The system is designed to provide image storage, display, and workflow integration. The image display architecture provides capabilities for near-realtime capabilities for radiologists as well as image reviewing workgroup members and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks.

Device Description

UltraVisual Vortex™ is an integrated client-server software package, which may be marketed as software only, that is used in conjunction with standard PC hardware. UltraVisual Vortex™ is a PC-based, DICOM-compliant PACS device that is able to receive, transmit and display DICOM images over both local and wide area network. Images sent to the UltraVisual Vortex™ server are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by UltraVisual Vortex™ to create JPEG and wavelet images follow known and accepted protocols.

Vortex™ can be used within a hospital, a managed care facility or an isolated imaging center. It can also be used for image distribution over the network for teleradiology/review purpose.

UltraVisual Vortex™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the UltraVisual Vortex™ software, structured according to your request:

Acceptance Criteria and Study for UltraVisual Vortex™ Software

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" for the UltraVisual Vortex™ software are primarily focused on substantial equivalence to predicate devices and functional parity in terms of image handling and display capabilities. The document doesn't explicitly state quantitative performance metrics or acceptance criteria in the typical sense (e.g., minimum accuracy percentages). Instead, it demonstrates effectiveness by comparing its features and intended use to already cleared devices.

Acceptance Criterion (Implied)	Reported Device Performance
Substantial Equivalence	The device is substantially equivalent to Voxar Plug 'n View (K992654) and AMICAS Web/Intranet Image Server (K970064).
DICOM Compliance	DICOM 3.0 compliant for image input.
Image Storage & Display	Receives, transmits, and displays DICOM images over local and wide area networks. Stores images in a local cache.
Web-Enabled Viewing	Converts images into formats suitable for viewing in a web browser.
Standard Hardware & Network	Uses standard PC hardware and communicates via TCP/IP.
Software Development Process	Designed, developed, tested, and validated according to written procedures, including coding, unit testing, validation testing, and field maintenance.
General Safety	Device labeling contains instructions for use and indications for use. Hardware components are "off the shelf." "Level of Concern" is "minor," implying no expected death or injury from failure or latent design flaw.
Basic Image Manipulation	Scales Image to Display, Image Measurement, Cine tool, Comparison Mode, Flip/Rotate of Images, Patient & Study Browser.
Advanced Visualization	Volume Rendering (with interactive opacity/transparency control, clipping VOI, zoom, pan, rotate), Multi-Planar Reformatting (MPR into any user-defined linear plane), Maximum Intensity Projection (MIP with interactive window-level, clipping VOI, zoom, pan, rotate).

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set in terms of patient cases or images. It states: "Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers." This suggests internal testing and perhaps user acceptance testing, but no formal, documented clinical test set of specific size is mentioned.

Therefore, the data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied that the testing involved internally generated data or data readily available to the development team.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for any specific test set. The validation focuses on functional equivalence and internal testing by various staff members, not on clinical performance or diagnostic accuracy validated against expert consensus.

4. Adjudication Method for the Test Set

Since no formal test set with ground truth established by experts is described, there is no adjudication method mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document does not describe any study comparing human readers with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The validation described is primarily a standalone functional validation of the software. It verifies that the algorithm can perform its stated functions (receive, convert, display images, perform 3D rendering, etc.) and that these functions are comparable to predicate devices. However, this is not a study of diagnostic performance or clinical effectiveness, but rather a verification of its technical capabilities. There is no mention of measuring the algorithm's diagnostic performance without human interaction.

7. The Type of Ground Truth Used

Given the nature of the device (an image processing, communication, and visualization workstation) and the described validation, the "ground truth" used would primarily be functional correctness and adherence to standards. For example:

DICOM compliance: Verified by successfully processing DICOM 3.0 images.
Image integrity: Verified that images are displayed correctly after conversion (e.g., JPEG and wavelet conversion following "known and accepted protocols").
Feature functionality: Verified that tools like volume rendering, MPR, and MIP operate as designed and produce expected outputs for various inputs.
Substantial equivalence: Verified by feature-by-feature comparison with predicate devices.

There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for diagnostic accuracy, as this device primarily handles image viewing and manipulation, not automated diagnosis.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The Vortex™ software is described as using "known and accepted protocols" for image conversion and processing. This suggests that the algorithms are based on established methods rather than a machine learning model that would require a distinct training set.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set or machine learning algorithms in the context of a training phase, there is no information provided on how ground truth for a training set was established.

Summary

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Koi 2097

JUL 1 2 2001

510(k) SUMMARY

In accordance with the provisions of the Safe Medical Device Act of 1990, UltraVisual Medical Systems is providing a summary of safety and effectiveness information regarding the Vortex™ software.

