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. Five breast shield sizes are offered (21 mm, 27 mm, 27 mm, 30 mm, and 36 mm). The kits are pre-assembled and sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MilkMate Breast Pump, focusing on the substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and study information, based on the input provided:

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

The document does not explicitly state formal "acceptance criteria" for clinical performance in a quantifiable manner (e.g., specific thresholds for milk production increase or user satisfaction ratings). Instead, the performance testing focused on demonstrating that the new breast shield sizes perform comparably to the predicate device in terms of vacuum and cycle settings.

However, based on the non-clinical performance testing summary, here's what can be inferred as performance metrics evaluated:

Acceptance Criteria (Implied)	Reported Device Performance
Vacuum Performance
Equivalent vacuum pressures across new breast shield sizes (21 mm, 24 mm) in both single and double pumping modes.	"Testing covered... The size 21 mm and 24 mm kits... Both single and double pumping... Low, middle, and high vacuum pressures..." Results "demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device."
Equivalent vacuum pressures at low, middle, and high settings.	"Testing covered... Low, middle, and high vacuum pressures..." Results "demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device."
Equivalent vacuum pressures when powered by battery and AC.	"Testing covered... Battery and AC power..." Results "demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device."
Equivalent vacuum pressures in stimulation and expression modes.	"Testing covered... Stimulation and expression modes..." Results "demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device."
Cycle Performance
Equivalent cycle settings across new breast shield sizes (21 mm, 24 mm) in both single and double pumping modes.	"Testing covered... The size 21 mm and 24 mm kits... Both single and double pumping... Low, middle, and high cycle settings..." Results "demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device."
Equivalent cycle settings at low, middle, and high settings.	"Testing covered... Low, middle, and high cycle settings..." Results "demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device."
Equivalent cycle settings when powered by battery and AC.	"Testing covered... Battery and AC power..." Results "demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device."
Equivalent cycle settings in stimulation and expression modes.	"Testing covered... Stimulation and expression modes..." Results "demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device."
Safety and Effectiveness	"The results... demonstrate that the MilkMate Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not provide details on the sample size for the test set or the data provenance. The testing appears to be primarily non-clinical performance testing of the device's physical characteristics (vacuum and cycle behavior) rather than real-world user data. Therefore, concepts like country of origin or retrospective/prospective are not directly applicable in the way they would be for clinical studies involving human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to the type of non-clinical performance testing described. Ground truth in this context would be the objective measurements of vacuum and cycle settings, typically established by engineering standards and calibrated equipment. There is no mention of human experts establishing "ground truth" for these technical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable as the testing described is non-clinical performance testing, not a study evaluating interpretations or conditions that would require adjudication among human reviewers.

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:

This is not applicable. The device is a breast pump, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant.

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

This is not applicable. The device is a physical breast pump, not an algorithm.

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

The "ground truth" for the non-clinical performance testing would be the engineering specifications and objective measurements of vacuum pressure and cycle speed using calibrated instruments. The goal was to confirm that the modified device's performance aligns with these objective specifications and the performance of the predicate device.

8. The sample size for the training set:

This is not applicable. The document describes a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable, as there is no training set for an algorithm.

Summary

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July 12, 2024

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

Re: K241705

Trade/Device Name: MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 11, 2024 Received: June 13, 2024

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 (the 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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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) K241705

Device Name

MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24)

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 - K241705

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

DATE: July 12, 2024

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

PREDICATE DEVICE:

MilkMate Breast Pump (K223084)

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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.

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. Five breast shield sizes are offered (21 mm, 27 mm, 27 mm, 30 mm, and 36 mm). The kits are pre-assembled and sterile.

INDICATION FOR USE:

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 abilitv 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, and the home.

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.

