K Number
K052632
Device Name
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
Manufacturer
Date Cleared
2005-12-15

(80 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. Cardiac Functional Analysis (CFA) The CT CFA option is intended to be used with CT studies of the heart to assist cardiologists in evaluating heart and left ventricle function when producing a cardiac evaluation. The CFA option includes semi-automatic heart and left ventricle segmentation, including identification of long and short axes 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. Coronary Artery Analysis The separately-licensed CT Coronary Artery Analysis, which is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive survey of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi-automatically determine contrasted lumen boundaries, obtain measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics. 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, multi-planar reformatted images, supine and prone images, and transparent wall view. Vessel Probe The separately-licensed general Vessel Probe option is intended for determining the presence and extent of peripheral vascular obstructive disease by providing a non-invasive survey of a patient's peripheral 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. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on a ratio of the largest diameter. In addition, clinicians can manually edit 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 images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Device Description
The Vitrea2 system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange 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 .
More Information

Not Found

No
The document describes image processing and analysis techniques, but does not mention AI, ML, or related terms like neural networks or deep learning. The focus is on semi-automatic segmentation and measurement tools.

No
The device is described as a "medical diagnostic system" and "medical diagnostic device" that aids clinicians in "analysis of anatomy and pathology" and "evaluating heart and left ventricle function." It does not provide any treatment or therapy.

Yes

The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that Vitrea2 is a "medical diagnostic system" and a "medical diagnostic device," respectively. It aids clinicians in analyzing digital images to evaluate anatomy and pathology, including assessing heart function, detecting coronary obstructive disease, and examining the colon.

No

The device is described as a "system" that allows processing, review, analysis, communication, and media interchange of images acquired from "a variety of imaging devices." While it heavily relies on software for image processing and analysis, the description implies it interacts with and potentially includes components beyond just software to handle image acquisition, communication (DICOM), and output (printers, other DICOM devices). The term "system" generally suggests a combination of hardware and software.

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.
  • Device Function: The Vitrea2 system processes, reviews, and analyzes digital images acquired from imaging devices like CT scanners. It does not perform tests on biological samples.
  • Intended Use: The intended use describes the device's purpose as assisting clinicians in evaluating anatomy and pathology based on medical images. This is distinct from analyzing biological samples.

The device is a medical diagnostic system that utilizes imaging data, not in vitro samples.

N/A

Intended Use / Indications for 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.

Cardiac Functional Analysis (CFA)
The CT CFA option is intended to be used with CT studies of the heart to assist cardiologists in assessing and evaluating heart and left ventricle function when producing a cardiac evaluation. The CFA option includes semi-automatic heart and left ventricle segmentation, including identification of long and short axes 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.

Coronary Artery Analysis
The separately-licensed CT Coronary Artery Analysis option is intended for determining the presence and extent of coronary obstructive disease by providing a non-invasive survey of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi-automatically determine contrasted lumen measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics.

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, multi-planar reconstruction, supine and prone images, and transparent wall view.

Vessel Probe
The separately-licensed general Vessel Probe option is intended for determining the presence and extent of peripheral vascular obstructive disease by providing a non-invasive survey of a patient's peripheral 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. Cross-sectional measurements can be obtained using standard Vitrea2 software measuring tools. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on a ratio of the largest diameter. In addition, clinicians can manually trace 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 images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.

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

LLZ

Device Description

The Vitrea2 system is a medical diagnostic device that allows the processing, review, and administration 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.
  • Export views to another DICOM device.
  • Retrieve reports that are archived on a Web server.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT

Anatomical Site

Heart, Coronary Arteries, Colon, Peripheral Arteries

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinicians, Cardiologists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

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

The 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.

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.

K043333

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.

Not Found

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

§ 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).

0

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
Software |
|------------------------|------------------------------------------------------------|
| Common / Usual
Name | System, Image Processing, Radiological |
| Classification Name | LLZ, Class II, CFR 21 892.2050 |
| Predicate Devices | Vitrea2, Version 3.7 (K043333)
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 .

1

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

2

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.

3

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.

4

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
Other240-276-0100

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 (800) 638-2041 or (301) 443-6597 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

5

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 UseX
(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

Page

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number