MICROSPAN HYSTEROSCOPE

K961688 · Imagyn Medical, Inc. · HIH · Oct 15, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K961688
• Device Name: MICROSPAN HYSTEROSCOPE
• Applicant: Imagyn Medical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Oct 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

The MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Story

MicroSpan Hysteroscope; small-diameter, rigid, fiberoptic endoscope; no through lumens. Components: stainless steel shaft, illumination fibers, imaging fiber bundle, distal lens, rotatable eyepiece. Operation: connects to external endoscopic light source via light cables; transmits light to distal end; distal lens focuses image onto fibers; proximal lens magnifies image for eyepiece viewing or camera coupling. Used in clinical settings by physicians for visualization of cervical canal and uterine cavity. Facilitates diagnostic and surgical procedures by providing direct visual access to uterine anatomy.

Clinical Evidence

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

Technological Characteristics

Rigid, fiberoptic hysteroscope. Materials: stainless steel shaft. Illumination: external light source (e.g., xenon) via fiber bundles. Imaging: distal/proximal lens systems with fiber bundle transmission. Connectivity: compatible with standard video cameras/monitors via optical coupler. Non-powered, non-electronic device.

Indications for Use

Indicated for patients requiring visualization of the cervical canal and uterine cavity for diagnostic and surgical procedures.

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
• Imagyn MicroLap Laparoscope
• Karl Storz Miniscope Straight Forward Telescope
• Optim ed Technologies Rigid Fiber Optic Hysteroscope

Submission Summary (Full Text)

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Imagyn

OCT 15 1996

# 510(k) Summary

K9616 88

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

Summary Preparation:
April 30, 1996

Device:
MicroSpan Hysteroscope

Predicate Devices:
Imagyn Hysteroscope
Imagyn MicroLap Laparoscope
Karl Storz Miniscope Straight Forward Telescope
Optim ed Technologies Rigid Fiber Optic Hysteroscope

Device Description:
The MicroSpan Hysteroscope is a small diameter, rigid, fiberoptic hysteroscope without through lumens. The device consists 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 hysteroscope 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 MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine 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 hysteroscope 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 hysteroscope for viewing and/or directly to standard video cameras, monitors and recording equipment. The MicroSpan Hysteroscope 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]