(154 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on basic modes and controls, with no mention of adaptive or learning capabilities.
No
The device's intended use is to express and collect milk from breasts, which is not considered a therapeutic function.
No
The device is a breast pump intended to express and collect milk. Its functions relate to physical milk expression (e.g., vacuum pressure, cycle speed), not diagnosing medical conditions.
No
The device description clearly outlines physical hardware components such as a pump body, LED display, on/off switch, vacuum adjustment, and a rechargeable battery. While it mentions embedded software, it is integral to the operation of the physical device, not a standalone software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Wearable Breast Pump Function: The Wearable Breast Pump's intended use is to physically express and collect milk from the breast. It does not analyze any biological samples or provide diagnostic information.
- Lack of Diagnostic Information: The provided information clearly describes the device's mechanical function (pumping) and its features related to that function (modes, vacuum adjustment, battery). There is no mention of any analysis of the collected milk or any diagnostic output.
Therefore, based on the provided description, the Wearable Breast Pump (Model W8) is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Wearable Breast Pump (Model W8) 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 W8) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast.
There are 4 modes available for the device which are Expression mode, Massage mode, Auto mode and Stimulation mode. There is a LED status display for W8, including working mode, and battery indicator can be shown on the pump body. The user interface includes on/off switch, mode selection/long press, and vacuum adjustment.
W8 operated as a single or double pumping system, one on each breast. The pump is provided non-sterile and reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). W8 is designed not to be used during charging.
The breast pump does not incorporate any off-the-shelf (OTS) software. 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 which is applicable for the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Lactating women / 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)
Performance and Use Life Verification:
Bench performance testing was conducted to evaluate device performance:
-Vacuum pressure
-Cycle speed
-Backflow protection
-Battery capacity & service time
-Charging time
Device specifications were met for all tests conducted.
Biocompatibility testing:
Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2021)
Irritation (ISO 10993-10:2021)
Key results: The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical safety and electromagnetic compatibility (EMC)
Key results: The system complies with the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, IEC 60601-1-11:2015, IEC 60601-1-2 :2014/A1:2021, IEC 62133-2 :2017.
Software Verification and Validation Testing
Software verification and validation was conducted as recommended in the 2023 FDA guidance document, "Content of Premarket Submissions for Device Software Functions." with a Basic Documentation Level.
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2025
Shenzhen TPH Technology Co., Ltd. Peter Chen General Manager Room 203, 2nd floor,29th Building,Lianchuang Technology Park No.21 Bulan Rd, Xialilang Cmty, Nanwan St, Longgang Dist Shenzhen, Guangdong 518100 CHINA
Re: K242850
Trade/Device Name: Wearable Breast Pump (model W8) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Received: January 23, 2025
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 (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"
1
(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 OS 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 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-reportingcombination-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 Rue"). 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-device-advicecomprehensive-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-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
2
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 (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
3
Indications for Use
510(k) Number (if known) K242850
Device Name Wearable Breast Pump (Model W8)
Indications for Use (Describe)
The Wearable Breast Pump (Model W8) 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)
|X | 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."
4
510(k) Summary – K242850
| 1. Submitter: | 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.: +86-755-82703212 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peter Chen
General Manager
Shenzhen TPH Technology Co., Ltd.
peter@tph-tech.com |
| Date Prepared: | February 21, 2025 |
| 2. Device
Information: | Device Name: Wearable Breast Pump (Model W8)
Common Name: Powered breast pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered breast pump
Product code: HGX (Pump, Breast, Powered)
Classification Panel: Obstetrics/Gynecology
Regulatory Class: Class II |
| 3. Predicate Device
Information | Wearable Breast Pump, model S12 cleared under K212180.
The predicate device has not been subject to a design-related recall. |
| 4. Device
Description: | The Wearable Breast Pump (Model W8) is a wearable powered breast pump designed for
lactating woman to express and collect milk from the breast.
There are 4 modes available for the device which are Expression mode, Massage mode, Auto
mode and Stimulation mode. There is a LED status display for W8, including working mode,
and battery indicator can be shown on the pump body. The user interface includes on/off
switch, mode selection/long press, and vacuum adjustment.
W8 operated as a single or double pumping system, one on each breast. The pump is provided
non-sterile and reusable by a single user. The device is powered by rechargeable Li-ion battery
(3.7V, 1200mAh). W8 is designed not to be used during charging.
