiac option is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive approach to survey a patient's coronary arteries. The vessel probe technology integrated into the CT Cardiac option allows physicians to click on an artery to simultaneously view the highlighted vessel in 3D, two curved vessel views orthogonal to each other, and cross-sectional views. Cardiac Functional Analysis The Cardiac Functional Analysis (CFA) component of the Vitrea CT Cardiac option is intended to be used with CT studies of the heart to assist cardiologists and radiologists in the cardiac evaluation. The CFA component of the CT Cardiac option includes semi-automatic heart and left ventricle segmentation, including identification of long axis and mitral valve across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots. Lung Analysis 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.

Device Story

Vitrea2 is a medical image processing system for multi-dimensional visualization of digital images. It retrieves DICOM data over networks; displays images via dedicated protocols; allows interactive manipulation, annotation, and measurement. Options include: CT Colonography (lumen examination, auto-segmentation, prone/supine display); CT Cardiac (Coronary Artery Analysis for obstructive disease assessment via vessel probe technology; Cardiac Functional Analysis for heart/ventricle segmentation and global/regional metric calculation); and Lung Analysis (nodule characterization, diameter/volume measurement over time). Used in clinical settings by physicians/radiologists to aid diagnosis and pathology review. Output includes 2D/3D views, reports, and film/paper prints. Benefits include non-invasive assessment of coronary arteries and automated quantification of cardiac/lung metrics to support clinical decision-making.

Clinical Evidence

Bench testing only. Software was designed, tested, and validated according to written procedures, including product specifications, coding, testing, and maintenance. Potential hazards were addressed via a Risk Management Plan. No clinical trial data provided.

Technological Characteristics

Medical image processing software; DICOM-compliant; networked connectivity. Features include auto-segmentation, vessel probe technology, and multi-dimensional visualization. Software-based analysis for cardiac, colon, and lung imaging. No specific hardware materials or energy sources defined as it is a software system.

Indications for Use

Indicated for clinicians requiring processing, review, and analysis of multi-dimensional digital CT images for colonography, coronary artery disease assessment, cardiac functional evaluation, and lung nodule characterization.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Vitrea2, Version 3.5 (K040305)
• Vitrea2, Version 3.4 (K032748)
• Toshiba Cardiac Functional Analysis (K023760)
• R2 ImageChecker - LN500 (K023003)

Submission Summary (Full Text)

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## 6.0 510(k) Summary

DEC 1 5 2004

## Submitter's Name / Contact Person

Timothy J. Kappers, MBA, RAC Manager, Regulatory Affairs Vital Images, Inc. 3300 Fernbrook Lane N, Suite 200 Plymouth, MN 55447

### General Information

| Trade Name | Vitrea2, Version 3.7 Medical Image Processing<br>Software |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual<br>Name | System, Image Processing, Radiological |
| Classification Name | LLZ, Class II, CFR 21 892.2050 |
| Predicate Devices | Vitrea2, Version 3.5 (K040305) /Version 3.4 (K032748)<br>Vital Images, Inc. Toshiba Cardiac Functional Analysis (K023760)<br>Toshiba America Medical Systems, Inc. R2 ImageChecker - LN500 (K023003)<br>R2 Technologies, Inc. |

## Device Description

The Vitrea2 system is a medical diagnostic device that allows the processing, review, The Vitreaz System is a moulotal and media interchange of multi-dimages acquired images acquired andiyals, sommandation and ess. Vitrea2, Version 3.7 is an upgrade to Vitrea2, Version 3.5 (cleared under K040305).

The Vitrea2 system provides multi-dimensional visualization of digital images to aid climicals alimical slimical slimical slimical slimical slimical slimical slimical r he Vitreaz System provises minpathology. The Vitrea2 user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:

- Retrieve image data over the network via DICOM .
- Display images that are automatically adapted to exam type via dedicated protocols .
- Select images for closer examination from a gallery of up to six 2D or 3D views .

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- Interactively manipulate an image in real-time to visualize anatomy and pathology .
- Annotate, tag, measure, and record selected views .
- Output selected views to standard film or paper printers, or post a report to an Intranet . Output Selectorer or export views to another DICOM device
- Retrieve reports that are archived on a Web server .

## Intended Use

Vitrea™ 2 is a medical diagnostic system that allows the processing, review, analysis, Vitrea 2 is a medical diagriosite system that allows thought from a
communication and media interchange of multi-dimensional digital increased inoma communication and media interchange of mail: ambrider 3.7 has the following additional indications:

CT Colonography The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, an examilling the fulfien of the colon asing reatures out. It is and supine images, and transparent wall view.

CT Cardiac The separately-licensed CT Cardiac option contains two components: Coronary O Lardiac Trie Separately-licensed of Cardiao option'ital Mages' CT Cardiac option Aftery Analysis and Ourdial Analysis Analysis vith clinical CT images of the coronary arteries, heart, and surrounding tissue.

### Coronary Artery Analysis

The Coronary Artery Analysis component of the Vitrea CT Cardiac option is intended for The Odfonaly Analysis oomponent of the vise of the visease by providing a nondelemining the presence and oxient's coronary arteries. The vessel probe technology invasive approducts on our of a pation allows physicians' to click on an artery to integrated into the OT Octatus option thighlighted vessel in 3D, two curved vessel views orthogonal to each other, and cross-sectional views.

#### Cardiac Functional Analysis

The Cardiac Functional Analysis (CFA) component of the Vitrea CT Cardiac option is a intended to be used with CT studies of the heart to assist cardiologists and reditorials in the CT intended to be used with OF Stadios or and neavaluation. The CFA component of the CT assessing lunction which producing a taranatic heart and left ventricle segmentation, including Gardiac option includes some addination in and milliple phases; calculation identification of long uxio and mitral varies blume, end systolic volume, stroke volume, of grobal methos, moduling one access index, stroke index, and myocardial mass, and cloulation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.

