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The ON-Q SilverSoaker Catheter is intended to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for perioperative and postoperative pain management. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations.
The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The ON-Q SilverSoaker Catheter consists of two design options:
Fenestrated Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment
Soaker Catheter: a modified epidural catheter with multiple holes at the distal end up to a 10 inch infusion segment. This version of the ON-Q SilverSoaker Catheter contains a hollow fiber along the inner lumen of the catheter to provide even distribution of medication along the infusion segment.
This 510(k) adds an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

The provided text is a 510(k) Summary for the ON-Q SilverSoaker Catheter, which is an anesthetic conduction catheter. It describes the device, its intended use, and states that it is substantially equivalent to existing devices.

However, the document does not contain any information regarding acceptance criteria or the results of a study (clinical or otherwise) proving device performance against such criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device that does not require premarket approval. It's not typically a full clinical trial where specific performance metrics are measured against pre-defined acceptance criteria with detailed statistical analysis.

Therefore, I cannot provide the requested information in the structured format because the source document does not contain it. The 510(k) summary only states:

"The ON-Q SilverSoaker Catheter is substantially equivalent to the existing ON-Q Catheter product line and predicate devices."

This is the "conclusion" of the submission, based on technology comparison, not a study demonstrating new performance criteria.

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