(87 days)
The Cysto-Urethroscopes 'E-Line' and Accessories are used to visualize and manipulate the bladder, urethra and ureter via natural passages.
The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage.
The obturator/vlewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed.
The inserts are used to guide and angle flexible auxiliary instruments.
The attachments (adapters) serve to connect endoscope and sheath.
The forceps/optical forceps and scissors are used for endoscopically controlled grasping, manipulating, cutting, dissecting and removal of tissue, bladder stones and foreign bodies via natural and surgically created passages.
Optical forceps with unipolar HF connections are used for coagulation by means of high frequency currents to treat minor hemorrhages.
The Cysto-Urethroscopes "E-Line" submission consists of Sheaths, Obturators, Inserts, Adapters and Optical Forceps.
The provided document is a 510(k) premarket notification summary for the Cysto-Urethroscope "E-Line" and Accessories device. It states that no clinical tests were performed (Section 6.0 of the 510(k) Summary of Safety and Effectiveness). Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, cannot be extracted from this document because no clinical performance data is presented. The submission relies on substantial equivalence to predicate devices and conformance with the Medical Device Directive 93/42/EEC, rather than on new clinical performance data.
§ 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.