The Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.

Device Description

The subject devices are wearable-style breast pumps designed for lactating women to express and collect milk from the breast. They are electrically powered, software controlled, digital pumps for a single user. The subject devices include The INs, The INs Gen 2, The INs NEXT, P1s, and P3 models, which are capable of expression, massage, and mixed modes with ten associated suction levels for each. All five models have a single pumping configuration and can be operated in 'normal' or 'quiet' modes.
Massage, expression, and mixed pumping modes consist of 10 vacuum levels. Each Youha and BEBEBAO electric breast pump model is capable of providing vacuum levels from 40-190 mmHg with cycling rates from 90-110 cycles per minute in massage mode, vacuum levels from 80-280 mmHg with cycling rates from 40-75 cycles per minute in expression mode, and vacuum levels from 80-280 mmHg with cycling rates from 6-46 cycles per minute in mixed mode. The Youha electric 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. Software updates by end-users are not supported. The subject devices do not have wireless capability or other external functionality (i.e., no Bluetooth or mobile application). The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.
The motor unit operates on a rechargeable battery and can function when charging.
The breast pump expresses milk by creating a seal around the nipple using the breast shield and applying and releasing suction to the nipple. The milk is collected in a milk 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.
All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

AI/ML Overview

The provided FDA 510(k) summary for the Youha electric breast pumps (K242725) outlines the device's technical specifications and the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device. However, this document does not detail acceptance criteria and a study proving that the device meets those acceptance criteria in the context of an AI/ML medical device, as it is a powered breast pump, not an AI/ML system.

The prompt's request for detailed information such as "sample size used for the test set," "number of experts used to establish ground truth," "MRMC comparative effectiveness study," and "standalone (algorithm only) performance" are typical requirements for the validation of AI/ML-driven medical devices, particularly those involving image analysis or diagnostic support.

Since the Youha electric breast pump is a physical device with a software component that controls its operation (massage, expression, mixed modes, vacuum levels, cycle speeds), and not an AI/ML diagnostic or therapeutic device, the requested information (acceptance criteria for AI performance, clinical study results comparing AI-assisted vs. non-AI scenarios, etc.) is not applicable to this type of submission.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria (as defined for an AI/ML device) using the provided document. The document focuses on performance testing relevant to a mechanical/electronic medical device, such as biocompatibility, electrical safety, electromagnetic compatibility, software validation (at a basic documentation level, not AI performance), vacuum level verification, backflow protection, use life, and battery performance.

To answer your specific questions based on the provided document and its scope:

A table of acceptance criteria and the reported device performance:
The document describes various performance tests and implies their acceptance criteria are met (e.g., "Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications."). However, it does not present these in a formal table of acceptance criteria vs. specific reported values in the way one would for an AI/ML device's diagnostic performance (e.g., sensitivity, specificity, AUC).

Examples of Implicit Acceptance Criteria and Performance (derived from "Performance Testing" section):

Acceptance Criteria (Implied)	Reported Device Performance
Device meets mode/cycle specifications for vacuum levels.	"Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications."
No liquid backflow into tubing.	"Backflow protection testing was conducted to verify liquid does not backflow into the tubing."
Device maintains specifications throughout proposed use life.	"Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life."
Battery remains functional during stated battery use-life.	"Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life."
Battery status indicator remains functional during stated battery life.	"Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life."

Sample sized used for the test set and the data provenance: Not applicable in the context of AI/ML test sets. The testing here refers to physical device units rather than data samples for an algorithm. The document does not specify the number of physical units tested for each non-clinical test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., for disease detection or image interpretation) is not established for a breast pump's functional performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for establishing ground truth in AI/ML studies.
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/ML devices that assist human interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's software controls its mechanical function; it's not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be engineering specifications and validated physical measurements (e.g., actual vacuum levels vs. specified, absence of backflow).
The sample size for the training set: Not applicable. The "software" mentioned refers to embedded code controlling the hardware, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable for the reasons stated above.

In summary, the provided document details a 510(k) submission for an electric breast pump, which is a traditional medical device regulated under 21 CFR 884.5160 as a Class II powered breast pump. The testing described (biocompatibility, electrical safety, EMC, software validation at a basic level, and performance tests for vacuum, backflow, life, and battery) is appropriate for this type of device. The questions posed in the prompt are tailored for AI/ML device submissions, which are not relevant to this specific FDA clearance document.

Summary

U.S. Food & Drug Administration

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

May 30, 2025

Ningbo Youhe Electrical Appliance Technology Co.,Ltd.
℅ Daniel Qiu
Project Manager
Shanghai Qisheng Business Consulting Co., Ltd.
Room 1301, Building 46, Jing Gu Zhong Rd. 58
Minhang District
Shanghai, 200240
CHINA

Re: K242725
Trade/Device Name: Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Regulatory Class: II
Product Code: HGX
Received: May 1, 2025

Dear Daniel Qiu:

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.

