(124 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on simulation and visualization based on anatomical images and a proprietary heuristic methodology, not AI/ML algorithms.
No
The device is a software application that assists medical professionals in planning and visualizing stimulation for DBS devices, but it does not directly perform therapy itself.
No
The device assists in planning stimulation programming for DBS devices and visualizes stimulation fields, but it does not diagnose medical conditions.
Yes
The device description explicitly states it is a "software application" and consists of "multiple software components." While it is used in combination with other applications and compatible with hardware, the core device itself is described solely as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: Brainlab Elements Guide XT is a software application used by medical professionals to plan and visualize stimulation programming for deep brain stimulation (DBS) devices. It works with anatomical images and simulates stimulation fields.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens from the patient. Its function is focused on image processing and simulation related to the physical placement and programming of an implanted device.
Therefore, its intended use and functionality fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
QQC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Load patient imaging data
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals, neurosurgeons and neurologists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
SureTune4 Software (DEN210003)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
Indications for Use
510(k) Number (if known) K213930
Device Name Brainlab Elements Guide XT, Guide 3.0
Indications for Use (Describe)
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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is an abstract design featuring a series of triangles in varying shades of blue. The triangles are arranged in a pattern that creates a sense of movement or flow from left to right. The left side of the design has darker blue triangles, while the right side transitions to lighter shades, eventually fading to almost white.
Image /page/3/Picture/1 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 symbol appears to be three curved lines stacked on top of each other. The text is in a bold, sans-serif font.
510(k) Summary
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
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.
2. 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. Below the full list of components:
510(k) Summary
4
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 Manager | |
| 2.7 | This software provides a start screen. The different applications and available |
| video sources are visualized and can be selected. | |
| Backbone 1.6 | The software receives and distributes live-video streams, video routing |
| information and other general messages from/to applications on the local | |
| computer. | |
| Backbone Viewer | |
| 1.6 | The software displays images that were distributed by Backbone and capturing |
| display including user input content of connected displays to send it to the | |
| Backbone | |
| Patient Selection | |
| 6.1 | The software allows to manage patients' records available in different sources |
| configured in the system. Additionally, Patient Selection application allows | |
| managing patients in the sense of editing, merging, deleting and creation as part | |
| of the general IT-infrastructure and converting and exporting planning contents | |
| into other data formats. | |
| Data Selection 6.1 | The software main purpose is to search, filter and select data. This data is sorted |
| into clusters and made available to the user. | |
| Dicom Proxy 4.3 | Allows to retrieve patient data from hospital servers and distribute it to other |
| software applications. It is used as central patient data server for patient data | |
| communication, storage and exchange based on the DICOM standard. This is | |
| an externally facing electronic interfaces via USB and LAN. | |
| Brainlab Elements | |
| Trajectory Planning | |
| 2.5 | Software for trajectory planning and lead definition. Uses the lead localization |
| configuration of the Trajectory Planning 2.5. Lead Localization (Element) allows | |
| the creation of trajectories and automatic detection of leads in post-operative | |
| images. | |
| Guide XT 3.0 | This software enables stimulation field simulation and visualization of the |
| stimulation 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 | Risk
Related |
|-------------------------------------------------------------------------------|-----------------|
| Load patient imaging data | X |
| Fuse Image Sets | X |
| Create supplemental treatment plan content (e.g. segmentations, fiber tracts) | X |
5
Image /page/5/Picture/0 description: The image is an abstract design featuring a pattern of triangles in varying shades of blue and white. The triangles are arranged in a mosaic-like fashion, with the darker blue shades concentrated on the left side of the image, gradually transitioning to lighter shades and white towards the right. The white spaces between the triangles create a sense of depth and complexity, giving the design a modern and geometric feel.
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 | Risk
Related |
|--------------------------------------------------------------------------------------------------------------|-----------------|
| 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 and
supplemental 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)
-
- 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.)
-
- Lead Localization
- Trajectory/ Path Coordinates 6.
-
- Manual Anatomical Segmentation: Subject Device allows manual outline of the shape of anatomical structures
-
- Automatic Anatomical Seqmentation: Subject Device registers anatomical atlas to patient and automatically segments anatomical structures.
-
- 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