(171 days)
Aesculap's ventriculoscope and associated instruments are designed for visual orientation and therapeutic neurosurgical procedures within the ventricular system, such as vetriculostomies, biopsies and removal of cysts, tumors and other obstructions.
The Ventriculoscope System presented in this submission consists of eleven devices: a working channel, rigid endoscopes, flexible instruments and electrodes. The primary material of construction is stainless steel. The electrodes are coated with a biocompatible fluoropolymer.
This document is a 510(k) summary for a medical device (Aesculap Ventriculoscope System) from 1995. It describes the device's intended use, technological characteristics, and sterilization methods, and claims substantial equivalence to other existing devices.
However, the provided text does not contain any information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects related to performance evaluation (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance) that your request outlines.
Therefore, I cannot populate the requested table or answer the specific questions based on the provided input. The document focuses on regulatory submission aspects rather than detailed performance study results.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).