The Electric breast pump is a single-patient reusable device, intended to be used by lactating women to express and collect milk from their breasts. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The Electric breast pump has two models: RH-228 and RH-338. Model RH-228 is capable of single pumping and has two modes - stimulate mode and expression mode. The RH-228 user interface consists of a panel keypad and LED display in which the user switches between modes and controls the vacuum pressure. Model RH-338 is capable of single pumping and has three modes - stimulate mode, massage mode and expression mode. The RH-338 user interface consists of a panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure. The RH-228 is externally powered by 5Vdc USB. The RH-338 is internally powered by 3.7Vdc lithium battery or externally powered by 5Vdc USB. The external adapter also charges the battery. Both models of the Electric breast pump are provided with a breast shield, cylinder cap, cylinder, valve, vacuum tubing, feeding bottle, and a nipple kit. Model RH-338 also includes a massage cushion and a dust cap. The user-contacting materials are limited to polypropylene (breast shield) and silicone (massage cushion).

AI/ML Overview

This document is a 510(k) Premarket Notification summary for an Electric Breast Pump, specifically models RH-228 and RH-338. It details the device's characteristics and the testing performed to demonstrate its substantial equivalence to a predicate device (Youha electric breast pump, Model YH-8006IV, K163136).

Based on the provided text, here's a description of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated by compliance with recognized consensus standards and meeting pre-defined specifications through performance testing. The document heavily relies on the concept of "substantial equivalence" to a predicate device, meaning the new device performs at least as safely and effectively as a legally marketed device.

Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Electrical Safety & EMI	Compliance with: - IEC 60601-1:2005+A1:2012 (General requirements for basic safety & essential performance)- IEC 60601-1-11:2015 (Home healthcare environment)- IEC 60601-1-2:2014 (Electromagnetic Compatibility)	Tests Conducted: - Electrical Safety and Electromagnetic Compatibility: Specifically mentioned compliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2. The implication is that the device met the requirements of these standards.
Battery Safety	Compliance with IEC 62133:2012 (Secondary cells and batteries safety requirements)	Tests Conducted: - Battery Performance Testing: Conducted to demonstrate the battery remains functional during its stated use-life. - Battery Status Indicator Testing: Conducted to demonstrate the indicator remains functional during its stated battery life. - Compliance with IEC 62133 for battery safety. The implication is that the battery met the requirements of these standards and performed as specified.
Biocompatibility	Compliance with FDA guidance "Use of International Standard ISO-10993" (Part 1, 5, 10)	Tests Conducted: - Cytotoxicity (ISO 10993-5:2009)- Sensitization (ISO 10993-10:2010)- Irritation (ISO 10993-10:2010)Result: "The user-contacting materials were shown to be biocompatible."
Software Verification	Compliance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)	Tests Conducted: Software verification and validation. The implication is that the software met the requirements of the guidance.
Performance (Vacuum & Cycle Rate)	Device meets its own specifications for vacuum pressure and cycle rate at all settings.	Tests Conducted: "Vacuum pressure and cycle rate testing was conducted at all settings for each device model and demonstrated that the devices met their specifications."
Performance (Backflow)	Liquid does not backflow into the tubing/pump.	Tests Conducted: "Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump." The implication is that the device prevented backflow.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify sample sizes for performance testing (e.g., how many units were tested for vacuum pressure or backflow). It also does not discuss data provenance in terms of country of origin or whether the studies were retrospective or prospective, beyond stating that "Non-clinical tests were conducted."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This document describes non-clinical performance and safety testing directly against technical standards and specifications, not clinical studies involving human observers or "ground truth" derived from expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical testing against technical specifications, not human adjudication of results.

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 document is for an electric breast pump, a mechanical device, and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This device is not an algorithm, so standalone AI performance is not relevant.

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

The "ground truth" for this device's testing is primarily established engineering and medical device standards (e.g., IEC 60601 series, ISO 10993 series) and the device's own pre-defined design specifications (e.g., target vacuum pressure ranges, specific cycle rates). For biocompatibility, it's the biological response as defined by the ISO 10993 standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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April 9, 2021

Cixi Ruihong Electric Appliance Co., Ltd. Kelong Zhang General Manager No. 18, Xiamaojia Road, Shuangqingpu Village, Xinpu Town, Cixi Ningbo. Zhejiang 315322 China

Re: K201903

Trade/Device Name: Electric breast pump (Models: RH-228 and RH-338) Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 9, 2021 Received: March 8, 2021

Dear Kelong Zhang:

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 (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 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,

Michael T. Bailey -S

For

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) K201903

Device Name

Electric breast pump (Models: RH-228 and RH-338)

Indications for Use (Describe)

The Electric breast pump is intended to be used by lactating women to express and collect milk from their breast. 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

