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Not for injection, for suction catheter procedures. Hydrox Sterile Saline 0.9% Sodium Chloride Solution is intended to be used in device lubrication, moistening and flushing. It is not intended for wound irrigation or IV or IM administration and is labeled as such.

Sterile Saline 0.9% Sodium Chloride Solution

In the provided text, the FDA 510(k) letter for "Hydrox Saline Solution 0.9% Sodium Chloride" (K974759) does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The letter focuses on the substantial equivalence determination of the device to pre-existing legally marketed devices, in this case, "Orion 0.9% Sodium Chloride Solution K943834 and Kit Pak Sterile 0.9% Sodium Chloride Solution." The FDA's decision is based on the device's indications for use being the same as the predicate devices, and an assumption of compliance with Good Manufacturing Practice (GMP) requirements.

Therefore, I cannot provide the requested information, including:

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 their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
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

This type of detailed study information is not typically included in an FDA 510(k) clearance letter for a Class II device like a saline solution, especially when the clearance is based on substantial equivalence to predicate devices, where the focus is on whether the new device is as safe and effective as a legally marketed device.

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