(177 days)
The Galileo Hysteroscopes are rigid endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Galileo Laparoscopes are intended for direct visualization of the organs within the peritoneum for diagnostic and surgical procedures on the female genital organs. The Galileo Laparoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.
The Galileo Hysteroscopes and Laparoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Hysteroscopes and Laparoscopes will be available in various lengths, diameters and configurations for the convenience of the user. Two designs of endoscopes are available: Galileo Rod and Lens Design Endoscope and Galileo Fiber Optic Design Endoscope.
This 510(k) summary does not contain information related to acceptance criteria or a study proving device performance. The document describes the device, its intended use, and compares it to legally marketed predicate devices, focusing on technological equivalence rather than performance validation against specific criteria.
Therefore, I cannot provide the requested information.
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510(k) Summary Galileo Electro-Optics Corporation Galileo Hysteroscopes and Laparoscopes
K962256 P193
Sponsor/Applicant Name and Address 1.
Galileo Electro-Optics Corporation Galileo Park P.O. Box 550 Sturbridge, MA 01566 Telephone (508) 347-9191
Contact Person
Kin M. Wong, Director of Quality Assurance
Date of Summary Preparation
June 11, 1996
Device Name 2.
| Proprietary Name: | Galileo Hysteroscopes and Laparoscopes |
|---|---|
| Common/Usual Name: | Hysteroscopes and Laparoscopes |
| Classification Name: | Hysteroscopes and accessories |
| Laparoscopes and accessories |
Identification of Predicate or Legally Marketed Device(s) 3.
The Galileo Hysteroscopes and Laparoscopes are substantially equivalent to several legally marketed endoscopes including the Karl Storz Hysteroscopes and Laparoscopes, (K88270 and K935277) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378).
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4. Device Description
The Galileo Hysteroscopes and Laparoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Hysteroscopes and Laparoscopes will be available in various lengths, diameters and configurations for the convenience of the user. Two designs of endoscopes are available:
Galileo Rod and Lens Design Endoscope:
The rod and lens design Galileo Endoscope functions by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and an alternating set of rod and lenses to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor.
Galileo Fiber Optic Design Endoscope:
The fiber optic design Galileo Endoscope functions by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and a fiberoptic imaging bundle (instead of a rod and lens) to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor.
5. Intended Use
The Galileo Hysteroscopes are rigid endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Galileo Laparoscopes are intended for direct visualization of the organs within the peritoneum for diagnostic and surgical procedures on the female genital organs. The Galileo Laparoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.
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6. Comparison of Technological Characteristics
The Galileo Hysteroscopes and Laparoscopes and the substantially equivalent devices are identical in intended use in that they are all rigid endoscopes intended to be passed through a lumen of an introducer or into natural body cavities for visualization of body cavities, tissues, organs or canals.
The Galileo Hysteroscopes and Laparoscopes and the substantially equivalent devices are similar in designs in that they all offer various configurations including rod/lens or fiberoptic design, optional working channels, several OD's and lengths, and use external light sources, and similar stainless steel materials.
The Galileo Hysteroscopes and Laparoscopes and the substantially equivalent devices are similar in technological characteristics in that they offer a channel for either viewing body cavities, tissues, organs or canals and an optional channel for passing instruments into the desired anatomical sites.
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§ 884.1690 Hysteroscope and accessories.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.