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The double loop ureteral stents are used for:

• drainage of the upper urinary tract over fistulas or ureteral obstacles
• healing of the ureter

Vortek® Double Loop Ureteral Stents in this submission and both predicates. Vortek® Hydro-Coated Double Loop Ureteral Stents and Vortek® Double Loop Ureteral Stents, are implantable autostatic catheters used to maintain urine drainage and to allow for ureteral healing. They are inserted during a surgical procedure using either an antegrade or a retrograde technique or by open surgery typically using a guidewire and a pusher.
Stents are supplied in diameters between 4.8 and 8 Fr and lengths between 12 and 30 cm long. The stents can have either both tips open (0/0) or the vesical tip open and renal tip closed (0/c).
Vortek® Double Loop Ureteral Stents in this submission and the predicates are supplied in kits which include the following components:

• A double-loop ureteral stent
• A pusher
• A guide wire
  And in some kits:
• A ureteric catheter
  The Vortek® Double Loop Ureteral Stent and accessories included in the kits are supplied sterile via ethylene oxide. The ureteral stent and each accessory are packaged and sterilized separately prior to being combined in the kit.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called "Vortek® Double Loop Ureteral Stents." It describes the device, its intended use, comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.

However, the provided text does not contain information about an AI/ML-based medical device or its acceptance criteria, performance studies, or ground truth establishment. The document focuses on a traditional medical device (a ureteral stent) and its non-clinical performance data (biocompatibility, mechanical testing, sterilization, packaging).

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from this document. The questions you've asked are relevant for AI/ML device submissions, but this specific FDA document does not pertain to such a device.

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Both the VORTEK and BIOSOFT versions of the ureteral double loop stent are intended for the exact same use as the current silicone ureteral double loop stent. The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The "flush" ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.

VORTEK® and BIOSOFT® Ureteral Double Loop Stents

This document is a 510(k) premarket notification decision letter from the FDA regarding VORTEK and BIOSOFT Ureteral Double Loop Stents. It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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