ELECTRIC BREAST PUMP

• K Number: K132882
• Device Name: ELECTRIC BREAST PUMP
• Manufacturer: SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD
• Date Cleared: 2014-04-24 ( 223 days)
• Product Code: HGX POW
• Regulation Number: 884.5160

Intended Use

The electric breast pump is to express and collect milk from breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for single user.

Device Description

The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed and manufactured by the Shantou Xinghe Electrical Apparatus Co., Ltd. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mother and baby occur. Two models of this device, Horigen, XN- 2203H2 and Droplet, XN-2203H4, are included in this Premarket Notification submission. The primary differences between the two models, Horigen XN- 2203H2 and Droplet, XN-2203H4 are the shape of the breast shield and the settings of the stimulating velocity, stimulating intensity, sucking velocity and sucking intensity. The specific settings are listing under the summary of non-clinical tests. The product uses a Single-Chip Microcomputer to imitate a baby's suckling action. The device is ergometrically designed to create comfortable milk stimulation, massage, and suction from the breast. Three (3) stimulation levels and five (5) speeds are available to imitate the rhythm and action of a baby's suckling. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm. The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed to mechanically interface with a mother's breast via a breast shield and withdraw, then collect, the breast milk. The device is driven by a microcomputer which electrically controls piston components. The pistons perform a reciprocating movement in the device cylinder and pump seat. A breast cup is fixed between the piston and the piston head on which negative and positive pressure is created by the piston action. A mobile magnet detects the mechanical movement and creates an electrical signal to the microcontroller.

Predicate Devices

K100435

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description mentions a "Single-Chip Microcomputer" and "electronic memory" to imitate a baby's suckling action and store settings. While this involves electronic control and programming, it does not describe the adaptive learning or pattern recognition capabilities typically associated with AI/ML. The description of fixed stimulation levels and speeds further suggests a pre-programmed, non-adaptive system.

Therapeutic

No.
The device is used to express and collect milk from a lactating woman's breast, alleviate engorgement, and maintain lactation. These functions are primarily supportive for breastfeeding and managing associated discomfort rather than directly treating a disease or medical condition.

Diagnostic

No

The device is an electric breast pump used to express and collect milk, alleviate breast engorgement, and maintain lactation. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as pistons, cylinders, pump seats, breast shields, and a mobile magnet, indicating it is a physical device with mechanical and electrical components, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The described device is an electric breast pump. Its function is to mechanically express and collect breast milk directly from the breast. It does not analyze or test any biological specimen in vitro.
• Intended Use: The intended use clearly states its purpose is to express and collect milk, alleviate engorgement, maintain lactation, and provide milk for feeding. None of these activities involve in vitro diagnostic testing.

The device is a medical device, but it falls under a different category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are used to express and collect milk from the breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for single user.

Product codes

HGX

Device Description

The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed and manufactured by the Shantou Xinghe Electrical Apparatus Co., Ltd. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mother and baby occur. Two models of this device, Horigen, XN-2203H2 and Droplet, XN-2203H4, are included in this Premarket Notification submission. The primary differences between the two models, Horigen XN-2203H2 and Droplet, XN-2203H4 are the shape of the breast shield and the settings of the stimulating velocity, stimulating intensity, sucking velocity and sucking intensity. The specific settings are listing under the summary of non-clinical tests.
The product uses a Single-Chip Microcomputer to imitate a baby's suckling action. The device is ergometrically designed to create comfortable milk stimulation, massage, and suction from the breast. Three (3) stimulation levels and five (5) speeds are available to imitate the rhythm and action of a baby's suckling. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Breast

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The sponsor has performed bench testing to demonstrate the electric breast pump performs within specifications:
Model Droplet XN-2203H4
Stimulating velocity: 88T/min
Stimulating intensity: -0.018MPa (Max.), 3 adjustable degrees Sucking intensity: -0.028MPa (Max.), 5 adjustable degrees Sucking velocity: 34-63T/min, 5 adjustable speeds;
Model Horigen XN-2203H2
Stimulating velocity: 90T/min
Stimulating intensity: -0.012MPa (Max.), 3 adjustable degrees Sucking intensity: -0.024MPa (Max.), 5 adjustable degrees Sucking velocity: 35-63T/min, 5 adjustable speeds;
The proposed device has met acceptance criteria of performance testing including: biocompatibility (InVivo cytotoxicity, irritation, and sensitization testing) and electrical safety, EMC, and suction level and cycle time.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100435

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

APR 2 4 2014

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:

2013/09/05

Submitter:

Primary Contact Person:

Jun Deng

General Manager

Shantou Xinghe Electrical Apparatuses Co., Ltd.

