(214 days)
The Wearable Breast Pump (Model S12) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
The Wearable Breast Pump (Model S12), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, USB cable, valve, milk collector, and bra adjustment buckle. 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. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping). The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Both stimulation and expression mode consist of 9 vacuum levels. The S12 model is capable of providing vacuum levels from 40-105 mmHg with cycling rates from 75-109 cycles per minute in stimulation mode and vacuum levels from 40-245 mmHg with cycling rates from 28-85 cycles per minute in expression mode. The model S12 Wearable Breast Pump is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.
The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
All other components (i.e., motor unit) of the subject device are not in contact with the breast.
The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.
The subject device components are made of the following materials:
- · Motor unit: acrylonitrile-butadiene-styrene (ABS) plastic
- · Flange, tube, valve, diaphragm: Silicone
- · Linker, milk collection container: Polypropylene
All milk contacting components are compliant with 21 CFR 174-179.
The provided text describes the Wearable Breast Pump (Model S12) and its 510(k) submission to the FDA. However, it does not contain a study comparing the device's performance against specific acceptance criteria in a clinical setting with human subjects, nor does it detail a study that proves the device meets such criteria through statistical analysis or a clinical trial.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Willow Wearable Breast Pump) through non-clinical performance testing and a comparison of technological characteristics.
Therefore, many of the requested items cannot be extracted from this document, as they pertain to clinical efficacy or diagnostic performance studies that are not present here.
Here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it details non-clinical performance tests conducted to ensure the device's basic functionality and safety. The performance reported is that the device "meets mode/cycle specifications" and functions as intended, rather than quantitative patient-centric outcomes.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (from "Summary of Non-Clinical Performance Testing") |
|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, and non-sensitizing for user-contacting materials (tested per ISO 10993-5:2009, ISO 10993-10:2010). |
| Electrical Safety | Compliant with AAMI ANSI ES60601-1:2005/(R)2012, A1:2012; IEC 62133-2:2017; and IEC 60601-1-11:2015. |
| Electromagnetic Compatibility | Compliant with IEC 60601-1-2:2014. |
| Software Functionality | Evaluated as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (No specific performance metrics are given, only that it was evaluated per guidance). |
| Vacuum Level and Cycling Rate | "Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications." (Specific mmHg and cycles/minute ranges are listed in the comparison table, and the testing confirmed these are met.) For Stimulation: -40 to -105 (±5) mmHg, 70 to 114 cycles/minute. For Expression: -40 to -245 (±5) mmHg, 23 to 90 cycles/minute. |
| Backflow Protection | "Backflow protection testing was conducted to verify liquid does not backflow into the tubing." (Testing confirmed no backflow). |
| Use Life | "Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life." (Confirmed device maintains specifications). |
| Battery Performance | "Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life." (Confirmed battery functionality). |
| Battery Status Indicator | "Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life." (Confirmed indicator functionality). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes non-clinical engineering and safety tests (e.g., biocompatibility testing, electrical safety, vacuum verification), not studies involving human subjects or data sets in the context of clinical performance evaluation.
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)
This information is not provided. The testing described is primarily laboratory-based and engineering validation, not dependent on expert interpretation of medical data or images for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as it pertains to medical data interpretation, which is not part of this 510(k) submission's described testing.
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
There was no MRMC comparative effectiveness study described in the document. The device is a breast pump, not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the device's mechanical and electrical functions was done, as detailed in the "Summary of Non-Clinical Performance Testing". This includes vacuum level verification, backflow protection, use life, and battery performance testing. However, this is not "algorithm only" performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Biocompatibility: Ground truth established against standardized laboratory testing protocols (e.g., ISO 10993).
- Electrical Safety & EMC: Ground truth established against recognized international standards (e.g., IEC 60601 series).
- Software: Ground truth established by compliance with FDA guidance.
- Vacuum/Cycle, Backflow, Use Life, Battery: Ground truth established against engineering design specifications and internal requirements for functionality and durability.
There is no mention of expert consensus, pathology, or outcomes data, as these are typically used for clinical diagnostic or treatment efficacy studies, which are not detailed here.
8. The sample size for the training set
This information is not provided. The device does not appear to utilize machine learning algorithms that would require a "training set" in the traditional sense. Its software operates on embedded logic, not a learned model.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a training set for machine learning.
§ 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).