K Number
K182230
Device Name
Multi Modality Viewer
Manufacturer
Date Cleared
2018-09-07

(21 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Multi Modality Viewer is an option within Vitrea that allows the examination of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Device Description
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data. The Multi Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows reformatting of image data, enables clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
More Information

No
The document describes a standard medical image viewer with features for comparison and reformatting, and explicitly states "Mentions AI, DNN, or ML: Not Found".

No
The device is described as a viewer and manipulation tool for medical images, intended for diagnostic purposes and analysis by healthcare professionals, not for therapy or treatment.

Yes

Explanation: The device is described as allowing the examination and manipulation of medical images and enabling clinicians to compare multiple series, which are actions intrinsic to the diagnostic process performed by qualified healthcare professionals. While it does not generate the initial images, it provides the tools for their interpretation, leading to a diagnosis.

Yes

The device is described as an "option within Vitrea" and its function is the examination and manipulation of medical images. The description focuses entirely on software functionalities like viewing, comparing, reformatting, and accessing other applications. There is no mention of any associated hardware component being part of the device itself.

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 Multi Modality Viewer is a software application that allows for the viewing and manipulation of medical images obtained from various imaging modalities (MRI, CT, etc.). It processes and displays images that are already acquired from the patient's body.
  • Lack of Sample Analysis: The device does not perform any analysis on biological samples. Its function is solely related to the visualization and comparison of medical images.

Therefore, the Multi Modality Viewer falls under the category of medical imaging software, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

Multi Modality Viewer is an option within Vitrea that allows the examination of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.

Product codes

LLZ

Device Description

Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.

The Multi Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows reformatting of image data, enables clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.

Features
General image display:

  • Display of images, volumes, and time sequences from MR and CT modalities
  • Display of images and time sequences from Projection Modality modalities (CR, DX, RF, RG, XA)
  • Display of images and time sequences from Ultrasound modalities
  • Display of PET images in grayscale or with a color map
  • Display of PET-CT images acquired with the same frame of reference
  • Display of derived modality images and secondary capture (SC) images
  • 2D image display, MPR display, cine and 4D cine display for appropriate modalities
  • Maximum, minimum, or average intensity projection for MPR with adjustable thickness and full volume Maximum Intensity Projection (MIP)
  • Fused display of PET-CT images acquired with the same frame of reference
  • Full volume MIP display
  • Display of high-resolution (1024 matrix) CT images
  • 3D Volume and Luminance image rendering

3D segmentation:

  • Six planes interactive orthogonal clipping box
  • Manual 3D volume cutting tool
  • Automated table segmentation
  • Automated bone segmentation
  • Segmentation correction tools

Image cross-reference and comparison:

  • Single MPR plane, 3-plane orthogonal MPR, and oblique MPR display
  • Linked scrolling of MPR images and 2D images in the same plane
  • Linked pan, zoom, and matched presentation of images in the same plane
  • Cross-reference lines and MPR cross-hairs to indicate orthogonal planes
  • Focus tool to pinpoint the same location in all series
  • Linking of PET hotspots in MIP and MPR views
  • Automatic linking of series with the same frame of reference
  • Automated rigid registration of current study and/or prior study(ies) with caching of automated registration result
  • Manually set reference point for linking separately acquired series

Hanging and viewing adjustments

  • Ability to load only one study or including all priors
  • User-defined, flexible hanging layouts.
  • Automatic initial hanging, manual hanging using drag & drop thumbnails
  • Scroll, pan, zoom, W/L, W/L presets, fit to view, reset
  • lmage flip, rotate clockwise/counter clockwise, invert
  • Demographics more, less, on/off, reference lines on/off, linking on/off.

Measurement, annotation, and snapshots:

  • Length (ruler), angle, and Cobb angle measurement
  • Ellipse ROI and freehand ROI with pixel value statistics
  • HU measurement for CT, SUV measurement for PET
  • Time-Intensity Analysis ROI
  • Arrow and text annotation
  • Manual snapshots. Auto snapshot on measurement or annotation.
  • Ability to restore the presentation state of a snapshot

Derived series and specialized tools:

  • MPR batch series generation
  • lmage subtraction of two compatible series
  • Direct access to MR Stitching application
  • Access to all other applications on Vitrea system

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT

Anatomical Site

Not Found

Indicated Patient Age Range

Not Applicable

Intended User / Care Setting

Qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.

