OES LAPARO-THORACO VIDEOSCOPE TYPE V

K955403 · Olympus America, Inc. · HET · Mar 11, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K955403
• Device Name: OES LAPARO-THORACO VIDEOSCOPE TYPE V
• Applicant: Olympus America, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The OES Laparo-Thoraco Videoscope Type V has been designed for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity. The A4907 Lens Cleaning Sheath has been specifically designed to be used with an OES Laparo-Thoraco Videoscope Type V to clean the objective lens surface. The A4908 Valve has been specifically designed for use in conjunction with the A4907 Cleaning Sheath to provide irrigation and aspiration of liquids when connected to the insertion tube of the Olympus videoscope. The trocar tubes are intended to provide a passageway for the endoscope or hand instruments, and permit the insufflation of CO2 during the endoscopic procedure. The subject trocar tubes are specifically designed to use in conjunction with the OES Laparo-Thoraco Videoscope Type V. The trocars are intended to pierce the abdominal wall tissue layer during the endoscopic procedure. The subject trocars are specifically designed to use in conjunction with the Laparo-Thoracoscope.

Device Story

Device is a videoscope for thoracic/abdominal endoscopic procedures; utilizes distal-tip CCD for image capture; transmits video to external monitor for surgeon visualization. System includes A4907 lens cleaning sheath for objective lens maintenance and A4908 valve for irrigation/aspiration control. Trocar tubes and trocars facilitate instrument access and CO2 insufflation. Operated by physicians in clinical settings. Videoscope replaces fiber-optic bundles with distal CCD technology, improving image transmission. Output allows real-time anatomical visualization, aiding diagnosis and surgical intervention. Benefits include enhanced visualization and integrated cleaning/suction capabilities during minimally invasive procedures.

Clinical Evidence

No clinical data. Substantial equivalence based on design, intended use, and technological comparison to predicate devices.

Technological Characteristics

Videoscope features 11mm distal tip, 10.6mm insertion tube, 70° FOV, 18-100mm depth of field, 90° 4-way angulation. Includes color CCD sensor. Accessories include medical-grade silicone rubber valves and metal trocar housings. Irrigation/aspiration via manual plunger-style valves.

Indications for Use

Indicated for patients requiring endoscopic observation, diagnosis, and treatment within the thoracic and abdominal cavity.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• Olympus Flexible Tip Thoracoscope/Laparoscope (K942338 & K942339)
• Olympus OES LTF Flexible Tip Thoracoscope/Laparoscope (K915857)
• Cook Lens Cleaner
• Wiest Optic Shaft
• DevMed Group Inc. Lap Wash System
• T1020 Multiple Function Tube (K923982)
• Olympus MH-325 Valve (K915857)
• Olympus A5273 and A5276 Trocar Tubes (K923982)

Submission Summary (Full Text)

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510 (k) SUMMARY
K955403

# OLYMPUS OES LAPARO-THORACO VIDEO SCOPE TYPE V

MAR 11 1996

| Device Name: | Olympus OES Laparo-Thoraco Videoscope Type V, its associated accessories and ancillary equipment |
| --- | --- |
| Common/Usual Name: | Laparo-Thoraco Videoscope |
| Classification Name: | Endoscope and Accessories
Mediastinoscope and Accessories
Gynecologic Laparoscope and Accessories |
| Predicate Devices: | Olympus Flexible TipThoracoscope/Laparoscope
K942338 & K942339 |
| Submitted By:
(Contact Person) | Mr. Barry Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
[phone] |
| Summary Preparation Date: | November 22, 1995 |

## Statement of Intended Use

### OES Laparo-Thoraco Videoscope Type V

The OES Laparo-Thoraco Videoscope Type V has been designed for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity.

### A4907 Lens Cleaning Sheath

The A4907 Lens Cleaning Sheath has been specifically designed to be used with an OES Laparo-Thoraco Videoscope Type V to clean the objective lens surface.

### A4908 Valve

The A4908 Valve has been specifically designed for use in conjunction with the A4907 Cleaning Sheath to provide irrigation and aspiration of liquids when connected to the insertion tube of the Olympus videoscope.

### Trocar Tube and Trocars

The trocar tubes are intended to provide a passageway for the endoscope or hand instruments, and permit the insufflation of $\mathrm{CO}_{2}$ during the endoscopic procedure. The subject trocar tubes are specifically designed to use in conjunction with the OES Laparo-Thoraco Videoscope Type V.

