(287 days)
Not Found
Yes
The summary explicitly mentions "The training process begins with the model observing, and optimizing its parameters based on the training pool data." and "The model's prediction and performance are then evaluated aqainst the test pool." This language is indicative of machine learning model development and evaluation.
No
The device is described as software applications for processing medical image data to support image-guided surgery and radiation treatment planning. It provides tools for outlining structures, image co-registration, and visualization of white matter tracts and BOLD MRI data. These functions are for planning and analysis, not for providing therapy directly.
No
The text explicitly states that "The generated 3D structures are not intended to create physical replicas used for diagnostic purposes" and that the device is for "treatment planning procedures" and "image guided surgery."
Yes
The device description explicitly states that Brainlab Elements 6.0 are "applications" and "consist of the following software applications". The intended use and device description focus entirely on software functionalities for processing and visualizing medical image data. There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software applications are for "processing of medical image data to support the intended user group to perform image guided surgery and radiation treatment planning." This focuses on aiding surgical and treatment planning procedures, not on diagnosing a disease or condition based on in vitro analysis of biological samples.
- Device Description: The description details image processing, co-registration, segmentation, and visualization of medical image data for treatment planning. It does not mention any analysis of biological samples or the detection of substances within the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device works with medical images, which are not biological specimens in the context of IVD regulations.
While the device processes medical data and provides information that can be used in clinical decision-making, its function is centered around image manipulation and visualization for procedural planning, not in vitro diagnostic testing.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation treatment planning.
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.
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.
Brainlab Elements Fibertracking is an application of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures.
Brainlab Elements BOLD MRI Mapping provides tools to analyze task based blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data.
Product codes (comma separated list FDA assigned to the subject device)
QIH, LLZ, JAK
Device Description
The Brainlab Elements 6.0 are applications that transfer DICOM data to and from picture archiving and communication systems (PACS) and other storage media devices. They include modules for 2D & 3D image viewinq, imaqe processing, image co-registration, image seqmentation and 3D visualization of medical image data for treatment planning procedures.
They consist of the following software applications:
-
- Contouring 4.5
-
- Imaqe Fusion 4.5
-
- Fibertracking 2.0
-
- BOLD MRI Mapping 1.0
-
- Image Fusion Angio 1.0
This device is a successor of the Predicate Device Brainlab Elements 5.0 (K212420).
Brainlab Elements Contouring provides an interface with tools and views to outline, edit, refine, combine and manipulate structures in patient image data. The output is saved as 3D DICOM seqmentation object and can be used for further processing and treatment planning.
Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods.
The co-registration consists on providing spatial alignment/fusion of medical imaging data, which are derived from different or same imaging modalities (e.g. CT, MRI, PET, SPECT, US). Once two image sets are fused, they can be viewed simultaneously. All planned content (e.g. objects and trajectories) defined in one image set is visible in any other fused image set. The algorithm used in Image Fusion matches two image sets together with common anatomical structures for optimal fusion results. Therefore, the two image sets must share the same common anatomical area.
Brainlab Elements Fibertracking is an application for the processing and visualization of information based upon Diffusion Tensor Imaging (DTI) data, i.e. to calculate and visualize cranial white matter tracts in selected regions of interest, which can be used for treatment planning procedures.
Diffusion Tensor Imaging (DTI) is a magnetic resonance technique, that allows the measurement of diffusion anisotropy in the brain using diffusion weighted images that were scanned with magnetic field gradients applied in several directions. The Fibertracking software uses the scans to calculate the diffusion direction of the water molecules alonq potential white matter fibers for the entire data volume.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. It allows to register digital subtraction anqiographies to vascular images in order to combine flow and location information. In particular, 2D DSA (digital subtraction angiography) sequences can be fused to MRA, CTA and 3D DSA sequences.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
DICOM 3D imaging Modalities, e.g. CT/XT, MRI, NM/PET, OT, MR-DTI, MR-BOLD, US (ultrasound), 2D DSA (digital subtraction angiography) sequences, MRA, CTA, 3D DSA sequences.
