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510(k) Data Aggregation
(29 days)
The Freemie® Independence and Freemie® Liberty are powered breast pumps to be used by lactating women to express and collect milk from their breast. The Freemie® Independence and Freemie® Liberty pumps are intended for use by a single user.
The Freemie® Independence and Freemie® Liberty powered breast pumps utilizes the supplied previously cleared device (K130349) Freemie® Breast Pump Collection System to express and collect milk from the breast of a lactating woman. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The system is designed for mobile pumping (home, office, etc.) as the device is light weight, compact in size and can be attached to the user's clothing with a clip. Ten (10) suction levels, eleven (11) cycle speeds and three (3) memory settings (suction and cycle levels) are user adjustable via tactile switches (referred to as buttons). The pumps are powered by a rechargeable lithium-ion polymer battery which can be charged with a USB to micro USB provided cable (laptop, car, etc.) and alternatively with a supplied wall charge adapter with a USB port for charging the battery with mains power. The sole function of the Micro USB port on the pump is for charging the pump. The power to the pump is always supplied by the battery, even when charging. Firmware controls a low voltage DC swash plate vacuum pump and solenoid that is capable of providing vacuum levels from -10 to -280 mmHq with cycle speeds from 18 to 150 cycles per minute. A physical barrier on the collection side prevents backflow of milk into the pump. The Freemie® Independence Pump has a series of LED lights to indicate the pump's current use settings to the user and has a pre-programmed auto shut-off timer that turns the pump off after 40 minutes. The Freemie® Liberty Breast Pump has an LCD screen to indicate the pump's current use settings to the user and has an auto shut-off timer that is user adjustable in five minute increments from 5 to 40 minutes.
The provided text describes the 510(k) summary for the Freemie® Independence and Freemie® Liberty Breast Pump. This document is for a medical device that aims to demonstrate substantial equivalence to a predicate device, not for an AI/ML powered device. As such, many of the typical acceptance criteria and study details for AI/ML devices (like sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, or standalone performance metrics like AUC, sensitivity, specificity) are not applicable or not provided in this document.
However, I can extract the acceptance criteria related to the device's technical specifications and the non-clinical tests performed to demonstrate its performance and safety, which serve as the "study" proving it meets these criteria.
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and compliance with voluntary standards. The device performance is detailed through its specifications and test results ensuring compliance with these standards and similar functionality to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | Same intended use: to express and collect milk from the breast of a lactating woman. |
| Vacuum Generation Capability (similar to predicate) | Vacuum range: -10 to -280 mmHg (Predicate: -50 to -280 mmHg). The subject device covers a wider low-end range, but the upper limit is the same. |
| Cycle Speed Capability (similar to predicate) | Cycle speed: 18 to 150 cycles/minute (Predicate: 38 to 70 cycles/minute). The subject device offers a wider range of cycle speeds. |
| Backflow Protection | Yes (similar to predicate). Confirmed by "backflow protection (fill test)". |
| Software/Firmware Functionality | Embedded software. Software verification and validation testing conducted as per FDA guidance. |
| Safety Standards Compliance | |
| Electrical Safety | Complies with IEC 60601-1:2005 (2012 reprint). |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2:2014 (4th edition). |
| Usability (Electrical Safety) | Complies with IEC 60601-1-6:2010 (3rd edition) + A1:2013. |
| Electrical Safety for Home Healthcare Environment | Complies with IEC 60601-1-11:2015 (2nd edition). |
| Portable Battery Safety | Complies with IEC 62133:2012 (2nd edition) for portable sealed secondary cells and batteries. |
| Photobiological Safety of Lamps | Complies with IEC 62471:2006 (1st edition). |
| Risk Management | Risk Analysis developed in accordance with ISO 14971:2007. |
| Durability and Performance Tests | |
| Minimum & Maximum Vacuum Levels | Performance testing performed to determine these. |
| Cycle Speeds | Performance testing performed to determine these. |
| Motor Life Cycle | Performance testing performed. |
| Drop Test | Performance testing performed. |
| Voltage Verification | Performance testing performed. |
| Comparison Testing with Predicate | Spectra S1 Plus and S2 Plus comparison testing performed to ensure "similar level of vacuum" and overall performance. |
| Biocompatibility | The pump itself does not have direct or indirect user contact. It utilizes a previously cleared device (K130349) Freemie® Breast Pump Collection System, implying biocompatibility of the parts in contact with media is established through that cleared device. |
The "study" that proves the device meets these acceptance criteria is the Summary of Non-Clinical Tests section of the 510(k) submission (starting on page 5/6). This section explicitly lists the various tests and standards to which the device was subjected and found compliant.
Regarding AI/ML specific information, this document does not contain the following as it's not an AI/ML device submission:
2. Sample size used for the test set and the data provenance: Not applicable. Performance is validated through engineering tests and adherence to standards, not through a "test set" of data in the AI/ML sense. Data provenance is therefore not relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device usually refers to expert labels on data. For this breast pump, 'ground truth' is objective measurements against engineering specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 mechanical/electronic pump, not an AI diagnostic/interpretative tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's performance is inherently "standalone" in its mechanical function, but this term typically applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is adherence to established engineering specifications, safety standards (e.g., IEC 60601-1), and functional equivalence demonstrated through direct comparison measurements against the predicate device.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
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