The Electric Breast Pump (Models 918, HF918) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.

Device Description

The Electric Breast Pump (Model 918 and HF918) are powered breast pumps intended to express and collect milk from a lactating woman's breast. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The Electric Breast Pump is provided non-sterile and should be cleaned and disinfected according to the instructions for use prior to first use. The user employs buttons on the pump unit to select the pumping mode and vacuum level.

The Electric Breast Pump has five basic modes: Stimulation mode, Expression mode, Two-in-one mode, Dual-Frequency mode, and Simulation mode has 5 suction levels (vacuum levels: 60-217.5 ± 20 mmHg; cycle speed: 39-123 ± 5 cycles/min), expression mode (vacuum levels: 105-285 ± 20 mmHg; cycle speed: 24-84 ± 5 cycles/min), dual-frequency mode (vacuum levels: 67.5-277.5 ± 20 mmHg; cycle speed: 39-85 ± 5 cycles/min), and two-in-one mode (vacuum levels: 75-285 ± 20 mmHg; cycle speed: 59-123 ± 5 cycles/min) have seven suction levels, and simulation mode (vacuum levels: 187.5 ± 20 mmHg; cycle speed: 14 ± 5 cycles/min) has one suction level. Stimulation mode is for massaging the breast to stimulate breast milk secretion. Expression mode is for pumping breast milk. Dual Frequency mode is for cycling between strong and weak pumping strengths. Two-in-One mode cycles between massaging for 5 cycles and expressing breast milk for 1 cycle. Simulation mode operates at a single suction level to stimulate milk secretion.

The subject devices are available in two models: 918 and HF918. The hands-free (HF) model (HF918) is designed to be placed inside a user's bra and connect to the external pump unit. The milk collection cup is located on the breast. The HF model (HF918) includes breast shield assemblies, milk collection cups, single and double tubing sets, a bottle set, power adapter, and a pump unit. The non-HF model (918) includes a breast shield connected to a milk bottle. The non-HF model includes breast shield assemblies, bottles, bottle stands, single and double tubing sets, power adapter, and a pump unit.

The Electric Breast Pumps are intended for a single user.

AI/ML Overview

The provided document describes the substantial equivalence claim for an Electric Breast Pump (Models 918, HF918) against a predicate device (Electric breast pump, Models: RH-228 and RH-338). It does not contain information about acceptance criteria and study results in the typical format of a diagnostic device or AI/ML product.

Specifically, it does not provide the following information:

A table of acceptance criteria and reported device performance (for a diagnostic or AI device)
Sample size used for the test set or data provenance
Number of experts used to establish ground truth or their qualifications
Adjudication method for the test set
Whether an MRMC study was done or its effect size
Whether standalone performance was evaluated
The type of ground truth used (expert consensus, pathology, outcomes data)
Sample size for the training set
How the ground truth for the training set was established

Instead, the document details non-clinical tests performed to demonstrate substantial equivalence for a medical device (an electric breast pump). The acceptance criteria are implicitly that the device meets relevant safety and performance standards for its type.

Here's what the document does provide regarding "acceptance criteria" and "study" for this specific product, formatted as closely as possible to your request, but reflecting the nature of a breast pump clearance documentation rather than a diagnostic AI study:

1. A table of acceptance criteria and the reported device performance

For an electric breast pump, acceptance criteria primarily relate to safety, electrical performance, biocompatibility, and meeting design specifications. The performance is reported as compliance with these standards and specifications.

