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Two-Way Catheter: Urethral catheterization for bladder drainage.

Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation.

Radiopaque Catheter:

Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.

INTENDED USE For urological use only.

The catherer consists of a double or triple lumen drainage eye on the proximal tip. The threeway cather has an additional eye for irrigation purposes. The two-way catheter is available with a radiopaque option. The catherer is available in a combination of French sizes, balloon capacties and lengths to accommodate pediative and adult male and female applications. Available catheter lengths range from 10.6 to 15.8, French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.

This document describes the Rochester Medical Corporation All Silicone Foley Catheter. The submission is a 510(k) for substantial equivalence to previously marketed predicate devices.

Acceptance Criteria and Device Performance (Study Information)

The device, a urological catheter, needs to meet the requirements of ASTM F 623-89 Standard Specifications for Foley Catheters and demonstrate biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   ASTM F 623-89 Standard Specifications for Foley Catheters	Meets requirements with the exception of requirements 5.3 and 5.5 regarding catheter tip and shaft diameters. The document states: "These exceptions are due to the proprietary manufacturing process that allows Rochester Medical to manufacture catheters with balloons that are incorporated into the catheter than being applied during a secondary operation, the tip diameter is equivalent to the balloon diameter which complies with therefore is not considered clinically significant."
   Biocompatibility	Biocompatibility testing was completed on catheter samples including tests for: Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Muscle Implantation with Histopathology, Sensitization and Irritation. Results were acceptable for all tests.

2. Sample size used for the test set and the data provenance:
   The document does not specify the exact sample size for the test sets (ASTM F 623-89 testing and biocompatibility testing). It mentions "catheter samples" for biocompatibility. No information regarding country of origin or whether the data was retrospective or prospective is provided. These are laboratory/bench tests rather than clinical studies on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable (N/A). These are objective bench-top and laboratory tests, not subjective evaluations requiring expert consensus for ground truth.

4. Adjudication method for the test set:
   N/A. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for standard device performance and biocompatibility testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
   No. This is a 510(k) submission for a physical medical device (Foley catheter) and describes bench and biocompatibility testing, not an AI-assisted diagnostic tool or a comparative effectiveness study involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
   For the ASTM F 623-89 Standard Specifications, the ground truth is defined by the objective, measurable requirements stipulated in the standard.
   For Biocompatibility testing, the ground truth is established by the accepted scientific methodologies and criteria for evaluating biological responses to medical devices.

8. The sample size for the training set:
   N/A. This information is typically for AI/Machine Learning models, not for traditional medical device testing. The testing described is verification and validation.

9. How the ground truth for the training set was established:
   N/A. This information is typically for AI/Machine Learning models.

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