Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

K223106 · Brainlab AG · QIH · Jul 14, 2023 · Radiology

Device Facts

• Record ID: K223106
• Device Name: Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
• Applicant: Brainlab AG
• Product Code: QIH · Radiology
• Decision Date: Jul 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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.

Device Story

Brainlab Elements 6.0 is a suite of software applications for medical image processing, viewing, segmentation, and 3D visualization. Inputs include DICOM data from modalities like CT, MRI, PET, SPECT, and US. The system performs image co-registration (rigid/deformable), contouring, DTI-based white matter tract visualization, and BOLD MRI activation mapping. It includes a CNN-based AI/ML algorithm for identifying previously diagnosed lesions/tumors in T1-weighted contrast-enhanced MR volumes. Used in hospitals/clinics by physicians and clinical staff for surgical and radiotherapy planning. Outputs are visualized on-screen or saved as 3D DICOM objects for treatment planning. The device assists clinicians in anatomical alignment and structure definition, potentially improving surgical precision and treatment planning accuracy.

Clinical Evidence

Bench testing only. Verification included integration and unit testing. Clinical validation activities confirmed the device meets safety/performance requirements for cranial, ENT, CMF surgery, and radiotherapy planning. Usability was assessed as suitable for the intended user group.

Technological Characteristics

Software-based medical image management and processing system. Operates on Windows 8.1 64-bit hardware (min 4 cores, 6GB RAM). Supports DICOM 3D imaging. Features include rigid/deformable registration, manual/automatic segmentation, and CNN-based AI/ML for tumor identification. Connectivity via DICOM standard. No physical materials; software-only device.

Indications for Use

Indicated for processing medical image data to support image-guided surgery and radiation treatment planning. Used by clinicians in hospital/office environments. No specific patient population age/gender restrictions; not for diagnostic physical replica creation.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Brainlab Elements 5.0 (K212420)
• iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan View, iPlan Spine) (K113732)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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### 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) | |
|--------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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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.

K223106

## 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<br>(secondary) | LLZ, JAK |
| Regulation Number | 892.2050 |
| Regulatory Class | II |
| Panel | Radiology |
| Primary Predicate Device | K212420<br>Brainlab Elements, Brainlab Elements Contouring (4.0), Brainlab<br>Elements Fibertracking (2.0), Brainlab Elements Image Fusion<br>(4.0), Brainlab Elements Image Fusion Angio (1.0) |
| Secondary Predicate<br>Device | K113732<br>iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan<br>View, iPlan Spine) |
| Contact Information | |
| Primary Contact | Marc Bergenthal<br>Manager Regulatory Affairs<br>Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Alternate Contact | Sadwini Suresh<br>QM Consultant<br>Phone: [phone]<br>Email: [e-mail] |

### 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.

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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:

- 1. Contouring 4.5
- 2. Imaqe Fusion 4.5
- 3. Fibertracking 2.0
- 4. BOLD MRI Mapping 1.0
- 5. 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

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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<br>Elements Fibertracking (2.0), Brainlab Elements Image Fusion (4.5),<br>Brainlab Elements Image Fusion Angio (1.0), Brainlab Elements BOLD<br>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<br>device (K212420) | Brainlab Elements, Brainlab Elements Contouring (4.0), Brainlab<br>Elements Fibertracking (2.0), Brainlab Elements Image Fusion (4.0),<br>Brainlab Elements Image Fusion Angio (1.0) |
| Secondary<br>Predicate device<br>(K113732) | iPlan (iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan CMF, iPlan View,<br>iPlan Spine) |

