Waypoint Stereotactic System
FDA 510(k)Class II (US FDA 510(k))
by Fhc, Inc.
Identifiers
- 510(k) Number
- K092192 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)
The Waypoint Stereotactic System is a medical device classified as a stereotactic frame and navigation system, designed for precise localization and targeting in neurosurgical procedures. It integrates hardware and software to enable accurate placement of electrodes, leads, or implants within the brain, supporting applications such as deep brain stimulation (DBS) and epilepsy interventions. The system leverages advanced imaging and real-time tracking to enhance procedural precision, reducing variability and improving clinical outcomes. Its design aligns with regulatory standards for neurosurgical navigation tools, ensuring compatibility with MRI and other imaging modalities.
The system is supplied as a reusable medical device, intended for use in sterile operating environments such as neurosurgical suites or interventional radiology labs. It includes hardware components like the stereotactic frame and software (e.g., Waypoint Navigator) for procedural planning and guidance, with versions such as software version 4.6 referenced in documentation. The device adheres to FDA 510(k) clearance under the Neurology advisory committee (NE), with a product code of HAW, and is intended for single-patient use per procedure. Storage and handling follow standard aseptic protocols for reusable surgical instruments, with no explicit MRI safety classification noted in the data.
Frequently asked questions
What is the Waypoint Stereotactic System used for in neurosurgery?
The Waypoint Stereotactic System is designed for precise localization and targeting during neurosurgical procedures, such as deep brain stimulation (DBS) and epilepsy interventions. It integrates a stereotactic frame with advanced software (e.g., Waypoint Navigator) to enable accurate placement of electrodes, leads, or implants within the brain. This reduces procedural variability and improves clinical outcomes by leveraging real-time tracking and compatibility with MRI and other imaging modalities.
Is the Waypoint Stereotactic System reusable or single-use?
The Waypoint Stereotactic System is a reusable medical device, intended for use in sterile operating environments like neurosurgical suites or interventional radiology labs. As a reusable instrument, it must adhere to strict aseptic protocols for cleaning, sterilization, and storage between procedures. Each use is limited to a single patient per procedure, ensuring compliance with regulatory and clinical best practices.
What software versions are compatible with the Waypoint Stereotactic System?
The Waypoint Stereotactic System is compatible with software versions such as Waypoint Navigator 4.6, as referenced in its documentation. This software provides procedural planning and real-time guidance for accurate targeting during neurosurgical interventions. Always verify compatibility with the latest software updates and manufacturer guidelines before use.
How should the Waypoint Stereotactic System be stored and handled?
The system must be stored and handled according to standard aseptic protocols for reusable surgical instruments. This includes proper cleaning, sterilization, and storage in a clean, dry environment to prevent contamination. Since it is intended for single-patient use per procedure, ensure it is thoroughly sanitized and inspected before reuse in subsequent cases.
Does the Waypoint Stereotactic System have any specific MRI safety considerations?
The provided documentation does not explicitly state an MRI safety classification for the Waypoint Stereotactic System. However, its design aligns with regulatory standards for neurosurgical navigation tools intended for MRI-compatible use. Always confirm MRI safety with the manufacturer and follow their guidelines to ensure compatibility with specific MRI systems and protocols before use.
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: WayPoint™ Navigator Software - FHC, WayPoint Navigator, PDF WayPoint™ Navigator (software version 4.6) - Greydon Gilmore
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092192 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA 510(k) K092192 24 fields · synced Oct 1, 2026