(71 days)
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description indicates it uses embedded software for control, not AI.
No
The device is intended to express milk from lactating women, which is a collection or assistive function, not a therapeutic treatment for a disease or medical condition.
No
The device is a breast pump intended to express and collect milk from lactating women, not to diagnose a condition.
No
The device description clearly states "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." This indicates the device has significant hardware components beyond just software. The entire submission describes a physical breast pump, not a standalone software application.
No.
Reasoning: The device is a breast pump, intended for collecting milk, not for performing tests on samples derived from the human body to provide information for diagnostic, monitoring or compatibility purposes.
No.
This clearance letter does not mention a Predetermined Change Control Plan (PCCP) in any section. PCCP authorization is typically explicitly stated when granted by the FDA.
Intended Use / Indications for Use
The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) are intended to express milk from lactating women in order to collect milk from their breasts. These devices are intended for a single user.
Product codes
HGX
Device Description
The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) is intended to express milk from lactating women in order to collect milk from their breasts. 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 device has two modes of operation - Expression mode and Stimulation mode, with multiple suction levels for each 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 subject 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 in 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 is designed not to be used during charging.
The breast pump does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177.
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
Not Found
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 testing: The materials, final finished form, and intended use of the subject device are identical to those of the predicate device (K223886) including formulation, processing, and cleaning. Therefore, biocompatibility information was leveraged from the predicate device to support the biocompatibility of patient-contacting components of the subject device. The milk contacting components of the device are also compliant with 21 CFR 177.
Electrical safety and electromagnetic compatibility (EMC): The subject device electrical design and components including the power source (Li-ion battery) and charger are identical to those of the predicate device (K223886). Therefore, electrical safety, battery safety and electromagnetic compatibility testing was leveraged from the predicate device to support electrical safety, battery safety and electromagnetic compatibility for the subject device.
Software Verification and Validation Testing: The subject device includes identical software as the predicate device (K223886). Therefore, software documentation, including verification & validation, was leveraged from the predicate device to support the validity of the subject device software-controlled functions.
Performance and Use Life Verification: The subject device has identical functions and mode of operations as the predicate device (K223886) and therefore following testing were leveraged from the predicate device to demonstrate that the device meets its design requirements and performs as intended:
- Vacuum level and cycle frequency testing for each mode/cycle to demonstrate that the device meets mode/cycle specifications.
- Backflow protection testing to verify liquid does not backflow into the tubing.
- Use life testing to demonstrate that the device maintains its specifications throughout its proposed use life.
- Battery capacity, service time and charging time testing to demonstrated that battery functions as specified during stated battery use-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).
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.04
Silver Spring, MD 20993
www.fda.gov
April 2, 2025
Shenzhen TPH Technology Co., Ltd.
Xiaoyan Yang
Quality Engineer
Room 203, 2nd floor, 29th Building,
Lianchuang Technology Park, No.21 Bulan Road, Xialilang
Shenzhen, Guangdong 518100
CHINA
Re: K250152
Trade/Device Name: eufy Wearable Breast Pump S1 (T8D02);
eufy Wearable Breast Pump E10 (T8D03);
eufy Wearable Breast Pump S1 Pro (T8D04);
eufy Wearable Breast Pump E20 (T6060);
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Dated: January 18, 2025
Received: January 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.
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K250152 - Xiaoyan Yang Page 2
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" (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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K250152 - Xiaoyan Yang Page 3
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, PhD
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: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K250152
Device Name
eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060)
Indications for Use (Describe)
The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) are intended to express milk from lactating women in order to collect milk from their breasts. These devices are 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."
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary – K250152
Prepared in accordance with the requirements of 21 CFR Part 807.92
1. Submitter Information:
Shenzhen TPH Technology Co., Ltd.
Room 203,2nd floor,29th Building, Lianchuang Technology Park, No. 21 Bulan Road, Xialilang Community, Nanwan Street, Longgang District, Shenzhen, China.
Tel.: +86-13302476262
Contact Person: Xianzi Chen
2. Date Prepared:
April 1, 2025
3. Device name Information:
Device Name:
- eufy Wearable Breast Pump S1 (T8D02)
- eufy Wearable Breast Pump E10 (T8D03)
- eufy Wearable Breast Pump S1 Pro (T8D04)
- eufy Wearable Breast Pump E20 (T6060)
Common Name: Powered Breast Pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Product code: HGX
Regulatory Class: II
4. Predicate Device Information:
Device Name: Wearable Breast Pump (Model S18)
510(k) Number: K223886
Manufacturer: Shenzhen TPH Technology Co., Ltd.
