(199 days)
Not Found
No
The summary mentions embedded software for control but does not describe any features or functionalities that utilize AI or ML, such as adaptive pumping based on user feedback or milk flow analysis.
No.
The device is intended to express and collect milk from lactating women and does not appear to treat or diagnose a disease or condition.
No
The device is described as a breast pump intended to express and collect milk, not to diagnose any condition.
No
The device description explicitly lists multiple hardware components (flange, pump motor, silicone diaphragm, USB cable, milk collector, bra adjustment buckle, valve, battery, LED display) and describes physical performance testing related to these components (vacuum level, backflow protection, use life, battery performance). While it incorporates embedded software, 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 detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The Wearable Breast Pump (Model S18) is designed to express and collect milk from a lactating woman's breast. It is a mechanical device that physically interacts with the body to extract a substance.
- Lack of Diagnostic Testing: The description does not mention any function related to analyzing the collected milk or performing any diagnostic tests on it. Its sole purpose is the physical collection of milk.
Therefore, based on the provided information, the Wearable Breast Pump (Model S18) falls under the category of a medical device, but specifically one used for physical collection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Wearable Breast Pump (Model S18) 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 (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Wearable Breast Pump (Model S18) is designed for lactating woman to express and collect milk from the breast. It is an electrically powered, software-controlled, digital single user pump. The device consists of the following key components: flange, pump motor, silicone diaphragm, USB cable, milk collector, bra adjustment buckle, and valve. 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.
There are two modes, with multiple suction levels for each mode, available for the device: Expression mode and Stimulation mode. Both modes consist of nine vacuum levels. Expression mode consists of pressures ranging from 120-245 mmHg and cycle speeds of 20-66 cycles/min and stimulation mode consists of ranges from 40-120 mmHg and cycle speeds of 69-92 cycles/min. There is an LED status display shown on the pump body, which displays the working mode and battery indicator.
The device may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two devices at the same time, one on each breast. The pump is provided non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device should not be used while charging.
The device incorporates embedded software which controls all the features of the product.
All milk contacting components of the device are compliant with 21 CFR 177.
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 Performance Testing:
- Biocompatibility: Materials identical to K212180, leveraging information from K212180.
- Electrical Safety and Electromagnetic Compatibility (EMC): Testing according to ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 62133-2:2017, IEC 60601-1-11:2015, and IEC 60601-1-2:2014.
- Software: Evaluated for a moderate level of concern 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 at each mode/cycle demonstrated that the device meets 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 functions 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 (Model S18) 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, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION". The logo is clean and professional, reflecting the organization's role in regulating food and drugs.
July 14, 2023
Shenzhen TPH Technology Co., Ltd. Peter Chen General Manager 5th floor, Lianchuang 2nd technology Park, Bulan Road Nanwan Community, Longgang District Shenzhen, Guangdong 518100 China
Re: K223886
Trade/Device Name: Wearable Breast Pump (Model S18) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 13, 2023 Received: June 13, 2023
Dear Peter Chen:
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) K223886
Device Name Wearable Breast Pump Model S18)
Indications for Use (Describe)
The Wearable Breast Pump (Model S18) 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart G) |
_ | 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 - K223886
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter
Information | Applicant: Shenzhen TPH Technology Co., Ltd.
Contact: Peter Chen
Phone: +86-755-82703212
Address: 5th floor, Building NO.29 East side, Lianchuang 2nd technology Park, Longgang
District, Shenzhen, China. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Date Prepared: | July 13, 2023 |
| 3. Device
Information: | Device Name: Wearable Breast Pump (Model S18)
Common Name: Powered Breast Pump
Regulation Number: 21 CFR 884.5160
Regulation Name: Powered Breast Pump
Product Code: HGX (Powered, Breast, Pump)
Regulatory Class: Class II |
| 4. Predicate Device
Information: | Device Name: Wearable Breast Pump (Model S12)
510(k) Number: K212180
Manufacturer: Shenzhen TPH Technology Co., Ltd.
The predicate device has not been subject to a design-related recall. |
5. Device Description
The Wearable Breast Pump (Model S18) is designed for lactating woman to express and collect milk from the breast. It is an electrically powered, software-controlled, digital single user pump. The device consists of the following key components: flange, pump motor, silicone diaphragm, USB cable, milk collector, bra adjustment buckle, and valve. 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.