## Brainlab Elements – Image Fusion 4.5

| Topic/ Feature | Primary Predicate Device<br>(Brainlab Elements Image Fusion<br>4.0 (K212420)) | Subject Device (Brainlab<br>Elements Image Fusion 4.5) | Comment |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for use | Brainlab Elements Image Fusion<br>is an application for the co-<br>registration of image data within<br>medical procedures by using<br>rigid and deformable registration<br>methods. It is intended to align<br>anatomical structures between<br>data sets.<br>The device itself does not have<br>clinical indications. | Brainlab Elements Image<br>Fusion is an application for<br>the co-registration of image<br>data within medical<br>procedures by using rigid<br>and deformable registration<br>methods. It is intended to<br>align anatomical structures<br>between data sets.<br>The device itself does not<br>have clinical indications. | Same as the<br>predicate. |
| Use Environment | The system shall be used in a<br>hospital office environment or<br>rooms appropriate for surgical<br>interventions or radiotherapy<br>planning. | The system shall be used in<br>a hospital office<br>environment or rooms<br>appropriate for surgical<br>interventions or<br>radiotherapy planning. | Same as the<br>predicate. |
| Computer<br>Hardware<br>Requirements | Brainlab Elements can be used<br>on hardware that fulfills the<br>defined minimum requirements:<br>- Operating System:<br>Windows 8.1 64bit<br>- Minimum 4 logical cores<br>- Minimum RAM: 6 GB<br>- Graphics: Direct X<br>- compatible | Brainlab Elements can be<br>used on hardware that<br>fulfills the defined minimum<br>requirements:<br>- Operating System:<br>Windows 8.1 64bit<br>- Minimum 4 logical<br>cores | Same as the<br>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<br>x 1080 (Full HD) | - Minimum RAM: 6<br>GB<br>- Graphics: Direct X<br>compatible<br>- Display Resolution:<br>1920 x 1080 (Full HD) | - |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Data Sets<br>Format | DICOM 3D imaging Modalities,<br>e.g. CT/XT, MRI, NM/PET, OT,<br>are supported for automatic<br>fusion.<br><br>Other modalities are supported<br>for manual fusion (alignment) | DICOM 3D imaging<br>Modalities, e.g. CT/XT, MRI,<br>NM/PET, OT, are supported<br>for automatic fusion.<br><br>Other modalities are<br>supported for manual fusion<br>(alignment) | Same as the<br>predicate. |
| Rigid co-<br>registration, rigid<br>image fusion | Automatic rigid co-registration<br>(rigid fusion) of 3D DICOM image<br>data: CT (incl. low-dose CT), MR,<br>OT (e.g. Perfusion), MR-DTI, MR-<br>BOLD, NM/PET<br><br>Manual rigid co-registration (rigid<br>fusion) of other (unknown) 3D<br>DICOM image data, e.g. US<br>(ultrasound). | Automatic rigid co-<br>registration (rigid fusion) of<br>3D DICOM image data: CT<br>(incl. low-dose CT), MR, OT<br>(e.g. Perfusion), MR-DTI,<br>MR-BOLD, NM/PET, US<br>(ultrasound).<br><br>Manual rigid co-registration<br>(rigid fusion) of other<br>(unknown) 3D DICOM<br>image data. | The subject device<br>additionally<br>provides<br>functionality to<br>automatically fuse<br>US to MR images.<br><br>Safety and efficacy<br>of this feature was<br>verified via Risk<br>Management and<br>Verification<br>activities. |

