The MilkMate 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 multiple users in places of work, shared spaces, healthcare facilities, hospitals, and the home.

Device Description

The MilkMate Breast Pump includes a multi-user breast pump and disposable breast pump kits for the convenience of pumping in the workplace, shared spaces, healthcare facilities, hospitals, or the home environment.

The breast pump provides two modes: stimulation and expression mode. It can be operated using AC power or a built-in rechargeable li-ion cylindrical battery.

The kits are comprised of two each of a breast shield, breast shield body, backflow protector, valve and membrane, standard neck bottle pouch with cap, tubing, and tubing connector. Three breast shield sizes are offered (27 mm, 30 mm, and 36 mm). The kits are pre-assembled and sterile.

AI/ML Overview

The provided document outlines the substantial equivalence determination for the MilkMate Breast Pump (K223084) to a predicate device (Electric Breast Pump, Model XN/MS-2224B, K201152). As such, the acceptance criteria are primarily focused on demonstrating that the new device is as safe and effective as the predicate device, relying heavily on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Conclusion
Biocompatibility	ISO 10993-5:2009 (Cytotoxicity)	Acceptable levels demonstrated.
	ISO 10993-10:2021 (Sensitization)	Acceptable levels demonstrated.
	ISO 10993-23:2021 (Irritation)	Acceptable levels demonstrated.
Sterilization	Sterility Assurance Level (SAL) of 10-6 per ISO 11135:2014, ISO 11737-1:2006, and ISO 11737-2:2019	Ethylene oxide sterilization process for the MilkMate kit was developed and validated to achieve a SAL of 10-6.
EO Residue	Acceptable levels of EO and Ethylene Chlorohydrin (ECH) per ISO 10993-7:2008	Acceptable levels of EO residue and ECH residue demonstrated.
Shelf Life	1-year shelf life, with package integrity maintained after accelerated aging and simulated transport (ASTM F1980:2021)	Accelerated aging tests supported a 1-year shelf life. Package integrity was evaluated and demonstrated acceptability after accelerated aging, preconditioning, and simulated handling/transportation to maintain sterility.
Pump Performance	Vacuum and cycle testing across full range of kit sizes, fresh/end-of-shelf-life kits, single/double pumping, low/mid/high vacuum/cycle settings, battery/AC power, stimulation/expression modes. Performance must align with device specifications and be comparable to predicate where applicable for safety and effectiveness.	Vacuum and cycle testing were completed, covering all specified conditions (kit sizes, kit age, pumping mode, vacuum/cycle settings, power source, operation mode). The results demonstrated alignment with performance specifications and supported the substantial equivalence determination. The document states: "Vacuum and cycle testing were completed to demonstrate the performance of the MilkMate breast pump and kits." And "The results of the performance testing described above demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence." This implies successful demonstration against established internal specifications, and implicitly, comparable performance to the predicate device in relevant aspects of safety and effectiveness.
Leak Testing	Maintain pouch integrity throughout shelf-life per ASTM F2096-11	Leak testing demonstrated that the pouch maintains its integrity throughout the shelf-life.
Backflow Protection	Demonstrate anti-backflow design works as intended with disposable kits when milk collection bottle is full in both stimulation and expression modes, to support multi-user use.	Backflow testing was performed and demonstrated that the breast pump anti-backflow design works as intended with the disposable kits when the milk collection bottle is full in both stimulation and expression modes.

Study Proving Device Meets Acceptance Criteria:

The device's acceptance criteria are primarily met through a series of non-clinical performance tests. These tests are designed to evaluate the safety and effectiveness of the MilkMate Breast Pump, especially given certain technological differences from the predicate device (e.g., suction strength, use of a single-use sterilized kit) and broader intended use (multi-user, various environments). The "SUMMARY OF NON-CLINICAL PERFORMANCE TESTING" section explicitly lists these studies.

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

The document does not specify exact numerical sample sizes for the test sets (e.g., number of kits tested for biocompatibility, number of aging units, number of pumps in performance tests). The studies involve material, sterilization, and mechanical performance testing, not human subjects.

