(154 days)
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 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.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the Wearable Breast Pump (Model W8).
It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical performance testing rather than clinical efficacy studies often associated with AI/ML devices or studies directly proving therapeutic effect. Therefore, many of the requested points related to AI, human readers, ground truth establishment for patient outcomes, and clinical study designs will not be present. The "device" in this context is a physical breast pump, not an AI algorithm.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
For a breast pump, "acceptance criteria" primarily relate to engineering specifications and safety standards rather than diagnostic performance metrics like sensitivity/specificity. The document states that the device was tested against its own specifications, and "Device specifications were met for all tests conducted."
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance (Model W8) | Notes |
|---|---|---|---|
| Performance Testing | Vacuum pressure (Stimulation Mode) | 40-170 mmHg | This is the specification for the device. The document states "Device specifications were met for all tests conducted," indicating the tested device performed within this range. The predicate's range was 35-110 mmHg, showing a difference that was found to not raise new questions of safety/effectiveness. |
| Cycle speed (Stimulation Mode) | 77 to 127 cycles/minute | Specification. Predicate: 70 to 114 cycles/minute. | |
| Vacuum pressure (Expression Mode) | 120-245 mmHg | Specification. Predicate: 35-245 mmHg. The predicate has a wider range covering lower vacuum, implying the Model W8 starts at a higher minimum expression vacuum. This was deemed acceptable. | |
| Cycle speed (Expression Mode) | 32 to 92 cycles/minute | Specification. Predicate: 23 to 90 cycles/minute. | |
| Vacuum pressure (Massage Mode) | 40-140 mmHg | Specification. Predicate had no "Massage Mode." | |
| Cycle speed (Massage Mode) | 79-143 cycles/minute | Specification. Predicate had no "Massage Mode." | |
| Vacuum pressure (Auto Mode) | 40-245 mmHg | Specification. Predicate had no "Auto Mode." | |
| Cycle speed (Auto Mode) | 32-136 cycles/minute | Specification. Predicate had no "Auto Mode." | |
| Suction levels | 15 levels | Specification. Predicate had 9 levels. | |
| Backflow protection | Confirmed YES | Functional requirement. Indicates successful demonstration of backflow prevention. | |
| Battery capacity & service time | Specifications met | Functional requirement. | |
| Charging time | Specifications met | Functional requirement. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | The user-contacting materials (milk collector, linker, flange, valve, diaphragm) were tested and found to meet these safety standards. |
| Sensitization (ISO 10993-10:2021) | Non-sensitizing | ||
| Irritation (ISO 10993-10:2021) | Non-irritating | ||
| Electrical Safety & EMC | IEC 60601-1 (Basic safety & essential performance) | Device complies | The device, including all modules and accessories, was tested and demonstrated compliance with these international standards for medical electrical equipment. |
| IEC 60601-1-11 (Home healthcare environment) | Device complies | ||
| IEC 60601-1-2 (Electromagnetic disturbances) | Device complies | ||
| IEC 62133-2 (Safety requirements for portable sealed secondary lithium cells) | Device complies | Specifically for the Li-ion battery (3.7V, 1200mAh) powering the device. | |
| Software V&V | Content of Premarket Submissions for Device Software Functions (Basic Level) | Software verification and validation conducted as recommended in FDA guidance, with a Basic Documentation Level. Implies successful completion. | The device incorporates embedded software to control features. The V&V ensures the software functions correctly and safely within its design specifications, as per FDA guidance for software in medical devices. The "acceptance criteria" here would be the successful completion of all V&V activities and meeting documented software requirements. |
| Material Compliance | Milk-contacting components compliant with 21 CFR 177 | All milk-contacting components (Polypropylene for collector/linker, Silicone for flange/valve/diaphragm) are compliant with 21 CFR 177 (food-contact). | This is a regulatory requirement for safety and material compatibility with expressed milk. The materials used were listed and their compliance indicated, meaning they meet the "acceptance criteria" for safe contact with food/milk, preventing contamination or adverse reactions from material leaching. |
The subsequent points (2-9) are typically relevant for studies involving AI/ML devices, clinical performance, or diagnostic effectiveness based on expert interpretation. As this 510(k) is for a physical medical device (a breast pump) and not an AI/ML diagnostic tool, a direct equivalent for many of these points is not applicable or explicitly mentioned in the provided summary. The summary focuses on engineering, safety, and compatibility testing.
