Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial

K223552 · Brainlab AG · HAW · Apr 19, 2023 · Neurology

Device Facts

• Record ID: K223552
• Device Name: Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
• Applicant: Brainlab AG
• Product Code: HAW · Neurology
• Decision Date: Apr 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures. Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/ device can be identified relative to images of the anatomy. This includes, but is not limited to, the following Cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy): - Catheter placement - Depth electrode placement (SEEG procedures) - Lead placement and detection (DBS procedures) - Probe placement - Cranial biopsies

Device Story

Software for pre-, intra-, and postoperative planning of minimally invasive neurosurgical trajectories. Inputs: anatomical images (axial, coronal, sagittal reconstructions), co-registrations, segmentations, and fiber tracts (DICOM). Operation: user-defined trajectory creation; automatic/semi-automatic detection of FHC WayPoint bone anchors on CT; stereotactic arc or FHC STarFix platform planning. Outputs: surgical coordinates, measurements (point, distance, angle), and trajectory plans. Used in clinical settings by neurosurgeons and neurologists. Output informs surgical intervention (e.g., arc settings, platform positioning). Benefits: enables precise, image-guided surgical planning for functional neurosurgery.

Clinical Evidence

Bench testing only. Validation included software verification (integration/unit tests), FHC anchor detection accuracy/robustness testing (non-inferiority to WayPoint Planner Software), and summative usability evaluation for the STarFix workflow, plan locking, image blending, and GUI coordinate interaction.

Technological Characteristics

Software-based planning tool. Operates on Windows 7 64-bit (min 4 cores, 6GB RAM). Supports DICOM data. Integrates with stereotactic hardware (Inomed SUSy Arc, FHC STarFix). Features include image reconstruction, co-registration, segmentation, and trajectory calculation. Cybersecurity and SOUP items verified.

Indications for Use

Indicated for patients undergoing stereotactic neurosurgical procedures requiring instrument/device placement, including catheter, depth electrode (SEEG), lead (DBS), probe placement, and cranial biopsies. Applicable to both frame-based and frame alternative-based stereotaxy.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Brainlab Elements Trajectory Planning (2.5) (K211544)
• Waypoint Stereotactic System (K092192)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 19, 2023

Brainlab AG Sadwini Suresh QM Consultant Olof-Palme-Str.9 Munich, BY 81829 Germany

Re: K223552

Trade/Device Name: Brainlab Elements - Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 25, 2022 Received: November 25, 2022

Dear Sadwini Suresh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for "Adam D. Pierce -S". The date of the signature is 2023.04.19, and the time is 18:01:44 -04'00'.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices 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) K223552

#### Device Name

Brainlab Elements Trajectory Planning (2.6), Elements Lead Localization, Elements Trajectory Planning Cranial

#### Indications for Use (Describe)

Brainlab Elements Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical procedures. Its use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/device can be identified relative to images of the anatomy.

This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):

- · Catheter placement
- · Depth electrode placement (SEEG procedures)
- · Lead placement and detection (DBS procedures)
- · Probe placement
- · Cranial biopsies

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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# 510(k) Summary

K223552 Page 1 of 9

| General Information | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Names | Brainlab Elements - Trajectory Planning (2.6) Elements Stereotaxy Elements Lead Localization Elements Trajectory Planning Cranial |
| Classification Name | Neurological Stereotaxic Instrument |
| Product Code | HAW |
| Regulation Number | 882.4560 |
| Regulatory Class | II |
| Panel | Neurology |
| Primary Predicate Device | (K211544) Brainlab Elements Trajectory Planning (2.5) |
| Additional Predicate Device | (K092192) Waypoint Stereotactic System |
| Contact Information | |
| Primary Contact | Sadwini Suresh<br>QM Consultant<br>Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Alternate Contact | Chiara Cunico<br>Senior Manager Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |

# 1. Indications for Use

Brainlab Elements - Trajectory Planning software is intended for pre-, intra- and postoperative image-based planning and review of either open or minimally invasive neurosurgical and neurological procedures.

lts use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate for the placement of instruments/devices and where the position of the instrument/ device can be identified relative to images of the anatomy.

