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510(k) Data Aggregation
(229 days)
Willow Generation 3 Breast Pump
The Willow® Generation 3 Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
The Willow Gen 3 is a small electromechanical breast pump intended for lactating women to express and collect breast milk. It is a reusable single user device which is provided non-sterile. The device consists of a Pump, Flange, Flextube, and either Milk Bag (single use, disposable) or Milk Container (multiple use, reusable) assembled into one unit and is designed to fit on the user's breast. The pump component does not come into direct or indirect contact with the breast milk. Users can pump one breast using one Willow Pump or pump both breasts simultaneously using two Willow pumps. The device operates on a battery which can be charged with the provided charger using a standard 120V wall outlet. Two pumping modes are provided: stimulation and expression. The pump is controlled by the user through either the tactile buttons on the pump or optionally through the Mobile App or Apple Watch App.
Acceptance Criteria and Device Performance for Willow® Generation 3 Breast Pump (K230570)
This document summarizes the acceptance criteria and performance data for the Willow® Generation 3 Breast Pump, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device: Willow Gen 2) | Reported Device Performance (Willow Gen 3) |
|---|---|---|
| Primary Functional Parameters | ||
| Intended Use | Express milk from lactating women to collect milk. Intended for a single user. | Same. "The Willow® Generation 3 Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user." (Word "breast" added for clarification). |
| Suction Levels (range) | 60-245 mmHg | 40-245 mmHg (Same upper limit) |
| Maximum Suction Level | 270 mmHg | 270 mmHg (Same) |
| Adjustable Suction Levels / Number of Settings | Yes, 7 levels. | Yes, 7 levels. (Same) |
| Suction Cycles (cycles/second) | 1-1.5 | 0.7 to 1.5 (Same upper limit) |
| Number of Phases | Two (Stimulation, Expression) | Same |
| Milk Collection Volume | 4 oz | Same |
| Safety & Performance Standards | ||
| Software Level of Concern | Minor (as per 2005 FDA Guidance) | Minor (The addition of app control did not change the level of concern.) |
| Electrical Safety & EMC (ANSI AAMI ES60601-1 etc.) | Compliance with referenced standards | All testing passed and all requirements were met. |
| Usability (IEC 60601-1-6) | Compliance | All testing passed and all requirements were met. |
| Home Healthcare (IEC 60601-1-11) | Compliance | All testing passed and all requirements were met. |
| Electromagnetic Disturbances (ANSI AAMI IEC 60601-1-2) | Compliance | All testing passed and all requirements were met. |
| Performance Testing | ||
| Vacuum level verification | Device meets specifications for vacuum levels at each level/cycle. | All testing passed and all requirements were met. (Indicating vacuum level verification at each level/cycle was successful). |
| Use life testing | Device demonstrates intended use life. | All testing passed and all requirements were met. |
| Battery performance testing | Device battery performs as specified. | All testing passed and all requirements were met. |
| Battery status indicator testing | Battery status indicator functions as intended. | All testing passed and all requirements were met. |
| Other Attributes | ||
| Mobile App Features | View pumping history. | Expanded features to allow user to control the pump. (This is an enhancement, not a failure against predicate criteria, as the core functionality is still present). |
Summary of Device Performance:
The Willow® Generation 3 Breast Pump was found to be substantially equivalent to its predicate device, the Willow® Wearable Breast Pump 2.0 (K191577). The summary explicitly states: "The minor technological differences between the Willow Gen 3 and its predicate device do not raise any new questions of safety or effectiveness. The results from the testing meet the previous performance requirements established for Willow Gen 2. The conclusions drawn from the nonclinical tests demonstrate that the Willow Gen 3 is as safe and effective and performs as well as the previously cleared Willow Gen 2."
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a "test set" in the context of clinical studies with human subjects. The testing described is primarily non-clinical performance testing. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) for clinical data is not available in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not available in the provided document. The device approval is based on non-clinical performance, electrical safety, EMC, and software testing to demonstrate substantial equivalence to a predicate device, rather than a diagnostic device relying on expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable and not available in the provided document, as no clinical test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned or reported in the provided 510(k) summary. The submission focuses on non-clinical testing for substantial equivalence. Therefore, there is no information available on effect size of human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable and not available in the provided document. The Willow® Generation 3 Breast Pump is a physical medical device; while it utilizes software, it is not an AI algorithm for diagnostic or assistive performance in the traditional sense that would require a standalone algorithm performance study. The software evaluation was for "minor level of concern" and its integration into the device's functionality.
7. Type of Ground Truth Used
The "ground truth" used for this device's acceptance is based on engineering specifications, regulatory standards, and performance against the established characteristics of the predicate device. For example:
- Engineering Specifications: Vacuum levels, suction cycles, battery performance, use life.
- Regulatory Standards: ANSI AAMI ES60601-1, IEC 60601-1-6, IEC 60601-1-11, ANSI AAMI IEC 60601-1-2 for electrical safety, EMC, and usability.
- Predicate Device Performance: The "previous performance requirements established for Willow Gen 2."
There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth in this particular 510(k) submission summary.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention a "training set" in the context of machine learning or AI algorithm development. The device is a "Powered Breast Pump," and its validation relies on engineering and performance testing. Therefore, this information is not applicable and not available.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of AI/ML, this information is not applicable and not available.
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