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
Indications for 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
(714) 362-2500
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: (714) 362-2500
Fax: (714) 362-2520
