LogoFDA 510(k) Search
K Number
K211016
Device Name
Powered Breast Pump (Models 7V and 7X)
Manufacturer
Haenim Co., Ltd.
Date Cleared
2022-06-29

(450 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
Obstetrics/Gynecology
Reference & Predicate Devices
K200675
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Powered Breast Pump (Models 7V and 7X) is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

Device Description

The Powered Breast Pump (Models 7V and 7X) is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. The device is intended for a single user and can be used in home and professional healthcare environments.

The subject device can be used for single or double breast pumping and consists of the following key components: a motor unit with a press-button user interface, expression kits (NexusFit™ Cap, Diaphragm, Pump Body, Breast Shield, and Valve; areola shield; milk collection kit), and a silicone vacuum tube.

The Powered Breast Pump (Models 7V and 7X) has two operational modes (massage and expression), with user-selectable vacuum and cycle levels in each mode (levels are shown in Section 7 of the summary). Both device models are powered by an external AC power supply, while all 7V and select 7X models can be operated using an internal rechargeable lithium-ion battery. The device is provided nonsterile.

All milk contacting components are compliant with 21 CFR 174-179

AI/ML Overview

The provided document is a 510(k) summary for a Powered Breast Pump (Models 7V and 7X). It does not contain information about the acceptance criteria and study proving device meets acceptance criteria in the context of an AI/ML powered medical device. The document is for a physical medical device and discusses electrical safety, electromagnetic compatibility, software evaluation based on the 2005 FDA guidance (not specific to AI/ML), and physical performance testing such as vacuum level verification and use-life testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML powered device from this document.

§ 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).