(238 days)
The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy,and to facilitate the placement of endourological instruments during diagnostic or interventional procedures
The XenX device combines several features in one device which facilitate an endoscopic procedure. The XenX easily tracks past ureteral kidney stone and is navigated under fluoroscopy like a urologic guidewire. Once in place, a self expandable braided structure is deployed to block the ureteral lumen and prevent stone particle migration towards the kidney. The braided structure enables a constant irrigation flow for clear uretroscopic vision during the procedure. Following stone fragmentation and if required the physician can choose to propagate a urinary stent over the device for ureteral placement.
Here's an analysis of the provided text regarding the XenX device, structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria with specific thresholds for device performance. Instead, it states that "Testing showed that the XenX is as safe, effective and performs as well as, or better than the predicates." The performance data section describes a series of nonclinical tests conducted to demonstrate equivalence to predicate devices.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Tip flexibility | Tested; found to perform as well as, or better than predicates. |
| Deployment/retrieval force | Tested; found to perform as well as, or better than predicates. |
| Tensile strength | Tested; found to perform as well as, or better than predicates. |
| Pushability test | Tested; found to perform as well as, or better than predicates. |
| Radial expansion | Tested; found to perform as well as, or better than predicates. |
| Functional Performance | |
| Stenting compatibility | Tested; found to perform as well as, or better than predicates. |
| Particle sieving (stone entrapment) | Tested; found to perform as well as, or better than predicates (prevents retrograde migration of calculi, can disintegrate stone particles down to 1mm). |
| Radiopacity | Tested; found to perform as well as, or better than predicates. |
| Overall Safety & Effectiveness | "As safe, effective and performs as well as, or better than the predicates." |
2. Sample Size for Test Set and Data Provenance
The 510(k) summary does not provide information on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are "nonclinical testing," implying bench testing or in-vitro studies, not human clinical trials with patient data.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided as the studies are "nonclinical testing" and do not involve human expert assessment of a test set for ground truth establishment.
4. Adjudication Method
This information is not applicable/not provided as there is no mention of a clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not reported in this summary). The studies are nonclinical and do not involve human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
This is not applicable as the XenX is a physical medical device (guidewire with a braided structure), not an AI algorithm. Hence, standalone performance for an algorithm is not relevant.
7. Type of Ground Truth Used
The ground truth for the nonclinical tests would have been established by physical measurements, engineering specifications, and established testing protocols for medical device performance. For example, a "Tensile strength" test would have a defined breaking point or force resistance that the device must meet, which serves as the "ground truth" for that particular performance metric. There is no mention of expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies.
8. Sample Size for Training Set
There is no mention of a training set sample size, as this device does not involve machine learning or AI that would require a "training set."
9. How Ground Truth for Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.