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FLASH EVD System (10-0002)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242480

by 7D Surgical ULC

Identifiers

510(k) Number
K242480 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 FLASH EVD System (10-0002) is a stereotactic image-guided surgical navigation system designed for cranial procedures. It provides real-time spatial positioning and orientation assistance for external ventricular drainage (EVD) catheter placement, leveraging pre-operative 3D imaging data for precision guidance during surgery.

This system is intended for use in operating rooms, intensive care units, or emergency rooms by neurosurgeons. It combines pre-operative tomographic imaging with intraoperative structured light scanning for patient registration, enabling accurate catheter placement at the bedside. The device is supplied as a reusable system with FDA 510(k) clearance under the product code HAW, and its use is regulated under the Neurology advisory committee classification.

Frequently asked questions

What types of clinical settings is the FLASH EVD System designed for, and how does it assist neurosurgeons during procedures?

The FLASH EVD System is designed for use in operating rooms, intensive care units, and emergency rooms. It assists neurosurgeons by providing real-time spatial positioning and orientation guidance for external ventricular drainage (EVD) catheter placement. By integrating pre-operative 3D imaging data (like CT or MRI scans) with intraoperative structured light scanning, the system enables precise patient registration and accurate catheter targeting at the bedside, reducing the risk of misplacement.

Is the FLASH EVD System reusable, and if so, what does this mean for maintenance and cost considerations?

Yes, the FLASH EVD System is supplied as a reusable device. This means it is designed for multiple uses across different procedures, which can help reduce single-use costs over time. However, it requires proper cleaning, sterilization, and maintenance between uses to ensure accuracy and safety. Facilities should follow the manufacturer’s guidelines for upkeep to maintain performance and compliance with regulatory standards.

How does the FLASH EVD System integrate with pre-operative imaging, and why is this important for EVD catheter placement?

The FLASH EVD System integrates pre-operative tomographic imaging (such as CT or MRI scans) with intraoperative structured light scanning to create a precise 3D map of the patient’s anatomy. This integration is critical because it allows the system to guide the neurosurgeon in placing the EVD catheter with high accuracy, minimizing the risk of off-target insertion, which can lead to complications like hemorrhage or infection.

What regulatory pathway was followed for the FLASH EVD System, and how does this affect its use in clinical practice?

The FLASH EVD System received FDA 510(k) clearance under the product code HAW, classified under the Neurology advisory committee (NE). This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards. Clinicians can rely on this clearance as evidence of regulatory review, though they should still follow institutional protocols and manufacturer instructions for proper 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: FLASH EVD Cranial Navigation Platform, FLASH EVD System (10-0002) - physicianaitools.com, FLASH EVD System (10-0002) (K242480) — FDA 510(k) | Innolitics, FLASH EVD System (10-0002) (K242480) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
7D Surgical ULC

Sources (1)

  • FDA 510(k) K242480 24 fields · synced Sep 19, 2026