(160 days)
The intended use for Söhniks Endoscopy, Inc.'s Cystoscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of the urether, prostate, bladder, and other urologic problems. This device is used m a visualization device and can be used in conjunction with other instruments to perform various diagnostic and therapeutic procedures.
The Söhniks Cystoscopes are reusable manually operated surgical devices that are provided in non-sterile and must be cleaned and sterilized by the user prior to use. The parts that contact the body are composed of surgical grade stainless steel, which has a long history of biocompatibility for human use.
Based on the provided text, there is no acceptance criteria and no study that demonstrates the device meets acceptance criteria.
The document is a 510(k) summary for a "Cystoscope," which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. The core of a 510(k) submission is to argue substantial equivalence, not to prove performance against specific acceptance criteria through a clinical study.
Here's why the requested information cannot be extracted from this document:
- Type of Document: This is an FDA 510(k) summary and approval letter. It focuses on regulatory approval based on "substantial equivalence" to existing devices, not on detailed performance studies with acceptance criteria.
- Content: The document describes the device, its intended use, device description, and claims substantial equivalence to predicate devices (e.g., "The basic design, materials and intended uses are the same and the device is constructed with the same materials as a [predicate device name, e.g., K023783], there are no new issues of safety and effectiveness."). It doesn't present data from a clinical trial or performance study against specific, quantified acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions because the provided text does not contain the information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.
§ 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.