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Like the predicate device, the proposed Eventlo Comfort East Pump . Like the predicate device to the latest of and one been a manage of any and is a non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.

non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.

The provided document is a 510(k) premarket notification approval letter for the Evenflo Comfort Ease Manual Breast Pump Kit from the FDA, dated December 2, 2001. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) summary typically includes a section on "Substantial Equivalence Discussion" which would reference performance data comparing the new device to a predicate device. However, this document is merely the FDA's approval letter, not the 510(k) summary itself. The letter states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the FDA determined that the Evenflo breast pump performs as safely and effectively as existing breast pumps already on the market, based on the information provided in the original 510(k) submission.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval and contact information for further inquiries.

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