(61 days)
The Karl Storz Video Lower G.I. Endoscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the lower digestive tract including the anus, rectum, colon and ileocecal valve. The Karl Storz Video Lower G.I. Endoscope System is intended to provide optical visualization via a video monitor and therapeutic access to the lower digestive tract.
The Karl Storz Video Lower G.I. Endoscope System includes flexible endoscopes with distal-CCD chip technology which connects to the Karl Storz Camera Control Processor treatment of the lower digestive tract. The flexible video endoscopes contain an image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Lower G.I. Endoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.
This appears to be a 510(k) summary for a medical device submitted to the FDA, specifically for the Karl Storz Video Lower G.I. Endoscope System.
Based on the provided text, there is no information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies.
The document primarily focuses on:
- Applicant and contact information.
- Device identification (common name, trade name, indication for use).
- Device description (flexible endoscopes with distal-CCD chip technology, image module, air/water insufflation, jet nozzle, suction, illumination light, and biopsy channels).
- Regulatory classification (Class II, 21CFR876.1500).
- FDA's substantial equivalence determination letter.
Therefore, I cannot provide the requested information as it is not present in the given text.
Medical devices like endoscopes typically have performance criteria related to optics (resolution, field of view, illumination), mechanical properties (insertion tube flexibility, angulation, working channel dimensions), and electrical safety. However, these specific details or any studies validating them are not described in this 510(k) summary. The FDA's substantial equivalence determination is based on the device being similar enough to a previously cleared predicate device, implying its safety and effectiveness are comparable without necessarily requiring new clinical performance studies for every aspect.
§ 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.