(48 days)
This instrument is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The KSEA MVM 7.5 French Ureteroscope is comprised of a video module, and a endoscope module. The endoscope module is a flexible, fiber optic endoscope. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 7.5 French Ureteroscope are composed of medical grade polyurethane, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided text is a 510(k) summary for the Karl Storz Endoscopy - America, Inc. MVM 7.5 French Ureteroscope. This document does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML medical device.
The content focuses on demonstrating substantial equivalence to predicate devices. This regulatory pathway means the manufacturer is asserting the new device is as safe and effective as a legally marketed device, and therefore does not require new widespread clinical trials or detailed performance studies with strict acceptance criteria as might be seen for novel devices or AI-powered diagnostics.
Here's why the requested information cannot be extracted from the provided text:
- No specific performance metrics are mentioned for the device itself. The device is a video endoscope, and the performance is implicitly handled by showing it's similar to previously approved models.
- The document does not describe a "study" in the traditional sense of a clinical trial or performance evaluation with a test set, ground truth, or expert readers. It's a regulatory submission demonstrating equivalence based on design, materials, and intended use.
- There is no AI/ML component. The device is a physical endoscope.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies because these details are not present in the provided 510(k) summary for this type of medical 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.