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510(k) Data Aggregation
(173 days)
MEGNA BREAST PUMPS
The powered Megna Breast Pumps are intended to express and collect milk from the breast of a lactating woman. The M5 model is a single pump. The M7, M10, and M12 models are double pumps with a single pumping option. All models are intended for single users.
The Megna breast pumps are electrically powered breast pumps for over-the-counter use, intended to be used at home to express a nursing mother's breast milk. The Megna breast pumps are provided in 4 models: Model M5 - Megna Digital Single Breast Pump, Model M7 Megna Digital Double Breast Pump, Model M10 - Megna Digital Double Breast Pump, Model M12 - Megna Digital Double Breast Pump.
The provided text describes a 510(k) premarket notification for Megna Breast Pumps (Models M5, M7, M10, and M12), which are powered breast pumps. The document focuses on demonstrating substantial equivalence to a predicate device (K113664, Closer to Nature Electric Breast Pump).
Here's an analysis based on your request:
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating that the Megna Breast Pumps meet various safety and performance standards equivalent to a predicate device, rather than defining specific diagnostic acceptance criteria for an AI/ML device.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this document is for a breast pump, the "acceptance criteria" are related to safety, electrical performance, biocompatibility, and functional specifications, compared to a predicate device. The "reported device performance" are the results of these tests and comparisons.
| Acceptance Criteria Category (implied) | Specific Tests / Performance | Reported Device Performance |
|---|---|---|
| Biocompatibility | Skin irritation test (0.9% sodium chloride extract, Sesame oil extract) | Massage pad on outer rim of breast shield passed. |
| Skin Sensitization Test (0.9% sodium chloride extract, Sesame Oil extract) | Massage pad on outer rim of breast shield passed. | |
| In Vitro Cytotoxicity Test | Massage pad on outer rim of breast shield passed. | |
| Food Safety (Milk Contacting Materials) | 21 CFR 177.2600 (total extractives from rubber articles) | Cylinder, Nipple and Silicone Sealant, Membrane passed. |
| 21 CFR 177.1520 (extractable/soluble fraction for polypropylene) | Pump Body, Sealing Cover, Bottle passed. | |
| Material Composition | Not manufactured with BPA | Device labeling states it is not manufactured with BPA. |
| Software Validation | FDA guidance and product specifications | Software for all 4 models was validated. |
| Electrical Safety | IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1:2012; IEC 60601-1-11: 2010-04 (Home Healthcare) | All models (M5, M7, M10, M12) passed these standards. |
| EMC Testing | EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007 | All models (M5, M7, M10, M12) passed these standards. |
| Performance - Backflow | No milk able to back flow into pump | Backflow testing showed that no milk is able to back flow into the pump. |
| Performance - Cleaning Validation | Cleaning procedures do not affect device performance | Cleaning Validation Testing showed that after cleaning procedures as recommended in the user manual do not affect device performance. |
| Performance - Suction | Suction strength and cycle speed specifications | Suction curves for each mode for each model show that the device performs to suction strength and cycle speed specifications (specific ranges provided in the "Device Comparison Table" for suction strength and cycle speed across models M5, M7, M10, M12, and compared to predicate). Differences are deemed "not significant." |
| Indications for Use (Equivalence) | Express and collect milk from the breast of a lactating woman | Proposed device (Megna Breast Pumps) and predicate device (Closer to Nature Electric Breast Pump) have the same indication. |
| Technological Characteristics (Equivalence) | Pumping Options, Back Flow Protection, Pump Type, Power Supply, Cycling/Suction Control Mechanism, Number of Suction Levels, Suction Strength, Cycle Speed, Suction Flow Rate | Similarities noted (e.g., Reciprocating Diaphragm, Microprocessor control, yes backflow protection, single/double pumping option). Differences in specific values (e.g., suction strength, cycle speed, flow rate) are presented and deemed "not significant" or not raising new safety/effectiveness concerns. |
2. Sample size used for the test set and the data provenance:
The document pertains to the regulatory clearance of a physical medical device (breast pump), not an AI/ML algorithm that processes diagnostic images or data. Therefore, the concept of a "test set" in the context of an AI/ML model's performance on patient data is not applicable here. The "tests" mentioned are engineering and material compatibility tests performed on the device components or prototypes. No information on "data provenance" (country of origin, retrospective/prospective) for clinical or diagnostic data is provided because such data is not relevant to this type of device clearance based on the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is a breast pump, not an AI/ML diagnostic or predictive tool. "Ground truth" in the context of expert consensus on medical conditions is not relevant here. The "truth" is established by adherence to engineering standards, material safety regulations, and a comparison to the functional specifications of a legally marketed predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a physical device clearance. Adjudication methods are typically used in clinical studies to resolve disagreements among experts when establishing ground truth for diagnostic AI/ML systems.
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:
Not applicable. This is a breast pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device clearance is adherence to established regulatory standards (e.g., 21 CFR, ISO 10993, IEC 60601, EN 60601), successful completion of specific engineering and material tests, and demonstrable functional equivalence to a legally marketed predicate device. There is no biological or diagnostic "ground truth" in the AI/ML sense.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established:
Not applicable. No AI/ML training set is mentioned or implied.
In summary, the provided document is a 510(k) summary for a powered breast pump. It details the device's compliance with various safety and performance standards and its substantial equivalence to a predicate device, rather than addressing the specific criteria and study design relevant to AI/ML device validation.
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