MICROSPAN HYSTEROSCOPE SHEATH

K961506 · Imagyn Medical, Inc. · HIH · Jul 3, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961506
• Device Name: MICROSPAN HYSTEROSCOPE SHEATH
• Applicant: Imagyn Medical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

The MicroSpan Hysteroscope Sheath is indicated for use in providing access to the uterine cavity for the Imagyn Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.

Device Story

MicroSpan Hysteroscope Sheath provides access to uterine cavity for hysteroscopes/instruments; features irrigation/insufflation and aspiration ports plus instrument channel. Used in clinical settings by physicians during diagnostic/operative hysteroscopy. Maintains uterine distention during insertion. Single-use, sterile device.

Clinical Evidence

Bench testing only. Leak and flow testing performed to demonstrate adequate performance for intended use.

Technological Characteristics

Constructed of metal and plastic components. Features irrigation/insufflation and aspiration ports and an instrument channel. Sterile, single-use device.

Indications for Use

Indicated for patients undergoing diagnostic and operative hysteroscopic procedures requiring access to the uterine cavity.

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

• Imagyn Hysteroscope Sheaths
• Olympus Hysteroscope 4/5 mm System
• Circon ACMI Office Operative Hysteroscope Sheath
• Karl Storz Mini-Hysteroscopy Operating Sheath

Submission Summary (Full Text)

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Imagyn

# 510(k) Summary

K961506

JUL - 3 1996

## Submitted By:

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

## Summary Preparation:

February 29, 1996

## Device:

MicroSpan Hysteroscope Sheath

## Predicate Devices:

Imagyn Hysteroscope Sheaths
Olympus Hysteroscope 4/5 mm System
Circon ACMI Office Operative Hysteroscope Sheath
Karl Storz Mini-Hysteroscopy Operating Sheath

## Device Description:

The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is provided sterile, for single-use, and is made from both metal and plastic components.

## Intended Use of Device:

The MicroSpan Hysteroscope Sheath is indicated for use in providing access to the uterine cavity for the Imagyn Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.

## Technological Comparisons:

The device has equivalent technological characteristics to the predicate devices, as well as to numerous other legally marketed devices, to achieve hysteroscope and/or hysteroscopic instrument insertion without loss of uterine distention.

## Performance Summary:

Non-clinical tests were performed to demonstrate that the device performed according to its description and intended use. Leak and flow testing performed showed adequate performance for the intended use.

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