Anatomical Site
cranial (referring to white matter tracts), cerebrovascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended user group to perform image guided surgery and radiation treatment planning. The system 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
The training process begins with the model observing, and optimizing its parameters based on the training pool data.
Description of the test set, sample size, data source, and annotation protocol
The model's prediction and performance are then evaluated aqainst the test pool. The test pool data is set aside at the beginning of the project.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification: Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid. Software verification verifies all specifications, including SOUP items and cybersecurity. For newly added components, interoperability tests were carried out, in addition to the individual component verification.
Clinical Validation: As a part of the design validation process, pre-clinical validation activities were carried out for the Subject Device pertaining to its indications for use.
The Clinical Validation activities concluded that the Subject Device:
- Provides state of the art features for the purposes of pre-planning for Cranial, ENT, CMF Surgery and Radiotherapy Planning.
- All applicable safety and performance requirements are fulfilled.
- Device does not pose significant levels of risk and adequate risk mitigation measures are implemented.
- Usability aspects have been considered during the development of the device and the device was found to be suitable for the user group stated.
- Clinical data collected establishes the performance and safety of the Subject Device and that the clinical benefits outweigh any potential risks associated with the product.
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 14, 2023
Brainlab AG % Marc Bergenthal Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, 81829 GERMANY
Re: K223106
Trade/Device Name: Brainlab Elements 6.0, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio, Brainlab Elements Contouring, Brainlab Elements BOLD MRI Mapping, Brainlab Elements Fibertracking Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ, JAK Dated: June 23, 2023 Received: June 23, 2023
Dear Marc Bergenthal:
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.
1
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 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.
D.G.K.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223106
Device Name
Brainlab Elements 6.0, Brainlab Elements Image Fusion Ango, Brainlab Elements Contouring, Brainlab Elements BOLD MRI Mapping, Brainlab Elements Fibertracking
Indications for Use (Describe)
Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation treatment planning.
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.
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.
Brainlab Elements Fibertracking is an application of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures.
Brainlab Elements BOLD MRI Mapping provides tools to analyze task based blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data.
| 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
Image /page/3/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink caduceus symbol on the left, followed by the word "BRAINLAB" in large, bold, pink letters. The caduceus symbol appears to be a stylized representation of a snake wrapped around a staff, commonly associated with medicine and healthcare.
510(k) Summary
July 14, 2023
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Names | Brainlab Elements Image Fusion Brainlab Elements Image Fusion Angio Brainlab Elements Contouring Brainlab Elements BOLD MRI Mapping Brainlab Elements Fibertracking |
| Classification Name | Medical image management and processing system |
| Product Code (primary) | QIH |
| Product Codes | |
| (secondary) | LLZ, JAK |
| Regulation Number | 892.2050 |
| Regulatory Class | II |
| Panel | Radiology |
| Primary Predicate Device | K212420 |
| 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) | |
| Secondary Predicate | |
| Device | K113732 |
| iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan | |
| View, iPlan Spine) | |
| Contact Information | |
| Primary Contact | Marc Bergenthal |
| Manager Regulatory Affairs | |
| Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | |
| Alternate Contact | Sadwini Suresh |
| QM Consultant | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com |
1. Indication for Use
Brainlab Elements are software applications indicated for the processing of medical image data to support the intended user group to perform image guided surgery and radiation treatment planning.
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.
4
Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink brain-like symbol on the left, followed by the word "BRAINLAB" in pink, block letters. The brain symbol is made up of three curved lines that resemble the folds of a brain.
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.
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.
Brainlab Elements BOLD MRI Mapping provides tools to analyze task based blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-reqistration of cerebrovascular image data.
2. Device Description
The Brainlab Elements 6.0 are applications that transfer DICOM data to and from picture archiving and communication systems (PACS) and other storage media devices. They include modules for 2D & 3D image viewinq, imaqe processing, image co-registration, image seqmentation and 3D visualization of medical image data for treatment planning procedures.
They consist of the following software applications:
-
- Contouring 4.5
-
- Imaqe Fusion 4.5
-
- Fibertracking 2.0
-
- BOLD MRI Mapping 1.0
-
- Image Fusion Angio 1.0
This device is a successor of the Predicate Device Brainlab Elements 5.0 (K212420).
