VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE

K052632 · Vital Images, Inc. · LLZ · Dec 15, 2005 · Radiology

Device Facts

• Record ID: K052632
• Device Name: VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
• Applicant: Vital Images, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Vitrea2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.

Device Story

Vitrea2 is a medical image processing software system used by clinicians to visualize, analyze, and report on multi-dimensional digital images from various imaging devices. Input data is retrieved via DICOM network protocols. The system provides tools for 2D/3D visualization, interactive image manipulation, annotation, and measurement. Specific modules include Cardiac Functional Analysis (segmentation, global/regional metrics), Coronary Artery Analysis (lumen boundary detection, stenosis measurement), CT Colonography (axial/multi-planar imaging, transparent wall views), Vessel Probe (vascular survey, stenosis calculation), and VScore (cardiac scoring). Clinicians use the interface to review anatomy and pathology, aiding in clinical decision-making and diagnostic assessment. The system supports output to printers, Intranet, or DICOM-compliant devices.

Clinical Evidence

No clinical data. Software was designed, developed, tested, and validated according to internal procedures. Integration and verification testing were performed, and a Risk Management Plan was implemented to control potential hazards.

Technological Characteristics

Medical image processing software; DICOM-compliant; supports multi-dimensional visualization; includes semi-automatic segmentation and measurement tools for cardiac, vascular, and colon imaging; EKG Gate and Auto Gate processing for motion artifact reduction; standalone software application.

Indications for Use

Indicated for clinicians to assist in cardiac evaluation (CT CFA), coronary obstructive disease assessment (CT Coronary Artery Analysis), colon lumen examination (CT Colonography), peripheral vascular obstructive disease assessment (Vessel Probe), and cardiac scoring/atherosclerotic plaque quantification (VScore) using CT-derived images.

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 3.7 (K043333)

Submission Summary (Full Text)

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K052632

# DEC 1 5 2005

# 6.0 510(k) Summary

# Submitter's Name / Contact Person

Timothy J. Kappers, MBA, RAC Timothy of Rappors, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343

#### General Information

| Trade Name | Vitrea2®, Version 3.8 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 3.7 (K043333)<br>Vital Images, Inc. |

### Device Description

The Vitrea2 system is a medical diagnostic device that allows the processing, review, The Virous oyetem is a ministration of multi-dimensional digital images acquired from a variety of imaging devices.

The Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. 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 .
- 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 oblooks export views to another DICOM device
- Retrieve reports that are archived on a Web server .

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# Intended Use

Vitrea2 is a medical diagnostic system that allows the processing, review, analysis, villeaz is a modifornial of multi-dimensional digital images acquired from a variety of imaging devices.

# Cardiac Functional Analysis (CFA)

Carrillac I uncludinal Alliaryon ( O : 1 )
The CT CFA option is intended to be used with CT studies of the heart to assist cardiologists The OF Of A option is intonest to aches producing a cardiac evaluation. The CFA option includes semi-automatic heart and left ventricle segmentation, including identification of long includes scini adtomation across multiple phases; calculation of global metrics, including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac including only diactelle force index, and myocardial mass; and calculation of regional metrics; including wall motion, percentage of wall thickening, regional ejection fraction, and polar plots.

# Coronary Artery Analysis

Ouronaly Artery Printryon intended for determining the presence and extent of coronary obstructive disease by interious for dolormining survey of a patient's coronary arteries. Clinicians can select any providing a non in railowing anatomical references: the highlighted vessel in 3D, two ochonary artery to from thesel views displayed at 90 degree angles to each other, and cross rolations of the vessel. The clinician can semi-automatically determine contrasted lumen booking of the roosen reasurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics.

## CT Colonography

o i octoriography
The separately-licensed CT Colonography option is intended for closely examining the lumen The soparately noones such as auto-segmentation, axial imaging, multi-planar of the colon doing roctared back as a supine images, and transpes, and transparent wall view.

## Vessel Probe

The separately-licensed general Vessel Probe option is intended for determining the rne soparatory normood groupheral vascular obstructive disease by providing a non-invasive probonot and one on one al arteries. Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Crosssectional measurements can be obtained using standard Vitrea software measuring tools. Southerns can manually measure the lumen width to obtain percentage stenosis calculations, Olimolano oun'in a ratio of the largest diameter. In addition, clinicians can manually bubod on a rates of the centerline in standard curved MPR views and examine Houndsfield unit or signal intensity statistics.

## VScore

The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select

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images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.

# Predicate Device Comparison

The Vitrea2, Version 3.8 system and its predicate device allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices. All devices support the DICOM protocol for communication of images with other medical imaging devices.

# Summary of Studies

The software utilized was designed, developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.

The Vitrea2, Version 3.8 system will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.

