ELECTRIC BREAST PUMP

K132882 · Shantou Xinghe Electrical Apparatuses Co., Ltd. · HGX · Apr 24, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K132882
• Device Name: ELECTRIC BREAST PUMP
• Applicant: Shantou Xinghe Electrical Apparatuses Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 Story

The Horigen (XN-2203H2) and Droplet (XN-2203H4) are powered breast pumps for single-user, home, or clinical use. The device interfaces with the breast via a shield; a single-chip microcomputer controls piston-driven mechanical suction. A mobile magnet detects piston movement, providing feedback to the microcontroller to regulate pressure. The device mimics infant suckling through adjustable stimulation and suction levels (3 stimulation levels, 5 speeds). Users operate the device via a control panel with an LCD screen; settings are stored in electronic memory. The pump provides rhythmic suction to express milk into a collection container. This process helps alleviate engorgement and supports continued lactation for mothers separated from their infants.

Clinical Evidence

Bench testing only. Performance testing verified suction levels, cycle times, electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2). Biocompatibility testing (cytotoxicity, irritation, and sensitization) confirmed materials are safe for human contact.

Technological Characteristics

Powered piston-style breast pump. Materials meet 21 CFR 176, 177, and 178. Features a single-chip microcomputer, LCD interface, and magnetic sensor for mechanical feedback. Operates on AC power. Complies with IEC 60601-1 (3rd Ed), IEC 60601-1-2 (2007), and ISO 10993 standards.

Indications for Use

Indicated for breastfeeding women to express and collect breast milk, alleviate engorgement, and maintain lactation when separated from their infant.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Ameda Platinum electric breast pump (K100435)

Submission Summary (Full Text)

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# 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

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

| Specification | Predicate Device | Proposed Device | Discussion of Differences |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Device Name | Ameda Platinum<br>Breast Pump | Horigen,<br>XN2203H2 and<br>Droplet,<br>XN2203H4 | |
| K Number | K100435 | K132882 | |
| Indications for Use | The electric breast<br>pump is to express<br>and collect milk<br>from the mother's<br>breast, to alleviate<br>engorgement of<br>the breast,<br>maintain the<br>ability of lactation,<br>and provide<br>mother's milk for<br>future feedings<br>when separation of<br>mother and baby<br>occurs. The electric<br>breast pump is<br>intended for a<br>single user. | The electric breast<br>pump is to express<br>and collect milk<br>from the mother's<br>breast, to alleviate<br>engorgement of<br>the breast,<br>maintain the<br>ability of lactation,<br>and provide<br>mother's milk for<br>future feedings<br>when separation of<br>mother and baby<br>occurs. The electric<br>breast pump is<br>intended for a<br>single user. | Same |
| Patient Population | Breastfeeding<br>women | Breastfeeding<br>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<br>maximum vacuum<br>range of the<br>proposed device is<br>less than the<br>predicate device |
| Specification | Predicate Device | Proposed Device | Discussion of<br>Differences<br>which would not<br>involve any harm. |
| Cycle Speed | 30-80 | 90 maximum | Similar |
| Overflow<br>Protection | No | No | Same |
| Adjustable Section<br>Levels | Yes | Yes | Same |
| Software | Yes | Yes | Same |
| Anatomical Sites | Breast | Breast | same |
| Energy Used<br>and/or Delivered | AC<br>Battery | AC | same |
| Design and<br>Materials | All food or human<br>contact<br>components are<br>manufactured<br>from materials that<br>meet FDA food<br>additive criteria as<br>set forth in 21<br>Code of Federal<br>Regulations Part<br>176, 177 and 178. | All food or human<br>contact<br>components are<br>manufactured<br>from materials that<br>meet FDA food<br>additive criteria as<br>set forth in 21<br>Code of Federal<br>Regulations Part<br>176, 177 and 178. | Same |
| Performance | Stimulation,<br>suction and<br>collection | Stimulation,<br>suction and<br>collection | Same |
| Standards Met | IEC 60601-1, 1988;<br>Amendment 1,<br>1991-11,<br>Amendment 2,<br>1995. (General)<br>IEC 60601-1-2,<br>(Edition 2:2001<br>with Amendment<br>1:2004; Edition 2.1<br>(Edition 2:2001<br>consolidated with<br>Amendment<br>1:2004)).<br>(General)<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | IEC 60601-1, 3rd<br>Edition<br>IEC 60601-1-2<br>Edition 3:2007-03<br>ISO 10993-<br>1:Fourth Edition<br>2009-10-15<br>ISO 10993-5:2009<br>ISO 10993-10;<br>Third Edition<br>2010-08-01 | Same |
| Biocompatibility | Not cytotoxic | Not cytotoxic | Same |
| Specification | Predicate Device | Proposed Device | Discussion of -<br>Differences |
| | irritating or a<br>dermal sensitizer | irritating or a<br>dermal sensitizer | |
| Electrical Safety | Electromagnetic<br>compatibility tests<br>are provided to<br>illustrate that<br>electrical safety<br>meets IEC 60601-<br>1-2. | Electromagnetic<br>compatibility tests<br>are provided to<br>illustrate that<br>electrical safety<br>meets IEC 60601-<br>1-2. | Same |
| Mechanical Safety | Mechanical cycling<br>suction regulator. | Mechanical cycling<br>suction regulator. | Same |

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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.

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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.

:

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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

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## 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

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