(134 days)
Unknown
The document mentions "Automatic segmentation of anatomical structures" and "Processing of co-registered data to highlight differences between distinct scanning sequences or to assess the response to a treatment," which could potentially utilize AI/ML. However, the document does not explicitly state the use of AI, ML, or related terms like deep learning or neural networks. The description of validation tests focuses on accuracy and usability without detailing the underlying algorithms.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states "The device itself does not have clinical indications," and the "Device Description" section states it is used to support treatment planning, not to provide therapy itself.
No
The 'Intended Use / Indications for Use' section explicitly states: "The generated 3D structures are not intended to create physical replicas used for diagnostic purposes. The device itself does not have clinical indications." This indicates it's for treatment planning, not diagnosis.
Yes
The device description explicitly states "Brainlab Elements is a medical device for processing of medical images" and details various software functionalities for image viewing, processing, co-registration, segmentation, and visualization. There is no mention of accompanying hardware components that are part of the device itself. While it interacts with PACS and other storage media devices, these are external systems, not part of the Brainlab Elements device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states that the generated 3D structures are "not intended to create physical replicas used for diagnostic purposes" and that "The device itself does not have clinical indications." This directly contradicts the purpose of an IVD, which is to provide information for diagnostic purposes.
- Device Description: The description focuses on processing medical images to support treatment planning for surgical or radio-therapeutical procedures. While it involves image processing and analysis, its ultimate goal is not diagnosis.
- Lack of Diagnostic Claims: There are no claims or descriptions related to diagnosing diseases, conditions, or states of health.
- Focus on Treatment Planning: The entire description revolves around tools and functionalities used in the planning phase of medical interventions.
In summary, the device's intended use and functionalities are centered around image processing and visualization for treatment planning, not for providing diagnostic information.
N/A
Intended Use / Indications for Use
Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The generated 3D structures are not intended to create physical replicas used for diagnostic purposes. The device itself does not have clinical indications.
Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures. The device itself does not have clinical indications.
Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets. The device itself does not have clinical indications.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. The device itself does not have clinical indications.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, JAK
Device Description
Brainlab Elements is a medical device for processing of medical images, that is used to support treatment planning of surgical or radio-therapeutical procedures.
The Brainlab Elements applications transfer DICOM data to and from picture archiving and communication systems (PACS) and other storage media devices. They include modules for 2D & 3D image viewing, image processing, image co-registration, image segmentation and 3D visualization of medical image data for treatment planning procedures.
Brainlab Elements main software functionalities include:
- Visualization of medical image data in DICOM format -
- Co-registration of different imaging modalities by using both rigid and deformable registration methods
- Processing of co-registered data to highlight differences between distinct scanning sequences or to assess the response to a treatment
- Contouring and delineation of objects and anatomical structures -
- -Automatic segmentation of anatomical structures
- Manipulation of objects and seqmented structures (e.g. splitting, mirroring, etc.) -
- -Measuring tools
- Co-reqistration of cerebrovascular image data -
- Visualization of Diffusion Tensor Imaging (DTI) based data and processing of such data to visualize e.g. cranial white matter tracts
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM data, 2D-DSA images, Diffusion Tensor Imaging (DTI) data
Anatomical Site
Cranial white matter tracts, cerebrovascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The intended users are medical professionals. Typical users as defined in the use case descriptions are:
- -Image Guided Surgery: Neurosurgeons, Ear-Nose-Throat (ENT) surgeons and Cranio-Maxillofacial (CMF) surgeons including their assistants
- Radiotherapy: medical professionals who perform radiation treatment planning (medical physicists, radiation oncologists, dosimetrists, physicians, etc.)
The device shall be used in a hospital office environment or rooms appropriate for surgical interventions or radiotherapy planning.
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
Validation tests using retrospective patient data and phantom data were performed to compare the results of the modified algorithm to the results of the algorithm which was present in the predicate device.
Accuracy of co-registrations, generated by the devices Elements Image Fusion and Elements Image Fusion Angio
Accuracy of automatically segmented objects, generated by the device Elements Contouring
Accuracy of fiber tracts, generated by the device Elements Fibertracking
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation tests were performed to demonstrate that the products fulfill critical state of the art requirements:
- -Accuracy of co-registrations, generated by the devices Elements Image Fusion and Elements Image Fusion Angio
- -Accuracy of automatically segmented objects, generated by the device Elements Contouring
- Accuracy of fiber tracts, generated by the device Elements Fibertracking -
In all cases, acceptance criteria for the validation tests were derived from scientific literature.
