The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for a single user in a home or hospital environment.

Device Description

The Electric Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. This Electric Breast Pump is intended for a single user in a home or hospital environment. The Electric Breast Pump has two models: XN/MS-2224A and XN/MS-2224B. Both models are capable of single and double pumping and have two modes: stimulation and expression mode. Both models can be operated using AC power, a built-in rechargeable li-ion polymer battery, or AA batteries.

AI/ML Overview

This document is a 510(k) Premarket Notification Summary for an Electric Breast Pump, not a study describing the acceptance criteria and performance of an AI/ML medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML, sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models are not applicable to the content provided.

The document focuses on the substantial equivalence of the new Electric Breast Pump to a legally marketed predicate device (Spectra S3 Plus Breast Pump) based on non-clinical performance testing, electrical safety, electromagnetic compatibility, biocompatibility, and software verification.

Here's an analysis of the provided document in the context of device acceptance criteria, but note it's for a physical medical device (breast pump), not an AI/ML algorithm.

Analysis of Acceptance Criteria and Study for the Electric Breast Pump (from the provided document)

Since the document describes a physical medical device (Electric Breast Pump) and not an AI/ML device, the questions regarding AI/ML-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and training data are not directly applicable. However, I can extract the closest parallels and relevant information:

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

The document doesn't present a formal table of acceptance criteria with corresponding performance results in the typical machine learning sense. Instead, it describes various performance tests that were conducted and implied acceptance through successful completion.

Implied Acceptance Criteria and Reported Performance (from Section 7: SUMMARY OF NON-CLINICAL PERFORMANCE TESTING):

Test Category	Implied Acceptance Criteria	Reported Performance
Electrical Safety & EMC	Compliance with relevant IEC standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62133).	Not explicitly detailed in numerical results, but implied that the device met these standards as it supports a determination of substantial equivalence.
Biocompatibility	User-contacting materials must be non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993.	"The user-contacting materials were shown to be non-cytotoxic, non-sensitizing, and non-irritating." (Success)
Software Verification	Compliance with FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	Not explicitly detailed, but implied that software verification and validation were conducted in accordance with the guidance, supporting substantial equivalence.
Vacuum Pressure & Cycle Rate	Functional operation across all settings for each model within acceptable ranges (implicitly comparable to predicate).	"Vacuum pressure and cycle rate testing was conducted at all settings for each device model." (Implied successful performance, as it contributes to substantial equivalence claim). The comparison table (Section 6) shows specific ranges for the subject device (e.g., Stimulation Mode: 70-105 cycles/min, 37.5-187.5 mmHg).
Backflow Prevention	Liquid must not backflow into the tubing/pump.	"Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump." (Success)
Use Life Testing	Maintenance of vacuum level and battery performance over time (implicitly throughout intended lifespan).	"Use life testing of vacuum level and battery performance" was conducted. (Implied successful performance.)
Battery Status Indicator	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." (Success)

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the sample size for each performance test (e.g., how many units were tested for electrical safety, how many materials samples for biocompatibility). The testing appears to be primarily laboratory-based engineering and material testing rather than a clinical trial with human subjects for performance evaluation.
Data Provenance: Not explicitly stated, but the testing would have been conducted by or on behalf of the manufacturer, Guangdong Horigen Mother & Baby Products Co., Ltd., likely in China where the company is based. The data would be retrospective in the sense that it was generated prior to the 510(k) submission.

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

This question is not applicable as there is no "ground truth" in the context of an AI/ML model being established by human experts for this physical device. The "ground truth" for these tests are objective measurements based on engineering standards and physical laws. For instance, the ground truth for electrical safety is whether the device adheres to predefined safety limits as measured by calibrated equipment.

4. Adjudication method for the test set:

Not applicable for a physical device's non-clinical performance testing. Adjudication methods (like 2+1 or 3+1) are common in clinical studies or for establishing ground truth in AI/ML tasks where human interpretation is involved. Here, results are determined by instrumentation and adherence to standards.

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 pertains to AI/ML algorithm evaluation in clinical decision-making. The Electric Breast Pump is a direct-use medical device, not an AI assistance tool.

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

Not applicable. This question refers to AI/ML algorithm performance. The "performance testing" described in the document (vacuum pressure, backflow, etc.) is the device's inherent function, which could be considered "standalone" in a very broad sense but not in the context of an AI algorithm.

7. The type of ground truth used:

For this device, "ground truth" is established through:
- Engineering Standards and Specifications: Metrics like suction strength (mmHg), cycle speed (cycles/min), electrical safety parameters (e.g., leakage current limits), and material properties (cytotoxicity, sensitization).
- Objective Measurement: Performance values are measured using calibrated equipment against defined thresholds or ranges from relevant international standards (e.g., IEC, ISO).
- Functional Demonstrations: For tests like backflow prevention, the "ground truth" is simply the observable fact that liquid does not backflow.

