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510(k) Data Aggregation
(167 days)
The MilkMate Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for multiple users in places of work, shared spaces, healthcare facilities, hospitals, and the home.
The MilkMate Breast Pump includes a multi-user breast pump and disposable breast pump kits for the convenience of pumping in the workplace, shared spaces, healthcare facilities, hospitals, or the home environment.
The breast pump provides two modes: stimulation and expression mode. It can be operated using AC power or a built-in rechargeable li-ion cylindrical battery.
The kits are comprised of two each of a breast shield, breast shield body, backflow protector, valve and membrane, standard neck bottle pouch with cap, tubing, and tubing connector. Three breast shield sizes are offered (27 mm, 30 mm, and 36 mm). The kits are pre-assembled and sterile.
The provided document outlines the substantial equivalence determination for the MilkMate Breast Pump (K223084) to a predicate device (Electric Breast Pump, Model XN/MS-2224B, K201152). As such, the acceptance criteria are primarily focused on demonstrating that the new device is as safe and effective as the predicate device, relying heavily on non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) | Acceptable levels demonstrated. |
| ISO 10993-10:2021 (Sensitization) | Acceptable levels demonstrated. | |
| ISO 10993-23:2021 (Irritation) | Acceptable levels demonstrated. | |
| Sterilization | Sterility Assurance Level (SAL) of 10-6 per ISO 11135:2014, ISO 11737-1:2006, and ISO 11737-2:2019 | Ethylene oxide sterilization process for the MilkMate kit was developed and validated to achieve a SAL of 10-6. |
| EO Residue | Acceptable levels of EO and Ethylene Chlorohydrin (ECH) per ISO 10993-7:2008 | Acceptable levels of EO residue and ECH residue demonstrated. |
| Shelf Life | 1-year shelf life, with package integrity maintained after accelerated aging and simulated transport (ASTM F1980:2021) | Accelerated aging tests supported a 1-year shelf life. Package integrity was evaluated and demonstrated acceptability after accelerated aging, preconditioning, and simulated handling/transportation to maintain sterility. |
| Pump Performance | Vacuum and cycle testing across full range of kit sizes, fresh/end-of-shelf-life kits, single/double pumping, low/mid/high vacuum/cycle settings, battery/AC power, stimulation/expression modes. Performance must align with device specifications and be comparable to predicate where applicable for safety and effectiveness. | Vacuum and cycle testing were completed, covering all specified conditions (kit sizes, kit age, pumping mode, vacuum/cycle settings, power source, operation mode). The results demonstrated alignment with performance specifications and supported the substantial equivalence determination. The document states: "Vacuum and cycle testing were completed to demonstrate the performance of the MilkMate breast pump and kits." And "The results of the performance testing described above demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence." This implies successful demonstration against established internal specifications, and implicitly, comparable performance to the predicate device in relevant aspects of safety and effectiveness. |
| Leak Testing | Maintain pouch integrity throughout shelf-life per ASTM F2096-11 | Leak testing demonstrated that the pouch maintains its integrity throughout the shelf-life. |
| Backflow Protection | Demonstrate anti-backflow design works as intended with disposable kits when milk collection bottle is full in both stimulation and expression modes, to support multi-user use. | Backflow testing was performed and demonstrated that the breast pump anti-backflow design works as intended with the disposable kits when the milk collection bottle is full in both stimulation and expression modes. |
Study Proving Device Meets Acceptance Criteria:
The device's acceptance criteria are primarily met through a series of non-clinical performance tests. These tests are designed to evaluate the safety and effectiveness of the MilkMate Breast Pump, especially given certain technological differences from the predicate device (e.g., suction strength, use of a single-use sterilized kit) and broader intended use (multi-user, various environments). The "SUMMARY OF NON-CLINICAL PERFORMANCE TESTING" section explicitly lists these studies.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact numerical sample sizes for the test sets (e.g., number of kits tested for biocompatibility, number of aging units, number of pumps in performance tests). The studies involve material, sterilization, and mechanical performance testing, not human subjects.
The data provenance is not explicitly stated in terms of country of origin of the data. However, the tests are conducted according to internationally recognized standards (ISO, ASTM), implying standard laboratory conditions. These are retrospective tests on manufactured devices and components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the evaluation is based on non-clinical performance testing against established standards and specifications, not on expert interpretation of medical images or patient data to establish a "ground truth" in the clinical sense.
4. Adjudication Method for the Test Set:
This information is not applicable as the evaluation is based on objective, quantifiable non-clinical performance test results against specified criteria in standards (e.g., pass/fail for biocompatibility, specific numerical ranges for vacuum/cycle, sterility assurance level). There is no "adjudication" in the sense of resolving disagreements among human reviewers of qualitative data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases with and without AI assistance. The MilkMate Breast Pump is a mechanical and electrical device for breast milk expression; therefore, an MRMC study is not applicable.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
This concept is not applicable in the traditional sense for a breast pump. The device has "software" as indicated in the comparison table, which would control its mechanical functions (vacuum, cycle speed, modes). The performance tests described evaluate the device's functional integrity as a complete system. The "algorithm" itself (i.e., the software's functional logic) is tested as part of the overall pump's performance rather than isolated standalone algorithm performance typical of AI/CADe devices.
7. Type of Ground Truth Used:
The ground truth used in these non-clinical studies is based on:
- International Standards: ISO 10993 (biocompatibility, EO residue), ISO 11135, ISO 11737 (sterilization), ASTM F1980 (accelerated aging), ASTM F2096-11 (leak testing).
- Device Specifications: Internal design specifications for vacuum strength, cycle speed, battery life, and other functional parameters.
- Predicate Device Characteristics: Comparison of technological features and performance parameters to the predicate device to demonstrate substantial equivalence.
8. Sample Size for the Training Set:
This information is not applicable. The MilkMate Breast Pump is a mechanical/electrical device, not a machine learning or AI-driven diagnostic tool that requires a "training set" of data in the common sense for model development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of this device.
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