(89 days)
The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast.
The Evenflo Comfort Select Breast Pump and Comfort Select Dual Breast Pump are battery/electric powered suction device used to express milk from the breast of lactating women.
The Evenflo Comfort Select Auto-cycle Breast Pump is an electrically powered breast pump that uses the principle of negative suction to express milk from the breast. The Evenflo pump is sold in single and dual models. The dual model allows the user to pump one or both breasts at a time, and is designed with ergonomics in mind so as to be comfortable for the user. The single model applies the same ergonomics but is used to pump only one breast at a time.
This document is a 510(k) premarket notification for the Evenflo Comfort Select Auto-cycle Breast Pump Kit. It focuses on establishing substantial equivalence to legally marketed predicate devices rather than detailing a specific performance study with acceptance criteria.
Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design, sample sizes for test/training, expert adjudication, MRMC studies, standalone performance, type of ground truth, etc.) are not available in this document.
Here's what can be extracted and inferred from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as specific performance metrics. The underlying acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This typically means showing that the device is as safe and effective as a predicate device and performs as intended.
- Reported Device Performance: The document states the device "uses the principle of negative suction to express milk from the breast" and is "designed with ergonomics in mind so as to be comfortable for the user." However, no quantitative performance data (e.g., suction pressure, efficiency, comfort ratings) are provided in support of these claims in this submission.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (as stated or implied in the document) |
|---|---|
| Substantial equivalence to predicate devices in terms of safety and effectiveness, and intended use. | "Uses the principle of negative suction to express milk from the breast." |
| Device functions as an electrically operated suction device to express milk. | The device is an "electrically operated suction device used to express milk from the breast." |
| Ergonomic design for user comfort. | "designed with ergonomics in mind so as to be comfortable for the user." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not provided. This document does not describe a performance study with a test set of data or subjects. The submission relies on a comparison to predicate devices and a description of the device.
- Data Provenance: Not applicable / Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable / Not provided. No test set or ground truth establishment process is described.
- Qualifications of Experts: Not applicable / Not provided.
4. Adjudication method for the test set
- Adjudication Method: Not applicable / Not provided. No test set requiring adjudication is 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
- MRMC Study: No. This is a breast pump, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is not an algorithm, but a physical medical device (breast pump). The 510(k) process for such devices typically involves demonstrating mechanical functions, biocompatibility, electrical safety, and often comparisons to existing devices, but not "standalone algorithm performance."
7. The type of ground truth used
- Type of Ground Truth: Not applicable / Not provided. The submission focuses on substantial equivalence based on device description and comparison to predicates, not on validating a diagnostic or predictive performance against a "ground truth."
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not provided. There is no AI component or training set involved in this 510(k) submission.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable / Not provided. There is no AI component or training set involved in this 510(k) submission.
Summary of available information related to the device's "study":
The "study" in this context is the 510(k) premarket notification process itself, which aims to demonstrate that the Evenflo Comfort Select Auto-cycle Breast Pump Kit is substantially equivalent to legally marketed predicate devices.
- Predicate Products:
- Medela Double Pumping Mini-Electric Breast Pump
- The First Years Natural Comfort Breast Pump
- Evenflo Personal Comfort Dual Breast Pump
- Basis for Equivalence: The document states, "Evenflo believes its Comfort Select Auto-cycle Breast Pump is substantially equivalent to lawfully marketed breast pumps." The specific evidence for this equivalence (e.g., technical specifications comparison, performance testing data) is not detailed in the provided text, but would have been included in the full 510(k) submission.
- FDA Determination: The FDA reviewed the submission (K022933) and determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This determination allows the device to be marketed.
- Performance Standards: The FDA has established no specific performance standards for breast pumps (as stated in Section 6, page 2).
- Intended Use: "The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast." (Page 1, Section 2) The "Indications for Use" from the enclosure (Page 4) specifies it's "a battery/electric powered suction device used to express milk from the breast of lactating women."
§ 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).