(130 days)
The BubbleView™ Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The BubbleView™ is intended to provide visualization via ViewHub® video processor and can be used with endoscopic accessories.
BubbleView™ is intended for use in a hospital environment or medical office environment. BubbleView™ is designed for use in adults.
ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.
The Single-Use Digital Flexible Cystoscope System consists of BubbleView™ Single-Use Digital Flexible Cystoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with itsaccessories including power cables. The BubbleView™ is provided sterile (sterilized by EQ) 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 BubbleView™ Single-Use Digital Flexible Cystoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal into an electrical signal: the endoscope cable connects the BubbleView™ to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handleconnected 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 connected endoscope, controls the lightat the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.
The provided text is a 510(k) summary for the BubbleView™ Single-Use Digital Flexible Cystoscope and ViewHub® Video Processor. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/ML-driven device. As such, it does not contain the detailed information requested regarding acceptance criteria, study methodologies for AI/ML performance, ground truth establishment, or multi-reader multi-case studies.
The document primarily describes:
- The device and its intended use.
- A comparison to a legally marketed predicate device (Pusen Single Use Flexible Video Cystoscope System K222602) to establish substantial equivalence based on indications for use and technological characteristics.
- Non-clinical performance tests for mechanical and optical characteristics. These tests are to support the safety and effectiveness of the hardware (the cystoscope and video processor) itself, not an AI component.
Therefore, I cannot extract the information requested about acceptance criteria and study data for an AI/ML device from this specific FDA submission document. The questions you posed are highly relevant for AI/ML medical devices, but this document appears to be for a traditional medical imaging device without an explicitly stated AI/ML component.
§ 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.