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

External Validation:
Two sets of external validation were performed to ensure the clinical safety and effectiveness of the Multi Modality Viewer software.

Clinical Effectiveness Validation:
Three evaluators from three different clinical locations clinically reviewed anonymized datasets using the Multi Modality Viewer software. The reviewers were presented with a list of questions with regards to the functionality and image quality for the following software features: Full volume MIP, Clip Plane Box (Orthogonal Clipping pane), 2-click bone/base separation tool, 1-click bone/base separation tool, 1 Click Visible Seed (1-click segmentation), Automatic table segmentation and Automatic bone segmentation. 3D and Luminance rendering Automatic Rigid Registration (Auto Linked Navigation of Current and Priors)and basic ultrasound visualization support.

Substantial Equivalence Validation:
Three evaluators from three different clinical locations clinically reviewed anonymized datasets using the Multi Modality Viewer software, Vitrea Advanced Visualization software, Mirada XD software, and Vitrea View software. The evaluators were presented with a list of questions with regards to the functionality and image quality for the following software features: Full volume MIP, Clip Plane Box (Orthogonal Clipping pane), 3D Cutting Tool (Manual 3D Segmentation), 2-click bone/base separation tool, 1-click bone/base separation tool. 1 Click Visible Seed (1-click segmentation), Automatic table segmentation and Automatic bone segmentation, 3D and Luminance rendering, automatic registration and basic ultrasound visualization support.

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

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, requirements and risk mitigations. Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly.

The software validation team's primary goal was to assure that 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.

External Validation:
Two sets of external validation were performed to ensure the clinical safety and effectiveness of the Multi Modality Viewer software.

Clinical Effectiveness Validation:
Three evaluators from three different clinical locations clinically reviewed anonymized datasets using the Multi Modality Viewer software. There was no negative feedback received from the evaluators. The evaluators confirmed the Multi Modality software was sufficient to read the images and the software was determined to remain safe and effective for its intended use.

Substantial Equivalence Validation:
Three evaluators from three different clinical locations clinically reviewed anonymized datasets using the Multi Modality Viewer software, Vitrea Advanced Visualization software, Mirada XD software, and Vitrea View software. There were no instances recorded where the subject device performed inferior to one of the reference devices. Multi Modality Viewer was rated as equal to or better than the reference devices. This validation demonstrates substantial equivalence between Multi Modality Viewer and its predicate and reference devices with regards to intended use, clinical effectiveness and safety.

The overall outcome of the clinical validations performed demonstrate the clinical safety and effectiveness of the Multi Modality Viewer software.

Summary of Clinical Tests:
The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K163574

Reference Device(s)

K172855, K163232, K101228

Predetermined Change Control Plan (PCCP) - All Relevant Information

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).

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

Vital Images, Inc. Fei Li Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA, MN 55343-4414

Re: K182230

Trade/Device Name: Multi Modality Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 16, 2018 Received: August 17, 2018

Dear Fei Li:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

September 7, 2018

1

devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Balyer

for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182230

Device Name Multi Modality Viewer

Indications for Use (Describe)

Multi Modality Viewer is an option within Vitrea that allows the examination of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "VITAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.

510K Summary, K182230

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 expand
the Indications for Use and to establish substantial equivalence
between the Multi Modality Viewer Software (subject device) and the
FDA cleared predicate device Multi Modality Viewer Software
(K163574) and reference devices. |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment
Registration: | 2134213 |
| Contact Person: | Fei Li
Regulatory Affairs Specialist
Phone: 952-487-9739
Fax: 952-487-9510
E-mail: fli@vitalimages.com
Alternate Contact Person:
Vince Swenson
Sr. Director of Quality and Regulatory
Phone: 952-487-9548
Fax: 952-487-9510
E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | August 16, 2018 |
| Device Trade Name: | Multi Modality Viewer |
| Device Common
Name/ Requlatory
Description: | Radiological Image Processing Software, Picture Archiving and
Communications System |
| Device Classification
Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory
Classification: | Class II |
| Device Panel: | Radiology |

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Image /page/4/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The background is white.

