(227 days)
The intended use of the electrically powered (diaphragmtype) suction device is to express milk from the breast of lactating women.
This portable electric breast pump model 1002 is powered by a variable speed DC motor that drives a diaphragm pump. The diaphragm pump creates the negative pressure reguired to extract breast milk. This pump has variable speed cycling rates, which is controlled by a knob located on the control panel. The breast pump is capable of providing multiple vacuum levels, which are user selectable by use of a knob located on the front panel. A maximum vacuum of 250-mm Hg. is applied to one or both breast through a disposable filter that is connected by way of flexible tubing to the breast cup(s).
It can be operated by use of either an AC/DC wall converter or a 12-Volt battery.
All materials used in the manufacturing of this device that has contact with food or human tissue meet requirement of the FDA and international regulations concerning food contact and/or biocompatability.
The provided text is a 510(k) summary for the Limerick Portable Electric Breast Pump Model 1002. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where specific acceptance criteria are defined and then proven by the device's performance through a rigorous study. Therefore, the requested information elements related to such a study are not available in the provided text.
Specifically, the document states: "As our comparison chart indicates, as well as our testing data, Limerick Portable Electric Breast Pump Model 1002 raises no new questions of safety or effectiveness." This implies that internal testing was conducted to ensure the device's performance aligns with its intended use and safety profile, similar to its predicates. However, the details of this "testing data" are not provided.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or a table of device performance against such criteria are provided in the document. The document's closest equivalent is a comparison table that outlines the characteristics of the proposed device against predicate devices.
| Characteristics | Proposed Device (Limerick Portable Electric Breast Pump Model 1002) | Predicate Devices (Medela Pump In Style, Ameda/Egnell Expresse, Ameda/Egnell Premier) |
|---|---|---|
| Intended Use | As described in 21 CFR 884.5160 | As described in 21 CFR 884.5160 |
| Suction Levels | 20-240 mm Hg. | 80-240 mm Hg. (Medela), |
§ 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).