IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES

K965055 · Imagyn Medical, Inc. · HET · Mar 6, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K965055
• Device Name: IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
• Applicant: Imagyn Medical, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Indications for Use

The MicroLap™ and MicroLap Gold Laparoscopes are used to permit viewing of the abdominal cavity for the purpose of performing diagnostic and surgical procedures.

Device Story

Small diameter, rigid, fiberoptic laparoscopes; no through lumens. Stainless steel shaft; inner illumination fibers; imaging fiber bundle; distal lens; rotatable eyepiece. Connects to external endoscopic light source via light cables; optional connection to camera head via focusing optical coupler for video display/recording. Used in clinical settings by physicians for abdominal cavity visualization; facilitates diagnostic and surgical procedures; provides direct optical or video-assisted visualization.

Clinical Evidence

Bench testing only. Evaluated optical and mechanical characteristics, effects of simulated reuse, thermal characteristics, and biocompatibility.

Technological Characteristics

Rigid, fiberoptic laparoscope; stainless steel shaft; fiber bundle imaging; fiber illumination. External light source (e.g., xenon) required. No through lumens. Optical transmission via distal/proximal lens systems.

Indications for Use

Indicated for patients requiring visualization of the abdominal cavity during diagnostic and surgical 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

• Imagyn MicroLap Laparoscope
• Medical Dynamics Optical Catheter
• Optimized Technologies Model F18-200 Laparoscope
• Origin Medsystems, Inc. Small Diameter Endoscope
• Galileo Endoscope

Submission Summary (Full Text)

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Imagyn

# 510(k) Summary

K965055

MAR - 6 1997

Submitter:
Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92656-3917
[phone]
Contact: Debra A. Rinderer

Summary Preparation:
December 17, 1996

Device:
MicroLap™ and MicroLap Gold Laparoscopes

Predicate Devices:
Imagyn MicroLap Laparoscope
Medical Dynamics Optical Catheter
Optimized Technologies Model F18-200 Laparoscope
Origin Medsystems, Inc. Small Diameter Endoscope
Galileo Endoscope

Device Description:
The MicroLap™ and MicroLap Gold Laparoscopes are small diameter, rigid, fiberoptic laparoscopes without through lumens. The devices consist of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the laparoscopes through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera.

Intended Use of Device:
The MicroLap™ and MicroLap Gold Laparoscopes are used to permit viewing of the abdominal cavity for the purpose of performing diagnostic and surgical procedures.

Technological Comparisons:
Light from a high intensity light source (e.g. xenon) is transmitted through illumination fibers to the distal end of the laparoscope in order to illuminate the target object. The distal lens system focuses the image of the object onto image fibers, which then transmits the image to the proximal lens system. The proximal lens system magnifies and focuses the image onto an eyepiece at the proximal end of the laparoscope for viewing and/or directly to standard video cameras, monitors and recording equipment. The MicroLap™ and MicroLap Gold Laparoscopes and the predicate devices all have equivalent technological characteristics.

Performance Summary
Non-clinical tests were performed to demonstrate that the device performed according to its description. Testing included evaluation of optical and mechanical characteristics of the device and the effect of simulated reuses on these characteristics. The device was also evaluated for its thermal characteristics and biocompatibility.

Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677
Tel: [phone]
Fax: [phone]