Predicate Device(s):

Predicate DeviceManufacturerFDA 510(k) Number
Multi Modality ViewerVital Images, Inc.K163574

Reference Device(s):

Reference DeviceManufacturerFDA 510(k) Number
Vitrea Advanced
VisualizationVital Images, Inc.
5850 Opus Parkway, Suite 300,
Minnetonka, Minnesota 55343 U.S.A.K172855
Vitrea ViewVital Images, Inc.
5850 Opus Parkway, Suite 300,
Minnetonka, Minnesota 55343 U.S.A.K163232
Mirada XDMIRADA MEDICAL LTD.
Mill Street
Innovation House
Oxford, Oxfordshire, GB Ox2 0JXK101228

Device Description:

Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.

The Multi Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows reformatting of image data, enables clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.

Features

General image display:

  • Display of images, volumes, and time sequences from MR and CT modalities ●
  • Display of images and time sequences from Projection Modality modalities (CR, DX, RF, ● RG, XA)
  • Display of images and time sequences from Ultrasound modalities
  • Display of PET images in grayscale or with a color map ●
  • Display of PET-CT images acquired with the same frame of reference ●
  • Display of derived modality images and secondary capture (SC) images ●
  • 2D image display, MPR display, cine and 4D cine display for appropriate modalities
  • Maximum, minimum, or average intensity projection for MPR with adjustable thickness ● and full volume Maximum Intensity Projection (MIP)
  • . Fused display of PET-CT images acquired with the same frame of reference
  • Full volume MIP display
  • Display of high-resolution (1024 matrix) CT images
  • . 3D Volume and Luminance image rendering

3D segmentation:

  • Six planes interactive orthogonal clipping box ●
  • Manual 3D volume cutting tool ●
  • . Automated table segmentation

5

  • . Automated bone segmentation
  • Segmentation correction tools .

Image cross-reference and comparison:

  • Single MPR plane, 3-plane orthogonal MPR, and oblique MPR display ●
  • Linked scrolling of MPR images and 2D images in the same plane ●
  • Linked pan, zoom, and matched presentation of images in the same plane .
  • Cross-reference lines and MPR cross-hairs to indicate orthogonal planes ●
  • Focus tool to pinpoint the same location in all series ●
  • Linking of PET hotspots in MIP and MPR views .
  • Automatic linking of series with the same frame of reference .
  • Automated rigid registration of current study and/or prior study(ies) with caching of ● automated registration result
  • . Manually set reference point for linking separately acquired series

Hanging and viewing adjustments

  • Ability to load only one study or including all priors ●
  • . User-defined, flexible hanging layouts.
  • Automatic initial hanging, manual hanging using drag & drop thumbnails ●
  • Scroll, pan, zoom, W/L, W/L presets, fit to view, reset ●
  • . lmage flip, rotate clockwise/counter clockwise, invert
  • Demographics more, less, on/off, reference lines on/off, linking on/off .

Measurement, annotation, and snapshots:

  • Length (ruler), angle, and Cobb angle measurement ●
  • Ellipse ROI and freehand ROI with pixel value statistics .
  • HU measurement for CT, SUV measurement for PET ●
  • . Time-Intensity Analysis ROI
  • . Arrow and text annotation
  • Manual snapshots. Auto snapshot on measurement or annotation. .
  • Ability to restore the presentation state of a snapshot

Derived series and specialized tools:

  • MPR batch series generation ●
  • lmage subtraction of two compatible series ●
  • Direct access to MR Stitching application .
  • . Access to all other applications on Vitrea system

Proposed Intended Use / Indications for Use:

Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.

Intended for Disease / Condition / Patient Population:

Multi Modality Viewer is medical image viewer software. Therefore, particular information on the intended for disease, condition, and patient population is not applicable.

