AESCULAP VENTRICULOSCOPE SYSTEM

K954394 · Aesculap, Inc. · GWG · Mar 7, 1996 · Neurology

Device Facts

• Record ID: K954394
• Device Name: AESCULAP VENTRICULOSCOPE SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: GWG · Neurology
• Decision Date: Mar 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aesculap's ventriculoscope and associated instruments are designed for visual orientation and therapeutic neurosurgical procedures within the ventricular system, such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

Device Story

System consists of rigid endoscopes, working channels, flexible instruments, and electrodes; used for visual orientation and therapeutic neurosurgical procedures within ventricular system. Physician operates device in OR setting; provides direct visualization of ventricular anatomy. Enables minimally invasive interventions like biopsies, cyst/tumor removal, and ventriculostomies. Benefits include reduced invasiveness compared to open surgery. Instruments and scopes are non-sterile, requiring EtO or steam sterilization prior to use.

Clinical Evidence

Bench testing only. Testing confirmed device compatibility, safety, and effectiveness. Heat build-up testing performed on rigid scopes. Sterilization validation performed by NAmSA per USP methods to SAL 10⁻⁶.

Technological Characteristics

Materials: stainless steel; electrodes coated with biocompatible fluoropolymer. Components: rigid endoscopes, working channels, flexible instruments, electrodes. Energy: fiber optic illumination. Sterilization: EtO or pre-vacuum steam (validated to SAL 10⁻⁶).

Indications for Use

Indicated for patients requiring neurosurgical procedures within the ventricular system, including ventriculostomies, biopsies, and removal of cysts, tumors, or other obstructions.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Reference Devices

• Aesculap Neuroendoscope
• R. Wolf Cerebral-Endoskop
• Neuro-Navigational Neuroview™ Endoscope
• Codman Neurological Rigid Endoscopes
• Gaab Neuroendoscope
• Chavantes-Zamorano Neuroendoscope
• Steerable Endoscope

Submission Summary (Full Text)

{0}

510(k) Premarket Notification
Aesculap Ventriculoscope System

MAR - 7 1996

510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990

Aesculap Ventriculoscope System

September 15, 1995

Submitted by: Aesculap®, Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080
Contact: Victoria Mackinnon
Phone: [phone] x346
FAX: [phone]

Products: Aesculap Ventriculoscope System
Common Names: Ventriculoscope and Accessories

**Intended Use**
Aesculap's ventriculoscope and associated instruments are designed for visual orientation and therapeutic neurosurgical procedures within the ventricular system, such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

**Technological Characteristics**
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.

**Testing**
All the products have undergone testing to ensure that the devices work well with each other and are safe and effective. Heat build-up testing was also performed on the rigid scopes.

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{1}

510(k) Premarket Notification
Aesculap Ventriculoscope System

## Sterilization

The ventriculoscope and associated instruments are provided non-sterile and must be sterilized prior to use. The devices may be sterilized by EtO or by pre-vacuum steam sterilization. The ventriculoscope and instruments have been sterilized and validated by both methods to a SAL of 10⁻⁶. Validation testing was performed by NAmSA following USP methods.

## Substantial Equivalence

Aesculap's Ventriculoscope System shares similar features and function with corresponding devices distributed by:

- Aesculap [Neuroendoscope]
- R. Wolf [Cerebral-Endoskop];
- Neuro-Navigational [Neuroview™ Endoscope]
- Codman's Neurological Rigid Endoscopes, Gaab and Chavantes-Zamorano Neuroendoscopes and the Steerable Endoscope.

All of these neuroendoscopes are intended for visualization and therapeutic procedures during neurological applications. They utilize fiber optics within a outer catheter sheath, and they are similar in dimensions and features. Associated endoscopic instruments available with the Codman Gaab and Chavantes-Zamorano neuroendoscopes are similar in dimensions and use as those in Aesculap's Ventriculoscope System.

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