The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breasts, to alleviate engorgement of the breasts, 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 multiple users in a hospital setting. It is also intended for home use by a single user.

Device Description

The Electric Breast Pump is a multi-user electric breast pump designed for lactating women to express and collect milk from the breast. It is intended for use in the hospital and home environments and can also be used by a single user. The device is an electrically powered pump consisting of the following key components: a flange, breast shield body, silicone diaphragm, tubing/tubing connector, pump motor, AC/DC adapter, and milk collector. The Electric Breast Pump contains two models, SMG and GEA. Both models can be operated in single and double pumping modes while connected to AC power and have an onboard rechargeable lithium-ion battery.

The SMG model has an LCD display, and the user can select between stimulation or expression mode. Stimulation mode has 5 vacuum levels and expression mode has 16 vacuum levels. For every vacuum level, the user can independently select among 9 cycle speed levels (for stimulation) and 16 cycle speeds (for expression up to vacuum level 11; higher vacuum levels have less available cycle speeds). The SMG model is wirelessly operable via Bluetooth connection to a smart device.

The GEA model also has an LCD display, and the user can select stimulation or expression mode. Stimulation mode and expression mode have 10 levels. Stimulation speed is set to 70 cycles per minute, whereas expression mode allows for cycling speed between 3 levels.

Both devices operate via an electric negative pressure module that runs discontinuously to generate periodic negative pressure suction and are controlled by a magnetic valve for negative pressure adjustment. Each vacuum pump operates with a DC motor and corresponding DC power supply. Both devices have a 40 min stimulation and expression duration. To prevent milk from flowing into the vacuum, a backflow protection mechanism physically separates the milk-contacting pathway from the vacuum system.

AI/ML Overview

The provided text is an FDA 510(k) summary for an Electric Breast Pump (K212564). It details the device, its intended use, comparison to a predicate device, and non-clinical performance testing.

However, the document does not describe an AI/ML medical device, nor does it contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The document describes the testing performed for a standard medical device (an electric breast pump), primarily focusing on biocompatibility, electrical safety, electromagnetic compatibility, software evaluation (for embedded device software, not AI), and general performance tests like vacuum level verification and battery performance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 6, 2022

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: K212564

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 31, 2022 Received: April 7, 2022

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/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.

{1}------------------------------------------------

Page 2

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 medical devices and radiation-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212564

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) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X 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."

{3}------------------------------------------------

510(k) Summary - K212564

1. Submitter Information

Applicant:	Guangdong Horigen Mother & BabyProducts Co. Ltd.
Address:	No. 18, Pingnan Industrial Zone, MianbeiStreet, Chaoyang District, 515100 ShantouGuangdong, China

2. Correspondent Information

Contact:	Olivia MengRegulatory Affairs Manager
Phone:	+ 86 (754) 836-13668
Email:	hui.meng@osmundacn.com

3. Date prepared: May 5, 2022

4. Device Information

Device Name:	Electric Breast Pump
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:	Spectra 3 Plus Breast Pump
510(k) Number:	K181784
Manufacturer:	Uzinmedicare Co.

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

6. Device Description

{4}------------------------------------------------

The user can record a pumping session, tracking any changes to vacuum levels, cycle speeds, and their duration for up to 2 "pumping programs." The display presents the vacuum level, timer, battery status symbol, Bluetooth symbol, external power connected indicators for programmed pumping sessions, and images reflecting whether the user is in the stimulation or expression phase.

Similarly, the user can record a pumping session, tracking any changes to vacuum levels, cycle speeds, and their duration. The pump can record 1 "pumping program." The display presents the vacuum level, cycle level, timer, battery status symbol, external power connected indicators for programmed pumping sessions, and images reflecting whether the user is in the stimulation or expression phase.

Only the silicone cushion and breast shield body components are in direct contact with the skin and breast tissue. All other components (i.e., motor unit) of the subject device are not in contact with the breast.

The subject device components are made of the following materials:

· Dust cover, Breast Shield Body, Cap, Bottle, Bottle Adapter, Bottle Lid, Disc Collar, Nipple Dust Cover, Bottle Stand: Polypropylene
· Cushion/Flange, diaphragm, nipple, diaphragm: Silicone
· Tubing: Silicone

