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510(k) Data Aggregation
(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), <100-265 mbar (Ameda/Egnell) |
| Suction Cycle | 20-50 cycles per minute | 48 per minute (Medela), 30-60 cycles per minute (Ameda/Egnell) |
| Filter between kit and pump | Yes | No |
| Power Supply | Rechargeable NiMH battery, AC adapter, 12 V adapter | Rechargeable battery, AC adapter, 12 V adapter (varies by predicate model) |
| Cycle/Suction Control mechanism | Mechanical cycling suction regulator | Mechanical cycling suction regulator (Medela), Microprocessor (Ameda/Egnell) |
| Weight | 5.5 pounds | 7 pounds (Medela), 1.1 pounds (Ameda/Egnell) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "testing data" but does not detail the specifics of any test set, its sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the document does not describe a study involving expert-established ground truth for a test set. This type of detail is typical for diagnostic algorithms, not for physical medical devices of this nature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. This is not relevant for the type of device and submission described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/CAD devices, not for a breast pump.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone algorithm performance study was not done. This is not applicable to a physical device without an AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of diagnostic performance is not applicable or provided for this device. The demonstration of safety and effectiveness relies on comparison to predicate devices, material biocompatibility, and functional testing (referred to only as "testing data" without details).
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not provided. This is not applicable to the device described.
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