This includes, but is not limited to, the following cranial procedures (including frame-based stereotaxy and frame alternative-based stereotaxy):

- o Catheter placement
- Depth electrode placement (SEEG procedures) o
- Lead placement and detection (DBS procedures) 0
- Probe placement ●
- Cranial biopsies

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## 2. Device Description

Brainlab Elements Trajectory Planning is a software used to plan minimally invasive possible pathways (Trajectories') for surgical instruments on scanned images. It is used for the processing and viewing of anatomical images (for example: axial, coronal and sagittal reconstructions, etc.) and corresponding planning contents (for example: co-registrations, seqmentations, fiber tracts created by compatible applications and stored as DICOM data) and the planning of trajectories based on this data. The device is also used for the creation of coordinates and measurements that can be used as input data for surgical intervention (e.g.: stereotactic arc settings or FHC STarFix platform settings). Depending on the workflow and available licenses, Brainlab Elements Trajectory Planning might be used in different roles where only specific application features are available.

The following roles are available for Trajectory Planning:

- · Trajectory (Element): allows the creation of trajectories
· Stereotaxy (Element): allows the creation of trajectories and supports stereotactic procedures based on Stereotactic Arc Settings or FHC STarFix platform settings

· Lead Localization (Element): allows the creation of trajectories and automatic detection of leads in post-operative images.

All roles are enabled to be used for cranial trajectory planning procedures after installation of Trajectory as well as the corresponding workflow files for Cranial Planning, Stereotactic Planning or Post-Op Review.

## 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:

| Device | Name |
|-----------------------------|-------------------------------------------------------|
| Primary Predicate Device | (K211544) Brainlab Elements Trajectory Planning (2.5) |
| Additional Predicate device | (K092192) Waypoint Stereotactic System |

