(281 days)
K172418 OpenSight
No
The summary describes a standard medical image viewer with basic manipulation and measurement tools. There is no mention of AI, ML, or any features that would typically utilize these technologies for image analysis, diagnosis support, or other advanced functions. The performance studies focus on usability, compatibility, and basic functionality verification.
No
The device is a software viewer for medical images and other healthcare data, intended for display, review, manipulation, and basic measurements. It is explicitly stated that it is "not intended for primary image diagnosis," which is a key characteristic of therapeutic devices. Therapeutic devices are generally used to treat or alleviate a medical condition, whereas this device is for viewing and manipulating existing data.
No
The device is explicitly stated as "not intended for primary image diagnosis." Its functions are for displaying, manipulating, and measuring medical images, which are supportive functions rather than direct diagnostic capabilities.
Yes
The device description explicitly states "Viewer is a software for viewing of DICOM data" and details its functionality as software-based interactions on various platforms (PCs, touch screens, mobile devices, Mixed Reality glasses). While it mentions interaction with hardware like Mixed Reality glasses, the device itself is described as the software component. The verification and validation summaries focus on software aspects (user interface, DICOM compatibility, unit/integration tests) and usability, not hardware performance or safety.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "display of medical images and other healthcare data" and is "not intended for primary image diagnosis". IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device deals with medical images, not biological specimens.
- Device Description: The description focuses on software for viewing and manipulating DICOM data (medical images). It describes functions related to image display, measurement, and interaction, all of which are typical for medical image viewers. There is no mention of analyzing biological samples or performing tests on them.
- Lack of IVD-related information: The document does not mention any aspects related to IVD testing, such as reagents, calibrators, controls, or analysis of biological samples.
Therefore, based on the provided text, this device falls under the category of medical image viewing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 (Multiplanar 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
Viewer is a software for viewing of DICOM data. The device provides basic measurement functionality for distances and anqles.
These are the operating principles:
- On desktop PCs the interaction with the software is mainly performed with mouse and/or keyboard.
- On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface.
- On Mixed Reality qlasses the interaction is performed with a dedicated pointing device.
The subject device provides or integrates the following frequently used functions:
- Select medical images and other healthcare data to be displayed
- Select views (e.g. axial, coronal & sagittal reconstruction views and 3D volume rendering views)
- Change view layout (e.g. maximize / minimize views, close / open / reorder views)
- Manipulate views (e.g. scroll, zoom, pan, change windowing)
- Perform measurements (e.g. distance or angle measurements)
- Place annotations at points of interests
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM
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)
Verification summary:
Verification of communication and cybersecurity between Viewer and Magic Leap Mixed Reality glasses has been tested. All interactive testing of user interface have successfully passed.
Validation summary:
The validation comprises usability tests which ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria.
As conclusion, the nonclinical and clinical tests (discussed above) demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
Test: User interface, Test Method Summary: Interactive testing of user interface, Results: All tests passed
Test: DICOM compatibility, Test Method Summary: Interactive testing with companywide test data, which are identical for consecutive version of the SW, Results: All tests passed
Test: Views, Test Method Summary: Interactive testing of user interface, Results: All tests passed
Test: Unit test /Automatic tests, Test Method Summary: Automated or semi-automated cucumber tests or unit tests are written on the applicable level for new functionalities of the Viewer in respect to previous versions. Exiting tests have to pass., Results: All tests passed
Test: Integration test, Test Method Summary: Interactive testing on various platforms and combination with other products following test protocols, combined with explorative testing. The software is developed with daily builds, which are explanatively tested., Results: All tests passed
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.
K153653 DICOM Viewer
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.
K172418 OpenSight
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
January 23, 2020
Brainlab AG % Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 81829 Munich, De GERMANY
Re: K191014
Trade/Device Name: Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: December 16, 2019 Received: December 26, 2019
Dear Chiara Cunico:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191014
Device Name Viewer
Indications for Use (Describe)
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 (Multiplanar 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510 (K) SUMMARY VIEWER
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| General Information | |||
|---|---|---|---|
| Manufacturer | Brainlab AG, Olof-Palme-Straße 9, 81829 Munich, Germany | ||
| Establishment Reg. # | 8043933 | ||
| Device name: | Viewer | ||
| Trade name: | Elements Viewer | ||
| Common name | DICOM Viewer | ||
| Classification name: | Picture archiving and communications system (21 CFR 892.2050) | ||
| Review Panel | Radiology | ||
| Product Code: | LLZ | ||
| Device Class: | Class II | ||
| Predicate Device: | K153653 DICOM Viewer | ||
| Reference Device | K172418 OpenSight | ||
| Date of preparation | 23 September 2019 |
| Contact Information | |
|---|---|
| Primary contact person | Alternate contact person |
| Chiara Cunico | Regulatory Affairs Brainlab |
| Manager RA | phone: +49 89 99 15 68 0 |
| phone: +49 89 99 15 68 1738 | fax: +49 89 99 15 68 5033 |
| Email: Chiara.cunico@brainlab.com | Email: regulatory.affairs@brainlab.com |
Intended use:
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 (Multiplanar reconstructions and 3D volume rendering). It is not intended for primary image diagnosis or the review of mammographic images.
