(85 days)
The vRad PACS with Mammography software is used with general purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with vRad PACS Storage component. The vRad PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities. The vRad Storage component is intended to handle the DICOM protocol and store images as DICOM files to a location where they can be read by vRad PACS Cache and transmitted to radiologists' workstations for viewing by the vRad PACS Viewer.
vRad PACS with Mammography may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and displayed on a monitor that meets technical specifications reviewed and cleared by FDA.
vRad PACS with Mammography is a device which consists solely of software that allows electronic transmission of radiological patient images from one location to another. The device is capable of accepting, storing, digitally processing, and displaying medical images for the purposes of providing digital diagnostic image interpretation services by trained radiologists on PC workstations. The software provides functions for performing operations related to manipulation, enhancement, compression, and quantification of medical images.
vRad PACS with Mammography is a modified version of vRad PACS (K090649) that will now allow display of presentation-quality digital mammography images.
The provided text describes a PACS system (Picture Archiving and Communications System) with mammography capabilities, not an AI or CAD (Computer-Aided Detection) device. Therefore, the concept of "acceptance criteria" as it relates to statistical performance metrics (like sensitivity, specificity, AUC) for disease detection, or the effect size of AI assistance on human readers, is not directly applicable in the same way it would be for an AI-powered diagnostic tool.
This 510(k) submission is for a PACS system, which is essentially software for managing and displaying medical images. The "acceptance criteria" here are primarily functional, performance, and safety requirements to demonstrate that the device is substantially equivalent to a predicate device.
However, I can extract information related to the device's performance claims and the testing conducted, aligning it to the closest relevant categories from your request.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of quantitative acceptance criteria with reported performance in the way an AI diagnostic device would (e.g., "Sensitivity > X%"). Instead, the acceptance criteria are implicitly met by successfully passing a comprehensive set of tests and showing substantial equivalence to the predicate device.
| Acceptance Criteria Category | Reported Device Performance / Assessment |
|---|---|
| Functional Equivalence | Shown through a detailed comparison demonstrating vRad PACS with Mammography has features and functionalities (e.g., display of digital mammography images, on-demand access to database, viewing study lists, decompression, display images, viewing reports, hanging protocol, spine labeling, reference line display, key images identification, link multiple series, measurement tools, annotation tools, standard image manipulation tools) that are equivalent to the predicate device (Synapse Workstation). |
| Technical Equivalence | Demonstrated through comparison of technical characteristics such as product availability (software only), operating systems (Windows 7), web browser (Internet Explorer), image and data processing (client side), technology platforms (Windows .Net for client, Windows Server for server), and programming languages (C++, C# .Net for client). |
| Safety and Efficacy | "vRad PACS with Mammography introduces no new safety or efficacy issues other than those already identified with the cleared vRad PACS (K090649)." Hazard analysis conducted, and appropriate mitigations taken, indicating the device is of moderate concern. Labeling contains instructions, cautions, warnings, and notes for safe and effective use. Concluded to be "as safe and effective as the predicate device." |
| Verification & Validation | "vRad PACS with Mammography tested successfully with reference to its product requirements, as well as design verification and validation document and traceability matrix document." This included system-level functionality test, component testing, verification testing, integration testing, usability testing, labeling testing, and risk mitigation testing. "Pass/fail criteria were based on the requirements and intended use of the product. Test result results showed that all tests successfully passed." Established performance, functionality, and reliability characteristics. |
| Compliance with Standards | The device is in compliance with NEMA PS 3.1 3.20 (DICOM), IEC 62304 Ed. 1.1 (Medical Device Software Life Cycle), ISO 14971 2nd Ed. (Risk Management), and ISO 16142-1 (Essential principles of safety and performance). The submission also considered various FDA guidance documents. |
| Substantial Equivalence | The overall conclusion is that the device "does not introduce any new significant potential safety risks and is substantially equivalent to the predicate device in terms of performance, safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of a dataset of medical images used to evaluate diagnostic performance (like sensitivity/specificity for disease detection). The testing described is software verification and validation. Therefore, there's no mention of sample size for a clinical test set or data provenance in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this is not an AI/CAD diagnostic device, there's no mention of expert-established ground truth for a test set of medical images. The "ground truth" for the software's functionality would be its adherence to design specifications and user requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned. The device's purpose is to display, store, and transmit images, not to provide diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a PACS system, which is a tool for human radiologists. It does not perform diagnostic tasks independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the conventional sense of diagnostic performance for a disease. The "ground truth" for this device's testing relates to its correct functioning against design specifications and user requirements, not medical conditions.