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Key Changes from the last 510(k) clearance K163574:

The following features and tools were added to the Multi Modality Viewer software:

  • Full volume MIP
  • · Volume image rendering
  • 3D Cutting Tool (Manual 3D Segmentation) .
  • · Clip Plane Box (Orthogonal Clipping panes)
  • · 2-click bone/base separation tool (2-click bone/base segmentation)
  • · 1-click bone/base separation tool (1-click bone/base segmentation)
  • · 1 Click Visible Seed (1-click segmentation)
  • · Automatic table segmentation
  • Automatic bone segmentation
    • Head/Neck Extremities
    • Chest/Abdominal/Pelvis
  • US 2D Cine Viewer
  • · Automatic Rigid Registration (Auto Linked Navigation of Current and Priors)

Substantial Equivalence Comparison:

Regulatory Comparison:

Subject DevicePredicate Device
CharacteristicMulti Modality ViewerMulti Modality Viewer (K163574)Comparison
Classification NameSystem, Image Processing, RadiologicalSystem, Image Processing, RadiologicalSame
Regulatory Number892.2050892.2050Same
Product CodeLLZLLZSame
ClassificationClass IIClass IISame
Review PanelRadiologyRadiologySame
Decision DateUnder ReviewJan 26, 2017Predicate device is cleared

