(190 days)
The Wearable Breast Pump is a powered breast pump 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: 1203) is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout, and bra adjuster. All components (minus the pump) are reusable and may be manually cleaned. The Wearable Breast Pump includes rotary electric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes. The Wearable Breast Pump is a battery-powered electro-mechanical device that can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed, and pumping history information. All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.
The Wearable Breast Pump has undergone non-clinical testing to demonstrate that it meets design specifications and is substantially equivalent to the predicate device (Elvie Pump, K181863).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety, Electromagnetic Compatibility, and Wireless Technology | Compliance with: | Non-clinical tests were conducted and demonstrate compliance: |
| - IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | - Device meets basic safety and essential performance requirements. | |
| - IEC 60601-1-2:2014 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests) | - Device meets electromagnetic disturbance requirements. | |
| - IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020 (second edition) (Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance-Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environments) | - Device meets requirements for use in home healthcare environments. | |
| - IEC 62133:2012 (Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications) | - Device's battery components meet safety requirements. | |
| - Compliance with FDA Guidance document, "Radio Frequency Wireless Technology in Medical Devices" dated August 14, 2013 | - Documentation demonstrating compliance with wireless technology guidance was provided. | |
| Biocompatibility | User-contacting materials must be non-cytotoxic, non-irritating, and non-sensitizing, in accordance with ISO 10993. | Biocompatibility testing demonstrated that user-contacting materials are non-cytotoxic, non-irritating, and non-sensitizing, per ISO 10993-5:2009 and ISO 10993-10:2010. |
| Software Validation | Software validation for a "moderate level of concern" as per FDA guidance (2005 guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). | Software validation testing was conducted for a "moderate level of concern" and deemed compliant. |
| Performance Testing | - Vacuum pressure and cycle rate must meet device specifications at all settings. | - Vacuum pressure and cycle rate testing demonstrated that the device met its specifications. |
| - No backflow of liquid into the tubing/pump. | - Backflow testing confirmed that liquid does not backflow into the tubing/pump. | |
| - Device maintains specifications throughout its proposed use life. | - Use life testing demonstrated that the device maintains its specifications throughout its proposed use life. | |
| - Battery remains functional during its stated use-life. | - Battery performance testing demonstrated that the battery remains functional during its stated battery use-life. | |
| - Battery status indicator remains functional during its stated battery life. | - Battery status indicator testing demonstrated that the battery status indicator remains functional during its stated battery life. |
2. Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" in the context of clinical data for the Wearable Breast Pump. The testing appears to be primarily non-clinical, focusing on engineering, safety, and performance standards. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not provided. The testing conducted falls more under product validation and verification based on regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the "ground truth" for the non-clinical tests described is based on established engineering and safety standards (e.g., IEC, ISO) and the device's own design specifications, rather than expert interpretation of clinical data.
4. Adjudication method for the test set:
Not applicable, as this refers to a clinical adjudication process. The non-clinical testing relies on objective measurements against predefined standards.
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 device is a powered breast pump, not an AI-assisted diagnostic or interpretative system that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical-electronic device, not an algorithm, so standalone algorithm performance is not a relevant concept here.
7. The type of ground truth used:
The ground truth for the non-clinical testing is based on:
- International Standards: e.g., IEC 60601 series for electrical safety and EMC, ISO 10993 for biocompatibility.
- FDA Guidance Documents: e.g., for wireless technology and software validation.
- Device Specifications: Internal design requirements for vacuum pressure, cycle rate, backflow prevention, use life, and battery performance.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML product that utilizes a training set for algorithm development.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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).