(51 days)
Not Found
No
The document describes a medical image viewer with standard viewing and navigation tools. There is no mention of AI, ML, or any advanced analytical capabilities that would typically be associated with such technologies. The focus is on accessibility, compatibility, and basic image manipulation.
No
The device is a medical image viewing and information distribution application, not intended for therapeutic purposes. It supports clinicians in viewing images and treatment planning, but does not itself provide therapy.
No
The text explicitly states, "VitreaView is not intended for primary diagnosis" and "When accessed from a mobile tablet, VitreaView is for informational purposes only and not intended for diagnostic use."
Yes
The device description explicitly states "VitreaView is a cross-browser, cross-platform, zero-footprint universal image viewer solution" and highlights its software-based features and integrations, with no mention of accompanying hardware components being part of the device itself. While it interacts with hardware (monitors, tablets), the device being cleared is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that VitreaView is a medical image viewing and information distribution application. It is explicitly stated as "not intended for primary diagnosis" and "for informational purposes only and not intended for diagnostic use" when accessed from a mobile tablet.
- Device Description: The description focuses on displaying and accessing medical images and related information from various sources. It describes features related to viewing, navigation, and integration with other medical record systems.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. VitreaView does not perform any such analysis of biological specimens. Its function is to display existing medical images and data.
Therefore, VitreaView falls under the category of medical image management and viewing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VitreaView is a medical image viewing and information distribution application that provides access, through the Internet and within the enterprise, to multi-modality softcopy medical images, reports and other patient-related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis. When accessed from a mobile tablet, VitreaView is for informational purposes only and not intended for diagnostic use.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Product codes
LLZ
Device Description
VitreaView is a cross-browser, cross-platform, zero-footprint universal image viewer solution capable of displaying both DICOM and non-DICOM medical images. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning.
VitreaView offers medical professionals a universal viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint, zero- download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessed from a mobile tablet, no advanced image processing is performed by the tablet.
Some of the general features include:
- . Performance speed
- . Zero-footprint architecture
- DICOM and non-DICOM display –
- Vendor neutrality .
- Function within a virtual environment .
- Multi-modality review of data .
- . Basic image review tools (zoom, pan, measure)
- Easy study navigation and search capability .
- Radiology key images .
- Comparative review .
- . Cross-platform viewing capabilities (Windows, Linux, Mac OS)
- Leveraging of next-generation protocols for image viewing (i.e. MINT) .
- Single sign-on .
- . MPR and 3D viewing
- . Access on various iOS and Android tablet devices through the default internet browser
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality softcopy medical images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians and other medical professionals / 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)
Non-Clinical Tests: VitreaView was designed, developed, and tested according to written procedures. Testing included verification, validation, and evaluation of previously acquired medical images. The software verification team's primary goal was to assure the software fully satisfies all expected new and previously defined detailed level system requirements and features through new feature test case authoring and execution. The software validation team's primary goal was to assure the software conforms to user needs and intended uses through workflow testing, internal beta testing, internal user acceptance testing, and installation and upgrade path testing.
Clinical Tests: The subject of this traditional 510(k) notification, VitreaView, did not require clinical studies to support safety and effectiveness of the software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VitreaView (K111892)
Reference Device(s)
Not Found
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).
0
| 2 2 | 3e
Vital Images
VitreaView 510(k) Pre-market Notification
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.
| Purpose of
Submission: | Vital Images, Inc. hereby submits this traditional 510(k) to provide notification
submission for an addition to the Indications for Use of our already cleared VitreaView
software. | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway
Suite 300
Minnetonka, MN 55343-4414 | | |
| | Image: SEP 7 2012 | | |
| Establishment
Registration: | 2134213 | | |
| Contact Person: | Ian Nemerov
Vice President, General Counsel & Secretary
Phone: 952-487-9622
Fax: 952-487-9510
E-mail: inemerov@vitalimages.com | | |
| 510(k) Type: | Traditional 510(k) | | |
| Summary Date: | August 27, 2012 | | |
| Device Name | Trade Name: | VitreaView | |
| | Common Name: | Picture Archiving and Communications System | |
| | Classification Name: | System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ) | |
- Predicate Device: VitreaView (K111892)
Device Description:
VitreaView is a cross-browser, cross-platform, zero-footprint universal image viewer solution capable of displaying both DICOM and non-DICOM medical images. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning.
