Electric Breast Pump

K172989 · Joytech Healthcare Co. , Ltd. · HGX · Dec 20, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K172989
• Device Name: Electric Breast Pump
• Applicant: Joytech Healthcare Co. , Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Dec 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.

Device Story

Personal-use electric breast pump; single-user; powered by internal batteries or AC adapter. Device uses diaphragm-type vacuum pump driven by DC motor; controlled by microcontroller. Two modes: Stimulation (fast cycles, low vacuum) to initiate flow; Expression (slow cycles, high vacuum) for milk collection. Components include motor, breast shields, tubing, bottle, and valve. Operated by lactating women in home environment. User adjusts suction levels via interface; device provides visual feedback via LCD. Benefits include efficient, gentle milk expression.

Clinical Evidence

Bench testing only. Testing included vacuum pressure range, maximum vacuum, backflow-leakage, and battery life. Compliance verified for AAMI/ANSI ES60601-1, IEC 60601-1-11, and IEC 60601-1-2. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation).

Technological Characteristics

Materials: silicone (breast shield), polypropylene (body/bottle). Diaphragm-type vacuum pump; DC-motor; microcontroller-based control. Power: 4 AA batteries or AC adapter (DC6.0V, 1000mA). Vacuum range: -60 to -250 mmHg. LCD interface. Non-sterile. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for lactating women to express and collect breast milk. Intended for single-user use.

Regulatory Classification

Identification

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

Predicate Devices

• Medela Swing Breast Pump (K053052)

Submission Summary (Full Text)

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December 20, 2017

Joytech Healthcare Co., Ltd. Ren Yunhua General manager No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City, Zhejiang 311100 China

K172989 Re: Trade/Device Name: Electric Breast Pump (Models LD-202 and LD-213) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 15, 2017 Received: September 27, 2017

Dear Ren Yunhua:

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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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); 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.

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

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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) K172989

Device Name

Electric Breast Pump (Models LD-202 and LD-213)

## Indications for Use (Describe)

The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. 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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# JOYTECH HEALTHCARE CO. LTD.

## 510(k) Summary

## K172989

## 1. Date Prepared: 2017.12.19

## 2. Submitter's Identification:

Name: JOYTECH HEALTHCARE CO., LTD.

- Address: No.365, Wuzhou Road, Yuhang Economic Development Zone,Hangzhou City, 311100 Zhejiang,China
Contact Person: Yunhua Ren

Phone: [phone]

Fax: [phone]

[e-mail] Email:

## 3. Name of the Device:

Trade Name: Electric Breast Pump (Models LD-202, LD-213)

## 4. Classification Information:

| Common Name: | Electric Breast Pump |
|----------------------|--------------------------|
| Classification name: | Powered breast pump |
| Regulation number: | 884.5160 |
| Product Code: | HGX, Powered breast pump |
| Device Class: | II |
| Panel: | Obstetrics/Gynecology |

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Image /page/4/Picture/1 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is Chinese characters.

## JOYTECH HEALTHCARE CO. LTD.

#### 5. Predicate Device Information:

Medela Swing Breast Pump (K053052); Medela AG

The predicate device has not been subject to a design-related recall.

### 6. Indications for Use:

The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The electric breast pump is intended for a single user.

## 7. Device Description:

The Electric Breast Pump is a personal use electric breast pump capable of single pumping. The device is electrically powered from either internal batteries or an external AC powered supply and is provided non-sterile.

The Electric Breast Pump consists of the motor, breast shields, tubing, bottle and valve. The materials used are silicone (breast shield) and polypropylene (Pump body and bottle).

The electric breast pump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release).

The device has two modes of operation:

- Stimulation mode: Suction patterns with fast cycles and low vacuum to start ● milk flowing
- . Expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.

| | Subject Device<br>K172989 | Predicate<br>device<br>K053052 | Comparison |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------|
| Indication for use | A powered breast pump<br>to be used by lactating<br>women to express and<br>collect milk from<br>their breasts. | A powered breast pump<br>to be used by lactating<br>women to express and<br>collect milk from<br>their breasts. | Identical |
| Patient Population | Lactating women | Lactating women | Identical |
| Environment of Use | Home | Home or Hospital | Similar |
| Single/double pump | Single pump | Single pump | Identical |
| Re-usable | Yes | Yes | Identical |
| Direct user contact | Yes | Yes | Identical |
| Adjustable<br>suction<br>levels | Yes | Yes | Identical |

## 8. Predicate Device Comparison:

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| | JOYTECH HEALTHCARE CO. LTD. | | |
|-----------------------------------------|-------------------------------------------------------------|------------------------------------------------|-----------|
| Visual indicator | LCD Screen | LED | Similar |
| Vacuum range<br>(mmHg) | -60~-250mmHg | -50~-250mmHg | Similar |
| Cycling/Suction<br>Control<br>Mechanism | Microprocessor | Microprocessor | Identical |
| Breastshield size | 24mm or 27mm | 21mm,24mm,27mm,30mm<br>or 36mm | Similar. |
| Cleaning method for<br>Accessories | Soap and warm water | Soap and warm water | Identical |
| Battery type | 4 AA batteries or Medical<br>AC Adapter (DC6.0V,<br>1000mA) | 4 AA batteries or<br>AC Adapter (DC4.8V, 1.2A) | Similar |
| Battery use life | Approx.1.5h for pumping time | Approx.1.5h for<br>pumping time | Identical |
| Low<br>battery<br>indicator | Yes | Yes | Identical |
| Automatic<br>Power-<br>Off | Yes | Yes | Identical |

The Electric Breast Pump has the same intended use but minor differences in technological characteristics compared to the predicate device. These minor differences in technological characteristics do not raise different questions of safety and effectiveness.

## 9. Performance data

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

Performance testing was conducted to validate and verify that the Electric Breast Pump met all requirements of the applicable standards, including electrical safety, EMC, and biocompatibility. Results of these tests demonstrate compliance to the following standards:

Electrical Safety and performance requirements:

- AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment
Home-used medical equipment requirements and environmental test:

- · IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic compatibility requirements:

- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation for patient contacting components:

- Cytotoxicity ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests . for in vitro cytotoxicity
- Sensitization ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: . Tests for irritation and skin sensitization

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# JOXTEC-11116

## JOYTECH HEALTHCARE CO. LTD.

- Irritation ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for . irritation and skin sensitization
## Software Validation

The software/firmware verification and validation was provided in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

## Bench Performance Testing

The following bench testing was completed on the subject device:

- . Vacuum pressure range (suction)
- Maximum vacuum pressure .
- Backflow-leakage testing .
- Battery life testing .

## 10. Conclusions:

The performance testing provided is sufficient to support substantial equivalence determination. Based on the information provided in this submission, the Joytech Electric Breast Pump is as safe and effective as the predicate Medela Swing Breast Pump.