(27 days)
The Ardo Bellis is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Bellis is intended for a single user and multiple users.
The Ardo Bellis is a breast pump unit for collecting breast milk by application of a defined vacuum with a defined frequency on a woman's breast. The pump needs to be connected to a single or double pump set (Carum and Calypso Powered Breast Pumps, cleared under K141742) to be used on one or two breasts. The case and controls of the pump unit have limited contact with the user and are intended only to control the activities of the device parts that contact the user's breast. The device is comprised of an ON/OFF button and two +/- buttons for adjusting (increasing or decreasing) the vacuum and cycle speed. The pump can also be operated using the accompanying mobile application. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. An integrated battery allows for portable use of the device. With the supplied power adapter, the device can be recharged.
Ardo Bellis can be used indoors in professional as well as home care environments.
This is a 510(k) premarket notification for the Ardo Bellis powered breast pump (K230590). The 510(k) summary explicitly states that the purpose of this submission is not to test a new device or its performance, but to modify the indications for use statement of an existing device (Ardo Bellis) to include "multiple users." The Ardo Bellis itself appears to be a modification of the predicate device, Ardo Alyssa (K212773).
Therefore, this document does not contain an independent study designed to prove that the Ardo Bellis meets specific acceptance criteria based on performance data generated for this 510(k) submission. Instead, it leverages the performance testing done for the predicate device, Ardo Alyssa (K212773), and argues that the changes in the Ardo Bellis (primarily case design and the multiple-user indication) do not raise new questions of safety or effectiveness.
Because there is no new, independent study described in this document for the Ardo Bellis (K230590), most of the requested information regarding acceptance criteria and study particulars cannot be extracted. The document specifically states:
"The changes made to the design and indications for use of the subject device do not raise different questions of safety and effectiveness. Therefore, the performance testing included in K212773 can be leveraged to support the safety and effectiveness of the subject device."
Therefore, I cannot populate the requested information. The document explicitly indicates that the performance data from K212773 (Ardo Alyssa) is being leveraged, not that new performance data was generated for K230590.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).