(256 days)
Not Found
No
The document describes standard image viewing and manipulation software with basic measurement and 3D visualization capabilities. While it mentions "analyzing and processing medical image data" and "autosegmentation information," it does not explicitly mention AI, ML, deep learning, or any related terms, nor does it describe the characteristics of an AI/ML model (training data, test data, performance metrics like AUC, sensitivity, specificity, etc.). The described functionalities appear to be based on traditional image processing techniques.
No
The device is a medical image viewing and processing software. It is explicitly stated that "Viewer is not intended for diagnosis nor for treatment planning," which are functions typically associated with therapeutic devices. Therapeutic devices are generally used to treat or alleviate diseases, injuries, or conditions, which this software does not do.
No
The "Intended Use / Indications for Use" section states: "Viewer is not intended for diagnosis nor for treatment planning."
No
While the core device is software, the description explicitly mentions use with mobile devices and a stereoscopic head-mounted display, and the performance studies include tests related to the display quality and hospital environment compatibility of hardware (head-mounted display and various hardware platforms). This indicates the device's functionality and validation are tied to specific hardware components, making it more than just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states, "Viewer is not intended for diagnosis nor for treatment planning." IVDs are specifically intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's intended use is for displaying, reviewing, manipulating, and visualizing medical images and data.
- Device Description: The description focuses on viewing and manipulating existing medical image data (DICOM). IVDs typically involve analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples.
The device is clearly focused on the visualization and manipulation of medical imaging data, which falls under the category of medical image processing and viewing software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Viewer is a software for viewing DICOM data, such as native slices generated with medical imaging devices, axial, coronal and sagittal reconstructions, and data specific volume rendered views (e.g., skin, vessels, bone). Viewer supports basic manipulation such as windowing, reconstructions or alignment and it provides basic measurement functionality for distances and angles. Viewer is not intended for diagnosis nor for treatment planning. The Subject Device (Viewer) for which we are seeking clearance consists of the following software modules.
- · Viewer 5.4 (General Viewing)
- · Universal Atlas Performer 6.0
- Universal Atlas Transfer Performer 6.0
Universal Atlas Performer: Software for analyzing and processing medical image data with Universal Atlas to create different output results for further use by Brainlab applications
Universal Atlas Transfer Performer: Software that provides medical image data autoseqmentation information to Brainlab applications
When installed on a server, Viewer can be used on mobile devices like tablets. No specific application or user interface is provided for mobile devices. In mixed reality, the data and the views are selected and opened via desktop PC. The views are then rendered on the connected stereoscopic head-mounted display. Multiple users in the same room can connect to the Viewer session and view/review the data (such as already saved surgical plans) on their mixed reality glasses.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM data, such as native slices generated with medical imaging devices
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)
Software Verification and Validation Testing: conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests. The documentation submitted is for enhanced level.
Bench Tests:
Ambient Light Test: To determine the Magic Leap 2 display quality for sufficient visualization in a variety of ambient lighting conditions
Hospital Environment Tests: To test compatibility of the Subject Device with various hardware platforms and compatible software's.
Display Quality Tests: Tests were carried out to measure and compare the optical transmittance, and luminance non-uniformity and Michelson contrast of the head mounted display to ensure seamless integration of real and virtual content, and maintenance of high visibility and image quality. The tests were carried out with and without segmented dimming.
Measurement accuracy test: Tests were performed to evaluate the accuracy of 3D measurement placement using a Mixed Reality user interface, specifically Magic Leap control in relation to mouse and touch as input methods.
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.
K191014; 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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Brainlab AG Sadwini Suresh OM Consultant Olof-Palme-StraBe 9 Münich, BY 81829 GERMANY
May 21, 2024
Re: K232759
Trade/Device Name: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 8, 2023 Received: April 25, 2024
Dear Sadwini Suresh:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232759
Device Name
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
Indications for Use (Describe)
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
| 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)
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3
Image /page/3/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling three interconnected shapes. To the right of the symbol, the word "BRAINLAB" is written in pink, using a bold, sans-serif font. The overall design is clean and modern.
K232759 510(k) Summary
May 17, 2024
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Name | Viewer 5.4; |
| Elements Viewer; | |
| Mixed Reality Viewer; | |
| Smart Layout ; | |
| Elements Viewer Smart Layout | |
| Classification Name | System, Image Processing, Radiological |
| Product Code | LLZ |
| Regulation Number | 892.2050 |
| Regulatory Class | II |
| Panel | Radiology |
| Predicate Device(s) | K191014; Viewer |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Sadwini Suresh | |
| QM Consultant - Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | Chiara Cunico |
| Phone: +49 89 99 15 68 0 | |
| Fax: +49 89 99 15 68 5033 | |
| Email: chiara.cunico@brainlab.com |
1. Indications for Use
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.
2. Device Description
Viewer is a software for viewing DICOM data, such as native slices generated with medical imaging devices, axial, coronal and sagittal reconstructions, and data specific volume rendered views (e.g., skin, vessels, bone). Viewer supports basic manipulation such as windowing, reconstructions or alignment and it provides basic measurement functionality for distances and angles. Viewer is not intended for diagnosis nor for treatment planning. The Subject Device (Viewer) for which we are seeking clearance consists of the following software modules.
