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)

K241705 · Milkmate Products, Inc. · HGX · Jul 12, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: 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)
• Applicant: Milkmate Products, Inc.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Jul 12, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Indications 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 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 Story

MilkMate Breast Pump is a multi-user powered breast pump for lactating women. Device operates in stimulation and expression modes; powered by AC or internal rechargeable Li-ion battery. User interface includes buttons for vacuum/cycle settings, mode selection, alarm, child lock, and night light; LED display provides status updates. System uses diaphragm-based suction; includes sterile, single-use kits with breast shields (21, 24, 27, 30, 36 mm), backflow protectors, valves, membranes, and pouches. Used in homes, workplaces, and healthcare facilities to express milk; helps alleviate engorgement and maintain lactation during mother-baby separation. Healthcare providers or patients operate the device; output is collected breast milk.

Clinical Evidence

Bench testing only. Performance testing evaluated vacuum and cycle parameters across new 21 mm and 24 mm breast shield sizes, including single/double pumping, various vacuum/cycle settings, power sources (battery/AC), and operation modes (stimulation/expression).

Technological Characteristics

Powered diaphragm pump; 7 stimulation levels, 12 expression levels; 3 stimulation cycle speeds (70-105 cpm), 6 expression cycle speeds (34-54 cpm). Power: 100-240V AC or 11.1V 2000mAh Li-ion battery. Components: sterile, ethylene oxide-sterilized single-use kits. User interface: LED display, button controls.

Indications for Use

Indicated for lactating women to express/collect breast milk, alleviate engorgement, maintain lactation, and provide milk for future feedings during mother-baby separation. Intended for multiple users in workplaces, shared spaces, healthcare facilities, hospitals, and homes.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• MilkMate Breast Pump (K223084)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------|
| | <div> <input type="checkbox"/> </div> |
| | <div> <input type="checkbox"/> </div> |

| | 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. [phone] [e-mail]

# SECONDARY CONTACT PERSON:

Patrice Meagher Founder and CEO MilkMate Products Inc. [phone] [e-mail]

## 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 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.

## 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 Breast<br>Pump | Predicate MilkMate Breast<br>Pump (K223084) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristics | | |
| Product<br>Name | MilkMate Breast Pump | MilkMate Breast Pump |
| Manufacturer | Guangdong Horigen Mother &<br>Baby Products Co., Ltd. | Guangdong Horigen Mother &<br>Baby Products Co., Ltd. |
| US<br>Distributor | MilkMate Products Inc. | MilkMate Products Inc. |
| Product Code | HGX | HGX |
| Regulation<br>No. | 21 C.F.R. § 884.5160 | 21 C.F.R. § 884.5160 |
| Class | Class II | Class II |
| | Modified MilkMate Breast<br>Pump | Predicate MilkMate Breast<br>Pump (K223084) |
| Patient<br>Population | Lactating women | Lactating women |
| Indications<br>for Use | The MilkMate Breast Pump is<br>intended to be used by lactating<br>women to express and collect<br>milk from their breast, to alleviate<br>engorgement of the breast,<br>maintain the ability of lactation,<br>and provide mother's milk for<br>future feedings when separation<br>of mother and baby occurs. It is<br>intended for multiple users in<br>places of work, shared spaces,<br>healthcare facilities, hospitals and<br>the home. | The MilkMate Breast Pump is<br>intended to be used by lactating<br>women to express and collect<br>milk from their breast, to alleviate<br>engorgement of the breast,<br>maintain the ability of lactation,<br>and provide mother's milk for<br>future feedings when separation<br>of mother and baby occurs. It is<br>intended for multiple users in<br>places of work, shared spaces,<br>healthcare facilities, hospitals and<br>the home. |
| Intended Use | To express and collect breast<br>milk. | To express and collect breast<br>milk. |
| Environment<br>of Use | Places of work, shared spaces,<br>healthcare facilities, hospitals,<br>and the home. | Places of work, shared spaces,<br>healthcare facilities, hospitals,<br>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 Breast<br>Pump | Predicate MilkMate Breast<br>Pump (K223084) |
| Visual<br>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 | • Pump Operating Time |
| | • Battery Status | • Battery Status |
| Night Light | LED light with two lighting<br>levels | LED light with two lighting<br>levels |
| Modes of<br>Operation | Stimulation, Expression | Stimulation, Expression |
| Single/Double<br>Pumping | Single or Double | Single or Double |
| Cleaning –<br>Multi-User<br>Pump Unit | The pump body should be wiped<br>down with a clean paper towel or<br>soft cloth after each use. | The pump body should be wiped<br>down with a clean paper towel or<br>soft cloth after each use. |
| | Technological Characteristics | |
| Pump Type | Diaphragm | Diaphragm |
| Suction<br>Levels | 7 Levels Stimulation<br>12 Levels Expression | 7 Levels Stimulation<br>12 Levels Expression |
| Suction<br>Strength | Across all breast shield sizes (21,<br>24, 27, 30, and 36 mm)<br>Stimulation: | Across all breast shield sizes (27,<br>30, and 36 mm)<br>Stimulation: |
| | • Single -37.5 to -165 ±30 mmHg | • Single -37.5 to -165 ±30 mmHg |
| | • Double -15 +15/-30 to<br>-105 ±30 mmHg<br>Expression: | • Double -15 +15/-30 to<br>-90 ±30 mmHg<br>Expression: |
| | • Single -37.5.5 to -232.5<br>±30 mmHg<br>• Double -15 +15/-30 to<br>-195 ±30 mmHg<br>Maximum: -262.5 mmHg | • Single -37.5.5 to -232.5<br>±30 mmHg<br>• Double -15 +15/-30 to<br>-187.5 ±30 mmHg<br>Maximum: -262.5 mmHg |
| Cycle Speed | 3 Levels Stimulation, 70 – 105<br>cycles/minute<br>6 Levels Expression, 34-54<br>cycles/min | 3 Levels Stimulation, 70 – 105<br>cycles/minute<br>6 Levels Expression, 34-54<br>cycles/min |
| | Modified MilkMate Breast<br>Pump | Predicate MilkMate Breast<br>Pump (K223084) |
| Power Supply<br>(Conventional<br>Outlet) | AC/DC wall converter<br>Input: 100V – 240V, 50/60Hz<br>Output: 15V, 1.6A | AC/DC wall converter<br>Input: 100V - 240V, 50/60Hz<br>Output: 15V, 1.6A |
| Power Supply<br>(Battery) | Rechargeable Lithium Ion Battery<br>11.1V 2000mAh Li-ion<br>Cylindrical Battery | Rechargeable Lithium Ion Battery<br>11.1V 2000mAh Li-ion<br>Cylindrical Battery |
| Back Flow<br>Protection | Yes, provided by diaphragm<br>backflow protector in kit | Yes, provided by diaphragm<br>backflow 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.