(69 days)
The Proture Double Electric Breast Pump to be used by lactating women in a home setting to express and collect milk from their breasts. This device is intended for a single user.
The Proture Double Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting and is for a single user. It comprises a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer.
This electric breast pump imitates baby's sucking rhythm with help of a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk suction speed intensities to imitate rhythm of a baby's suction. The keyboard of the control panel is soft. The screen is an LCD, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 15 to 247 mmHg with cycle rates up to 107 cycles per minute.
The Proture Double Electric Breast Pump provides the following user features:
- Closed system with anti-backflow
- LCD screen touch button operation
- 2-phase expression: Stimulation and Expression phases
- Stimulation Phase: Suction pattern with fast cycles (53-107 cycles/min) and low vacuum (15-120mmHg) to start milk flowing, 5 levels
- Expression Phase: Suction pattern with slower cycles (19~47T/min) and higher vacuum (82-247mmHg) to express milk, 9 levels
- Double-pumping ability: single or double pumping
- Dual power source: it can be operated by A/C adapter or batteries
All parts of the device that directly contact with breast and milk are to be sanitized by boiling in water for 5 minutes, followed by drying with a clean towel. After use, all parts that directly contact the breast and milk are to be cleaned in warm, soapy water.
This document provides a 510(k) summary for the Proture Double Electric Breast Pump. Let's extract the requested information based on the provided text.
Based on the provided document, the device in question is a Proture Double Electric Breast Pump. The studies conducted are primarily focused on safety and performance, comparing the device to a predicate device (Naya Breast Pump System). There is no mention of a study involving AI, human readers, or a ground truth established by medical experts for diagnostic purposes, as this is a breast pump, not a diagnostic imaging device.
Therefore, many of the requested categories (like sample size of test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, and how ground truth for training set was established) are not applicable to the type of device and study described here.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
The document mentions that "All of the tested parameters meet the predefined acceptance criteria" for performance testing, but it does not explicitly list these criteria in a table format alongside the reported device performance. It mainly discusses the types of tests conducted.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Cytotoxicity | Complied with ISO 10993-5:2009/(R)2014; non-cytotoxic |
| Sensitization | Complied with ISO 10993-10:2010; non-sensitizing |
| Skin Irritation | Complied with ISO 10993-10:2010; non-irritating |
| Electrical Safety | Complies with IEC 60601-1:2012 |
| EMC | Complies with IEC 60601-1-2:2007 |
| Performance Testing | |
| Working Current | Met predefined acceptance criteria |
| Pressure | Met predefined acceptance criteria |
| Cycle Rate | Met predefined acceptance criteria |
| Noise | Met predefined acceptance criteria |
| Stability of Vacuum Level | Met predefined acceptance criteria |
| Use-life | Met predefined acceptance criteria |
| Software Verification and Validation | Functions as specified in software requirement specifications |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "Performance testing was conducted on the Proture Double Electric Breast Pump" but does not give a sample size (e.g., number of units tested).
- Data Provenance: Not specified. The manufacturer is Guangdong Horigen Mother & Baby Products Co., Ltd. in China, implying testing was likely done in China, but this is not explicitly stated. The studies are non-clinical (laboratory testing), not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This is a physical device (breast pump) and the "ground truth" is based on engineering and safety standards, not expert medical opinion on a diagnostic image or patient outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As the "ground truth" is based on compliance with international standards (ISO, IEC) and engineering specifications, an adjudication method for expert consensus is not relevant.
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 is a breast pump, not a diagnostic AI device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Ground truth is defined by compliance with International Standards (ISO 10993-1, ISO 10993-5, ISO 10993-10) demonstrating non-cytotoxicity, non-sensitization, and non-irritation.
- For electrical safety and EMC: Ground truth is defined by compliance with International Standards (IEC 60601-1, IEC 60601-1-2).
- For performance testing: Ground truth is defined by predefined acceptance criteria based on technical parameters (working current, pressure, cycle rate, noise, vacuum level stability, use-life).
- For software: Ground truth is defined by software requirements specifications.
8. The sample size for the training set:
- Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no mention of a training set.
§ 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).