Shantou Xinghe Electrical Apparatuses Co., Ltd.

Tel: [phone]-866

Fax: [phone]

Secondary Contact Person:

Mike Gu

Regulatory Affairs Manager

OSMUNDA Medical Device Consulting Co., Ltd.

Tel: [phone]

Fax: (+86) -20-8633 0253

Device:

Trade Name: Horigen, Model XN-2203H2 and Droplet, Model XN-2203H4

Common/Usual Name:

Classification Names:

Regulation Number:

Product Code:

Powered breast pump

Powered breast pump

CFR 884.5160

HGX

Predicate Device(s):

K100435, Ameda Platinum electric breast pump

1

、

.

| Device Description: | The Electric Breast Pump, model Horigen, XN-2203H2
and model Droplet, XN2203H4 are designed and
manufactured by the Shantou Xinghe Electrical
Apparatus Co., Ltd. It is intended to express and collect
milk from a lactating woman's breast. This action helps
to alleviate engorgement of the breast, maintain the
woman's ability to lactate, and provide a mother's milk
for future feedings when separation of the mother and
baby occur. Two models of this device, Horigen, XN-
2203H2 and Droplet, XN-2203H4, are included in this
Premarket Notification submission. The primary
differences between the two models, Horigen XN-
2203H2 and Droplet, XN-2203H4 are the shape of the
breast shield and the settings of the stimulating
velocity, stimulating intensity, sucking velocity and
sucking intensity. The specific settings are listing under
the summary of non-clinical tests.
The product uses a Single-Chip Microcomputer to
imitate a baby's suckling action. The device is
ergometrically designed to create comfortable milk
stimulation, massage, and suction from the breast.
Three (3) stimulation levels and five (5) speeds are
available to imitate the rhythm and action of a baby's
suckling. The control panel is soft and viewing is
provided by a LCD screen. Once programmed, the
pump's electronic memory stores the selected rhythm |

---------------------

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Intended Use: | The Electric Breast Pump, model Horigen, XN-2203H2
and model Droplet, XN2203H4 are used to express and
collect milk from the breast, to alleviate engorgement of
the breast, maintain the ability of lactation, and provide
mother's milk for future feedings when separation of
mother and baby occurs. The device is intended for
single user. |

---------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

·

:

| Technology: | The Electric Breast Pump, model Horigen, XN-2203H2
and model Droplet, XN2203H4 are designed to
mechanically interface with a mother's breast via a
breast shield and withdraw, then collect, the breast
milk. The device is driven by a microcomputer which |

-------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

2

.

| | electrically controls piston components. The pistons
perform a reciprocating movement in the device
cylinder and pump seat. A breast cup is fixed between
the piston and the piston head on which negative and
positive pressure is created by the piston action. A
mobile magnet detects the mechanical movement and
creates an electrical signal to the microcontroller. |

--	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Determination of Substantial Equivalence:

