(136 days)
The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user.
The Powered Breast Pump provides the option of pumping on one breast or on both breasts at the same time. The Powered Breast Pump can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle-mode and suction level. The Powered Breast Pump is capable of providing vacuum levels from 75 to 220 mmHg with 3 different cycle modes. Mothers are able to choose the most comfortable / preferred vacuum level and cyclemode.
This is a device for a powered breast pump. The provided content indicates that this is a Special 510(k) submission for modifications to a previously cleared breast pump, primarily to cycle speeds and suction settings to enhance user comfort.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not explicitly state "acceptance criteria" for the performance tests in a quantitative manner. Instead, it states that the tests were conducted to ensure "satisfactory performance" or to "illustrate substantial equivalence." The performance data is primarily presented as a comparison to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Suction curves demonstrate substantial equivalence to predicate | Suction curves provided (details not explicitly given) |
| Satisfactory backflow performance | Backflow test conducted (details not explicitly given) |
| Validated cleaning instructions | Cleaning validation study conducted (details not explicitly given) |
Device Comparison Details (from the table provided):
| Feature | New Device (Powered Breast Pump) | Predicate Device (Affinity Double Electric Breast Pump) |
|---|---|---|
| Suction Levels (stimulation) | 55 - 140 mmHg | 50 - 150 mmHg |
| Cycles per Second (stimulation) | 1.55 - 2.4 | 1.85 (fixed) |
| Suction Levels (expression) | 80 - 220 mmHg | 50 - 250 mmHg |
| Cycles per Second (expression) | 0.61 - 1.52 | 0.51 - 1.0 |
| Suction Settings | 8 | 8 |
| Power Supply | 6 AA batteries, AC Adapter | 6 AA batteries, AC Adapter |
| Pumping Option | Single or Double | Single or Double |
| Back Flow Protection | Yes | Yes |
| Let Down Function | Yes | Yes |
| Cycling/Suction Control Mechanism | Microprocessor | Microprocessor |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance Testing" including "Suction Curves," "Back Flow Test," and "Cleaning Validation Study." However, it does not specify the sample sizes used for these tests. There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The performance tests described (suction curves, backflow, cleaning validation) are technical tests of the device's functionality rather than assessments requiring expert medical interpretation or "ground truth" derived from patient data.
4. Adjudication Method for the Test Set:
This information is not applicable or provided. The tests mentioned are objective engineering and validation tests, not clinical studies requiring adjudication of results based on expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted as this is a breast pump, not a diagnostic imaging device typically evaluated with such studies. The document focuses on demonstrating substantial equivalence to a predicate device through technical performance characteristics and intended use.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study, as typically understood for an algorithm or AI without human interaction, was not done. The "device" is a physical breast pump, and its performance is evaluated through its functional capabilities (suction, cycles, backflow protection).
7. Type of Ground Truth Used:
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) is not relevant for this breast pump submission. The performance assessment is based on physical and functional measurements and validation against pre-defined engineering or safety standards (e.g., suction curves, backflow prevention, cleaning effectiveness). The "ground truth" for these types of devices is their ability to perform their intended mechanical function within acceptable parameters.
8. Sample Size for the Training Set:
This information is not provided and is likely not applicable in the context of this device. A breast pump does not typically involve machine learning algorithms that require a "training set" of data in the sense that an AI diagnostic tool would.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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).