K961860 · Olympus America, Inc. · HET · Aug 29, 1996 · Obstetrics/Gynecology
Device Facts
Record ID
K961860
Device Name
A4907 LENS CLEANING SHEATH
Applicant
Olympus America, Inc.
Product Code
HET · Obstetrics/Gynecology
Decision Date
Aug 29, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.1720
Device Class
Class 2
Indications for Use
The A4907 Lens Cleaning Sheath has been specifically designed to be used with the Olympus A4908 Valve and LTF-V OES V Laparo-Thoraco Videoscope to clean of the objective lens surface.
Device Story
Lens cleaning sheath; attaches to Olympus LTF-V OES Laparo-Thoraco Videoscope; provides irrigation and suction capabilities; enables cleaning of objective lens surface during endoscopic procedures; used by clinicians in surgical/endoscopic settings; maintains clear visualization; improves procedural efficiency.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Accessory for endoscope; provides irrigation and suction channels for lens cleaning; compatible with Olympus A4908 Valve and LTF-V OES Laparo-Thoraco Videoscope.
Indications for Use
Indicated for cleaning the objective lens surface of the Olympus LTF-V OES Laparo-Thoraco Videoscope during endoscopic procedures.
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
Cook Lens Cleaner
Wiest Optic Shaft
DevMed Lap wash
Submission Summary (Full Text)
{0}
K961860
AUG 29 1996
510 (k) SUMMARY
# Olympus A4907 Lens Cleaning Sheath
| Device Name: | Olympus A4907 Lens Cleaning Sheath |
| --- | --- |
| Common/Usual Name: | Lens Cleaning Tube |
| Classification Name: | Endoscope and Accessories
21 CFR 876 1500, Class II |
| Predicate Devices: | Cook
Lens Cleaner (Unknown)
Wiest
Optic Shaft (Unknown)
DevMed
Lap wash (Unknown) |
| Submitted By:
(Contact Person) | Subhash Patel
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
(516) 844-5481 |
| Summary Preparation Date: | May 8, 1996 |
## Statement of Intended Use:
The A4907 Lens Cleaning Sheath has been specifically designed to be used with the Olympus A4908 Valve and LTF-V OES V Laparo-Thoraco Videoscope to clean of the objective lens surface.
## Device Description
The A4907 Lens Cleaning Sheath has been specifically designed for use with the Olympus A4908 Valve and LTF-V OES Laparo-Thoraco Videoscope. It will be included in the standard set of LTF-V Laparo-Thoraco Videoscope and will also be marketed separately.
When connected to the main body of LTF-V 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.
## General Safety
When compared with the predicate devices, Olympus A4907 Lens Cleaning Sheath does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness of the subject device.
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