(114 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard image viewing and manipulation functions. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is a software for displaying medical images and other healthcare data, "It is not intended for primary image diagnosis or the review of mammographic images." It does not provide any treatment or therapy.
No
The device is explicitly stated as "not intended for primary image diagnosis". It is used for displaying medical images and healthcare data "for non-diagnostic purposes".
Yes
The device description explicitly states "The DICOM Viewer is software for web based viewing of DICOM data," and the anatomical site description reinforces this by stating "The device is software only." The performance studies focus on software verification and validation, with no mention of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "not intended for primary image diagnosis". IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is for viewing existing medical images.
- Device Description: It's described as software for viewing DICOM data. This aligns with image display, not in vitro testing.
- Input: The input is DICOM data (medical images), not biological samples.
- Functionality: The functions listed (image review, manipulation, measurements, 3D visualization) are related to image display and analysis, not laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
While it is a medical device used in healthcare settings and is regulated, its function is focused on the display and manipulation of medical images, not on performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
DICOM Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering).
It is not intended for primary image diagnosis or the review of mammographic images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The DICOM Viewer is software for web based viewing of DICOM data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The device is software only which allows viewing of DICOM data. Hence it does not interact with any body/tissue part and the viewing is not limited to any body/tissue part.
Indicated Patient Age Range
The device is software which allows viewing of DICOM data. Hence there is no specific patient population.
Intended User / Care Setting
Operator profile
The device is generally used by medical professionals such as doctors, their assistants or nursing staff which are in need of displaying medical (DICOM) images and other healthcare data for non-diagnostic purposes.
Intended use environment
The software is intended to be used:
- In Operating Rooms
- In Office environments within hospitals or at any other location offering a computer
- At any location on tablet devices
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)
Verification
The verification of the System DICOM Viewer has been carried out thoroughly both at the top level and on underlying modules. The verification was done to demonstrate that the design specifications are met.
Non-clinical validation
- DICOM Viewer 2.2 and DICOM Viewer 3.0 are substantially equivalent regarding user group, use scenario, use related risks and the user interface being nearly identical. Thus safe use of the device can be posed on post-market evaluation for the DICOM Viewer 2.2.
- Validation contained reviews of the MAUDE, BfArM and Brainlab internal complaint databases regarding incidents of similar products including the DICOM Viewer 2.2. The search results did not result in any necessary actions for the DICOM Viewer.
- The validation of the intended use, user needs and primary operating functions of the DICOM Viewer 3.0 is additionally covered by specific sections in the verification protocols.
- Formative usability tests have been performed as listed in the Usability Evaluation Summary. The prototype is substantially equivalent with the user interface being nearly identical to the final device. Only bug fixes and minor improvements of the software with no effect on the results of the formative usability tests have been incorporated afterwards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Digital Lightbox (K093117), CONI (K130624)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol to the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three intertwined strands and a stylized wing-like element at the top. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 Feldkirchen 85622 GERMANY
Re: K153653
Trade/Device Name: DICOM Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 2, 2016 Received: March 7, 2016
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 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.
1
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.'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
2
Indications for Use
510(k) Number (if known) K153653
Device Name
DICOM Viewer
Indications for Use (Describe)
DICOM Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering).
It is not intended for primary image diagnosis or the review of mammographic images.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510 (K) SUMMARY DICOM VIEWER
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| Manufacturer: | Brainlab AG
Kapellenstrasse 12
85622 Feldkirchen
Germany |
|--------------------------------------|-------------------------------------------------------------------|
| | Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 33 |
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 11/5/2015 |
| Device: | Image Viewer |
| Trade name: | DICOM Viewer |
| Device Classification
Regulation: | 892.2050 - Picture archiving and communications system |
| Regulatory Class: | Class II |
| Product Code: | LLZ - System, Image Processing, Radiological |
| Main Predicate Device: | Digital Lightbox (K093117) |
| Secondary Predicate
Device: | CONI (K130624) |
INTENDED USE: 1
DICOM Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering).
It is not intended for primary image diagnosis or the review of mammographic images.
DEVICE DESCRIPTION: 2
The DICOM Viewer is software for web based viewing of DICOM data.
Operator profile
The device is generally used by medical professionals such as doctors, their assistants or nursing staff which are in need of displaying medical (DICOM) images and other healthcare data for non-diagnostic purposes.
