EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)

K053281 · Emageon, Inc. · LLZ · Dec 7, 2005 · Radiology

Device Facts

• Record ID: K053281
• Device Name: EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
• Applicant: Emageon, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

The Enterprise Visual Medical System(TM) is classified as a picture archive and communications system. It is a software only solution developed by Emageon Inc., that utilizes off the shelf software, standard computer workstations and standard storage devices that allow authorized physicians and authorized other clinicians to access, visualize and store digital medical images, and data associated with the images, across the enterprise using advanced content management and clinical workflow through a graphical user interface. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D Advanced Visualization (image Visions), Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth, image export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, viewing of digital mammography images provided that a cleared 510(k) are used and that digitized secondary captures of those images are not viewed for assisting in diagnosis, utilization of third-party electronic templates, the display of Standard Uptake Value, recording of third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data.

Device Story

EVMS is a client-server software-only PACS solution operating on off-the-shelf hardware. It ingests DICOM 3.0 medical images via network protocols (TCP/IP). The system provides advanced visualization tools including 2D viewing, 3D volume rendering (with opacity/transparency control, clipping, zoom, pan, rotate), multi-planar reformatting (MPR) for oblique planes and irregular datasets, and automatic region growing. It also supports Standard Uptake Value (SUV) display and image fusion. Used in clinical environments by radiologists and clinicians to review diagnostic images, the system facilitates clinical decision-making by providing integrated workflow management and diagnostic viewing capabilities. It benefits patients by enabling efficient access to medical imaging data across the enterprise.

Clinical Evidence

Bench testing only. Extensive validation performed by programmers, non-programmers, quality assurance staff, potential customers, and contracted third parties to verify software performance and compliance with QSR 21 CFR Part 820, ISO 13485:2003, and ISO 14971:2000.

Technological Characteristics

Software-only PACS; client-server architecture; runs on off-the-shelf computer hardware. Connectivity via TCP/IP; supports DICOM 3.0. Image processing includes Wavelet/JPEG compression, 3D volume rendering, and MPR. Compliant with ISO 13485:2003 and ISO 14971:2000/Amd 1:2003(E).

Indications for Use

Indicated for use by radiologists, referring physicians, tertiary care physicians, medical technologists, and IT professionals for the storage, display, and workflow integration of digital medical images across healthcare enterprises.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Vortex™ (K012097)
• Ultravisual™ (K042008)

Submission Summary (Full Text)

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K053281

#### DEC 7 2005

# 510(k) SUMMARY

In accordance with the provisions of the Safe Medical Device Act of 1990, Emageon Inc. is providing a summary of safety and effectiveness information regarding the EVMS™ Enterprise Visual Medical System software.

- Company Identification 1.1
Emageon Inc. 10 W. Mifflin Street Suite 400 Madison WI 53703 Establishment Registration Number: 2135350 Contact: Inger Hanson Tel: [phone] Fax: [phone] Email: [e-mail]

- Official Correspondent 1.2
Inger L. Hanson Director of Quality and Regulatory Affairs Emageon Inc. 10 W. Mifflin Street Suite 400 Madison WI 53703 Establishment Registration Number: 2135350 Tel: [phone] Fax: [phone] Email: [e-mail]

- Date of Submission 1.3
October 31st, 2005

#### 1.4 Device Name

| Classification Name: | Image Processing System, 21 CFR<br>§892.2050, ProCode LLZ |
|----------------------|-----------------------------------------------------------|
| Common/Usual Name: | Picture Archiving and Communication System |
| Proprietary Name: | EVMS™ (formerly Ultravisual™) |

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Cleared Device(s): Vortex™ , 510(k): K012097, UltravisualTM, 510(k) K042008

- Device Description and Intended Use 1 .5
Emageon Inc.'s EVMS™ software is integrated client-server software package comprised of features that were previously cleared in Vortex ™, 510(k): K012097, and Ultravisual™, 510(k) K042008. The main difference is that the software will now allow display Standard Uptake Value measurements, MPR on irregular data sets and in oblique planes, and automatic region growing, the naming conventions of the components have been modified, the design architecture and the overall design and development process in order to synchronize the existing compliance to the federal QSR 21 CFR, Part 820 with ISO 13485:2003 and ISO 14971:2000/Amd 1 .: 2003(E).

- Software Development 1.6
Emageon Inc. certifies that the EVMS™ 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 ad designs, coding and unit testing, validation testing and field maintenance. These procedures are documented in accordance with the Federal QSR, 21, CFR, Part 820 and with ISO 13485:2003 and ISO 14971:2000/Amd 1.:2003(E) . Emageon Inc. holds ISO 13485:2003 UKAS and CMDCAS quality system certificates for both the Madison, WI and Birmingham, AL locations.

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#### Safety and Effectiveness 1.7

## 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, non-programmers, quality assurance staff, potential customers, and contracted third parties.

### Substantial Equivalence:

The intended use of Emageon Inc.'s EVMS™ software is substantially equivalent in the opinion of Emageon Inc. to the feature set described in the original Vortex™ software, 510(k) K012097; Ultravisual™ software, 510(k) K042008 and do not pose any new issues of safety and effectiveness.