Brainlab Elements Contouring provides an interface with tools and views to outline, edit, refine, combine and manipulate structures in patient image data. The output is saved as 3D DICOM seqmentation object and can be used for further processing and treatment planning.
Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods.
The co-registration consists on providing spatial alignment/fusion of medical imaging data, which are derived from different or same imaging modalities (e.g. CT, MRI, PET, SPECT, US). Once two image sets are fused, they can be viewed simultaneously. All planned content (e.g. objects and trajectories) defined in one image set is visible in any other fused image set. The algorithm used in Image Fusion matches two image sets together with common anatomical structures for optimal fusion results. Therefore, the two image sets must share the same common anatomical area.
Brainlab Elements Fibertracking is an application for the processing and visualization of information based upon Diffusion Tensor Imaging (DTI) data, i.e. to calculate and visualize
5
Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized brain icon on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.
cranial white matter tracts in selected regions of interest, which can be used for treatment planning procedures.
Diffusion Tensor Imaging (DTI) is a magnetic resonance technique, that allows the measurement of diffusion anisotropy in the brain using diffusion weighted images that were scanned with magnetic field gradients applied in several directions. The Fibertracking software uses the scans to calculate the diffusion direction of the water molecules alonq potential white matter fibers for the entire data volume.
Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. It allows to register digital subtraction anqiographies to vascular images in order to combine flow and location information. In particular, 2D DSA (digital subtraction angiography) sequences can be fused to MRA, CTA and 3D DSA sequences.
Al Features:
Artificial Intelligence features included for the device refers to the identification of previously diagnosed lesions or tumors in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images.
Such functionality was already present in previous versions of the devices, where it was based on a tumor segmentation algorithm without machine learning. As research has shown that tumor segmentation algorithms based on Al / ML can achieve better performance metrics than non-machine learning algorithms, the tumor seqmentation algorithm is complemented with an AI / ML based algorithm that is preferred in case suitable T1+C MR volumes are provided to a device.
The Al/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and verification of the algorithm.
The training process begins with the model observing, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated aqainst the test pool. The test pool data is set aside at the beginning of the project.
3. Substantial Equivalence
The Subject Device has similar intended use and technological features as the predicate devices. An overview of the similarities and differences can be found in the tables below:
| Predicate Device | Name |
|---|---|
| Subject Device | Brainlab Elements, Brainlab Elements Contouring (4.5), Brainlab |
| Elements Fibertracking (2.0), Brainlab Elements Image Fusion (4.5), | |
| Brainlab Elements Image Fusion Angio (1.0), Brainlab Elements BOLD | |
| MRI Mapping (1.0) |
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Image /page/6/Picture/0 description: The image shows the word "BRAINLAB" in pink font. To the left of the word is a pink symbol that looks like a caduceus. The symbol is a stylized version of the traditional medical symbol, with three intertwined snakes instead of two. The word "BRAINLAB" is written in all capital letters and is in a bold, sans-serif font.
| Predicate Device | Name |
|---|---|
| Primary Predicate | |
| device (K212420) | 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) | |
| Secondary | |
| Predicate device | |
| (K113732) | iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan View, |
| iPlan Spine) |
Brainlab Elements – Image Fusion 4.5
| Topic/ Feature | Primary Predicate Device
(Brainlab Elements Image Fusion
4.0 (K212420)) | Subject Device (Brainlab
Elements Image Fusion 4.5) | Comment |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for use | 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 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. | Same as the
predicate. |
| Use Environment | The system shall be used in a
hospital office environment or
rooms appropriate for surgical
interventions or radiotherapy
planning. | The system shall be used in
a hospital office
environment or rooms
appropriate for surgical
interventions or
radiotherapy planning. | Same as the
predicate. |
| Computer
Hardware
Requirements | Brainlab Elements can be used
on hardware that fulfills the
defined minimum requirements:
- Operating System:
Windows 8.1 64bit - Minimum 4 logical cores
- Minimum RAM: 6 GB
- Graphics: Direct X
- compatible | Brainlab Elements can be
used on hardware that
fulfills the defined minimum
requirements: - Operating System:
Windows 8.1 64bit - Minimum 4 logical
cores | Same as the
predicate. |
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Image /page/7/Picture/0 description: The image shows the word "BRAINLAB" in pink font. To the left of the word is a pink symbol that looks like a stylized brain. The word and symbol are the only elements in the image. The logo is simple and modern.
