(337 days)
Not Found
No
The description focuses on the mechanical and electrical components, user interface, and basic software for operation, with no mention of AI or ML capabilities.
No.
The device is intended to express and collect milk from the breast of a lactating woman, which is a supportive function rather than a treatment for a disease or condition.
No
The device is a breast pump, intended to express and collect milk from a lactating woman. Its purpose is not to diagnose any condition.
No
The device description clearly outlines multiple hardware components including a motor unit, pump body, LCD display, air tube connectors, breast milk collection bottles, and a rechargeable battery. While it mentions embedded software, the device is fundamentally a physical breast pump with integrated software, not a standalone software application.
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 provide information about a person's health. These tests are performed outside of the body.
- Device Function: The TT Electric Breast Pump and TT Double Electric Breast Pump are designed to express and collect milk directly from the breast. This is a physical process performed on the body, not a diagnostic test performed on a sample.
- Intended Use: The stated intended use is to "express and collect milk from the breast of a lactating woman." This is a functional purpose, not a diagnostic one.
The device description and performance studies further support that this is a mechanical device for milk expression, not an IVD.
N/A
Intended Use / Indications for Use
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. This powered breast pump is intended for a single user and is intended to be used in a home environment.
Product codes
HGX
Device Description
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. The devices are intended for a single user.
The subject devices are for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile.
The subject devices are electrically powered double (TT Double Electric Breast Pump) and single (TT Electric Breast Pump) breast pumps consisting of the following key components: a motor unit with a press-button user interface, pump body, LCD display, air tube connectors, and breast milk collection bottles. The motor unit operates on embedded software. Software updates by end-users are not supported.
The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a protection membrane physically separates the milkcontacting pathway from the vacuum system.
The motor unit operates on a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation.
All other components of the subject devices are not in contact with the breast.
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
Biocompatibility studies, including Skin Irritation Testing, and Skin Sensitization testing were performed in accordance with the 2016 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.
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) 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 verification and validation testing was conducted at 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."
Other 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.
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
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August 26, 2021
Wuxi Xinzhongrui Baby Supplies Co., Ltd. % Shelley Li Manager Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Jingan District Shanghai, 200071 China
Re: K202802
Trade/Device Name: TT Electric Breast Pump, TT Double Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: August 11, 2021 Received: August 16, 2021
Dear Shelley Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202802
Device Name
TT Electric Breast Pump, TT Double Electric Breast Pump
Indications for Use (Describe)
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. This powered breast pump is intended for a single user and is intended to be used in a home environment.
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 - K202802
1. Submitter Information
| Applicant: | Wuxi Xinzhongrui, Baby Supplies Co., Ltd. |
|---|---|
| Address: | No. 117 Xinhua, Road, Meicun, |
| New Wu District, Wuxi, | |
| Jiangsu, 214000, China. |
2. Correspondent Information
| Contact: | Shelley Li |
|---|---|
| Manager, Regulatory Affairs | |
| Phone: | + 86 (021) 803-17636 |
| Email: | shelley.li@landlink-healthcare.com |
3. Date prepared: August 24, 2021
4. Device Information
| Device Name: | TT Electric Breast Pump
TT Double Electric Breast Pump |
|--------------------|-----------------------------------------------------------|
| 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: | Megna Breast Pumps (Models M5, M7, M10 and M12 |
|---|---|
| 510(k) Number: | K142479 |
| Manufacturer: | Wuxi Xinzhongrui, Baby Supplies Co., Ltd. |
| Product Code: | HGX (Pump, Breast, Powered) |
The predicate device has not been subject to a design-related recall.
6. Device Description
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. The devices are intended for a single user.
The subject devices are for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile.
The subject devices are electrically powered double (TT Double Electric Breast Pump) and single (TT Electric Breast Pump) breast pumps consisting of the following key components: a motor unit with a press-button user interface, pump body, LCD display, air tube connectors, and breast milk collection bottles. The motor unit operates on embedded software. Software updates by end-users are not supported.
The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a protection membrane physically separates the milkcontacting pathway from the vacuum system.
4
The motor unit operates on a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation.
All other components of the subject devices are not in contact with the breast.
Table 1: Subject Device variants
| Trade/Device | Number of | User | Battery | Expression |
|---|---|---|---|---|
| Name | pumps | Interface | kit type | |
| TT Electric | ||||
| Breast Pump, | ||||
| Model:1162 | 1 | 4 buttons and | ||
| LCD display | With battery | Diaphragm | ||
| TT Electric | ||||
| Breast Pump, | ||||
| Model:1183 | 2 | 5 buttons and | ||
| LCD display | With Battery | Diaphragm |
The subject devices consist of the following materials:
- Motor unit: ABS, mABS, HTV Silicone
- · Cushion, tube, milk valve, diaphragm: Silicone
- · Pump body, milk collection container: Polypropylene
- · Flange: Polypropylene, Polybutylene Terephthalate, Silicone
All milk contacting components are compliant with 21 CFR 177.1520 and 21 CFR 177.2600.
7. Indications for Use
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. This powered breast pump is intended for a single user and is intended to be used in a home environment.
