(35 days)
The FG-36UX, Fiber Ultrasound Gastroscope, is intended to provide optical visualization of , ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small There monded out is not room to introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the appropriate itemble insertion tube, a control body, and Umbilicus . The umbilicus is bifurcated where one connector is connected to the Lightsource and contains connections for air/water and suction. The other umbilicus Comments is connected at the ultrasound scanner. The control body includes controls for up/ down/ left/ right angulation an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, allyon insulflation, an accessory inlet port, and the endoscopic image viewing occular. The device contains light oundon insurrition, and to illuminate the body cavity another to optically visualize the anatomy, and an ultrasound carrying out to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). A convex linear array transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the allay aunsation on for display. The instrument is immersable (with the use of supplied cleaning accessories) Onazound Deminer for Gisplay : The measur (as described in the Endoscope operator Manual cleaning instructions).
This looks like a 510(k) summary for a medical device, which typically describes the device, its intended use, and how it is substantially equivalent to a predicate device. It doesn't contain detailed information about a study proving the device meets specific acceptance criteria with performance metrics, sample sizes, and expert qualifications.
The document explicitly states: "The substantial equivalence was not based on an assessment of clinical performance data."
Therefore, I cannot provide the requested information because the document does not contain details about a study with acceptance criteria and device performance. The device's clearance was based on substantial equivalence to predicate devices, not on a new clinical performance study demonstrating direct fulfillment of specific performance metrics.
§ 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.