Search Results

The Kendall CURITY Suprapubic Catheter Trays and kits are intended to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a useful method of controlling urinary bladder drainage postoperatively.

The Kendall Suprapubic Catheter Trays and Kits are sterile, single use devices which are designed to provide suprapubic access to the bladder for bladder irrigation and urine drainage. The proposed device consists of 100% silicone suprapubic catheters in 10, 12 and 14 French sizes packaged with various accessories.

The catheters are two-way balloon catheters having a drainage and inflation lumen.

This is a 510(k) summary for a suprapubic catheter. 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not on clinical studies proving device performance against acceptance criteria in the way a PMA (Pre-Market Approval) submission would. Therefore, the information requested in your prompt regarding acceptance criteria, study design, ground truth, sample sizes, and expert adjudication for proving device performance is generally not applicable or not present in a 510(k) summary.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

   • Not applicable in the context of a 510(k) summary. This document does not describe specific numerical acceptance criteria for clinical performance that would be met by a clinical study. Substantial equivalence is demonstrated through material, function, indications for use, and design comparison to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable. No clinical test set or data provenance is mentioned in this 510(k) summary. The testing performed was non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. No ground truth establishment by experts is described as there were no clinical studies or test sets that would require such an assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No clinical test set requiring adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This device is a suprapubic catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not applicable. No ground truth is established for clinical performance as no clinical studies are described. The equivalence is based on engineering and material properties.

8. The sample size for the training set

   • Not applicable. There is no "training set" in the context of a 510(k) submission for this type of physical device.

9. How the ground truth for the training set was established

   • Not applicable. See point 8.

Information that is provided in the 510(k) summary related to testing:

The 510(k) summary does mention Nonclinical Testing:

• Biocompatibility testing: Performed following ISO-10993 Biological Evaluation of Medical Devices. The finding was that "the material contained no toxic diffusible substances." This is a pass/fail criterion based on established standards. No specific numerical metrics are given beyond this qualitative statement.
• Functional/Mechanical testing: Performed to determine:
  • Flow rates
  • Balloon burst volume
  • Valve retention
  • Funnel/shaft bond strength
  • Static load
  • Dynamic load
  • Water loss
  • Non-deflator test
  • Reported Finding: "Testing showed equivalence between the proposed catheter and commercially available suprapubic catheters." Again, this is a statement of equivalence rather than a specific performance metric against a pre-defined acceptance criterion. The acceptance criteria for these tests would be internal specifications (e.g., "flow rate must be within X% of predicate," "balloon burst volume must be Y mL ± Z%"), but these are not disclosed in the 510(k) summary.

In summary, for a 510(k) submission like this, the focus is on demonstrating that the new device is "substantially equivalent" to an already legally marketed predicate device, primarily through non-clinical testing and comparison of design, materials, and intended use. It does not typically involve the type of clinical performance studies with acceptance criteria, ground truth, and expert adjudication that would be found in a PMA or a submission for a novel, high-risk device.

Ask a specific question about this device