(149 days)
The Solo™ / Swing Maxi™ breast pumps are powered breast pumps to be used by lactating women to express and collect milk from their breasts.
The Solo™ / Swing Maxi™ breast pumps are intended for a single user.
The breast pumps are intended to be used in a home environment.
Solo™ and Swing Maxi™ are breast pump systems intended to be used in a home environment (or similar such as an office). Solo™ and Swing Maxi™ comprise a pump unit, power adapter, and one (Solo™) or two (Swing Maxi™) PersonalFit Flex™ connectors that include the connector body, membrane (diaphragm), and connector back cap. The breast pump systems also include breast shields (21, 24, 27, and 30 mm), bottle lid, bottle stand, and tubing. The device is provided non-sterile.
The breast pumps can be used on one breast (single pumping; Solo™ and Swing Maxi™)) or on both breasts (double pumping) at the same time (Swing Maxi 101).
The Solo"M and Swing Maxi™ breast pumps feature 2-Phase Expression® technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm. A DC motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk. The pump unit includes the following features:
- user-adjustable controls: "On/Pause/Off" for powering on/off or pausing the device, "Letdown" for switching between pumping modes, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
- a port for connection of the tubing that channels the vacuum for breast pumping;
- a port for connection of the power supply;
- a central LED light as status indicator; and
- a textile lanyard as an interface to the user's clothes/body.
The Solo™ and Swing Maxi™ breast pump systems allow the user to adjust the vacuum levels in both phases (stimulation and expression). The powered breast pumps are preprogrammed with variable vacuum levels and cvcle rates. The powered breast pumps are capable of providing vacuum levels from -45 to -140 mmHg with cycle speeds up to 111 cycles per minute for stimulation and from -45 to -245 mmHg with cycle speeds from 75 to 45 cycles per minute for expression.
Two different product configurations are available for the Swing Maxi™ breast pump: without and with Bluetooth®. These two product configurations share the same mechanical and electrical design components; however, the Swing Maxi111 breast pump with Bluetooth® additionally features always-on enabled Bluetooth® connectivity. This allows monodirectional wireless data transmission from the breast pump to a Bluetooth®-enabled personal mobile device, such as a smartphone or tablet computer. When the Medela FamilyTM smart application is installed on a compatible mobile device and the device is paired via Bluetooth® with the breast pump unit, the user can: automatically record pumping data (session length, phases, and vacuum intensity levels), manually input the amount of milk expressed, and get notified when the battery is low as indicated in provided instructional material and in-app information.
The provided document is a 510(k) premarket notification for the Medela Solo™ / Swing Maxi™ breast pumps. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
The document states that the breast pumps comply with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, and usability. It also lists performance data provided to support the substantial equivalence determination. These performance data are:
- Electrical Safety testing: In accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, and IEC 60601-11:2015.
- Risk analysis: In accordance with ISO 14971:2007.
- Electromagnetic compatibility testing: In accordance with IEC 60601-1-2:2014.
- Biocompatibility evaluation: Completed according to FDA guidance "Use of International Standard ISO 10993-1," concluding no new testing was required as patient-contacting materials are identical to the predicate device.
- Software validation: In accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The software was considered a "Moderate" level of concern.
- Bench testing: Conducted to determine minimum and maximum vacuum levels and cycle rates compared to specifications.
- Battery and pump use life testing: Conducted to demonstrate device maintenance of specifications throughout its use life.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria are met for an AI/ML device because the provided text is for a traditional medical device (breast pump) and does not describe an AI/ML component or associated performance studies against specific AI/ML metrics.
If you have a document related to an AI/ML medical device, please provide that, and I will do my best to extract the information you need.
§ 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).