The data provenance is not explicitly stated in terms of country of origin of the data. However, the tests are conducted according to internationally recognized standards (ISO, ASTM), implying standard laboratory conditions. These are retrospective tests on manufactured devices and components.

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

This information is not applicable as the evaluation is based on non-clinical performance testing against established standards and specifications, not on expert interpretation of medical images or patient data to establish a "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation is based on objective, quantifiable non-clinical performance test results against specified criteria in standards (e.g., pass/fail for biocompatibility, specific numerical ranges for vacuum/cycle, sterility assurance level). There is no "adjudication" in the sense of resolving disagreements among human reviewers of qualitative data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases with and without AI assistance. The MilkMate Breast Pump is a mechanical and electrical device for breast milk expression; therefore, an MRMC study is not applicable.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This concept is not applicable in the traditional sense for a breast pump. The device has "software" as indicated in the comparison table, which would control its mechanical functions (vacuum, cycle speed, modes). The performance tests described evaluate the device's functional integrity as a complete system. The "algorithm" itself (i.e., the software's functional logic) is tested as part of the overall pump's performance rather than isolated standalone algorithm performance typical of AI/CADe devices.

7. Type of Ground Truth Used:

The ground truth used in these non-clinical studies is based on:

International Standards: ISO 10993 (biocompatibility, EO residue), ISO 11135, ISO 11737 (sterilization), ASTM F1980 (accelerated aging), ASTM F2096-11 (leak testing).
Device Specifications: Internal design specifications for vacuum strength, cycle speed, battery life, and other functional parameters.
Predicate Device Characteristics: Comparison of technological features and performance parameters to the predicate device to demonstrate substantial equivalence.

8. Sample Size for the Training Set:

This information is not applicable. The MilkMate Breast Pump is a mechanical/electrical device, not a machine learning or AI-driven diagnostic tool that requires a "training set" of data in the common sense for model development.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no "training set" in the context of this device.

Summary

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March 16, 2023

MilkMate Products, Inc. % Adrienne Lenz Principal Medical Device Regulatory Expert Hymann, Phelps & McNamara P.C. 700 Thirteenth Street. N.W.. Suite 1200 Washington, DC 20005

Re: K223084

Trade/Device Name: MilkMate Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 17, 2023 Received: February 17, 2023

Dear Adrienne Lenz:

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,

Monica D. Garcia -S

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) K223084

Device Name MilkMate 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)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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K223084

510(k) Summarv

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: March 16, 2023

SUBMITTER:

MilkMate Products Inc. 41 Purdy Ave Box #1052 Rye, NY 10580

PRIMARY CONTACT PERSON:

Adrienne R. Lenz Principal Medical Device Regulatory Expert Hyman, Phelps, & McNamara, P.C. (202) 737-4292 alenz@hpm.com

SECONDARY CONTACT PERSON:

Patrice Meagher Founder and CEO MilkMate Products Inc. (917) 613-2315 patrice@milkmate.com

DEVICE INFORMATION:

DEVICE/TRADE NAME: MilkMate Breast Pump COMMON/USUAL NAME: Powered breast pump REGULATION NUMBER: 21 CFR 884.5160 REGULATION NAME: Powered breast pump REGULATORY CLASS: II PRODUCT CODE: HGX (Pump, Breast, Powered) REVIEW PANEL: Obstetrics/Gynecology

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PREDICATE DEVICE:

Electric Breast Pump, Model XN/MS-2224B (K201152)

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

DEVICE DESCRIPTION:

The breast pump provides two modes: stimulation and expression mode. It can be operated using AC power or a built-in rechargeable li-ion cylindrical battery.

