(214 days)
Not Found
No
The summary describes a standard electrically powered breast pump with user-controlled modes and vacuum levels. There is no mention of adaptive algorithms, data analysis for personalized pumping, or any other features indicative of AI/ML. The software mentioned is likely for basic device control and user interface.
Yes
The "Intended Use / Indications for Use" section states: "The Wearable Breast Pump (Model S12) is intended to express milk from lactating women in order to collect milk from their breasts." While a breast pump is not typically considered a therapeutic device in a medical sense, it is used to alleviate a physical condition (milk expression from lactation) and is regulated as a medical device by the FDA ("All milk contacting components are compliant with 21 CFR 174-179"). Thus, it can be broadly classified as therapeutic.
No
The device description indicates its purpose is to "express milk from lactating women in order to collect milk from their breasts." There is no mention of it being used to diagnose any condition or provide diagnostic information.
No
The device description clearly outlines multiple hardware components including a flange, linker, silicone diaphragm, pump motor, USB cable, valve, milk collector, bra adjustment buckle, and a motor unit with a user interface and LED display. While it mentions embedded software, it is not a software-only 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 of extracting a bodily fluid, not a test performed on a sample of the bodily fluid to diagnose or provide information about a medical condition.
- Device Description: The description details a mechanical pump that creates suction to extract milk. It does not describe any components or processes related to analyzing or testing the milk itself.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (like milk) for specific analytes or markers.
- Providing diagnostic information about a disease or condition.
- Using reagents or other substances to perform a test.
- Generating results that are interpreted to inform clinical decisions.
The device is a medical device, specifically a breast pump, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
HGX
Device Description
The Wearable Breast Pump (Model S12), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, USB cable, 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). 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 S12 model is capable of providing vacuum levels from 40-105 mmHg with cycling rates from 75-109 cycles per minute in stimulation mode and vacuum levels from 40-245 mmHg with cycling rates from 28-85 cycles per minute in expression mode. The model S12 Wearable Breast Pump 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, 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 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 (Implied adult or beyond)
Intended User / Care Setting
single user in a 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: Skin Irritation Testing, and Skin Sensitization testing in accordance with 2020 FDA guidance document Use of International Standard ISO 10993-1, and ISO 10993-1:2009. Testing showed user-contacting 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 62133-2:2017, and IEC 60601-1-11:2015.
- 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."
- Other Performance Tests:
- Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
- Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
- Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
- Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
Key results: The performance data demonstrate that the subject device is substantially equivalent to the predicate device.
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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
February 11, 2022
Shenzhen TPH Technology Co., Ltd. Peter Chen General Manager Bulan Road, Nanwan Community, Longgang District Shenzhen, Guangdong 518100 China
Re: K212180
Trade/Device Name: Wearable Breast Pump (Model S12) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: January 10, 2022 Received: January 14, 2022
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,
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) K212180
Device Name Wearable Breast Pump (Model S12)
Indications for Use (Describe)
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.
| 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 - K212180
1. Submitter Information
| Applicant: | Shenzhen TPH Technology Co., Ltd. |
|---|---|
| Address: | 5th Floor, Building No.29 East side, |
| Lianchuang 2th technology park, Bulan | |
| Road, Nanwan Community, Longgang | |
| District, Shenzhen, China |
2. Correspondent Information
| Contact: | Peter Chen |
|---|---|
| General Manager | |
| Phone: | + 86 (755) 827-03212 |
| Email: | peter@tph-tech.com |
3. Date prepared: February 10, 2022
4. Device Information
| Device Name: | Wearable Breast Pump (Model S12) |
|---|---|
| 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: | Willow Wearable Breast Pump |
|---|---|
| 510(k) Number: | K191577 |
| Manufacturer: | Exploramed NC7, Inc. |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Wearable Breast Pump (Model S12), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, USB cable, 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). 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 S12 model is capable of providing vacuum levels from 40-105 mmHg with cycling rates from 75-109 cycles per minute in stimulation mode and vacuum levels from 40-245 mmHg with cycling rates from 28-85 cycles per minute in expression mode. The model S12 Wearable Breast Pump 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, which can be used for storage. To
4
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 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.
7. Indications for Use
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.
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 S12
K212180
Subject Device | Willow Wearable
Breast Pump 2.0
K191577
Predicate Device | Comparison |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Wearable Breast Pump | Willow Wearable 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 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. | The Willow Wearable Breast
Pump 2.0 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 |
| Pump Options | Single | Single or Double | Different: The difference in pump
options do not raise different
questions of safety and
effectiveness. |
| Cycling control
mechanism | Microcontroller | Microcontroller | Same |
| Backflow Protection | Yes | Yes | Same |
| Suction Modes | Stimulation Mode and
Expression Mode | Stimulation Mode and
Expression Mode | Same |
| Suction levels | 9 | 7 | 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 | 21 mm, 24 mm, and 27 mm | Different: The difference in flange
sizes do not raise different
questions of safety and
effectiveness. |
| Vacuum range:
Stimulation | -40 to -105 (±5) mmHg | -60 to -105 (±5) mmHg | Different: The difference in
specification does not raise
different questions of safety and
effectiveness. Differences in
maximum suction pressure were
substantiated by performance
testing below. |
| Vacuum range:
Expression | -40 to -245 (±5) mmHg | -60 to -245 (±5) mmHg | Different: The difference in
specification does not raise
different questions of safety and
effectiveness. Differences in
maximum suction pressure were
substantiated by performance
testing below. |
| Cycle Speed:
Stimulation | 70 to 114 cycles/minute | 90 cycles/minute | Different: The difference in
specification does not raise
different questions of safety and
effectiveness. Differences in cycle
speed were substantiated by
performance testing below. |
| Cycle Speed:
Expression | 23 to 90 cycles/minute | 60 cycle/minute | Different: The difference in
specification does not raise
different questions of safety and
effectiveness. Differences in cycle
speed were substantiated by
performance testing below. |
| Controls | On/Off button;
Mode selection
Increase/decrease vacuum
button; | On/Off button;
Increase/decrease vacuum
button: | 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 | Same |
| Indicators | Yes, LED | Yes | Similar: The subject device has an
LED display. Differences in visual
indicators do not raise different
questions of safety and
effectiveness. |
| Materials | Milk Container: Polypropylene
Flange: Silicone
Pump Outer Housing:
Acrylonitrile Butadiene
Styrene (ABS) plastic | Milk Container: Co-polymer
polypropylene and silicone
Flange: Polypropylene (grade
changed) and silicone
Pump Outer Housing:
Polycarbonate and
Thermoplastic polyurethane | Different: The subject and
predicate devices are comprised of
different materials. Differences in
composition do not raise different
questions of safety and
effectiveness. |
5
The indications for use of the subject and predicate device are identical.
6
The subject and predicate devices have similar technological features, including device design, user interface, 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.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies, including Skin Irritation Testing, and Skin 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" and ISO 10993- 1:2009 as follows:
- Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-10:2010)
- Skin Irritation (ISO 10993-10:2010) ●
The testing supports the biocompatibility of the device. The user-contacting materials 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 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."
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.
7
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.