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Continuous or intermittent multiple access connection port between IV devices such as patient access sites, catheters, syringes, or IV administrations sets.

The sharps injury prevention feature of this device is the need for a needle. The device (valve) is activated by inserting a standard male luer on the end of marketed I.V. administration sets and syringes into the proximal end of the SurgeN.

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The provided document is a 510(k) clearance letter from the FDA for the SurgeN Valve, indicating that the device is substantially equivalent to a legally marketed predicate device. This type of document does not contain the detailed information necessary to answer the questions about acceptance criteria and study data.

Specifically, the letter is an approval notice, not a technical report or scientific study. It merely states that the device is cleared for marketing based on prior submissions.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Results of any multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of any standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) submission itself (which is confidential) or in published studies relating to the device, neither of which are part of the provided text.

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