| - | - Display Resolution: 1920
x 1080 (Full HD) | - Minimum RAM: 6
GB
- Graphics: Direct X
compatible - Display Resolution:
1920 x 1080 (Full HD) | - |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Data Sets
Format | DICOM 3D imaging Modalities,
e.g. CT/XT, MRI, NM/PET, OT,
are supported for automatic
fusion.
Other modalities are supported
for manual fusion (alignment) | DICOM 3D imaging
Modalities, e.g. CT/XT, MRI,
NM/PET, OT, are supported
for automatic fusion.
Other modalities are
supported for manual fusion
(alignment) | Same as the
predicate. |
| Rigid co-
registration, rigid
image fusion | Automatic rigid co-registration
(rigid fusion) of 3D DICOM image
data: CT (incl. low-dose CT), MR,
OT (e.g. Perfusion), MR-DTI, MR-
BOLD, NM/PET
Manual rigid co-registration (rigid
fusion) of other (unknown) 3D
DICOM image data, e.g. US
(ultrasound). | Automatic rigid co-
registration (rigid fusion) of
3D DICOM image data: CT
(incl. low-dose CT), MR, OT
(e.g. Perfusion), MR-DTI,
MR-BOLD, NM/PET, US
(ultrasound).
Manual rigid co-registration
(rigid fusion) of other
(unknown) 3D DICOM
image data. | The subject device
additionally
provides
functionality to
automatically fuse
US to MR images.
Safety and efficacy
of this feature was
verified via Risk
Management and
Verification
activities. |
Brainlab Elements Contouring 4.5
| Topic/ Feature | Primary Predicate Device
(Brainlab Elements Image Fusion
4.0 (K212420)) | Subject Device (Contouring
4.5) | Comment |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 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. | 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 | Same as the
predicate. |
| Use Environment | The device itself does not have
clinical indications
The system shall be used in a
hospital office environment or
rooms appropriate for surgical
interventions or radiotherapy
planning. | used for diagnostic
purposes.
The device itself does not have
clinical indications
The system shall be used in
a hospital office
environment or rooms
appropriate for surgical
interventions or
radiotherapy planning. | Same as the
predicate. |
| Automatic
Segmentation of
Objects | The application automatically
creates segmentation objects
provided by the Universal Atlas.
Workflow relevant segmentation
objects are created automatically
or, if required by a workflow, on
a single button click.
The application also offers the
possibility to define customized
segmentation templates. | The application
automatically creates
segmentation objects
provided by the Universal
Atlas.
Workflow relevant
segmentation objects are
created automatically or, if
required by a workflow, on
a single button click.
The application also offers
the possibility to define
customized segmentation
templates. | Same as the
predicate. |
| Manual Creation
and Refinement of
Objects | The application provides tools for
the manipulation of objects:
The application provides tools for
manual creation and refinement
of segmentation objects:
- SmartShaper
- Brush 3D / Erase 3D
- Brush 2D / Erase 2D
- Smart Brush
- Threshold Segmentation | The application provides
tools for the manipulation of
objects:
The application provides
tools for manual creation
and refinement of
segmentation objects: - SmartShaper
- Brush 3D / Erase 3D
- Brush 2D / Erase 2D
- Smart Brush
- Threshold
- Segmentation | Same as the
predicate. |
| Object Manipulation | The application provides tools for
the manipulation of objects:
Copy | The application provides
tools for the manipulation of
objects: | Same as the
predicate. |
| - | Margins
Smoothing
Mirroring
Shifting and Rotation
Splitting
Automatic Object Fitting | Copy
Margins
Smoothing
Mirroring
Shifting and
Rotation
Splitting
Automatic Object
Fitting | |
| Object Review | The application provides
functionality to control the review
state of objects. In case of
leaving the application with
unreviewed semi-automatically
or automatically created objects,
a message is displayed. | The application provides
functionality to control the
review state of objects. In
case of leaving the
application with unreviewed
semi-automatically or
automatically created
objects, a message is
displayed. | Same as the
predicate. |
| Volumetric Report | It is possible to create a printable
report for an object in a platform
independent file format, giving
information about the object's
volume, its diameter according to
the Macdonald criteria and its
response evaluation criteria
(RECIST).