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Electrical Safety & EMC	IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 (General requirements for basic safety and essential performance)	Complied with the standard.
	IEC 60601-1-2:2014 (Electromagnetic Compatibility)	Complied with the standard.
	IEC 60601-1-11:2010, AMD1:2013 (Home healthcare environment requirements)	Complied with the standard.
	IEC 62133:2012 (Secondary cells and batteries safety)	Complied with the standard.
Biocompatibility	ISO 10993-5:2009 (Tests for in vitro cytotoxicity)	Complied with the standard.
	ISO 10993-10:2010 (Tests for irritation and skin sensitization)	Complied with the standard.
Software Verification	FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005	Verified in accordance with the guidance.
Functional Performance	Suction strength: Demonstrate subject device meets design specifications throughout use life. Predicate Suction Ranges:Stimulation mode: RH-228: 60-150 mmHg, RH-338: 45-165 mmHgExpression mode: RH-228: 120-275 mmHg, RH-338: 110-300 mmHgMassage mode: RH-338: 135-255 mmHg (This specific mode not in subject device comparison, but predicate has it)Subject device reported ranges:Stimulation: 60-217.5 ± 20 mmHgExpression: 105-285 ± 20 mmHgTwo-in-one: 75-285 ± 20 mmHgDual-frequency: 67.5-277.5 ± 20 mmHgSimulation: 187.5 ± 20 mmHg	All test results complied with the design specifications of the subject device throughout the use life. (The subject device's ranges are within or comparable to the predicate for shared modes, and it introduces new modes.)
	Backflow protection: No liquid backflow into tubing/pump motor even if bottle is over-filled.	No backflow during the test.
	Cycle speed: Demonstrate subject device meets design specifications throughout use life.Subject device reported ranges:Stimulation: 39-123 ± 5 cycles/minExpression: 24-84 ± 5 cycles/minTwo-in-one: 59-123 ± 5 cycles/minDual-frequency: 39-85 ± 5 cycles/minSimulation: 14 ± 5 cycles/min	All test results complied with the design specifications of the subject devices throughout the use life.
	Battery performance: Battery remains functional during stated use-life.	Demonstrated battery remains functional.
	Battery status indicator: Indicator remains functional during stated battery life.	Demonstrated indicator remains functional.

2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The "tests" are engineering and regulatory compliance tests, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there is no "ground truth" in the clinical diagnostic sense for a breast pump's functional testing. Electrical safety, biocompatibility, and functional performance are assessed against established standards and design specifications by accredited labs and engineers.

4. Adjudication method for the test set
Not applicable.

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 is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used
The "ground truth" equivalent here is compliance with recognized international standards (e.g., IEC 60601 series, ISO 10993 series) and the manufacturer's own validated design specifications for functional parameters (suction strength, cycle speed, backflow).

8. The sample size for the training set
Not applicable. This is not a machine learning device.

9. How the ground truth for the training set was established
Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 11, 2022

Shantou Huihengqi Electronic Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Shanghai 200120 China

Re: K211024

Trade/Device Name: Electric Breast Pump (Models 918, HF918) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: January 8, 2022 Received: January 11, 2022

Dear Diana Hong:

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,

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) K211024

Device Name Electric Breast Pump (Models 918, HF918)

Indications for Use (Describe)

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 K211024

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR 807.92.

Date of 510(k) Summary Preparation: February 10, 2022 1.
1. Sponsor Identification

Shantou Huihengqi Electronic Technology Co., Ltd.

501, 5/F, Block C, 14A Industrial Zone, Longhu District, Shantou, 515000, China

Establishment Registration Number: Not registered

Contact Person: Gensong Yang Position: Quality Supervisor Tel: +86-0754-88893348 Email: 357732164@qq.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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Page 2

Trade Name: Electric Breast Pump (Models 918, HF918) Common Name: Electric Breast Pump Models: 918, HF918

Regulatory Information Classification Name: Powered Breast Pump Product Code: HGX: Classification: II Regulation Number: 21 CFR 884.5160

Identification of Predicate device న్.
510(k) Number: K201903 Product Name: Electric breast pump (Models: RH-228 and RH-338)

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

Device Description: 6.

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cup is located on the breast. The HF model (HF918) includes breast shield assemblies, milk collection cups, single and double tubing sets, a bottle set, power adapter, and a pump unit. The non-HF model (918) includes a breast shield connected to a milk bottle. The non-HF model includes breast shield assemblies, bottles, bottle stands, single and double tubing sets, power adapter, and a pump unit.

The Electric Breast Pumps are intended for a single user.

1. Indication for Use:
  The Electric Breast Pump (Models 918, HF918) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump is intended for a single user.
Comparison of Technological Characteristics 8.