Lung Analysis The separately-licensed Lung Analysis option is intended for the review and Eurig Analysis of the objaration in the purposes of characterizing nodules in the lung in a

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single study, or over the time course of several thoracic studies. Characterizations include
s and the success of the successions. The system automatically performs the single study, or over the time course of several them as banks and the matter, would be the matter, volume the diameter, volume and volume over time. The oyetting to be displayed.
measurements, allowing lung nodules and measurements to be displayed.
Theasurements, allowing lung nodule

## Predicate Device Comparison

The Vitrea2, Version 3.7 system and its predicate devices allow for the analysis, communication and The Virea2, Version 3.7 system and its predicate and a couisition devices. All devices support
media interchange of digital images acquired from a variety of acquisition devi media interchange of digital magos with other medical imaging devices.
the DICOM protocol for communication of images with other medical imaging devices.

## Summary of Studies

The software utilized was designed, tested, and validated according to written procedures.
In and The software utilized was designed, doroloped, to the supportune to developing and These procedures Spoolly inamedial
approving product specifications, coding, testing, validating and maintenance.

The Vitrea2, Version 3.7 system will successfully complete integration testing prior The Vitrea2, Version 3.7 system will Successfully completed prior to release. In
to Beta validation. Software Beta testing/validation will be successfully completed prior to to Beta validation. Sonware bela testing validation in the Management Plan.
addition, potential hazards have been studied and controlled by a Risk Management Plan.

### Conclusion

The Vitrea2, Version 3.7 system has similar intended uses as the predicate devices and has very
the stime the similar in the similar in the indelifferences do not raise any The Vitrea2, Version 3.7 system has similar interest do not raise any new questions
similar technological characteristics. Minor technological Version 2 7 evetem is substanti similar technological characteristics. Minor coonnological 1equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an image of a stylized bird, with three wavy lines representing its body and wings. The bird is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2004

Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K043333 Trade/Device Name: Vitrea™2, Version 3.7 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 29, 2004 Received: December 3, 2004

Dear Mr. Job:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (0S) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This Ictter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 3.0 Intended Use Statement

# 510(k) Number (if known): 长۵4 了333 5 ro(k) Number (if known), ersion 3.7 Medical Image Processing Software

Vitrea" 2 is a medical diagnostic system that allows the processing, review, analysis, communication and media
n, the Vitrea™ 2 is a medical diagnosic system that allows the processing, review, and more of the manage of man and the mana
interchange of multi-dimensional digital indical indic Interchange of multi-dimonolonal angladitional indications:

CT Colonography The separately-licensed CT Colonography option is intended for closely examining the lumen
the separated on the secure commentation, axial imaging multi-plan CT Colonography The separately-licensed CT Colonography option in ricehoo nor of the colorion of the colorida
of the colon using features such as auto-segment wall view of the colon using reatures such as auto Segmentation, the color of the color wall view.
simultaneous display of prone and supine images, and transparent wall view.

CT Cardiac The separately-licensed CT Cardiac option contains two components: Coronary Artery Analysis and
continued on the Child China and OT Cardine online and online a v CT Cardiac The separately-licensed CT Cardiac option continues a variey of tools and views for
Cardiac Functional Analysis. The Vital Images CT Cardiac provides a variey of t Cardiac Functional Analysis. The Vital Inages OT Garalao Spiro (1)
working with clinical CT images of the coronary arteries, heart, and surrounding tissue.

#### Coronary Artery Analysis

The Coronary Artery Analysis component of the Vitrea CT Cardian is intended for determing the survey a The Coronary Artery Analysis component on the Virtualing apprins since approach to survey a
presence and extent of coronary obstructive disease by providing and international presence and extent of coronary obserse by proving a not the CT Cardiac option allows
patient's coronary arteries. The vessel problem the CT Cardiac option allows patient's coronary arteries. The vessel problem the one of our and of on and of the super of the curved
physicians' to click on an antery to simultaneously view the highlight physicians 10 click on an antory to other, and cross-sectional views.

#### Cardiac Functional Analysis

The Cardiac Functional Analysis (CFA) component of the Vitea option is intended to be used The Cardiac Functional Analysis (CFA) component of Caranao optionship and consisted on the producing a
with CT studies of the heart to assist cardios esting includes semi-auc with CT studies of the heart to assist cardions in Lososeng includes sem-automatic heart and left
cardiac evaluation. The CFA component of the CT Cardiac option includes sero cardiac evaluation. The CFA component of the U Canado option installed on matries across multiple
ventricle segmentation, including identification of long endership volume, s ventricle segmentation, including dentification of this and thirds, end systolic volume, stores volume,
phases; calculation of global metrics, including end diastolic volume, phases; calculation of global metrics, fincluding end myserdial mass; and calculation of
ejection fraction, cardiac output, cardiac incex, and myocardial nestion, and c ejection fraction, cardiac output, cardiac index, and hyoourial mass .
regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, an plots.

Lung Analysis The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic
and of the separately-links and single in the lung in a single Lung Analysis The separately-licensed Ling Antalysis option is not rover the time course of
CT images for the purposes of characterizing hodules in the stidy, or over the sys CT images for the purposes of characterizing nodules in the surgest of the system.
several thoracic studies. Characterizations include diameter, volume and volume over time. several thoracic studies. Characterizations include diameter, volune and reasurements to be displayed.
automatically performs the measurements, allowing lung nodules and meas

| Prescription Use | X | AND/OR | Over-The-Counter Use |
|-----------------------------|---|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices 10/3332

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510(k) Number ________________________________________________________________________________________________________________________________________________________________

X0433333