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.

Device Description

The Wearable Breast Pump (Model S18) is designed for lactating woman to express and collect milk from the breast. 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 are two modes, with multiple suction levels for each mode, available for the device: Expression mode and Stimulation 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 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 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 should not be used while charging.

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.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding a Wearable Breast Pump (Model S18). While it confirms the device's substantial equivalence to a predicate device, it does not contain the level of detail typically found in a clinical study report for an AI/ML medical device regarding acceptance criteria and performance studies.

Therefore, I cannot extract the specific information requested about acceptance criteria and study details for an AI/ML device from this document. This document primarily focuses on regulatory approval based on comparison to a predicate device, rather than detailed performance metrics of a novel AI algorithm.

Here's what I can extract and infer from the provided text, acknowledging that it does not fully answer your request for AI/ML device study details:

Regarding the device: The device is a "Wearable Breast Pump (Model S18)". It is a Class II medical device, product code HGX. Its intended use is "to express milk from lactating women in order to collect milk from their breasts" and is "intended for a single user."

The acceptance criteria and reported device performance (based on the context of a breast pump, not an AI/ML device):

The "Performance Testing" section (Page 6) outlines general performance tests, not specific acceptance criteria in the format requested for an AI/ML model. These are more focused on mechanical and electrical function.

Acceptance Criteria (Inferred from Performance Tests)	Reported Device Performance (Inferred)
Device meets mode/cycle specifications for vacuum levels.	Verified at each mode/cycle.
Liquid does not backflow into the tubing.	Backflow protection testing conducted and verified.
Device maintains specifications throughout proposed use life.	Use life testing conducted and verified.
Battery remains functional during stated battery use-life.	Battery performance testing conducted and verified.
Battery status indicator remains functional during stated battery life.	Battery status indicator testing conducted and verified.

Missing/Not Applicable Information (as this is not an AI/ML device submission):

Sample sized used for the test set and the data provenance: Not applicable/not provided. The performance tests are functional, not data-driven in the sense of AI/ML.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML medical device would typically involve expert annotations of medical images or data. For a breast pump, "ground truth" is its mechanical and electrical function.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" for this device's performance is whether it meets its mechanical and electrical specifications.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Additional points mentioned in the document:

Biocompatibility: Leveraged from the predicate device (K212180) because materials are identical.
Electrical Safety and EMC: Tested according to ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 62133-2:2017, IEC 60601-1-11:2015, and IEC 60601-1-2:2014.
Software: Evaluated for a "moderate level of concern" as per FDA guidance (2005). The document states "The device incorporates embedded software which controls all the features of the product," but no detailed software performance validation or AI/ML specific details are provided.

In summary, this document establishes the substantial equivalence of a breast pump based on its design, materials, and functional performance tests compared to a previously cleared device. It does not provide the detailed AI/ML specific acceptance criteria and study information you requested.

Summary

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July 14, 2023

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: K223886

Trade/Device Name: Wearable Breast Pump (Model S18) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 13, 2023 Received: June 13, 2023

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.

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.

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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 (QS) 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 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 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) K223886

Device Name Wearable Breast Pump Model S18)

Indications for Use (Describe)

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.

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 G)

_ | 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 - K223886

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. SubmitterInformation	Applicant: Shenzhen TPH Technology Co., Ltd.Contact: Peter ChenPhone: +86-755-82703212Address: 5th floor, Building NO.29 East side, Lianchuang 2nd technology Park, LonggangDistrict, Shenzhen, China.
2. Date Prepared:	July 13, 2023
3. DeviceInformation:	Device Name: Wearable Breast Pump (Model S18)Common Name: Powered Breast PumpRegulation Number: 21 CFR 884.5160Regulation Name: Powered Breast PumpProduct Code: HGX (Powered, Breast, Pump)Regulatory Class: Class II
4. Predicate DeviceInformation:	Device Name: Wearable Breast Pump (Model S12)510(k) Number: K212180Manufacturer: Shenzhen TPH Technology Co., Ltd.The predicate device has not been subject to a design-related recall.

5. Device Description

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.

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6. Indications for Use

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.

7. Predicate Device Comparison

The table below compares the intended use and technological characteristics of the subject and predicate device.

	Proposed DeviceWearable Breast PumpModel S18K223886	Predicate DeviceWearable Breast PumpModel S12K212180	Comparison
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 forUse	The Wearable Breast Pump(Model S18) 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 deviceis intended for a single user.	Same
PatientPopulation	Lactating women	Lactating women	Same
Single user	YES	YES	Same
Single/doublepump	Single	Single	Same
BackflowProtection	YES	YES	Same
Cycling/SuctionControlMechanism	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	40-105 mmHg	Different
Cycle Speed:Stimulation	69 to 92 cycles/minute	70 to 114 cycles/minute	Different
Suction Strength(Expression)	120-245 mmHg	40-245 mmHg	Different
Cycle Speed:Expression	20 to 66 cycles/minute	23 to 90 cycles/minute	Different
Suction levels	9	9	Same
User interface
User control	On-off switch, vacuumadjustment	On-off switch, vacuumadjustment	Same
Adjustablesuction levels	YES	YES	Same

	Table 1. Specific Comparison to Predicate

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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	21mm, 24mm, and 27mm	24mm and 27mm	Different
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 pumping options, control mechanism, user interface, backflow protection, and device indicators. However, as shown in the table above, there are technological differences between the subject and predicate devices, including different vacuum and cycle specifications and flange sizes. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.

8. Summary of Non-Clinical Performance Testing

Biocompatibility

The materials of the subject device are identical to K212180 in formulation, processing, and cleaning. Therefore, biocompatibility information from K212180 was leveraged to support the biocompatibility of patient-contacting components of the subject device.

Electrical Safety and Electromagnetic Compatibility (EMC)

Testing was conducted in accordance with ANSI/AAMI ES60601-1:2005 + A1:2012, 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 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 l - 11 : General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical systems used in the home healthcare environment.

Testing was conducted in accordance with IEC 60601-1-2:2014, Medical electrical equipment - Part I-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and Tests.

Software

Software was evaluated for a moderate level of concern as recommended in the 2005 FDA guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

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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 at each mode/cycle demonstrated that the device meets 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 functions 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.

9. Conclusion

The results of the performance testing described above demonstrate that the Wearable Breast Pump (Model S18) is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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).