Specification	Predicate Device	Proposed Device	Discussion of Differences
Device Name	Ameda Platinum
Breast Pump	Horigen,
XN2203H2 and
Droplet,
XN2203H4
K Number	K100435	K132882
Indications for Use	The electric breast
pump is to express
and collect milk
from the mother's
breast, to alleviate
engorgement of
the breast,
maintain the
ability of lactation,
and provide
mother's milk for
future feedings
when separation of
mother and baby
occurs. The electric
breast pump is
intended for a
single user.	The electric breast
pump is to express
and collect milk
from the mother's
breast, to alleviate
engorgement of
the breast,
maintain the
ability of lactation,
and provide
mother's milk for
future feedings
when separation of
mother and baby
occurs. The electric
breast pump is
intended for a
single user.	Same
Patient Population	Breastfeeding
women	Breastfeeding
women	Same
5-40°C	5-40°C	5-40°C	Same
Pump Style	Piston	Piston	Same
Vacuum Range	30-250	180 maximum	Similar, the
maximum vacuum
range of the
proposed device is
less than the
predicate device
Specification	Predicate Device	Proposed Device	Discussion of
Differences
which would not
involve any harm.
Cycle Speed	30-80	90 maximum	Similar
Overflow
Protection	No	No	Same
Adjustable Section
Levels	Yes	Yes	Same
Software	Yes	Yes	Same
Anatomical Sites	Breast	Breast	same
Energy Used
and/or Delivered	AC
Battery	AC	same
Design and
Materials	All food or human
contact
components are
manufactured
from materials that
meet FDA food
additive criteria as
set forth in 21
Code of Federal
Regulations Part
176, 177 and 178.	All food or human
contact
components are
manufactured
from materials that
meet FDA food
additive criteria as
set forth in 21
Code of Federal
Regulations Part
176, 177 and 178.	Same
Performance	Stimulation,
suction and
collection	Stimulation,
suction and
collection	Same
Standards Met	IEC 60601-1, 1988;
Amendment 1,
1991-11,
Amendment 2,

1995. (General)
      IEC 60601-1-2,
      (Edition 2:2001
      with Amendment
      1:2004; Edition 2.1
      (Edition 2:2001
      consolidated with
      Amendment
      1:2004)).
      (General)
      ISO 10993-1
      ISO 10993-5
      ISO 10993-10 | IEC 60601-1, 3rd
      Edition
      IEC 60601-1-2
      Edition 3:2007-03
      ISO 10993-
      1:Fourth Edition
      2009-10-15
      ISO 10993-5:2009
      ISO 10993-10;
      Third Edition
      2010-08-01 | Same |
      | Biocompatibility | Not cytotoxic | Not cytotoxic | Same |
      | Specification | Predicate Device | Proposed Device | Discussion of -
      Differences |
      | | irritating or a
      dermal sensitizer | irritating or a
      dermal sensitizer | |
      | Electrical Safety | Electromagnetic
      compatibility tests
      are provided to
      illustrate that
      electrical safety
      meets IEC 60601-
      1-2. | Electromagnetic
      compatibility tests
      are provided to
      illustrate that
      electrical safety
      meets IEC 60601-
      1-2. | Same |
      | Mechanical Safety | Mechanical cycling
      suction regulator. | Mechanical cycling
      suction regulator. | Same |

.

.

3

.

.

:

:

·

.

:

.

:

. ・

:

4

Summary of Non-Clinical Tests:

The sponsor has performed bench testing to demonstrate the electric breast pump performs within specifications:

Model Droplet XN-2203H4

Stimulating velocity: 88T/min

Stimulating intensity: -0.018MPa (Max.), 3 adjustable degrees Sucking intensity: -0.028MPa (Max.), 5 adjustable degrees Sucking velocity: 34-63T/min, 5 adjustable speeds;

Model Horigen XN-2203H2

Stimulating velocity: 90T/min

Stimulating intensity: -0.012MPa (Max.), 3 adjustable degrees Sucking intensity: -0.024MPa (Max.), 5 adjustable degrees Sucking velocity: 35-63T/min, 5 adjustable speeds;

The proposed device has met acceptance criteria of performance testing including: biocompatibility (InVivo cytotoxicity, irritation, and sensitization testing) and electrical safety, EMC, and suction level and cycle time.

Conclusion:

Shountou Xinghe Electrical Apparatuses Co. Ltd. considers the electric breast pump to be as safe, as effective, and performance is substantially equivalent to the predicate device.

5

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2014

Shantou Xinghe Electrical Apparatuses Co., Ltd. Jun Deng General Manager NO.8, Yi Road, Pingbei Industrial Zone, Chaoyang District Shantou, Guangdong 515100 China

Re: K132882

Trade/Device Name: Electric breast pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: March 25, 2014 Received: March 27, 2014

Dear Jun Deng,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

:

6

Page 2 - Jun Deng

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K132882

Device Name

Electric breast pump

Indications for Use (Describe)

The electric breast pump is to express and collect milk from breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The device is intended for single user.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

MENT SERVICE MARK STORE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Herbert P. Lerner -S 2014.04.24 11:15:43 -04

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, Including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."