(251 days)
Not Found
No
The 510(k) summary describes a standard electrically powered breast pump with software control for basic functions like mode switching and suction level adjustment. There is no mention of AI, ML, or any features that would suggest adaptive learning, predictive capabilities, or complex data analysis beyond basic device operation. The performance studies focus on standard engineering and functional tests, not AI/ML performance metrics.
No
A breast pump is a device used to express and collect milk, which is a physiological process, not a therapeutic intervention for a disease or condition. Its purpose is to facilitate breastfeeding, not to treat a medical ailment.
No
The device is a breast pump, not used for diagnosing any medical condition. Its purpose is to express and collect milk.
No
The device description explicitly states it is an "electrically powered" device with physical components like an LED display, soft-touch buttons, a rechargeable battery, a power adapter, a flange, a milk collection container, and a backflow protection membrane. While it is "software controlled," it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Wearable Breast Pump Function: The Wearable Breast Pump's function is to physically express and collect milk from a lactating woman's breast. It does not perform any diagnostic tests on the milk or any other bodily fluid. It's a device for physical collection, not for analyzing samples for diagnostic purposes.
- Intended Use: The intended use clearly states it's for "expressing and collecting milk from their breasts." This is a physical process, not a diagnostic one.
The provided information describes a medical device used for a therapeutic/supportive purpose (milk expression), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Wearable Breast Pump is an electrically powered, software controlled, digital, single user, wearable breast pump for lactating women to express and collect milk from the breast. The subject device is capable of expression and stimulation modes, with nine associated suction levels for each. The vacuum pressure ranges from 80-200 mmHg for stimulation mode and 90-240 mmHg for expression mode. The device is powered by a rechargeable battery or a power adapter.
The device has an LED display, which shows the power button, pumping mode, suction level, timer, and battery charge level. Surrounding the front panel display are soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression modes, and control the vacuum strength.
The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the breast. The milk is collected in a milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
The subject device components are made of the following materials:
·Valve: Silicone
·Breast shield, bottle, suction cap: Polypropylene
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Not Found
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)
Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.
Electrical Safety
- IEC 60601-1:2005+AMD 1:2012+AMD2:2020, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11:2015+AMD1:2020, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in The Home Healthcare Environment
Electromagnetic Compatibility
- IEC 60601-1-2:2014+AMD1:2020, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation
Tests performed on the material which contacts with human for Biocompatibility:
- Cytotoxicity (ISO 10993-5:2009)
- Skin irritation (ISO 10993-23:2021)
- Skin Sensitization (ISO 10993-10:2021)
Software
Software was evaluated as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Performance Testing
- Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
- Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
- Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
- Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
Key results: The results of the performance testing described above demonstrate that the Wearable 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
September 21, 2023
Huizhou LVB Maternal And Infant Supplies Co.Ltd. Rain Yip Registration Engineer Block A 16 Huifengxi 3rd, Pingnan Industry Zone, Zhongkai H-i-tech District Huizhou, Guangdong 516000 China
Re: K230102
Trade/Device Name: Wearable Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: August 17, 2023 Received: August 21, 2023
Dear Rain Yip:
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) K230102
Device Name Wearable Breast Pump
Indications for Use (Describe)
Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.
| 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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3
510(k) summary - K230102
Date Prepared: September 20, 2023
l Submitter
Applicant: HuiZhou LVB Maternal and Infant Supplies Co., Ltd. Address: NO. 114,Xin Xing North Road, Sandong Town, Huicheng District, Huizhou City, Guangdong Province, P.R. China
Contact person: Dongan Zhang Position: Head of Firm Phone: +86-13075210606 Fax:+86-0752-5311318 E-mail: zhda7311@163.com
II Proposed Device
| Device Name: | Wearable Breast Pump |
|---|---|
| (Model: ABP-1508) | |
| Common Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Powered Breast Pump |
| Regulatory Class: | Class II |
| Product code: | HGX (Pump, Breast, Powered) |
III Predicate Devices
| 510(k) Number: | K212180 |
|---|---|
| Trade name: | Wearable Breast Pump (Model S12) |
| Manufacturer : | Shenzhen TPH Technology Co., Ltd. |
The predicate device has not been subject to a design-related recall.
IV Device description
The Wearable Breast Pump is an electrically powered, software controlled, digital, single user, wearable breast pump for lactating women to express and collect milk from the breast. The subject device is capable of expression and stimulation modes, with nine associated suction levels for each. The vacuum pressure ranges from 80-200 mmHg for stimulation mode and 90-240 mmHg for expression mode. The device is powered by a rechargeable battery or a power adapter.