Usability tests were performed to demonstrate the devices meet usability requirements as defined in IEC 62366.
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.
Mimics Medical (K183105), iPlan (K113732), Image Fusion (K170816)
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.
Brainlab Elements Image Fusion Angio (K190042)
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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
Brainlab AG % Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, Bayern 80809 GERMANY
December 16, 2021
Re: K212420
Trade/Device Name: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, JAK Dated: November 10, 2021 Received: November 15, 2021
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
1
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 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 (OS) 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 mediation-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) K212420
Device Name
Brainlab Elements, Brainlab Elements Contouring (4.0), Brainlab Elements Fibertracking (2.0), Brainlab Elements Image Fusion (4.0), Brainlab Elements Image Fusion Angio (1.0)
Indications for Use (Describe)
Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The generated 3D structures are not intended to create physical replicas used for diagnostic purposes. The device itself does not have clinical indications.
Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Tensor Imaging (DTT) data for use in treatment planning procedures. The device itself does not have clinical indications.
Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets. The device itself does not have clinical indications.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. The device itself does not have clinical indications.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is an abstract design featuring a pattern of triangles in varying shades of blue. The triangles are arranged in a way that creates a sense of depth and movement. The color palette transitions from a darker blue on the left to a lighter, almost white, blue on the right. The overall effect is modern and geometric.
RAINLAB
510(k) Summary
November 10, 2021
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Name | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements |
| Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements | |
| Image Fusion Angio | |
| Classification Name | System, image processing, radiological |
| Product Code | LLZ, JAK |
| Regulation Number | 892.2050 |
| Regulatory Class | Class II |
| Panel | Radiology |
| Predicate Device(s) | Mimics Medical (K183105) – Primary Predicate |
| iPlan (K113732) – Second predicate | |
| Image Fusion (K170816) – Third predicate | |
| Reference Device | Brainlab Elements Image Fusion Angio (K190042) |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Chiara Cunico | Regulatory Affairs Brainlab |
| Manager RA | Phone: +49 89 99 15 68 0 |
| Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 |
| Email: chiara.cunico@brainlab.com | Email: regulatory.affairs@brainlab.com |
1. Indication for Use
Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The generated 3D structures are not intended to create physical replicas used for diagnostic purposes. The device itself does not have clinical indications.
Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures. The device itself does not have clinical indications.
Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets. The device itself does not have clinical indications.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. The device itself does not have clinical indications.
4
Image /page/4/Picture/0 description: The image is an abstract design featuring a pattern of interconnected triangles. The triangles vary in shades of blue, ranging from a deep, saturated blue on the left to a lighter, almost white blue on the right. White lines connect the triangles, creating a geometric, fragmented appearance.
2. Device Description
Brainlab Elements is a medical device for processing of medical images, that is used to support treatment planning of surgical or radio-therapeutical procedures.
The Brainlab Elements applications transfer DICOM data to and from picture archiving and communication systems (PACS) and other storage media devices. They include modules for 2D & 3D image viewing, image processing, image co-registration, image segmentation and 3D visualization of medical image data for treatment planning procedures.
Brainlab Elements main software functionalities include:
- Visualization of medical image data in DICOM format -
- Co-registration of different imaging modalities by using both rigid and deformable registration methods
- Processing of co-registered data to highlight differences between distinct scanning sequences or to assess the response to a treatment
- Contouring and delineation of objects and anatomical structures -
- -Automatic segmentation of anatomical structures
- Manipulation of objects and seqmented structures (e.g. splitting, mirroring, etc.) -
- -Measuring tools
- Co-reqistration of cerebrovascular image data -
- Visualization of Diffusion Tensor Imaging (DTI) based data and processing of such data to visualize e.g. cranial white matter tracts
The intended users are medical professionals. Typical users as defined in the use case descriptions are:
- -Image Guided Surgery: Neurosurgeons, Ear-Nose-Throat (ENT) surgeons and Cranio-Maxillofacial (CMF) surgeons including their assistants
- Radiotherapy: medical professionals who perform radiation treatment planning (medical physicists, radiation oncologists, dosimetrists, physicians, etc.)
The device shall be used in a hospital office environment or rooms appropriate for surgical interventions or radiotherapy planning.
