Search Results

Ureteric catheters for retrograde ureteropyelography are intended for injection of contrast medium or saline during endourological procedures.

The Ureteric Catheters for retrograde ureteropyelography are flexible tubular devices designed with open proximal and distal ends. The bulb shaped distal end permits the catheter to enter the lowest part of the ureter maintaining water tightness when injecting contrast or saline. The Ureteric Catheters are made from a polyvinyl chloride (PVC) material and have soft bulbous tip to help position the device in the ureter meatus. The devices are provided sterile and are intended for single use. The Ureteric Catheters have a Chevassu open tip, do not have side eyes, and range in diameter from 3 Fr to 7 Fr for the catheter body and 4 Fr to 10 FR for the Chevassu bulb. They are supplied with a metal stylet to facilitate insertion and a Luer-lock syringe connector. They are provided in two lengths, 69.5 and 73 cm. The longer version is intended to be compatible with a 0.035" guidewire. The shaft is marked at one centimeter increments along the length to aid in advancement and is radiopaque for fluoroscopic visualization.

The provided document is a 510(k) summary for a medical device (Ureteric catheter) and does NOT contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot extract the requested information from this document. The document details:

• Device Name: Ureteric catheter
• Regulation Number: 21 CFR § 876.5130 (Urological Catheter and Accessories)
• Product Code: EYB
• Predicate Devices: PORGES™ Ureteral Catheters (K021856) and Floppy Tip Hydro-Coated Ureteric Catheter (K171043)
• Non-Clinical Performance Data: Biocompatibility testing (Cytotoxicity, Sensitization, Irritation), Performance testing (Visual Evaluation, Compatibility with Guidewire or Stylet, Compatibility with Connector, Compatibility with Liquid, Tensile Strength on Catheter Bulb, Tensile Strength on Catheter Tube, Flow Rate, Simulation of Use, Radiopacity), Sterilization, and Packaging and Distribution testing.
• Absence of Clinical Studies: Explicitly states "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

No AI/ML software is mentioned, nor are any acceptance criteria or studies related to AI/ML performance.

Ask a specific question about this device

Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline.

Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.

Ureteric catheters are ethylene oxide sterilized, single use devices intended to restore or maintain drainage of the upper urinary tract and to flush or inject contrast medium or saline during an endoscopic procedure. All ureteric catheters include a connector nut with a Luer fitting. The connector nut is inserted into the proximal end of the catheter allowing the Luer fitting to connect to collecting or injection devices. Ureteric catheters are open at the distal end (farthest away from the surgeon) to allow use over a guidewire.

Flush Ureteric Catheters and Ureteric Catheters come in three different tip configurations (straight, open coudé with side eyes, open coudé without side eyes). A stylet in included with the catheters to aid during the catheter insertion. The Flush Ureteric Catheters and Ureteric Catheters are supplied in a 74 cm length and diameters range from 3 Fr. to 8 Fr. The Floppy Tip Hydro-coated Ureteric catheters are 70 cm long and have 5,6, and 7 Fr. diameters.

The Flush Ureteric Catheters and Ureteric Catheters are made from polyether block amide materials. The Floppy Tip Hydro-coated Ureteric catheters are made from polyvinyl chloride (PVC), have a hydrophilic coating over the distal tip (farthest away from the surgeon), and a soft tip which allows for easier insertion and advancement of the catheter. The materials have a radiopaque filler to allow for fluoroscopic visibility.

This document describes the performance testing and acceptance criteria for Ureteric catheters, Flush Ureteric catheters, and Floppy Tip Hydro-Coated Ureteric Catheters.

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device