The device has an LED display, which shows the power button, pumping mode, suction level, timer, and battery charge level. Surrounding the front panel display are soft-touch
4
buttons allowing the user to power the device on/off, switch between stimulation and expression modes, and control the vacuum strength.
The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the breast. The milk is collected in a milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
The subject device components are made of the following materials: ·Valve: Silicone ·Breast shield, bottle, suction cap: Polypropylene
V Indication for use
Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.
VI Comparison of technological characteristics with the predicate device
| Item | Subject Device | Predicate
Device
(K212180) | Comparison |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Product name | Wearable Breast
Pump (ABP-1508) | Wearable Breast
Pump (Model S12) | N/A |
| Product code | HGX | HGX | same |
| Regulation No. | 21 CFR 884. 5160 | 21 CFR 884. 5160 | same |
| Class | Class II | Class II | same |
| Indication for use | Wearable Breast
Pump is a powered
breast pump to be
used by lactating
women to express
and collect milk from
their breasts. The
device is intended
for a single user. | The powered
Electric Double
Breast Pumps are
intended to express
and collect milk from
the breast of a
lactating woman.
They are double
pumps with a single
pumping option and
intended for single
user. | same |
| Pumping options | Single | Single | same |
| Item | Subject Device | Predicate
Device
(K212180) | Comparison |
| Cycling control
Mechanism | Microcontroller | Microcontroller | same |
| Suction modes | Stimulation Mode and
Expression Mode | Stimulation Mode and
Expression Mode | same |
| Suction levels | 9 | 9 | same |
| Adjustable suction
levels | Yes | Yes | same |
| Flange size | 21, 24, mm and 27 mm | 24 mm and 27 mm | Different |
| Vacuum
range:
Stimulation | -80 to -200 (±5) mmHg | -40 to -105 (±5)
mmHg | Different: The
difference in
vacuum range
do not raise
different
questions of
safety and
effectiveness. |
| Vacuum
range:
Expression | -90 to -240 (±5) mmHg | -40 to -245 (±5)
mmHg | Different: The
difference in
vacuum range
do not raise
different
questions of
safety and
effectiveness. |
| Cycle
speed:
stimulation | 64 to 108 cycles/minute | 70 to 114
cycles/minute | Different: The
difference in
cycle speed
do not raise
different
questions of
safety and
effectiveness. |
| Cycle
speed:
Expression | 26 to 48 cycles/minute | 23 to 90 cycles/minute | Different: The
difference in
cycle speed
do not raise
different
questions of
safety and
effectiveness. |
| Item | Subject Device | Predicate
Device
(K212180) | Comparison |
| | | | safety and
effectiveness. |
| Power supply | Li-Ion Battery | Li-Ion Battery | same |
| Indicators | Yes, LED | Yes, LED | same |
| Back flow protection | Yes | Yes | same |
| Materials | Valve: Silicone
Breast shield, bottle,
suction cap:
Polypropylene | Milk Container:
Polypropylene
Flange: Silicone
Pump Outer Housing:
Acrylonitrile Butadiene
Styrene (ABS) plastic | Similar |
5
6
The indications for use of the subject and predicate devices are identical and they have the same intended use (i.e., the collection of breast milk from the breasts of lactating women).
The subject and predicate devices have different technological features, including different device design, user interface, vacuum pressure range, cycle speeds, materials, flange sizes, and power source. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.
VII Non-Clinical Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device.
Electrical Safety
- IEC 60601-1:2005+AMD 1:2012+AMD2:2020, Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- . IEC 60601-1-11:2015+AMD1:2020, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in The Home Healthcare Environment
Electromagnetic Compatibility
- IEC 60601-1-2:2014+AMD1:2020, Medical electrical equipment Part 1-2: General .
7
requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation
Per the 2022 FDA guidance document "Use of international Standard ISO 10993-1, Biological evaluation of medical - Part 1: Evaluation and testing within a risk management process," the following tests performed on the material which contacts with human for Biocompatibility:
- Cytotoxicity (ISO 10993-5:2009)
- . Skin irritation (ISO 10993-23:2021)
- . Skin Sensitization (ISO 10993-10:2021)
Software
Software was evaluated as recommended in the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Performance Testing
Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:
- . Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
- . Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
- . Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
- . Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- . Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
IX Conclusion
The results of the performance testing described above demonstrate that the Wearable Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.