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510(k) Data Aggregation
(229 days)
Willow Innovations, Inc.
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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(128 days)
Willow Innovations, Inc.
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.
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