	Modified MilkMate BreastPump	Predicate MilkMate BreastPump (K223084)
General Device Characteristics
ProductName	MilkMate Breast Pump	MilkMate Breast Pump
Manufacturer	Guangdong Horigen Mother &Baby Products Co., Ltd.	Guangdong Horigen Mother &Baby Products Co., Ltd.
USDistributor	MilkMate Products Inc.	MilkMate Products Inc.
Product Code	HGX	HGX
RegulationNo.	21 C.F.R. § 884.5160	21 C.F.R. § 884.5160
Class	Class II	Class II
	Modified MilkMate BreastPump	Predicate MilkMate BreastPump (K223084)
PatientPopulation	Lactating women	Lactating women
Indicationsfor Use	The MilkMate Breast Pump isintended to be used by lactatingwomen to express and collectmilk from their breast, to alleviateengorgement of the breast,maintain the ability of lactation,and provide mother's milk forfuture feedings when separationof mother and baby occurs. It isintended for multiple users inplaces of work, shared spaces,healthcare facilities, hospitals andthe home.	The MilkMate Breast Pump isintended to be used by lactatingwomen to express and collectmilk from their breast, to alleviateengorgement of the breast,maintain the ability of lactation,and provide mother's milk forfuture feedings when separationof mother and baby occurs. It isintended for multiple users inplaces of work, shared spaces,healthcare facilities, hospitals andthe home.
Intended Use	To express and collect breastmilk.	To express and collect breastmilk.
Environmentof Use	Places of work, shared spaces,healthcare facilities, hospitals,and the home.	Places of work, shared spaces,healthcare facilities, hospitals,and the home.
	User Interface
User Control	Buttons to control Vacuum Setting Cycle Speed Setting Mode of Operation	Buttons to control Vacuum Setting Cycle Speed Setting Mode of Operation
	User Mode Alarm Clock Switch/Pause Child Lock Night Light	User Mode Alarm Clock Switch/Pause Child Lock Night Light
	Lithium Battery Power Switch	Lithium Battery Power Switch
	Modified MilkMate BreastPump	Predicate MilkMate BreastPump (K223084)
VisualIndicator	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	• Pump Operating Time
	• Battery Status	• Battery Status
Night Light	LED light with two lightinglevels	LED light with two lightinglevels
Modes ofOperation	Stimulation, Expression	Stimulation, Expression
Single/DoublePumping	Single or Double	Single or Double
Cleaning –Multi-UserPump Unit	The pump body should be wipeddown with a clean paper towel orsoft cloth after each use.	The pump body should be wipeddown with a clean paper towel orsoft 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 (21,24, 27, 30, and 36 mm)Stimulation:	Across all breast shield sizes (27,30, and 36 mm)Stimulation:
	• Single -37.5 to -165 ±30 mmHg	• Single -37.5 to -165 ±30 mmHg
	• Double -15 +15/-30 to-105 ±30 mmHgExpression:	• Double -15 +15/-30 to-90 ±30 mmHgExpression:
	• Single -37.5.5 to -232.5±30 mmHg• Double -15 +15/-30 to-195 ±30 mmHgMaximum: -262.5 mmHg	• Single -37.5.5 to -232.5±30 mmHg• Double -15 +15/-30 to-187.5 ±30 mmHgMaximum: -262.5 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
	Modified MilkMate BreastPump	Predicate MilkMate BreastPump (K223084)
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
Power Supply(Battery)	Rechargeable Lithium Ion Battery11.1V 2000mAh Li-ionCylindrical Battery	Rechargeable Lithium Ion Battery11.1V 2000mAh Li-ionCylindrical Battery
Back FlowProtection	Yes, provided by diaphragmbackflow protector in kit	Yes, provided by diaphragmbackflow protector in kit
Components	Breast Pump Kit Breast shield (21 mm, 24 mm, 27 mm, 30 mm, 36 mm) Breast shield body Backflow protector (diaphragm, top cap and bottom cap) Valve and membrane 200 mL pouch with cap Tubing Tubing connector	Breast Pump Kit Breast shield (27 mm, 30 mm, 36 mm) Breast shield body Backflow protector (diaphragm, top cap and bottom cap) Valve and membrane 200 mL pouch with cap Tubing Tubing connector
Cleanliness	Ethylene oxide sterilized	Ethylene oxide sterilized

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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 levels, cycle speed, battery life, and use-life). The subject device differs from the predicate device in the available sizes of the breast pump 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.

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SUMMARY OF NON-CLINICAL PERFORMANCE TESTING:

There are no differences in the pump hardware and software between the MilkMate Breast Pump and predicate device. The MilkMate Breast Pump was modified to include two new breast pump kit sizes: 21 mm and 24 mm. Other than the breast shield component, all other components of the breast pump kits, the materials, and sterilization are identical to the predicate device.

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

Vacuum and cycle testing were completed to demonstrate the performance of the . MilkMate breast pump and new kits. Testing covered:
- The size 21 mm and 24 mm kits, O
- Both single and double pumping, O
- Low, middle, and high vacuum pressures, O
- o Low, middle, and high cycle settings,
- o Battery and AC power, and
- Stimulation and expression modes o

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).