8. The sample size for the training set
Not applicable. The vRad PACS with Mammography is not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2016
Virtual Radiologic Corporation % Ms. Melinda Sewell Quality and Regulatory Compliance Manager 11995 Singletree Lane, Suite 500 EDEN PRAIRIE MN 55344
Re: K162145
Trade/Device Name: vRad PACS with Mammography Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 7, 2016 Received: October 11, 2016
Dear Ms. Sewell:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert 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)
Device Name
vRad PACS with Mammography
Indications for Use (Describe)
The vRad PACS with Mammography software is used with general purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf g minimum specifications and networked with vRad PACS Storage component. The vRad PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, Xray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOMcompliant modalities. The vRad Storage component is intended to handle the DICOM protocol and store images as DICOM files to a location where they can be read by vRad PACS Cache and transmitted to radiologists' workstations for viewing by the vRad PACS Viewer.
vRad PACS with Mammography may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and displayed on a monitor that meets technical specifications reviewed and cleared by FDA.
| 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) | |||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
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510(k) Summary for vRad PACS with Mammography
Applicant:
Virtual Radiologic Corporation 11995 Singletree Lane, Suite 500 Eden Prairie, MN 55344
| Establishment Registration | |
|---|---|
| Number: | 3007795813 |
| Telephone: | 952.595.1100 |
| Fax: | 952.942.3361 |
Company Contact: Melinda Sewell, Quality and Regulatory Compliance Manager
Date Prepared: October 7, 2016
Device Name and Classification:
| Proprietary Name: | vRad PACS with Mammography |
|---|---|
| Device Common Name: | Picture Archiving and Communications System (PACS) |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Device Classification: | Class II |
| Review Panel: | Radiology |
Predicate Device:
FujiFilm Medical Systems, Synapse Workstation Software Version 3.3.0, K112439
Device Description:
vRad PACS with Mammography is a device which consists solely of software that allows electronic transmission of radiological patient images from one location to another. The device is capable of accepting, storing, digitally
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processing, and displaying medical images for the purposes of providing digital diagnostic image interpretation services by trained radiologists on PC workstations. The software provides functions for performing operations related to manipulation, enhancement, compression, and quantification of medical images.
vRad PACS with Mammography is a modified version of vRad PACS (K090649) that will now allow display of presentation-quality digital mammography images.
Indications for Use:
The vRad PACS with Mammography software is used with general-purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with vRad PACS Storage component. The vRad PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities. The vRad Storage component is intended to handle the DICOM protocol and store images as DICOM files to a location where they can be read by vRad PACS Cache and transmitted to radiologists' workstations for viewing by the vRad PACS Viewer.
vRad PACS with Mammography may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and displayed on a monitor that meets technical specifications reviewed and cleared by FDA.
Substantial Equivalence Comparison:
Virtual Radiologic believes vRad PACS with Mammography is substantially equivalent to Synapse Workstation.
| Characteristic | vRad PACS withMammography | Synapse Workstation(K112439) |
|---|---|---|
| Indications for Use | The vRad PACS withMammography software isintended for use withgeneral purpose | FujiFilm SynapseWorkstation Software isintended for installation onan off-the-shelf PC |
| Characteristic | vRad PACS withMammography | Synapse Workstation(K112439) |
| computing hardware whichmeets or exceedsminimum specifications.vRad PACS withMammography is intendedto receive, transmit, storeand display images forclinical purposes and iscomprised of threecomponents: Viewer,Storage, and Cache. ThevRad PACS Viewercomponent is intended forinstallation on an off-the-shelf PC meeting orexceeding minimumspecifications andnetworked with the vRadPACS Storage component.The vRad PACS Viewer isintended to serve as theprimary user interface forthe processing of medicalimages for presentation ondisplays appropriate to themedical task beingperformed. The vRadPACS Viewer can processmedical images fromDICOM modalities such asX-ray radiography, X-raycomputed tomography,magnetic resonanceimaging, ultrasound,nuclear medicine, andimages from other DICOM-compliant modalities. ThevRad Storage componentis intended to handle theDICOM protocol and storeimages as DICOM files toa location where they canbe read by vRad PACSCache and transmitted toradiologists' workstationsfor viewing by the vRadPACS Viewer. | meeting or exceedingminimum specificationsand networked with FujiSynapse PACS. The FujiSynapse Workstation isintended to serve as theprimary user interface forthe processing of medicalimages for presentationon displays appropriate tothe medical task beingperformed. The SynapseWorkstation can processmedical images from thefollowing modality types:plane X-ray radiography,X-ray computedtomography, magneticresonance imaging,ultrasound, nuclearmedicine and images fromother DICOM compliantmodalities.The Synapse Workstationmay be used to processDICOM MG "ForProcessing" images andalso for the display,manipulation, andinterpretation of losslesscompressed or non-compressedmammography imagesthat have been receivedin the DICOM ForPresentation format anddisplayed on FDA cleared,DICOM compatibledisplays formammography. | |