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FAL Vil

Subject DevicePredicate DeviceComparison
CriteriaMulti Modality ViewerMulti Modality Viewer
(K163574)
Indications for
UseMulti Modality Viewer is
an option within Vitrea
that allows the
examination and
manipulation of a series
of medical images
obtained from MRI, CT,
CR, DX, RG, RF, US, XA,
PET, and PET/CT
scanners. The option also
enables clinicians to
compare multiple series
for the same patient,
side-by-side, and switch
to other integrated
applications to further
examine the data.Multi Modality Viewer is
an option within Vitrea
that allows the
examination
and manipulation of a
series of medical images
obtained from MRI, CT,
CR, DX, RG, RF, XA,
PET, and PET/CT
scanners. The option
also enables clinicians to
compare multiple series
for the same patient,
side-by-side, and switch
to other integrated
applications to further
examine the data.Similar
Added support for the
ability to examine and
manipulate medical
images obtained from
US modality which
was not part of the
predicate device's
indications for use.
Intended UsersQualified healthcare
professionals including,
but not restricted to,
radiologists, non-
radiology specialists,
physicians and
technologists.Qualified healthcare
professionals including,
but not restricted to,
radiologists, non-
radiology specialists,
physicians and
technologists.Same
Patient
PopulationMulti Modality Viewer is
medical image viewer
software. Therefore,
particular information of
intended for disease,
condition, and patient
population is not
applicable.Multi Modality Viewer
software is medical
image viewer software.
Therefore, particular
information of intended
for disease, condition,
and patient population is
not applicable.Same
Modality
SupportMRI, CT, CR, DX, RG,
RF, US, XA, PET, and
PET/CTCT, MRI, CR, DX, RG,
RF, XA, PET, and
PET/CTSimilar
Added support for the
ability to examine and
manipulate medical
images obtained from
US modality which
was not part of the
predicate device's
Subject DevicePredicate Device
CriteriaMulti Modality ViewerMulti Modality Viewer
(K163574)Comparison
Data Loading
Image
Communication
Standard: DICOMYesYesSame
Data Viewing Support
2D Image ReviewYesYesSame
2D Comparative
ReviewYesYesSame
Features and Capabilities
Multi-Planner
ReformattingYesYesSame
Maximum and
Minimum Intensity
Projection
(MIP/MinIP)YesYesSame
Image Editing,
Setting, SavingYesYesSame
Annotation &
Tagging Tools
(Label)YesYesSame
Display Options
(e.g. thickness)YesYesSame
Quantitative
MeasurementsYesYesSame
SnapshotYesYesSame
Cine Image DisplayYesYesSame
Multi-frame DisplayYesYesSame
Color Image DisplayYesYesSame
CriteriaSubject Device
Multi Modality ViewerPredicate Device
Multi Modality Viewer
(K163574)Comparison
Simultaneous Multiple Studies ReviewYesYesSame
Cross-reference Lines SupportYesYesSame
Display of Selected Images, Series, or Entire StudyYesYesSame
Comparison of Multiple Series or StudiesYesYesSame
Scroll ImageYesYesSame
Zoom ImageYesYesSame
Pan ImageYesYesSame
Focus ImageYesYesSame
Rotate ImageYesYesSame
Flip Image - VerticalYesYesSame
Flip Image - HorizontalYesYesSame
Rotate Image - ClockwiseYesYesSame
Rotate Image - Counter-clockwiseYesYesSame
Invert ImageYesYesSame
ArrowYesYesSame
Auto Window Level/Width SettingYesYesSame
Measurement of DistanceYesYesSame
Subject DevicePredicate Device
CriteriaMulti Modality ViewerMulti Modality Viewer
(K163574)Comparison
Measurement of
AngleYesYesSame
Measurement of
Cobb AngleYesYesSame
Identification and
Display of Ellipse
Regions of Interest
(ROIs)YesYesSame
Identification and
Display of Freehand
Regions of Interest
(ROIs)YesYesSame
Manual RegistrationYesYesSame
Image subtraction of
two series/datasetsYesYesSame
Study and Series
LinkingYesYesSame
Semi-automated
Image StitchingYesYesSame
Time Intensity
AnalysisYesYesSame
Batch Save of
MPR ReformatsYesYesSame
Examination
and manipulation
of a series of
medical images
obtained from
MRI, CT, CR, DX,
RF, RG, XA, PET
and PET-CT
datasetsYesYesSame
Subject DevicePredicate
Device
CriteriaMulti Modality
ViewerMulti Modality
Viewer
(K163574)Comparison
Full volume MIPYesNoAdded functionality of full volume
MIP visualization.
Note: The Full volume MIP feature
is the same as the feature available
on the Vitrea Advanced
Visualization software ("Reference
Device"), which was cleared by the
FDA under K172855. Therefore,
this added feature does not raise
different questions of safety and
effectiveness.
Volume image
renderingYesNoAdded Volume image rendering
(Standard 3D rendering method
and Luminance rendering method)
and accompanying presets.
Note: The Volume image rendering
methodology is similar to the
methodology available on the Vitrea
Advanced Visualization software
("Reference Device"), which was
cleared by the FDA under K172855.
Therefore, this added methodology
does not raise different questions of
safety and effectiveness.
3D Cutting Tool
(Manual 3D
Segmentation)YesNoAdded functionality to assign voxels
rendered visible and within or
without a user drawn region of
interest to a distinct segmentation
object.
Note: The 3D Cutting Tool feature
is the same as the feature available
on the Vitrea Advanced
Visualization software ("Reference
Device"), which was cleared by the
FDA under K172855. Therefore,
this added feature does not raise
different questions of safety and
effectiveness.
Clip Plane Box
(Orthogonal
Clipping panes)YesNoAdded functionality to display only
part of the scanned volume in 3D
rendering mode instead of the
entire volume.
Subject DevicePredicate
Device
CriteriaMulti Modality
ViewerMulti Modality
Viewer
(K163574)Comparison
Note: The clipping planes feature is
the same as the feature available
on the Vitrea Advanced
Visualization software ("Reference
Device"), which was cleared by the
FDA under K172855. Therefore,
this added feature does not raise
different questions of safety and
effectiveness.
2-click bone/base
separation tool
(2-click
bone/base
segmentation)YesNoAdded functionality to separate two
connected anatomical features, to
two distinct segmentation objects.
Note: The 2-click bone/base
separation tool is the same as the
feature available on the Vitrea
Advanced Visualization software
("Reference Device"), which was
cleared by the FDA under K172855.
Therefore, this added feature does
not raise different questions of
safety and effectiveness.
1-click bone/base
separation tool
(1-click
bone/base
segmentation)YesNoAdded functionality to allow user to
toggle visually isolated structures
from the Bone to the Base
segmentation object or vice versa.
Note: The 2-click bone/base
separation tool is the same as the
feature available on the Vitrea
Advanced Visualization software
("Reference Device"), which was
cleared by the FDA under K172855.
Therefore, this added feature does
not raise different questions of
safety and effectiveness.
1 Click Visible
Seed (1-click
segmentation)YesNoAdded functionality to toggle one of
two non-connected anatomical
features, to belong to the same or a
distinct segmentation object as the
other anatomical feature.
Note: The 1 Click Visible Seed
feature is the same as the feature
available on the Vitrea Advanced
Visualization software ("Reference
Device"), which was cleared by the
FDA under K172855.
CriteriaSubject Device
Multi Modality
ViewerPredicate
Device
Multi Modality
Viewer
(K163574)Comparison
Automatic table
segmentationYesNothis added feature does not raise
different questions of safety and
effectiveness.
Added algorithm for automatic
recognition of gantry table
structures and isolating those in a
dedicated segmentation object.
Note: The Automatic table
segmentation feature is the same
as the feature available on the
Vitrea Advanced Visualization
software ("Reference Device"),
which was cleared by the FDA
under K172855. Therefore, this
added feature does not raise
different questions of safety and
effectiveness.
Automatic bone
segmentation
  • Head/Neck
  • Extremities
  • Chest/Abdomi
  • nal/Pelvis | Yes | No | Added algorithm for automatic
    recognition of bone anatomy
    structures and isolating those in a
    dedicated segmentation object.
    Note: The Automatic bone
    segmentation feature is the same
    as the feature available on the
    Vitrea Advanced Visualization
    software ("Reference Device"),
    which was cleared by the FDA
    under K172855. Therefore, this
    added feature does not raise
    different questions of safety and
    effectiveness. |
    | US 2D Cine
    Viewer | Yes | No | Added support for 2D display of
    static and dynamic ultrasound
    images.
    Note: The US 2D Cine Viewer
    feature is the same as the feature
    available on the Vitrea View
    software ("Reference Device"),
    which was cleared by the FDA
    under K163232. Therefore, this
    added feature does not raise
    different questions of safety and
    effectiveness. |
    | | Subject Device | Predicate
    Device | |
    | Criteria | Multi Modality
    Viewer | Multi Modality
    Viewer
    (K163574) | Comparison |
    | Automatic Rigid
    Registration
    (Auto Linked
    Navigation of
    Current and
    Priors) | Yes | No | Added algorithm for automatic rigid
    registration of two or multiple
    studies displayed in MM Viewer.

