(88 days)
An electrically powered breast pump used to express milk from the breast of a lactating woman.
The Playtex electric breast pump is a small, quiet, safe and effective system for expressing milk from a lactating mother's breast(s). This device is comprised of 4 major assemblies: a pump assembly, a breast cup assembly, a carry bag, and some commercially available items (i.e., bottles, bottle liners, etc). The device is designed with 5 pre-set suction levels and 5 pre-set speed settings, which are selectable by the user via a button pad. The device is powered by a 12V DC power supply, which is included with the package.
Here's an analysis of the provided text regarding the Playtex Breast Pump (K022594), addressing the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the Playtex Breast Pump (K022594) does not outline explicit acceptance criteria or report specific device performance metrics in the way one would expect for a diagnostic or AI device (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence for this medical device (a breast pump) is primarily demonstrated through comparison to predicate devices and adherence to material safety standards.
However, based on the comparative table, we can infer some "performance" characteristics relative to the predicate devices:
| Characteristic | Acceptance Criteria (Inferred from Predicate Devices) | Reported Playtex Breast Pump Performance |
|---|---|---|
| Intended Use | To express milk from the breast of lactating women. | To express milk from the breast of lactating women. |
| Highest Vacuum Setting | Within range of predicate devices (e.g., 6.7 - 9.8 in Hg) | 9.0 in Hg |
| Lowest Vacuum Setting | Within range of predicate devices (e.g., 0.0 - 3.7 in Hg) | 2.5 in Hg |
| Range of Cycle Speeds | Within range of predicate devices (e.g., 29 - 60 cycles/min for adjustable, 49 for fixed) | 45 - 75 cycles/min |
| Power Source | DC Power Supply (some predicates also offer batteries) | DC Power Supply |
| Pump Type | Reciprocating Piston or Diaphragm | Reciprocating Piston |
| Single or Double Pumping | Both | Both |
| Adjustable Suction Levels | Yes | Yes |
| Adjustable Cycle Speed | Yes (most, but not all predicates) | Yes |
| Overflow Protection | Yes (most, but not all predicates) | Yes |
| Breast Cup-to-Breast Interface | Rigid Plastic (some with partial silicone) | Soft Silicone (difference highlighted as a feature) |
| Active Breast Massage | No (for predicate devices) | Yes (difference highlighted as a feature) |
| Hospital Grade System | Yes (some predicates) | Yes |
| Usable on Tabletop or Inside Bag | Tabletop (some predicates), Inside (one predicate) | Both |
| Material Safety | All milk and human contact components manufactured from FDA food additive compliant materials. | All milk and human contact components meet FDA food additive criteria (21 CFR Parts 176, 177, 178). Silicone breast cup insert tested for biocompatibility. |
| Functionality | Provides sufficient vacuum pressure to effectively express and collect milk. | "provides sufficient vacuum pressure to effectively express and collect milk from lactating women." (Conclusion) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary explicitly states:
- "No clinical tests have been conducted on this device."
- "Testing of the device has demonstrated that the Playtex breast pump meets established requirements when used in the manner and environment specified in product labeling."
Therefore, there was no "test set" in the context of clinical studies with human subjects or a dataset for algorithm evaluation. The testing mentioned refers to non-clinical, likely engineering or bench testing, to confirm specifications and material compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical tests or data-driven evaluations were performed for a "test set," no experts were used to establish ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. No "test set" or clinical evaluation requiring adjudication was described.
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 breast pump, not an AI-powered diagnostic or interpretive system that would involve human "readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical breast pump and does not involve an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's approval is primarily established through:
- Predicate Device Comparison: The functional and performance characteristics (vacuum, cycle speeds, etc.) are deemed acceptable by virtue of being comparable to, or within the established range of, legally marketed predicate breast pumps.
- Material Science and Biocompatibility Standards: Compliance with FDA food additive criteria and biocompatibility testing for human contact components serves as a "ground truth" for safety.
- Engineering Specifications: The "testing of the device" mentioned in the non-clinical tests section implies verification against internal engineering specifications.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, no ground truth was established in this manner.
Summary of Approach for this Device:
The 510(k) clearance for the Playtex Breast Pump relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This approach primarily involves:
- Comparing the new device's intended use, technological characteristics, and performance specifications to predicate devices.
- Ensuring material safety and biocompatibility through standard testing and compliance with regulations.
- Verifying that non-clinical tests (likely engineering/bench testing) confirm the device meets established requirements.
The submission explicitly states that "No clinical tests have been conducted on this device," which is common for devices seeking 510(k) clearance where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.
§ 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).