(177 days)
Not Found
No
The description focuses on standard breast pump functionality, user interface controls, and basic embedded software for motor operation. There is no mention of adaptive algorithms, learning from user data, or any features typically associated with AI/ML.
No.
The device is intended to express and collect milk from lactating women, which is not a therapeutic function.
No
Explanation: The device's intended use is to express milk from lactating women, not to diagnose any medical condition. It is a pump that collects milk.
No
The device description explicitly lists multiple hardware components (flange, linker, silicone diaphragm, pump motor, etc.) and describes their physical function in expressing milk. While it mentions embedded software, it is clearly a hardware device with integrated software, not a software-only medical device.
Based on the provided information, 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 performed on the body to collect a biological sample (breast milk).
- Device Description: The description details a mechanical pump that applies suction to the breast. It does not describe any components or processes that analyze biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples, or any diagnostic purpose. The device's function is purely for collection.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This breast pump does not perform any such analysis.
N/A
Intended Use / Indications for Use
The Wearable Breast Pump (Model S1DW) 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 S1DW) is an electrically powered wearable single or double breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, USB charging cable, silicone tubing, valve, milk collector, and bra adjustment buckle. 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) or two breasts (double 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 S1DW model is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 38-51 cycles per minute in stimulation mode and vacuum levels from 120-245 mmHg with cycling rates from 19-40 cycles per minute in expression mode. The model SIDW Wearable Breast Pump is charged with a 5 V DC USB adaptor and powered by an internal rechargeable lithium-ion polymer battery. 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 device is provided non-sterile.
The breast pump expresses breast milk by creating a seal around the nipple using the flange and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
All other components (i.e., motor unit) of the subject device are not in contact with the breast.
The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged using 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, tubing, 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
Not Found
Intended User / Care Setting
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)
Biocompatibility: Testing performed in accordance with ISO 10993-5:2009, ISO 10993-10:2010. User-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety: Testing conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015.
Electromagnetic Compatibility: Testing conducted in accordance with IEC 60601-1-2:2014.
Software: Evaluated as recommended in the 2005 FDA guidance document.
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): 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). 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.
January 4, 2023
Shenzhen TPH Technology Co.,Ltd. % Carmen Zhang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A. Zhongguan Times Square Liuxian Avenue, Xili Town, Nanshan District Shenzhen. Guangdong 518000 China
Re: K222045
Trade/Device Name: Wearable Breast Pump (Model S1DW) Regulation Number: 21 CFR$ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: November 30, 2022 Received: December 5, 2022
Dear Carmen Zhang:
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.
Michael T. Bailey -S
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
2
Indications for Use
510(k) Number (if known) K222045
Device Name Wearable Breast Pump (Model S1DW)
Indications for Use (Describe)
The Wearable Breast Pump (Model S1DW) 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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3
510(k) Summary - K222045
1. Submitter Information
| Applicant: | Shenzhen TPH Technology Co., Ltd. |
|---|---|
| Contact: | Peter Chen |
| Phone: | + 86 (400) 788-9005 |
| Email: | peter@tph-tech.com |
| Address: | 5th Floor, Building No.29 East side, |
| Lianchuang 2th technology park, Bulan | |
| Road, Nanwan Community, Longgang | |
| District, Shenzhen, China |
2. Correspondent Information
| Contact: | Carmen Zhang
Consultant |
|----------|-------------------------------|
| Firm: | Shenzhen Joyantech Consulting |
| Phone: | + 86 (755) 860-69197 |
| Email: | carmen@cefda.com |
3. Date prepared: January 3, 2023
4. Device Information
| Device Name: | Wearable Breast Pump (Model S1DW |
|---|---|
| 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: | Electric Breast Pump |
|---|---|
| 510(k) Number: | K211755 |
| Manufacturer: | Zhejiang Carebao Co., Ltd. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Wearable Breast Pump (Model S1DW) is an electrically powered wearable single or double breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, USB charging cable, silicone tubing, valve, milk collector, and bra adjustment buckle. 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) or two breasts (double 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 S1DW model is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 38-51 cycles per minute in stimulation mode and vacuum levels from 120-245 mmHg with cycling rates from 19-40 cycles per minute in expression mode. The model SIDW Wearable Breast Pump is charged with a 5 V DC USB adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not
4
supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile.
