(30 days)
The EndoGastric Solutions, StomaphyX System with SerosaFuse Fastener is intended for transoral tissue approximation, ligation and full-thickness plication in the G.I. tract.
The EndoGastric Solutions StomaphyX Delivery System and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants delivered through a fastener cartridge. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device, The device uses vacuum to invaginate tissue through a port into a chamber and fastens it using Hshaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. The three elements run the length of the device, inside the outer shaft. The pusher is a hollow tube that rides over the length of the stylet provides a "pilot" hole for the fastener to pass through the tissue and both ride inside the lumen. The stylet is a wire three-faceted, sharpened tip at the distal end to pierce tissue. A fastener is loaded for deployment by depressing the lever on the removable, fastener cartridge located at the proximal end of the device. This action automatically snaps the fastener onto the stylet. When the pusher tube is pushed by the operator, the stylet carnes the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.
This 510(k) summary does not contain information on device acceptance criteria or a study proving the device meets those criteria. The provided text is a summary of a 510(k) submission for a medical device (StomaphyX Delivery Device and Fasteners) seeking substantial equivalence to predicate devices. It describes the device, its intended use, and compares it to existing predicate devices. It also includes the FDA's clearance letter.
Therefore, I cannot populate the table or answer the questions based on 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.