Note: The Auto Linked Navigation
of Current and Priors feature is the
same as the feature available on
the Mirada XD software
("Reference Device"), which was
cleared by the FDA under K101228.

Therefore, this added feature does
not raise different questions of
safety and effectiveness. |

Indications for Use Comparison with Predicate Device:

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Image /page/8/Picture/0 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The font is simple and sans-serif. The background is white.

Similarities in Technology with Predicate Device:

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Image /page/9/Picture/1 description: The image shows the word "ViTAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.

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Image /page/10/Picture/1 description: The image shows the word "ViTAL" in a sans-serif font. The letters are black, except for the dot on the "i", which is red. The letters are evenly spaced and the word is centered.

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Image /page/11/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are all capitalized except for the "i".

Differences in Technology with the Predicate Device:

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100 million and the same of the same of the same of the same of the same of the same of the subject of the states of the states of the states of the states of the states of t

ViTAL

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Image /page/13/Picture/1 description: The image shows the word "ViTAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is horizontally aligned.

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Similarities in Technology with the Reference Devices

| | Subject
Device | Reference
Device | Comparison |
|------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Criteria | Multi
Modality
Viewer | Vitrea
Advanced
Visualization
(K172855) | |
| Full volume MIP | Yes | Yes | Same |
| Volume image rendering | Yes | Yes | Similar
The Standard 3D
rendering method added
is the same as 3D
rendering method used in
the Vitrea Advanced
Visualization software
("Reference Device"). The
Luminance 3D rendering
method is another form of
3D volume rendering and
is an option in the Multi
Modality Viewer software
("Subject Device"). The
verification and validation
testing performed
demonstrate the subject
device is safe and
effective and does not
raise any different
questions of safety and
effectiveness. |
| Criteria | Subject
Device