# Conclusion

The Vitrea2, Version 3.8 system has the same intended uses as previously cleared Vitrea systems and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the Vitrea2, Version 3.8 system is substantially equivalent to the predicate device.

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DEC 15 2005

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines. Surrounding the eagle is a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052632 Trade/Device Name: Vitrea2®, Version 3.8 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 5, 2005 Received: December 6, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to maket the device referenced We have reviewed your Section 510(x) premaries nonivalent (for the indications for use stated in
above and have determined the device is substantially equivalent (for the sec above and have deleminned the devices marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been May 28, 1976, the enactinent date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordatice with the proval application (PMA). You may, therefore, market the A do not require approval of a prematics approviding of the general controls provisions of the Act
device, subject to the general controls provisions of the Act. The provise pr device, subject to the general controls of die real of the rear 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 If your device is classified (see above) into entrols - Existing major regulations affecting your Approval), it may be subject to such adultions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to B device can be tound in the coue vits concerning your device in the Federal Register.

Please be advised that FDA 's issuance of a substantial equivalence determination docs not mean that Please be advised mat 117A's Issualled of a succements of the requirements of the Act or any
FDA has made a determination that your device complies with all FDA has made a delemmation mar your ded be compress . You must comply with all the Federal statues and regulations administered by States of Sting (2 i CFR Part 807); labeling Act s requirements, including, out not minted to regionalisms.
(21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (05) (21 CFR Part 801), good manufacturing practice requirement radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a fegally premarket nothication: The PDA maing or our device and thus, permits your device to proceed to the market.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your derror on 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 Also, please note the regulation on your responsibilities under the Act from the 807.97). Tou may obtain other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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): ____________________________________________________________________________________________________________________________________________________ 5 for(r) Namber (if Rhow). - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Vitrea2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange in Vitreaz is a medical diagnostic system that allows the provins a variety of imaging devices.

#### Cardiac Functional Analysis (CFA)

Cardiac Functional Analysis (CFA)
The CT CFA option is intended to be artice indics of the heart to assist cartionalic head and left ventricle The CT CFA option is intended to be used will CT Studion to covi-ar the more of venticle of and eff venticle
function when producing a cardiation. The CF a ristial volunder s function when producing a cardiation. Ne CFA option incuran nical and more of consection of global
s egmentation, including identification of long and a velime, cordios card segmentation, including identification of intral are overlies institution cardiac output, cartiac index,
metrics, including end diastolic volume, end systell mation percent metrics, including end diastolic volume, end systolic volume, ejection including vall motion, percentage of wall thickening, regional ejection fraction, and polar plots.

#### Coronary Artery Analysis

Coronary Artery Analysis
The separately-licensed CT Coronary Artery Andrysis, which is intented by survey of a natient's corporary arteries The separately-licensed CT Cardiac option in the mainter on voy of a patients coronary atteries.
presence and extent of coronary obstructive disease by provided vessel in 3D, presence and extent of coronary attery to view the following an the relevised on the may on the see in 3D, wo
Clinicians can select any cornary attery to view to anto the can Clinicians can select any cornary attent of the more in and cross sections of the sesse. The rotatable curved MPF vesselyed at su degree ander is measurements, and maximum and
clinician can semi-automatically determine contrasted hymors heaving Houndsfield unit stati clinician can semi-automatically determine contrasted funen bounderies and examine Houndsfield unit statistics.
minimum lument in addition, clinicians can edit lumen boundari

#### CT Colonography

CT Colonography
The separately-licensed CT Colonography of the lument of the lumen of the colon using features The separately-licensed CT Colonography option is mended of Citsely Cathin Crice Color Color Color Color Color Color Sepine images, and transparent wall view.

Vessel Probe The separately-licensed general Vessel Problem in the love of userships and select any of the senseled any
vascular obstructive disease by providing a non-invasive survey of vascular obstructive disease by provincity of a patient of purprisental energen and MPR vessel views.
artery to view the following anatomical references: the hightighted mes atery to view the following anatomical references. In one wesser and measurements can be
displayed at angles orthogoral to each other, and cross sections of the umen with to displayed at angles orthoganal to each one, and closes counting neats the lument with to obtains of the lument with to obtain obtained using standard Virea somare measuring tools. Cincluded in addition, clinicians can
percentage stenosis calculations, based on a ratio of the langest diaments handre percentage stenosis calculations, based on a ratio of the shallest in dreams. In areast of the mail of the mail of it is gral intensity statistics.

VScore
The Vitrea VScore option is intended for cardias scoring from whole body CT derivas, including non-invasive The Vitrea VScore option is niended to cardial storing from whose EKG Stean ond Auto Gate, allow the detection and quantification of atheroscerous players of the Satish Internet of Coronary Artery Calcification Scoring.

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

Daniel A. Segerson

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