(86 days)
The Wearable Breast Pump (Model S9) 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 S9), 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 5 vacuum levels. The S9 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 S9 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 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.
{
"1_table_of_acceptance_criteria": {},
"2_sample_size_and_data_provenance": "Not applicable, as this device does not involve a test set for diagnostic accuracy or similar performance metrics. The testing focused on technical performance (e.g., vacuum levels, battery life) and safety (e.g., biocompatibility, electrical safety).",
"3_number_of_experts_and_qualifications": "Not applicable. No expert review was specified for establishing ground truth as the tests conducted were primarily engineering and safety performance tests against predefined technical specifications and standards.",
"4_adjudication_method": "Not applicable. Adjudication methods are typically relevant for studies involving subjective interpretation or diagnostic accuracy by multiple experts, which is not the case for the enumerated tests.",
"5_mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a breast pump, and the evaluation focused on its technical performance and safety, not on human reader performance or diagnostic improvement with AI assistance.",
"6_standalone_performance_study": "Yes, standalone performance studies were conducted. These studies include: \n- Biocompatibility testing\n- Electrical safety testing\n- Electromagnetic compatibility testing\n- Software evaluation\n- Vacuum level verification testing\n- Backflow protection testing\n- Use life testing\n- Battery performance testing\n- Battery status indicator testing\nThese tests demonstrate the device's technical performance and safety characteristics without human intervention as part of the performance evaluation.",
"7_type_of_ground_truth_used": "The ground truth relied on established engineering specifications, international safety standards (e.g., ISO, IEC), and regulatory guidelines (e.g., FDA guidance documents). For example, vacuum levels were verified against specified ranges, and biocompatibility was assessed against criteria defined in ISO 10993.",
"8_sample_size_for_training_set": "Not applicable. The document does not describe a training set as the device is not an AI/ML-driven diagnostic tool that requires machine learning training data.",
"9_how_ground_truth_for_training_set_was_established": "Not applicable, as there was no training set for an AI/ML model."
}
§ 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).