(28 days)
The EndoGastric Solutions EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single-use, sterile system consisting of an all-mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile by ethylene oxide (EO). The delivery device is limited contact and materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon.
The permanent contact, implantable SerosaFuse tissue fasteners are constructed of injection molded polypropylene and are of a strength equivalent to 3-0 suture. The SerosaFuse Implantable Fastener Cartridge is dual-lever containing 20 fasteners in each lever, and is designed to be removable. Each fastener consists of a leading leg, interconnecting web and trailing leg. The fastener's unique design allows it to be loaded onto a stylet, passed into and down a small delivery lumen of the device and subsequently delivered through apposed tissue surfaces in the GI tract. When deployed in tissue, the fastener serves as a suture-like implantable.
The system is used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The EsophyX Z+ device deploys the SerosaFuse fastener during an endoscopic procedure. A separate commercial endoscope operating independently down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. The EsophyX Z+ device is capable of transoral tissue approximation, ligation, and full thickness plication in the GI tract. The process essentially mimics the standard surgical technique of grasping tissue and apposing/approximating the tissue, piercing, and suturing the tissue fold. Each of these steps is controlled at the device proximal end, though plication, ligation and gastroesophageal valve formation is accomplished at the distal end of the device.
The provided text describes a 510(k) premarket notification for the EsophyX Z+ Device with SerosaFuse Fasteners and Accessories. The submission claims substantial equivalence to a predicate device, the EsophyX Z Device (K172811).
Crucially, this document does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria, particularly in the context of an AI/ML powered device. The document explicitly states: "This 510(k) submission primarily proposes changes to the instructions for use and other device labeling."
The "Performance Data" section only mentions "Non-clinical testing" including "Labeling verification" and "Benchtop performance testing," which are not clinical studies for efficacy. It concludes that "In all instances, the EsophyX Z+ device functioned as intended and demonstrated passing results." This refers to engineering and functional performance, not clinical outcome or comparative effectiveness against a defined set of clinical acceptance criteria.
Therefore, since the provided text does not contain the information required to answer the prompt (as it is not for an AI/ML device and does not detail a clinical study with acceptance criteria for device performance as a diagnostic or therapeutic tool), I must state that the information is not present in the given document.
The prompt asks for details typically found in submissions for AI/ML devices or devices requiring clinical performance data against specific endpoints (e.g., sensitivity, specificity, clinical outcome measures). This 510(k) submission focuses on a mechanical device demonstrating substantial equivalence through non-clinical testing of its functional similarities and minor labeling changes compared to a cleared predicate.
§ 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.