(31 days)
The EndoGastric Solutions EsophyX, HD Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the Gl 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. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less,
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 gastroesophageal iunction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic qastroesophaqeal 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 EndoGastric Solutions EsophyX Device models (EsophyX2 HD and EsophyX Z, K171307) with SerosaFuse Fasteners and Accessories are a prescription use only, disposable, single use systems consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The devices are used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure.
The 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 tissue fasteners are constructed of injection molded polypropylene.
These transoral devices and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the devices' flexible shaft lumen provides visualization of the procedure at all times, from device insertion through extraction. Two fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed 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 ready for deployment into tissue. The operator, controlling the distal end of the devices through the mechanical controls at the proximal end of the devices, captures and positions a fold of tissue at the gastroesophageal junction. The fastener controls deploy both fasteners simultaneously in the EsophyX Z model, or individually in the EsophyX2 HD model, at the captured tissue position. This creates a permanent surgical partial fundoplication. Additional fasteners are used as needed to complete the valve restoration.
This document is a 510(k) summary for the EsophyX®2 HD and EsophyX Z Fastener Delivery Devices, indicating substantial equivalence to previously cleared predicate devices. It focuses on a specification change rather than a new device with independent performance studies. Therefore, much of the requested information regarding new studies and performance data for acceptance criteria is not applicable in the context of this 510(k) submission.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria for a new device study because this submission is for a specification change to an already cleared device. The "performance" reported primarily indicates that the device's performance remains the same as the predicate device despite the specification change.
- Acceptance Criteria (Implied for this submission): The device, with the modified specification for clamping pressure, must maintain the same safety and effectiveness profile as the previously cleared predicate devices.
- Reported Device Performance: "As both submission devices are identical to the predicates devices, the performance characteristics remain the same as those cleared previously in submission K171307." The engineering specification change for clamping pressure "does not change either device's operation, safety or effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is for a specification change to an existing device. It explicitly states: "the EsophyX Z device/EsophyX2 HD devices (K171307) were used as the predicate without additional in vivo data needed for substantial equivalence as there are no changes made to the devices for this specification change proposal." Therefore, no new test set or data provenance details are provided for this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As no new in vivo or clinical study was conducted for this specific submission, there is no mention of experts establishing ground truth for a new test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new clinical data or test set requiring adjudication was generated for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a mechanical surgical tool, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human "readers" or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical surgical tool, not an algorithm. Its operation inherently involves a human-in-the-loop (the surgeon).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for this submission. The study proving "substantial equivalence" relies on the previous clearance of the predicate devices. The basis for those original clearances (K171307) would have included performance data, but specific "ground truth" modalities for those past studies are not detailed in this document.
8. The sample size for the training set
- Not applicable. This is a hardware device undergoing a specification change, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an AI algorithm.
Summary of the Study Discussed (Pertaining to this 510(k) submission):
The "study" described in the document is a technical assessment concluding that a proposed engineering specification change to increase the upper design limit for the clamping pressure of the existing EsophyX®2 HD and EsophyX Z devices does not alter the device's fundamental operation, safety, or effectiveness.
- Nature of the "Study": This was not a de novo clinical trial but rather an engineering evaluation and comparison to a previously cleared predicate device (K171307).
- Basis for Conclusion: The conclusion is based on:
- The devices being "identical" to the predicates, except for the specific clamping pressure tolerance.
- The principles of operation remaining the same.
- Reference to consensus standards.
- Verification and validation testing remaining "unchanged."
- Biocompatibility testing being consistent.
- The literature supporting the specification change.
- No New Clinical Data: The document explicitly states "without additional in vivo data needed for substantial equivalence as there are no changes made to the devices for this specification change proposal."
In essence, the "study" demonstrating that the device meets acceptance criteria for this 510(k) relies on the fact that the device (with the modified clamping pressure specification) is demonstrated to be substantially equivalent to a predicate device that has already proven its safety and effectiveness. The acceptance criteria effectively imply that the device with the new specification must perform equivalently to the predicate, and the provided document argues that this is indeed the case.
§ 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.