(209 days)
The device is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
The Single-Use Digital Flexible Ureteroscope System consists of CoralView® Single-Use Digital Flexible Ureteroscope (consists of a handle with control lever, endoscope cable and accessories, and a flexible body portion) and ViewHub® Video Processor with its accessories power cable and connector cables. The Coralliew® is provided sterile (sterilized by EO) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the CoralView® Single Ureteroscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal; the endoscope cable connects the CoralView® to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handle connected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion; the instrument channel delivers water and other instruments. The ViewHub® Video Processor is a video imaging system that receives video signals from the light at the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.
This document is a 510(k) summary for the CoralView® Single-use Digital Flexible Ureteroscope. It does not describe an AI medical device or software. Therefore, there is no information in the provided text to generate acceptance criteria or a study that proves the device meets acceptance criteria related to AI performance.
The content focuses on the substantial equivalence of this ureteroscope to a predicate device, based on non-clinical tests such as biocompatibility, electrical safety, mechanical performance, photobiological safety, and optical performance.
Specifically, the document states:
- Non-Clinical and/or Clinical Tests Summary & Conclusions: "Nonclinical tests demonstrated that the CoralView® Single-use Digital Flexible Ureteroscope is as safe and effective as the predicate device."
- Optical Performance: "Comparative testing was performed for the subject device to support substantial equivalence, including: Field of view (FOV), Resolution, Depth of field (DOF), Signal-to-noise ratio (SNR), Dynamic range, Image intensity uniformity (IIU), Unit relative distortion, Color performance."
Since the request is about "acceptance criteria and the study that proves the device meets the acceptance criteria" specifically framed for an AI/software device, and this document pertains to a physical medical device (a ureteroscope), I cannot fulfill the request as stated with the provided input.
§ 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.