(67 days)
This device is used to inject legally marketed injectable therapeutic agents into the lower urinary tract through the working channel of a cystoscope.
This device is a flexible, sheath covered injection needle The device consists of a device handle, flexible outer sheath, and needle assembly. The device has an outer diameter of 6Fr, a working length of 70 cm and a 23 ga needle for injection of legally marketed therapeutic agents into the lower urinary tract through the working channel of a cystoscope.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the "Injekt™ Cysto Flexible Injection Needle," primarily focused on establishing substantial equivalence to a legally marketed predicate device (Cook Injection Needles, K022484) and outlining the device's indications for use.
Therefore, I cannot populate the requested table or answer the specific questions about a study, sample sizes, ground truth, or expert involvement. The document explicitly states:
"Performance standards under Section 514 of the Federal ~Food, Drug and Cosmetic Act applicable to Injekt™ Cysto Flexible Injection Needle have not been established by the Food and Drug Administration."
This indicates that formal performance standards or acceptance criteria, as typically defined by the FDA for certain device types, were not established for this device at the time of this 510(k) submission. The substantial equivalence argument relies on comparison of characteristics and addressing risks through their Design Control Process.
§ 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.