The Wearable Breast Pump (Model S9) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Device Description

The Wearable Breast Pump (Model S9), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, USB cable, valve, milk collector, and bra adjustment buckle. 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. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping). The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Both stimulation and expression mode consist of 5 vacuum levels. The S9 model is capable of providing vacuum levels from 40-105 mmHg with cycling rates from 75-109 cycles per minute in stimulation mode and vacuum levels from 40-245 mmHg with cycling rates from 28-85 cycles per minute in expression mode. The model S9 Wearable Breast Pump 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 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 breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is 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.

AI/ML Overview

{
"1_table_of_acceptance_criteria": {},
"2_sample_size_and_data_provenance": "Not applicable, as this device does not involve a test set for diagnostic accuracy or similar performance metrics. The testing focused on technical performance (e.g., vacuum levels, battery life) and safety (e.g., biocompatibility, electrical safety).",
"3_number_of_experts_and_qualifications": "Not applicable. No expert review was specified for establishing ground truth as the tests conducted were primarily engineering and safety performance tests against predefined technical specifications and standards.",
"4_adjudication_method": "Not applicable. Adjudication methods are typically relevant for studies involving subjective interpretation or diagnostic accuracy by multiple experts, which is not the case for the enumerated tests.",
"5_mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a breast pump, and the evaluation focused on its technical performance and safety, not on human reader performance or diagnostic improvement with AI assistance.",
"6_standalone_performance_study": "Yes, standalone performance studies were conducted. These studies include: \n- Biocompatibility testing\n- Electrical safety testing\n- Electromagnetic compatibility testing\n- Software evaluation\n- Vacuum level verification testing\n- Backflow protection testing\n- Use life testing\n- Battery performance testing\n- Battery status indicator testing\nThese tests demonstrate the device's technical performance and safety characteristics without human intervention as part of the performance evaluation.",
"7_type_of_ground_truth_used": "The ground truth relied on established engineering specifications, international safety standards (e.g., ISO, IEC), and regulatory guidelines (e.g., FDA guidance documents). For example, vacuum levels were verified against specified ranges, and biocompatibility was assessed against criteria defined in ISO 10993.",
"8_sample_size_for_training_set": "Not applicable. The document does not describe a training set as the device is not an AI/ML-driven diagnostic tool that requires machine learning training data.",
"9_how_ground_truth_for_training_set_was_established": "Not applicable, as there was no training set for an AI/ML model."
}

Summary

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May 26, 2022

Shenzhen TPH Technology Co., Ltd. Peter Chen General Manager 5th floor, Lianchuang 2nd technology Park, Bulan Road, Nanwan Community, Longgang District Shenzhen, Guangdong 518100 China

Re: K220596

Trade/Device Name: Wearable Breast Pump (Model S9) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 25, 2022 Received: March 1, 2022

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 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, 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220596

Device Name Wearable Breast Pump (Model S9)

Indications for Use (Describe)

The Wearable Breast Pump (Model S9) is intended to express milk from lactating women in order to collect milk from their breasts. The device 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 - K220596

1. Submitter Information

Applicant:	Shenzhen TPH Technology Co., Ltd.
Address:	5th Floor, Building No.29 East side,Lianchuang 2th technology park, BulanRoad, Nanwan Community, LonggangDistrict, Shenzhen, China

2. Correspondent Information

Contact:	Peter Chen
	General Manager
Phone:	+ 86 (755) 827-03212
Email:	peter@tph-tech.com

Date prepared: May 24, 2022

4. Device Information

Device Name:	Wearable Breast Pump (Model S9)
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

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All other components (i.e., motor unit) of the subject device are not in contact with the breast.

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 subject device components are made of the following materials:

· Motor unit: acrylonitrile-butadiene-styrene (ABS) plastic
· Flange, tube, valve, diaphragm: Silicone
· Linker, milk collection container: Polypropylene

All milk contacting components are compliant with 21 CFR 174-179.

7. Indications for Use

The Wearable Breast Pump (Model S9) is intended to express milk from lactating women in order to collect milk from their breasts. The device 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.

	Wearable Breast Pump(Model S9)K220596Subject Device	Wearable Breast Pump(Model S12)K212180Predicate Device	Comparison
Product Name	Wearable Breast Pump (Model S9)	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 S9) is intended toexpress milk from lactatingwomen in order to collect milkfrom their breasts. The device isintended for a single user.	The Wearable Breast Pump(Model S12) is intended toexpress milk from lactatingwomen in order to collect milkfrom their breasts. The device isintended for a single user.	Same
Pump Options	Single	Single	Same
Cycling controlmechanism	Microcontroller	Microcontroller	Same
Backflow Protection	Yes	Yes	Same
Suction Modes	Stimulation Mode andExpression Mode	Stimulation Mode andExpression Mode	Same
Suction levels	5	9	Different: The differences insuction levels for each mode do notraise different questions of safetyand effectiveness.

Table 1: Comparator Table for Subject and Predicate Devices

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Adjustable suctionlevels	Yes	Yes	Same
Flange Size	21, 24, mm and 27 mm	24 mm and 27 mm	Different: The difference in flangesizes do not raise differentquestions of safety andeffectiveness.
Vacuum range:Stimulation	-40 to -105 (±5) mmHg	-40 to -105 (±5) mmHg	Same
Vacuum range:Expression	-40 to -245 (±5) mmHg	-40 to -245 (±5) mmHg	Same
Cycle Speed:Stimulation	75 to 109 cycles/minute	70 to 114 cycles/minute	Different: The difference inspecification does not raisedifferent questions of safety andeffectiveness. Differences in cyclespeed were substantiated byperformance testing below.
Cycle Speed:Expression	28 to 85 cycles/minute	23 to 90 cycles/minute	Different: The difference inspecification does not raisedifferent questions of safety andeffectiveness. Differences in cyclespeed were substantiated byperformance testing below.
Controls	On/Off button;Mode selectionIncrease/decrease vacuumbutton:	On/Off button;Mode selectionIncrease/decrease vacuumbutton:	Same
Power Supply	Li-Ion Battery	Li-Ion Battery	Same
Indicators	Yes, LED	Yes, LED	Similar: The predicate device hasan LED display while the subjectdevice has a battery status LED.Differences in visual indicators donot raise different questions ofsafety and effectiveness.
Materials	Milk Container: PolypropyleneFlange: SiliconePump Outer Housing:Acrylonitrile ButadieneStyrene (ABS) plastic	Milk Container: PolypropyleneFlange: SiliconePump Outer Housing:Acrylonitrile ButadieneStyrene (ABS) plastic	Same

The indications for use of the subject and predicate device are identical.

The subject and predicate devices have similar technological features, including device design, user interface, overall vacuum pressure range, materials, and power source. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility studies, including Skin Irritation Testing, Cytotoxicity, and Skin Sensitization testing were performed in accordance with the 2020 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" and ISO 10993- 1:2009 as follows:

Cytotoxicity (ISO 10993-5:2009) ●

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Skin Sensitization (ISO 10993-10:2010) ●
Skin Irritation (ISO 10993-10:2010) ●

The testing supports the biocompatibility of the device. The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.

Electrical Safety

Testing was conducted in accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), 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 as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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 subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.5160 Powered breast pump.

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