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| Topic/ Feature | Primary Predicate:<br>(K211544) Brainlab Elements Trajectory<br>Planning (2.5) | Subject Device (Trajectory Planning 2.6) | Comment |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Brainlab Elements Trajectory Planning<br>software is intended for pre-, intra- and<br>postoperative image-based planning and review<br>of either open or minimally invasive<br>neurosurgical and neurological procedures.<br>Its use is indicated for any medical condition in<br>which the use of stereotactic surgery may be<br>appropriate for the placement of<br>instruments/devices and where the position of<br>the instrument/ device can be identified relative<br>to images of the anatomy.<br>This includes, but is not limited to, the following<br>Cranial procedures (including frame-based<br>stereotaxy and frame alternative-based<br>stereotaxy):<br>- Catheter placement<br>- Depth electrode placement (SEEG procedures)<br>- Lead placement and detection (DBS<br>procedures)<br>- Probe placement<br>- Cranial biopsies | The Brainlab Elements Trajectory Planning<br>software is intended for pre-, intra- and<br>postoperative image-based planning and review<br>of either open or minimally invasive<br>neurosurgical and neurological procedures.<br>Its use is indicated for any medical condition in<br>which the use of stereotactic surgery may be<br>appropriate for the placement of<br>instruments/devices and where the position of<br>the instrument/ device can be identified relative<br>to images of the anatomy.<br>This includes, but is not limited to, the following<br>Cranial procedures (including frame-based<br>stereotaxy and frame alternative-based<br>stereotaxy):<br>- Catheter placement<br>- Depth electrode placement (SEEG procedures)<br>- Lead placement and detection (DBS<br>procedures)<br>- Probe placement<br>- Cranial biopsies | No Changes compared to the<br>primary predicate. |
| User Profile | The target user group are healthcare<br>professionals educated for the planning and | The target user group are healthcare<br>professionals educated for the planning and | No Changes compared to the<br>primary predicate. |
| Topic/ Feature | Primary Predicate: | Subject Device (Trajectory Planning 2.6) | Comment |
| | (K211544) Brainlab Elements Trajectory<br>Planning (2.5) | | |
| | execution of functional neurosurgery procedures.<br>These include neurosurgeons and neurologists. | execution of functional neurosurgery procedures.<br>These include neurosurgeons and neurologists. | |
| Hardware<br>requirements | Trajectory Planning can be used on computer<br>platforms that fulfill the defined minimum<br>requirements:<br>- Operating System: Windows 7 64bit SP1<br>- Minimum 4 logical cores<br>- Minimum RAM: 6 GB<br>- Graphics: Direct X compatible<br>- Display Resolution: 1920 x 1080 (Full HD) | Trajectory Planning can be used on computer<br>platforms that fulfill the defined minimum<br>requirements:<br>- Operating System: Windows 7 64bit SP1<br>- Minimum 4 logical cores<br>- Minimum RAM: 6 GB<br>- Graphics: Direct X compatible<br>- Display Resolution: 1920 x 1080 (Full HD) | No Changes compared to the<br>primary predicate. |
| View and Adjust | N/A | Adjust Windowing via dedicated windowing<br>parameter controls and presets | New GUI functionality added<br>to the Subject Device. Only<br>additional GUI options are<br>offered for adjusting the<br>windowing |
| Measurements | Make Measurements in the selected dataset with<br>different measurement tools:<br>- Margin Measurement: Create a margin around a<br>trajectory<br>- Distance Measurement: Measure the distance<br>between two points | Make Measurements in the selected dataset with<br>different measurement tools:<br>- Point Measurement: Mark individual points<br>in the dataset and get additional information<br>such as the DICOM coordinates of the point,<br>the grey values of the image dataset at this<br>point or the AC/PC coordinates of the point<br>- Angle Measurement: Measure the angle<br>between two lines | Only additional tool options for<br>measuring points, distances or<br>angles are offered . |
| Topic/ Feature | Primary Predicate:<br>(K211544) Brainlab Elements Trajectory<br>Planning (2.5) | Subject Device (Trajectory Planning 2.6) | Comment |
| Supported Non-<br>Brainlab<br>Stereotactic<br>Hardware | N/A | - Multiline Measurement: Measure the<br>distance between several points<br>Inomed SUSy Arc interfacing with Inomed<br>Titanium or Inomed Open Ceramic Headring | Additional stereotactic arc<br>system supported with the<br>subject device. |
| Stereotactic<br>Platform Support | N/A | FHC STARFIX Stereotactic Platform is supported | Added support of FHC STARFIX<br>Stereotactic Platforms |

