(65 days)
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No
The document describes a standard endoscope and does not mention any AI or ML capabilities, image processing, or performance metrics typically associated with AI/ML devices.
No
The device is described as an endoscope for direct visualization of body cavities, hollow organs, and canals for diagnostic purposes, not for treating conditions.
Yes
The device is intended for direct visualization of body cavities, hollow organs, and canals, which is a diagnostic function, as it helps in identifying abnormalities or conditions.
No
The device description explicitly states "The Galileo Disposable Endoscopes are a line of endoscopes based on existing endoscope technology" and mentions various lengths, diameters, and configurations, indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Intended Use: The Galileo Disposable Endoscopes are intended for direct visualization of body cavities, hollow organs, and canals. This is a direct examination of the body, not an examination of specimens taken from the body.
- Indications for Use: The listed indications (choledoscopy, cystoscopy, ureteroscopy, thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications) all involve direct visualization within the body.
Therefore, the function and intended use of the Galileo Disposable Endoscopes fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Galileo Disposable Endoscopes are endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Disposable Endoscopes are designed to be introduced through natural body cavities or surgical incisions 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 Disposable Endoscopes indications for use include choledoscopy, cystoscopy, ureteroscopy, thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Galileo Disposable Endoscopes are a line of endoscopes based on existing endoscope technology. The Galileo Disposable Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user.
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
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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510(k) Summary Galileo Corporation Galileo Disposable Endoscopes
K981928
SPONSOR/APPLICANT NAME AND ADDRESS 1.
- Galileo Corporation Galileo Park P.O. Box 550 Sturbridge, MA 01566 Telephone (508) 347-9191
CONTACT PERSON
Debbie Iampietro Director of Quality Assurance
DATE OF SUMMARY PREPARATION
June 1, 1998
-
- DEVICE NAME
Proprietary Name: Galileo Disposable Endoscopes Common/Usual Name: Endoscope Endoscope and accessories Classification Name:
- DEVICE NAME
IDENTIFICATION OF PREDICATE OR LEGALLY MARKETED DEVICE(S) 3.
The Galileo Disposable 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 Model 2010 Rigid Fiber Optic Sinuscope, the Model 4200 Fiber Optic Laparoscope and Fiber Optic Choledoscope, and the Rigid Sinuscope all manufactured by Saratoga Medical, and the Hopkins Laparoscopes and Thoracoscope manufactured by Karl Storz Endoscopy.
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DEVICE DESCRIPTION 4.
The Galileo Disposable Endoscopes are a line of endoscopes based on existing endoscope technology. The Galileo Disposable Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user.
INTENDED USE 5.
The Galileo Disposable Endoscopes are endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Disposable Endoscopes are designed to be introduced through natural body cavities or surgical incisions 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 Disposable Endoscopes indications for use include choledoscopy, cystoscopy, ureteroscopy, thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications.
A STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE 6. COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) CITED
The Galileo Disposable Endoscopes and the substantially equivalent devices are identical in intended use in that they are all 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 Disposable Endoscopes 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 Disposable Endoscopes 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 AUG
Galileo Electro-Optics Corporation c/o Medical Device Consultants, Inc. Mary McNamara-Cullinane 49 Plain Street North Attleboro, Massachusetts 02760
K981928 Re: Trade Name: Galileo Disposable Endoscopes Regulatory Class: II Product Code: GCJ Dated: June 1, 1998 Received: June 2, 1998
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System -Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mary McNamara-Cullinane
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _K 98 19 28
Device Name: Galileo Disposable Endoscopes
Indications For Use:
The Galileo Disposable Endoscopes are endoscopes intended for visualization of body cavities, hollow organs, and canals. The Galileo Disposable Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.
The indications include choledoscopy, cystoscopy, bronchoscopy, bronchoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
led
torative Devices LG B 192 192
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Galileo Corporation 510(k) Galileo Disposable Endoscopes 6/1/98
CONFIDENTIAL
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