The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

Device Description

The Youha electric breast pump is a single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. YH-8004 and YH-8016 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YH-8006IV and YH-8015 have a single pumping configuration only.

A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280mmHg. The user interface consists of a front panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure.

The device has three modes of operation:

Massage mode: Suction patterns with fast cycles and low vacuum to start milk flowing
Low expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.
High expression mode: Suction patterns with slower cycles and higher vacuum to express more milk efficiently.

YH-8004, YH-8015 and YH-8016 have 3 modes including massage mode, low expression mode and high expression mode. YH-8006IV has 2 modes including massage mode and high expression mode.

The device is electrically powered from either an internal rechargeable battery or an external AC power adapter. The external adapter also charges the battery.

AI/ML Overview

This document pertains to the 510(k) premarket notification for the Youha electric breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of diagnostic accuracy for an AI/ML device.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study design are not applicable to this regulatory submission for a powered breast pump.

Here's an attempt to extract relevant information and note where the requested information is not present in this document:

1. Table of Acceptance Criteria and Reported Device Performance

For a breast pump, "acceptance criteria" generally refer to meeting specified physical and performance characteristics, safety standards, and functional requirements. These are defined internally by the manufacturer and verified through non-clinical testing. The document highlights compliance with recognized standards.

Acceptance Criteria Category	Reported Device Performance / Compliance
Safety Standards	IEC 60601-1:2005 (3rd Ed.) with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 (Electrical Safety)
	IEC 60601-1-11:2015 (Safety for home use)
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2014 (EMC Testing)
Biocompatibility	ISO-10993 (Cytotoxicity, Sensitization, Irritation)
	ISO 10993-5:2009 (Cytotoxicity)
	ISO 10993-10:2010 (Sensitization, Irritation)
Risk Management	ISO 14971:2007 (Risk Analysis)
Software Validation	IEC 62304 (Software Life Cycle Processes)
	FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)
Performance - Vacuum Level	Met specifications for minimum and maximum vacuum levels (measured at minimum and maximum vacuum settings)
Performance - Cycle Rate	Met specifications (measured at minimum and maximum vacuum settings)
Performance - Backflow Protection	Met specifications (tested under single and double pumping mode with various power sources)
Functional Modes	Massage mode, Low expression mode, High expression mode (various models have different combinations)
Power Sources	Internal rechargeable battery or external AC power adapter (tested)
Pumping Configuration	Single and/or Double Pumping (model dependent, tested)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of an AI/ML device's diagnostic performance evaluation. The "test set" here refers to physical testing of device units. The document states "Performance testing was conducted at minimum and maximum vacuum settings" on the device, but it does not specify the number of units tested, the number of measurements, or any details about data provenance in the way it would for AI/ML algorithm evaluation. These are typically internal verification and validation tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. For a breast pump, "ground truth" relates to its physical and functional performance measurements against engineering specifications, not clinical diagnostic accuracy assessed by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. This relates to expert consensus for ground truth establishment in clinical studies, which is not relevant for a breast pump's functional testing.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of this submission for a breast pump.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. This refers to AI algorithm performance evaluation, not a physical medical device like a breast pump.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the breast pump's performance is derived from engineering specifications and recognized national/international standards (e.g., vacuum levels, cycle rates, electrical safety parameters, biocompatibility limits). The document states: "Performance testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection."

8. The sample size for the training set

This is not applicable. A breast pump does not use a "training set" in the sense of machine learning. Its design is based on engineering principles and verified through physical testing.

9. How the ground truth for the training set was established

This is not applicable. See point 8.

Summary of the Study (as described in the document for substantiating equivalence):

The "study" described in the document is a series of non-clinical performance tests conducted by the manufacturer to verify that the Youha electric breast pump meets its design specifications and complies with relevant safety and performance standards. It is a verification and validation (V&V) process rather than a clinical study or AI algorithm evaluation.

Objective: To verify that the Youha electric breast pump met all design specifications and is substantially equivalent to the predicate device (Spectra 9 Plus powered breast pump).
Methods: Physical testing was performed to assess:
- Compliance with various international standards for risk analysis (ISO 14971), electrical safety (IEC 60601-1, AAMI/ANSI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), home use safety (IEC 60601-1-11), and biocompatibility (ISO-10993 parts 5 and 10).
- Software validation according to IEC 62304 and FDA guidance.
- Performance characteristics such as minimum and maximum vacuum levels, cycle rate, and backflow protection under different conditions (minimum/maximum vacuum settings, single/double pumping mode, AC/DC vs. battery power).
Results: The test results demonstrated that the proposed device complies with the listed standards and met its specifications for vacuum level, cycle rate, and backflow protection under various operating conditions.
Conclusion: Based on the comparison with the predicate device and the non-clinical test results, the Youha electric breast pump was deemed substantially equivalent to the predicate device.