## Brainlab Elements Contouring 4.5

| Topic/ Feature | Primary Predicate Device<br>(Brainlab Elements Image Fusion<br>4.0 (K212420)) | Subject Device (Contouring<br>4.5) | Comment |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for Use | Brainlab Elements Contouring<br>provides an interface with tools<br>and views to outline, refine,<br>combine and manipulate<br>structures in patient image data.<br>The generated 3D structures are<br>not intended to create physical<br>replicas used for diagnostic<br>purposes. | Brainlab Elements<br>Contouring provides an<br>interface with tools and<br>views to outline, refine,<br>combine and manipulate<br>structures in patient image<br>data. The generated 3D<br>structures are not intended<br>to create physical replicas | Same as the<br>predicate. |
| Use Environment | The device itself does not have<br>clinical indications<br>The system shall be used in a<br>hospital office environment or<br>rooms appropriate for surgical<br>interventions or radiotherapy<br>planning. | used for diagnostic<br>purposes.<br>The device itself does not have<br>clinical indications<br>The system shall be used in<br>a hospital office<br>environment or rooms<br>appropriate for surgical<br>interventions or<br>radiotherapy planning. | Same as the<br>predicate. |
| Automatic<br>Segmentation of<br>Objects | The application automatically<br>creates segmentation objects<br>provided by the Universal Atlas.<br>Workflow relevant segmentation<br>objects are created automatically<br>or, if required by a workflow, on<br>a single button click.<br>The application also offers the<br>possibility to define customized<br>segmentation templates. | The application<br>automatically creates<br>segmentation objects<br>provided by the Universal<br>Atlas.<br>Workflow relevant<br>segmentation objects are<br>created automatically or, if<br>required by a workflow, on<br>a single button click.<br>The application also offers<br>the possibility to define<br>customized segmentation<br>templates. | Same as the<br>predicate. |
| Manual Creation<br>and Refinement of<br>Objects | The application provides tools for<br>the manipulation of objects:<br>The application provides tools for<br>manual creation and refinement<br>of segmentation objects:<br>- SmartShaper<br>- Brush 3D / Erase 3D<br>- Brush 2D / Erase 2D<br>- Smart Brush<br>- Threshold Segmentation | The application provides<br>tools for the manipulation of<br>objects:<br>The application provides<br>tools for manual creation<br>and refinement of<br>segmentation objects:<br>- SmartShaper<br>- Brush 3D / Erase 3D<br>- Brush 2D / Erase 2D<br>- Smart Brush<br>- Threshold<br>- Segmentation | Same as the<br>predicate. |
| Object Manipulation | The application provides tools for<br>the manipulation of objects:<br>Copy | The application provides<br>tools for the manipulation of<br>objects: | Same as the<br>predicate. |
| - | Margins<br>-<br>Smoothing<br>-<br>Mirroring<br>-<br>Shifting and Rotation<br>-<br>Splitting<br>-<br>Automatic Object Fitting | Copy<br>-<br>Margins<br>-<br>Smoothing<br>-<br>Mirroring<br>-<br>Shifting and<br>-<br>Rotation<br>-<br>Splitting<br>-<br>Automatic Object<br>-<br>Fitting | |
| Object Review | The application provides<br>functionality to control the review<br>state of objects. In case of<br>leaving the application with<br>unreviewed semi-automatically<br>or automatically created objects,<br>a message is displayed. | The application provides<br>functionality to control the<br>review state of objects. In<br>case of leaving the<br>application with unreviewed<br>semi-automatically or<br>automatically created<br>objects, a message is<br>displayed. | Same as the<br>predicate. |
| Volumetric Report | It is possible to create a printable<br>report for an object in a platform<br>independent file format, giving<br>information about the object's<br>volume, its diameter according to<br>the Macdonald criteria and its<br>response evaluation criteria<br>(RECIST).<br>If multiple objects are selected<br>and a volumetric report is<br>created, it contains information<br>about all objects. | It is possible to create a<br>printable report for an<br>object in a platform<br>independent file format,<br>giving information about the<br>object's volume, its<br>diameter according to the<br>Macdonald criteria and its<br>response evaluation criteria<br>(RECIST).<br>If multiple objects are<br>selected and a volumetric<br>report is created, it contains<br>information about all<br>objects. | Same as the<br>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<br>(iPlan (K113732)) | Subject Device (Brainlab<br>Elements BOLD MRI<br>Mapping) | Comment |
|---------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------|
| Indications for Use | iPlan's indications for use are the<br>viewing, presentation, and<br>documentation of medical | Brainlab Elements BOLD<br>MRI Mapping provides tools<br>to analyze task based blood | Both devices<br>contain highly<br>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<br>modules for image processing,<br>image fusion, atlas assisted<br>visualization and segmentation,<br>intraoperative functional planning<br>where the output can be used<br>e.g. with stereotactic image<br>guided surgery or other devices<br>for further processing and<br>visualization.<br>The device itself does not have<br>specific clinical indications. | oxygen level dependent<br>data (BOLD MRI Data) to<br>visualize the activation<br>signal.<br>The device itself does not<br>have clinical indications | features that deal<br>with data handling<br>rather than specific<br>indications for use.<br>The BOLD MRI<br>Mapping Element<br>re-implements<br>existing tools and<br>functionality offered<br>by iPlan BOLD MRI<br>Mapping with<br>regards to<br>functional planning. |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preprocessing | - Brain Mask Filtering<br>- Spatial Smoothing<br>- Motion Correction<br>(Optional)<br>- Slice Time Correction<br>(Optional)<br>- Denoising (Low Pass<br>Filtering) | - Brain Mask Filtering<br>- Spatial Smoothing<br>- Motion Correction<br>- Optionally use of<br>Distortion Correction from<br>Brainlab Elements Image<br>Fusion<br>- Only for task-based<br>analysis: Denoising (Low<br>Pass Filtering) | The following<br>preprocessing tools<br>were added:<br>- Optionally<br>use of Distortion<br>Correction from<br>Brainlab Elements<br>Image Fusion,<br>These tools were<br>evaluated for safety<br>via risk<br>management<br>activities carried out<br>validated via<br>performance<br>validation testing<br>and literature<br>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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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.