(220 days)
The Karl Storz Video Gastroscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the upper digestive tract including the esophagus, stomach, and duodenum. The Video Gastroscope System is intended to provide optical visualization via a video monitor and therapeutic access to the upper digestive tract.
The Karl Storz Video Gastroscope System is a flexible endoscope with a distal-CCD chip technology which connects to the Karl Storz Camera Control Processor (CCU) to provide clear images on the video monitor during the examination and treatment of the upper digestive tract. The flexible video gastroscope contains image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Gastroscope is a Class II device under 21CFR876.1500, Endoscope and accessories.
This 510(k) summary does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The provided document is a 510(k) summary for the Karl Storz Video Gastroscope System, which is a flexible endoscope used for visual examination and treatment of the upper digestive tract. The summary focuses on establishing substantial equivalence to predicate devices.
Here's why the requested information is absent:
- No specific performance study is detailed. The document asserts that "The Karl Storz Video Gastroscope System is substantially equivalent to predicate devices since the basic technology and design are similar. The intended usage is similar to predicate devices and raise no new issues of safety and effectiveness. The minor differences between the Karl Storz Video Gastroscope System and predicate devices have no effect on the performance, function or intended use of the devices." This indicates that the device's performance was not explicitly tested against novel acceptance criteria in a standalone study described here. Instead, it relies on the established safety and effectiveness of its predicate devices.
- No acceptance criteria are stated. Since no specific performance study is presented, there are no acceptance criteria for device performance to be found.
- No reported device performance metrics are provided.
- No information on sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is included. These are typically found in detailed study reports, which are not part of this 510(k) summary intended for establishing substantial equivalence.
In essence, the 510(k) process for this device, as described, did not require a new, extensive clinical or performance study with defined acceptance criteria because it demonstrated substantial equivalence to existing, legally marketed devices.
§ 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.