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The electric breast pump is to express and collect milk from 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 device is intended for single user.

The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed and manufactured by the Shantou Xinghe Electrical Apparatus Co., Ltd. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mother and baby occur. Two models of this device, Horigen, XN- 2203H2 and Droplet, XN-2203H4, are included in this Premarket Notification submission. The primary differences between the two models, Horigen XN- 2203H2 and Droplet, XN-2203H4 are the shape of the breast shield and the settings of the stimulating velocity, stimulating intensity, sucking velocity and sucking intensity. The specific settings are listing under the summary of non-clinical tests. The product uses a Single-Chip Microcomputer to imitate a baby's suckling action. The device is ergometrically designed to create comfortable milk stimulation, massage, and suction from the breast. Three (3) stimulation levels and five (5) speeds are available to imitate the rhythm and action of a baby's suckling. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm. The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed to mechanically interface with a mother's breast via a breast shield and withdraw, then collect, the breast milk. The device is driven by a microcomputer which electrically controls piston components. The pistons perform a reciprocating movement in the device cylinder and pump seat. A breast cup is fixed between the piston and the piston head on which negative and positive pressure is created by the piston action. A mobile magnet detects the mechanical movement and creates an electrical signal to the microcontroller.

The provided text describes a 510(k) Summary for an electric breast pump, models Horigen XN-2203H2 and Droplet XN-2203H4. The summary details the device's description, intended use, technology, and a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "acceptance criteria of performance testing" and reports the specifications for the proposed devices.

• Stimulating velocity: 88 T/min
• Stimulating intensity: -0.018 MPa (Max.), 3 adjustable degrees
• Sucking intensity: -0.028 MPa (Max.), 5 adjustable degrees
• Sucking velocity: 34-63 T/min, 5 adjustable speeds

Model Horigen XN-2203H2:

• Stimulating velocity: 90 T/min
• Stimulating intensity: -0.012 MPa (Max.), 3 adjustable degrees
• Sucking intensity: -0.024 MPa (Max.), 5 adjustable degrees
• Sucking velocity: 35-63 T/min, 5 adjustable speeds |
  | Biocompatibility | Not cytotoxic, irritating, or a dermal sensitizer (met "FDA food additive criteria as set forth in 21 Code of Federal Regulations Part 176, 177 and 178"). | "Not cytotoxic, irritating or a dermal sensitizer" (implied to meet the criteria mentioned for predicate device). |
  | Electrical Safety | Meets IEC 60601-1-2. | "Meets IEC 60601-1-2." (Specific edition not elaborated for the proposed device, but stated in the standards met section as IEC 60601-1, 3rd Edition and IEC 60601-1-2 Edition 3:2007-03) |
  | EMC (Electromagnetic Compatibility) | Meets IEC 60601-1-2. | "Meets IEC 60601-1-2." (Specific edition not elaborated for the proposed device, but stated in the standards met section as IEC 60601-1, 3rd Edition and IEC 60601-1-2 Edition 3:2007-03) |
  | Suction Level | Comparable to predicate device (Predicate: 30-250, Proposed: 180 maximum). | Suction level met (specific range is 180 maximum, which is considered "similar" to the predicate, with the discussion that the lower maximum vacuum range of the proposed device "would not involve any harm"). |
  | Cycle Time | Comparable to predicate device (Predicate: 30-80, Proposed: 90 maximum). | Cycle time met (specific range is 90 maximum, considered "similar" to the predicate). |
  | Standards Met | IEC 60601-1; IEC 60601-1-2; ISO 10993-1; ISO 10993-5; ISO 10993-10 | All listed standards were met, specifically: IEC 60601-1, 3rd Edition; IEC 60601-1-2 Edition 3:2007-03; ISO 10993-1:Fourth Edition 2009-10-15; ISO 10993-5:2009; ISO 10993-10;Third Edition 2010-08-01. |

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The sponsor has performed bench testing to demonstrate the electric breast pump performs within specifications." It does not specify a "test set" in terms of subject data (e.g., lactating women). The testing appears to be purely bench testing (laboratory-based performance measurements). Therefore, sample size for a test set of human subjects is not applicable/not provided. The "data provenance" is implied to be from the manufacturer's internal testing. There is no mention of country of origin for any human data or whether it was retrospective or prospective, as no human data appears to have been used in the performance testing described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since the performance testing described is bench testing of physical parameters, there were no human experts used to establish ground truth for a clinical test set. The "ground truth" for the bench tests would be the established engineering specifications and international standards.

4. Adjudication Method for the Test Set

As no human experts or clinical test set are described, an adjudication method is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is bench testing of a physical device against technical specifications and a predicate device. This type of study is not relevant for evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not directly applicable. The device is an electric breast pump, a mechanical and electrical device, not an AI algorithm. Its performance is inherent to its design and function. The "standalone" performance here refers to the device operating on its own as designed, which is what the bench tests demonstrate. There is no AI component to evaluate for standalone performance in the context of typical AI device submissions.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation consists of:

• Engineering Specifications: The defined operating parameters for stimulating velocity, stimulating intensity, sucking intensity, and sucking velocity for both models.
• International Standards: Compliance with ISO 10993 (biocompatibility), IEC 60601-1 (general safety), and IEC 60601-1-2 (electrical safety/EMC).
• Comparison to Predicate Device: The performance parameters (vacuum range, cycle speed) were benchmarked against the predicate device (Ameda Platinum electric breast pump, K100435) to demonstrate substantial equivalence, implying that the predicate's established performance serves as a ground truth for comparison.

8. The Sample Size for the Training Set

This question is not applicable. The device is an electric breast pump, not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this device.

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