(145 days)
Not Found
No
The document describes a standard electrically powered breast pump with a user interface for controlling modes and vacuum levels. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typically associated with AI/ML technologies in medical devices. The software is described as embedded with no end-user updates supported, further indicating a lack of dynamic, learning capabilities.
No.
The device is strictly for collecting milk and does not claim any therapeutic function.
No.
The device's intended use is to express milk from lactating women, which is a functional purpose, not a diagnostic one. It does not analyze any physiological data to provide a diagnosis or information about a medical condition.
No
The device description explicitly lists multiple hardware components (flange, linker, silicone diaphragm, pump motor, etc.) and describes physical mechanisms of action (creating a seal, applying suction). While it mentions embedded software, the device is fundamentally a physical breast pump with integrated software for control, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Wearable Breast Pump Function: The Wearable Breast Pump's intended use is to express milk from lactating women. It is a mechanical device that physically collects milk. It does not analyze or test any biological specimen to provide diagnostic information.
- Device Description: The description details the mechanical components and operation of the pump, not any analytical or testing capabilities.
- Performance Studies: The performance studies focus on the physical and electrical safety and functionality of the pump (biocompatibility, electrical safety, EMC, software, vacuum levels, backflow protection, battery performance), not on the analysis of a biological sample.
The Wearable Breast Pump is a medical device, but it falls under a different category than In Vitro Diagnostics. It is a device used for a therapeutic or supportive purpose (collecting breast milk), not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Wearable Breast Pump (Model S10) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Product codes
HGX
Device Description
The Wearable Breast Pump (Model S10), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, type-C USB cable, valve, and milk collector. It is designed to work in the user's bra and has a rechargeable battery so it can be used handsfree without any external power cords. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping). The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Both stimulation and expression mode consist of 9 vacuum levels. The S10 model is capable of providing vacuum levels from 45-112 mmHg with cycling rates from 49-100 cycles per minute in stimulation mode and vacuum levels from 133-225 mmHg with cycling rates from 20-57 cycles per minute in expression mode. The Wearable Breast Pump (Model S10) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.
The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. 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 motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter.
The subject device components are made of the following materials:
- Motor unit: acrylonitrile-butadiene-styrene (ABS) plastic
- · Flange, tube, valve, diaphragm: Silicone
- · Linker, milk collection container: Polypropylene
All milk contacting components are compliant with 21 CFR 174-179.
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
Single user, home environment
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 Performance Testing:
Biocompatibility: Testing in accordance with ISO 10993-1, including Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), and Irritation (ISO 10993-10:2010). Results showed patient-contacting device materials were non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety: Testing in accordance with AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-11:2015, and IEC 62133-2:2017.
Electromagnetic Compatibility: Testing in accordance with IEC 60601-1-2:2014.
Software: 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: Demonstrated that the devices meet mode/cycle specifications at each mode/cycle point.
Backflow protection testing: Verified liquid does not backflow into the device pump.
Use-life testing: Demonstrated that the device maintains its specifications throughout its proposed use-life.
Battery performance testing: Demonstrated that the battery remains functional during its stated battery use-life.
Battery status indicator testing: Demonstrated that the battery status indicator remains functional during its stated battery life.
Battery charging testing: Demonstrated the duration of time needed to fully recharge the battery.
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).
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Image /page/0/Picture/0 description: The image shows 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, 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.
June 27, 2022
Shenzhen Lutejiacheng Technology Co., Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Avenue Shanghai, 200122 China
Re: K220309
Trade/Device Name: Wearable Breast Pump (Model S10) Regulation Number: 21 CFR$ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: May 26, 2022 Received: May 26, 2022
Dear Eva Li:
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.
1
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 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 (OS) 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 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 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,
For 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) K220309
Device Name Wearable Breast Pump (Model S10)
Indications for Use (Describe)
The Wearable Breast Pump (Model S10) is intended to express milk from lactating women in order to 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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510(k) Summary - K220309
1. Submitter Information
| Applicant: | Shenzhen Lutejiacheng Technology Co.,
Ltd. |
|------------|---------------------------------------------------------------------------------|
| Contact: | Johnny Dai |
| Phone: | 0086-755-8486 1362 |
| Email: | yanhe.dai@rootglobal.net |
| Address: | Rm 903 Jiangnan Bldg, No 1 Bantian
Ave.South, Ma'antang,Bantian St. Shenzhen |
2. Correspondent Information
| Contact: | Eva Li |
|---|---|
| Phone: | + 86 (215) 881-7802 |
| Email: | eatereva@hotmail.com |
| Address: | Shanghai SUNGO Management Consulting |
| Co., Ltd. Room 1401, Dongfang Building, | |
| 1500# Century Ave, Shanghai, 200122 CHN |
3. Date prepared: June 24, 2022
4. Device Information
| Device Name: | Wearable Breast Pump (Model S10) |
|---|---|
| Common Name: | Powered Breast Pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Powered Breast Pump |
| Product Code: | HGX (Pump, Breast, Powered) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | Youha electric breast pump |
|---|---|
| 510(k) Number: | K163136 |
| Manufacturer: | Ningbo Youhe Electrical Appliance Technology Co., Ltd. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Wearable Breast Pump (Model S10), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, type-C USB cable, valve, and milk collector. It is designed to work in the user's bra and has a rechargeable battery so it can be used handsfree without any external power cords. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping). The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Both stimulation and expression mode consist of 9 vacuum levels. The S10 model is capable of providing vacuum levels from 45-112 mmHg with cycling rates from 49-100 cycles per minute in stimulation mode and vacuum levels from 133-225 mmHg with cycling rates from 20-57 cycles per minute in expression mode. The Wearable Breast Pump (Model S10) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software updates
4
by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.
