(206 days)
The Freemie breast pump collection system is intended to be used in conjunction with an approved powered breast pump for the purpose of expressing human milk.
The device is to be used by connection to an approved breast pump, and will be used in place of the pump's original breast milk collection equipment. The device has a funnel-shaped breast funnel, internal valve assembly and enclosing reservoir shaped like a bowl. Additional accessories, associated with the device to replicate the functional and performance characteristics necessary for use with some pump brands, will be sold separately but in conjunction with the sale of the Freemie when those specific brands are identified by the user. The Freemie device is designed to be supported within a woman's ordinary or nursing brassiere, and held in place there while the lactating woman is pumping. When the pump extracts milk, the milk flows out through the end of the funnel and enclosing valve system, where it gathers and is collected in the cup. When the lactating woman is done pumping, she turns off the pump, removes the Freemie from her brassiere and transfers the milk to a storage container for later use.
The Freemie device is available with two cup variations. The first (identified as "Round" or "Standard") is similar in shape to the predicate Freemie (K111411). The second (referred to as "Shaped" or "Natural" or "Formed") is a shaped cup that is intended to approximate a shape that, for aesthetic purposes, more resembles the natural shape of a breast supported by an ordinary brassiere. Both variants are made from the same materials, function identically and use the same valve and funnel assembly and will be chosen by the user based on individual preference. The interfaces where the cup and cone variants attach to each other are identical.
The Freemie will also be available in 3 funnel variants, a 25mm (similar to the predicate Freemie), identified by DAO Health as FG008 (Standard) and FG011 (Form Shape), and larger 28mm (FG009 for the Standard and FG012 for the Form Shape) and 32mm (FG010 for Standard and FG013 for the Form Shape) funnels. All funnel sizes are made from the same material, fit with either of the cup variants and use the same universal valve assembly.
The Freemie® Breast Pump Collection System, as described in the provided 510(k) summary, demonstrates its acceptance through various performance tests, primarily focusing on demonstrating equivalence to predicate devices and ensuring safety and effectiveness.
Here's an breakdown outlining the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Since the provided text does not explicitly detail a "table of acceptance criteria" with numerical targets and direct comparisons, I will synthesize the information to create a table based on the various performance testing categories mentioned and the general conclusion of equivalence.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Biocompatibility | Passed all biocompatibility testing. |
| Breast Funnel Design | Demonstrated equivalence to the predicate device and other marketed accessories. (Implies meeting functional and safety aspects of design). |
| Compatible Pumps | Demonstrated compatibility with approved breast pumps, with accessories available to replicate functional and performance characteristics for specific pump brands. |
| Vacuum Performance | Bench testing demonstrated equivalence to the predicate device. (Implies maintaining effective vacuum for milk expression). |
| Capacity | Bench testing demonstrated equivalence to the predicate device. (Implies holding an appropriate volume of milk without issue). |
| Freedom from Leakage | Bench testing demonstrated equivalence to the predicate device. (Implies no leaks during use, ensuring proper milk collection). |
| Ability to be Supported | Bench testing demonstrated equivalence to the predicate device. (Implies stable and secure placement within a brassiere during pumping). |
| Material Equivalence | Constructed of similar materials as the Predicate Device(s) and other currently marketed accessories. |
| Design Equivalence | Similar design to the Predicate Device(s) and other currently marketed accessories. |
| Indications for Use | Same indications as the Predicate Device(s) and other currently marketed accessories, i.e., "intended to be used in conjunction with an approved powered breast pump for the purpose of expressing human milk." |
| General Safety & Effectiveness | Bench and biocompatibility testing have demonstrated equivalence and the safety and effectiveness of the device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that "Performance testing was conducted to demonstrate Safety and Effectiveness and for comparison to the predicate device."
The specific sample sizes for tests such as Breast Funnel Design, Compatible Pumps, Vacuum Performance, Capacity, Freedom from Leakage, and Ability to be Supported are not explicitly mentioned in the provided summary.
The data provenance is not stated, but the testing would typically be conducted by the manufacturer or contracted labs within the country of origin (USA, based on the submitter's address). The nature of the performance tests (bench testing) suggests that this was likely prospective testing designed specifically for this submission, rather than retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The provided information does not specify the number of experts or their qualifications used to establish ground truth. The tests described are primarily engineering/bench performance tests rather than clinical evaluations requiring expert interpretation. For biocompatibility, certified labs and toxicologists would establish "ground truth" through adherence to established standards (e.g., ISO 10993).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given that the tests described are bench performance and biocompatibility evaluations, an "adjudication method" in the sense of clinical human-reader consensus (e.g., 2+1 for image interpretation) is not applicable or described. The results of bench tests are typically objective measurements against predefined specifications or comparison points.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of data, often with AI assistance. The Freemie Breast Pump Collection System is a mechanical device for milk expression, not a diagnostic tool, and involves no AI component or human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Freemie Breast Pump Collection System is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests mentioned (Breast Funnel Design, Compatible Pumps, Vacuum Performance, Capacity, Freedom from Leakage, Ability to be Supported), the 'ground truth' was based on:
- Predicate device performance: direct comparison to the established characteristics of the legally marketed predicate device (Freemie Breast Pump Collection System K111411 and Medela® Pump in Style Advanced® Breastpump K031614).
- Established engineering specifications/standards: adherence to functional and safety requirements for breast pumps, even if no formal performance standards are promulgated (as stated, "Performance standards have not been promulgated for powered breast pumps," but general engineering principles and safety considerations would apply).
- Biocompatibility standards: meeting established international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
8. The sample size for the training set
Not applicable. This device is hardware and does not utilize a training set in the context of machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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).