(26 days)
The EndoGastric Solutions EsophyX Z Device with SerosaFuse is indicated for use in transoral tissue approximation, full thickness plication and ligation 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 gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single use 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 (EO). 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. Two polypropylene fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed simultaneously from the proximal device end, to the distal end down two separate channels via lumens in a flexible shaft where they are then in position for deployment into the tissue. The operator, controlling the distal end of the device through the mechanical controls captures and positions a fold of tissue at the gastroesophageal junction. The delivery trigger mechanism deploys both fasteners simultaneously at the captured tissue position, creating a permanent surgical fundoplication. Additional fasteners are used as needed to complete the valve restoration.
This document is a 510(k) Premarket Notification for the EsophyX® Z Device with SerosaFuse Fasteners and Accessories. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study design with specific numbers (sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria with quantitative performance metrics for the device. Instead, it relies on demonstrating that the modified device "met the design specifications and user needs" and performed "as well as the predicate device."
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Design Specifications | Met design specifications. |
| User Needs | Met user needs. |
| Mechanical Performance | Verified and validated. |
| Dimensional Performance | Verified and validated. |
| Biocompatibility | Meets all relevant requirements. |
| Safety and Effectiveness | As safe and effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "cadaver and animal labs" for "design validation" and "fastener deployment in various tissue types," but it does not provide specific sample sizes for these tests. The data provenance is experimental (cadaver and animal labs), not derived from human patient data in a test set. It does not mention country of origin or whether it was retrospective or prospective in detail, but given the nature of cadaver and animal labs, it would be prospective in an experimental setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to "design specifications and user needs" and "biocompatibility testing," which are typically evaluated against established technical standards and test protocols, not directly against ground truth established by medical experts in a clinical study context for performance metrics.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-read test set requiring adjudication in the context of device performance metrics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not mentioned or performed as the purpose of this submission is to demonstrate substantial equivalence of a medical device (EsophyX® Z Device with SerosaFuse Fasteners and Accessories) to a predicate device (EsophyX Z System), not to assess human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a medical instrument (Endoscopic Clip Applier, Implantable Fastener and Accessories) and not an algorithm or AI software. Therefore, an "algorithm only" performance study was not conducted.
7. Type of Ground Truth Used
For the mechanical, dimensional, and performance specifications, the ground truth would be based on engineering standards, design specifications, and successful operation within experimental settings (cadaver and animal tissue). For biocompatibility, the ground truth is established by validated laboratory tests (cytotoxicity, sensitization, and irritation or intracutaneous reactivity) against regulatory standards. There is no mention of pathology or outcomes data as a ground truth for the verification and validation reported.
8. Sample Size for the Training Set
This is not applicable as the device is a medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned for this device.
§ 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.