(15 days)
Powered Breast Pump to express milk from the breast.
The miPump Electric / Battery Breast Pump is a quiet, small, safe and effective system to express milk from the breast. It has electrical pressure control pumping system to generate suction. This device is designed with eight suction levels, which are selectable by the user via pressing the suction button. It is powered either by four (4) AA batteries (not included with package) or powered electrically by utilizing the AC adaptor (6V) which is provided in the package and can be plugged into any standard wall outlet.
The provided text describes a 510(k) summary for the "miPump Electric/Battery Breast Pump" and its accessories. It details the device's characteristics, components, materials, and its classification. However, the document does not contain information regarding objective performance acceptance criteria or a study designed to prove the device meets such criteria.
The document is a regulatory submission to the FDA for market clearance, focusing on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission typically emphasizes technical specifications, safety, and functional equivalence rather than clinical performance studies with specific statistical endpoints.
Therefore, for your request, I can only provide the device description and regulatory classification:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device, adherence to material safety standards (FDA food additive criteria), and electrical safety (Class 2 Transformer).
- Reported Device Performance:
- Function: Express milk from the breast.
- Features: Quiet, small, eight selectable suction levels.
- Power: Four (4) AA batteries or AC adaptor (6V).
- Material Safety: Materials for components in contact with skin and breast milk meet FDA food additive criteria (21 CFR, sections 175-178). No information suggesting tissue irritation, sensitization, or cell damage with these materials.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The document primarily describes the device's design, materials, and regulatory compliance, not a clinical or performance testing study with a "test set" in the context of AI/diagnostic device performance.
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)
- Not applicable/Not provided. This section is relevant for studies involving expert interpretation or diagnostic performance, which is not the focus of this 510(k) submission for a breast pump.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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/Not provided. This device is a breast pump, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" in this context pertains to compliance with material safety standards and functional design, rather than clinical outcomes or diagnostic accuracy. The material safety claims are supported by a "BV test Report (5108 196-0003)" which likely refers to laboratory testing against the specified FDA regulations.
8. The sample size for the training set
- Not applicable/Not provided. This information is typically for machine learning models, which is not relevant to this device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of available information related to performance/safety:
- Device Description: miPump Electric/Battery Breast Pump (Single, Double, Deluxe Double)
- Purpose: To express milk from the breast.
- Key Features: Quiet, small, safe, effective, electrical pressure control, eight suction levels.
- Power Source: 4 AA batteries or AC adaptor (6V).
- Material Safety: Components in contact with user's skin and breast milk are manufactured from materials that meet FDA food additive criteria per 21 CFR sections 175-178. This compliance is supported by "BV test Report (5108 196-0003)". The document states there is "no information suggesting that there have been any tissue irritation, sensitization, or cell damage response with these materials."
- Predicate Device Equivalence: The FDA's letter (K082802) states the device is "substantially equivalent" to legally marketed predicate devices. This is the primary "proof" for 510(k) submissions.
§ 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).