INDICATION FOR USE:

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

	Subject DeviceMilkMate Breast Pump	Predicate DeviceElectric Breast PumpModel XN/MS-224B(K201152)
General Device Characteristics
ProductName	MilkMate Breast Pump	Electric Breast Pump, ModelXN/MS-224B
	Subject DeviceMilkMate Breast Pump	Predicate DeviceElectric Breast PumpModel XN/MS-224B(K201152)
Manufacturer	Guangdong Horigen Mother &Baby Products Co., Ltd.	Guangdong Horigen Mother &Baby Products Co., Ltd.
US Distributor	MilkMate Products Inc.	Not applicable
Product Code	HGX	HGX
RegulationNo.	21 C.F.R. § 884.5160	21 C.F.R. § 884.5160
Class	Class II	Class II
PatientPopulation	Lactating women	Lactating women
Indicationsfor Use	The MilkMate Breast Pump isintended to be used by lactatingwomen to express and collectmilk from their breast, toalleviate engorgement of thebreast, maintain the ability oflactation, and provide mother'smilk for future feedings whenseparation of mother and babyoccurs. It is intended formultiple users in places of work,shared spaces, healthcarefacilities, hospitals and thehome.	The Electric Breast Pump isintended to be used by lactatingwomen to express and collectmilk from their breast, toalleviate engorgement of thebreast, maintain the ability oflactation, and provide mother'smilk for future feedings whenseparation of mother and babyoccurs. It is intended for a singleuser in a home or hospitalenvironment.
Intended Use	To express and collect breastmilk.	To express and collect breastmilk.
Environmentof Use	Places of work, shared spaces,healthcare facilities, hospitalsand the home.	Hospital, Home
	Subject Device	Predicate Device
	MilkMate Breast Pump	Electric Breast Pump
		Model XN/MS-224B
		(K201152)
	User Interface
User Control	Buttons to control	Buttons to control
	• Vacuum Setting	• Vacuum Setting
	• Cycle Speed Setting	• Cycle Speed Setting
	• Mode of Operation	• Mode of Operation
	• User Mode	• User Mode
	• Alarm Clock	• Alarm Clock
	• Switch/Pause	• Switch/Pause
	• Child Lock	• Child Lock
	Lithium Battery Power Switch• Night Light	Lithium Battery Power Switch• Night Light
Visual Indicator	LED display indicates	LED display indicates
	• Vacuum Setting	• Vacuum Setting
	• Cycle Speed Setting	• Cycle Speed Setting
	• Mode of Operation	• Mode of Operation
	• Pump Operating Time• Battery Status	• Pump Operating Time• Battery Status
Night Light	LED light with two lighting levels	LED light with two lighting levels
Modes of Operation	Stimulation, Expression	Stimulation, Expression
Single/Double	Single or Double	Single or Double
	Subject Device	Predicate Device
	MilkMate Breast Pump	Electric Breast Pump
		Model XN/MS-224B
		(K201152)
Cleaning –Multi-UserPump Unit	The pump body should be wipeddown with a clean paper towelor soft cloth after each use.	The pump body should be wipeddown with a clean paper towelor soft cloth after each use.
Technological Characteristics
Pump Type	Diaphragm	Diaphragm
SuctionLevels	7 Levels Stimulation12 Levels Expression	7 Levels Stimulation12 Levels Expression
SuctionStrength	Across all breast shield sizes(27, 30, and 36 mm)Stimulation:Single -37.5 to -165 ±30 mmHg Double -15 to -90 +15/-30 mmHg Expression: Single -37.5.5 to -232.5 ±30 mmHg Double -15 to -187.5 +15/-30 mmHg Maximum: -262.5 mmHg	With Horigen 25 mm 3D breastshieldStimulation:Single -37.5 to -187.5 ±20 mmHg Double -15 to -105 +15/-20 mmHg Expression: Single -75 to -247.5 ±20 mmHg Double -15 to -225 +15/-20 mmHg Maximum: -267.5 mmHg
Cycle Speed	3 Levels Stimulation, 70 – 105cycles/minute6 Levels Expression, 34-54cycles/min	3 Levels Stimulation, 70 – 105cycles/minute6 Levels Expression, 34-54cycles/min
Power Supply(ConventionalOutlet)	AC/DC wall converterInput 100V - 240V, 50/60HzOutput : 15V, 1.6A	AC/DC wall converterInput 100V - 240V, 50/60HzOutput : 15V, 1.6A
	Subject Device	Predicate Device
	MilkMate Breast Pump	Electric Breast Pump
		Model XN/MS-224B
		(K201152)
Power Supply(Battery)	Rechargeable Lithium IonBattery11.1V 2000mAh Li-ionCylindrical Battery	Rechargeable Lithium IonBattery11.1V 2000mAh Li-ionCylindrical Battery
Back FlowProtection	Yes, provided by diaphragmbackflow protector in kit	Yes, provided by diaphragmbackflow protector in kit
Software	Yes	Yes
ElectricalProtectionType	Class II and/or internallypowered equipment	Class II and/or internallypowered equipment
Degree ofprotectionagainstelectric shock	Type BF applied parts	Type BF applied parts
ElectricalMode ofOperation	Continuous	Continuous
	Breast Pump Kit
Components	• Breast shield (27 mm, 30mm, 36 mm)• Breast shield body• Backflow protector(diaphragm, top cap andbottom cap)• Valve and membrane• 200 mL pouch with cap• Tubing• Tubing connector	• Dust cover• Silicone cushion• Breast shield body• Backflow protector(diaphragm, cap)• 120 ML bottle with cap• Bottle stand• Tubing• Tubing connector• Bottle adaptor• Nipple• Disc collar• Nipple dust cover
Cleanliness	Milk collection kit is Ethyleneoxide sterilized	Clean prior to first use. Cleanafter every use