FDA U.S. FOOD & DRUG ADMINISTRATION

May 30, 2025

Dear Daniel Qiu:

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

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K242725 - Daniel Qiu 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-

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K242725 - Daniel Qiu 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, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K242725

Device Name
Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

Indications for Use (Describe)
The Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They 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 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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510(k) Summary – K242725

1. Submitter Information

Applicant: Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Contact: Huang Yun Jun
Address: No.567, Xintang Road, Fuhai Town, Cixi City, Zhejiang Province, China
Tel.: +86-574-63860315
Fax.: +86-574-23660066

2. Correspondent Information

Contact: Daniel Qiu
Project Manager
Shanghai Qisheng Business Consulting Co., Ltd.
Email: danielqj@aliyun.com
Phone: +86 (186) 166-28661

3. Date prepared: May 29, 2025

4. Device Information

Device Name: Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
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: Elvie Stride
510(k) Number: K210936
Manufacturer: Chiaro Technology Limited.

The predicate device has not been subject to a design-related recall.

6. Device Description

Massage, expression, and mixed pumping modes consist of 10 vacuum levels. Each Youha and BEBEBAO electric breast pump model is capable of providing vacuum levels from 40-190 mmHg with cycling rates from 90-110 cycles per minute in massage mode, vacuum levels from 80-280 mmHg with cycling rates from 40-75 cycles per minute in expression mode, and vacuum levels from 80-280 mmHg with cycling rates from 6-46 cycles per minute in mixed mode. The Youha electric 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

K242725
Page 1 of 5

Page 6

software. Software updates by end-users are not supported. The subject devices do not have wireless capability or other external functionality (i.e., no Bluetooth or mobile application). The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.

The motor unit operates on a rechargeable battery and can function when charging.

The breast pump expresses milk by creating a seal around the nipple using the breast shield and applying and releasing suction to the nipple. The milk is collected in a milk 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.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

7. Indications for Use

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.

Table 1: Comparator Table for Subject and Predicate Devices

	Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) K242725 Subject Device	Elvie Stride K210936 Predicate Device	Comparison
Product Name	Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)	Elvie Stride	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 Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) are powered breast pumps intended to be used by lactating	The Elvie Stride is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Stride is intended for a single user.	Similar

K242725
Page 2 of 5

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	Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) K242725 Subject Device	Elvie Stride K210936 Predicate Device	Comparison
	women to express and collect milk from their breasts. They are intended for a single user.
Pump Options	Single	Single or Double	Different
Cycling control mechanism	Microcontroller	Microcontroller	Same
Backflow Protection	Yes	Yes	Same
Suction Modes	Massage Mode, Expression Mode, Mixed Mode	Stimulation Mode and Expression Mode	Different
Suction levels	10	10	Same
Adjustable suction levels	Yes	Yes	Same
Vacuum range: Massage	-40 to -190 mmHg	35-260 mmHg (double) 55-300 mmHg (single)	Different
Vacuum range: Expression	-80 to -280 mmHg	35-260 mmHg (double) 55-300 mmHg (single)	Different
Vacuum range: Mixed Pumping	-80 to -280 mmHg	N/A	Different
Cycle Speed: Massage	90 to 110 cycles/minute	31 to 83 cycles/min (Stimulation)	Different
Cycle Speed: Expression	40 to 75 cycles/minute	18 to 51 cycles/min (Expression)	Different
Cycle Speed: Mixed Pumping	6 to 46 cycles/minute	N/A	Different
Controls	The INs: one physical button (on/off/mode switch) and two touch keys (increase vacuum and decrease vacuum) The INs Gen 2: three physical button (on/off/mode switch, increase vacuum and decrease vacuum) The INs NEXT: three physical button (on/off/mode switch, increase vacuum and decrease vacuum) P1s: four physical button (on/off, mode switch, increase vacuum and decrease vacuum) P3: three touch keys (on/off/mode switch, increase vacuum and decrease vacuum)	On pump body and/or through app	Different
Power Supply	USB cable (battery charger) and Li-Ion Battery	USB cable (battery charger) and Li-Ion Battery	Same
Indicators	The INs: LED light on the on/off button indicates the mode; LED light momentarily displays the remaining time before battery depletion The INs Gen 2: LED light on the on/off button indicates the mode. LED light momentarily displays the remaining time before battery depletion The INs NEXT: LED Screen displays modes, level, timer, minute, battery indicator	Not specified	Different

K242725
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	Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) K242725 Subject Device	Elvie Stride K210936 Predicate Device	Comparison
	P1s: LED Screen displays modes, level/timer, minute, battery indicator P3: LED Screen displays modes, level/timer, minute, battery indicator
Design	Wearable pump	Not specified	N/A

The indications for use of the subject and predicate device are similar, and 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 wearable operation, power supply, and available vacuum levels. However, as shown in the table above, there are technological differences between the subject and predicate device, including different overall vacuum/cycle specifications, user interface, controls, and available modes. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility information was provided in accordance with Attachment G of 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."

Electrical Safety

Testing was conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), IEC 62133-2:2017/A1:2021, 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/A1:2020 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/A1:2020 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 at the Basic Documentation level as recommended in the 2023 FDA guidance document "Content of Premarket Submissions for Device Software Functions."

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 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.

K242725
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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 results of the performance testing described above demonstrate that the Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) are as safe and effective as the predicate device and supports a determination of substantial equivalence.

K242725
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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).