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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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Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flusling. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
The intended use of this device is the same as the intended use of similar devices currently in the market.

Hydrox Sterile Water 4 oz. Cup 120 ml, Trade Name: Hvdrox Sterile Water 100 ml Bottle

The provided text is a 510(k) premarket notification letter from the FDA regarding "Hydrox Sterile Water." This document does not describe an AI/ML medical device, nor does it contain any information related to acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input document does not contain this type of information. It is a regulatory clearance letter for a sterile water product, not an AI/ML device study report.

Ask a specific question about this device