4
Device description
Viewer is a software for viewing of DICOM data. The device provides basic measurement functionality for distances and anqles.
These are the operating principles:
- On desktop PCs the interaction with the software is mainly performed with mouse and/or keyboard. -
- On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface. -
- -On Mixed Reality qlasses the interaction is performed with a dedicated pointing device.
The subject device provides or integrates the following frequently used functions:
- -Select medical images and other healthcare data to be displayed
- -Select views (e.g. axial, coronal & sagittal reconstruction views and 3D volume rendering views)
- Change view layout (e.g. maximize / minimize views, close / open / reorder views) -
- Manipulate views (e.g. scroll, zoom, pan, change windowing) -
- Perform measurements (e.g. distance or angle measurements) -
- -Place annotations at points of interests
Changes to Predicate Device
Convenience function have been added for view and object selection.
Magic Leap Mixed reality glasses have been added to the Subject Device as additional means of display. The Mixed Reality views are started from within the desktop version of Viewer. The view selection is done on the desktop, the views are cloned into the virtual space of Mixed Reality. The 2D views are shown on a 2D view pane in Mixed Reality. The 3D views are placed as virtual objects in to the real world.
| | Cleared device
feature/specification
DICOM Viewer (K153653) | Modified device
feature/specification
Viewer 5.0 | Substantial
Equivalent |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| HW Environment | Server based, for viewing via
HTML5 client or RDP on
individual client computer | Server and local installation, ,
for viewing via HTML5 client
or RDP, or local execution on
individual client computer | yes |
| Data inputs | DICOM | | yes |
| Viewing Data | • Skin
• Bone
• Skin/Bone
• Vessels
• Bone/Vessels
• Skin/Vessels
• Skin/Bone/Vessels
• Maximum Intensity Projection (MIP)
• Digital Reconstructed Radiograph (DRR) | | yes |
| | Cleared device
feature/specification
DICOM Viewer (K153653) | Modified device
feature/specification
Viewer 5.0 | Substantial
Equivalent |
| Measurement | Distance in slice sets
•
Diameter
•
Angle
• | Distance in slice sets
and X-ray images
•
Diameter
•
Angle (incl. open
angle) | yes |
| "Smart View" | Individual selectable visibility
of objects (tumor, fibers etc.) | Individual selectable visibility
of objects (tumor, fibers etc.)
Additional view: with a slider
it is possible to change
visibility of objects. | yes |
| View Layouts | Manual selection of
appropriate view. | Manual selection of
appropriate view.
Additional: Cranial, Spine
and Angio layouts load views
in the presence of certain
modalities in the Subject
Device. | yes |
| Probe's Eye View
(available in Mixed
Reality) | Align crop box to any desired
direction for the display of
MPR perpendicular and
parallel (inline) to the given
direction. | Align crop box to any desired
direction for the display of
MPR perpendicular and
parallel (inline) to the given
direction.
In Mixed Reality the user can
point in a desired direction and
view MPR perpendicular and
parallel (inline) to the given
direction. | yes |
Technological Characteristics of the Subject Device in comparison to the Predicate Device
5
6
Technological Characteristics of the Subject Device in comparison to the Reference Device:
| | Cleared device
feature/specification
OpenSight K172418 | Modified device
feature/specification
Viewer 5.0 | Substantial
Equivalent |
|------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------|
| Supported Mixed
Reality Device | Microsoft HoloLens | Magic Leap One | yes |
| Supported device
electrical medical
device according to
IEC 60601-1 | No | No | yes |
| Mixed Reality | 2D slices and MPRs
3D Views | 2D slices and MPRs
3D Views | yes |
| Registration to
patient | yes | no | No, this is not part of
the Subject Device.
Equivalence is not
claimed |
Verification summary:
Verification of communication and cybersecurity between Viewer and Magic Leap Mixed Reality glasses has been tested. All interactive testing of user interface have successfully passed.
Validation summary:
The validation comprises usability tests which ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria.
As conclusion, the nonclinical and clinical tests (discussed above) demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
| Test | Test Method Summary | Results |
|---|---|---|
| User interface | Interactive testing of user interface | All tests passed |
| DICOM compatibility | Interactive testing with companywide test data, which are | |
| identical for consecutive version of the SW | All tests passed | |
| Views | Interactive testing of user interface | All tests passed |
| Unit test /Automatic tests | Automated or semi-automated cucumber tests or unit | |
| tests are written on the applicable level for new | ||
| functionalities of the Viewer in respect to previous | ||
| versions. Exiting tests have to pass. | All tests passed |
7
| Test | Test Method Summary | Results |
|---|---|---|
| Integration test | Interactive testing on various platforms and combination | |
| with other products following test protocols, combined | ||
| with explorative testing. | All tests passed | |
| The software is developed with daily builds, which are | ||
| explanatively tested. |
Substantial equivalence
The comparison of the Viewer with the predicate device shows that the Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate device. Verification activities ensure that the design specifications are met and that the Viewer does not introduce new issues concerning safety and effectiveness. Hence the Viewer is substantial equivalent to the predicate device.