(184 days)
The EndoGastric Solutions StomaphyXTM system with SerosaFuse™ Fastener is intended for tissue approximation, ligation and full-thickness plication in the G.I. tract.
The EndoGastric Solutions StomaphyX™ Delivery Device and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. 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 fasten it using H shaped polypropylene fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries 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.
The provided text is a 510(k) summary for the EndoGastric Solutions StomaphyX Delivery Device, Fasteners and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study.
Therefore, the document does not contain the acceptance criteria or the details of a study that proves the device meets specific acceptance criteria in the manner requested.
The 510(k) summary states:
- "Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, the EndoGastric Solutions StomaphyX™ system with SerosaFusc ™ Fastener has been shown to be substantially equivalent to currently marketed predicate devices."
This indicates that the submission relies on demonstrating similarity to existing devices, rather than presenting a performance study with defined acceptance criteria for a new clinical performance claim.
Specifically, the document does not include information on:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance for such a study.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone (algorithm only) performance study.
- The type of ground truth used in a performance study (as no such study is detailed).
- Sample size for a training set (as no AI/algorithm training is implied).
- How ground truth for a training set was established.
The document's purpose is to establish substantial equivalence for market clearance, not to report on a clinical performance study with specific acceptance criteria that would typically be seen for a new or novel device's functional performance claims.
§ 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.