Smart double sides wearable breast pump, Electric bilateral breast pump

K230102 · Huizhou Lvb Maternal and Infant Supplies Co., Ltd. · HGX · Sep 21, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K230102
• Device Name: Smart double sides wearable breast pump, Electric bilateral breast pump
• Applicant: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Sep 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Wearable Breast Pump (Model ABP-1508) is an electrically powered, single-user device for lactating women to express and collect breast milk. Device uses a flange to create a seal around the nipple; applies and releases vacuum pressure to the breast. Features stimulation and expression modes, each with nine adjustable suction levels. Vacuum pressure ranges: 80-200 mmHg (stimulation) and 90-240 mmHg (expression). Powered by rechargeable Li-Ion battery or power adapter. User interface includes LED display showing mode, suction level, timer, and battery status; soft-touch buttons control power, mode, and suction. Backflow protection membrane prevents milk from entering the vacuum system. Device is intended for home use by the patient. Output is collected milk in a container. Benefits include efficient milk expression and collection.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-23, ISO 10993-10). Performance testing verified vacuum levels, backflow protection, use life, and battery functionality.

Technological Characteristics

Powered breast pump; materials include silicone (valve) and polypropylene (breast shield, bottle, suction cap). Microcontroller-based cycling control. Energy source: Li-Ion battery or power adapter. Connectivity: None. Sterilization: Not specified. Software: Microcontroller-based control of vacuum and cycle timing.

Indications for Use

Indicated for lactating women to express and collect milk from their breasts. 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

• Wearable Breast Pump (Model S12) (K212180)

Submission Summary (Full Text)

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September 21, 2023

Huizhou LVB Maternal And Infant Supplies Co.Ltd. Rain Yip Registration Engineer Block A 16 Huifengxi 3rd, Pingnan Industry Zone, Zhongkai H-i-tech District Huizhou, Guangdong 516000 China

Re: K230102

> Trade/Device Name: Wearable Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: August 17, 2023 Received: August 21, 2023

Dear Rain Yip:

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. 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Monica D. Garcia -S

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230102

Device Name Wearable Breast Pump

Indications for Use (Describe)

Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device 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 - K230102

Date Prepared: September 20, 2023

#### l Submitter

Applicant: HuiZhou LVB Maternal and Infant Supplies Co., Ltd. Address: NO. 114,Xin Xing North Road, Sandong Town, Huicheng District, Huizhou City, Guangdong Province, P.R. China

Contact person: Dongan Zhang Position: Head of Firm Phone: [phone] Fax:[phone] E-mail: [e-mail]

#### II Proposed Device

| Device Name: | Wearable Breast Pump |
|--------------------|-----------------------------|
| | (Model: ABP-1508) |
| Common Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Powered Breast Pump |
| Regulatory Class: | Class II |
| Product code: | HGX (Pump, Breast, Powered) |

#### III Predicate Devices

| 510(k) Number: | K212180 |
|----------------|-----------------------------------|
| Trade name: | Wearable Breast Pump (Model S12) |
| Manufacturer : | Shenzhen TPH Technology Co., Ltd. |

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

#### IV Device description

The Wearable Breast Pump is an electrically powered, software controlled, digital, single user, wearable breast pump for lactating women to express and collect milk from the breast. The subject device is capable of expression and stimulation modes, with nine associated suction levels for each. The vacuum pressure ranges from 80-200 mmHg for stimulation mode and 90-240 mmHg for expression mode. The device is powered by a rechargeable battery or a power adapter.

The device has an LED display, which shows the power button, pumping mode, suction level, timer, and battery charge level. Surrounding the front panel display are soft-touch

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buttons allowing the user to power the device on/off, switch between stimulation and expression modes, and control the vacuum strength.