Multi
Modality
Viewer | Reference
Device

Vitrea
Advanced
Visualization
(K172855) | Comparison |
| 3D Cutting Tool (Manual 3D
Segmentation) | Yes | Yes | Same |
| Clip Plane Box (Orthogonal
Clipping panes) | Yes | Yes | Same |
| 2-click bone/base separation
tool (2-click bone/base
segmentation) | Yes | Yes | Same |
| 1-click bone/base separation
tool (1-click bone/base
segmentation) | Yes | Yes | Same |
| 1 Click Visible Seed (1-click
segmentation) | Yes | Yes | Same |
| Automatic table segmentation | Yes | Yes | Same |
| Automatic bone segmentation

  • Head/Neck Extremities
  • Chest/Abdominal/Pelvis | Yes | Yes | Same |
    | Criteria | Subject
    Device

Multi
Modality
Viewer | Reference
Device

Vitrea View
(K163232) | Comparison |
| US 2D Cine Viewer | Yes | Yes | Same |
| Criteria | Subject
Device

Multi
Modality
Viewer | Reference
Device

Mirada XD
(K101228) | Comparison |
| Automatic Rigid Registration
(Auto Linked Navigation of
Current and Priors) | Yes | Yes | Same |

15

Software Development Enviornment Description:

The changes to the Multi Modality Viewer software were designed, and tested according to written procedures that included risk management. Software verification 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 Multi Modality Viewer software:

  • Risk Management .
  • Requirements Reviews

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  • Code Designs
  • Code Development Testing .
  • . Code Reviews
  • Design Reviews ●
  • Verification of the software that included performance and safety testing .
  • . Validation of the software - that included simulated usability testing by experienced professionals.

Risk Management:

Each risk associated with the Multi Modality Viewer software 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 "Incredible". All risks for these modifications were collectively reviewed to determine if the benefits outweigh the risk. Based on Post Market information and because of the risk control measures included in these modifications, it is believed that the risk for these modifications as a whole are extremely low. Considering all risks against the benefits, it has been assessed that the benefits do outweigh the risks for these modifications.

During the design review, the following conclusions were reached:

  • All risks have been reduced as low as possible. ●
  • The overall residual risk for the software product is deemed acceptable.
  • Of the unresolved defects remaining in the released application, each has been carefully . evaluated and it has been determined that the software can be used safely and effectively.
  • . The medical benefits of the device outweigh the residual risk for each individual risk and all risks together.

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, requirements and risk mitigations. Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly.

Validation:

The software validation team's primary goal was to assure that 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.

External Validation:

Two sets of external validation were performed to ensure the clinical safety and effectiveness of the Multi Modality Viewer software.

The goals of the external validations were to:

  • a) Establish the clinical safety and effectiveness of the Multi Modality Viewer software
  • b) Establish the substantial equivalence between Multi Modality Viewer with the predicate and reference devices
  • Clinical Effectiveness Validation a)

Three evaluators from three different clinical locations clinically reviewed anonymized datasets using the Multi Modality Viewer software. The reviewers were presented with a list of questions

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Image /page/17/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The image is simple and clean, with a focus on the word itself.

with regards to the functionality and image quality for the following software features: Full volume MIP, Clip Plane Box (Orthogonal Clipping pane), 2-click bone/base separation tool, 1-click bone/base separation tool, 1 Click Visible Seed (1-click segmentation), Automatic table segmentation and Automatic bone segmentation. 3D and Luminance rendering Automatic Rigid Registration (Auto Linked Navigation of Current and Priors)and basic ultrasound visualization support.

There was no negative feedback received from the evaluators. The evaluators confirmed the Multi Modality software was sufficient to read the images and the software was determined to remain safe and effective for its intended use.

Substantial Equivalence Validation b)

Three evaluators from three different clinical locations clinically reviewed anonymized datasets using the Multi Modality Viewer software, Vitrea Advanced Visualization software, Mirada XD software, and Vitrea View software. The evaluators were presented with a list of questions with regards to the functionality and image quality for the following software features: Full volume MIP, Clip Plane Box (Orthogonal Clipping pane), 3D Cutting Tool (Manual 3D Segmentation), 2-click bone/base separation tool, 1-click bone/base separation tool. 1 Click Visible Seed (1-click segmentation), Automatic table segmentation and Automatic bone segmentation, 3D and Luminance rendering, automatic registration and basic ultrasound visualization support.