3. Substantial Equivalence
| ltem | Information | 510 (k) | Product Code;
Subsequent
Product Code(s) | Subject Device |
|--------------------------------|----------------|---------|------------------------------------------------|----------------------------------|
| Primary
Predicate
device | Mimics Medical | K183105 | LLZ | Brainlab Elements Contouring 4.0 |
5
Image /page/5/Picture/0 description: The image is an abstract design featuring a pattern of interconnected triangles in varying shades of blue and white. The triangles are arranged in a seemingly random fashion, creating a sense of depth and complexity. The color gradient transitions from a darker blue on the left to a lighter, almost white shade on the right, adding a sense of movement and visual interest. The overall effect is modern and geometric, with a clean and crisp aesthetic.
BRAINLAB
| Item | Information | 510 (k) | Product Code;
Subsequent
Product Code(s) | Subject Device |
|-------------------------------|-------------------------------------------------------------------------------------------------|---------|------------------------------------------------|------------------------------------------------------------------------------|
| Second
Predicate
device | iPlan (iPlan Cranial, iPlan
Stereotaxy, iPlan ENT,
iPlan CMF, iPlan View,
iPlan Spine) | K113732 | JAK; LLZ | Brainlab Elements Fibertracking
2.0; Brainlab Elements
Countouring 4.0 |
| Third
Predicate
device | Image Fusion 3.0 | K170816 | LLZ; JAK | Brainlab Elements Image Fusion
4.0 |
| Reference
Device | Image Fusion Angio 1.0 | K190042 | LLZ; JAK | Brainlab Elements Image Fusion
Angio 1.0.1 |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
At a high level, the subject and predicate devices are based on the following same technological elements:
Image Fusion and Image Fusion Angio:
- -Principle of image co-registration (rigid and deformable)
- -Verification tools
- Viewing of images and DICOM data -
Contouring:
- Object segmentation using manual, semi-automatic or fully automatic algorithms -
- 3D model calculation
- -Measuring functionalities
- Verification tools -
- Viewing of images and DICOM data -
Fibertracking:
- -Automatic DTI data processing
- Region-of-interest (ROI) definition -
- 3D visualization -
In addition, the subject device indications for use are equivalent to that of the predicate device.
The following technological differences exist between the subject and predicate device(s):
- New/modified user interface -
- Fibertracking algorithm improvements (compared to predicate device iPlan) -
- -Contouring: support of 2D-DSA images (compared to predicate device iPlan)
- -Functionality: The device shares the main functionalities of the predicate devices, but is organized in a different way and tools and views are slightly different.
Validation of differences compared to predicate devices:
6
Image /page/6/Picture/0 description: The image is an abstract design featuring a series of interconnected triangles. The triangles are filled with varying shades of blue, creating a gradient effect from darker to lighter hues. White lines separate the triangles, adding contrast and definition to the geometric shapes.
- INLAB
- The new/modified user interface and views as well as the modified interactions with tools were subject of several formative and summative usability tests.
- -Validation tests using retrospective patient data and phantom data were performed to compare the results of the modified algorithm to the results of the algorithm which was present in the predicate device.
4. Performance Data
Product specifications and the implementation of risk control measures have been tested in verification tests for the device according to IEC 62304 and ISO 14971.
Validation tests were performed to demonstrate that the products fulfill critical state of the art requirements:
- -Accuracy of co-registrations, generated by the devices Elements Image Fusion and Elements Image Fusion Angio
- -Accuracy of automatically segmented objects, generated by the device Elements Contouring
- Accuracy of fiber tracts, generated by the device Elements Fibertracking -
In all cases, acceptance criteria for the validation tests were derived from scientific literature.
Usability tests were performed to demonstrate the devices meet usability requirements as defined in IEC 62366.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a major level of concern, since:
- Prior to mitigation of hazards, a failure of the Software could result in death or serious injury of the patient, because the software provides information that directly drives a decision regarding treatment or therapy
- A malfunction of, or a latent design flaw in, the software could lead to an erroneous diagnosis or delay in delivery of appropriate medical care that would likely lead to Minor Injury.
5. Conclusion
The comparison of Brainlab Elements with the predicate devices shows that the Brainlab Elements have similar functionality, intended use, technological characteristics and users like the predicate device(s). Verification and validation activities ensured that the design specifications are met and that Brainlab Elements does not introduce new issues concerning safety and effectiveness. Hence, Brainlab Elements is substantially equivalent to the predicate device(s).