The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the breast. The milk is collected in a milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

The subject device components are made of the following materials: ·Valve: Silicone ·Breast shield, bottle, suction cap: Polypropylene

#### V Indication for use

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

#### VI Comparison of technological characteristics with the predicate device

| Item | Subject Device | Predicate<br>Device<br>(K212180) | Comparison |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Product name | Wearable Breast<br>Pump (ABP-1508) | Wearable Breast<br>Pump (Model S12) | N/A |
| Product code | HGX | HGX | same |
| Regulation No. | 21 CFR 884. 5160 | 21 CFR 884. 5160 | same |
| Class | Class II | Class II | same |
| Indication for use | Wearable Breast<br>Pump is a powered<br>breast pump to be<br>used by lactating<br>women to express<br>and collect milk from<br>their breasts. The<br>device is intended<br>for a single user. | The powered<br>Electric Double<br>Breast Pumps are<br>intended to express<br>and collect milk from<br>the breast of a<br>lactating woman.<br>They are double<br>pumps with a single<br>pumping option and<br>intended for single<br>user. | same |
| Pumping options | Single | Single | same |
| Item | Subject Device | Predicate<br>Device<br>(K212180) | Comparison |
| Cycling control<br>Mechanism | Microcontroller | Microcontroller | same |
| Suction modes | Stimulation Mode and<br>Expression Mode | Stimulation Mode and<br>Expression Mode | same |
| Suction levels | 9 | 9 | same |
| Adjustable suction<br>levels | Yes | Yes | same |
| Flange size | 21, 24, mm and 27 mm | 24 mm and 27 mm | Different |
| Vacuum<br>range:<br>Stimulation | -80 to -200 (±5) mmHg | -40 to -105 (±5)<br>mmHg | Different: The<br>difference in<br>vacuum range<br>do not raise<br>different<br>questions of<br>safety and<br>effectiveness. |
| Vacuum<br>range:<br>Expression | -90 to -240 (±5) mmHg | -40 to -245 (±5)<br>mmHg | Different: The<br>difference in<br>vacuum range<br>do not raise<br>different<br>questions of<br>safety and<br>effectiveness. |
| Cycle<br>speed:<br>stimulation | 64 to 108 cycles/minute | 70 to 114<br>cycles/minute | Different: The<br>difference in<br>cycle speed<br>do not raise<br>different<br>questions of<br>safety and<br>effectiveness. |
| Cycle<br>speed:<br>Expression | 26 to 48 cycles/minute | 23 to 90 cycles/minute | Different: The<br>difference in<br>cycle speed<br>do not raise<br>different<br>questions of<br>safety and<br>effectiveness. |
| Item | Subject Device | Predicate<br>Device<br>(K212180) | Comparison |
| | | | safety and<br>effectiveness. |
| Power supply | Li-Ion Battery | Li-Ion Battery | same |
| Indicators | Yes, LED | Yes, LED | same |
| Back flow protection | Yes | Yes | same |
| Materials | Valve: Silicone<br>Breast shield, bottle,<br>suction cap:<br>Polypropylene | Milk Container:<br>Polypropylene<br>Flange: Silicone<br>Pump Outer Housing:<br>Acrylonitrile Butadiene<br>Styrene (ABS) plastic | Similar |

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The indications for use of the subject and predicate devices are identical and they have the same intended use (i.e., the collection of breast milk from the breasts of lactating women).

The subject and predicate devices have different technological features, including different device design, user interface, vacuum pressure range, cycle speeds, materials, flange sizes, and power source. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.

### VII Non-Clinical Testing

Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.

Electrical Safety

- IEC 60601-1:2005+AMD 1:2012+AMD2:2020, Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- . IEC 60601-1-11:2015+AMD1:2020, 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

#### Electromagnetic Compatibility

- IEC 60601-1-2:2014+AMD1:2020, Medical electrical equipment Part 1-2: General .

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requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

#### Biocompatibility Evaluation

Per the 2022 FDA guidance document "Use of international Standard ISO 10993-1, Biological evaluation of medical - Part 1: Evaluation and testing within a risk management process," the following tests performed on the material which contacts with human for Biocompatibility:

- Cytotoxicity (ISO 10993-5:2009)
- . Skin irritation (ISO 10993-23:2021)
- . Skin Sensitization (ISO 10993-10:2021)

#### Software

Software was evaluated as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

#### Performance Testing

Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:

- . Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
- . Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
- . Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
- . Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- . Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.

#### IX Conclusion

The results of the performance testing described above demonstrate that the Wearable Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.