GALILEO ENDOSCOPES

K962116 · Galileo Electro-Optics Corp. · EOB · Nov 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K962116
• Device Name: GALILEO ENDOSCOPES
• Applicant: Galileo Electro-Optics Corp.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The Galileo Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Endoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The Galileo Endoscopes indications for use include thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.

Device Story

Reusable rigid endoscopes; available in rod-lens or fiber-optic imaging configurations. Light transmitted from external high-intensity source via optical fibers to distal tip; image captured by objective lens and transmitted to proximal eyepiece via rod-lens system or fiber-optic bundle. Used by physicians in clinical settings for direct visualization of body cavities, hollow organs, and canals. Output viewed directly through eyepiece or via video camera to monitor. Assists clinicians in diagnostic or surgical visualization; facilitates minimally invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Reusable rigid endoscope; rod-lens or fiber-optic imaging bundle; stainless steel construction; external high-intensity light source; various lengths and diameters; manual operation.

Indications for Use

Indicated for patients requiring direct visualization of body cavities, hollow organs, and canals via thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Imagyn Laparoscope (Imagyn Medical)
• Optimed Rigid Fiber Optic Endoscope (Optimed Technologies, Inc.)
• Fiber Optic Laparoscope (Medical Dynamics)
• Model 2010 Rigid Fiber Optic Sinuscope (Saratoga Medical)
• Model 4200 Fiber Optic Laparoscope (Saratoga Medical)
• Fiber Optic Choledoscope (Saratoga Medical)
• Rigid Sinuscope (Saratoga Medical)
• Hopkins Laparoscopes (Karl Storz Endoscopy)
• Thoracoscope (Karl Storz Endoscopy)

Submission Summary (Full Text)

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NOV 27 1996
K962116

# 510(k) Summary
## Galileo Electro-Optics Corporation
### Galileo Endoscopes

## 1. SPONSOR/APPLICANT NAME AND ADDRESS

Galileo Electro-Optics Corporation
Galileo Park
P.O. Box 550
Sturbridge, MA 01566
Telephone [phone]

**Contact Person**

Kin M. Wong, Director of Quality Assurance

**Date of Summary Preparation**

October 30, 1996

## 2. DEVICE NAME

Proprietary Name: Galileo Endoscopes
Common/Usual Name: Endoscope
Classification Name: Endoscope and accessories

## 3. IDENTIFICATION OF PREDICATE OR LEGALLY MARKETED DEVICE(S)

The Galileo Endoscopes are substantially equivalent to several legally marketed endoscopes including the Imagyn Laparoscope manufactured by Imagyn Medical, the Optimed Rigid Fiber Optic Endoscope manufactured by Optimed Technologies, Inc., the Fiber Optic Laparoscope manufactured by Medical Dynamics and the Model 2010 Rigid Fiber Optic Sinuscope, the Model 4200 Fiber Optic Laparoscope and Fiber Optic Choledoscope, and the Rigid Sinuscope all manufactured by Saratoga Medical, and the Hopkins Laparoscopes and Thoracoscope manufactured by Karl Storz Endoscopy.

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# 4. DEVICE DESCRIPTION

The Galileo Endoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user. Two designs of endoscopes are available:

## Galileo Rod and Lens Design Endoscope:

The rod and lens design Galileo Endoscope functions by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and an alternating set of rod and lenses to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor.

## Galileo Fiber Optic Design Endoscope:

The fiber optic design Galileo Endoscope functions by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and a fiberoptic imaging bundle (instead of a rod and lens) to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor.

# 5. INTENDED USE

The Galileo Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Endoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The Galileo Endoscopes indications for use include thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.

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# 6. STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) CITED

The Galileo Endoscopes and the substantially equivalent devices are identical in intended use in that they are all rigid endoscopes intended to be passed through a lumen of an introducer or into natural body cavities for visualization of body cavities, tissues, organs or canals.

The Galileo Endoscopes and the substantially equivalent devices are similar in designs in that they all offer various configurations including rod/lens or fiberoptic design, several OD's and lengths, and use external light sources, and similar stainless steel materials.

The Galileo Endoscopes and the substantially equivalent devices are similar in technological characteristics in that they offer a channel for viewing body cavities, tissues, organs or canals.

Galileo Endoscopes 510(k) - K962116
10/30/96
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