(133 days)
The Stryker Ureteroscope is indicated for use during minimally invasive urological surgical procedures accessed through natural body orifices, and is intended for, but not limited to, transurethral examination of the urinary tractures and, utilizing additional accessories, to perform various diagnostic and therapeutic procedures.
The Stryker Ureteroscope is a new product developed by Stryker. The Stryker Ureteroscope is a new product and polymers.
The provided text is a 510(k) summary for the Stryker Ureteroscope and the associated FDA clearance letter. It does not describe any acceptance criteria or a study proving that the device meets those criteria.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting performance data against defined acceptance criteria.
Therefore, I cannot provide the requested information from the given input. The document explicitly states:
- "There are no significant technological or performance differences between the Stryker Ureteroscope and the identified predicate device, nor are there any new questions raised Ureteroscope and the luentified produce the Stryker Ureteroscope is substantially equivalent to the identified predicate device."
This indicates that the submission relies on the predicate device's established safety and effectiveness, rather than new performance studies of the Stryker Ureteroscope against specific criteria.
§ 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.