(65 days)
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.
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.
This 510(k) summary for the Galileo Disposable Endoscopes does not contain the specific details about acceptance criteria, a study proving performance against those criteria, or the methodology for such a study.
The document focuses on establishing substantial equivalence to legally marketed predicate devices, which is the primary requirement for a 510(k) submission. It describes the device, its intended use, and compares its technological characteristics to existing devices.
Therefore, I cannot provide the requested information from this document. The sections you asked for, such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are typically found in detailed performance studies, which are not included in this 510(k) summary.
§ 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.