(182 days)
The Evenflo Comfort Control Breast Pump and Comfort Control Dual Breast Pump are personal use battery/electric powered suction devices used to express milk from the breast of lactating women. These devices are not intended for hospital use.
The Evenflo Comfort Control Adjustable Speed Breast Pump with Automatic Cycling, and the Evenflo Comfort Control Dual Adjustable Speed Breast Pump with Automatic Cycling are diaphragm type pumps, driven by small DC motors, that create cycling negative pressure. The negative pressure generated by the pump is sufficient to overcome the resistance to the outflow of milk that is created by the muscles, yet gentle enough to prevent tissue damage to the user. The cycling speed and the strength of the negative pressure are controlled by individual rotary controls located on the pump unit. The combination of cycling speed and negative pressure control allow for a range of pressures to be selected. When used as a single collection pump, the maximum negative pressure ranges from 173 mm Hg to 56 mm Hg, and when used in the dual mode, it ranges from 173 mm Hg to 43 mm Hg.
The provided text describes a 510(k) submission for the Evenflo Comfort Control Breast Pump and Evenflo Comfort Control Dual Breast Pump. As such, the "acceptance criteria" and "device performance" are framed in terms of substantial equivalence to predicate devices, rather than strict quantitative performance metrics against a defined standard typical of a new device's clinical trial.
Here's the information extracted and organized as requested:
Acceptance Criteria and Device Performance for Evenflo Comfort Control Breast Pump
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are implicitly defined by the performance characteristics of the predicate devices. The Evenflo Comfort Control Breast Pump aims to demonstrate substantial equivalence by matching or exceeding the performance of these predicates in key areas.
| Performance Characteristic | Acceptance Criteria (Predicate Range/Value) | Evenflo Comfort Control Performance (Reported Value) |
|---|---|---|
| Intended Use | To Express Milk | To Express Milk |
| Power Source | AC Adapter / Batteries | AC Adapter or 2 C Batteries |
| Single or Double Pumping | Yes / Single Only | Yes (for Dual model) |
| Adjustable Suction Levels | Yes | Yes |
| Adjustable Cycle Speed | Yes / No | Yes |
| Overflow Protection | Yes | Yes, valve in horn |
| Highest Vacuum Setting (mm Hg) | 165 - 185 mm Hg | 173 mm Hg |
| Lowest Vacuum Setting (mm Hg) | 30 - 109 mm Hg | 43 mm Hg |
| Range of Cycle Speeds (Cycles/Minute) | 29 - 60 Cycles/Minute | 36 - 54 Cycles/Minute |
| Nipple Adapter | Yes | Yes |
| Time to 75% Initial Vacuum on Batteries (hours) | 1 - 20 hours | 7 hours |
| Time to 0% Initial Vacuum on Batteries (hours) | 5 - 37 hours | 10 hours |
Note: The acceptance criteria are derived from the range of performance observed across the predicate devices listed. The Evenflo device's reported performance falls within, or is comparable to, these ranges, supporting its claim of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific performance tests. The testing was conducted on "its Comfort Control Pumps and each of the predicate devices" implying at least one unit of each model.
- Data Provenance: Not specified, but likely internal testing conducted by Evenflo Company, Inc. It is not mentioned whether it was retrospective or prospective, or the country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The "ground truth" for this device's performance is objective physical measurements (vacuum pressure, cycle speed, battery life), not expert consensus on medical outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance was measured objectively, not interpreted by adjudicators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic or imaging devices where human interpretation is a key factor.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the performance testing described as "Non-Clinical Testing" on the Evenflo Comfort Control Pumps and predicate devices would be considered standalone performance, as it involves objective measurement of device parameters (negative pressure, cycle speed, battery life) without a human operator's influence on the outcome beyond operating the device for the test.
7. The Type of Ground Truth Used
- Type of Ground Truth: Objective physical measurements and specifications. The "ground truth" for this device's performance evaluation is based on direct measurements of mechanical parameters such as vacuum pressure (mm Hg), cycle speed (cycles/minute), and battery life (hours).
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is a mechanical breast pump, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and engineering would be based on general principles and regulatory requirements, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no "training set" for a mechanical device like this. The device design and safety would be established through engineering principles, material science, and regulatory standards for medical devices.
§ 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).