Brainlab Elements Guide XT provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Boston Scientific deep brain stimulation (DBS) devices.

Device Description

Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment. Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc. Guide XT is compatible with selected Boston Scientific leads and implantable pulse generators but does not directly interact with the surgeon. The subject device Brainlab Elements Guide XT consists of multiple software components including the Guide XT 3.0 application that provides the core functionality for stimulation field model creation and visualization in the context of the patient anatomy.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and performance data for the Brainlab Elements Guide XT device. It broadly states that "the device was demonstrated to be as safe and effective as the predicate device" based on "verification and non-clinical tests."

However, I can extract the information that is present and indicate where specific details are missing based on your request.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics. It only mentions general testing and verification without quantifiable results.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states: "Additionally, the performance test for the VTA (Volume of Tissue Activated) simulation was conducted supporting the use of a proprietary heuristic methodology for the prediction of threshold current (Ith) maps in the vicinity of implanted leads stimulated by the Deep Brain Stimulation (DBS) system from Boston Scientific Neuromodulation (BSN)."

Sample Size for Test Set: Not explicitly stated.
Data Provenance: Not specified (e.g., country of origin). The study is described as a "performance test for the VTA simulation," suggesting it's likely a retrospective analysis of existing data or a simulated environment, but not explicitly stated as retrospective or prospective human subject data. "Clinical data was leveraged from the existing literature sources to validate the indications and intended use of the device," but this refers to the validation of the indications, not the direct performance test of the device itself. The device "was not used for any clinical tests for the purposes of this 510(k) submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The document describes a "proprietary heuristic methodology" for VTA simulation, but it does not mention expert involvement in establishing ground truth for the performance test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document explicitly states: "The Subject Device was not used for any clinical tests for the purposes of this 510(k) submission." Therefore, an MRMC comparative effectiveness study was not conducted with human readers using the device. The device is a "planning software" to "assist medical professionals in planning," so human-in-the-loop performance would be relevant, but it was not tested in this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance test was done for the VTA simulation. The document states: "Additionally, the performance test for the VTA (Volume of Tissue Activated) simulation was conducted supporting the use of a proprietary heuristic methodology for the prediction of threshold current (Ith) maps in the vicinity of implanted leads stimulated by the Deep Brain Stimulation (DBS) system from Boston Scientific Neuromodulation (BSN)."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document mentions that the VTA simulation performance test "supporting the use of a proprietary heuristic methodology." This implies the ground truth might have been established through a computational model or prior validated data from Boston Scientific, rather than directly from expert consensus, pathology, or outcomes data from independent cases for this specific performance test. The document does not definitively state the type of ground truth used for this VTA simulation performance evaluation.

8. The sample size for the training set

The document does not mention a training set or its sample size. The VTA simulation uses a "proprietary heuristic methodology," which might imply a model without explicit training data or a model trained externally, but no details are provided here.

9. How the ground truth for the training set was established

Since no training set is mentioned, this information is not provided.

Summary

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April 19, 2022

Brainlab AG Chiara Cunico Manager, Regulatory Affairs Olof-Palme-Str.9 Munich, Bayern 81829 Germany

Re: K213930

Trade/Device Name: Brainlab Elements Guide XT, Guide 3.0 Regulation Number: 21 CFR 882.5855 Regulation Name: Brain Stimulation Programming Planning Software Regulatory Class: Class II Product Code: QQC Dated: February 24, 2022 Received: February 28, 2022

Dear Chiara Cunico:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine 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) K213930

Device Name Brainlab Elements Guide XT, Guide 3.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K213930

April 18, 2022

General Information
Manufacturer	Brainlab AG; Olof-Palme Str.9, 81829, Munich, Germany
Establishment Registration	8043933
Device Name	Brain stimulation programming planning software
Trade Name	Brainlab Elements Guide XT;Guide (3.0)
Classification Name	Brain stimulation programming planning software
Product Code	QQC
Regulation Number	882.5855
Regulatory Class	II
Panel	Neurology
Predicate Devices	Predicate device: SureTune4 Software (DEN210003)

Contact Information
Primary Contact	Alternate Contact
Chiara Cunico	Regulatory Affairs Brainlab
Manager RA	Phone: +49 89 99 15 68 0
Phone: +49 89 99 15 68 0	Fax: +49 89 99 15 68 5033
Email: chiara.cunico@brainlab.com	Email: regulatory.affairs@brainlab.com

1. Indications for Use

2. Device Description

Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc.

Guide XT is compatible with selected Boston Scientific leads and implantable pulse generators but does not directly interact with the surgeon.

The subject device Brainlab Elements Guide XT consists of multiple software components including the Guide XT 3.0 application that provides the core functionality for stimulation field model creation and visualization in the context of the patient anatomy. Below the full list of components:

510(k) Summary

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Image /page/4/Picture/0 description: The image shows the logo for Brainlab. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in bold, sans-serif font on the right. The symbol appears to be three curved lines stacked on top of each other.

Image /page/4/Picture/1 description: The image is a geometric design composed of triangles. The triangles are arranged in a pattern that spans across the image. The color of the triangles varies from a darker blue on the left to a lighter blue on the right, creating a gradient effect.