There were no instances recorded where the subject device performed inferior to one of the reference devices. Multi Modality Viewer was rated as equal to or better than the reference devices. This validation demonstrates substantial equivalence between Multi Modality Viewer and its predicate and reference devices with regards to intended use, clinical effectiveness and safety.

The overall outcome of the clinical validations performed demonstrate the clinical safety and effectiveness of the Multi Modality Viewer software.

Summary of Clinical Tests:

The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software.

Cyber and Information Security:

The Multi Modality Viewer software follows internal documentation which includes information based on the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Internal documentation covers the following:

    1. Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with your device, including:
    • A specific list of all cybersecurity risks that were considered in the design of your ● device:
    • A specific list and justification for all cybersecurity controls that were established ● for vour device.
    1. A traceability matrix that links your actual cybersecurity controls to the cybersecurity risks that were considered;
    1. A summary describing the plan for providing validated software updates and patches as needed throughout the lifecycle of the medical device to continue to assure its safety and effectiveness. The FDA typically will not need to review or approve medical device software changes made solely to strengthen cybersecurity.

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Image /page/18/Picture/0 description: The image shows the word "VITAL" in black font, with the dot of the "i" in red. The letters are bold and slightly blurred, giving them a soft appearance. The word is horizontally oriented and centered in the image.

  • A summary describing controls that are in place to assure that the medical device 4. software will maintain its integrity (e.g. remain free of malware) from the point of origin to the point at which that device leaves the control of the manufacturer; and
  • Device instructions for use and product specifications related to recommended 5. cybersecurity controls appropriate for the intended use environment (e.g. anti-virus software, use of firewall).

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.

The Multi Modality Viewer software complies with the following voluntary recognized consensus standards:

| Standard No. | Standards
Organization | Standard Title | Version | Date |
|------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| PS 3.1- 3.20 (2016)
(Recognition
Number 12-300) | NEMA | Digital Imaging and
Communications in Medicine
(DICOM) Set (Radiology) | 3 | 06/27/2016 |
| ISO 14971:2007/
(R)2010
(Recognition
Number 5-70) | AAMI / ANSI
/ ISO | Medical Devices -
Applications of Risk
Management to Medical
Devices | 2007 | 06/27/2016 |
| IEC 62304:2006
(Recognition
Number 13-32) | AAMI / ANSI
/ IEC | Medical Device Software -
Software Life Cycle
Processes (Software /
Informatics) | 2006 | 08/20/2012 |

Substantial Equivalence Analysis Conclusion:

Vital Images believes the Multi Modality Viewer software has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed, predicate device Multi Modality Viewer (K163574) and reference devices.

In addition.

  • (1) The added features and tools for Full volume MIP, Volume image rendering, 3D Cutting Tool, Clip Plane Box, 2-click bone/base separation tool, 1-click bone/base separation tool, 1 Click Visible Seed, Automatic table segmentation and Automatic bone segmentation are similar to the features and tools in the reference device, Vitrea Advanced Visualization which was cleared by the FDA under K172855;
  • (2) The addition of US 2D Cine Viewer which allows for the examination and manipulation images obtained from the Ultrasound modality is similar to the feature in the reference device. Vitrea View which was cleared by the FDA under K163232:
  • (3) The added feature to allow for automated rigid registration of current study and/or prior study(ies) with caching of automated registration result is similar to the feature in the reference device, Mirada XD which was cleared by the FDA under K101228.

The verification and validation testing performed demonstrate the subject device is as safe and effective as the predicate and reference devices and does not raise any different questions of safety and effectiveness. Therefore, Vital believes the enhancements in the Multi Modality Viewer software does not alter the fundamental scientific technology, safety or intended use of the device.

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Image /page/19/Picture/1 description: The image shows the word "VITAL" in black letters. The dot above the "i" is red. The letters are bold and sans-serif. The word is centered and takes up most of the frame.

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 and validation 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.