(145 days)
The Wearable Breast Pump (Model S10) 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 S10), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, type-C USB cable, valve, and milk collector. It is designed to work in the user's bra and has a rechargeable battery so it can be used handsfree 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 S10 model is capable of providing vacuum levels from 45-112 mmHg with cycling rates from 49-100 cycles per minute in stimulation mode and vacuum levels from 133-225 mmHg with cycling rates from 20-57 cycles per minute in expression mode. The Wearable Breast Pump (Model S10) 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. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
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.
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.
This document describes the FDA clearance for the Wearable Breast Pump (Model S10) and not a study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, is not present in this regulatory submission.
The document does include:
- Indications for Use: The Wearable Breast Pump (Model S10) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
- Performance Testing (Non-Clinical):
- Vacuum level verification testing.
- Backflow protection testing.
- Use-life testing.
- Battery performance testing.
- Battery status indicator testing.
- Battery charging testing.
However, the specific acceptance criteria values for these performance tests are not explicitly outlined, nor are the detailed results presented in a table format that quantifies "reported device performance" against those criteria. The document states that testing demonstrated that the devices meet mode/cycle specifications, but doesn't provide the raw data or the specific numerical thresholds for "meeting specifications."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them with the level of detail regarding AI/ML validation metrics, as this document pertains to a traditional medical device clearance and not an AI/ML-driven device validation study.
§ 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).