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 2: Comparator Table for Subject and Predicate Devices
| | TT Electric Breast Pump
K202802
Subject Device | Megna Breast Pumps
K142479
Predicate Device | Comparison |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | TT Electric Breast Pump, TT
Double Electric Breast Pump | Megna Models M5, M7, M10
and M12 | |
| Product Code | HGX | HGX | Same |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Class | Class II | Class II | Same |
| Patient Population | Lactating Women | Lactating Women | Same |
| Environment of use | Home Environment | Home Environment | Same |
| Indications for Use | The TT Electric Breast Pump and
TT Double Electric Breast Pump
are intended to express and collect
milk from the breast of a lactating
woman. This powered breast pump
is intended for a single user and is
intended to be used in a home
environment. | The powered Megna Breast
Pumps are intended to express and
collect milk from the breast of a
lactating woman. The M5 model
is a single pump. The M7, M10,
and M12 models are double
pumps with a single pumping
option. All models are intended
for single users. | Same |
| Pump Options | Single or Double | Single or Double | Same |
| Backflow Protection | Yes | Yes | Same |
| Suction Modes | Stimulation Mode and Expression
Mode | Stimulation Mode and
Expression Mode | Same |
| Pump Type | Reciprocating Diaphragm | Reciprocating Diaphragm | Same |
| Transition between
suction modes | Automatic or Manual | Manual | Same |
| Adjustable suction levels | Yes | Yes | Same |
| Vacuum range:
Stimulation | 1162: -75 to -300 mmHg
1183: -75 to -300 mmHg | M5 Single: -120 to -304 mmHg
M7 Single & Double: -68 to -300
mmHg
M10 Single: -60 to -297 mmHg
M10 Double: -60 to -300 mmHg
M12 Single: -60 to -297 mmHg
M12 Double: -64 to -297 mmHg | Different: The difference
in specification does not
raise different questions
of safety and
effectiveness. Difference
in maximum suction
pressure were
substantiated by
performance testing
below. |
| Vacuum range:
Expression | 1162: -105 to -300 mmHg
1183: -105 to -300 mmHg | M5 Single: -120 to -304 mmHg
M7 Single & Double: -68 to -300
mmHg
M10 Single: -60 to -297 mmHg
M10 Double: -60 to -300 mmHg
M12 Single: -60 to -297 mmHg
M12 Double: -64 to -297 mmHg | Different: The difference
in specification does not
raise different questions
of safety and
effectiveness. Difference
in maximum suction
pressure were
substantiated by
performance testing
below. |
| Cycle Speed:
Stimulation | 1162: 72 to 117 cycles/min
1183: 69 to 114 cycles/min | M5: 26 to 80 cycles/min
M7: 15 to 68 cycles/min
M10: 38 to 139 cycles/min
M12: 13 to 48 cycles/min | Different: The difference
in specification does not
raise different questions
of safety and
effectiveness. Difference
in cycle speed were
substantiated by
performance testing
below. |
| Cycle Speed:
Expression | 1162: 23 to 86 cycles/min
1183: 24 to 92 cycles/min | M5: 26 to 80 cycles/min
M7: 15 to 68 cycles/min
M10: 38 to 139 cycles/min
M12: 13 to 48 cycles/min | Different: The difference
in specification does not
raise different questions
of safety and
effectiveness. Difference
in cycle speed were
substantiated by
performance testing |
| | | | below. |
| Controls | On/Off button:
Increase/decrease vacuum button;
Switch mode button;
(1183 only) Switch between
double/single pumping mode; | Manual Controls | Similar: The subject and
predicate have similar
controls. Differences in
controls do not raise
different questions of
safety and effectiveness. |
| Indicators | Yes, LCD | Yes | Similar: The subject
device has an LCD
display. Differences in
visual indicators do not
raise different questions
of safety and
effectiveness. |
| Power Supply | In: 100 - 240 VAC 50/60 Hz
0.4A
Mains Out: 5VDC, 1.5A
Batt Out: 3.7VDC 2200mAh | M5, M7, and M12: 6V DC
Adaptor or 4 1.5V Batteries
M10: 6V DC Adaptor | Different: The subject
device has a different
power supply.
Differences in power
supply are substantiated
by ES/EMC testing and
do not raise different
questions of safety and
effectiveness. |
| Accessories | Pump body
Milk collection container
Cushion
Tube
Milk valve
Diaphragm
Motor unit
Flange | Pump Body
Sealing Cover
Bottle
Cylinder
Nipple
Membrane | Different: The subject
device has different
packaged components.
Differences in onboard
accessories do not raise
different questions of
safety and effectiveness. |
5
K202802
Page 3 of 5
6
The indications for use of the subject and predicate device are identical.
The subject and predicate devices have similar technological features, including design, user interface, vacuum pressure range, cycle speeds, and power source. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.
9. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies, including Skin Irritation Testing, and Skin Sensitization testing were performed in accordance with the 2016 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.
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
7
essential performance (IEC 60601-1:2005, MOD) 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 verification and validation testing was conducted at 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."
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. ●
10. Conclusion
The performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence.