IMAGYN FALLOPOSCOPY SYSTEM

K963580 · Imagyn Medical, Inc. · MKO · Jan 31, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K963580
• Device Name: IMAGYN FALLOPOSCOPY SYSTEM
• Applicant: Imagyn Medical, Inc.
• Product Code: MKO · Obstetrics/Gynecology
• Decision Date: Jan 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube.

Device Story

System comprises Linear Everting (LE) Fallopian Tube Access Catheter and Falloposcope; used for intratubal catheterization to evaluate fallopian tube occlusions. Device facilitates visual assessment of tubal lumen; operated by clinicians in clinical settings. Provides direct visualization to assist in diagnosing tubal pathology; aids clinical decision-making regarding fertility or tubal health.

Clinical Evidence

Clinical and non-clinical tests performed to demonstrate device performance according to description and intended use.

Technological Characteristics

System includes Linear Everting (LE) Fallopian Tube Access Catheter and Falloposcope. Fiber optic visualization technology. Mechanical catheterization mechanism.

Indications for Use

Indicated for patients requiring intratubal catheterization for the evaluation of fallopian tube occlusions.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

• Baxter Healthcare Corp. LE PTA Catheter
• Conceptus Fallopian Tube Catheterization System
• OvaMed GyneSys Dx Uterine Ostial Access Catheter
• OvaMed Saratoga Modular Miniature Endoscope System
• Optimed Technologies, Inc. Flexible Fiber Optic Hysteroscopes

Submission Summary (Full Text)

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FEB - 3 1997
Imagyn
k963580

# 510(k) Summary

## Submitted By:
Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677-3917
[phone]
Contact: Debra A. Rinderer

## Summary Preparation:
September 5, 1996

## Device:
Imagyn Falloposcopy System

## Predicate Devices:
- Baxter Healthcare Corp. LE PTA Catheter
- Conceptus Fallopian Tube Catheterization System
- OvaMed GyneSys Dx Uterine Ostial Access Catheter
- OvaMed Saratoga Modular Miniature Endoscope System
- Optimed Technologies, Inc. Flexible Fiber Optic Hysteroscopes

## Device Description:
The Imagyn Falloposcopy System consists of the following components:
- Linear Everting (LE) Fallopian Tube Access Catheter
- Falloposcope

## Intended Use of Device:
The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube.

## Technological Comparisons:
The device has equivalent technological characteristics to the predicate devices to achieve intratubal catheterization for evaluation of occlusions in the fallopian tube.

## Performance Summary:
Clinical and non-clinical tests were performed to demonstrate that the device performed according to its description and intended use.

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