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## 1.8 Substantial Equivalence Chart

| Product Name | UltraVisual Vortex™ | Emageon UV, Inc.,<br>Ultravisual | Emageon Inc.<br>EVMS™ |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For<br>Use | The system is<br>designed to provide<br>image storage,<br>display, and<br>workflow integration<br>capabilities for<br>healthcare<br>enterprises. The<br>image display<br>architecture provides<br>workgroup diagnostic<br>viewing capabilities<br>for radiologists as<br>well as image<br>reviewing<br>functionality for<br>referring physicians<br>and other clinicians.<br>In addition to<br>traditional 2D image<br>viewing<br>functionality, the<br>image display system<br>provides advanced<br>3D features including<br>volume rendering<br>and multi-planar<br>reconstruction<br>designed to function<br>in web-enabled<br>viewers over both<br>local and wide area<br>networks.<br>Intended users of the<br>image distribution<br>system include<br>radiologists, referring<br>physicians, tertiary | Same with the addition<br>of viewing<br>presentation quality<br>digital mammography<br>images sent via the<br>DICOM standard as<br>documented in the<br>Indications for Use. | Same with the addition<br>of Standard Uptake<br>Value Display, Display<br>of oblique planes in<br>MPR mode and<br>display of MPR on<br>Irregular data sets,<br>automatic region<br>growing, and<br>component renaming. |
| | care physicians,<br>medical<br>technologists, and<br>information<br>technology<br>professionals. | | |
| Windows O.S. – Client | Yes | Same | Same |
| Uses Standard. Monitor | Yes | Same | Same |
| Scales Image to Display. | Yes | Same | Same |
| Image Input | DICOM 3.0 | Same | Same |
| Images stored on remote NT server | Yes | Same | Same |
| Network Protocol | TCP-IP | Same | Same |
| Compression | Wavelet/JPEG | Same | Same |
| Image Measurement | Yes | Same | Standard Uptake Value Added |
| Cine tool | Yes | Same | Same |
| Comparison Mode | Yes | Same | Same |
| Flip / Rotate of Images | Yes | Same | Same |
| Patient & Study Browser | Yes | Same | Same |
| Volume Rendering | Volume rendering with interactive opacity/ transparency control, clipping volume of interest (VOI), zoom, pan and rotate | Same | Same |
| Multi-Planar Reformatting (MPR) | MPR into any user-defined linear plane. | Same | Added Oblique planes and Irregular data sets. |
| Maximum Intensity Projection (MIP) | MIP with interactive window-level, clipping VOI, zoom, pan and rotate | Same | Same |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The image is in black and white, and the seal appears to be a scanned or reproduced version, as the lines are not perfectly smooth.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 7 2005

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

Re: K053281

Trade/Device Name: EVMS™ Enterprise Visual Medical System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: LLZ Dated: November 21, 2005 Received: November 25, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced in We have reviewed your Section 510(N) prohisantially equivalent (for the indications for use stated in above and have determined the do need in accessions in interstate commerce prior to the enclosure) to regally marketed predicato do too wice Amendments, or to devices that have been May 28, 1976, the ellacinent date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the proval application (PMA). You may, therefore, market the do not require approval of a premance approvation (The general controls provisions of the Act.)
device, subject to the general controls provisions of the Act. The general co device, subject to the general controls provided of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) into entrols. Existing major regulations affecting your driver Approval), it may be subject to such adentions, Title 21, Parts 800 to 898. In addition, FDA device Car be Tound in the Code of soncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mart 1271 s 1.suanee or a successor plies with other requirements of the Accordination FDA nas made a detenmination maily of the Federal agencies. You must comply with all the r caeral statues and regulations administered on only institution and listing (21 CFR Parl 807): Abeling Act s requirements, mending, but not mintee to vegance its set forth in the quality systems (QS) (21 CFR Fart 801); good manufacturing practice request radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
The same and the same of the same of started as would see a gagal This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA Inding of Sacsaminer of proceed to the market.

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

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

Also, please note the regulation entitled, "Misbranding by reference to prematic notification the Antification the Also, please note the regulation entities, "hissrantion on your responsibilities under the Act from the 807.97). You may obtain other general monitation of your of its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy C. Higdon

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

Enclosure

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## Indications for Use

1053281

510(k) Number (if known): Vortex™: K012097; IVMS: UltraVisual™: K042008

Device Name: EVMS™ Enterprise Visual Medical System

Indications For Use:

The Enterprise Visual Medical System(TM) is classified as a picture archive and The Enterprioe Vious system. It is a software only solution developed by Emageon Inc., communioutions oyotem. 11.10 a f the shelf software, standard computer workstations and standard storage devices that allow authorized physicians and authorized and standard othor donos than e, access, visualize and store digital medical images, noakhours profession with the images, across the enterprise using advanced and uatu abooolatou with throntent management and clinical workflow through a graphical user interface.

Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D Advanced Visualization (image Visions), M. Planar Reformatting (MPR), Real-time obligue imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth oblique imaging, image Note export, Presentation States, Annotation and Otleaming, 01 മാഹനം Automated linking, Display protocols, Enterprise Worklist, prior micasuremont tools, natomateving of digital mammography images provided that study management, och a cleared 510(k) are used and that digitized secondary only of these images are not viewed for assisting in diagnosis, utilization of thirdcaptures of those imaged a emplates, the display of Standard Uptake Value, recording party electronic of third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lynn

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

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