(68 days)
The KSEA ureter resectoscope is designed to be used for diagnostic and therapeutic procedures in the transurethral resection of tissue in the ureters and renal pelvis.
The KSEA ureter resectoscope is a manually operated, reusable surgical device consisting of a straight forward view telescope (0), a working element, a sheath, cutting loops, electrodes, a cold knife and high frequency cables. The instrument is long enough to gain access to the surgical area and is designed to be used as an urological endoscope. The body contact materials are surgical grade stainless steel.
The provided document is a 510(k) summary for a medical device called the "Karl Storz Ureter Resectoscope." This document is not a study that describes acceptance criteria and device performance in the context of an AI or diagnostic algorithm, but rather a regulatory submission for a traditional surgical instrument.
Therefore, the requested information elements related to acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not present in this document.
The document mainly focuses on:
- Device Identification: Common Name, Trade Name
- Indication: Diagnostic and therapeutic procedures in transurethral resection of tissue in ureters and renal pelvis.
- Device Description: Manually operated, reusable surgical device consisting of various components (telescope, working element, sheath, etc.), made of surgical grade stainless steel.
- Substantial Equivalence: Stating that it is substantially equivalent to predicate devices with similar basic features, design, and intended uses, and that minor dimensional differences do not raise new safety/effectiveness issues.
To answer your request, I would need a different type of document – specifically, a study report or clinical validation report that details the performance of an AI or diagnostic algorithm.
§ 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.