(153 days)
The Stryker Video Ureteroscope is designed to be used with a Stryker video system, monitor and other accessories for endoscopic diagnosis and treatment within the urethra, bladder, ureter, and kidney.
The Stryker Video Ureteroscope is a flexible ureteroscope with a video sensor mounted on the distal tip, which provides the user visualization of the anatomy of the kidney and other urological structures. The bending section is controlled by the user with an articulation lever, to provide control of the position of the sensor. An integrated working channel provides the user the ability to introduce diagnostic or therapeutic instruments into the operative site. A light emitting diode is mounted internally in the handle and is connected to the light fibers that are integrated into the scope, which emit light from the distal tip of the scope, providing.illumination of anatomy. The Video Ureteroscope is powered and controlled by a console, which also provides video output to displays, capture devices, and other accessories.
This 510(k) summary describes the Stryker Video Ureteroscope and its equivalence to a predicate device. There is no information in the provided text regarding acceptance criteria for an AI/CADe (Computer-Assisted Detection/Diagnosis) device, nor any study proving the device meets such criteria. The document describes a traditional medical device (a video ureteroscope) and its performance testing as per design specifications and applicable standards, not AI-based performance metrics.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/CADe device meets them. The provided text discusses general device performance and regulatory compliance for a physical medical instrument.
§ 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.