(265 days)
The KARL STORZ Flexible Uretero-Reno-Fiberscope is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The optical component of the KARL STORZ flexible ureteroscope consists of:
• A light post connection with screw-on adapters for fiberoptic light cables.
• A fiber optic light conductor
• An optical image bundle behind an objective lens
• A flexible shaft housing
• A magnifying eyepiece with a focusing ring that rotates to adjust to the appropriate diopter correction for the user
• A reticle, or marker in the field of view, that indicates the 12 o'clock position as a point of reference
The insertable portion of the instrument is divided into a flexible shaft section and a deflection section. The features of the shaft include:
• A working channel that accepts flexible accessories at the proximal end and features a T-LUER Lock fitting for irrigation
• A deflection lever, for active distal tip deflection
• A proximal strain relief that connects the flexible shaft to the handpiece
The provided document is a 510(k) Summary for a medical device, the KARL STORZ Flexible Uretero-Reno-Fiberscope. It outlines the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence.
However, the document states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."
This means that a study proving the device meets acceptance criteria in terms of clinical performance (human-in-the-loop, standalone algorithm performance, or using human experts for ground truth) was not conducted or submitted for this 510(k) clearance.
Therefore, it is not possible to provide the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The document focuses on demonstrating substantial equivalence through:
- Biocompatibility testing (ISO 10993)
- Reprocessing validation (AAMI ST91:2021, ANSI/AAMI/ISO 14937:2009, FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling)
- Additional bench testing to meet design specifications, complying with IEC 60601-2-18:2009, IEC 62471:2006, and ISO 8600-5:2020.
These non-clinical tests were deemed sufficient for demonstrating the device's safety and effectiveness and its substantial equivalence to predicate devices for its intended use.
§ 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.