(177 days)
Advanced Viewer is a web based software for medical professionals that provides doctors with tools for secure online image (DICOM) review including measurement functions and the display of voxel objects.
It is not intended for detailed treatment planning, treatment of patients or the review of mammographic images. It is also not intended to be used on mobile systems.
Advanced Viewer is integrated in the online collaboration platform Quentry to share, discuss and transfer medical image data. The viewer provides capabilities to visualize medical images (DICOM) that have been uploaded to the platform before.
Quentry is a software platform consisting of a set of server-based components providing functions for transfer and storage of medical data, as well as user access via a web-based portal for data management, sharing, and download. The platform is integrated with desktop and server-based applications for upload and download of medical data from workstations and network-based image archive servers. The platform also provides interfaces for integration of third-party systems and applications. Quentry platform is an FDA class I product.
The provided text describes the "Advanced Viewer," a web-based software for medical professionals to review DICOM images. However, the document does not contain specific acceptance criteria, a detailed study that proves the device meets those criteria, or the other requested information like sample sizes, expert qualifications, or ground truth details.
The document primarily focuses on establishing substantial equivalence to predicate devices (CONi and iPlan) for regulatory approval (510(k)). It highlights that the Advanced Viewer offers more viewing features than CONi but states these do not introduce new safety or effectiveness concerns, and that it provides identical functionalities to iPlan, running on a different platform but using the same software framework.
The "Verification/validation summary" section mentions that verification was done to demonstrate that design specifications are met, and non-clinical validation included usability tests that were rated as successful according to their acceptance criteria. However, it does not detail what those acceptance criteria were or the specifics of the validation study.
Therefore, most of the information requested cannot be extracted from this document.
Here's a summary of what can be inferred from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative metrics or specific thresholds. The document generally implies that the device must function equivalently or better than the predicate devices for image viewing and manipulation.
- Reported Device Performance: Not explicitly detailed with specific performance metrics. The document states that "All test reports were finally rated as successful according to their acceptance criteria" for usability tests, but doesn't elaborate on the results.
Missing Information (Not Available in the Provided Text):
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The device's purpose is for viewing existing DICOM images, not for generating a diagnosis that would require ground truth in the typical AI/CAD context.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is a viewer, not an AI-based diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device is fundamentally a human-in-the-loop viewer.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned, and likely not applicable in the traditional sense for a medical image viewer. The "ground truth" for a viewer would relate to proper display and accurate measurements, likely verified against source DICOM data and expert visual inspection.
- The sample size for the training set: Not mentioned. There is no indication of machine learning or AI algorithm training in the description.
- How the ground truth for the training set was established: Not mentioned, and likely not applicable given the device's description.
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FEB 2 8 2014
KB2763
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510 (K) SUMMARY ADVANCED VIEWER
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| Manufacturer: | Brainlab AGKapellenstrasse 1285622 FeldkirchenGermany | |
|---|---|---|
| Phone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33 | ||
| Submitter: | Rainer Birkenbach | |
| Contact person: | Alexander Schwiersch | |
| Summary date: | 8/30/2013 | |
| Device: | Advanced Viewer | |
| Trade name: | Advanced Viewer | |
| Common/ClassificationName: | Picture archiving and communications system | |
| Main Predicate Device: | CONi (K130624) | |
| Secondary PredicateDevice: | iPlan (K113732) | |
| Device classificationname: | system, image processing, radiological | |
| Regulatory Class: | Class II | |
| Regulation Number: | 892.2050 | |
| Product Code: | LLZ | |
| Intended use: | Advanced Viewer is a web based software for medical professionals thatprovides doctors with tools for secure online image (DICOM) review includingmeasurement functions and the display of voxel objects. | |
| It is not intended for detailed treatment planning, treatment of patients or thereview of mammographic images. It is also not intended to be used on mobilesystems. | ||
| Device description: | Advanced Viewer is integrated in the online collaboration platform Quentry toshare, discuss and transfer medical image data. The viewer providescapabilities to visualize medical images (DICOM) that have been uploaded tothe platform before. | |
| Quentry is a software platform consisting of a set of server-based componentsproviding functions for transfer and storage of medical data, as well as useraccess via a web-based portal for data management, sharing, and download.The platform is integrated with desktop and server-based applications forupload and download of medical data from workstations and network-basedimage archive servers. The platform also provides interfaces for integration ofthird-party systems and applications. Quentry platform is an FDA class I | ||
| FORM 04-195 | REVISION 1 | PAGE 1 OF 4 |
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product.
Advanced Viewer is generally used by medical professionals such as doctors, their assistants or nursing staff, within a clinic or at a doctor's office, or even at home.
Typical use cases of the embedded viewer together with the functionality of the web portal are:
- . Physicians asking/providing colleagues for/with 2nd opinion
- Physicians refer patients to other hospitals and send pictures upfront .