- · Viewer 5.4 (General Viewing)
- · Universal Atlas Performer 6.0
- Universal Atlas Transfer Performer 6.0
4
Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" on the right. The symbol appears to be a stylized representation of the brain. The word "BRAINLAB" is written in a bold, sans-serif font. The color of the logo is pink.
Universal Atlas Performer: Software for analyzing and processing medical image data with Universal Atlas to create different output results for further use by Brainlab applications
Universal Atlas Transfer Performer: Software that provides medical image data autoseqmentation information to Brainlab applications
When installed on a server, Viewer can be used on mobile devices like tablets. No specific application or user interface is provided for mobile devices. In mixed reality, the data and the views are selected and opened via desktop PC. The views are then rendered on the connected stereoscopic head-mounted display. Multiple users in the same room can connect to the Viewer session and view/review the data (such as already saved surgical plans) on their mixed reality glasses.
-
- Substantial Equivalence
For the Substantial Equivalence determination, comparison of the Subject Device features with the following predicate device(s) was carried out:
- Substantial Equivalence
Viewer 5.0; K191014
The predicate was chosen since its similar to the subject device w.r.t the indications for use, technological characteristics and use cases.
The main differences compared to the predicate device are the version of the Maqic Leap glasses and Launcher app compatibility as well as the segmented dimming functionality. For the rest of the features, they existed in the predicate and have been improved/ modified.
| Feature | Predicate Device | Subject Device |
|---|---|---|
| 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. | The software displays medical | |
| images and data. It also includes | ||
| functions for image review, | ||
| image manipulation, basic | ||
| measurements and 3D | ||
| visualization. The device itself | ||
| does not have clinical | ||
| indications. | ||
| Computer | ||
| hardware | ||
| requirements | - Graphics: DirectX 11 | |
| compatible with 512 MB | ||
| graphics memory | - Graphics: DirectX 11 | |
| compatible with 512 MB | ||
| graphics memory | ||
| Feature | Predicate Device | Subject Device |
| - Display resolution: | ||
| 1280x1024 | - Display resolution: | |
| 1280x1024 | ||
| - Processor: 4 physical cores | - Processor: 4 physical cores | |
| - RAM: 4GB, 8GB for 3D | ||
| Stereo | - RAM: 4GB, 8GB for 3D | |
| Stereo | ||
| - With a mouse or touchscreen | ||
| as pointing device | - With a mouse or touchscreen | |
| as pointing device | ||
| Mixed Reality | ||
| Glasses | Magic Leap 1 | Magic Leap 2 |
| Operating | ||
| System | Windows Server 2008, 2012, | |
| 2016 | ||
| min Windows 7 | ||
| MacOS | Windows Server 2012, 2016, 2019 | |
| min Windows 10 | ||
| MacOS | ||
| Buzz Virtual | ||
| Viewer Remote | ||
| Control | Viewer can be mirrored to | |
| mobile devices. It is also | ||
| possible to interact with the | ||
| Viewer remotely. | The views streamed to Buzz | |
| Virtual from Viewer, can be | ||
| interacted through mobile | ||
| devices with a special layout. | ||
| This remote control layout | ||
| consists of predefined | ||
| essentials tools: | ||
| • Scroll | ||
| • Switch | ||
| • Pan | ||
| • Rotate | ||
| • Zoom | ||
| • Scroll | ||
| • Windowing | ||
| • reset | ||
| Feature | Predicate Device | Subject Device |
| Mixed Reality | ||
| Segmented | ||
| Dimming | Not included | The background of the 2D area |
| Mixed Reality scene is displayed | ||
| in real black (instead of dark | ||
| transparent) in Mixed Reality, | ||
| depending on distance between | ||
| user and 2D area. | ||
| Distance Display | Distance measurements are set | |
| and displayed on 2D Slices only | ||
| on desktop Viewer. | Distance measurements can be | |
| set and displayed on 2D Slices | ||
| on desktop viewer and also on | ||
| 3D mixed reality views. | ||
| Moreover, 3D distance | ||
| measurements can be displayed | ||
| over multiple 2D views. |
5
Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling interconnected shapes, followed by the word "BRAINLAB" in pink, block letters. The overall design is clean and modern.
6
Image /page/6/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in capital letters on the right. Both the symbol and the word are in a bright pink color. The symbol appears to be three curved lines stacked on top of each other.
4. Performance Data
-
Software Verification and Validation Testing a.
Software verification and validation testing has been conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests. The documentation submitted is for enhanced level. -
b. Bench Tests
The following performance bench tests were carried out:
Ambient Light Test: To determine the Magic Leap 2 display quality for sufficient visualization in a variety of ambient lighting conditions
Hospital Environment Tests: To test compatibility of the Subject Device with various hardware platforms and compatible software's.
- c. Display Quality Tests
Tests were carried out to measure and compare the optical transmittance, and luminance non-uniformity and Michelson contrast of the head mounted display to ensure seamless integration of real and virtual content, and maintenance of high visibility and image quality. The tests were carried out with and without segmented dimming.
7
Image /page/7/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized brain symbol on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.
d. Measurement accuracy test
Additionally, tests were performed to evaluate the accuracy of 3D measurement placement using a Mixed Reality user interface, specifically Magic Leap control in relation to mouse and touch as input methods.
-
- Conclusion
The comparison of the Subject Device with the predicate device shows that the Viewer 5.4 has similar functionality, intended use and technological characteristics as the predicate devices. Based on the comparison to the predicate and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate device.
- Conclusion