(65 days)
The flexible fiberscopes are used to examine body cavities and hollow organs via natural accesses or surgically created accesses.
For examination, diagnosis, and / or therapy in connection with endoscopic accessories and auxiliary instruments, in particular, for intracorporal flexible lithotripsy probes, e.g., via the working channel of the instrument.
The instruments are used in the medical disciplines of urology, surgery, gynecology, and ENT by adequately trained medical personnel. Applications to the heart, the heart, the circulatory systems are excluded.
Important! Product dimensions must correspond to the anatomic requirements, i.e., use the flexible fiberscope appropriate to the medical discipline.
The flexible fiberscopes consist of a flexible insertion part, a control part, a bent eyepiece for direct view or connection of a video camera and straight working channel, especially for the use with lithotripsy probes.
The tip of the sheath has an active 130° / 160° up/down. The image is transmitted via objective, fiber bendle and eyepiece for direct view or connection of a video camera. The straight working channel is used for procedures such as lithotripsy and biopsy removal while simultaneously providing irrigation. The bent eyepiece funnel can be moved to the right or left. Auxiliary instruments, such as gaping forceps, sone extractors, or HF button electrodes are inserted by a proximal mounted insertion cock with supply and discharge. A leakage test unit or a gas sterilization valve can be connected to an attachment of the fiberscope.
I am sorry, but based on the provided text, I cannot provide the requested information about acceptance criteria, device performance, or study details.
The document is a 510(k) premarket notification from the FDA regarding a "Flexible Fiberscope" by Richard Wolf Medical Instruments Corporation. This type of document primarily establishes substantial equivalence of a new device to a predicate device already on the market. It describes the device's intended use, technological characteristics, and claims of substantial equivalence, but it does not contain:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Details on adjudication methods, MRMC studies, or standalone algorithm performance.
- The type and method of establishing ground truth for either test or training sets.
The document explicitly states:
- "No known FDA performance standard exists." (Section 5.0 Performance Data)
- "No clinical tests performed." (Section 6.0 Clinical Tests)
Therefore, the requested information is not present within the provided text.
§ 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.