(111 days)
The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope, CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system 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
The ECN Video Cystonephroscope is a flexible endoscope that incorporates video sensor technology to capture the endoscopic image, replacing the fiber optic image bundle typically used in most endoscopes. The ECN Video Cystonephroscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney
This 510(k) premarket notification for the ACMI ECN Video Cystonephroscope does not contain the detailed information required to answer the questions about acceptance criteria and a study that proves the device meets those criteria.
The document is a submission to the FDA for substantial equivalence to legally marketed predicate devices, not a report on a clinical or performance study with defined acceptance criteria. It primarily focuses on comparing the new device's technological characteristics and intended use to existing devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Here's why the information is missing:
- 510(k) Premarket Notification: This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, primarily through comparison of technological characteristics and intended use. It often does not require new clinical trials or performance studies with specific statistical endpoints like those requested in your prompt, unless there are significant differences from the predicate that raise new questions of safety or effectiveness.
- Focus on Substantial Equivalence: The document explicitly states its purpose is to show "Technological Characteristics and Substantial Equivalence." It lists predicate devices and highlights how the ECN Flexible Video Cystonephroscope utilizes existing flexible endoscope technology, video sensor technology (CMOS), and video processing technology found in those predicates.
- Lack of Performance Data: The provided text does not include any performance metrics, success criteria, or results from a study designed to quantify the device's accuracy, sensitivity, specificity, or inter-reader agreement.
In summary, the provided document is a regulatory filing for market clearance based on substantial equivalence, not 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.