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

	Electric Breast PumpK212564Subject Device	Spectra 3 Plus BreastPumpK181784Predicate Device	Comparison
Product Name	Electric Breast Pump	Spectra 3 Plus Breast Pump	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 in a Home orHospital Setting.	Lactating Women in a Home or SameHospital Setting.
Indications for Use	The Electric Breast Pump isintended to be used by lactatingwomen to express and collectmilk from their breasts, toalleviate engorgement of thebreasts, maintain the ability oflactation, and provide mother'smilk for future feedings whenseparation of mother and babyoccurs. This electric breast pumpis intended for multiple users ina hospital setting. It is alsointended for home use by asingle user.	The Spectra 3 Plus Breast Pumpis a powered breast pump to beused by lactating women toexpress and collect milk fromtheir breast. The Spectra 3 PlusBreast Pump is intended formultiple users in a hospitalsetting. It is also intended forhome use by a single user.	Same
Pump Options	Single or Double	Single or Double	Same
Cycling controlmechanism	Microcontroller	Microcontroller	Same
Backflow Protection	Yes	Yes	Same
Suction Modes	Stimulation Mode andExpression Mode	Massage Mode and Expression SimilarMode
Suction levels	SMG: 16 Level Expression5 Level StimulationGEA: 10 Level Expression andStimulation	5 level Massage12 levels Expression	Different: The differences insuction levels for each mode do notraise different questions of safetyand effectiveness.
Adjustable suctionlevels	Yes	Yes	Same
Vacuum range:Stimulation	SMG:$45 - 165 (\pm7.5)$ mmHg Single$15 - 98 (\pm7.5)$ mmHg DoubleGEA:$30 - 135 (\pm7.5)$ mmHg Single$15 - 83 (\pm7.5)$ mmHg Double	$50 (\pm 50) - 270 (-50)$ mmHg	Different: The difference inspecification does not raisedifferent questions of safety andeffectiveness. Differences inmaximum suction pressure weresubstantiated by performancetesting below.
Vacuum range:Expression	SMG:$45 - 240 (\pm7.5)$ mmHg Single$15 - 195 (\pm7.5)$ mmHg DoubleGEA:$60 - 240 (\pm7.5)$ mmHg Single$30 - 195 (\pm7.5)$ mmHg Double	$50 (\pm 50) - 270 (-50)$ mmHg	Different: The difference inspecification does not raisedifferent questions of safety andeffectiveness. Differences inmaximum suction pressure weresubstantiated by performancetesting below.
Cycle Speed:Stimulation	SMG:$72 - 104 (\pm5)$ cycles/minGEA:$70 (\pm5)$ cycles/min	$38 - 70$ cycles/minute	Different: The difference inspecification does not raisedifferent questions of safety andeffectiveness. Differences in cyclespeed were substantiated byperformance testing below.
Cycle Speed:Expression	SMG:$40 - 70 (\pm5)$ cycles/minGEA:$24 - 70 (\pm5)$ cycles/min	$38 - 70$ cycle/minute	Different: The difference inspecification does not raisedifferent questions of safety andeffectiveness. Differences in cyclespeed were substantiated byperformance testing below.
Controls	LCD, push buttons	LCD, push buttons	Similar: The subject and predicatehave similar controls. Differences
Power Supply	AC and batterySMG:- AC: 100-240 V AC, 50/60 Hzand an output of 15 V / 1.6 A DC- Battery: 11.1 V 2,000 mAh Li-ionGEA:- AC: 100-240 V AC, 50/60 Hzand an output of 5 V / 2 A- Battery: 3.7 V 2700 mAh Li-ion	AC: 100-240 V AC, 50/60 Hz,600mA and an output of 12 V / 2 A DCBattery: 11.1 V 2,000 mAh Li-ion Polymer	in controls do not raise different questions of safety and effectiveness.Similar: Both devices are operable while connected to AC power and internally via rechargeable battery. On their own, differences in power source specifications do not raise different questions of safety and effectiveness.
Mobile Applicationand Wirelessfunctionality	SMG: Bluetooth connectivityGEA: None	None	Different: The SMG subject device has Bluetooth wireless functionality. Differences in wireless technology do not, on their own, raise different questions of safety and effectiveness.

{5}------------------------------------------------

{6}------------------------------------------------

The indications for use of the subject and predicate device are similar, with only minor differences in wording. The intended use environments for both the subject and predicate devices are the same.

The subject and predicate devices have similar technological features, including device design, user interface, materials, and power source. As noted in the table above, the different technological characteristics of the subject device do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility studies, including irritation, cytotoxicity, and sensitization testing were performed in accordance with the 2020 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" and ISO 10993- 1:2009 as follows:

Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010) ●
Dermal Irritation (ISO 10993-10:2010) ●

The testing supports the biocompatibility of the device. The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.

Electrical Safety

Testing was conducted in accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), IEC 62133-2:2017, 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 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.

{7}------------------------------------------------

Electromagnetic Compatibility

Testing was conducted in accordance with IEC 60601-1-2:2014 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 as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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. .
Cross Contamination testing was conducted to verify the pump could not be contaminated or ● damaged by multiple users.
. 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 subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device 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).