(128 days)
The Lucy Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Lucy Breast Pump is intended for a single user.
The Lucy Breast Pump (Lucy) is a cordless, software-controlled, battery powered breast pump that is intended for use by lactating women to express and collect breast milk. The Lucy Breast Pump is intended for a single user and provided as a non-sterile device. The user has the option to pump from one breast (single pumping) or two breasts simultaneously (double pumping). The fully assembled Lucy Breast Pump, consisting of the Flange, Pump Body, Pump Diaphragm, and Container Assembly, is designed to work in the user's nursing bra that allows it to be used handsfree. The Lucy Breast Pump provides two operational modes (stimulation and expression), with three vacuum/cycle levels in stimulation mode and four vacuum/cycle levels in expression mode. Switching between modes and changing the levels within each mode is done through the physical interface on the pump.
The FDA 510(k) summary for the Lucy Breast Pump (K213311) details non-clinical performance testing conducted to demonstrate substantial equivalence to its predicate device, the Medela Pump In Style (K200508).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Electrical Safety/EMC | Compliance with various standards including: ANSI/AAMI ES60601-1:2005/(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012, IEC 60601-1-11:2015, ANSI/AAMI/IEC 60601-1-2:2014, IEC 62133-2:2017, UN 38.3, UL 1642, UL 2054 2nd edition. | "Testing was conducted in accordance with" the listed standards, implying compliance. The document states, "The performance data demonstrate that the subject device is as safe and effective as the predicate device," which includes electrical safety aspects. |
| Biocompatibility | User-contacting materials to be non-cytotoxic, non-irritating, and non-sensitizing, based on ISO 10993-5:2009 and ISO 10993-10:2010, and FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." | "The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing." |
| Performance Bench Testing | Vacuum Pressure and Cycle Rate: Device must meet established specifications at all settings. | |
| Backflow: Liquid should not backflow into the pump. | ||
| Use-Life: Device must maintain specifications throughout its proposed use-life. | ||
| Battery Performance: Battery must remain functional during its stated use-life. | ||
| Battery Status Indicator: Indicator must reflect the minimum number of pumping sessions remaining at each color level as stated in labeling. | ||
| Battery Charging: Demonstrate the duration of time needed to fully recharge the battery. | "Vacuum pressure and cycle rate testing was conducted at all settings and demonstrated that the device met its specifications." | |
| "Backflow testing was conducted to demonstrate that liquid does not backflow into the pump." | ||
| "Use-life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use-life." | ||
| "Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life." | ||
| "Battery status indicator testing was conducted to demonstrate that the battery status indicator reflects the minimum number of pumping sessions remaining at each color level as stated in device labeling." | ||
| "Battery charging testing to demonstrate the duration of time needed to fully recharge the battery." | ||
| Software | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005 FDA guidance document) to support a moderate level of concern. | "Software verification and validation was conducted in accordance with the 2005 FDA guidance document... to support a moderate level of concern." |
| Reprocessing | Cleaning validation study in accordance with the 2015 FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." | "A cleaning validation study was conducted and supporting information provided in accordance with the 2015 FDA guidance document..." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes non-clinical bench testing. It does not mention a "test set" in the context of human subjects or a clinical study. Therefore, information regarding sample size, data provenance, or retrospective/prospective nature is not applicable here as the studies are focused on device performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The reported studies are non-clinical bench tests (e.g., electrical, biocompatibility, performance, software V&V, reprocessing validation) and do not involve human subject data requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable, as there is no "test set" in the context of human subject data demanding adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The provided document focuses on non-clinical performance and safety testing to establish substantial equivalence based on engineering and material specifications, not a clinical comparison of reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The Lucy Breast Pump is a physical medical device, not an AI algorithm for diagnostic or prognostic purposes. While it has embedded software, the performance studies are related to the hardware's functional and safety aspects.
7. Type of Ground Truth Used:
For the non-clinical tests described, the "ground truth" is established by:
- Engineering specifications and industry standards: For electrical safety, EMC, vacuum pressure, cycle rate, use-life, and battery performance.
- Regulatory guidance and international standards: For biocompatibility (ISO 10993) and cleaning validation.
- Internal design specifications: For how the device is intended to perform (e.g., backflow prevention, battery indicator accuracy).
8. Sample Size for the Training Set:
Not applicable. The Lucy Breast Pump is not an AI/ML device that requires a training set of data. The "software" referred to is embedded control software for device operation, not machine learning software trained on data.
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).