(322 days)
The Yooeehouse breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users.
The Yooeehouse pumpset should be used in combination with Yooeehouse breast pump and is intended to be used by lactating women to express and collect milk from their breast. The pumpset can be used both as a single pumpset and as a double pumpset.
The subject device is a breast pump that is intended to be a single patient reusable device. The device is used in a home environment and is capable of single and dual pumping. The submission includes four different breast pumps: L08, L10, S08, and S10.
The breast pump uses a USB adapter. The breast pump consists of a pump, a non-sterile pumpset (composed of silicone, polypropylene, acrylonitrile butadiene styrene, and polyphenylene sulfone), and a power adapter. The breast pump has a negative pressure module that utilizes a microcomputer-controlled system to set and adjust the mode (massage or expression), velocity and intensity of stimulation and suction. The vacuum pump component of the device creates the negative pressure used to extract milk from the breast. The vacuum pump is connected to a solenoid valve that provides variable vacuum cycling rates ranging from 24-110 cycles/minutes. In the massage mode, there is single vacuum pressure of 30 mmHg, while the expression mode has vacuum pressures ranging from 60 to 220 mmHg depending on the expression setting selected. A light-emitting diode indicator (Models S08 and S10) or liquid-crystal display (models L08 and L10) indicate the status of operation.
This document K163183 is a 510(k) premarket notification for a breast pump, which is a Class II medical device. The information provided outlines the device's characteristics, intended use, and the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.
The prompt asks for details related to acceptance criteria and studies proving the device meets those criteria, specifically in the context of an AI/ML medical device. However, the provided document does not describe an AI/ML medical device. It details a physical medical device (a breast pump) and its mechanical and electrical performance. Therefore, many of the specific questions about AI/ML study design (like sample size for training/test sets, expert adjudication, MRMC studies, ground truth establishment, etc.) are not applicable to the content of this document.
I will address the parts of your request that are relevant to the provided content.
1. A table of acceptance criteria and the reported device performance
The document summarizes performance tests and states that specifications were met. It does not provide a specific table of acceptance criteria with corresponding numerical results for each one. Instead, it lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Bench Testing | |
| Backflow Protection | Performance testing conducted to assess prevention of milk ingress into pump tubing or pump. (Implied: Met expectations) |
| Vacuum Profile | Performance testing conducted at minimum and maximum vacuum settings to determine min & max vacuum levels. Specifications were met for vacuum level, cycle rate, and backflow protection. Testing conducted under single and double pumping conditions with appropriate power sources. |
| Durability | Performance testing conducted to assess use-life of the device. (Implied: Met expectations) |
| Electrical Safety | |
| AAMI / ANSI ES60601-1:2005/ (R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 | Complied (Implied by inclusion in non-clinical performance test summary) |
| IEC 60601-1-11:2015 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Electromagnetic Compatibility | |
| IEC 60601-1-2:2014 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Biocompatibility | |
| Sensitization ISO 10993-10:2010 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Irritation - ISO 10993-10:2010 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Cytotoxicity - ISO10993-5:2009 | Complied (Implied by inclusion in non-clinical performance test summary) |
| Software Validation | |
| FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005. | Complied (Implied by inclusion in non-clinical performance test summary) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes (e.g., number of devices tested for durability, or number of cycles for vacuum testing). It also does not mention data provenance in terms of country of origin or retrospective/prospective nature, as the testing described is standard laboratory bench testing for a physical device, not a clinical study involving 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, not an AI/ML algorithm requiring expert ground truth for interpretation of medical images or data. Ground truth for a breast pump would be based on engineering specifications and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to expert review and consensus for AI/ML performance evaluation, not to the bench testing of a physical device.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for performance testing is established by engineering specifications, physical measurement standards, and regulatory requirements (e.g., IEC standards, ISO standards). For example, a vacuum pressure measurement is compared against a specified range (e.g., 60-220 mmHg).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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).