(424 days)
Not Found
No
The description focuses on basic electrical and mechanical functions, user-controlled modes, and standard performance testing. There is no mention of adaptive learning, pattern recognition, or any other AI/ML characteristics.
Yes
The device is described as a breast pump intended to express milk from lactating women, which aligns with the definition of a therapeutic device as it provides a medical benefit related to the physiological function of lactation.
No
The device's intended use is to express and collect milk from lactating women, which is a functional purpose, not a diagnostic one. It does not analyze or interpret physiological data to identify a medical condition or disease.
No
The device description explicitly lists multiple hardware components (pump, diaphragm, container valve, container bowl, flange, seal ring, joint pipe, USB charging cable, motor unit, LED display, rechargeable battery) and describes their physical function in expressing milk. While it mentions embedded software, the device is fundamentally a physical breast pump with software controlling its operation, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express milk from lactating women in order to collect milk from their breasts." This is a physical process of extracting a bodily fluid, not a diagnostic test performed on a sample of that fluid to gain information about a person's health or condition.
- Device Description: The description details the mechanical components and operation of a pump designed to create suction and collect milk. It does not mention any components or processes related to analyzing or testing the milk itself.
- Lack of Diagnostic Elements: There are no mentions of reagents, assays, analysis of biological samples, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and electrical performance of the pump (vacuum levels, backflow protection, battery life, safety standards), not on the accuracy or reliability of any diagnostic results.
In vitro diagnostics are devices used to examine specimens (like blood, urine, or in this case, potentially milk) outside of the body to provide information for diagnosis, monitoring, or screening. This breast pump's function is purely to collect the milk, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The BASEN™ Wearable Breast Pump (Model: YM-801, YM-805, YM-805, YM-806, YM-808) 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 BASEN™ Wearable Breast Pump is an electrically powered wearable breast pump consisting of the following key components: pump, pump diaphragm, container valve, 5-ounce (150 milliliter) container bowl, flange, seal ring, joint pipe, and USB charging cable. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free 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, massage mode, and expression mode and control the vacuum levels within those modes.
Both stimulation and expression mode consist of 9 vacuum levels. The pump can provide vacuum levels from -40 to -105 mmHg with cycling rates from 70 to 114 cycles per minute in stimulation and massage mode. Expression mode had vacuum levels from -40 to -245 mmHg with cycling rates from 23 to 90 cycles per minute.
The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. 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 collection container bowl. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. The device is provided not sterile.
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 if the motor unit is not in operation.
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 (age not specified beyond this)
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: Meets recommendations of Attachment G of the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 2023).
- Electrical Safety: Conducted in accordance with IEC 60601-1:2005+A1:2012+A2:2020- Part 1: General requirements for basic safety and essential performance, and 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: Conducted in accordance with IEC 60601-1-2:2014+A1:2020 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- Software: Evaluated at a basic documentation level as recommended in the 2023 FDA guidance document "Guidance for the Content of Premarket Submissions for device software function."
- 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 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 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2024
Dongguanshi Yiyingmei Technology Co., Ltd. Chen Jian Quality Manager Room 701, No. 31 Tangxi Street Shatou, Chang'an Town Donguang, Guangdong 523000 CHINA
Re: K231969 Trade/Device Name: BASEN™ Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Received: August 1, 2024
Dear Chen Jian:
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 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"
1
(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 OS 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 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
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
BASEN™ Wearable Breast Pump (YM-801,YM-803,YM-805,YM-806,YM-808)
Indications for Use (Describe)
The BASEN™ Wearable Breast Pump (Model: YM-801, YM-805, YM-805, YM-806, YM-808) 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary — K231969 Dongguanshi Yiyingmei Technology Co., Ltd. Wearable Breast Pump (Model YM-801, YM-803, YM-805, YM-806, YM-808)
Submitter Information 1.
| Applicant | Dongguanshi Yiyingmei Technology Co., Ltd. |
|---|---|
| Address | Room 701, No. 31 Tangxi Street Shatou, Chang'an Town, |
| Dongguan City, 523000 Guangdong Province, China | |
| Contact person | Chen Jian |
| Tel | +86-13612905723 |
| orchard.chan@qq.com | |
| Date Prepared | July 8, 2024 |
2. Subject Device Information
| Proprietary Name | BASEN™ Wearable Breast Pump |
|---|---|
| Common Name | Powered Breast Pump |
| Model | Model: YM-801, YM-803, YM-805, YM-806, YM-808 |
| Regulation Name | Powered Breast Pump |
| Regulation Number | 21 CFR§ 884.5160 |
| Product Code | HGX (Pump, Breast, Powered) |
| Regulation Number | 21 CFR§ 884.5160 |
| Regulatory Class | II |
Predicate Device 3.
| Manufacturer | Shenzhen TPH Technology Co., Ltd. |
|---|---|
| 510(k) Number | K212180 |
| Trade/Device Name | Wearable Breast Pump |
The predicate device has not been subject to a design-related recall.
Indications for Use 4.
