Wearable Breast Pump (Model S18)

K223886 · Shenzhen TPH Technology Co., Ltd. · HGX · Jul 14, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K223886
• Device Name: Wearable Breast Pump (Model S18)
• Applicant: Shenzhen TPH Technology Co., Ltd.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Jul 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Wearable Breast Pump (Model S18) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Device Story

Wearable Breast Pump (Model S18) is an electrically powered, software-controlled, digital single-user pump designed for hands-free use inside a bra. Device components include flange, pump motor, silicone diaphragm, milk collector, and valve. Powered by a rechargeable Li-ion battery; charged via 5V DC adapter. Operates in two modes: Stimulation (40-120 mmHg; 69-92 cycles/min) and Expression (120-245 mmHg; 20-66 cycles/min), each with nine vacuum levels. User interface includes LED status display for mode and battery. Device provides backflow protection. Used by lactating women in home settings to express milk; output is collected milk. Healthcare providers do not interact with device output; device facilitates milk collection for infant feeding.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (leveraged from K212180), electrical safety (ANSI/AAMI ES60601-1, IEC 60601-1-11), battery safety (IEC 62133-2), EMC (IEC 60601-1-2), and performance testing (vacuum verification, backflow protection, use-life, and battery functionality).

Technological Characteristics

Materials: Polypropylene (collector/linker), Silicone (flange/valve/diaphragm), ABS (housing). Compliant with 21 CFR 177. Sensing/Actuation: Microprocessor-controlled vacuum pump. Energy: Rechargeable Li-ion battery. Connectivity: None (standalone). Sterilization: Non-sterile. Software: Embedded, moderate level of concern.

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

• Wearable Breast Pump (Model S12) (K212180)

Submission Summary (Full Text)

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July 14, 2023

Shenzhen TPH Technology Co., Ltd. Peter Chen General Manager 5th floor, Lianchuang 2nd technology Park, Bulan Road Nanwan Community, Longgang District Shenzhen, Guangdong 518100 China

Re: K223886

> Trade/Device Name: Wearable Breast Pump (Model S18) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 13, 2023 Received: June 13, 2023

Dear Peter Chen:

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) K223886

Device Name Wearable Breast Pump Model S18)

Indications for Use (Describe)

The Wearable Breast Pump (Model S18) is intended to express milk from lactating women in order to 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) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart G) |

_ | 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 - K223886

#### Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Submitter<br>Information | Applicant: Shenzhen TPH Technology Co., Ltd.<br>Contact: Peter Chen<br>Phone: [phone]<br>Address: 5th floor, Building NO.29 East side, Lianchuang 2nd technology Park, Longgang<br>District, Shenzhen, China. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Date Prepared: | July 13, 2023 |
| 3. Device<br>Information: | Device Name: Wearable Breast Pump (Model S18)<br>Common Name: Powered Breast Pump<br>Regulation Number: 21 CFR 884.5160<br>Regulation Name: Powered Breast Pump<br>Product Code: HGX (Powered, Breast, Pump)<br>Regulatory Class: Class II |
| 4. Predicate Device<br>Information: | Device Name: Wearable Breast Pump (Model S12)<br>510(k) Number: K212180<br>Manufacturer: Shenzhen TPH Technology Co., Ltd.<br>The predicate device has not been subject to a design-related recall. |

#### 5. Device Description

The Wearable Breast Pump (Model S18) is designed for lactating woman to express and collect milk from the breast. It is an electrically powered, software-controlled, digital single user pump. The device consists of the following key components: flange, pump motor, silicone diaphragm, USB cable, milk collector, bra adjustment buckle, and valve. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free without any external power cords.

There are two modes, with multiple suction levels for each mode, available for the device: Expression mode and Stimulation mode. Both modes consist of nine vacuum levels. Expression mode consists of pressures ranging from 120-245 mmHg and cycle speeds of 20-66 cycles/min and stimulation mode consists of ranges from 40-120 mmHg and cycle speeds of 69-92 cycles/min. There is an LED status display shown on the pump body, which displays the working mode and battery indicator.

The device may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two devices at the same time, one on each breast. The pump is provided non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device should not be used while charging.

The device incorporates embedded software which controls all the features of the product.