- Expert service: Several hospitals share one radiology department .
- . Basic diagnostic tasks (measurement function and display of structures)
Device Features
Advanced Viewer provides the following functions
| Load and import DICOM images | Load DICOM images from clouddatabase |
|---|---|
| View DICOM images | Viewer converts DICOM images toPNG format for viewing |
| Adjustment (pan, zoom, window,color scheme adjustment) | Review patient data with variousadjustment |
| Reconstruction | Review patient data from differentorientation |
| Measurement - distance | Viewer provides distancemeasurement between two arbitrarypoints |
| Measurement - Point | Viewer provides gray levelmeasurement for an arbitrary point |
| Voxel object | Review imported DICOM objects |
| Fused images | Review aligned patient data, e.g.CT, PT and so on |
| Cine loop playing | Display multiframe DICOM images |
Substantial equivalence:
Both Advanced Viewer and CONi (the main predicate device) are webbased/cloud-based software for viewing DICOM images. Both of the proposed and predicate devices are to be used with any computer with appropriate internet connection. Equivalent with the predicate device, Advanced Viewer is software installed in a web server that will communicate with the client via internet connection. Advanced Viewer utilizes encrypted browser communication. Image viewing and manipulation are provided by both devices.
Whereas Advanced Viewer provides more viewing features than CONi as discussed in the substantial equivalence table; Advanced Viewer and iPlan (the secondary predicate device) provide identical functionalities of viewing, adjusting, and measuring DICOM images. Equivalent to the predicate device. Advanced Viewer is intended for medical professionals to view and adjust DICOM images. Advanced Viewer and iPlan use the same software framework.
As a conclusion Advanced Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate devices.
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| Conclusion: | Hence Advanced Viewer does not introduce any new issues concerning safetyand effectiveness, and is substantial equivalent to the predicate devices.CONi and Advanced Viewer have similar functionality. Advanced Viewerprovides further viewing features which are substantially equivalent with iPlan.These extended viewing features neither constitute any new intended use, norraise any questions that affect safety and effectiveness, since they provideusers with more advanced functions viewing images but no function more thanviewing..Compared with iPlan, Advanced Viewer runs on a different platform. However,since Advanced Viewer and iPlan provide identical functionalities and utilizethe same software framework, Advanced Viewer does not introduce anyissues concerning safety and effectiveness.Advanced Viewer has similar functionality, intended use, technologicalcharacteristics, and typical users as the predicate devices. Hence AdvancedViewer does not introduce any new issues concerning safety andeffectiveness, and is substantially equivalent to the predicate devices. |
|---|---|
| Verification/validationsummary: | VerificationThe verification of the System Advanced Viewer has been carried outthoroughly both at the top level and on the underlying subsystems. Theverification was done to demonstrate that the design specifications are met.Non-clinical validationThe validation contained usability tests which should ensure that workflows oruser interface result in a useful interface.All test reports were finally rated as successful according to their acceptancecriteria. The non-clinical validation has been performed with software and unitsthat are considered equivalent to the final version of the product, as warrantedby 21 CFR 820.30 (g) and which have the UI as planned for the release.The user tests were done in combination with the Quentry.com Portal 2.0.1which is developed and released by Voyant Health, a Brainlab company. TheAdvanced Viewer workflow included also patient selection as interfacebetween Quentry.com Portal and the Advanced Viewer. |
| Intended operationalEnvironment | Standard computer with internet connection and mouse.Operating SystemThe following versions or higher:Windows XPMac OS X |
:
.
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- Chrome 10 .
- Safari 5 .
Microsoft® Silverlight® 5 Plugin needed
Hardware
- 2GB RAM recommended •
- Screen resolution: 1024x768 or higher .
- Mouse with scroll wheel recommended 1 .
Network
- Internet connection with at least 1Mbit/sec (2 Mbit/sec recommended). The . internet connection
- must be stable. You may need to restart the viewer if the internet connection . is unstable.
- Firewall with open outbound port 80/443 (http and https) t
- Known Exceptions
- · 64bit browsers are not supported by Microsoft® Silverlight®
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure embracing three overlapping lines, which represent the department's mission to protect and promote the health and well-being of Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
February 28, 2014
Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 85622 Feldkirchen GERMANY
Re: K132763 Trade/Device Name: Advanced Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 10, 2014 Received: January 13, 2014
Dear Mr. Schwiersch:
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 Cosmatic 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 of any freather 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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Page 2-Mr. Schwiersch
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fdaggov/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sm.p)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132763
Device Name Advanced Viewer
Indications for Use (Describe)
Advanced Viewer is a web based software for medical professionals that provides doctors with tools for secure online image (DICOM) review including measurement functions and the display of voxel objects.
It is not intended for detailed treatment of patients of patients or the review of mammographic images. It is also not intended to be used on mobile systems.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Smh.7)
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§ 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).