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The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters.

The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nepluostomy fascial tract, urethra and ureters. The constructions of the materials are polyethylcuse and vinyl. The lydrophilic coating will allow the catheters to become lubricious which will reduce friction.

This document is a 510(k) summary for a medical device called "AQ Hydrophilic Dilators." It is a premarket notification to the FDA. The document focuses on establishing substantial equivalence to predicate devices based on indications for use, design, and materials, rather than providing a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The document primarily describes:

• Device Name: AQ Hydrophilic Dilators
• Intended Use: To dilate the suprapubic and/or nephrostomy fascial tract, urethra, and ureters.
• Materials: Polyethylene and vinyl with a hydrophilic coating for lubricity.
• Predicate Devices: Ureteral Dilators with Hydro Plus™ (Microvasive) and uncoated dilators (Cook Urological).
• Substantial Equivalence Argument: Based on similar indications, design, materials, manufacturing processes, packaging, and sterilization to predicate devices.

There is no mention of a clinical study or performance data against specific acceptance criteria in this 510(k) summary.

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