(90 days)
The KSEA 'Gelet' uretero-renoscopes are designed to view the ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Alken motion control device attaches to an instrument channel to precisely guide the introduction of a laser fiber, electrode or small instrument into the patient.
The KSEA 'Gelet' uretero-renoscopes are semi-rigid endoscopes with graduated shafts and a remote eveniece. The Alken motion control device is an attachment to the irrigation/instrument channel to control the introduction and movement of accessories. Both devices are manually operated, reusable surgical devices. The body contact materials are chromium plated Monel 400®.
The provided text is a 510(k) summary for a medical device (semi-rigid ureteroscope and accessory). It focuses on establishing substantial equivalence to a predicate device, rather than detailing performance studies and acceptance criteria for a novel AI/software solution. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document.
The document indicates that:
- Device Identification: Karl Storz 'Gelet' Uretero-Renoscopes and Karl Storz Alken motion control device.
- Indication: To view the ureter and perform diagnostic and therapeutic procedures using accessories. The Alken device guides the introduction of instruments.
- Device Description: Semi-rigid endoscopes and an attachment for instrument channel control. Manually operated, reusable surgical devices.
- Substantial Equivalence: Claimed due to "basic features, design and intended uses are the same or similar" to predicate devices. Minor dimensional differences are stated to raise no new issues of safety and effectiveness and have no effect on performance, function, or intended use.
This type of submission typically bypasses the need for extensive clinical performance studies that establish acceptance criteria against specific metrics, as it relies on the known safety and efficacy of the predicate device. Therefore, the information requested in your numbered points is not present 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.