(125 days)
The powered Melodi Prime Breast Pump is intended to express and collect milk from the breast of a lactating woman. This device is a double pump with a single pumping option; it is intended for a single user.
The Melodi Prime breast pump is a battery operated breast pump. It operates with 4 AA size batteries. It comes with a power adapter as it can be used with a power adapter without batteries as well. The power adapter does not charge the batteries.
The Melodi Prime breast pump is designed to be a single patient use device. It consists of a LCD display that allows the user to see the current settings of the device. It is an easy to use device, consist of 5 buttons (On/Off, + , - , Phase 1/ Phase 2, & Single/ Double Pumping).
The breast pump allows for single pumping and double pumping options. The suction hose connections are independent of each other. Inside the device, it consists of a PCB, motor and valve.
The accessories that comes with the device are from Ardo Medical AG. The PumpSets are approved under K141742.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Melodi Prime Breast Pump:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a tabulated format. However, it describes performance characteristics that were tested and deemed acceptable for demonstrating substantial equivalence.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Consistent Pressure and Cycles | The pressure level and cycles per minute remain consistent throughout the bench test and show a constant and uniform behavior. |
| Back-flow Prevention (Pump to Tubing) | Back-flow tests confirm that the Melodi Prime Breast Pump can prevent back-flow of the liquid from the Pump Set into the tubing. |
| Back-flow Prevention (Bottle to Pump) | The Pump Sets are also able to prevent liquid going out from the bottle to the pump. |
| Durability / Reliability | The system was tested for more than 72 hours without any problems or errors. |
| Suction Pressure Range | 60-250 mmHg (This is a specification, also serving as an implicit criterion. The reported performance implies it meets this range, as it's directly compared to the predicate's 50-250 mmHg, with the subject device's range being within acceptable physiological limits.) |
| Electrical Safety | Passed electrical safety testing. (Implicit criterion related to the difference in power source from the predicate). |
| Electromagnetic Compatibility (EMC) | Passed electromagnetic compatibility (EMC) testing. (Implicit criterion related to the difference in power source from the predicate). |
| Biocompatibility/Food Safety | PumpSets used in the subject device are a cleared device, therefore, no concerns on biocompatibility and food safety. (Implicit criterion, relies on prior clearance of components). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "bench tests" and "back flow tests" but does not detail the number of units or test repetitions.
- Data Provenance: Not explicitly stated, but the context indicates these were conducted internally by the manufacturer or a contract lab as part of the 510(k) submission process. There is no mention of country of origin for the data or whether it was retrospective or prospective, though bench testing is inherently prospective experimentation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. The "ground truth" for technical performance criteria (like pressure consistency, back-flow prevention, and durability) is typically established through objective measurements and engineering standards, not expert clinical consensus in this context.
- Qualifications of Experts: Not applicable for the described tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests described are objective bench tests, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a breast pump, and its effectiveness is determined by mechanical performance, safety, and functionality, not by interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- Standalone Study: Yes, in essence, the "Performance Data" section describes standalone testing of the device's mechanical and functional characteristics without human intervention influencing the fundamental performance results. It's not an "algorithm" in the typical software sense, but the device's inherent operation was tested.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the performance tests was based on objective measurements against engineering specifications and physical principles. For example, pressure levels are measured by sensors, back-flow is visually or mechanically confirmed, and durability is timed.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a mechanical breast pump, not an AI/ML algorithm that requires a "training set" of data in the typical sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.
§ 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).