(265 days)
The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The Youha electric breast pump is a single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. YH-8004 and YH-8016 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YH-8006IV and YH-8015 have a single pumping configuration only.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280mmHg. The user interface consists of a front panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure.
The device has three modes of operation:
- Massage mode: Suction patterns with fast cycles and low vacuum to start milk flowing
- Low expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.
- High expression mode: Suction patterns with slower cycles and higher vacuum to express more milk efficiently.
YH-8004, YH-8015 and YH-8016 have 3 modes including massage mode, low expression mode and high expression mode. YH-8006IV has 2 modes including massage mode and high expression mode.
The device is electrically powered from either an internal rechargeable battery or an external AC power adapter. The external adapter also charges the battery.
This document pertains to the 510(k) premarket notification for the Youha electric breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of diagnostic accuracy for an AI/ML device.
Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study design are not applicable to this regulatory submission for a powered breast pump.
Here's an attempt to extract relevant information and note where the requested information is not present in this document:
1. Table of Acceptance Criteria and Reported Device Performance
For a breast pump, "acceptance criteria" generally refer to meeting specified physical and performance characteristics, safety standards, and functional requirements. These are defined internally by the manufacturer and verified through non-clinical testing. The document highlights compliance with recognized standards.
| Acceptance Criteria Category | Reported Device Performance / Compliance |
|---|---|
| Safety Standards | IEC 60601-1:2005 (3rd Ed.) with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 (Electrical Safety) |
| IEC 60601-1-11:2015 (Safety for home use) | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 (EMC Testing) |
| Biocompatibility | ISO-10993 (Cytotoxicity, Sensitization, Irritation) |
| ISO 10993-5:2009 (Cytotoxicity) | |
| ISO 10993-10:2010 (Sensitization, Irritation) | |
| Risk Management | ISO 14971:2007 (Risk Analysis) |
| Software Validation | IEC 62304 (Software Life Cycle Processes) |
| FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) | |
| Performance - Vacuum Level | Met specifications for minimum and maximum vacuum levels (measured at minimum and maximum vacuum settings) |
| Performance - Cycle Rate | Met specifications (measured at minimum and maximum vacuum settings) |
| Performance - Backflow Protection | Met specifications (tested under single and double pumping mode with various power sources) |
| Functional Modes | Massage mode, Low expression mode, High expression mode (various models have different combinations) |
| Power Sources | Internal rechargeable battery or external AC power adapter (tested) |
| Pumping Configuration | Single and/or Double Pumping (model dependent, tested) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of an AI/ML device's diagnostic performance evaluation. The "test set" here refers to physical testing of device units. The document states "Performance testing was conducted at minimum and maximum vacuum settings" on the device, but it does not specify the number of units tested, the number of measurements, or any details about data provenance in the way it would for AI/ML algorithm evaluation. These are typically internal verification and validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. For a breast pump, "ground truth" relates to its physical and functional performance measurements against engineering specifications, not clinical diagnostic accuracy assessed by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. This relates to expert consensus for ground truth establishment in clinical studies, which is not relevant for a breast pump's functional testing.
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. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of this submission for a breast pump.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This refers to AI algorithm performance evaluation, not a physical medical device like a breast pump.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the breast pump's performance is derived from engineering specifications and recognized national/international standards (e.g., vacuum levels, cycle rates, electrical safety parameters, biocompatibility limits). The document states: "Performance testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection."
8. The sample size for the training set
This is not applicable. A breast pump does not use a "training set" in the sense of machine learning. Its design is based on engineering principles and verified through physical testing.
9. How the ground truth for the training set was established
This is not applicable. See point 8.
Summary of the Study (as described in the document for substantiating equivalence):
The "study" described in the document is a series of non-clinical performance tests conducted by the manufacturer to verify that the Youha electric breast pump meets its design specifications and complies with relevant safety and performance standards. It is a verification and validation (V&V) process rather than a clinical study or AI algorithm evaluation.
- Objective: To verify that the Youha electric breast pump met all design specifications and is substantially equivalent to the predicate device (Spectra 9 Plus powered breast pump).
- Methods: Physical testing was performed to assess:
- Compliance with various international standards for risk analysis (ISO 14971), electrical safety (IEC 60601-1, AAMI/ANSI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), home use safety (IEC 60601-1-11), and biocompatibility (ISO-10993 parts 5 and 10).
- Software validation according to IEC 62304 and FDA guidance.
- Performance characteristics such as minimum and maximum vacuum levels, cycle rate, and backflow protection under different conditions (minimum/maximum vacuum settings, single/double pumping mode, AC/DC vs. battery power).
- Results: The test results demonstrated that the proposed device complies with the listed standards and met its specifications for vacuum level, cycle rate, and backflow protection under various operating conditions.
- Conclusion: Based on the comparison with the predicate device and the non-clinical test results, the Youha electric breast pump was deemed substantially equivalent to the predicate device.
Key takeaway for AI/ML context: This document is an example of a 510(k) submission for a traditional medical device, not a software as a medical device (SaMD) or an AI/ML-driven device. Therefore, the requirements for demonstrating diagnostic accuracy and clinical performance for AI/ML are inherently different and not addressed here.
§ 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).