(26 days)
The Gyrus ACMI® Invisio® ICN (CystoNephroscope) System (which includes the ICN Endoscope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.
Like the predicate ACMI® Invisio® ICN CystoNephroscope System, the Gyrus ACMI® Invisio® ICN is a flexible endoscope that incorporates CMOS (complementary metal-oxide-semiconductor) sensor technology to generate an image of the interior of the bladder or kidney when inserted either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney.
The ICN incorporates the same basic video imaging technology located in the endoscope as the predicate device. There is a miniature CMOS sensor located in the endoscope tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.
Like the predicate device, the ICN uses the same Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
This Special 510(k) proposes video sensor performance modifications to the ACMI® Invisio® ICN. The indications for use, labeling, principles of operation, materials and overall dimensions of the proposed Gyrus ACMI® Invisio® ICN remain the same as in the predicate device.
The provided text describes a Special 510(k) Notification for the Gyrus ACMI® Invisio® ICN, which is a flexible endoscope. This notification specifically concerns "video sensor performance modifications" to the device.
However, the provided document does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in comprehensive device validation reports.
Instead, this document is a summary of safety and effectiveness for a 510(k) submission, confirming that the modified device is substantially equivalent to a predicate device. It explicitly states: "The proposed modification in design specifications, performance specifications, and software specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
Therefore, I cannot populate the requested table or answer the other questions as the information is not present in the provided text. The document focuses on regulatory equivalence rather than a detailed performance study with acceptance criteria.
§ 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.