(130 days)
The CystoSure™ Urinary Access System provides catheterization and visualization for the female urinary bladder.
The CystoSure™ rigid metal scope is used to visualize the urinary bladder for diagnostic procedures. The CystoSure™ access catheter accessory provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of the CystoSure™ scope.
The Emmy Medical CystoSure Urinary Access System is intended for use in the diagnostic visualization of the female bladder. The CystoSure cystoscope is a reusable, rod lens optic that can be used with standard O.R. camera couplers and light guides. The length and field of view of the Emmy Medical cystoscope are optimized for inspection of the female bladder. The Emmy Medical cystoscope does not include the traditional outer sheath as those functions are provided by the access catheter accessory.
The CystoSure Access Catheter accessory provides a single use access catheter with four ports: One for bladder drainage, one for bladder irrigation, one for balloon inflation and one for the CystoSure cystoscope. The access catheter encompasses only one balloon size (5 cc) and length (female only) and it does not include any hydrophilic or antimicrobial coatings or features to make it radiopaque.
This document is a 510(k) Premarket Notification for the CystoSure™ Urinary Access System. It does not contain information about an AI-powered device or a study comparing AI with human readers. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as these are not relevant to the content provided.
The document focuses on demonstrating substantial equivalence of the CystoSure™ Urinary Access System to legally marketed predicate devices based on design, materials, construction, intended use, and technological characteristics, supported by nonclinical testing, biocompatibility, and sterilization validation.
§ 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.