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Explicitly Stated for Clinical Outcomes: The summary describes bench performance testing on the device itself and biocompatibility testing of materials, not a clinical study on human subjects with a "test set" of patient data. For bench testing, the "sample size" would refer to the number of devices or components tested, which is not detailed but assumed to be sufficient for engineering verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This relates to human interpretation of data for ground truth establishment in diagnostic studies. For a breast pump, "ground truth" is established by engineering specifications and objective measurements (e.g., pressure gauges, timers, chemical analysis).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Again, this pertains to expert review and consensus for diagnostic ground truth, which is not relevant for the type of testing described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This is specific to AI-assisted diagnostic workflows. No human reader interaction or AI assistance is mentioned or relevant for a breast pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to standalone AI algorithm performance. This device is a physical breast pump, not an algorithm. While it has embedded software, its performance is evaluated as an integrated system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is driven by:
- Engineering Specifications: Defined ranges for vacuum pressure, cycle speed, battery life, etc.
- International Standards: Compliance with ISO (e.g., ISO 10993 for biocompatibility) and IEC (e.g., IEC 60601 for electrical safety and EMC) standards.
- Regulatory Requirements: Compliance with 21 CFR regulations (e.g., 21 CFR 177 for milk-contacting materials).
- Functional Verification: Demonstrating features like backflow protection and proper software operation.
8. The sample size for the training set
- Not Applicable: This applies to AI/ML models. This device is not an AI/ML system trained on data.
9. How the ground truth for the training set was established
- Not Applicable: This applies to AI/ML models.
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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"
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(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
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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
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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)
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510(k) Summary – K242850
| 1. Submitter: | Shenzhen TPH Technology Co., Ltd.Room 203, 2nd floor, 29th Building, Lianchuang Technology Park No.21 Bulan Road, XialilangCommunity, Nanwan Street, Longgang District, Shenzhen, China.Tel.: +86-755-82703212 |
|---|---|
| Contact Person: | Peter ChenGeneral ManagerShenzhen TPH Technology Co., Ltd.peter@tph-tech.com |
| Date Prepared: | February 21, 2025 |
| 2. DeviceInformation: | Device Name: Wearable Breast Pump (Model W8)Common Name: Powered breast pumpRegulation Number: 21 CFR 884.5160Regulation Name: Powered breast pumpProduct code: HGX (Pump, Breast, Powered)Classification Panel: Obstetrics/GynecologyRegulatory Class: Class II |
| 3. Predicate DeviceInformation | Wearable Breast Pump, model S12 cleared under K212180.The predicate device has not been subject to a design-related recall. |
| 4. DeviceDescription: | The Wearable Breast Pump (Model W8) is a wearable powered breast pump designed forlactating woman to express and collect milk from the breast.There are 4 modes available for the device which are Expression mode, Massage mode, Automode 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/offswitch, mode selection/long press, and vacuum adjustment.W8 operated as a single or double pumping system, one on each breast. The pump is providednon-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 deviceincorporates embedded software which controls all the features of the product. All milkcontacting components of the device are compliant with 21 CFR 177 which is applicable for thesubject device. |
| 5. Indications forUse: | The Wearable Breast Pump (Model W8) is a powered breast pump intended to be used bylactating women to express and collect milk from their breasts. It is intended for a single user. |
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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 (ModelW8) | Wearable Breast Pump, modelS12 (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 breastpump intended to be used bylactating women to express andcollect milk from their breasts. Itis intended for a single user. | The Wearable Breast Pump,model S12 is intended toexpress milk from lactatingwomen in order to collectmilk from their breasts. Thedevice is intended for a singleuser. | Similar |
| Patient Population | Lactating women | Lactating women | Same |
| Anatomical Sites | Breast | Breast | Same |
| Single user | YES | YES | Same |
| Single/doublepump | Single | Single | Same |
| Media separation(backflowprotection) | YES | YES | Same |
| Cycling/SuctionControlMechanism | 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, modeselection/long press, vacuumadjustment | On-Off switch, modeselection, vacuum adjustment | Different |
| Adjustable suctionlevels | YES | YES | Same |
| Wirelesstechnology | No | No | Same |
| Component design | Milk collector and flange | Milk collector and flange | Same |
| Milk collectorCapacity | 180 ml | 180ml | Same |
| Flange size | 24mm and 27mm | 24mm and 27mm | Same |
| Material | |||
| Milkcollector/Linker | Polypropylene | Polypropylene | Same |
| Flange/Valve/Diaphragm | Silicone | Silicone | Same |
| Pump motor/outerhousing | ABS | ABS | Same |
Table 1. Comparison to Predicate Device
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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.
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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.
§ 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).