All milk contacting components of the device are compliant with 21 CFR 177.

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## 6. Indications for Use

The Wearable Breast Pump (Model S18) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

### 7. Predicate Device Comparison

The table below compares the intended use and technological characteristics of the subject and predicate device.

| | Proposed Device<br>Wearable Breast Pump<br>Model S18<br>K223886 | Predicate Device<br>Wearable Breast Pump<br>Model S12<br>K212180 | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification | Pump, Breast, Powered | Pump, Breast, Powered | Same |
| Regulation | Class II, 21 CFR 884.5160 | Class II, 21 CFR 884.5160 | Same |
| Product code | HGX | HGX | Same |
| Indications for<br>Use | The Wearable Breast Pump<br>(Model S18) is intended to<br>express milk from lactating<br>women in order to collect milk<br>from their breasts. The device is<br>intended for a single user. | The Wearable Breast Pump,<br>model S12 is intended to<br>express milk from lactating<br>women in order to collect milk<br>from their breasts. The device<br>is intended for a single user. | Same |
| Patient<br>Population | Lactating women | Lactating women | Same |
| Single user | YES | YES | Same |
| Single/double<br>pump | Single | Single | Same |
| Backflow<br>Protection | YES | YES | Same |
| Cycling/Suction<br>Control<br>Mechanism | Microprocessor | Microprocessor | Same |
| Specifications | | | |
| Power Supply | Li-ion battery | Li-ion battery | Same |
| Suction Modes | Stimulation and Expression | Stimulation and Expression | Same |
| Suction Strength<br>(Stimulation) | 40-120 mmHg | 40-105 mmHg | Different |
| Cycle Speed:<br>Stimulation | 69 to 92 cycles/minute | 70 to 114 cycles/minute | Different |
| Suction Strength<br>(Expression) | 120-245 mmHg | 40-245 mmHg | Different |
| Cycle Speed:<br>Expression | 20 to 66 cycles/minute | 23 to 90 cycles/minute | Different |
| Suction levels | 9 | 9 | Same |
| User interface | | | |
| User control | On-off switch, vacuum<br>adjustment | On-off switch, vacuum<br>adjustment | Same |
| Adjustable<br>suction levels | YES | YES | Same |

| | Table 1. Specific Comparison to Predicate | |
|--|-------------------------------------------|--|
| | | |

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| Wireless technology | No | No | Same |
|--------------------------|---------------------------|---------------------------|-----------|
| Component design | Milk collector and flange | Milk collector and flange | Same |
| Milk collector Capacity | 180 ml | 180ml | Same |
| Flange size | 21mm, 24mm, and 27mm | 24mm and 27mm | Different |
| Material | | | |
| Milk collector/Linker | Polypropylene | Polypropylene | Same |
| Flange/Valve/Diaphragm | Silicone | Silicone | Same |
| Pump motor/outer housing | ABS | ABS | Same |

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

The subject and predicate devices have similar technological features, including pumping options, control mechanism, user interface, backflow protection, and device indicators. However, as shown in the table above, there are technological differences between the subject and predicate devices, including different vacuum and cycle specifications and flange sizes. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.

#### 8. Summary of Non-Clinical Performance Testing

#### Biocompatibility

The materials of the subject device are identical to K212180 in formulation, processing, and cleaning. Therefore, biocompatibility information from K212180 was leveraged to support the biocompatibility of patient-contacting components of the subject device.

#### Electrical Safety and Electromagnetic Compatibility (EMC)

Testing was conducted in accordance with ANSI/AAMI ES60601-1:2005 + A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems, and IEC 60601-1-11:2015, Medical electrical equipment - Part l - 11 : General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical systems used in the home healthcare environment.

Testing was conducted in accordance with IEC 60601-1-2:2014, Medical electrical equipment - Part I-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and Tests.

#### Software

Software was evaluated for a moderate level of concern as recommended in the 2005 FDA guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

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#### 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 at each mode/cycle demonstrated that the device meets 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 functions 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.

## 9. Conclusion

The results of the performance testing described above demonstrate that the Wearable Breast Pump (Model S18) is as safe and effective as the predicate device and supports a determination of substantial equivalence.