510(k) · Neurology

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

by 7D Surgical Inc.

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is an AI-enabled medical device from 7D Surgical Inc. that the U.S. FDA cleared through 510(k) K192945 on November 27, 2019. Its lead review panel is Neurology and its primary product code is HAW (Neurological Stereotaxic Instrument).

See also FDA-cleared AI neurology devices in 2019, all FDA AI clearances in 2019, top neurology AI devices.

Key facts

Submission numberK192945
Pathway510(k)
Date of final decision
Company (FDA list)7D Surgical Inc.
Lead review panelNeurology
Primary product codeHAW — Neurological Stereotaxic Instrument
Applicant (openFDA)7D Surgical, Inc.
Applicant locationToronto, CA
Device classClass 2
Regulation number21 CFR 882.4560
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application went through this pathway (K192945).

openFDA lists it as a Class 2 device under 21 CFR 882.4560. Class II devices are moderate risk and are subject to general and special controls.

Product code HAW covers 8 devices on the FDA AI list. By decision date, this device is #1 of 8 under that code. 7D Surgical Inc. has 1 AI-enabled device on the list, and the Neurology panel accounts for 73 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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