| Characteristic | vRad PACS withMammography | Synapse Workstation(K112439) |
| vRad PACS withMammography may beused for the display,manipulation, andinterpretation of losslesscompressed or non-compressedmammography imagesthat have been receivedin the DICOM" ForPresentation" formatand displayed on anFDA-approved monitorthat meets technicalspecifications reviewedand accepted by FDA. | ||
| Display of DigitalMammographyImages | Yes | Yes |
| On-demand accessto database andimages | Yes | Yes |
| Viewing study lists | Yes | Yes |
| Decompression forcompressed imagesbefore display | Yes | Yes |
| Display images | Yes | Yes |
| Viewing reports | Yes | Yes |
| Hanging protocol | Yes | Yes |
| Spine labeling | Yes | Yes |
| Reference linedisplay | Yes | Yes |
| Key imagesidentification | Yes | Yes |
| Link multiple series | Yes | Yes |
| Measurement tools | Yes | Yes |
| Annotation tools | Yes | Yes |
| Standard imagemanipulation tools(Window width/level,zoom, pan, etc) | Yes | Yes |
| Characteristic | vRad PACS withMammography | Synapse Workstation(K112439) |
| FCR IPSS for Fuji-CRimages | No (proprietary toFuijfilm) | Yes |
| CT IPSS for CTimages | No (proprietary toFuijfilm) | Yes |
Functional Comparison:
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Technical Comparison:
| Characteristic | vRad PACS withMammography | Synapse Workstation(K112439) |
|---|---|---|
| Productavailability | Software only | Software only |
| OperatingSystems | Windows 7 | Windows 2000/XP |
| Web Browser | Internet Explorer | Internet Explorer |
| Image and DataProcessing | Client Side | Client Side |
| TechnologyPlatform (Client) | Windows .Net | Windows Active-X |
| TechnologyPlatform (Server) | Windows Server | Windows Server |
| ProgrammingLanguages (Client) | C++, C# .Net | C++, Active-X |
Safety Information
vRad PACS with Mammography introduces no new safety or efficacy issues other than those already identified with the cleared vRad PACS (K090649). The results of the hazard analysis combined with the appropriate mitigations taken indicate that the device is of moderate concern, as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The vRad PACS with Mammography labeling contains instructions for use and necessary cautions, warnings, and notes to provide the safe and effective use of the device.
Testing Information
vRad PACS with Mammography tested successfully with reference to its product requirements, as well as design verification and validation document and traceability matrix document. Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the
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vRad PACS with Mammography software, which is found to be as safe and effective as the predicate device.
Testing involved system-level functionality test, component testing, verification testing, integration testing, usability testing, labeling testing, as well as the testing for risk mitigations associated with the risk management process.
Pass/fail criteria were based on the requirements and intended use of the product. Test result results showed that all tests successfully passed.
Performance Standards:
The subject device is in compliance with the following standards:
- NEMA PS 3.1 3.20 (2016) Digital Imaging and Communications in ● Medicine (DICOM) Set
- IEC 62304 Ed. 1.1 (2015) Medical Device Software Software Life Cycle ● Processes
- ISO 14971 2nd Ed. (2007) Medical Devices Application Of Risk ● Management To Medical Devices
- ISO 16142-1, 1st Ed. (2016) Medical Devices Recognized essential . principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards.
This 510(k) submission was prepared in consideration of the following quidance documents:
- Guidance for the Submission of Premarket Notifications for Medical Image . Management Devices (2000)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014)
- Applying Human Factors and Usability Engineering to Medical Devices ● (2016)
- Display Accessories for Full-Field Digital Mammography Systems -Premarket Notification (510(k)) Submissions (2008)
- . Guidance for Off the Shelf Software Used in Medical Devices (1999)
Conclusion
The predicate device was cleared based on non-clinical supportive information. The comparison of features, technical characteristics, devices hazards, and verification and validation testing demonstrate that the subject device is as safe
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and effective as the predicate device currently marketed for the same intended use.
In conclusion, the subject device, vRad PACS with Mammography does not introduce any new significant potential safety risks and is substantially equivalent to the predicate device in terms of performance, safety and effectiveness.
§ 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).