Microtargeting Drive System
FDA 510(k)Class II (US FDA 510(k))
by Fhc, Inc.
Identifiers
- 510(k) Number
- K003776 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 Microtargeting Drive System is a neurosurgical device classified as a stereotactic drive mechanism (Product Code HAW), designed for precise advancement and retraction of microelectrodes, stimulation electrodes, or other instruments within the brain or nervous system. It provides controlled, incremental movement to facilitate accurate neurosurgical procedures, including deep brain stimulation (DBS) and electrode placement.
This system is supplied as a reusable, non-sterile device intended for use in operating rooms or neurosurgical suites. It requires sterilisation prior to each use and is compatible with leading stereotactic systems via optional frame adapters. The device holds FDA 510(k) clearance (K003776) under the Traditional review pathway, with a decision date of February 23, 2001, and is distributed by FHC, Inc. (Bowdoinham, ME, USA).
Frequently asked questions
Is the Microtargeting Drive System designed for single-use or can it be reused after sterilization?
The Microtargeting Drive System is not intended for single-use. It is explicitly labeled as a reusable device, but it must be sterilized before each use to ensure safety and compliance with surgical standards. This makes it suitable for repeated use in operating rooms or neurosurgical suites, provided proper sterilization protocols are followed.
How is the Microtargeting Drive System compatible with other stereotactic systems, and what does that mean for my procedure?
The system is designed to integrate with leading stereotactic systems through optional frame adapters. This compatibility ensures seamless attachment to existing neurosurgical setups, allowing precise advancement and retraction of microelectrodes or stimulation electrodes during procedures like deep brain stimulation (DBS). The adapters bridge the drive mechanism to your chosen stereotactic frame, maintaining alignment and accuracy.
What sterilization method should I use for the Microtargeting Drive System before each use?
The device is supplied non-sterile and requires sterilization prior to each use. While the documentation does not specify a particular sterilization method, common practices for reusable neurosurgical instruments—such as autoclaving (steam sterilization) or ethylene oxide (ETO) gas—are typically recommended. Always follow your facility’s validated sterilization protocols to ensure efficacy and safety.
What does the FDA’s clearance under the Traditional review pathway mean for the reliability of this device?
The device holds FDA 510(k) clearance (K003776) under the Traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This pathway involves a thorough review by the FDA’s Neurology (NE) advisory committee, ensuring the device meets established safety and effectiveness standards for stereotactic drive mechanisms. The clearance date of February 23, 2001, reflects the regulatory timeline, not the device’s current performance.
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: STar™ Drive Manual System - FHC - fh-co.com, FHC MICROTARGETING DRIVE SYSTEM (K011992) — FDA 510 (k) | Innolitics, FHC, INC. MT-DS microTargeting™ Drive System - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K003776 | Class II | Active |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA 510(k) K003776 24 fields · synced Sep 19, 2026