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510(k) Data Aggregation
(55 days)
The Evenflo Advanced Double Electric Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.
The Evenflo Advanced Double Electric Breast Pump is an electrically powered breast pump that uses negative pressure to express milk from a lactating woman's breasts. A reciprocating vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels between 25 and 254 mmHg. The flange system is convertible between single and double pumping. Four buttons on the user interface allow the user to select one of 32 settings (eight vacuum levels and four cycle rates for each vacuum level) and the LED interface displays the selected setting. Additionally, there are three different flange sizes that allow the user to select the size that best fits their breasts. These features allow the user to customize the device, improving the comfort of their pumping experience. The device can be powered by six "AA" batteries or the provided mains adapter.
The provided 510(k) summary for the Evenflo Advanced Double Electric Breast Pump (K131153) describes the acceptance criteria and the study that proves the device meets those criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Vacuum Range (double pumping) | Within performance specification ranges of predicate devices (K973501: 75-200 mmHg) | 25-254 mmHg |
| Vacuum Range (single pumping) | Within performance specification ranges of predicate devices (K973501: 75-270 mmHg, K102600: 3-254 mmHg) | 25-270 mmHg |
| Cycle Speed | Within performance specification ranges of predicate devices (K973501: 30-60, K102600: 46 fixed) | 30 - 80 cycles/minute (Note: This is broader than the primary predicate K973501 but overlaps and is consistent with the general concept of variable cycle speed in predicate devices) |
| Electrical Safety | UL 1431, FCC 15A, CISPR 11:2009 compliant | Demonstrated compliance with UL 1431, FCC 15A, CISPR 11:2009 (Implied by "General Electrical Safety UL 1431, FCC 15A, CISPR 11:2009" and the conclusion of substantial equivalence based on non-clinical testing). |
| Sound Pressure | Within specifications | No specific quantitative acceptance criteria or performance values are provided beyond "Sound Pressure" being part of the non-clinical testing. |
| Operational Forces | Within specifications for assembly/disassembly | No specific quantitative acceptance criteria or performance values are provided beyond "Operational Forces to assemble and disassemble components" being part of the non-clinical testing. |
| Check Valve Functionality | Within specifications | No specific quantitative acceptance criteria or performance values are provided beyond "Check Valve" being part of the non-clinical testing. |
| Battery Life | Within specifications | No specific quantitative acceptance criteria or performance values are provided beyond "Battery Life" being part of the non-clinical testing. |
| Comparative Vacuum and Cycle Testing | Proposed device is substantially equivalent to predicate devices | "It was demonstrated that the proposed device is substantially equivalent to the predicate device" in these areas. This implies the performance fell within acceptable ranges relative to the predicates, even if exact numerical criteria aren't explicitly stated for all aspects. |
| Indications for Use | To express milk from lactating women for a single user (consistent with predicates) | "Indications for use are to express milk of lactating women. This is for a single user." (Stated as not identical to predicates, but the intended use is the same). |
| Technology/Principle of Operation | Identical to predicates (reciprocating vacuum pump, flange/collection system) | "The technology and principle of operation for the proposed device is identical to the predicates." |
| Materials (milk/user contact) | Identical to predicate K102600 and ISO 10993 Compliant (for materials not identical) | "The materials which are in contact with the user and the expressed milk are identical to the predicate." and "ISO 10993 Compliant" (for predicate K102600, implying the new device also needs to be). |
| Environment of Use | Identical to predicates (Home) | "The environment of use, home, is identical to the predicates." |
| Patient Population | Identical to predicates (Lactating women) | "The patient population is lactating women which is identical to the predicates." |
| Sterilization Method for Accessories | Boiling water (identical to predicate K102600) | "Boiling water" (stated as "Identical to Predicate K102600"). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any specific "test set" in the context of clinical or user performance data analysis. The studies described are bench tests (non-clinical testing). Therefore, concepts like country of origin or retrospective/prospective data generation are not applicable here.
The "studies" are laboratory-based bench testing and comparative measurements against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As the studies are bench tests, there is no "ground truth" to be established by experts in the sense of clinical image interpretation or diagnosis. The "ground truth" for bench tests is typically derived from calibrated measurement equipment and engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. This submission focuses on engineering performance bench tests.
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
No. This device is a breast pump, not an AI-powered diagnostic device necessitating an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a mechanical/electrical product, not an algorithm. Standalone performance refers to the output of an algorithm itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests would be:
- Instrumental measurements: Calibrated devices measuring vacuum, cycle speed, sound pressure, electrical parameters, operational forces, and battery life.
- Engineering specifications/standards: Compliance with UL 1431, FCC 15A, CISPR 11:2009, and ISO 10993 implied for material biocompatibility.
- Predicate device performance: The performance of the legally marketed predicate devices (K973501 and K102600) served as a benchmark for comparison to demonstrate substantial equivalence.
8. The sample size for the training set
N/A. This product does not involve machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established
N/A. Not applicable due to the nature of the device.
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