(84 days)
The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories are intended used for by a physican in thevisual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories includes a flexible endoscope and accessory items designed for treatment of urological endoscopic procedures. The Karl Storz Pediatric Flexible Cysto-Urethnel Fiberscope is a Class II device under 21CFR876.1500, Endoscope and accessories.
This looks like a 510(k) premarket notification for a medical device (Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories). However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on:
- Identification of the applicant and device.
- Device description and intended use.
- Claim of substantial equivalence to a predicate device.
- FDA's letter of clearance for marketing the device.
For medical devices that clear via substantial equivalence to a predicate, extensive primary studies demonstrating performance and adherence to acceptance criteria are often not required to be submitted in the 510(k) itself, particularly for devices with well-established technologies and similar specifications to existing devices. The FDA clearance letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the device's safety and effectiveness are inferred from its similarity to an already approved device, rather than requiring new, detailed performance studies to meet specific acceptance criteria.
Therefore, I cannot provide the requested information. The document as provided does not contain the data to fill out your table or answer your specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies.
§ 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.