K201903

1. Submitter Information:

Name:	Cixi Ruihong Electric Appliance Co., Ltd.
Address:	No.18, Xiamaojia Road, Shuangqingpu Village,Xinpu Town, Cixi, Ningbo, 315322, Zhejiang, China

Contact Person:	Mr. Kelong Zhang
Position:	General Manager
Phone:	+86-574-63581761
Fax:	+86-574-63581761
Email:	1020666000@qq.com

Date 510(k) Summary Prepared: April 7, 2021

2. Device Information

Trade/Proprietary Name: Electric breast pump (Models: RH-228 and RH-338)

Regulation Name:	Powered breast pump
Regulation Number:	21 CFR 884.5160
Common Name:	Powered breast pump
Product Code:	HGX (Pump, Breast, Powered)
Regulatory Class:	Class II
Review Panel:	Obstetrics/Gynecology

3. Predicative Device

510(k) Number:	K163136
Manufacturer:	Ningbo Youhe Electrical Appliance Technology Co., Ltd.
Device Name:	Youha electric breast pump (Model: YH-8006IV)

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

4. Device Description:

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The Electric breast pump has two models: RH-228 and RH-338. Model RH-228 is capable of single pumping and has two modes - stimulate mode and expression mode. The RH-228 user interface consists of a panel keypad and LED display in which the user switches between modes and controls the vacuum pressure. Model RH-338 is capable of single pumping and has three modes - stimulate mode, massage mode and expression mode. The RH-338 user interface consists of a panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure.

The RH-228 is externally powered by 5Vdc USB. The RH-338 is internally powered by 3.7Vdc lithium battery or externally powered by 5Vdc USB. The external adapter also charges the battery.

Both models of the Electric breast pump are provided with a breast shield, cylinder cap, cylinder, valve, vacuum tubing, feeding bottle, and a nipple kit. Model RH-338 also includes a massage cushion and a dust cap. The user-contacting materials are limited to polypropylene (breast shield) and silicone (massage cushion).

5. Indications for Use

The 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.

6. Comparison of Intended Use and Technological Characteristics

The following table compares the subject device to the predicate device with respect to the indications for use and technological characteristics:

Characteristics	Subject DeviceElectric breast pumpK201903	Predicate DeviceYouha Electric Breast PumpModelYH-8006IVK163136
Indications for Use	The Electric breast pump isintended to be used bylactating women to expressand collect milk from theirbreasts. It is intended for asingle user.	The Youha electric breast pumpis intended to be used bylactating women to express andcollect milk from their breasts. Itis intended for a single user.
Single-user	Yes	Yes
Provided	Yes	Yes
Non-sterile
Re-usable		Yes	Yes
Direct user contact		Yes	Yes
Patient population		Lactating women	Lactating women
Anatomical Sites		Breast	Breast
Suction strength(mmHg)	RH-228	Expression mode:120-275Stimulate mode:60-150Massage mode:135-255	High expression mode:125-280Massage mode: 50-190
	RH-338	Stimulate mode:45-165Expression mode:110-300
Suction Levels	RH-228	Expression mode: 4levelsStimulate mode: 5levels	10 levels
	RH-338: 9 levels
Cycle Speed(cycles/min)	RH-228	Expression mode:28-52Stimulate mode:58-90Massage mode:56-72	High expression mode:32-57Massage mode: 71-100
	RH-338	Stimulate mode:115-155Expression mode:25-52
Backflowprotection		Yes	Yes
Single or Doublepumping		Single pumping	Single Pumping
Visual Indicator		RH-228: LEDRH-338: LCD	LCD
Pump Type		Diaphragm	Diaphragm

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The subject and predicate device have identical indications for use statements. Therefore, they have the same intended use, i.e., for collection of breast milk from the breasts of a single user.

The subject and predicate device have different technological features, including the user interface, expression levels, suction strength, cycle speed, and power source. These technological differences do not raise different questions of safety or effectiveness.

7. Summary of Non-clinical Performance Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications and that the subject devices are substantially equivalent to the predicate device.

a. Electrical Safety and Electromagnetic Compatibility:
- 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 with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- . 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, Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
- IEC 62133:2012 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
b. Biocompatibility:

Biocompatibility testing in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments:

Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices . -- Part 5: Tests for in vitro cytotoxicity
. Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

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Irritation per ISO 10993-10:2010 Biological evaluation of medical devices --. Part 10: Tests for irritation and skin sensitization
The user-contacting materials were shown to be biocompatible.
c. Software Verification:
- . Software verification and validation in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
d. Performance testing:
- . Vacuum pressure and cycle rate testing was conducted at all settings for each device model and demonstrated that the devices met their specifications.
- . Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- 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.

8. Conclusion:

The comparison and analysis above demonstrate that the Electric breast pump is as safe and effective as the predicate device and supports a determination of substantial equivalence 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).