Electric Breast Pump

K182413 · Guangdong Horigen Mother & Baby Products Co., Ltd. · HGX · Mar 7, 2019 · Obstetrics/Gynecology

Device Facts

• Record ID: K182413
• Device Name: Electric Breast Pump
• Applicant: Guangdong Horigen Mother & Baby Products Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Mar 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Electric Breast Pump is intended 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.

Device Story

Electric breast pump for single-user home use; expresses and collects milk; alleviates engorgement; maintains lactation. System comprises pump unit, expression collection kit, tubing. Materials: polypropylene, liquid/solid silicone, thermoplastic elastomer. Operates via negative pressure module controlled by single-chip microcomputer; mimics natural nursing rhythm. Features 2-phase expression: Stimulation (fast cycles, low vacuum) and Expression (slower cycles, higher vacuum). User interface includes touch-button control panel with LCD/LED screen for process monitoring. Powered by AC adapter, AA batteries, or rechargeable Li-ion polymer battery. Closed system with anti-backflow mechanism. Provides vacuum levels 30–247.5 mmHg; cycle rates up to 100 cycles/min. Supports single or double pumping. Healthcare provider/user monitors output via screen; device facilitates milk collection for future feedings.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility per ISO 10993-1 (cytotoxicity, sensitization, skin irritation). Electrical safety per IEC 60601-1:2012; EMC per IEC 60601-1-2:2014. Performance testing evaluated vacuum stability, cycle rates, pressure levels, backflow protection, and battery specifications. All parameters met predefined acceptance criteria.

Technological Characteristics

Diaphragm pump; materials: polypropylene, liquid/solid silicone, thermoplastic elastomer. Vacuum range: 30–247.5 mmHg; cycle rate: 24–100 cycles/min. Power: AC mains, AA batteries, or rechargeable Li-ion polymer battery. Closed system with anti-backflow. User interface: LCD/LED screen with touch buttons. Software: single-chip microcomputer-based control. Standards: ISO 10993-1, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for lactating women to express and collect breast milk, alleviate engorgement, and maintain lactation. Intended for single-user home use.

Regulatory Classification

Identification

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

Predicate Devices

• Electric Breast Pump (K143585)

Submission Summary (Full Text)

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March 7, 2019

Guangdong Horigen Mother & Baby Products Co., Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co.,Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China

Re: K182413

> Trade/Device Name: Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 1, 2019 Received: February 4, 2019

Dear Mike Gu:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jason Roberts -S

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

510(k) Number (if known) K182413

Device Name Electric Breast Pump

Models: XN-2212M2, XN-2219M1, XN-2219M2, XN-2223M2, XN-2223M2, XN-2233M1, XN-2233M2

Indications for Use (Describe)

The Electric Breast Pump is intended 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

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

## 1. SUBMITTER

Guangdong Horigen Mother & Baby Products Co., Ltd. NO.8, Yi Road, Pingbei Industrial Zone, Chaoyang District, Shantou, 515100, Guangdong, China Phone: [phone] Fax: [phone]

| Primary Contact | Mike Gu |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Person: | Regulatory Affairs Manager<br>Guangzhou Osmunda Medical Device Technical Service<br>Co., Ltd.<br>Tel: [phone]<br>Fax: (+86) -20-8633 0253 |
| Secondary Contact | Jun Deng |
| Person: | General Manager<br>Guangdong Horigen Mother & Baby Products Co., Ltd.<br>Tel: [phone]-866<br>Fax: [phone] |
| Date prepared | March 6, 2019 |
| 2. DEVICE | |
| Device Name: | Electric Breast Pump |
| Common/Usual Name: | Powered breast pump |
| Model: | XN-2212M2, XN-2219M1, XN-2219M2, XN-2223M1,<br>XN-2223M2, XN-2233M1 and XN-2233M2 |
| Regulation number | 21 CFR 884.5160 Powered breast pump |
| Regulation Class: | II |
| Product Code: | HGX Pump, Breast, Powered |

## 3. PREDICATE DEVICE

Predicate device: K143585, Electric Breast Pump

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This predicate and the referenced have not been subject to a design-related recall. No reference devices were used in this submission.

