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510(k) Data Aggregation
(258 days)
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:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | In accordance with ISO 10993-1 and FDA guidance for "Biological Evaluation of Medical Devices part I: Evaluation and Testing within a risk management system". Devices categorized as surface contacting devices in contact with mucous membrane for a limited (<24 hours) duration. | Passed all tests for: Cytotoxicity, Sensitization, Irritation, Systemic toxicity (Floppy Tip Hydro-Coated Ureteric Catheter only), Sub-chronic toxicity (Floppy Tip Hydro-Coated Ureteric Catheter only), Implantation (Floppy Tip Hydro-Coated Ureteric Catheter only). |
| Performance Testing | Maintain safety and effectiveness for intended use throughout product shelf life (including after 5 years accelerated aging). | Passed all tests for: Visual, Compatibility, Dimensional, Viscous Fluid Test / Injection of contrast liquid, Flow Rate, Tensile, Friction Strength Test (distal tip), Radiopacity. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Samples were tested at T=0 (initial state) and after 5 years of accelerated aging. The specific number of samples tested for each performance test is not explicitly stated in the provided document.
- Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective. It implies the performance data was generated as part of the 510(k) submission to demonstrate substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes performance testing of a physical medical device (catheter) rather than an AI/software device that requires expert review for ground truth establishment. The ground truth for these tests is based on objective measurements and established standards.
4. Adjudication method for the test set:
- Not Applicable. As mentioned above, this is not an AI/software device requiring human adjudication of results. The performance tests yield objective data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not an AI/software device. MRMC studies are typically used to evaluate the performance of diagnostic imaging aids where human readers interpret images with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. The "standalone" performance refers to the device's inherent functionality against specified criteria.
7. The type of ground truth used:
- The ground truth for the performance tests is based on objective measurements against predefined specifications and industry standards. For example, dimensional measurements are compared to design specifications, flow rates are measured against expected values, and biocompatibility is assessed against ISO 10993-1.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As this is not an AI/machine learning device, there is no training set and therefore no ground truth establishment for a training set.
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