(25 days)
The Navigator™ HD Ureteral Access Sheath Set is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
The Navigator ™ HD Ureteral Access Sheath Set 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 exchanges. Like all ureteral access sheath sets, Navigator™ HD also protects the ureter during device exchanges, thus helping reduce tissue trauma. This set consists of two components: an inner tapered semirigid dilator and an outer semi-rigid sheath. The outer sheath fits over the inner dilator, and the design of the hub allows the dilator to lock into the sheath. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. The device is offered in three French sizes, 11/13 Fr, 12/14 Fr and 13/15 Fr, in lengths up to 46cm. The Navigator ™ HD Ureteral Access Sheath Set is intended for single use only.
The provided text is for a 510(k) summary for a medical device called the "Navigator™ HD Ureteral Access Sheath Set" by Boston Scientific. The information pertains to the regulatory submission process and describes the device's characteristics and intended use, comparing it to a predicate device.
Crucially, this document does NOT describe a study that involves an AI or software algorithm, nor does it provide performance metrics in the way you've requested for an AI/software-based device.
The "Performance Testing (Bench Evaluation)" section refers to physical bench tests conducted on the device, such as "Dilator Tip Weld / Shaft Integrity" and "Flexible Tip Weld Integrity (Durability)", to support the addition of a flexural durability specification. This is a hardware device, not a software or AI device.
Therefore, I cannot provide details on:
- Acceptance criteria and reported device performance related to AI/software metrics.
- Sample sizes for test sets, data provenance, or ground truth establishment for AI/software.
- Number of experts, their qualifications, or adjudication methods for AI/software ground truth.
- MRMC comparative effectiveness studies or standalone AI performance.
- Sample size or ground truth for a training set for an AI/software algorithm.
In summary, the provided document does not contain the information requested as it describes a physical medical device (a ureteral access sheath) and its bench testing, not an AI or software-based 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.