(167 days)
Not Found
No
The summary does not mention AI or ML, and the performance testing focuses on hardware, software (leveraged from a predicate device), biocompatibility, sterilization, aging, packaging, vacuum/cycle testing, leak testing, and backflow testing. There is no indication of any learning or adaptive capabilities.
No.
The device functions to express and collect milk, alleviate engorgement, and maintain lactation ability, which are supportive functions for breastfeeding rather than direct treatment or diagnosis of a disease or condition.
No
Explanation: The MilkMate Breast Pump is intended to express and collect milk, alleviate engorgement, and maintain lactation. It is not used to diagnose any medical condition or disease.
No
The device description explicitly states it includes a "multi-user breast pump" which is a hardware component. The performance studies also detail testing of the "Pump hardware and software".
Based on the provided information, the MilkMate Breast Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to express and collect milk from a lactating woman's breast. This is a physical process involving the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a pump and associated collection kits. It does not involve reagents, assays, or any components typically used for in vitro diagnostic testing.
- Performance Studies: The performance studies focus on the mechanical function of the pump, the sterility and integrity of the kits, biocompatibility, and backflow prevention. These are all related to the physical operation and safety of the device for its intended use, not diagnostic accuracy.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like milk) for diagnostic purposes, providing information about a disease or condition, or using the device to make a diagnosis.
IVD devices are used to examine specimens (like blood, urine, tissue, etc.) outside of the body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The MilkMate Breast Pump does not fit this description.
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 (comma separated list FDA assigned to the subject device)
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. Three breast shield sizes are offered (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
Not Found
Intended User / Care Setting
Lactating women; multiple users 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)
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 devices -- Part 5: Tests for in vitro cytotoxicity
- Sensitization per ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- 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.
- 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,
- Both fresh kits and kits that were at the end of the shelf-life,
- 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
- 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.
Key results: 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
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.
1
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
2
Indications for Use
510(k) Number (if known) K223084
Device Name MilkMate Breast Pump
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) | |
|---|---|
| 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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3
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
4
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 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.
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 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, 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
| | Subject Device
MilkMate Breast Pump | Predicate Device
Electric Breast Pump
Model XN/MS-224B
(K201152) |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Device Characteristics | | |
| Product
Name | MilkMate Breast Pump | Electric Breast Pump, Model
XN/MS-224B |
| | Subject Device
MilkMate Breast Pump | Predicate Device
Electric Breast Pump
Model 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 |
| Regulation
No. | 21 C.F.R. § 884.5160 | 21 C.F.R. § 884.5160 |
| Class | Class II | Class II |
| 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 Electric 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 a single
user in a home or hospital
environment. |
| 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. | 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-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
(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 breast
shield
Stimulation:
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 – 105
cycles/minute
6 Levels Expression, 34-54
cycles/min | 3 Levels Stimulation, 70 – 105
cycles/minute
6 Levels Expression, 34-54
cycles/min |
| 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 |
| | Subject Device | Predicate Device |
| | MilkMate Breast Pump | Electric Breast Pump |
| | | Model XN/MS-224B |
| | | (K201152) |
| 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 |
| Software | Yes | Yes |
| Electrical
Protection
Type | Class II and/or internally
powered equipment | Class II and/or internally
powered equipment |
| Degree of
protection
against
electric shock | Type BF applied parts | Type BF applied parts |
| Electrical
Mode of
Operation | Continuous | Continuous |
| | Breast Pump Kit | |
| Components | • 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 | • 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 Ethylene
oxide sterilized | Clean prior to first use. Clean
after every use |
5
6
7
8
9
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.
10
- 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.