Patient population
4
The device is software which allows viewing of DICOM data. Hence there is no specific patient population.
Intended use environment
The software is intended to be used:
- . in Operating Rooms
- in Office environments within hospitals or at any other location offering a computer
- at any location on tablet devices ●
Operating principle
There are different operating principles:
- On desktop PCs the interaction with the software is mainly performed with mouse and/or kevboard
- -On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface.
Primary operating functions
Non-diagnostic viewing of medical images and other healthcare data in DICOM format.
Use scenarios
- A user wants to review DICOM data in an OR before or during a surgery in order to think about the procedure or to talk about the procedure with his colleagues.
- -A user wants to review DICOM data of patients in a reqular board meeting in order to discuss aspects of treatments with his colleaques
- -A user wants to review DICOM data of patients in a meeting where the participants are not in the same room in order to discuss aspects of treatments with his colleagues or to get the opinion of an external expert
Intended part of the body or type of tissue applied to or interacted with
The device is software only which allows viewing of DICOM data. Hence it does not interact with any body/tissue part and the viewing is not limited to any body/tissue part.
Essential performance characteristics
Image Viewer is essentially software for medical image visualization. A hardware shutdown, power failure or other hardware issue that makes the software inoperable does not cause harm. Hence, no unacceptable risk arises if the hardware loses performance. Therefore, the hardware does not have any essential performance characteristics.
The software risks were analyzed to find risks in the non-acceptable area. No risks have been identified in the non-acceptable area. Hence, no measures are considered essential performance characteristics. In summary, the Image Viewer software does not have any essential performance characteristics.
6 SUBSTANTIAL EQUIVALENCE
DICOM Viewer has similar functionality, intended use, technological characteristics, and typical users as
5
the predicate devices.
Both DICOM Viewer and the primary predicate device, Digital Lightbox (K093117) are used to display medical images including multiplanar reconstructions and 3D volume rendering, perform basic image manipulations and measurements, and load and visualize planning data as fusions, objects and trajectories. Both devices are Brainlab products, have been developed by the same R&D team and use the same software framework. Both DICOM Viewer and all two predicate devices (Digital Lightbox (K093117) and CONi (K130624)) are intended to view medical images.
In contrast to the primary predicate device. Digital Lightbox (K093117), the DICOM Viewer has a web frontend which is available on multiple devices (computers, Android tablets and iPads); whereas, the Digital Lightbox is accessible and running on a dedicated system only. However the other predicate device CONi (K130624) is also web-based software for viewing DICOM Images.
In addition the DICOM Viewer can display fiber objects generated by other Brainlab applications and align images sets and persist the align state. These enhancements in respect to the predicate devices do not affect the intended use, alter the fundamental technology of the primary predicate device, Digital Lightbox (K093117) nor do they introduce any new issues concerning safety and effectiveness.
4 VERIFICATION/VALIDATION SUMMARY
Verification
The verification of the System DICOM Viewer has been carried out thoroughly both at the top level and on underlying modules. The verification was done to demonstrate that the design specifications are met.
Non-clinical validation
- . DICOM Viewer 2.2 and DICOM Viewer 3.0 are substantially equivalent regarding user group, use scenario, use related risks and the user interface being nearly identical. Thus safe use of the device can be posed on post-market evaluation for the DICOM Viewer 2.2.
- Validation contained reviews of the MAUDE, BfArM and Brainlab internal complaint databases ● regarding incidents of similar products including the DICOM Viewer 2.2. The search results did not result in any necessary actions for the DICOM Viewer.
- . The validation of the intended use, user needs and primary operating functions of the DICOM Viewer 3.0 is additionally covered by specific sections in the verification protocols.
- . Formative usability tests have been performed as listed in the Usability Evaluation Summary. The prototype is substantially equivalent with the user interface being nearly identical to the final device. Only bug fixes and minor improvements of the software with no effect on the results of the formative usability tests have been incorporated afterwards.
CONCLUSION 5
The comparison of the DICOM Viewer with the predicate devices using available labelling (Digital Lightbox K093117 and CONi K130624) and Brainlab internal specifications (Digital Lightbox K093117) shows that the DICOM Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate devices. Verification and validation activities ensure that the design specifications are met and that the DICOM Viewer does not introduce new issues concerning safety and effectiveness. Hence DICOM Viewer is substantial equivalent to the predicate devices.