Electric Double Breast Pumps

K151284 · Wuxi Xinzhongrui Baby Supplies Co., Ltd. · HGX · Dec 21, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K151284
• Device Name: Electric Double Breast Pumps
• Applicant: Wuxi Xinzhongrui Baby Supplies Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Dec 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The powered Electric Double Breast Pumps are intended to express and collect milk from the breast of a lactating woman. They are double pumps with a single pumping option and intended for single user.

Device Story

Electrically powered, software-controlled, reciprocating diaphragm breast pumps (models XB-8636, XB-8703); intended for single-user home use. Device operates via microprocessor-controlled suction cycles; user selects suction levels. XB-8636 features 120-second stimulation mode followed by 30-minute expression mode; 7 suction levels. XB-8703 features 180-second stimulation mode followed by 30-minute expression mode; 9 suction levels. Both models include automatic shutdown. Powered by 6V DC adapter or 4 AA batteries. User adjusts suction levels via interface. Benefits include efficient milk expression and collection; backflow prevention mechanism protects motor from liquid ingress.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), home healthcare environment requirements (IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), suction performance, backflow prevention, and use-life/disinfection durability testing.

Technological Characteristics

Reciprocating diaphragm pump; microprocessor-controlled; 6V DC or 4xAA battery power. XB-8636: 7 suction levels, 60-240 mmHg, 25-103 cycles/min. XB-8703: 9 suction levels, 60-240 mmHg, 22-120 cycles/min. Software-controlled timing and suction profiles. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2.

Indications for Use

Indicated for lactating women requiring breast milk expression and collection. 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

• Megna Breast Pumps (K142479)

Submission Summary (Full Text)

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

December 21, 2015

Wuxi Xinzhongrui Baby Supplies Co., Ltd % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K151284

> Trade/Device Name: Electric Double Breast Pumps Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: Class II Product Code: HGX Dated: November 17, 2015 Received: November 23, 2015

Dear Diana Hong,

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. 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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

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

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

Sincerely yours,

# Benjamin R. Fisher -S

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) K151284

Device Name Electric Double Breast Pumps

Indications for Use (Describe)

The powered Electric Double Breast Pumps are intended to express and collect milk from the breast of a lactating woman. They are double pumps with a single pumping option and intended for 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 K151284

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

- 1. Date of Preparation: 12/07/2015
- 2. Sponsor Identification

Wuxi Xinzhongrui Baby Supplies Co., Ltd No.117 Xinhua Road, Meicun, New District, Wuxi, Jiangsu, 214000, China

Contact Person: Shaozhong Chen Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

- 4. Identification of Proposed Device
Trade Name: Electric Double Breast Pumps Common Name: Powered breast pump Models: XB-8636, XB-8703

Regulatory Information Classification Name: Pump, Breast, Powered; Classification: II; Product Code: HGX; Regulation Number: 21 CFR 884.5160; Review Panel: Obstetrics/Gynecology;

Intended Use Statement: The powered Electric Double Breast Pumps are intended to express and collect milk from the breast of a lactating woman. They are double pumps with a single pumping option and intended for single user.

Device Description

The Electric Double Breast Pumps are designed and manufactured to express and collect milk from a lactating woman's breast. Both models, XB-8636 and XB-8703, are electrically powered, softwarecontrolled, digital single-user pumps.

When powered, the XB-8636 starts with stimulation mode for 120 seconds then automatically switches to expression mode for 30 minutes before automatic shutdown. This model has seven suction levels. When powered, the XB-8703 starts with stimulation mode for 180 seconds then automatically switches to expression mode for 30 minutes before automatic shutdown. This model has nine suction levels. Both models allow the user to adjust the suction levels when necessary.

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- 5. Identification of Predicate Device
510(k) Number: K142479 Product Name: Megna Breast Pumps Model Name: M10

#### 6. Substantially Equivalent (SE) Comparison

| Item | Proposed Devices | Predicate Device |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HGX | HGX |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Class | Class II | Class II |
| Indications for Use | The powered Electric Double Breast<br>Pumps are intended to express and<br>collect milk from the breast of a<br>lactating woman. They are double<br>pumps with a single pumping option<br>and intended for single user. | The powered Megna Breast Pumps<br>are intended to express and collect<br>milk from the breast of a lactating<br>woman.<br>The M5 model is a single pump. The<br>M7, M10, and M12 models are double<br>pumps with a single pumping option.<br>All models are intended for single<br>users. |
| Pump Type | Reciprocating Diaphragm | Reciprocating Diaphragm |
| Pumping Options | Single or Double | Single or Double |
| Cycling/Suction<br>Control Mechanism | Microprocessor | Microprocessor |
| Suction Levels | XB-8636: 7<br>XB-8703: 9 | 9 |
| Suction Strength | Single & Double: 60 - 240 mmHg | Single: 60 - 297 mmHg<br>Double: 60 - 300 mmHg |
| Cycle Speed | XB-8636:<br>Single: 36 - 103 cycles / min<br>Double: 25 - 76 cycles / min<br>XB-8703:<br>Single: 38 - 120 cycles / min<br>Double: 22 – 68 cycles / min | 38 – 139 cycles / min |
| Suction Flow Rate | XB-8636:<br>Single & Double: 4 – 40 ml / min<br>XB-8703:<br>Single & Double: 4 – 60 ml / min | Single: 9 – 65 ml / min<br>Double: 10 – 67 ml / min |
| Power Supply | 6V DC Adaptor or 4 AA 1.5V<br>batteries | 6V DC Adaptor |

Table 1 Comparison of Technology Characteristics

The differences in suction level, suction strength, cycle speed, and suction flow rate between the subject and predicate device do not raise different questions of safety and effectiveness.

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- 7. Summary of Non-Clinical Tests
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- . IEC 60601-1: 2005 + CORR.1 (2006) + CORR.2 (2007) + AM1 (2012), Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
- . IEC 60601-1-11: 2010, Medical Electrical Equipment - Part 1-11: 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.
- . IEC 60601-1-2: 2007, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.

Additionally, the following non-clinical tests were conducted:

- Suction Curves of proposed devices were tested. All the tests results complied with the design . specifications of the proposed devices.
- . Back flow testing was conducted to ensure that even if the bottle is over-filled, no liquid will backflow into the tubing, and therefore no liquid can backflow into the pump motor. The test results showed that there was no backflow during the test.
- . Use-life testing was conducted on the proposed devices. The test result showed there was no significant difference in suction strength or simulating milk suction flow rate of new-manufactured devices and devices after two-year use and 1000 cycles' disinfection.
- 8. Summary of Clinical Tests

Clinical testing was not required to demonstrate substantial equivalence of the Electric Double Breast Pumps to the predicate device.

- 9. Substantially Equivalent (SE) Conclusion
The differences between the Electric Double Breast Pumps and its predicate device do not introduce a new intended use and do not raise different issues of safety and effectiveness. Performance testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.