(24 days)
The ACMI® INVISIO ICN (ICN) Digital Flexible CystoNephroscope System (which includes the ICN scope 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® Electronic Video CystoNephroscope (ECN) System, the ACMI® INVISIO ICN (ICN) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. The ICN can be introduced 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 distal 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 modifications in the proximal handle design, a reduction in flexible shaft outer diameter, elimination of the secondary active deflection mechanism, and a minor software algorithm modification for the ACMI® INVISIO ICN. The indications for use, principles of operation, working channel length and diameter of the ACMI® INVISIO ICN remain the same as in the predicate device.
The provided document is a 510(k) Summary of Safety and Effectiveness for a medical device (ACMI® INVISIO ICN). It states that the device is substantially equivalent to a predicate device and outlines its intended use and modifications. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
This type of submission (Special 510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might. The "summary of safety and effectiveness" here is an assertion that the modifications do not significantly affect safety or efficacy, based on the principle of substantial equivalence to the predicate.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used, ground truth establishment, or details about MRMC or standalone studies because this information is not present in the provided text.
The document states: "The proposed modifications for the ACMI® INVISIO ICN, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, dimensional specifications, and software specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This suggests that the primary "proof" relies on the established safety and effectiveness of the predicate device and the minor nature of the changes to the new device.
§ 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.