(71 days)
The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) are intended to express milk from lactating women in order to collect milk from their breasts. These devices are intended for a single user.
The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) is intended to express milk from lactating women in order to collect milk from their breasts. It is an electrically powered, software-controlled, digital single user pump. The device consists of the following key components: flange, pump motor, silicone diaphragm, USB cable, milk collector, bra adjustment buckle, and valve. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free without any external power cords.
There device has two modes of operation - Expression mode and Stimulation mode, with multiple suction levels for each mode. Both modes consist of nine vacuum levels. Expression mode consists of pressures ranging from 120-245 mmHg and cycle speeds of 20-66 cycles/min and stimulation mode consists of ranges from 40-120 mmHg and cycle speeds of 69-92 cycles/min. There is an LED status display shown on the pump body, which displays the working mode and battery indicator.
The subject device may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two devices at the same time one on each breast. The pump is provided in non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device is designed not to be used during charging.
The breast pump does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177.
The provided FDA clearance letter and its associated 510(k) summary pertain to the eufy Wearable Breast Pumps (models S1, E10, S1 Pro, E20). However, the document does not describe any specific acceptance criteria or an original study to prove that the device meets acceptance criteria.
Instead, the submission leverages data and testing from a predicate device (Wearable Breast Pump Model S18, K223886) to demonstrate substantial equivalence. The core argument for clearance is that the subject devices are identical or sufficiently similar to the predicate device in terms of design, materials, components, and intended use, such that the predicate's performance and safety data can be applied to the new devices.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment for the subject device are not present in this document because they refer to the original studies performed for the predicate device, not new studies for the eufy Wearable Breast Pumps.
Here's a breakdown based on the information provided and the absence of specific details for the subject device's new studies:
Acceptance Criteria and Device Performance (Leveraged from Predicate Device)
Since the subject device leverages performance data from the predicate device (K223886), the acceptance criteria and reported performance for the eufy Wearable Breast Pumps are assumed to be met if they match or are within the validated ranges of the predicate device. The document explicitly states that the subject device has "identical functions and mode of operations" as the predicate device.
| Acceptance Criterion (Based on Predicate Device) | Reported Device Performance (Leveraged from Predicate) |
|---|---|
| Biocompatibility: Materials are safe for patient contact. | Materials (Polypropylene, Silicone, ABS) are identical to predicate and compliant with 21 CFR 177, proving biocompatibility. |
| Electrical Safety: Device meets electrical safety standards. | Electrical design, components (Li-ion battery), and charger are identical to predicate, proving electrical safety. |
| Electromagnetic Compatibility (EMC): Device meets EMC standards. | Identical to predicate device, proving EMC compliance. |
| Software Verification & Validation: Software functions correctly and reliably. | Identical software to predicate device, proving software validity. |
| Vacuum Level & Cycle Frequency: Device operates within specified ranges for stimulation and expression modes. | Stimulation Mode: Suction Strength: 40-120 mmHg, Cycle Speed: 69-92 cycles/minute. Expression Mode: Suction Strength: 120-245 mmHg, Cycle Speed: 20-66 cycles/minute. (These match the predicate device specifications, thus acceptance criteria are met). |
| Backflow Protection: Prevents milk backflow into tubing. | Demonstrated effectiveness in preventing liquid backflow. |
| Use Life: Device maintains specifications throughout its proposed use life. | Demonstrated to maintain specifications over its proposed use life. |
| Battery Performance: Battery capacity, service time, and charging time meet specifications. | Battery functions as specified during its stated use-life. |
Study Details for eufy Wearable Breast Pumps (K250152)
Because this clearance relies heavily on leveraging data from a predicate device (K223886) rather than conducting wholly new, independent studies for all aspects, many of the specific study details you requested for this submission are not applicable or not provided. The document repeatedly states that testing was "leveraged from the predicate device."
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Sample size used for the test set and the data provenance:
- No specific sample size for new test sets is provided for the eufy Wearable Breast Pumps in this document. The performance testing was "leveraged from the predicate device (K223886)."
- Therefore, the provenance of the original data would refer to the studies conducted for the predicate device, which are not detailed here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as new "ground truth" establishment for clinical performance is not described for the subject device in this document. Performance data was leveraged from the predicate's testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no new test set requiring expert adjudication for a clinical endpoint is described in this document.
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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 powered breast pump, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study is not relevant to its clearance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device incorporates embedded software which controls its features. The document states, "software documentation, including verification & validation, was leveraged from the predicate device to support the validity of the subject device software-controlled functions." This implies that standalone software performance was assessed during the predicate device's evaluation, and that assessment is accepted for the subject device due to identical software.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical performance aspects (vacuum, cycle speed, backflow, electrical safety, battery life), the "ground truth" is defined by engineering specifications and objective measurements against those specifications. For example, a vacuum gauge and timer would provide the "ground truth" for vacuum level and cycle speed.
- For biocompatibility, the ground truth is compliance with regulatory standards (e.g., 21 CFR 177) and material testing results.
- For software, the "ground truth" is its adherence to functional and performance requirements established through verification and validation.
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The sample size for the training set:
- Not applicable. This device involves hardware and embedded software; it does not utilize machine learning or AI models that require a "training set" in the typical sense. The software is deterministic and based on design specifications.
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How the ground truth for the training set was established:
- Not applicable, as no machine learning training set is involved.
§ 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).