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The device is a tubular device that is inserted through the urethra and utilized for passage of fluids from or to the urinary tract.

The catheter consist of a PVC tube with 2 or 3 drainage eyes on the proximal tip. The catheter is available in a combination of French sizes and lengths to accommodate pediatric and adult male and female applications. The Catheter is used in urinary collection procedure is a way of obtaining a urine sample through a catheter (a thin PVC tube) inserted through the urethra into the bladder. The urine is obtained by this method to avoid contamination from the urethra, or if urine cannot be collected by the clean catch method. The Urethral Catheter is packaged as part of a convenience kit for Urine Catheter Kit. The Urethral Catheter packaged in a soft pouch with Tyvek lid. The pouch is heat-sealed. The convenience kit includes a variety of devices used in the Urinary Catheter procedure including vial, gloves, iodophor PVP Swabsticks, embossed drape, and lubricating jelly.

The provided text is a 510(k) summary for a Urethral Catheter, which is a medical device. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive studies on device performance against specific acceptance criteria.

Therefore, the document does not contain information on acceptance criteria or a study proving the device meets them in the way modern AI/software as a medical device (SaMD) clearances would.

Here's a breakdown based on your requested information, explaining why certain elements are not present:

Acceptance Criteria and Device Performance:

• Explanation: The document does not define specific "acceptance criteria" (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) that the device is intended to meet. Instead, the focus is on demonstrating "substantial equivalence" to a legally marketed predicate device. This means that the device is considered acceptable if it is as safe and effective as a device already on the market, based on similar technological characteristics and intended use.

Study Details (as requested, but largely not applicable to this 510(k) type):

1. Sample size used for the test set and the data provenance:

   • Not applicable. This submission doesn't describe a performance study with a test set in the modern sense of evaluating a device's diagnostic or predictive capabilities. It's for a physical medical device (catheter) where substantial equivalence is typically demonstrated through material comparisons, manufacturing processes, and intended use comparison.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. See explanation above.

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

   • Not applicable. See explanation above.

4. 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 physical catheter, not an AI or imaging diagnostic device.

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

   • Not applicable. This is not an algorithm or software device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. There is no "ground truth" as it would be understood in an AI/diagnostic performance study. The "ground truth" in a 510(k) for a physical device like this is implicitly the safety and effectiveness of the predicate device.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable. See explanation above.

Summary of the Document's Approach to "Proof":

The "study" or "proof" for this Urethral Catheter's acceptability in this 510(k) submission relies entirely on substantial equivalence to a predicate device. The manufacturer (Busse Hospital Disposables, Inc.) asserts that:

• The device has the same intended use: "a tubular device that is inserted through the urethra and utilized for passage of fluids from or to the urinary tract."
• The device has similar technological characteristics to the predicate. While not explicitly detailed in the provided text, this typically involves comparing materials (e.g., clear virgin PVC), dimensions (French sizes, lengths), design (drainage eyes), and manufacturing processes. The document states a PVC tube with 2 or 3 drainage eyes and indicates available sizes.
• The differences between the subject device and the predicate device are minor, leading to the conclusion that the device is "as safe and effective as the predicate devices."

The FDA's letter concurs with this assessment, finding the device "substantially equivalent" to legally marketed predicate devices, thereby permitting its marketing.

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