(71 days)
The Ureterorenoscope System consists of a sterile single-use Flexible Ureteroscope to be introduced within the urinary tract and video processor for clinical image processing. The device is indicated for endoscopic examination in the urinary track and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
The Ureterorenoscope System consists of a sterile single-use Flexible Ureteroscope to be introduced within the urinary tract and a non-sterile repeat use Video Processor for clinical image processing.
The provided document is a 510(k) Summary for the AnQing Medical Instrument Co., Ltd. Ureterorenoscope System (K201293). This document declares no clinical performance data was required or conducted to demonstrate substantial equivalence to the predicate device. Therefore, it does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt regarding acceptance criteria and a study proving the device meets those criteria with specific performance metrics, sample sizes, expert qualifications, or ground truth details.
The document focuses on non-clinical performance data and a comparison to a predicate device (Shanghai AnQing Medical Ureterorenoscope System K180367) to establish substantial equivalence.
Here's a breakdown of the relevant sections from the document that explain why no clinical study or specific performance criteria are described:
- Non-Clinical Performance Data: "The subject and predicate devices have the same fundamental technology, insertion section length, field and direction of view, light source, image display, number of uses and sterilization. The subject ureteroscope differs from the predicate in patient-contacting materials, and size of the primary package. These differences do not raise different questions of safety and effectiveness as compared to the predicate."
- Non-Clinical Performance Data (cont.): "As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the endoscope material changes and package size change. Verification testing were conducted to evaluate the modifications. The following tests associated with the device modifications were performed on the subject device according to methods and acceptance criteria outlined in the predicate device (K180367). The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence of the subject device."
- Clinical Performance Data: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
- Conclusion: "The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Ureterorenoscope System is substantially equivalent to the predicate devices."
Therefore, I cannot provide the requested table or study details because the submission states that no clinical studies were performed for this 510(k) clearance. The device's substantial equivalence was based on non-clinical bench testing and comparison to a predicate device, focusing on material and packaging changes.
§ 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.