(46 days)
The TUNIS™ probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection procedures. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary tract.
TUNIS™ - Transurethral Injection System Probe/Device
This document is a 510(k) clearance letter from the FDA for a medical device called the "Tunis™ Transurethral Injection/Aspiration System Probe Device." It signifies that the device has been found substantially equivalent to a predicate device and can be marketed.
Crucially, this document does not contain information about acceptance criteria, device performance details, or any study results proving the device meets acceptance criteria.
The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, ensuring similar safety and effectiveness. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a pre-market approval (PMA) would for novel, high-risk devices.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the original 510(k) submission document (K983765) itself, which might contain summaries of performance testing, albeit less rigorous than what's typically expected for a PMA.
§ 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.