1.1 Company Identification

UltraVisual Medical Systems 131 W. Wilson Street Suite 700 Madison WI 53703 Tel: 608 256 7775 Fax: 608 256 7779 Email: icouture@ultravisual.com

1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116 Tel: 510-276-2648 Fax: 510-276-3559 Email: regman1@home.com
1.3 Date of Submission
June 13, 2001

1.4 Device Name

Classification Name:	Image Processing System, 21 CFR§892.2050, ProCode LLZ
Common/Usual Name:	Teleradiology System
Proprietary Name:	Vortex™

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Substantial Equivalence 1 .5

The UltraVisual Vortex™ software is substantially equivalent to the Voxar Plug 'n View, K992654 and the AMICAS Web/Intranet Image Server, K970064).

Device Description and Intended Use 1.6

UltraVisual Vortex™ is an integrated client-serversoftware package, which may be marketed as software only, that is used in conjunction with standard PC UltraVisual Vortex™ is a PC-based, DICOM-compliant PACS hardware. device that is able to receive, transmit and display DICOM images over both local and wide area network. Images sent to the UltraVisual Vortex™server are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by UltraVisual Vortex™to create JPEG and wavelet images follow known and accepted protocols.

Vortex™ can be used within a hospital, a managed care facility or an isolated imaging center. It can also be used for image distribution over the network for teleradiology/review purpose.

UltraVisual Vortex™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.

1.7 Software Development

Ultravisual certifies that the Vortex™ software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications and designs, coding and unit testing, validation testing and field maintenance.

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Safety and Effectiveness 1.8

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and indications for use.

The hardware components specified (and/or optionally supplied) are all "off the shelf" computer components.

Validation and Effectiveness:

Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.

Substantial Equivalence:

The Ultravisual Vortex™ software is an integrated client-server software package used to receive DICOM images, convert them to an internal format, and to transfer those converted images to a viewing client.

Ultravisual Vortex™ has Indications for Use similar to other medical image devices such asAMICAS Web/Intranet Image Server (K970064) and Voxar Plug-n-View (K992654). VortexTM also shares with these devices a Target Population that is competent healthcare professionals.

Like the AMICAS Web/Intranet Image Server (K970064) product, VortexTM receives DICOM images on the server, converts them to wavelet format and displays them within a web enabled application at the client system.

Like the Voxar Plug 'n View (K992654) product, Vortex™ also provides tools for both 2D and 3D visualization of images, such as Volume Rendering, Multi Planar Reformatting (MPR) and Maximum Intensity Projection (MIP).

Any differences between the Ultravisual Vortex™ software and the equivalent devices have no significant influence on safety or effectiveness.

It is our conclusion that there is no software component in the UltraVisual Vortex™product or hardware component which would be used in conjunction with the UltraVisual Vortex™product that we know of whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus the "Level of Concern" of the Ultravisual Vortex™ product is "minor".

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1.9 Substantial Equivalence Chart

Product Name	UltraVisualVortex™	AMICAS	Voxar
Windows O.S. - Client	Yes	Yes	Yes
Uses Standard. Monitor	Yes	Yes	Yes
Scales Image to Display.	Yes	Yes	Yes
Image Input	DICOM 3.0	DICOM 3.0	DICOM 3.0
Images stored on remote NTserver	Yes	Yes	-
Network Protocol	TCP-IP	TCP-IP	TCP-IP
Compression	Wavelet/JPEG	Wavelet	-
Image Measurement	Yes	Yes	Yes
Cine tool	Yes	Yes	Yes
Comparison Mode	Yes	Yes	Yes
Flip / Rotate of Images	Yes	Yes	Yes
Patient & Study Browser	Yes	Yes	Yes
Volume Rendering	Volume rendering withinteractive opacity/transparency control,clipping volume of interest(VOI), zoom, pan and rotate	-	Same
Multi-Planar Reformatting(MPR)	MPR into any user-definedlinear plane.	-	Same
Maximum IntensityProjection (MIP)	MIP with interactivewindow-level, clippingVOI, zoom, pan and rotate	-	Same

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2001

UltraVisual Medical Systems % Mr. Mark Job TUV Product Service, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112 Re: K012097

Vortex (TELERADIOLOGY SYSTEM) Dated: July 2, 2001 Received: July 5, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Job:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Nancy C.Bogdon

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

Enclosure (s)

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Kol 2097 510(k) Number (if known):

Ultra Visual Medical Systems, Vortex™ Image Processing, Device Name: Communication and Visualization Workstation

Indications For Use:

The system is designed to provide image storage, display, and workflow integration The system is designed to provises. The image display architecture provides capabilities for neartheare capabilities for radiologists as well as image reviewing workgroup didgiostly froming capass and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks.

Intended users of the image distribution system include radiologists, referring nhended ason of the mage sicians, medical technologists, and information technology professionals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 901.109)

Over-the-Counter Use

(Optional Format 1-2-96)

David Li. Hyam

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012097

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

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