If multiple objects are selected
and a volumetric report is
created, it contains information
about all objects. | It is possible to create a
printable report for an
object in a platform
independent file format,
giving information about the
object's volume, its
diameter according to the
Macdonald criteria and its
response evaluation criteria
(RECIST).
If multiple objects are
selected and a volumetric
report is created, it contains
information about all
objects. | Same as the
predicate. |
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Image /page/8/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. The color of the logo is pink.
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Image /page/9/Picture/0 description: The image shows the word "BRAINLAB" in a bold, sans-serif font. To the left of the word is a stylized graphic that appears to be a symbol or logo. The color of both the text and the graphic is a bright pink.
Brainlab Elements BOLD MRI Mapping
| Topic/ Feature | Secondary Predicate Device
(iPlan (K113732)) | Subject Device (Brainlab
Elements BOLD MRI
Mapping) | Comment |
|---------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------|
| Indications for Use | iPlan's indications for use are the
viewing, presentation, and
documentation of medical | Brainlab Elements BOLD
MRI Mapping provides tools
to analyze task based blood | Both devices
contain highly
generic product |
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Image /page/10/Picture/0 description: The image shows the word "BRAINLAB" in a pink sans-serif font. To the left of the word is a pink graphic that resembles a stylized caduceus. The graphic is composed of three curved lines that are stacked on top of each other.
| | imaging, including different
modules for image processing,
image fusion, atlas assisted
visualization and segmentation,
intraoperative functional planning
where the output can be used
e.g. with stereotactic image
guided surgery or other devices
for further processing and
visualization.
The device itself does not have
specific clinical indications. | oxygen level dependent
data (BOLD MRI Data) to
visualize the activation
signal.
The device itself does not
have clinical indications | features that deal
with data handling
rather than specific
indications for use.
The BOLD MRI
Mapping Element
re-implements
existing tools and
functionality offered
by iPlan BOLD MRI
Mapping with
regards to
functional planning. |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preprocessing | - Brain Mask Filtering
- Spatial Smoothing
- Motion Correction
(Optional) - Slice Time Correction
(Optional) - Denoising (Low Pass
Filtering) | - Brain Mask Filtering - Spatial Smoothing
- Motion Correction
- Optionally use of
Distortion Correction from
Brainlab Elements Image
Fusion - Only for task-based
analysis: Denoising (Low
Pass Filtering) | The following
preprocessing tools
were added: - Optionally
use of Distortion
Correction from
Brainlab Elements
Image Fusion,
These tools were
evaluated for safety
via risk
management
activities carried out
validated via
performance
validation testing
and literature
review. |
4. Performance Data
Software Verification:
Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned
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Image /page/11/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized brain icon on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.
correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid. Software verification verifies all specifications, including SOUP items and cybersecurity. For newly added components, interoperability tests were carried out, in addition to the individual component verification.
Clinical Validation:
As a part of the design validation process, pre-clinical validation activities were carried out for the Subject Device pertaining to its indications for use.
The Clinical Validation activities concluded that the Subject Device:
-
Provides state of the art features for the purposes of pre-planning for Cranial, ENT, CMF Surgery and Radiotherapy Planning.
-
All applicable safety and performance requirements are fulfilled.
-
Device does not pose significant levels of risk and adequate risk mitigation measures are implemented.
-
Usability aspects have been considered during the development of the device and the device was found to be suitable for the user group stated.
-
Clinical data collected establishes the performance and safety of the Subject Device and that the clinical benefits outweigh any potential risks associated with the product.
5. Conclusion
Verification and validation activities carried out established that the set requirements were met and that the device performs as claimed.
The Subject Devices' comparison with the Predicate Devices establishes that they have similar functionality, intended use and technological characteristics. Therefore, we believe that the Subject Device can be considered substantially equivalent to the predicate device.