The BASEN™ Wearable Breast Pump (Model: YM-801, YM-805, YM-805, YM-806, YM-808) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
5. Device Description
The BASEN™ Wearable Breast Pump is an electrically powered wearable breast pump consisting of the following key components: pump, pump diaphragm, container valve, 5-ounce (150
5
milliliter) container bowl, flange, seal ring, joint pipe, and USB charging cable. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free 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, massage mode, and expression mode and control the vacuum levels within those modes.
Both stimulation and expression mode consist of 9 vacuum levels. The pump can provide vacuum levels from -40 to -105 mmHg with cycling rates from 70 to 114 cycles per minute in stimulation and massage mode. Expression mode had vacuum levels from -40 to -245 mmHg with cycling rates from 23 to 90 cycles per minute.
The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. 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 collection container bowl. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. The device is provided not sterile.
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 if the motor unit is not in operation.
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.
6. Comparison of Intended Use and Technological Characteristics
The table below compares the intended use and technological characteristics of the subject and predicate device.
6
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| 510(K) Number | K231969 | K212180 | / |
| Product Name | BASENT™ Wearable Breast Pump | ||
| (Model: YM-801, YM-803, YM-805, YM-806, YM-808) | Wearable Breast Pump | ||
| (Model S12) | / | ||
| Manufacturer | Dongguanshi Yiyingmei | ||
| Technology Co., Ltd. | Shenzhen TPH Technology | ||
| Co., Ltd. | / | ||
| Product Code | HGX | HGX | / |
| Regulation | |||
| Class | Class II | Class II | Same |
| Regulation | |||
| Number | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Indications for | |||
| Use | The BASENT™ Wearable Breast | ||
| Pump (Model: YM-801, YM-803, YM- 805, YM-806, YM-808) 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 Wearable Breast Pump | ||
| (Model S12) is intended to | |||
| express milk from lactating | |||
| women in order to collect milk | |||
| from their breasts. The device is | |||
| intended for a single user. | Same | ||
| Patient | |||
| Population | Lactating Women | Lactating Women | Same |
| Pump Options | Single | Single | Same |
| Cycling control | |||
| mechanism | Microcontroller | Microcontroller | Same |
| Suction Modes | Stimulation Mode, Massage Mode, | ||
| and Expression Mode | Stimulation Mode and Expression | ||
| Mode | Different | ||
| Suction levels | 9 | 9 | Same |
| Adjustable | |||
| suction levels | Yes | Yes | Same |
| Flange Size | 24 mm and 27 mm | 24 mm and 27 mm | Same |
| Vacuum range | |||
| Stimulation | -40 to -105 (±5) mmHg | -40 to -105 (±5) mmHg | Same |
| Vacuum range | |||
| Expression | -40 to -245 (±5) mmHg | -40 to -245 (±5) mmHg | Same |
| Vacuum range | |||
| Massage | -40 to -105 (±5) mmHg | N/A | Different |
| Cycle Speed | |||
| Stimulation | 70 to 114 cycles/minute | 70 to 114 cycles/minute | Same |
| Cycle Speed | |||
| Expression | 23 to 90 cycles/minute | 23 to 90 cycles/minute | Same |
| Cycle Speed | |||
| Massage | 70 to 114 cycles/minute | N/A | Different |
| Controls | On/Off button; | ||
| Mode selection | |||
| Increase/decrease vacuum | |||
| button; | On/Off button; | ||
| Mode selection | |||
| Increase/decrease vacuum | |||
| button; | Same | ||
| Power Supply | Li-Ion Battery | Li-Ion Battery | Same |
| Indicators | Yes, LED | Yes, LED | Same |
| Materials | -Motor unit: Acrylonitrile | ||
| Butadiene Styrene (ABS) | |||
| plastic | |||
| -Tube, valve, | |||
| diaphragm: Silicone | |||
| -Linker, milk collection | |||
| container: Polypropylene | -Milk Container: Polypropylene | ||
| -Flange: Silicone | |||
| -Pump Outer Housing: | |||
| Acrylonitrile Butadiene | |||
| Styrene (ABS) plastic | Same |
Table 1: Comparator Table for Subject Device and Predicate Device
7
The subject and predicate devices have similar technological features, including device design, overall vacuum pressure range, cycle speeds, materials, and power source. The different technological characteristics of the subject device do not raise different questions of safety and effectiveness.
7. Non-Clinical Performance Testing
Biocompatibility
This device meets the recommendations of Attachment G of the FDA Guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 2023). Therefore, this device is considered biocompatible.
Electrical Safety
Testing was conducted in accordance with IEC 60601-1:2005+A1:2012+A2:2020- Part 1: General
8
requirements for basic safety and essential performance, and 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
Testing was conducted in accordance with IEC 60601-1-2:2014+A1:2020 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 at a basic documentation level as recommended in the 2023 FDA guidance document "Guidance for the Content of Premarket Submissions for device software function."
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.
8. Conclusion
The results of the performance testing described above demonstrate that the BASEN™ Wearable Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.