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With I-Flow Corporation's ON-Q, PainBuster and C-bloc pain management kits; and As a stand alone device to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves. Routes of administration may be intraoperative, percutaneous, perineural. The Soaker version of the I-Flow Catheter is contraindicated for the epidural space.

The I-Flow Catheter consists of three design options which can utilize infusion segments ranging from epidural to 10 inches (same as the predicate devices with the exception of the 10 inch infusion segment): Standard epidural catheter: 3 radial holes at the distal end with an approximate 0.5 inch infusion segment. 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 I-Flow Catheter contains a hollow fiber along the inner lumen or along the outside diameter of the distal end of the catheter to provide even distribution of medication along the infusion segment.

This document is a 510(k) summary for a medical device (I-Flow Catheter) and does not contain the information requested in your prompt regarding acceptance criteria or a study proving device performance against such criteria.

The 510(k) submission process is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria in a clinical study as would be seen for new technology.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

What the document does indicate:

• Device: I-Flow Catheter (including Soaker Catheter, Fenestrated Catheter, Epidural Catheter, and a new 10-inch infusion segment model)
• Purpose of Submission: Special 510(k) for a new 10-inch I-Flow Catheter model.
• Basis for Approval: Substantial equivalence to already legally marketed predicate devices (I-Flow Catheter K991543, K994374, and K022869).
• Technology Comparison: The new 10-inch model "utilizes the exact same technology as the existing I-Flow Catheter product line."
• Conclusion: The new model is "substantially equivalent to the existing I-Flow Catheter product line."

In essence, this submission argues that because the new device is fundamentally the same as devices already on the market, it does not require new performance studies against specific acceptance criteria. Its performance is implicitly considered equivalent to the predicate devices.

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