The predicate device has not been subject to a design-related recall.
5. Device Description
The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) is intended to express milk from lactating women in order to collect milk from their breasts. 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 device has two modes of operation - Expression mode and Stimulation mode, with multiple suction
K250152
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K250152
Page 2 of 4
levels for each 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 subject 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 in 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 is designed not to be used during charging.
The breast pump does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177.
6. Indications for Use
The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) 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.
Table 1 Specific Comparison to Predicate
| Item | Subject Device eufy Wearable Breast Pump [Models E10 (T8D03); E20 (T6060); S1 Pro (T8D04); S1 (T8D02)] K250152 | Predicate Device Wearable Breast Pump (Model S18) K223886 | Comment |
|---|---|---|---|
| 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 Use | The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user. | 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. | Same |
| Patient Population | Lactating women | Lactating women | Same |
| Single user | Yes | Yes | Same |
| Single/double pump | Single | Single | Same |
| Backflow protection | Yes | Yes | Same |
| Cycling/Suction Control 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 (Stimulation) | 40 - 120 mmHg | 40 - 120 mmHg | Same |
| Cycle Speed: Stimulation | 69 - 92 cycles/minute | 69 - 92 cycles/minute | Same |
| Suction Strength (Expression) | 120 - 245 mmHg | 120 - 245 mmHg | Same |
| Cycle Speed: | 20 - 66 cycles/minute | 20 - 66 cycles/minute | Same |
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K250152
Page 3 of 4
| Expression | |||
|---|---|---|---|
| Suction levels | 9 | 9 | Same |
| User interface | |||
| User control | On-off switch, vacuum adjustment | On-off switch, vacuum adjustment | Same |
| Adjustable suction levels | Yes | Yes | Same |
| Wireless technology | No | No | Same |
| Component design and quantity | Milk collector (2 /2 /4 / 3), Flange (2 /2 /4 / 3), Pump motor (2/ 2/ 2/ 2), Silicone diaphragm (2 /3 /4 / 3), USB cable (1/ 1/ 1/ 1), Bra adjustment Buckle(1/ 1/ 1/ 1), Valve (2 /3 /4 / 3). | Milk collector (1), Flange (1), Pump motor (1), Silicone diaphragm (1), USB cable (1), Bra adjustment Buckle (1), Valve (1) | Different |
| Milk collector | |||
| Capacity | 180 ml | 180 ml | Same |
| Flange size | 21mm, 24mm and 27mm | 21mm, 24mm and 27mm | Same |
| 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 device design, pumping options, control mechanism, user interface, backflow protection, device power source, materials, and device indicators. However, as shown in the table above, the subject and predicate devices differ in the quantities of device components included in each model. These differences of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.
8. Performance Testing:
Biocompatibility testing
The materials, final finished form, and intended use of the subject device are identical to those of the predicate device (K223886) including formulation, processing, and cleaning. Therefore, biocompatibility information was leveraged from the predicate device to support the biocompatibility of patient-contacting components of the subject device. The milk contacting components of the device are also compliant with 21 CFR 177.
Electrical safety and electromagnetic compatibility (EMC)
The subject device electrical design and components including the power source (Li-ion battery) and charger are identical to those of the predicate device (K223886). Therefore, electrical safety, battery safety and electromagnetic compatibility testing was leveraged from the predicate device to support electrical safety, battery safety and electromagnetic compatibility for the subject device.
Software Verification and Validation Testing
The subject device includes identical software as the predicate device (K223886). Therefore, software documentation, including verification & validation, was leveraged from the predicate device to support the validity of the subject device software-controlled functions.
Performance and Use Life Verification
The subject device has identical functions and mode of operations as the predicate device (K223886) and therefore following testing were leveraged from the predicate device to demonstrate that the device meets its design requirements and performs as intended:
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K250152
Page 4 of 4
- Vacuum level and cycle frequency testing for each mode/cycle to demonstrate that the device meets mode/cycle specifications.
- Backflow protection testing to verify liquid does not backflow into the tubing.
- Use life testing to demonstrate that the device maintains its specifications throughout its proposed use life.
- Battery capacity, service time and charging time testing to demonstrated that battery functions as specified during stated battery use-life.
9. Substantial Equivalence Conclusion:
The results of the performance testing described above demonstrate that the eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump E20 (T6060); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump S1 (T8D02) is as safe and effective as the predicate device and supports a determination of substantial equivalence.