The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. 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 motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter.
The subject device components are made of the following materials:
- Motor unit: acrylonitrile-butadiene-styrene (ABS) plastic
- · Flange, tube, valve, diaphragm: Silicone
- · Linker, milk collection container: Polypropylene
All milk contacting components are compliant with 21 CFR 174-179.
7. Indications for Use
The Wearable Breast Pump (Model S10) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
8. 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.
Table 1: Comparator Table for Subject and Predicate Devices
| | Wearable Breast Pump
(Model S10)
K220309
Subject Device | Youha electric breast
pump
K163136
Predicate Device | Comparison |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Wearable Breast Pump (Model
S10) | Youha electric breast pump | N/A |
| Product Code | HGX | HGX | Same |
| Regulation Number | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Regulatory Class | Class II | Class II | Same |
| Patient Population | Lactating Women | Lactating Women | Same |
| Indications for Use | The Wearable Breast Pump
(Model S10) is intended to
express milk from lactating
women in order to collect milk
from their breasts. The device is
intended for a single user. | The Youha electric breast pump
is intended to be used by
lactating women to express and
collect milk from their breasts.
The device is intended for a
single user. | The indications for use statements
for the subject and predicate
devices are not identical, but both
devices have the same intended use
(i.e., express and collect milk from
the breasts of lactating women). |
| Pump Options | Single | Single or Double | Different: The difference in single
and double pumping between the
subject and predicate devices does
not raise different questions of
safety and effectiveness. |
| Cycling control | Microcontroller | Microcontroller | Same |
| mechanism | | | |
| Backflow Protection | Yes | Yes | Same |
| Suction Modes | Stimulation Mode and Expression Mode | Stimulation Mode and Low/High Expression Mode | Different: The differences in available modes do not raise different questions of safety and effectiveness |
| Suction levels | 9 | 6 - 10 depending on model | Different: The differences in suction levels for each mode do not raise different questions of safety and effectiveness |
| Adjustable suction levels | Yes | Yes | Same |
| Flange Size | 24 mm and 27 mm | Not Provided | Different: Differences in flange sizes do not raise different questions of safety and effectiveness. |
| Vacuum range: Stimulation | -45 to -112 (±5) mmHg | -34 to -190 mmHg depending on model | Different: The difference in specification does not raise different questions of safety and effectiveness. |
| Vacuum range: Expression | -133 to -225 (±5) mmHg | Low: -75 to -250 mmHg
High: -120 to -280 mmHg depending on model | Different: The difference in specification does not raise different questions of safety and effectiveness. |
| Cycle Speed: Stimulation | 49 to 100 (±2) cycles/minute | 71 to 113 cycles/minute depending on model | Different: The difference in specification does not raise different questions of safety and effectiveness. |
| Cycle Speed: Expression | 20 to 57 (±2) cycles/minute | Low: 36 to 69 cycles/minute
High: 16 to 57 cycles/minute depending on model | Different: The difference in specification does not raise different questions of safety and effectiveness. |
| Controls | On/Off button;
Mode selection
Increase/decrease vacuum button; | Front panel keypad for controls | Similar: The subject and predicate have similar controls. Differences in controls do not raise different questions of safety and effectiveness. |
| Power Supply | Li-Ion Battery | Li-Ion Battery and AC power | Different: The difference in power source does not raise different questions of safety and effectiveness. |
| Indicators | Yes. LED | Yes. LCD | Similar |
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The indications for use of the subject and predicate device are not identical in wording. However, the intended use for the subject and predicate devices are the same (i.e., express and collect milk from the breasts of lactating women).
The subject and predicate device have different technological features as noted in the table above. These technological differences do not raise different questions of safety or effectiveness.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility testing was conducted in accordance with the 2020 FDA guidance Use of
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International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. " Testing included:
- Cytotoxicity (ISO 10993-5:2009) .
- Sensitization (ISO 10993-10:2010) ●
- Irritation (ISO 10993-10:2010)
The testing supports the biocompatibility of the patient-contacting device materials that were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety
Testing was conducted in accordance with:
- AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- . IEC 60601-1-11:2015 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.
- . IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
Electromagnetic Compatibility
Testing was conducted in accordance with IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
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
Performance testing was conducted to demonstrate pump performance met established specifications in the following areas:
- 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 device pump.
- 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.
- . Battery charging testing to demonstrate the duration of time needed to fully recharge the battery.
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10. Conclusion
The subject and predicate devices have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.