Name	Description
Content Manager2.7	This software provides a start screen. The different applications and availablevideo sources are visualized and can be selected.
Backbone 1.6	The software receives and distributes live-video streams, video routinginformation and other general messages from/to applications on the localcomputer.
Backbone Viewer1.6	The software displays images that were distributed by Backbone and capturingdisplay including user input content of connected displays to send it to theBackbone
Patient Selection6.1	The software allows to manage patients' records available in different sourcesconfigured in the system. Additionally, Patient Selection application allowsmanaging patients in the sense of editing, merging, deleting and creation as partof the general IT-infrastructure and converting and exporting planning contentsinto other data formats.
Data Selection 6.1	The software main purpose is to search, filter and select data. This data is sortedinto clusters and made available to the user.
Dicom Proxy 4.3	Allows to retrieve patient data from hospital servers and distribute it to othersoftware applications. It is used as central patient data server for patient datacommunication, storage and exchange based on the DICOM standard. This isan externally facing electronic interfaces via USB and LAN.
Brainlab ElementsTrajectory Planning2.5	Software for trajectory planning and lead definition. Uses the lead localizationconfiguration of the Trajectory Planning 2.5. Lead Localization (Element) allowsthe creation of trajectories and automatic detection of leads in post-operativeimages.
Guide XT 3.0	This software enables stimulation field simulation and visualization of thestimulation field model in the context of anatomical images.

Brainlab Element Guide XT is compatible with the following selected Boston Scientific leads and implantable pulse generators.

Device	Article No.
DBS Lead	DB-2201
Vercise™ Cartesia™ 8 Contact DBS Directional Lead	DB-2202
Vercise Gevia™ 16 Contact Implantable Pulse Generator	DB-1200
Vercise™ Implantable Pulse Generator	DB-1110
Vercise PC™ Implantable Pulse Generator	DB-1140
Vercise Genus™ P16 Implantable Pulse Generator	DB-1416
Vercise Genus™ P32 Implantable Pulse Generator	DB-1432
Vercise Genus™ R16 Implantable Pulse Generator	DB-1216
Vercise Genus™ R32 Implantable Pulse Generator	DB-1232

These are the primary operating functions:

Primary Operating Functions	RiskRelated
Load patient imaging data	X
Fuse Image Sets	X
Create supplemental treatment plan content (e.g. segmentations, fiber tracts)	X

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Image /page/5/Picture/1 description: The image shows the logo for Brainlab. The logo consists of a stylized symbol on the left, resembling interconnected shapes, followed by the word "BRAINLAB" in a bold, sans-serif font. The entire logo is in black and white.

Primary Operating Functions	RiskRelated
Define lead position	X
Assign lead attributes	X
Model Lead/IPG Setup	X
Create and adapt stimulation simulations	X
Load Stimulation parameters stored by Programming Application	X
Interactive Viewing of stimulation simulations in the context of the imaging andsupplemental information	X
Store Simulations	X
Safe treatment plan data	X

3. Substantial Equivalence

The Subject Device and predicate are similar in terms of:

User profile, patient population ー
Identified risks (Patient Discomfort due to collateral Stimulation, Patient Discomfort due to 2. inadequate Stimulation)
1. VTA simulation
Annotations of observed clinical effects (Predicate device provides interface to annotate 4. observations made during surgery. The subject device provides interface to annotate observations made during programming.)
1. Lead Localization
Trajectory/ Path Coordinates 6.
1. Manual Anatomical Segmentation: Subject Device allows manual outline of the shape of anatomical structures
1. Automatic Anatomical Seqmentation: Subject Device registers anatomical atlas to patient and automatically segments anatomical structures.
1. AC/PC Coordinate System: Subject Device allows for manual placement of AC/PC coordinates and the midline plane on an image

The Subject Device and predicate differ in terms of:

Subject device only simulation fields for Boston Scientific electrodes and the 1. predicate device is intended to be used only with Medtronic electrodes.

Performance Data 4.

In addition to the software verification testing, usability evaluation was carried out for the Subject Device and the previous version of the Subject Device v 2.0. The data gathered from the version is considered to be representative of the Subject Device as well.

Additionally, the performance test for the VTA (Volume of Tissue Activated) simulation was conducted supporting the use of a proprietary heuristic methodology for the prediction of threshold current (Ith) maps in the vicinity of implanted leads stimulated by the Deep Brain Stimulation (DBS) system from Boston Scientific Neuromodulation (BSN).

The Subject Device was not used for any clinical tests for the purposes of this 510k) submission. Clinical data was leveraged from the existing literature sources to validate the indications and intended use of the device.

5. Conclusion

From the verification and non-clinical tests conducted, the device was demonstrated to be as safe and effective as the predicate device.

510(k) Summary

Regulation Number and Section

§ 882.5855 Brain stimulation programming planning software.

(a)
Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis must be performed.
(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(3) Labeling must include:
(i) The implanted brain stimulators for which the device is compatible.
(ii) Instructions for use.
(iii) Instructions and explanations of all user-interface components.
(iv) A warning regarding use of the data with respect to not replacing clinical judgment.