(12 days)
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 healthcare professionals to acquire, 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 Volume Rendering, Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, DICOM Image Note export, Presentation States, Annotation and Measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, archiving of digital mammography images provided that systems cleared via 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.
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).
The provided 510(k) summary for Emageon Inc.'s EVMS™ Enterprise Visual Medical System software focuses on demonstrating substantial equivalence to previously cleared devices (Vortex™ and Ultravisual™) rather than presenting a standalone study with defined acceptance criteria and performance metrics for the EVMS™ itself.
The submission states that EVMS™ is an integrated client-server software package comprised of features previously cleared. The main differences are the addition of Standard Uptake Value measurements, MPR on irregular datasets and in oblique planes, automatic region growing, modified naming conventions, and updates to the design architecture and development process to align with ISO standards.
Based on the provided document, here's a breakdown of the information requested, with explicit notes where information is not available or implied by the substantial equivalence approach:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, precision) are defined for EVMS™. The submission relies on the substantial equivalence of its features to previously cleared devices. Therefore, a table for this device cannot be constructed as the data is not present in the document.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The submission refers to "Extensive testing... performed by programmers, non-programmers, quality assurance staff, potential customers, and contracted third parties," but does not detail a specific test set or its origins.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document mentions "potential customers" testing, which might imply clinical users, but their specific qualifications for establishing ground truth are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No. The document does not mention a MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the software's functionality and equivalence to prior versions.
- Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study was performed or reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance Study: No. The document describes the software as an image processing system for display and analysis, intended for use by healthcare professionals. No standalone algorithm performance evaluation (e.g., for automated detection or diagnosis without human review) is reported.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not specified. Given the nature of the device (an image processing and PACS system), "ground truth" would likely relate to the accuracy of image display, measurements, and advanced visualization renderings compared to expected validated outputs or established clinical standards. However, no specific ground truth methodology is outlined.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable/Not specified. The device is described as an image processing system, not a machine learning or AI algorithm that undergoes "training" in the traditional sense, as understood for predictive models. Its development involves standard software engineering practices.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable/Not specified. As noted above, the concept of a "training set" and "ground truth" for it, as applied to machine learning, does not appear relevant to this submission. The development process refers to "design, developed, tested and validated according to written procedures" and compliance with QSR and ISO standards. The "ground truth" in this context would be the correct functioning of the software features as per specifications.
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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.
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Company Identification 1.1
Emageon Inc. 10 W. Mifflin Street Suite 400 Madison WI 53703 Establishment Registration Number: 2135350 Contact: Inger Hanson Tel: 608 256 7775 Fax: 608 256 7779 Email: Inger.Hanson@emageon.com -
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: 608 256 7775 Fax: 608 256 7779 Email: Inger.Hanson@emageon.com -
Date of Submission 1.3
October 31st, 2005
1.4 Device Name
| Classification Name: | Image Processing System, 21 CFR§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
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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.,Ultravisual | Emageon Inc.EVMS™ |
|---|---|---|---|
| Indications ForUse | The system isdesigned to provideimage storage,display, andworkflow integrationcapabilities forhealthcareenterprises. Theimage displayarchitecture providesworkgroup diagnosticviewing capabilitiesfor radiologists aswell as imagereviewingfunctionality forreferring physiciansand other clinicians.In addition totraditional 2D imageviewingfunctionality, theimage display systemprovides advanced3D features includingvolume renderingand multi-planarreconstructiondesigned to functionin web-enabledviewers over bothlocal and wide areanetworks.Intended users of theimage distributionsystem includeradiologists, referringphysicians, tertiary | Same with the additionof viewingpresentation qualitydigital mammographyimages sent via theDICOM standard asdocumented in theIndications for Use. | Same with the additionof Standard UptakeValue Display, Displayof oblique planes inMPR mode anddisplay of MPR onIrregular data sets,automatic regiongrowing, andcomponent renaming. |
| care physicians,medicaltechnologists, andinformationtechnologyprofessionals. | |||
| 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 (800) 638-2041 or (301) 443-6597 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 ________________________________________________________________________________________________________________________________________________________________
Page 1 of
§ 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).