ITEM	Subject DeviceElectric Breast Pump (918, HF918)K211024	Predicate DeviceElectric Breast Pump (Models:RH-228, RH-338)K201903
Product Code	HGX	HGX
Class	II	II
Regulation No.	21 CFR 884.5160	21 CFR 884.5160
Indication for Use	The Electric Breast Pump (Models 918,HF918) is a powered breast pump to beused by lactating women to expressand collect milk from their breast. TheElectric Breast Pump is intended for asingle user.	The Electric breast pump is intendedto be used by lactating women toexpress and collect milk from theirbreasts. It is intended for a singleuser.
Patient Population	Breastfeeding women	Breastfeeding women
Anatomical Sites	Breast	Breast
Single User	Yes	Yes
Provided Non-sterile	Yes	Yes
Direct user contact	Yes	Yes
Re-usable	Yes	Yes

Table 1 General Comparison

Table 2 Technological Comparison

ITEM	Subject Device	Predicate Device
	Electric Breast Pump (918,HF918)	Electric Breast Pump (Models:
	K211024	RH-228, RH-338)
		K201903

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Pump Type		Diaphragm	Diaphragm
Pumping Options		Single and Double Pumping	Single Pumping
Visual Indicator		918 & HF918: LED	RH-228: LEDRH-338: LCD
Backflow Protection		Yes	Yes
Suctionstrength	Stimulation mode	918 & HF918: 60-217.5	RH-228:60-150RH-338: 45-165
	Expression mode	918 & HF918: 105-285	RH-228:120-275RH-338: 110-300
	Two-in One mode	918 & HF918: 75-285	N/A
	Dual-frequency mode	918 & HF918: 67.5-277.5	N/A
	Simulation mode	918 & HF918:187.5	N/A
Suction level	Massage mode	N/A	RH-338: 135-255
	Stimulation mode	918 & HF918: 5 levels	RH-228: 5 levelsRH-338: 9 levels
	Expression mode	918 & HF918: 7 levels	RH-228: 4 levelsRH-338: 9 levels
	Two-in One mode	918 & HF918: 7 levels	N/A
	Dual-frequency mode	918 & HF918: 7 levels	N/A
	Simulation mode	918 & HF918: 1 level	N/A
Cycling Speed	Massage mode	N/A	RH-338: 9 levels
	Stimulation mode	918 & HF918: 39-123	RH-228: 58-90RH-338: 115-155
	Expression mode	918&HF918: 24-84	RH-228: 28-52RH-338: 25-52
	Two-in One mode	918 & HF918: 59-123	N/A
	Dual-frequency mode	918 & HF918: 39-85	N/A
	Simulation mode	918 & HF918:14	N/A
	Massage mode	N/A	RH-338: 56-72
Power Source		3.7 V, Lithium ion battery	3.7 V, Lithium ion battery
User Control		On pump body	On pump body

The subject and predicate device have same indications for use statements, and the same intended use. They are both used to express and collect milk from a lactating woman's breast.

The differences between the subject devices and the predicate devices are pumping options, suction levels, suction strength, and cycle speed. These differences do not raise different questions of safety and effectiveness.

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Non-Clinical Testing 9.

Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.

Electrical Safety and Electromagnetic Compatibility

IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment -Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
A IEC 60601-1-11:2010, AMD1:2013, 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 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

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:

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

Software Verification

▲ Software verification in accordance with the FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
Additionally, the following non-clinical tests were conducted:

Suction strength of subject devices was tested. All the test results complied with the design specifications of the subject device throughout the use life.

Backflow testing was conducted to ensure that even if the bottle is over-filled, no liquid will backflow into the tubing, and therefore no liquid can backflow into the pump motor. The test results showed that there was no backflow during the test.

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Cycle speed of subject devices was tested. All the test results complied with the design specifications of the subject devices throughout the use life.

Battery performance testing was conducted to demonstrate that the battery remains functional during its stated use-life.

Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.

1. Conclusion
  The comparison and analysis above demonstrate that the Electric Breast Pump (Models 918, HF918) 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).