Elements Trajectory Planning, Lead Localization
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K211544 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Elements Trajectory Planning, Lead Localization is a software application designed for pre-, intra-, and postoperative image-based planning and review of neurosurgical procedures. It facilitates precise trajectory planning for deep brain stimulation (DBS) lead placement, enabling clinicians to visualize and optimize trajectories in three-dimensional space. The software integrates with cranial stereotaxy workflows to enhance accuracy in targeting specific brain regions. It is part of Brainlab’s neurosurgical planning portfolio, supporting both open and minimally invasive procedures.
The device is supplied as software and is intended for use in clinical settings where advanced neurosurgical planning is required. It operates on standard medical imaging data and does not require sterility or single-use considerations. The software is compatible with MRI-safe environments, adhering to standard electromagnetic interference guidelines. Authorized for use in the United States under an FDA 510(k) clearance (K211544), it is classified under product code HAW and was reviewed by the Neurology Advisory Committee. No additional regulatory markings or certifications are stated beyond the FDA clearance.
Frequently asked questions
What is the Elements Lead Localization Trajectory Planning software used for?
The Elements Lead Localization Trajectory Planning software is designed for pre-, intra-, and postoperative planning and review of neurosurgical procedures, specifically for deep brain stimulation (DBS) lead placement. It allows clinicians to visualize and optimize trajectories in three-dimensional space, ensuring precise targeting of brain regions during both open and minimally invasive neurosurgical workflows. This integration with cranial stereotaxy enhances accuracy and supports advanced surgical planning.
How is the Elements Lead Localization Trajectory Planning software supplied and does it require sterility?
The software is supplied as a digital application and does not require physical sterility or single-use considerations, as it operates entirely within a clinical IT environment. It is intended for use in settings where advanced neurosurgical planning is performed, relying on standard medical imaging data for trajectory calculations and visualization. No physical packaging or sterilization processes are involved.
Is the software compatible with MRI-safe environments?
Yes, the Elements Lead Localization Trajectory Planning software adheres to standard electromagnetic interference guidelines, making it compatible for use in MRI-safe environments. This ensures it can be integrated seamlessly into clinical workflows where MRI imaging is part of the preoperative or intraoperative planning process.
What regulatory approval does the Elements Lead Localization Trajectory Planning software hold?
The software holds FDA 510(k) clearance (K211544) in the United States, classified under product code HAW. It was reviewed by the Neurology Advisory Committee and determined to be substantially equivalent to a predicate device. No additional regulatory markings or certifications beyond the FDA clearance are stated in the provided data.
Can this software be used for both open and minimally invasive neurosurgical procedures?
Yes, the Elements Lead Localization Trajectory Planning software is designed to support both open and minimally invasive neurosurgical procedures. Its trajectory planning capabilities are tailored to enhance precision in lead placement for deep brain stimulation (DBS), ensuring compatibility with a range of surgical approaches. This versatility makes it a valuable tool for clinicians performing diverse neurosurgical interventions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Functional Neurosurgery Planning Solutions | Brainlab, Elements: Radiotherapy & Radiosurgery Treatment Planning | Brainlab, Brainlab Elements - Trajectory Planning (2.6), Elements Stereotaxy ..., PDF Trajectory Planning 2
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211544 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K211544 24 fields · synced Oct 1, 2026