(273 days)
The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended to express and collect milk from the mother's 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. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended for a single user.
The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) are electric breast pumps that are intended for lactating women to express and collect breast milk. The Electric Breast Pump and Electric Double Breast Pump are intended for a single user and are to be used in the home environment. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053_01) are Li-ion-battery powered breast pumps that include following main components: the expressed milk collection kit, the pump unit, and tubing. The expressed milk collection kit includes a funnel cover, silicone cushion, funnel adapter, membrane, valve body, valve membrane cap, and milk bottle. The pump unit contains a chip that controls the work of the vacuum pump and solenoid valve to draw air inside of the funnel adapter to form negative pressure. The tubing has two connectors on the two ends. The user attaches the connector to the air vent of the membrane cap and the connector to the pump unit separately to ensure a tight fit.
This document is a 510(k) summary for the Electric Breast Pump (model KP033_01) and Electric Double Breast Pump (model KP053_01). It outlines the device's characteristics and the studies conducted to demonstrate its substantial equivalence to a predicate device.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (What was found) |
|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Skin Irritation) in accordance with ISO 10993-1, 10993-5, 10993-10 | Met the predefined acceptance criteria. |
| Electrical safety (IEC 60601-1:2012) | Met the predefined acceptance criteria. |
| Electromagnetic compatibility (EMC) (IEC 60601-1-2:2014) | Met the predefined acceptance criteria. |
| Software Verification and Validation | Conducted as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005)). Met the predefined acceptance criteria. |
| Minimum and maximum vacuum pressure (single and double pumping modes) | Met the predefined acceptance criteria. |
| Technical specifications for stimulation mode (all cycle and vacuum settings) | Met the predefined acceptance criteria. |
| Technical specifications for expression mode (all cycle and vacuum settings) | Met the predefined acceptance criteria. |
| Working current, pressure, cycle rate, and noise | Met the predefined acceptance criteria. |
| Backflow protection mechanism | Met the predefined acceptance criteria. |
| Battery specification validation and performance | Met the predefined acceptance criteria. |
| Use life testing (vacuum level and battery performance) | Met the predefined acceptance criteria. |
| Maximum Expression Pressure | 247.5mmHg (Matches predicate device) |
| Stimulation Pressure range (KP033_01) | 30-120 mmHg (Matches predicate device) |
| Stimulation Pressure range (KP053_01) | 37.5-112.5mmHg (Slight difference from predicate: 30-120 mmHg) |
| Stimulation Velocity | 100 Cycles/min (Matches predicate device) |
| Expression Velocity | 26-60 Cycles/min (Difference from predicate: 20-90 cycles/min) |
| Expression Pressure Range | 120-247.5 mmHg (Difference from predicate: 75-247.5 mmHg) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of devices or tests) for the performance, biocompatibility, electrical safety, or EMC testing. However, it indicates that "Performance testing was conducted on the subject device," implying physical testing of the device itself.
The data provenance is not explicitly stated as country of origin, but the submitting company is "Guangdong Horigen Mother & Baby Products Co., Ltd." in China. The study appears to be prospective testing of the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The testing appears to be objective, engineering, and laboratory-based, rather than requiring expert adjudication of results.
4. Adjudication method for the test set
This information is not applicable and not provided. The testing is based on objective measurements against predefined criteria.
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
This is not applicable. The device is an electric breast pump, not an AI-assisted diagnostic or imaging device used by human 'readers'.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product (breast pump), not an algorithm. The software component mentioned is for control of the device, not for independent diagnostic or analytical performance.
7. The type of ground truth used
For biocompatibility, electrical safety, EMC, software, and performance testing, the "ground truth" is defined by established international standards (ISO 10993-1, 10993-5, 10993-10; IEC 60601-1:2012; IEC 60601-1-2:2014) and predefined acceptance criteria based on those standards or engineering specifications. For comparison of certain parameters (e.g., maximum expression pressure), the predicate device's specifications served as a benchmark for substantial equivalence.
8. The sample size for the training set
This is not applicable. The device is not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
§ 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).