(105 days)
Pump In Style® is a powered breast pump to be used by lactating women to express and collect milk from their breasts. This powered breast pump is intended for a single user and is intended to be used in a home environment.
The Pump In Style® breast pump is used to express and collect milk from the breast of a lactating woman. The device is intended for daily use in a home environment to supplement breastleeding by a single user. Pumping can be performed on one breast (single pumping) or both breasts at the same time (double pumping).
The Pump In Style® breast pump is comprised of the breast pump unit, connector (including membranes, connector body and cap), breast shields, tubing, collection bottles, and power adaptor. In addition, optional accessories such as carry bag, bottle stand, battery pack, cooler bag, cooling element, vehicle power adaptor and additional milk collection containers may be included in the packaging as part of the product offering.
The Pump In Style® breast pump has user-adjustable controls for powering the device on/off, switching between two pumping modes, stimulation and expression, and controlling vacuum level within each of the modes. The Pump In Style® breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 140 cycles per minute. The tubing port is for connection of the tubing for pumping. The power supply port is for connection of the power supply or portable vehicle adaptor or battery pack.
The Pump In Style® breast pump provides the following user features:
- . 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm:
- o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing.
- O Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
- "Let-down" control to change between stimulation phase and expression phase.
- The option of either single or double breast pumping. ●
This document is a 510(k) premarket notification for a breast pump, which falls under medical device regulations. It is not an AI/ML device, and therefore the acceptance criteria and study information typically associated with AI/ML device approvals (like sensitivity, specificity, ROC curves, ground truth establishment with expert readers, etc.) are not applicable here.
The document discusses the regulatory review of a conventional medical device, a powered breast pump, and its substantial equivalence to a legally marketed predicate device. The "acceptance criteria" in this context refer to complying with relevant medical device regulations, standards, and demonstrating the device's technical specifications and safety.
However, I can extract the closest analogous information based on the request, reinterpreting "acceptance criteria" and "study" in the context of a traditional medical device submission.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance (Reinterpreted for a non-AI/ML device):
The acceptance criteria here are derived from the device's stated specifications and compliance with voluntary standards, especially in comparison to the predicate device. "Reported device performance" refers to the results of the bench testing and compliance reports.
| Acceptance Criteria (Derived from Device Specifications & Regulatory Requirements) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Biocompatibility: Patient-contacting components are safe. | Biocompatibility Evaluation concluded no new testing required as components are identical to other cleared Medela breast pumps. |
| Electrical Safety: Compliance with AAMI / ANSI ES60601-1:2005/(R)2012. | Testing in accordance with AAMI / ANSI ES60601-1:2005/(R)2012 and related amendments. |
| Electrical Safety (Home Use): Compliance with IEC 60601-1-11:2015. | Testing in accordance with IEC 60601-1-11:2015. |
| Risk Management: Compliance with ISO 14971:2007. | Risk analysis in accordance with ISO 14971:2007. |
| Electromagnetic Compatibility: Compliance with IEC 60601-1-2:2014. | Testing in accordance with IEC 60601-1-2:2014. |
| Software/Firmware Verification & Validation: Compliance with FDA guidance. | Verification and validation in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "minor" level of concern. |
| Vacuum Levels: Ability to provide specified vacuum levels. | Bench testing confirmed specifications were met for vacuum levels (from -50 to -240 mmHg). |
| Cycle Rate: Ability to provide specified cycle rates. | Bench testing confirmed specifications were met for cycle rate (97 to 140 cycles/minute for stimulation, 20 to 88 cycles/minute for expression). |
| Backflow Protection: Effective prevention of milk overflow. | Bench testing confirmed specifications were met for backflow protection. |
| Performance across Power Sources: Consistent performance with various power sources. | Results held under conditions of single and double pumping modes with varying power sources (AC/DC power adaptor, portable vehicle adaptor, external battery pack). |
2. Sample size used for the test set and the data provenance:
This information is not directly applicable in the terms of an AI/ML test set. The submission describes non-clinical bench testing. For such physical device testing, "samples" refer to the manufactured units of the device being tested. The document doesn't specify the exact number of units tested, but it implies standard engineering and regulatory testing practices. There's no "data provenance" in terms of patient data or geographical origin for this type of testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. "Ground truth" in the context of this breast pump refers to the physical and functional specifications of the device, established through engineering design, industry standards, and regulatory requirements, not expert interpretation of medical images or patient data.
4. Adjudication method for the test set:
Not applicable. There is no expert adjudication process described for the non-clinical bench testing of a breast pump.
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 a conventional medical device; there is no AI assistance involved, and therefore no MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a conventional medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is its engineering specifications, design requirements, and compliance with recognized national and international electrical, safety, and performance standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-11, ISO 14971, IEC 60601-1-2). These standards define acceptable ranges for vacuum, cycle rates, safety features, biocompatibility, and electrical characteristics.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for a physical breast pump.
§ 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).