The breast pump expresses breast milk by creating a seal around the nipple using the flange and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
All other components (i.e., motor unit) of the subject device are not in contact with the breast.
The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged using 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, tubing, 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 S1DW) 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 S1DW)
K222045
Subject Device | Electric Breast Pump
K211755
Predicate Device | Comparison |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Wearable Breast Pump (Model S1DW) | 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 S1DW) 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 electric breast pump is
intended to be used by lactating
women to express and collect
milk from their breasts. It is
intended for a single user. | Same Intended Use |
| Pump Options | Single or Double | Single or Double | Same |
| Cycling control
mechanism | Microcontroller | Microcontroller | Same |
| Backflow Protection | Yes | Yes | Same |
| Mobile Application | No | No | Same |
| Suction Modes | Stimulation Mode and
Expression Mode | Stimulation Mode and
Expression Mode | Same |
| Suction levels | 9 Stimulation, 9 Expression | YD-1130S: 5 stimulation, 9
expression
YD-1132S: 6 stimulation, 9
expression
YD-1168: 5 stimulation, 9
expression | Different- Differences in the
number of suction levels for each
mode do not raise different
questions of safety and
effectiveness (S&E). |
| Adjustable suction
levels | Yes | Yes | Same |
| Vacuum range:
Stimulation | -40 to -120 (±5) mmHg | YD-1130S: 34-190 mmHg
YD-1132S: 34-280 mmHg
YD-1168:
Single pumping: 34-190 mmHg
Double pumping: 89-190 mmHg | Different- The vacuum ranges of
the subject and predicate devices
are not the same, including a lower
maximum vacuum pressure for the
subject device. Differences in
vacuum specifications do not raise
different questions of S&E. |
| Vacuum range:
Expression | -120 to -245 (±5) mmHg | YD-1130S: 67-280 mmHg
YD-1132S: 97-280 mmHg
YD-1168:
Single pumping: 87-280 mmHg
Double pumping: 96-280 mmHg | Different - The vacuum ranges of
the subject and predicate devices
are not the same, including a lower
maximum vacuum pressure for the
subject device. Differences in
vacuum specifications do not raise
different questions of S&E. |
| Cycle Speed:
Stimulation | 38 to 45 (±2) cycles/minute for
double pumping
45 to 51 (±2) cycles/minute for
single pumping | YD-1130S: 40-140 cycles/min
YD-1132S: 10-140 cycles/min
YD-1168:
Single pumping: 52-140
cycles/min
Double pumping: 63-105
cycles/min | Different - The cycle speed ranges
of the subject and predicate devices
are not the same, including lower
maximum cycle speeds for the
subject device. Differences in cycle
speed specifications do not raise
different questions of S&E. |
| Cycle Speed:
Expression | 19 to 34 (±2) cycles/minute for
double pumping
22 to 40 (±2) cycles/minute for
single pumping | YD-1130S: 24-70 cycles/min
YD-1132S: 21-68 cycles/min
YD-1168:
Single pumping: 25-78
cycles/min
Double pumping: 28-83
cycles/min | Different - The cycle speed ranges
of the subject and predicate devices
are not the same, including lower
maximum cycle speeds for the
subject device. Differences in cycle
speed specifications do not raise
different questions of S&E |
| Controls | On/Off button;
Mode selection
Increase/decrease vacuum
button;
Double/single pumping | On/Off button;
Mode selection
Increase/decrease vacuum
button;
Double/Single Pumping | Similar: Both devices have push
button interfaces on their motor
units. Minor differences in visual
indicators do not raise different
questions of safety and
effectiveness. |
| Power Supply | Li-Ion Battery | Li-Ion Battery or AC Power | Different - The subject device is
only battery-operated, while the
predicate device can be operated
by battery or mains power. This
difference does not raise different
questions of S&E. |
| Indicators | Yes, LED | Yes, LED | Same |
5
6
The indications for use of the subject and predicate device are comparable, and 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 device, including vacuum and cycle specifications, power supply, and vacuum levels. The different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies, including irritation, cytotoxicity, and sensitization testing were performed in accordance with the 2020 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", as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) ●
- . Irritation (ISO 10993-10:2010)
The testing supports the biocompatibility of the device materials. The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing.
Electrical Safety
Testing was conducted in accordance with ANSI/AAMI ES60601- 1:2005/A2:2010 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 sealed 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 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 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
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.
7
- . 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.
10. Conclusion
The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.