(120 days)
The LumenaTM Ureteral Access Sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
The LumenaTM Ureteral Access Sheaths are designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The sheaths are available with both a bendable tip with a Y-shape joint on the proximal end and a straight tip with the outside diameters ranging from 11 to 15 French and lengths ranging from 35 to 45 centimeters. These devices are available in a single lumen configuration and include a sheath tube and a dilator. The bendable-tip sheath is intended to be connected to a negative pressure aspirator for the collection of stones or foreign bodies during the endoscopic procedure.
The provided FDA 510(k) clearance letter and summary for the LumenaTM Ureteral Access Sheath do not contain information about an AI/ML-driven device or study parameters related to AI/ML performance.
Instead, the document describes a traditional medical device (a ureteral access sheath) and the non-clinical bench testing, sterilization, packaging, shelf-life, and biocompatibility evaluations performed to demonstrate its safety and substantial equivalence to a predicate device.
Therefore, I cannot provide information on:
- A table of acceptance criteria and reported device performance specific to AI/ML. The document lists various non-clinical tests but doesn't detail specific acceptance criteria values or quantitative performance metrics in a table for these tests.
- Sample size used for the test set and the data provenance for an AI/ML study.
- Number of experts used to establish the ground truth and their qualifications for an AI/ML study.
- Adjudication method for an AI/ML study.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size of human improvement with AI assistance.
- Standalone (algorithm only) performance.
- Type of ground truth used for an AI/ML study.
- Sample size for the training set for an AI/ML study.
- How the ground truth for the training set was established for an AI/ML study.
The document explicitly states: "No clinical study is included in this submission." This further confirms that no studies involving human readers, ground truth establishment, or AI/ML performance evaluations were conducted as part of this submission.
The "acceptance criteria" mentioned in the document refer to the successful completion of the non-clinical performance tests. For example, "All the testing results meet the defined acceptance criteria." However, the specific numerical acceptance criteria and the detailed results for each non-clinical test (Tensile Performance, Hydrophilic Coating Performance, etc.) are not provided in this summary document. They would typically be found in the full 510(k) submission.
§ 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.