(322 days)
The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user.
The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user. This is accomplished by an electrical pump system generating a suck and release vacuum pattern. The suction strength is adjustable. The cycles per minute are adjustable. The electrical pumping unit of the device is connected to the breast shields via silicone tubing. The breast shield and screw housing is equipped with a flap valve separating the breast shield from the NUK breast milk container. The system is assembled in an airtight way to ensure that the system can build up vacuum when the breast shield is connected to the breast. The milk will flow through the flap back flow valve into the bottle. A voltage adaptor is provided with the device.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Device: NUK Expressive Double Electric Breast Pump
Intended Use: To express milk from the breasts, intended for use by a single user.
Acceptance Criteria and Reported Device Performance
The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than setting new, explicit acceptance criteria for performance beyond what is comparable to the predicate. The "acceptance criteria" can be inferred from the comparison points and the tests conducted to show equivalence.
Here's a table based on the comparison and performance sections:
Table: Acceptance Criteria (Inferred from Predicate Equivalence) and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (NUK Expressive Double Electric Breast Pump) |
|---|---|
| I. Functional Equivalence | |
| Intended Use: Express milk from breasts | Intended to express milk from the breasts. Intended for use by a single user. (Substantially equivalent to predicate) |
| Intended Users: Lactating women | Lactating women (Substantially equivalent to predicate) |
| Portability | Yes (Substantially equivalent to predicate) |
| Available over the counter | Yes (Substantially equivalent to predicate) |
| Single or double pumping capability | Single or double pumping (Substantially equivalent to predicate) |
| Vacuum range: adjustable, |
§ 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).