(180 days)
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No
The summary describes a rigid endoscope for direct visualization and does not mention any AI/ML capabilities or image processing.
No
Explanation: The device is an endoscope used for direct visualization of body cavities, not for therapeutic purposes.
Yes
Explanation: The device is described as an endoscope intended for direct visualization of body cavities, hollow organs, and canals for indications such as thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy. Direct visualization is a diagnostic process used to assess the state of internal body structures.
No
The device description explicitly states that the Galileo Endoscopes are "rigid endoscopes" and "reusable rigid endoscopes," which are physical hardware devices. The description details different designs (Rod and Lens, Fiber Optic) and configurations (lengths, diameters), all indicative of hardware components. There is no mention of the device being solely software.
Based on the provided information, the Galileo Endoscopes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "direct visualization of body cavities, hollow organs, and canals." This is a direct examination of the body, not the analysis of samples taken from the body.
- Device Description: The description focuses on the physical design and function of the endoscope for visualization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would involve testing samples outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Galileo Endoscopes are used for direct observation within the body.
N/A
Intended Use / Indications for Use
The Galileo Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Endoscopes 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 Endoscopes indications for use include thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.
Product codes
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Device Description
The Galileo Endoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Endoscopes 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 evepiece. 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
body cavities, hollow organs, and canals.
Indicated Patient Age Range
Not Found
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)
Imagyn Laparoscope, Optimed Rigid Fiber Optic Endoscope, Fiber Optic Laparoscope, Model 2010 Rigid Fiber Optic Sinuscope, Model 4200 Fiber Optic Laparoscope, Fiber Optic Choledoscope, Rigid Simuscope, Hopkins Laparoscopes, Thoracoscope
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
510(k) Summary Galileo Electro-Optics Corporation Galileo Endoscopes
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
October 30, 1996
DEVICE NAME 2.
Proprietary Name: Common/Usual Name: Classification Name:
Galileo Endoscopes Endoscope Endoscope and accessories
IDENTIFICATION OF PREDICATE OR LEGALLY MARKETED DEVICE(S) 3.
The Galileo Endoscopes are substantially equivalent to several legally marketed endoscopes including the Imagyn Laparoscope manufactured by Imagyn Medical, the Optimed Rigid Fiber Optic Endoscope manufactured by Optimed Technologies, Inc., the Fiber Optic Laparoscope manufactured by Medical Dynamics and the Model 2010 Rigid Fiber Optic Sinuscope, the Model 4200 Fiber Optic Laparoscope and Fiber Optic Choledoscope, and the Rigid Simuscope all manufactured by Saratoga Medical, and the Hopkins Laparoscopes and Thoracoscope manufactured by Karl Storz Endoscopy.
1
4. DEVICE DESCRIPTION
The Galileo Endoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Endoscopes 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 evepiece. 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 Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Endoscopes 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 Endoscopes indications for use include thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.
2
STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE 6. COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) CITED
The Galileo Endoscopes 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 Endoscopes and the substantially equivalent devices are similar in designs in that they all offer various configurations including rod/lens or fiberoptic design, several OD's and lengths, and use external light sources, and similar stainless steel materials.
The Galileo Endoscopes and the substantially equivalent devices are similar in technological characteristics in that they offer a channel for viewing body cavities, tissues, organs or canals.
10/30/96
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