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| Topic/ Feature | Additional Predicate: | Subject Device (Trajectory Planning 2.6) | Comment |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (K092192) Waypoint Stereotactic System | | |
| Indications for use | The WayPoint Stereotaxic System is intended<br>to be used with commercially available<br>stereotactic systems for neurosurgical<br>procedures which require the accurate<br>positioning of microelectrodes, stimulating<br>electrodes, implantable electrodes or other<br>instruments in the brain or nervous system. | The Brainlab Elements Trajectory Planning<br>software is intended for pre-, intra- and<br>postoperative image-based planning and<br>review of either open or minimally invasive<br>neurosurgical and neurological procedures.<br>Its use is indicated for any medical condition<br>in which the use of stereotactic surgery may<br>be appropriate for the placement of<br>instruments/devices and where the position of<br>the instrument/ device can be identified<br>relative to images of the anatomy.<br>This includes, but is not limited to, the<br>following Cranial procedures (including frame-<br>based stereotaxy and frame alternative-based<br>stereotaxy):<br>- Catheter placement<br>- Depth electrode placement (SEEG<br>procedures)<br>- Lead placement and detection (DBS<br>procedures)<br>- Probe placement | Similar indications for use. |
| Topic/ Feature | Additional Predicate: | Subject Device (Trajectory Planning 2.6) | Comment |
| | (K092192) Waypoint Stereotactic System | | |
| | | - Cranial biopsies | |
| | The application allows the user to configure<br>and review trajectory planning results to be<br>realized using FHC STarFix Platforms. These<br>are patient/case specific frameless<br>stereotactic platforms manufactured and<br>delivered by FHC Inc. | The application allows the user to configure<br>and review trajectory planning results to be<br>realized using FHC STarFix Platforms. These<br>are patient/case specific frameless<br>stereotactic platforms manufactured and<br>delivered by FHC Inc. | No changes. |
| Anchor Detection | User can detect (FHC WayPoint) anchors on<br>CT scans that are used as interface to the<br>patients head (based on stereotactic<br>registration). | User can detect (FHC WayPoint) anchors on<br>CT scans that are used as interface to the<br>patients head (based on stereotactic<br>registration). | No changes. |
| Stereotactic<br>Platforms | The following FHC STarFix Stereotactic<br>Platforms can be used (as selected by the<br>user):<br>- Four legged Unilateral Platforms<br>(2h2h)<br>- Four legged Bilateral Platforms<br>(2h2h, 2b2b)<br>- Three Legged Unilateral Platforms<br>(Unilateral)<br>- Staged Bilateral Platforms (Epilepsy<br>Multi-Hub) | The following FHC STarFix Stereotactic<br>Platforms can be used (as selected by the<br>user):<br>- Four legged Unilateral Platforms<br>(2h2h)<br>- Four legged Bilateral Platforms (2h2h,<br>2b2b)<br>- n/a<br>- n/a | Minor Difference<br>- Only four legged stereotactic<br>positioning platforms are supported<br>(reducing the number of options)<br>- Provided options are similar<br>to the predicate. |
| Registration | The following registration constraints are<br>applied: | The following registration constraints are<br>applied: | - Supporting only 4 anchors<br>furthermore prevents wrong<br>mounting of the platform |
| Topic/ Feature | Additional Predicate:<br>(K092192) Waypoint Stereotactic System | Subject Device (Trajectory Planning 2.6) | Comment |
| | - One and the same anchor length (4 mm or 5 mm) is supported for the required set of anchors<br>- 3 or 4 anchors are supported<br>- Anchor detections have to be accepted by the user | - One and the same anchor length (4 mm or 5 mm) is supported for the required set of anchors<br>- Only 4 anchors are supported<br>- Anchor detections have to be accepted by the user | Overall functionality is similar to the predicate. |

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K223552
Page 8 of 9

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## 4. Performance Data

## Verification

#### 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.

## Bench Testing

In addition to the routine verification tests, the following performance tests were carried out for the Subject Device.

### FHC anchor detection:

The objective of these validative tests is to verify for Trajectory Planning 2.6, that accuracy and robustness of the automatic and semi-automatic WayPoint anchor detection on CT data for FHC's 4 mm and 5 mm bone anchors are non-inferior to the SW application WayPoint™ Planner Software. The acceptance criteria specified in the test plan regarding the Brainlab automatic and semi-automatic anchor detection algorithm were fullfilled.

#### Summative Usability Evaluation:

Within version 2.6 of Trajectory Planning (Subject Device) the support of STarFix plaforms for DBS procedures including detection of WayPoint bone anchors and platform planning was introduced and thus the whole workflow of planning a STarFix platform in Stereotaxy Element was subject to summative evaluation. In addition, locking of plans and overlay/blending of two fused images sets were added as features as well and were included in the summative evaluation.

Additionally, the new interaction with the coordinates (e.g.AC/PC) caused by GUI changes was also evaluated.

## 5. Conclusion

The performed verification and validation activities established that the set requirements were met and that the device performs as intended.

The Subject Devices' comparison with the Predicate Devices establishes that they have similar functionality, intended use and technological characteristics. Therefore, we consider that the Subject Device can be considered substantially equivalent to the predicate device.