(57 days)
The EndoGastric Solutions EsophyX® 2 HD Device with SerosaFuse 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 junction and reduce hiatal hernia
The EndoGastric Solutions EsophyX® 2 HD Device with SerosaFuse Fasteners and Accessories consists of an all mechanical, flexible fastener delivery device with user controls outside the patient's body and sterile polypropylene fasteners delivered transorally through a flexible shaft into the GI tract via a common delivery mechanism comprised of three elements: a stylet, a pusher rod, and a delivery tube. All three fastener delivery elements run the length of the delivery device. The stylet runs down the inside of the lumen of the delivery tube and the pusher rod rides over the length of the stylet. The stylet is designed to pierce and hold the desired tissue plication in place and guide the fastener into position. There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded mechanically onto the stylet via a replaceable fastener cartridge containing ten fasteners for each channel. To load, the fastener cartridge lever is depressed, which snaps a fastener onto the stylet. The fastener is then pushed down the stylet from the proximal handle assembly to the distal tissue port via the pusher rod where it is then ready to be deployed into the tissue. When the desired tissue approximation/ plication is achieved, the pusher rod is used to push the fastener into the tissue, quided by the stylet which precedes it into the tissue. The leading leq of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing the leading leg of the fastener to disengage from the stylet and the fastener then seats across the desired tissue plication. A new fastener is loaded proximally in the device at the loading port, after retracting the pusher rod. The loading and fastening procedure can be repeated. The device is provided sterile and is a single use device.
The provided document is a 510(k) summary for the EndoGastric Solutions EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for algorithm performance as would be expected for an AI/ML device.
Therefore, much of the requested information cannot be extracted from this document, as it pertains to AI/ML device evaluation, which is not the subject of this 510(k) submission. This submission is for a physical medical device.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet design specifications and user needs. | Verification and validation testing demonstrates the device meets product specifications and user requirements. |
| Meet biocompatibility requirements. | Biocompatibility testing provides evidence the device meets biocompatibility requirements. |
| Compatible with high-definition endoscopes. | Verified and validated to be compatible with high definition endoscopes. |
| Maintain the same indications for use as the predicate device. | Same indications for use as predicate. |
| Maintain the same operating principle as the predicate device. | Same operating principle as predicate. |
| Maintain the basic design with a larger shaft diameter (60Fr versus 54Fr) compared to the predicate device. | Incorporates the same basic design with a larger shaft diameter (60Fr versus 54Fr). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided document. The document refers to "verification and validation testing" which included "dimensional, mechanical, and performance testing" but does not specify sample sizes for these tests, nor the nature of the data or its provenance.
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):
This information is not applicable as this is not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as this is not an AI/ML device requiring adjudication of a test set.
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:
This information is not applicable as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in terms of "ground truth" as it would be for an AI/ML device. For a physical device, performance evaluation typically involves engineering specifications, compatibility testing, and simulated use.
8. The sample size for the training set:
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This information is not applicable as this is not an AI/ML 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.