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The device is indicated to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions in the ureter. The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic techniques. It is recommended that the indwelling time not exceed 365 days. The stent is not intended as a permanent indwelling device.

The subject devices are coated ureteral stent that are supplied as a standalone product (including a pigtail straightener) or as part of a set, available in two configurations:

• Basic Set: Includes a ureteral stent, pigtail straightener, and positioner.
• Full Set: Includes a ureteral stent, pigtail straightener, positioner, and J-tip guide wire.

The coated stents are flexible tubular devices made of radiopaque polyurethane, featuring self-retaining coiled pigtail structures at both ends. The stent body incorporates multiple drainage holes to ensure smooth urine flow from the renal pelvis to the bladder. The dual-pigtail design positions the proximal end in the renal pelvis and the distal end in the bladder. Additionally, the stent surface is marked with graduated scales for precise intraoperative positioning.

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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.

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