(154 days)
The Wearable Breast Pump (Model W8) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The Wearable Breast Pump (Model W8) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast. There are 4 modes available for the device which are Expression mode, Massage mode, Auto mode and Stimulation mode. There is a LED status display for W8, including working mode, and battery indicator can be shown on the pump body. The user interface includes on/off switch, mode selection/long press, and vacuum adjustment. W8 operated as a single or double pumping system, one on each breast. The pump is provided non-sterile and reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). W8 is designed not to be used during charging. The breast pump does not incorporate any off-the-shelf (OTS) software. The device incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177 which is applicable for the subject device.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the Wearable Breast Pump (Model W8).
It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical performance testing rather than clinical efficacy studies often associated with AI/ML devices or studies directly proving therapeutic effect. Therefore, many of the requested points related to AI, human readers, ground truth establishment for patient outcomes, and clinical study designs will not be present. The "device" in this context is a physical breast pump, not an AI algorithm.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
For a breast pump, "acceptance criteria" primarily relate to engineering specifications and safety standards rather than diagnostic performance metrics like sensitivity/specificity. The document states that the device was tested against its own specifications, and "Device specifications were met for all tests conducted."
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance (Model W8) | Notes |
|---|---|---|---|
| Performance Testing | Vacuum pressure (Stimulation Mode) | 40-170 mmHg | This is the specification for the device. The document states "Device specifications were met for all tests conducted," indicating the tested device performed within this range. The predicate's range was 35-110 mmHg, showing a difference that was found to not raise new questions of safety/effectiveness. |
| Cycle speed (Stimulation Mode) | 77 to 127 cycles/minute | Specification. Predicate: 70 to 114 cycles/minute. | |
| Vacuum pressure (Expression Mode) | 120-245 mmHg | Specification. Predicate: 35-245 mmHg. The predicate has a wider range covering lower vacuum, implying the Model W8 starts at a higher minimum expression vacuum. This was deemed acceptable. | |
| Cycle speed (Expression Mode) | 32 to 92 cycles/minute | Specification. Predicate: 23 to 90 cycles/minute. | |
| Vacuum pressure (Massage Mode) | 40-140 mmHg | Specification. Predicate had no "Massage Mode." | |
| Cycle speed (Massage Mode) | 79-143 cycles/minute | Specification. Predicate had no "Massage Mode." | |
| Vacuum pressure (Auto Mode) | 40-245 mmHg | Specification. Predicate had no "Auto Mode." | |
| Cycle speed (Auto Mode) | 32-136 cycles/minute | Specification. Predicate had no "Auto Mode." | |
| Suction levels | 15 levels | Specification. Predicate had 9 levels. | |
| Backflow protection | Confirmed YES | Functional requirement. Indicates successful demonstration of backflow prevention. | |
| Battery capacity & service time | Specifications met | Functional requirement. | |
| Charging time | Specifications met | Functional requirement. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | The user-contacting materials (milk collector, linker, flange, valve, diaphragm) were tested and found to meet these safety standards. |
| Sensitization (ISO 10993-10:2021) | Non-sensitizing | ||
| Irritation (ISO 10993-10:2021) | Non-irritating | ||
| Electrical Safety & EMC | IEC 60601-1 (Basic safety & essential performance) | Device complies | The device, including all modules and accessories, was tested and demonstrated compliance with these international standards for medical electrical equipment. |
| IEC 60601-1-11 (Home healthcare environment) | Device complies | ||
| IEC 60601-1-2 (Electromagnetic disturbances) | Device complies | ||
| IEC 62133-2 (Safety requirements for portable sealed secondary lithium cells) | Device complies | Specifically for the Li-ion battery (3.7V, 1200mAh) powering the device. | |
| Software V&V | Content of Premarket Submissions for Device Software Functions (Basic Level) | Software verification and validation conducted as recommended in FDA guidance, with a Basic Documentation Level. Implies successful completion. | The device incorporates embedded software to control features. The V&V ensures the software functions correctly and safely within its design specifications, as per FDA guidance for software in medical devices. The "acceptance criteria" here would be the successful completion of all V&V activities and meeting documented software requirements. |
| Material Compliance | Milk-contacting components compliant with 21 CFR 177 | All milk-contacting components (Polypropylene for collector/linker, Silicone for flange/valve/diaphragm) are compliant with 21 CFR 177 (food-contact). | This is a regulatory requirement for safety and material compatibility with expressed milk. The materials used were listed and their compliance indicated, meaning they meet the "acceptance criteria" for safe contact with food/milk, preventing contamination or adverse reactions from material leaching. |
The subsequent points (2-9) are typically relevant for studies involving AI/ML devices, clinical performance, or diagnostic effectiveness based on expert interpretation. As this 510(k) is for a physical medical device (a breast pump) and not an AI/ML diagnostic tool, a direct equivalent for many of these points is not applicable or explicitly mentioned in the provided summary. The summary focuses on engineering, safety, and compatibility testing.
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Explicitly Stated for Clinical Outcomes: The summary describes bench performance testing on the device itself and biocompatibility testing of materials, not a clinical study on human subjects with a "test set" of patient data. For bench testing, the "sample size" would refer to the number of devices or components tested, which is not detailed but assumed to be sufficient for engineering verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This relates to human interpretation of data for ground truth establishment in diagnostic studies. For a breast pump, "ground truth" is established by engineering specifications and objective measurements (e.g., pressure gauges, timers, chemical analysis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Again, this pertains to expert review and consensus for diagnostic ground truth, which is not relevant for the type of testing described here.
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 specific to AI-assisted diagnostic workflows. No human reader interaction or AI assistance is mentioned or relevant for a breast pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to standalone AI algorithm performance. This device is a physical breast pump, not an algorithm. While it has embedded software, its performance is evaluated as an integrated system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is driven by:
- Engineering Specifications: Defined ranges for vacuum pressure, cycle speed, battery life, etc.
- International Standards: Compliance with ISO (e.g., ISO 10993 for biocompatibility) and IEC (e.g., IEC 60601 for electrical safety and EMC) standards.
- Regulatory Requirements: Compliance with 21 CFR regulations (e.g., 21 CFR 177 for milk-contacting materials).
- Functional Verification: Demonstrating features like backflow protection and proper software operation.
8. The sample size for the training set
- Not Applicable: This applies to AI/ML models. This device is not an AI/ML system trained on data.
9. How the ground truth for the training set was established
- Not Applicable: This applies to AI/ML models.
§ 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).