(109 days)
Not Found
No
The document states "Mentions AI, DNN, or ML: Not Found" and describes the device as using an "embedded control program" and "embedded software" to manage functions, with no indication of adaptive learning or AI capabilities.
No.
A therapeutic device is used for medical treatment or to cure a disease. A breast pump is used to express milk, which is not a therapeutic function.
No.
The device is a breast pump intended to express and collect milk, and its description and performance studies do not mention any diagnostic capabilities or functions.
No
The device is a physical, hardware-based breast pump that includes components such as a pump, valve, control board, milk collector, and motor unit, all powered by a lithium battery. While it utilizes embedded software to manage functions, the core medical device is the hardware itself, not just the software. The "Software" section under "Summary of Performance Studies" clarifies that the software was evaluated, but this refers to the embedded software within the hardware device, not a standalone software-only device.
No
The device is a breast pump, which is an external device for expressing milk and does not perform testing on samples derived from the human body.
No
Explanation: There is no mention of a Predetermined Change Control Plan (PCCP) in the provided clearance letter. The section for "Predetermined Change Control Plan (PCCP)" explicitly states "Not Found".
Intended Use / Indications for Use
The Wearable Breast Pump (Model S21) 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.
Product codes
HGX
Device Description
The Wearable Breast Pump (Model S21) 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. The Wearable Breast Pump (Model S21) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, and auto modes and control the vacuum levels within those modes.
All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model S21) is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 62-104 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 22-86 cycles per minute in expression mode, and vacuum levels from 40-120 mmHg with cycling rates from 22-104 cycles per minute in auto mode.
The Wearable Breast Pump (Model S21) 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 device is for repeated use by a single user in a home environment. The device is provided not 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 device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breasts
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Home environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility:
Biocompatibility information was provided in accordance with Attachment G of 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 ANSI/AAMI ES60601- 1:2005/A2:2010 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 60601-1-11:2015 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:
Testing was conducted in accordance with IEC 60601-1-2:2014 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
FDA 510(k) Clearance Letter - Wearable Breast Pump (Model S21)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 30, 2025
Shenzhen TPH Technology Co., Ltd.
Xiaoyan Yang
Quality Engineer
Room 203, 2nd floor, 29th Building, Lianchuang Technology Park, No.21 Bulan Road, Xialilang Community, Nanwan Street, Shenzhen, Guangdong 518100
CHINA
Re: K250368
Trade/Device Name: Wearable Breast Pump (Model S21)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered breast pump
Regulatory Class: II
Product Code: HGX
Received: April 30, 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"
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K250368 - 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
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K250368 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250368
Device Name
Wearable Breast Pump (Model S21)
Indications for Use (Describe)
The Wearable Breast Pump (Model S21) 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
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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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary – K250368
K250368
Page 1 of 4
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: May 29, 2025
4. Device Information
Device Name: Wearable Breast Pump (Model S21)
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 S21) 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. The Wearable Breast Pump (Model S21) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, and auto modes and control the vacuum levels within those modes.
All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model S21) is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 62-104 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 22-86 cycles per minute in expression mode, and vacuum levels from 40-120 mmHg with cycling rates from 22-104 cycles per minute in auto mode.
The Wearable Breast Pump (Model S21) 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 device is for repeated use by a single user in a home environment. The device is provided not sterile.
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K250368
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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 device 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 S21) 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 S21) K250368 Subject Device | Wearable Breast Pump (Model S12) K212180 Predicate Device | Comparison | |
|---|---|---|---|
| Product Name | Wearable Breast Pump (Model S21) | 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 S21) 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. | 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, Auto Mode | Stimulation Mode and Expression Mode | Different |
| Suction levels | 12 | 9 | Different |
| Adjustable suction levels | Yes | Yes | Same |
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K250368
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| Wearable Breast Pump (Model S21) K250368 Subject Device | Wearable Breast Pump (Model S12) K212180 Predicate Device | Comparison | |
|---|---|---|---|
| Vacuum range: Stimulation | -40 to -120 (±5) mmHg | -40 to -105 (±5) mmHg | Different |
| Vacuum range: Expression | -120 to -245 (±5) mmHg | -40 to -245 (±5) mmHg | Different |
| Vacuum range: Auto | -40 to -245 (±5) mmHg | N/A | Different |
| Cycle Speed: Stimulation | 62 to 104 (±2) cycles/minute | 70 to 114 cycles/minute | Different |
| Cycle Speed: Expression | 22 to 86 (±2) cycles/minute | 23 to 90 cycles/minute | Different |
| Cycle Speed: Auto | 22 to 104 (±2) cycles/minute | N/A | Different |
| Controls | On-Off switch, vacuum adjustment, mode change/power | 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 device are identical, and 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 wearable operation, power supply, and user interface. However, as shown in the table above, there are technological differences between the subject and predicate device, including different overall vacuum/cycle specifications and available modes. The different technological characteristics of the subject device, 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 provided in accordance with Attachment G of 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 ANSI/AAMI ES60601- 1:2005/A2:2010 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 60601-1-11:2015 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
Testing was conducted in accordance with IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: "General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests."
Software
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K250368
Page 4 of 4
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 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.
10. Conclusion
The results of the performance testing described above demonstrate that The Wearable Breast Pump (Model S21) is as safe and effective as the predicate device and supports a determination of substantial equivalence.