There are two modes, with multiple suction levels for each mode, available for the device: Expression mode and Stimulation mode. Both modes consist of nine vacuum levels. Expression mode consists of pressures ranging from 120-245 mmHg and cycle speeds of 20-66 cycles/min and stimulation mode consists of ranges from 40-120 mmHg and cycle speeds of 69-92 cycles/min. There is an LED status display shown on the pump body, which displays the working mode and battery indicator.
The device may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two devices at the same time, one on each breast. The pump is provided non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device should not be used while charging.
The device incorporates embedded software which controls all the features of the product.
All milk contacting components of the device are compliant with 21 CFR 177.
4
6. Indications for Use
The Wearable Breast Pump (Model S18) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
7. Predicate Device Comparison
The table below compares the intended use and technological characteristics of the subject and predicate device.
| | Proposed Device
Wearable Breast Pump
Model S18
K223886 | Predicate Device
Wearable Breast Pump
Model S12
K212180 | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification | Pump, Breast, Powered | Pump, Breast, Powered | Same |
| Regulation | Class II, 21 CFR 884.5160 | Class II, 21 CFR 884.5160 | Same |
| Product code | HGX | HGX | Same |
| Indications for
Use | The Wearable Breast Pump
(Model S18) 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 |
| Single user | YES | YES | Same |
| Single/double
pump | Single | Single | Same |
| Backflow
Protection | YES | YES | Same |
| Cycling/Suction
Control
Mechanism | Microprocessor | Microprocessor | Same |
| Specifications | | | |
| Power Supply | Li-ion battery | Li-ion battery | Same |
| Suction Modes | Stimulation and Expression | Stimulation and Expression | Same |
| Suction Strength
(Stimulation) | 40-120 mmHg | 40-105 mmHg | Different |
| Cycle Speed:
Stimulation | 69 to 92 cycles/minute | 70 to 114 cycles/minute | Different |
| Suction Strength
(Expression) | 120-245 mmHg | 40-245 mmHg | Different |
| Cycle Speed:
Expression | 20 to 66 cycles/minute | 23 to 90 cycles/minute | Different |
| Suction levels | 9 | 9 | Same |
| User interface | | | |
| User control | On-off switch, vacuum
adjustment | On-off switch, vacuum
adjustment | Same |
| Adjustable
suction levels | YES | YES | Same |
| Table 1. Specific Comparison to Predicate | ||
|---|---|---|
5
| Wireless technology | No | No | Same |
|---|---|---|---|
| Component design | Milk collector and flange | Milk collector and flange | Same |
| Milk collector Capacity | 180 ml | 180ml | Same |
| Flange size | 21mm, 24mm, and 27mm | 24mm and 27mm | Different |
| Material | |||
| Milk collector/Linker | Polypropylene | Polypropylene | Same |
| Flange/Valve/Diaphragm | Silicone | Silicone | Same |
| Pump motor/outer housing | ABS | ABS | Same |
The indications for use of the subject and predicate devices are identical; therefore, they have the same intended use (i.e., for collection of breast milk from the breasts of lactating women).
The subject and predicate devices have similar technological features, including pumping options, control mechanism, user interface, backflow protection, and device indicators. However, as shown in the table above, there are technological differences between the subject and predicate devices, including different vacuum and cycle specifications and flange sizes. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.
8. Summary of Non-Clinical Performance Testing
Biocompatibility
The materials of the subject device are identical to K212180 in formulation, processing, and cleaning. Therefore, biocompatibility information from K212180 was leveraged to support the biocompatibility of patient-contacting components of the subject device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Testing was conducted in accordance with ANSI/AAMI ES60601-1:2005 + A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems, and IEC 60601-1-11:2015, Medical electrical equipment - Part l - 11 : General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical systems used in the home healthcare environment.
Testing was conducted in accordance with IEC 60601-1-2:2014, Medical electrical equipment - Part I-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and Tests.
Software
Software was evaluated for a moderate level of concern as recommended in the 2005 FDA guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
6
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 at each mode/cycle demonstrated that the device meets 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 functions 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.
9. Conclusion
The results of the performance testing described above demonstrate that the Wearable Breast Pump (Model S18) is as safe and effective as the predicate device and supports a determination of substantial equivalence.