(214 days)
The BR128 Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.
The BR128 is an electrically powered breast pump that uses negative pressure to express milk from the breasts of lactating women. It adopts a Single-Chip Microcomputer to imitate a baby's suckling action and a reciprocating vacuum pump to generate the suction to extract the milk at vacuum levels between 0 and 170mmHg. It is intended for single pumping.
It is designed to mechanically interface with a mother's breast via a massage cushion and withdraw then collect the breast milk. The motor unit of the device is connected to the bottle via a silicone tube. Its suction strength is adjustable via the suction adjustment button on the device, but its cycles per minute are controlled by software and cannot be adjusted. The device can be powered by batteries or the provided mains adapter.
The provided text is a 510(k) Summary for the BR128 Breast Pump, which is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This document is a premarket notification for a medical device submitted to the FDA, asserting substantial equivalence to a legally marketed predicate device.
Based on the provided information, here's a breakdown of the acceptance criteria and the study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance metrics like "Stimulating Velocity" or "Sucking Intensity" that would typically be defined as a required range the device must operate within to be considered safe and effective. Instead, it presents a comparison table of the subject device's specifications against a predicate device. The underlying "acceptance" is based on the device demonstrating performance within a range that is considered safe and effective for breast pumps, primarily by showing substantial equivalence to a predicate device.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (BR128 Breast Pump) |
|---|---|---|
| Intended Use | Express and collect milk from a lactating woman's breasts; single user. | Express and collect milk from a lactating woman's breasts; single user. |
| Patient Population | Lactating women | Lactating women |
| Environment of Use | Home | Home |
| Pump Style | Reciprocating Vacuum Pump | Reciprocating Vacuum Pump |
| Adjustable Suction Levels | Yes | Yes |
| Adjustable Cycle Rates | Yes (Predicate: 30-80 cycles/min) | No |
| Stimulating Velocity | 30-80 cycles/min (Predicate) | 100-150 cycles/min |
| Stimulating Intensity | 50-270mmHg (Predicate - single) | 0-170mmHg |
| Sucking Velocity (Cycle Rate) | 30-80 cycles/min (Predicate) | 13-18 cycles/min |
| Sucking Intensity | 50-270mmHg (Predicate - single) | 0-170mmHg |
| Overflow Protection | Yes (Predicate) | No |
| Pressure Modulation Control | Microprocessor | Microprocessor |
| Software | Yes | Yes |
| Power Source | AC adaptor or 6 AA batteries (Predicate) | AC adaptor or 2 AA Batteries |
| Cleaning Method for Accessories | Boiling water | Boiling water |
| Patient Contact Material | Unknown (Predicate) | Silicone, PP, ABS (verified by ISO 10993) |
| Food Contact Material | Unknown (Predicate) | PP & Silicone (evaluated by 21 CFR food criteria) |
The justification for "acceptance" is that "These differences do not raise different questions of safety or effectiveness."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document focuses on non-clinical performance testing and does not report any clinical tests or studies involving a "test set" of patients or data in the way a diagnostic AI device would. The testing performed is primarily focused on engineering performance, electrical safety, EMC, biocompatibility, and software validation. Therefore, sample sizes for a test set of data or data provenance are not applicable in this context.
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. As noted above, this submission does not involve clinical data or "ground truth" established by experts in the context of diagnostic performance. The validation is against established safety and performance standards, and engineering specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" requiring adjudication by experts.
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 device is a breast pump, not a diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical breast pump with software control, not an algorithm being evaluated for standalone performance. Its "performance" is its ability to express milk, which is assessed through engineering tests (pressure, cycle speed, etc.), not through an "algorithm-only" evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" for proving substantial equivalence relates to:
- Compliance with recognized performance standards (e.g., minimum and maximum pressure, cycle speed, sound volume).
- Compliance with safety standards (biocompatibility, electrical safety, EMC).
- Food and patient contact material assessments against regulatory criteria (FDA 21 CFR and ISO 10993).
- Software validation against FDA guidance.
The "ground truth" is therefore regulatory and engineering compliance, rather than a clinical ground truth like pathology or expert consensus on clinical outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set" of data for algorithm development.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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).