VitreaView offers medical professionals a universal viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint, zero- download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessed from a mobile tablet, no advanced image processing is performed by the tablet.
Some of the general features include:
- . Performance speed
- . Zero-footprint architecture
- DICOM and non-DICOM display �
- Vendor neutrality .
- Function within a virtual environment .
- Multi-modality review of data .
1
Vital Images
- . Basic image review tools (zoom, pan, measure)
- Easy study navigation and search capability .
- Radiology key images .
- Comparative review .
- . Cross-platform viewing capabilities (Windows, Linux, Mac OS)
- Leveraging of next-generation protocols for image viewing (i.e. MINT) .
- Single sign-on .
- . MPR and 3D viewing
- . Access on various iOS and Android tablet devices through the default internet browser
Intended Use / Indications for Use:
VitreaView is a medical image viewing and information distribution application that provides access, through the Internet and within the enterprise, to multi-modality softcopy medical images, reports and other patient-related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis. When accessed from a mobile tablet, VitreaView is for informational purposes only and not intended for diagnostic use.
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Summary of Non-Clinical Tests:
VitreaView was designed, developed, and tested according to written procedures. Testing included verification, validation, and evaluation of previously acquired medical images.
The following quality assurance measures were applied to the development of VitreaView:
- Risk analysis .
- Requirements reviews .
- Design reviews .
- . Performance testing (Verification)
- Safety testing (Verification) .
- Simulated use testing (Validation) �
The software verification team had a primary goal of assuring that the software fully satisfies all expected new and previously defined detailed level system requirements and features. This was accomplished through new feature test case authoring on the system requirements and their execution. In addition to reviewing and authoring test cases based upon the system requirements and features the verification team reviewed and monitored the Requirements Traceability Matrix (RTM) to ensure coverage of said items as well as review and authoring of additional cases to meet the FMEA submitted for the project.
The software validation team had a primary goal of assuring that the software conforms to user needs and intended uses. The result of the validation team's efforts was evidence that system requirements and features were implemented, reviewed and met through workflow testing.
2
Vital Images
The software validation team provided internal validation of the VitreaView product once verification was completed. Internal validation included internal beta testing, internal user acceptance testing, and installation and upgrade path testing.
The software was designed, developed and tested according to written procedures, Software testing was completed to ensure the new feature functions according to its requirements and interacts without impact to existing functionality.
Summary of Clinical Tests:
The subject of this traditional 510(k) notification, VitreaView, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
VitreaView is designed to follow security best practices, including those outlined by the Open Web Application Security Project (OWASP) and Health Insurance Portability and Accountability Act (HIPAA), to limit the risk of unauthorized access to the system or data. Security is enforced at multiple layers within the system.
Measurement Accuracy:
Measurements and orientation in VitreaView were verified using various imaging phantoms. These imaging phantoms contain markers at known positions, distances, and angles from one another. The known positions, distances, and angles were used as input into expected results for verification tests that verified the spatial accuracy of image rendering of 2D and 3D images, the accuracy of distance, angular measurement, and navigational tools, and the accuracy of orientation markers within the VitreaView application.
Performance Standard:
The software is designed to meet NEMA PS 3.1-3.20 (2011) Digital Imaging and Communications in Medicine (DICOM).
Conclusion:
The VitreaView software is substantially equivalent to the predicate device and is safe and effective for its intended use.
3
Image /page/3/Picture/0 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features a stylized graphic of an abstract human form, composed of three curved lines, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-00002
Mr. Ian Nemerov Vice President, General Counsel & Secretary Vital Images. Inc. 5850 Opus Parkway, Suite #300 MINNETONKA MN 55343
Re: K122136
Trade/Device Name: VitreaView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 17, 2012 Received: July 18, 2012
Dear Mr. Nemerov:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
$\text{SEP} \qquad 7 \ 2012$
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirement as be form arketing your device as described in your Section 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 Parts 801 and 11 you dose contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
K 122136 510(k) Number (if known):
Device Name: VitreaView
Indications for Use:
VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise, to multi-modality softcopy medical images, reports and other patient-related information, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis. When accessed from a mobile tablet, VitreaView is for informational purposes only and not intended for diagnostic use. .
Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
In Vitro Diagnostic Device
510(k) K122136
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VitreaView
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