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The trocars are intended to pierce the abdominal wall tissue layer during the endoscopic procedure. The subject trocars are specifically designed to use in conjunction with the Laparo-Thoracoscope.

## Device Description

### OES Laparo-Thoraco Videoscope Type V

The OES Laparo-ThoracoVideoscope Type V is substantially equivalent in design to the predicate Olympus OES LTF Flexible Tip Thoracoscope/Laparoscope which was cleared in 510(k) # K915857. The predicate LTF Flexible Tip Thoracoscope/Laparoscope is a fiberscope. The only difference between these two endoscopes is that the predicate device which has a image guide (fiber bundle) to transmit an endoscopic image to the surgeon's eye or the CCD of the video camera. The subject device is a videoscope that places the CCD at the distal end of the endoscope. The subject OES Laparo-Thoraco Videoscope Type V has an 11 mm distal tip, 10.6 mm diameter insertion tube, 70° forward viewing field of view, depth of field of 18mm ~100mm, and 90° angulation in all four (Up-Down-Left-Right) directions. It contains the color Charged Couple Devices (CCD) for image transmission to the video monitor.

When compared to the previously cleared predicate scope, the subject OES Laparo-Thoraco Videoscope Type V does not raise any new questions of safety or effectiveness.

### A4907 Lens Cleaning Sheath

The A 4907 Lens Cleaning Sheath has been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V. It will be included in the standard set of Laparo-Thoraco Videoscope and will also be marketed separately.

When connected to the main body of videoscope, it offers lens cleaning, irrigation, and suction capabilities to the user during endoscopic procedures. It is substantially equivalent in design, intended use, and method of operation to the “Lens Cleaner” manufactured by Cook, “Optic Shaft” manufactured by Wiest, and “Lap Wash System” manufactured by DevMed Group Inc.

### A4908 Valve

The A4908 Valve has been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V and A4907 lens cleaning sheath. It will be included in the standard set of the OES Laparo-Thoraco Videoscope Type V and will also be marketed separately.

The A4908 Valve is substantially equivalent in intended use, functions, and method of use to the T1020 Multiple Function Tube (Irrigation/Suction Probe) which was approved in 510(k) # K923982. Both devices have separate “plunger-like” valves that permit the operator to control when to activate the suction or irrigation function. The housing of design is such that tubing sets are easily connected to the irrigation/suction source.

Additionally, the A4908 Valve is also substantially equivalent in design, material intended use, functions, and method of use to the Olympus MH-325 Valve which was cleared in 510(k) # K915857 with the exception that the A4908 Valve controls the irrigation and suction of liquids. It has separate irrigation port and suction port connections. The irrigation and aspiration functions are controlled by separate buttons.

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# Trocar Tubes

The A5822 and A5824 trocar tubes have been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V. The 5 mm trocar tube is designed to deliver endoscopic accessories into the abdominal cavity

| Model | Diameter | Description |
| --- | --- | --- |
| A5820 | 5 mm | Trocar Tube |
| A5822 | 11 mm | Trocar Tube |
| A5824 | 13 mm | Trocar Tube |

The A5822 and A5824 trocar tubes consist of a metal housing, a stopcock for insufflation of CO₂ gas, and a sealing valve. The A5820 trocar tubes does not have a stopcock for insufflation. The sealing valve is specifically designed to prevent damages to the insertion tube of the OES Laparo-Thoraco Videoscope Type V. It can also be purchased separately. These trocar tubes are substantially equivalent in intended use, functions, and method of use to the Olympus A5273 and A5276 Trocar Tubes with the exception that the predicate trocar tubes have a metal valve (flap or plunger type) while the subject trocar tubes have a medical grade silicone rubber valve. The predicate trocar tubes A5273 and A5276 were cleared in 510(k) # K923982.

# Trocars

The following trocars have been specifically designed for use in conjunction with the trocar tubes listed above:

| Model | Diameter | Description |
| --- | --- | --- |
| A5821 | 5 mm | Trocar |
| A5823 | 11 mm | Trocar |
| A5825 | 13 mm | Trocar |

# General Safety

When compared to the predicate devices, Olympus OES Laparo-Thoraco Videoscope Type V, its associated accessories and ancillary equipment do not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness. device.