The Wearable Breast Pump (Model W6), is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

Device Description

The Wearable Breast Pump (Model W6) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Wearable Breast Pump (Model W6) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump includes: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, auto, and hot compress modes and control the vacuum levels within those modes.

The Wearable Breast Pump (Model W6) is capable of providing 12 vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in stimulation mode, vacuum levels from 105-245 mmHg with cycling rates from 30-105 cycles per minute in expression mode, vacuum levels from 40-150 mmHg with cycling rates from 87-128 cycles per minute in massage mode, and vacuum levels from 40-245 mmHg with cycling rates from 30-143 cycles per minute in auto mode. The Wearable Breast Pump (Model W6) has a hot compress mode with one heating level <= 42 degrees Celsius. The Wearable Breast Pump (Model W6) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

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

All other components (i.e., motor unit/housing) of the subject devices are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

AI/ML Overview

This FDA 510(k) clearance letter pertains to a Wearable Breast Pump (Model W6), not an AI/software device that requires acceptance criteria for algorithm performance. The acceptance criteria and study detailed in the provided text are focused on the hardware performance, safety, and functionality of a physical medical device (a breast pump), not the diagnostic or analytical performance of an AI model.

Therefore, many of the requested items related to AI model evaluation (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

However, I can extract the acceptance criteria and the studies performed to prove the device meets these criteria as described in the 510(k) summary, reframing them to fit the provided sections where possible.

Acceptance Criteria and Device Performance for Wearable Breast Pump (Model W6)

Given that this document describes a physical medical device (a breast pump) and not an AI/software for diagnosis or analysis, the acceptance criteria and performance studies are focused on the device's functional safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (as implied or stated)	Reported Device Performance (from "Summary of Non-Clinical Performance Testing")
Biocompatibility	Compliance with ISO 10993-1 for patient contact materials.	Leveraged from predicate device; in accordance with 2023 FDA guidance. Implies successful demonstration of biocompatibility.
Electrical Safety	Compliance with IEC 60601-1 Ed 3.2, IEC 62133-2:2017, and IEC 60601-1-11 Ed 3.1.	Testing conducted successfully. Implies successful demonstration of electrical safety.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014+A1:2020.	Testing conducted successfully. Implies successful demonstration of electromagnetic compatibility.
Software Functionality	Software functions as intended and meets "Basic Documentation level" requirements per FDA guidance.	Evaluated at the Basic Documentation level successfully. Implies successful verification of software functionality.
Vacuum Level Verification	Devices meet specified vacuum ranges (±5 mmHg) for each mode. - Stimulation: 40-120 mmHg - Expression: 105-245 mmHg - Massage: 40-150 mmHg - Auto: 40-245 mmHg	Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual vacuum levels fall within the stated ranges.
Cycle Speed Verification	Devices meet specified cycling rates (±2 cycles/minute) for each mode. - Stimulation: 90-143 cycles/min - Expression: 30-105 cycles/min - Massage: 87-128 cycles/min - Auto: 30-143 cycles/min	Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual cycle speeds fall within the stated ranges.
Backflow Protection	Liquid does not backflow into the tubing.	Testing verified liquid does not backflow into the tubing. Implies successful backflow protection.
Use Life Consistency	Devices maintain specifications throughout their proposed use life.	Testing conducted to demonstrate devices maintain specifications. Implies successful use life performance.
Battery Performance	Battery remains functional during its stated battery use-life.	Testing conducted to demonstrate battery remains functional. Implies successful battery performance.
Battery Status Indicator Functionality	Battery status indicator remains functional during its stated battery life.	Testing conducted to demonstrate indicator remains functional. Implies successful battery status indicator performance.
Hot Compress Temperature	Hot compress function remains functional during stated use-life and provides a heating level ≤ 42 ºC.	Testing conducted to demonstrate hot compress function remains functional. Implies successful temperature control (≤ 42 ºC) and functionality throughout use-life.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for each performance test (e.g., number of units tested for vacuum, cycle speed, use-life, etc.). It only states that "testing was conducted."
Data Provenance: Not specified in terms of country of origin or whether the underlying studies were retrospective or prospective. These are typically laboratory performance tests, not clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This relates to evaluation of AI/diagnostic algorithms. For a physical device like a breast pump, "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human graders of images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. This relates to resolving discrepancies in expert labeling for AI/diagnostic algorithms. For device performance testing, adjudication is generally a process of reviewing test results against predefined engineering limits and specifications, not expert consensus on qualitative data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, not specified and not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes the performance of a physical breast pump.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable for the overall device performance in the context of typical AI review. While the breast pump does have "embedded software," the performance described (vacuum, cycle speed, battery, etc.) is the device's standalone performance, not an algorithm's diagnostic or analytical performance. The document states "Software was evaluated at the Basic Documentation level," which refers to standard software validation processes for medical devices, not an "algorithm-only" performance study in the AI sense.