8. The sample size for the training set:

Not applicable. This concept belongs to AI/ML model development. For a physical device, there isn't a "training set" in the computational sense. Development involves design, prototyping, and iterative testing.

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

Not applicable. As above, there's no "training set" for an AI/ML model here. The design and validation of the breast pump are based on established engineering principles, material science, and safety standards.

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 4, 2021

Guangdong Horigen Mother & Baby Products Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China

Re: K201152

Trade/Device Name: Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: March 29, 2021 Received: April 2, 2021

Dear Olivia Meng:

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/cdrl/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.

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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 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/cdrl-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, 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) K201152

Device Name Electric Breast Pump

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

K201152

1. SUBMITTER

Name:	Guangdong Horigen Mother & Baby Products Co., Ltd.
Address:	No. 18, Pingnan Industrial Zone, Mianbei Street, ChaoyangDistrict, 515100 Shantou, Guangdong, China
Phone:	+86-754-83613668
Fax:	+86-754-83843338
Primary Contact Person:	Olivia MengRegulatory Affairs ManagerGuangzhou Osmunda Medical Device Technical Service Co., Ltd.Tel: (+86)-20-6231 6262Fax: (+86) -20-8633 0253
Secondary Contact Person:	Changxin ChenGeneral Manager AssistantGuangdong Horigen Mother & Baby Products Co., Ltd.Tel: (+86)-754-83613668-866Fax: (+86)-754-83843338
Date prepared:	May 3, 2021
2. DEVICE
Device Name/Trade Name:	Electric Breast Pump
Models:	XN/MS-2224A and XN/MS2224B
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
3. PREDICATE DEVICE
510(k) Number:	K181784
Manufacturer:	Uzinmedicare Co.
Device Name:	Spectra S3 Plus Breast PumpThe predicate device has not been subject to a design-relatedrecall.

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DEVICE DESCRIPTION 4.

The Electric Breast Pump has two models: XN/MS-2224A and XN/MS-2224B. Both models are capable of single and double pumping and have two modes: stimulation and expression mode. Both models can be operated using AC power, a built-in rechargeable li-ion polymer battery, or AA batteries.

5. INDICATIONS FOR USE

COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS 6.

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

Specification	Subject Device	Predicate Device
	Electric Breast PumpK201152	Spectra S3 Plus Breast PumpK181784
Indications for Use	The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for a single user in a home or hospital environment.	The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
Patient Population	Lactating women	Lactating women
Use Environment	Hospital and home	Hospital and home
Pump Style	Diaphragm pump	Diaphragm pump
Pumping Option	Single or Double	Single or Double
Adjustable Levels(Stimulation Mode)	Suction StrengthXN/MS-2224A: 7 levelsXN/MS-2224B: 7 levels	12 levels
	Cycle SpeedXN/MS-2224A: 3 levelsXN/MS-2224B: 3 levels	N/A
Adjustable Levels(Expression Mode)	Suction StrengthXN/MS-2224A: 10 levelsXN/MS-2224B: 12 levels	12 levels
	Cycle SpeedXN/MS-2224A: 6 levelsXN/MS-2224B: 6 levels	N/A

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Cycle speed(cycles/min)Stimulation Mode	XN/MS-2224A: 70-105XN/MS-2224B: 70-105	38-70
Suction Strength(mmHg)Stimulation Mode	XN/MS-2224A:Single 37.5-187.5 mmHgDouble 15-105 mmHgXN/MS-2224B:Single 37.5-187.5 mmHgDouble 15-105 mmHg	50 (±50) mmHg to 270 (-50 mmHg)
Cycle speed(cycles/min)Expression Mode	XN/MS-2224A: 34-54XN/MS-2224B: 34-54	38-70
Suction Strength(mmHg)Expression Mode	XN/MS-2224A:Single 75-247.5 mmHgDouble 15-195 mmHgXN/MS-2224B:Single 75-247.5 mmHgDouble 15-225 mmHg	50 (±50) mmHg to 270 (-50 mmHg)
Maximum SuctionStrength (mmHg)	247.5	270
Backflow protection	Yes	Yes
Visual indicator	LED Display	LCD Display
Power source	a. AC/DC adapterb. Rechargeable li-ion battery	a. AC/DC Adapterb. Rechargeable li-ion battery

The subject and predicate device have similar indications for use statements. They both are intended to be used to express and collect milk for the breast of lactating women.

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

The following performance data were provided in support of a substantial equivalence determination:

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

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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 nonacid 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
. 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 non-cytotoxic, non-sensitizing, and non-irritating.

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.
- Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- Use life testing of vacuum level and battery performance
- Battery status indicator testing was conducted to demonstrate that the battery ● status indicator remains functional during its stated battery life.

8. CONCLUSION

The nonclinical performance testing described above demonstrate that the Electric Breast Pump 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).