(189 days)
The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
The Disposable Ureteral Access Sheath is one single use device, which is provided after EO sterilization. The shelf life of Disposable Ureteral Access Sheath is 3(three) years. The Disposable Ureteral Access Sheath consists of two major components: sheath assembly and dilator assembly. Sheath assembly consists of sheath hub, the dilator assembly consists of dilator, dilator hub and dilator clip. And there is a hydrophilic coating on the surface of the sheath and dilator. The Disposable Ureteral Access Sheath is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device changes. Like all ureteral access sheath sets, Beyo's Disposable Ureteral Access Sheath also protects the ureter during device exchanges, thus helping reduce tissue trauma. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. To guide the access sheath into the body orifice, the dilator is advanced over up to a 0.038" guidewire. The device can be visualized under X-ray(fluoroscopy) during placement to confirm location. The device can accept other urological instruments with OD's compatible with the sheath's OD of 10,12 and 14 Fr. The device has two assemblies, sheath assembly and dilator assembly, the two assemblies are combined through dilator clip, the dilator can insert and withdrawn easily from sheath, The dilator assembly can be fixed on the sheath assembly.
The provided text describes a 510(k) summary for a Disposable Ureteral Access Sheath, not a medical device that uses AI or machine learning. Therefore, the document does not contain information regarding acceptance criteria and study data for an AI/ML powered medical device.
The information I can extract pertains to the acceptance criteria for the physical ureteral access sheath device and how its performance was tested to establish substantial equivalence to a predicate device.
Here's a breakdown of what is available in the document, which primarily focuses on non-clinical performance testing for a physical device:
Acceptance Criteria and Device Performance (for a physical ureteral access sheath)
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Characteristics | Acceptance Criteria | Test Method | Reported Device Performance (Implied "SE" or "Complies") |
|---|---|---|---|---|
| 1 | Dimensions | Dimension of ureteral access sheath shall comply with the requirements of Table 3 Dimensions. | Using a universal gage. | SE (Substantially Equivalent) |
| 2 | Dilator & Sheath Compatibility | The dilator should be able to enter and withdraw smoothly and unobstructed within the sheath. | Pull the dilator out of the sheath, then insert it into the sheath cavity, repeat three times, the results should meet the requirements. | SE |
| 3 | Hub security | Dilator hub can lock onto the sheath hub, dilator can be fixed on the sheath hub, no relative slip. | The dilator hub is screwed off from the sheath hub and then inserted into the sheath in the same direction. The results should meet the requirements. | SE |
| 4 | Sheath Inner Lumen Passability | The dilator should be able to pass through the sheath with a minimum bending radius of 55 mm. | The sheath is bent under the condition that the marking length is 55 mm, the dilator pass through the sheath inner cavity, the results should meet the requirements. | SE |
| 5 | Dynamic Friction Force | The surface dynamic friction of the sheath after water contact should be |
§ 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.