7. The Type of Ground Truth Used

Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is derived from established international standards (IEC 60601 series, ISO 10993-1) and the device's own design specifications (e.g., specific vacuum ranges, cycle speeds, temperature limits). These are objective, measurable criteria. For example, a vacuum gauge provides the "ground truth" for vacuum level, and a timer/counter for cycle speed.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning. Its internal software is "embedded" and controls device functions based on pre-programmed logic, not learned from data.

9. How the Ground Truth for the Training Set was Established

Not applicable. (See point 8).

Summary

FDA 510(k) Clearance Letter - Wearable Breast Pump (Model W6)

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.08.00
Silver Spring, MD 20993
www.fda.gov

August 20, 2025

Shenzhen TPH Technology Co., Ltd.
Xiaoyan Yang
Quality Engineer
Rm 203, 2nd Floor, 29th Building, Lianchuang Technology Park
No.21 Bulan Rd, Xialilang Community, Nanwan St, Longgang Dis
Shenzhen, Guangdong 518100
CHINA

Re: K250383
Trade/Device Name: Wearable Breast Pump (Model W6)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: December 12, 2022
Received: July 21, 2025

Dear Xiaoyan Yang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

K250383 - Xiaoyan Yang Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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

Page 3

K250383 - Xiaoyan Yang Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Page 4

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250383

Device Name
Wearable Breast Pump (Model W6)

Indications for Use (Describe)
The Wearable Breast Pump (Model W6), is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It 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 C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary – K250843

1. Submitter Information

Applicant: Shenzhen TPH Technology Co., Ltd.
Address: Room 203, 2nd floor, 29th Building,
Lianchuang Technology Park, No.21 Bulan
Road, Xialilang, Shenzhen, Guangdong
518100 CHN
Tel.: 86 (133) 024-76262

2. Correspondent Information

Contact: Yang Xiaoyan
Quality Engineer
Shenzhen TPH Technology Co., Ltd.
Email: yangxiaoyan@tph-tech.com

3. Date prepared: August 19, 2025

4. Device Information

Device Name: Wearable Breast Pump (Model W6)
Common Name: Powered Breast Pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Product Code: HGX (Pump, Breast, Powered)
Regulatory Class: Class II

5. Predicate Device Information

Device Name: Wearable Breast Pump (Model S12)
510(k) Number: K212180
Manufacturer: Shenzhen TPH Technology Co., Ltd.

