(177 days)
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No
The document describes standard rigid endoscopes for direct visualization and does not mention any AI/ML capabilities or image processing beyond basic visualization.
No
The devices are endoscopes intended for direct visualization for diagnostic and surgical procedures, which are not primarily therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "direct visualization of cervical canal and uterine cavity for diagnostic and surgical procedures" and "direct visualization of the organs within the peritoneum for diagnostic and surgical procedures".
No
The device description clearly states that the Galileo Hysteroscopes and Laparoscopes are "reusable rigid endoscopes" and describes physical components like "various lengths, diameters and configurations" and "Rod and Lens Design Endoscope and Galileo Fiber Optic Design Endoscope." This indicates a hardware device, not software only.
Based on the provided information, the Galileo Hysteroscopes and Laparoscopes are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states that these devices are for direct visualization of internal body structures (cervical canal, uterine cavity, organs within the peritoneum, female genital organs) for diagnostic and surgical procedures. This involves looking inside the body.
- Device Description: The description confirms they are rigid endoscopes, which are instruments used to view inside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided text does not mention any analysis of specimens or any testing performed on samples taken from the body.
Therefore, the Galileo Hysteroscopes and Laparoscopes are medical devices used for visualization within the body, not for in vitro diagnostic testing.
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Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical canal and uterine cavity, organs within the peritoneum
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
K88270, K935277, K880314, K770378
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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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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K962256 P2 93
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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