The breast pump does not incorporate any off-the-shelf (OTS) software. 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 which is applicable for the
subject device. |
| 5. Indications for
Use: | The Wearable Breast Pump (Model W8) 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. |
5
K242850 Page 2 of 4
6. Comparison of Intended Use and Technological Characteristics of the Subject Device and Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
| Item | Proposed Device | Proposed Device | Comment |
|---|---|---|---|
| Wearable Breast Pump (Model | |||
| W8) | Wearable Breast Pump, model | ||
| S12 (K212180) | |||
| 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 Wearable Breast Pump | ||
| (Model W8) 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 | ||
| Patient Population | Lactating women | Lactating women | Same |
| Anatomical Sites | Breast | Breast | Same |
| Single user | YES | YES | Same |
| Single/double | |||
| pump | Single | Single | Same |
| Media separation | |||
| (backflow | |||
| protection) | YES | YES | Same |
| Cycling/Suction | |||
| Control | |||
| Mechanism | Microprocessor | Microprocessor | Same |
| Specifications | |||
| Power Supply | Li-ion battery | Li-ion battery | Same |
| Suction Strength | |||
| (Stimulation) | 40-170 mmHg | 35-110 mmHg | Different |
| Cycle Speed: | |||
| Stimulation | 77 to 127 cycles/minute | 70 to 114 cycles/minute | Different |
| Suction Strength | |||
| (Expression) | 120-245 mmHg | 35~245 mmHg | Different |
| Cycle Speed: | |||
| Expression | 32 to 92 cycles/minute | 23 to 90 cycles/minute | Different |
| Suction Strength | |||
| (Massage) | 40-140 mmHg | none | Different |
| Cycle Speed: | |||
| Massage | 79-143 cycles/minute | none | Different |
| Suction Strength | |||
| (Auto) | 40-245mmHg | none | Different |
| Cycle Speed: | |||
| Auto | 32-136 cycles/minute | none | Different |
| Suction levels | 15 | 9 | Different |
| User interface (LED display) | |||
| User control | On-Off switch, mode | ||
| selection/long press, vacuum | |||
| adjustment | On-Off switch, mode | ||
| selection, vacuum adjustment | Different | ||
| Adjustable suction | |||
| levels | YES | YES | Same |
| 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 | 24mm and 27mm | 24mm and 27mm | Same |
| Material | |||
| Milk | |||
| collector/Linker | Polypropylene | Polypropylene | Same |
| Flange/Valve/Diaphragm | Silicone | Silicone | Same |
| Pump motor/outer | |||
| housing | ABS | ABS | Same |
Table 1. Comparison to Predicate Device
6
In comparison to the predicate device, the subject device has the same intended use and similar indications for use - the expression and collection of breast milk.
As seen in the comparison table, the subject and predicate devices have different technological features, including the user interface, vacuum range, cycle speed range, suction levels. These technological differences do not raise different questions of safety and effectiveness.
7. Summary of Non-Clinical Performance Testing:
The following performance data were provided in support of the substantial equivalence determination:
Performance and Use Life Verification
Bench performance testing was conducted to evaluate device performance:
- -Vacuum pressure
- -Cycle speed
- -Backflow protection
- -Battery capacity & service time
- -Charging time
Device specifications were met for all tests conducted.
Biocompatibility testing
The biocompatibility evaluation for the Wearable Breast Pump was conducted 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,"" as follows:
- Cytotoxicity (ISO 10993-5:2009) ●
- Sensitization (ISO 10993-10:2021)
- Irritation (ISO 10993-10:2021) ●
The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Wearable Breast Pump device, consisting of all the modules and accessories in the system. The system complies with the following standards: - IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety, and essential performance.
7
K242850 Page 4 of 4
-
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,
-
IEC 60601-1-2 :2014/A1:2021 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
-
IEC 62133-2 :2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
Software Verification and Validation Testing
Software verification and validation was conducted as recommended in the 2023 FDA guidance document, "Content of Premarket Submissions for Device Software Functions." with a Basic Documentation Level.
8. Substantial Equivalence Conclusion:
The results of the performance testing described above demonstrate that the Wearable Breast Pump (Model W8) is as safe and effective as the predicate device and supports a determination of substantial equivalence.