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The intended use of the Simplicity Soft QD Micro Infusion Set is to provide a means to infuse insulin subcutaneously from a pump or syringe.

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The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Simplicity Soft QD Micro Infusion Set." It details the regulatory classification and approval process, but it does not contain any information about acceptance criteria or specific study data to prove the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market entry. However, substantial equivalence typically relies on demonstrating that the new device performs as intended and is as safe and effective as a predicate device, which may involve various tests, but the results of those tests and associated acceptance criteria are not included in this document.

Therefore, I cannot provide the requested information based on the text provided.

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