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The indications for use of the subject and predicate device are similar, with minor differences related to intended use population (single vs. multiple users) and environment of use (home, hospital, workplace, shared spaces, and healthcare facilities vs home, and hospital). The subject device and the predicate device have the same intended use: to express and collect milk from a lactating woman's breast.

The subject and predicate device have similar technological features, including identical pump and pump settings (vacuum settings, cycle speed, battery life, and use-life). The subject device differs from the predicate device in suction strength and the use of a single use ethylene oxide sterilized kit. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness, as these differences can be assessed by the performance testing outlined below.

SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

Pump hardware and software testing were leveraged from K201152. There are no differences in the pump hardware and software between the MilkMate Breast Pump and predicate device.

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

Biocompatibility testing of the sterile kits was performed for endpoints . recommended in the FDA guidance "Use of International Standard ISO- 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
- Cytotoxicity per ISO 10993-5:2009, Biological evaluation of medical O devices -- Part 5: Tests for in vitro cytotoxicity
- Sensitization per ISO 10993-10:2021 Biological evaluation of medical o devices - Part 10: Tests for skin sensitization
- o Irritation per ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
The ethylene oxide sterilization process used for the MilkMate kit was developed . and validated for a sterility assurance level of 106 per ISO11135: 2014, ISO 11737-1: 2006 and ISO11737-2: 2019.
Testing per ISO 10993-7: 2008 was performed on the MilkMate kits to ● demonstrate acceptable levels of EO residue and Ethylene Chlorohydrin (ECH) residue.

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Accelerated aging tests per ASTM-F1980:2021 were performed to support a 1-. year shelf life. At the end of the accelerated aging time, package integrity was evaluated.
After accelerated aging, packaged kits were preconditioned in atmospheric . conditions and subjected to simulated handling and transportation. After preconditioning and simulated transportation and handling, the kits were tested to demonstrate acceptability of the packaging to maintain the sterility of the MilkMate Kits over the shelf-life.
Vacuum and cycle testing were completed to demonstrate the performance of the . MilkMate breast pump and kits. Testing covered:
- The full range of kit sizes, o
- Both fresh kits and kits that were at the end of the shelf-life, o
- Both single and double pumping, O
- Low, middle, and high vacuum pressures, o
- o Low, middle, and high cycle settings,
- Battery and AC power, and o
- Stimulation and expression modes o
Leak testing was completed using methods described in ASTM F2096-11 to ● demonstrate that the pouch maintains its integrity throughout the shelf-life.
To support use by multiple users, backflow testing was performed to demonstrate that the breast pump anti-backflow design works as intended with the disposable kits when the milk collection bottle is full in both stimulation and expression modes.

CONCLUSION:

The results of the performance testing described above demonstrate that the MilkMate 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).