(85 days)
No
The document describes a PACS system for image management and display, with standard image processing functions. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
No
The device is a Picture Archiving and Communication System (PACS) used for displaying and processing medical images for diagnostic interpretation by radiologists, not for direct therapeutic treatment.
Yes
The device "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" and "allows display of presentation-quality digital mammography images." It explicitly states that it is for "providing digital diagnostic image interpretation services by trained radiologists." These functions indicate that it is used for diagnostic purposes.
Yes
The device description explicitly states that the device "consists solely of software". While it requires general purpose computing hardware, this hardware is not part of the medical device itself.
Based on the provided text, 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.
- Device Function: The vRad PACS with Mammography software is described as a system for receiving, transmitting, storing, and displaying medical images (radiological images). It processes and presents images for interpretation by trained radiologists.
- Lack of Biological Sample Analysis: The device does not analyze biological samples from the human body. Its input is medical images, not biological specimens.
The device falls under the category of medical image management and display software, which is distinct from in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
LLZ
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/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
4
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 with
Mammography | Synapse Workstation
(K112439) |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The vRad PACS with
Mammography software is
intended for use with
general purpose | FujiFilm Synapse
Workstation Software is
intended for installation on
an off-the-shelf PC |
| Characteristic | vRad PACS with
Mammography | Synapse Workstation
(K112439) |
| | 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 the 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. | meeting or exceeding
minimum specifications
and networked with Fuji
Synapse PACS. The Fuji
Synapse Workstation 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 Synapse
Workstation can process
medical images from the
following modality types:
plane X-ray radiography,
X-ray computed
tomography, magnetic
resonance imaging,
ultrasound, nuclear
medicine and images from
other DICOM compliant
modalities.
The Synapse Workstation
may be used to process
DICOM MG "For
Processing" images and
also 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 FDA cleared,
DICOM compatible
displays for
mammography. |
| Characteristic | vRad PACS with
Mammography | Synapse Workstation
(K112439) |
| | 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 an
FDA-approved monitor
that meets technical
specifications reviewed
and accepted by FDA. | |
| Display of Digital
Mammography
Images | Yes | Yes |
| On-demand access
to database and
images | Yes | Yes |
| Viewing study lists | Yes | Yes |
| Decompression for
compressed images
before display | Yes | Yes |
| Display images | Yes | Yes |
| Viewing reports | Yes | Yes |
| Hanging protocol | Yes | Yes |
| Spine labeling | Yes | Yes |
| Reference line
display | Yes | Yes |
| Key images
identification | Yes | Yes |
| Link multiple series | Yes | Yes |
| Measurement tools | Yes | Yes |
| Annotation tools | Yes | Yes |
| Standard image
manipulation tools
(Window width/level,
zoom, pan, etc) | Yes | Yes |
| Characteristic | vRad PACS with
Mammography | Synapse Workstation
(K112439) |
| FCR IPSS for Fuji-CR
images | No (proprietary to
Fuijfilm) | Yes |
| CT IPSS for CT
images | No (proprietary to
Fuijfilm) | Yes |
Functional Comparison:
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Technical Comparison:
| Characteristic | vRad PACS with
Mammography | Synapse Workstation
(K112439) |
|-----------------------------------|-------------------------------|----------------------------------|
| Product
availability | Software only | Software only |
| Operating
Systems | Windows 7 | Windows 2000/XP |
| Web Browser | Internet Explorer | Internet Explorer |
| Image and Data
Processing | Client Side | Client Side |
| Technology
Platform (Client) | Windows .Net | Windows Active-X |
| Technology
Platform (Server) | Windows Server | Windows Server |
| Programming
Languages (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
8
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
9
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.