(29 days)
No
The document describes a standard breast pump with different modes and power options. There is no mention of AI, ML, image processing, or any data-driven features that would suggest the use of these technologies. The performance studies focus on vacuum and cycle parameters, not algorithmic performance.
Yes.
The device is intended to alleviate engorgement of the breast and maintain the ability of lactation, which are therapeutic claims.
No
The device is a breast pump, used to express and collect milk. Its intended use and description do not mention any diagnostic capabilities.
No
The device description explicitly states that the MilkMate Breast Pump includes hardware components such as a multi-user breast pump, a built-in rechargeable battery, and disposable breast pump kits with various physical parts.
No, the MilkMate Breast Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- MilkMate Function: The MilkMate Breast Pump is a mechanical device used to physically express and collect breast milk directly from the breast. It does not analyze any biological specimens to provide diagnostic information.
The description clearly states its purpose is for expressing and collecting milk, alleviating engorgement, maintaining lactation, and providing milk for feeding. These are all physical and functional actions related to lactation, not diagnostic testing.
N/A
Intended Use / 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.
Product codes
HGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Lactating women in places of work, shared spaces, healthcare facilities, hospitals, and the home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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,
- Both single and double pumping,
- Low, middle, and high vacuum pressures,
- Low, middle, and high cycle settings,
- Battery and AC power, and
- Stimulation and expression modes
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
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
1
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
2
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
3
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) | |
|---|---|
| | 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 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
Pump | Predicate MilkMate Breast
Pump (K223084) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristics | | |
| Product
Name | MilkMate Breast Pump | MilkMate Breast Pump |
| Manufacturer | Guangdong Horigen Mother &
Baby Products Co., Ltd. | Guangdong Horigen Mother &
Baby Products Co., Ltd. |
| US
Distributor | MilkMate Products Inc. | MilkMate Products Inc. |
| Product Code | HGX | HGX |
| Regulation
No. | 21 C.F.R. § 884.5160 | 21 C.F.R. § 884.5160 |
| Class | Class II | Class II |
| | Modified MilkMate Breast
Pump | Predicate MilkMate Breast
Pump (K223084) |
| Patient
Population | Lactating women | Lactating women |
| 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. | 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. |
| Intended Use | To express and collect breast
milk. | To express and collect breast
milk. |
| Environment
of 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 Breast
Pump | Predicate MilkMate Breast
Pump (K223084) |
| 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 | • Pump Operating Time |
| | • Battery Status | • 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
Pumping | Single or Double | Single or Double |
| Cleaning –
Multi-User
Pump Unit | The pump body should be wiped
down with a clean paper towel or
soft cloth after each use. | The pump body should be wiped
down with a clean paper towel or
soft cloth after each use. |
| | Technological Characteristics | |
| Pump Type | Diaphragm | Diaphragm |
| Suction
Levels | 7 Levels Stimulation
12 Levels Expression | 7 Levels Stimulation
12 Levels Expression |
| Suction
Strength | 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 mmHg
Expression: | • Double -15 +15/-30 to
-90 ±30 mmHg
Expression: |
| | • Single -37.5.5 to -232.5
±30 mmHg
• Double -15 +15/-30 to
-195 ±30 mmHg
Maximum: -262.5 mmHg | • Single -37.5.5 to -232.5
±30 mmHg
• Double -15 +15/-30 to
-187.5 ±30 mmHg
Maximum: -262.5 mmHg |
| Cycle Speed | 3 Levels Stimulation, 70 – 105
cycles/minute
6 Levels Expression, 34-54
cycles/min | 3 Levels Stimulation, 70 – 105
cycles/minute
6 Levels Expression, 34-54
cycles/min |
| | Modified MilkMate Breast
Pump | Predicate MilkMate Breast
Pump (K223084) |
| Power Supply
(Conventional
Outlet) | AC/DC wall converter
Input: 100V – 240V, 50/60Hz
Output: 15V, 1.6A | AC/DC wall converter
Input: 100V - 240V, 50/60Hz
Output: 15V, 1.6A |
| Power Supply
(Battery) | Rechargeable Lithium Ion Battery
11.1V 2000mAh Li-ion
Cylindrical Battery | Rechargeable Lithium Ion Battery
11.1V 2000mAh Li-ion
Cylindrical Battery |
| Back Flow
Protection | Yes, provided by diaphragm
backflow protector in kit | Yes, provided by diaphragm
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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7
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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.
9
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.