AESCULAP ANGLED NEUROENDOSCOPES

K964281 · Aesculap, Inc. · GWG · Apr 21, 1997 · Neurology

Device Facts

• Record ID: K964281
• Device Name: AESCULAP ANGLED NEUROENDOSCOPES
• Applicant: Aesculap, Inc.
• Product Code: GWG · Neurology
• Decision Date: Apr 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2

Indications for Use

Aesculap's Angled Neuroendoscopes are intended for use in visualization of ventricles and structures within the brain.

Device Story

Rigid, rod-lens neuroendoscopes; 4.0mm diameter; 160mm working length; 0°, 30°, or 70° view angles. Eyepiece angled 90° for use with surgical microscope. Optional flexible titanium support arm allows hands-free positioning. Used in neurosurgical procedures by surgeons for visualization and illumination of intracranial structures. Reusable; requires steam sterilization.

Clinical Evidence

Bench testing only. Thermal safety testing performed. Compliance with IEC 601-1 and IEC 601-2-18 standards.

Technological Characteristics

Rigid rod-lens endoscope; stainless steel construction; 4.0mm diameter; 160mm length; 0°, 30°, 70° view angles. 90° angled eyepiece. Optional titanium support arm. Steam sterilization. Complies with IEC 601-1 and IEC 601-2-18.

Indications for Use

Indicated for visualization of brain ventricles and structures during endoscopy-assisted microsurgery.

Regulatory Classification

Identification

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

Predicate Devices

• Aesculap Neuroendoscope
• Codman Neuroendoscopes

Submission Summary (Full Text)

{0}

K964281

AESCULAP

APR 21 1997

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

Aesculap Angled Neuroendoscopes

January 30, 1997

Submitted by: Aesculap®, Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080
Contact: Mary Ellen Holden
Phone: [phone] x348
FAX: [phone]

Product: Aesculap Angled Neuroendoscopes
Common Name: Neuroendoscopes

## Intended Use

Aesculap's Angled Neuroendoscopes are intended for use in visualization of ventricles and structures within the brain.

## Technological Characteristics

The Angled Neuroendoscopes presented in this submission are designed to provide visual orientation and illumination in endoscopy-assisted microsurgery of the brain.

These rigid, rod-lens neuroendoscopes are 4.0mm in diameter, 160mm in working length, with either 0°, 30° or 70° direction of view. The lens eyepiece is angled at 90° to allow an unobstructed view when used in conjunction with a surgical microscope. The angled neuroendoscopes are reusable devices composed primarily of stainless steel.

An optional holding device, Aesculap's Flexible Titanium Support Arm (FF169R), can be used to position and hold the neuroendoscope. With use of the flexible support arm, the surgeon can freely operate with both hands.

1000 GATEWAY BOULEVARD • SOUTH SAN FRANCISCO, CA 94080-7030 • USA • 415-876-7000 • FAX: [phone]-

{1}

0 4

## Performance Standards

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Neuroendoscopes comply with the requirements of IEC 601-1 (Medical electrical equipment, Part 1: General Requirements for Safety) and IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.) The Angled Neuroendoscopes have undergone Thermal Safety testing to ensure they are safe for their intended use.

## Sterilization

The Angled Neuroendoscopes are provided non-sterile and must be sterilized prior to use. The devices may be sterilized by steam sterilization.

## Substantial Equivalence

Aesculap's Angled neuroendoscopes shares similar features and function with corresponding devices distributed by:

- Aesculap (Neuroendoscope, Endoscopes)
- Codman (Neuroendoscopes)