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Powered Breast Pump to express milk from the breast.

Natural Comfort ™ Battery / Electric Breast Pump

I am sorry, but based on the provided text, I cannot provide the requested information about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a breast pump, which confirms that the device is substantially equivalent to a legally marketed predicate device. It does not contain details about specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

And later:
"This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This indicates that the clearance is based on substantial equivalence to an already approved device, rather than a detailed performance study presented in this document.

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