#### 4. DEVICE DESCRIPTION

The Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting for a single user. It comprises of a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer.

This electric breast pump has a negative pressure module that utilizes a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk expression speed intensities. The keyboard of the control panel is soft. The screen is an LCD or LED screen, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 30 to 247.5 mmHg with cycle rates up to 100 cycles per minute.

The Electric Breast Pump provides the following user features:

- . Closed system with anti-backflow
- . LCD or LED screen touch button operation
- . 2-phase expression: Stimulation and Expression phases
- Stimulation Phase: Expression pattern with fast cycles (70~100 Cycles/min) and low vacuum (30 ~ 112.5 mmHg) to start milk flowing, 9 levels
- Phase: Expression cvcles (24~90Cycles/min) and higher vacuum (75 ~ 247.5 mmHg) to express milk, 9 levels
- Double-pumping ability: single or double pumping
- . Dual power source: it can be operated by A/C adapter or batteries
- Built-in rechargeable li-ion polymer battery or additional AA battery power option

#### 5. INDICATIONS FOR USE

The Electric Breast Pump is intended 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.

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The indications for use statement for the subject device is similar to that of the predicate, with minor alterations in text; however, the intended use of the subject and predicate devices is the same (express and collect milk from breasts of lactating women).

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| Device & Predicate Device(s): | K182413 | K143585 |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| General Device Characteristics | | |
| Environment of Use | Home | Home, institutions and<br>hospital |
| Single or Multiple-User | Single | Single |
| Pump Type | diaphragm pump | diaphragm pump |
| Adjustable Vacuum Levels | 9 levels | 9 levels |
| Maximum Expression Intensity | 247.5 | 270 |
| Stimulation Intensity range | 30-112.5 | 15.2-144.4 |
| Stimulation Velocity | 70 – 100 cycles/min | 95-105 |
| Expression Velocity | 24 – 90 cycles/min | 20-65 |
| User Interface | Hardware interface | Hardware interface |
| Backflow Protection (prevention<br>of backflow of liquid into<br>pump/tubing) | Yes | Yes |
| Overflow Protection (stops<br>pumping when the bottle is full<br>to prevent overflow) | No | No |
| Power Source | AC Mains 100-240 VAC,<br>50/60Hz, 1.5A/1A<br>4AA Alkaline battery<br>Rechargeable Li-Ion<br>Battery (7.4 V / 1750<br>mAh) | 4AA battery or AC/DC<br>adapter |

#### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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The subject device is different from the predicate and the referenced in suction pressure range, cycle speed, maximum suction pressure and the power source. However, these differences do not raise different questions of safety and effectiveness. The technological differences can be evaluated through the software, performance and EMC/electrical safety testing provided.

#### PERFORMANCE DATA 7.

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for the Electric Breast Pump was conducted in accordance with the International Standard ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

- Cytotoxicity - (ISO 10993-5: 2009)
- Sensitization - (ISO 10993-10:2010)
- Skin Irritation - (ISO 10993-10:2010)

## Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Electric Breast Pump. The device complies with the IEC 60601-1:2012, standard for electrical safety and the IEC 60601-1-2:2014 standard for EMC. Software Validation was performed per the FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.

## Performance testing

Performance testing was conducted on the Electric Breast Pump. Technical parameters of stimulation mode and expression mode, including working current, pressure, cycle rate and noise, backflow protection mechanism, and battery specification were evaluated in the performance testing. In addition, the stability of vacuum level and shelf life were evaluated. All of the tested parameters met the predefined acceptance criteria.

#### 8. CONCLUSION

The indications for use statement for the subject device is similar to that of the predicate. The differences between the Electric Breast Pump and its predicate device

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do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Electric Breast Pump should perform as intended in the specified use conditions.

From the results of non-clinical data including the performance testing described, Guangdong Horigen concludes that the Electric Breast Pump is as safe and as effective as the predicate device.