Key takeaway for AI/ML context: This document is an example of a 510(k) submission for a traditional medical device, not a software as a medical device (SaMD) or an AI/ML-driven device. Therefore, the requirements for demonstrating diagnostic accuracy and clinical performance for AI/ML are inherently different and not addressed here.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 31, 2017

Ningbo Youhe Electrical Appliance Technology Co., Ltd. % Daniel Qiu Project Manager Shanghai Qisheng Business Consulting Co.,ltd. Room 1301, Bld 46, Jing Gu Zhong Rd., No.58, Min Hang District, Shanghai, CN Shanghai, 200240 China

Re: K163136 Trade/Device Name: Youha electric breast pump, Models: YH-8004, YH-8016, YH-8006IV, YH-8015 Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 22, 2017 Received: June 22, 2017

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 (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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163136

Device Name

Youha electric breast pump, Models: YH-8004, YH-8016, YH-8006IV, YH-8015

Indications for Use (Describe)

The Youha electric breast pump is 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)
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| | 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

K163136

1. Submitter Information

Name:	Ningbo Youhe Electrical Appliance Technology Co., Ltd
Address:	No.226-228 San Jiao Tian Road, Fu Hai Town, CiXi City, Zhejiang, China
Telephone:	+86-574-63860315
Fax:	+86-574-23660066

Contact Person: Huang Yun Jun

1. Date Prepared: June 30, 2017

3. Device Information

Trade Name:	Youha electric breast pump
Common Name:	Powered breast pump
Models:	YH-8004, YH-8016, YH-8006IV, YH-8015
Regulation Class:	Class II
Regulation Number:	21CFR 884.5160, Powered breast pump
Review Panel:	Obstetrics/Gynecology
Product Code:	HGX (pump, breast, powered)

4. Predicate Device

K162415 510(k): Device Name: Spectra 9 Plus powered breast pump Manufacturer: Uzinmedicare Company

5. Device Description

The device has three modes of operation:

. Massage mode: Suction patterns with fast cycles and low vacuum to start milk flowing

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Low expression mode: Suction patterns with slow cycles and high vacuum to . express more milk gently and efficiently.
High expression mode: Suction patterns with slower cycles and higher vacuum to . express more milk efficiently.

YH-8004, YH-8015 and YH-8016 have 3 modes including massage mode, low expression mode and high expression mode. YH-8006IV has 2 modes including massage mode and high expression mode.

The device is electrically powered from either an internal rechargeable battery or an external AC power adapter. The external adapter also charges the battery.

6. Indications for Use

The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

7. Predicate Comparison

The following table compares the Youha Electric breast pump to the predicate device with respect to indications for use and technological characteristics:

Device & Predicate Device(s):	Subject Device:	Predicate Device:
	Youha electric breast pumpK163136	Spectra 9plusK162415
Indications for Use	The Youha electric breast pump isintended to be used by lactating womento express and collect milk from theirbreasts. It is intended for a single user.	The Spectra 9Plus is a single-user,powered breast pump intended toexpress and collect milk from thebreasts of lactating women.
Single user	Yes	Yes
Provided Non-sterile	Yes	Yes
Re-usable	Yes	Yes
Direct user contact	Yes	Yes
Power source	AC/DC wall converter andRechargeable	Power source
Suction Strength (ExpressionMode) (mmHg)	LowYH-8004:75-250YH-8016:75-250YH-8015:115-250YH-8006IV:N/A	50-270
	HighYH-8004:120-280YH-8016:120-280YH-8015: 120-280YH-8006IV:125-280
Suction Strength (MassageMode) (mmHg)	YH-8004:34-190YH-8016:34-190YH-8015: 50-190YH-8006IV: 50-190	50-150
Adjustable Suction levels	Yes	Yes
Suction Settings (High/low	YH-8004:6	10

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Expression Mode)	YH-8016:6
	YH-8015:9
	YH-8006IV:10
Suction Settings (Massage Mode)	YH-8004:6	5
	YH-8016:6
	YH-8015:9
	YH-8006IV:10
Cycle Speed (Expression Mode) (cycles/min)	Low	YH-8004:41-69	24-60
		YH-8016:41-69
		YH-8015:36-60
		YH-8006IV:N/A
	High	YH-8004:16-33
		YH-8016:16-33
		YH-8015:16-34
		YH-8006IV:32-57
Cycle Speed (Massage Mode)		YH-8004:94-113	70
		YH-8016:94-113
		YH-8015:80-122
		YH-8006IV:71-100
Backflow Protection		Yes	Yes
Single or Double Pumping		YH-8004/ YH-8016: Single and DoublePumping	Single and Double Pumping
		YH-8006IV/YH-8015:Single PumpingOnly
Visual Indicator		LCD	LCD
Pump Type		Diaphragm	Diaphragm

The Youha electric breast pump has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.

8. Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the Youha electric breast pump met all design specifications and is substantially equivalent to the predicate. The test results demonstrated that the proposed device complies with the following standards:

Risk Analysis developed in accordance with ISO 14971:2007.
Electrical Safety Testing in accordance with IEC 60601-1:2005 (3m Edition) with US ● deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
. Safety Testing for use in the home in accordance with IEC 60601-1-11:2015.
Biocompatibility Tests in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
Software Validation Software Life Cycle Processes in accordance with IEC 62304. ●

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. FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
Performance testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection. These results held under conditions of single and double pumping mode with varying power sources (e.g., AC/DC power vs. battery power).

Clinical Performance Data 9.

Not Applicable

10. Conclusion

Based on the comparison and analysis above, the Youha electric breast pump 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).