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

6. Device Description

The Wearable Breast Pump (Model W6) is capable of providing 12 vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in stimulation mode, vacuum levels from 105-245 mmHg with cycling rates from 30-105 cycles per minute in expression mode, vacuum levels from 40-150 mmHg with cycling rates from 87-128 cycles per minute in massage mode, and vacuum levels from 40-245 mmHg with cycling rates from 30-143 cycles per minute in auto mode. The Wearable Breast Pump (Model W6) has a hot compress mode with one heating level ≤ 42 ºC. The Wearable Breast Pump (Model W6) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices are for repeated use

K250843
Page 1 of 4

Page 6

by a single user in a home environment. The devices are provided non-sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

All other components (i.e., motor unit/housing) of the subject devices are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

7. Indications for Use

The Wearable Breast Pump (Model W6), is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

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

Table 1: Comparator Table for Subject and Predicate Devices

	Wearable Breast Pump (Model W6) Subject Device	Wearable Breast Pump (Model S12) K212180 Predicate Device	Comparison
Product Name	Wearable Breast Pump (Model W6)	Wearable Breast Pump (Model S12)	N/A
Product Code	HGX	HGX	Same
Regulation Number	21 CFR 884.5160	21 CFR 884.5160	Same
Regulatory Class	Class II	Class II	Same
Patient Population	Lactating Women	Lactating Women	Same
Indications for Use	The Wearable Breast Pump (Model W6) is powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.	The Wearable Breast Pump (Model S12) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.	Similar
Pump Options	Single	Single	Same
Cycling control mechanism	Microcontroller	Microcontroller	Same
Backflow Protection	Yes	Yes	Same
Suction Modes	Stimulation Mode, Expression Mode, Massage Mode, Auto Mode	Stimulation Mode and Expression Mode	Different
Suction levels	12	9	Different
Adjustable suction levels	Yes	Yes	Same

K250843
Page 2 of 4

Page 7

Hot Compress function	Yes	No	Different
Vacuum range: Stimulation	-40 to -120 (±5) mmHg	-40 to -105 (±5) mmHg	Different
Vacuum range: Expression	-105 to -245 (±5) mmHg	-40 to -245 (±5) mmHg	Different
Vacuum range: Massage	-40 to -150 (±5) mmHg	N/A
Vacuum range: Auto	-40 to -245 (±5) mmHg	N/A	Different
Cycle Speed: Stimulation	90 to 143 (±2) cycles/minute	70 to 114 cycles/minute	Different
Cycle Speed: Expression	30 to 105 (±2) cycles/minute	23 to 90 cycles/minute	Different
Cycle Speed: Massage	87 to 128 (±2) cycles/minute	N/A
Cycle Speed: Auto	30 to 143 (±2) cycles/minute	N/A	Different
Controls	On-Off switch/ mode change, vacuum adjustment, Hot compress switch button/pause	On/Off button; Mode selection Increase/decrease vacuum button;	Similar
Power Supply	Li-Ion Battery	Li-Ion Battery	Same
Indicators	Yes, LED	Yes, LED	Similar
Design	Wearable pump with combined Milk Collector and Flange	Wearable pump with combined Milk Collector and Flange	Same

The indications for use of the subject and predicate devices are similar, and both devices 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 wearable operation, power supply, and user interface. However, as shown in the table above, there are technological differences between the subject and predicate devices, including different overall vacuum/cycle specifications, available modes, and the inclusion of a warming feature. The different technological characteristics of the subject devices, as compared to the predicate device, do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility information was leveraged from the predicate device and was in accordance with the 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process."

Electrical Safety

Testing was conducted in accordance with IEC 60601- 1 Edition 3.2 2020-08 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 sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems, and IEC 60601-1-11 Edition 3.1 2020-07 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.

K250843
Page 3 of 4

Page 8

Electromagnetic Compatibility

Testing was conducted in accordance with IEC 60601-1-2:2014+A1: 2020 Medical Electrical Equipment - Part 1-2: "General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests."

Software

Software was evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document "Content of Premarket Submissions for Device Software Functions."

Performance Testing

Other performance testing was conducted to show that the devices meet their 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 devices maintain their 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.
Hot Compress Temperature testing was conducted to demonstrate that the Hot compress function remains functional during stated use-life.

10. Conclusion

The results of the performance testing described above demonstrate that Wearable Breast Pump (Model W6) is as safe and effective as the predicate device and support a determination of substantial equivalence.

K250843
Page 4 of 4

Regulation Number and Section

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).