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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the TT Electric Breast Pump and TT Double Electric Breast Pump. It does not describe an AI/ML powered device, but rather a powered breast pump. Therefore, many of the requested categories for AI/ML device descriptions, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "stand-alone study," "ground truth used," "training set sample size," and "training set ground truth establishment," are not applicable to this document.

However, I can extract information related to the acceptance criteria and performance testing for this non-AI device.

Here's the information extracted from the document, focusing on the acceptance criteria and performance testing:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might find for an AI/ML algorithm's metrics (e.g., sensitivity, specificity thresholds). Instead, it describes performance tests conducted to demonstrate that the device meets its design requirements and performs as intended, and that it is as safe and effective as the predicate device.

The "acceptance criteria" are implied by the successful completion of the listed tests and the comparison to the predicate device's specifications. The "reported device performance" is the successful outcome of these tests.

Acceptance Criteria (Implied)	Reported Device Performance (as stated in the document)
Biocompatibility: Device materials in contact with body fluids/tissue are biocompatible.	Testing (Cytotoxicity, Skin Sensitization, Skin Irritation per ISO 10993) supports the biocompatibility of the device.
Electrical Safety: Device meets general requirements for basic safety and essential performance of medical electrical equipment.	Testing (per AAMI ANSI ES60601-1 and IEC 60601-1-11) was conducted successfully.
Electromagnetic Compatibility (EMC): Device meets requirements for EMC for medical electrical equipment.	Testing (per IEC 60601-1-2) was conducted successfully.
Software Performance: Software functions as intended and meets "moderate level of concern" recommendations.	Software verification and validation testing was conducted at a "moderate level of concern" as recommended in the FDA guidance document and found to be acceptable.
Vacuum Level Verification: Device achieves and maintains specified vacuum levels for each mode/cycle.	Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
Backflow Protection: Liquid does not backflow into the tubing.	Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
Substantial Equivalence: Device is as safe and effective as the predicate device.	The performance testing described above demonstrates that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the performance tests (e.g., how many devices were tested for vacuum levels, backflow, or biocompatibility). It describes the types of tests performed on the device itself.

Data provenance is not mentioned, as these are technical performance tests of the physical device, not typically involving "data provenance" in the clinical data sense. The manufacturer is Wuxi Xinzhongrui Baby Supplies Co., Ltd. in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device, and "ground truth" in the context of expert consensus in radiology, for example, is not relevant here. The ground truth for device performance is based on established engineering and medical device standards (e.g., vacuum pressure ranges, electrical safety standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device requiring expert adjudication of outputs.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device. While the device has "embedded software," its performance evaluation is not framed as an "algorithm only" study in the context of an AI/ML submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for the performance tests (e.g., vacuum levels, electrical safety, biocompatibility) are defined by established international standards (ISO, IEC, AAMI ANSI ES60601-1) and the device's own design specifications compared to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device, so there is no "training set" or "ground truth" established for it in that context.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K202802

Device Name

TT Electric Breast Pump, TT Double Electric Breast Pump

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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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 PumpTT 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.

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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 ElectricBreast Pump,Model:1162	1	4 buttons andLCD display	With battery	Diaphragm
TT ElectricBreast Pump,Model:1183	2	5 buttons andLCD 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

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 PumpK202802Subject Device	Megna Breast PumpsK142479Predicate Device	Comparison
Product Name	TT Electric Breast Pump, TTDouble Electric Breast Pump	Megna Models M5, M7, M10and 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 andTT Double Electric Breast Pumpare intended to express and collectmilk from the breast of a lactatingwoman. This powered breast pumpis intended for a single user and isintended to be used in a homeenvironment.	The powered Megna BreastPumps are intended to express andcollect milk from the breast of alactating woman. The M5 modelis a single pump. The M7, M10,and M12 models are doublepumps with a single pumpingoption. All models are intendedfor single users.	Same
Pump Options	Single or Double	Single or Double	Same
Backflow Protection	Yes	Yes	Same
Suction Modes	Stimulation Mode and ExpressionMode	Stimulation Mode andExpression Mode	Same
Pump Type	Reciprocating Diaphragm	Reciprocating Diaphragm	Same
Transition betweensuction modes	Automatic or Manual	Manual	Same
Adjustable suction levels	Yes	Yes	Same
Vacuum range:Stimulation	1162: -75 to -300 mmHg1183: -75 to -300 mmHg	M5 Single: -120 to -304 mmHgM7 Single & Double: -68 to -300mmHgM10 Single: -60 to -297 mmHgM10 Double: -60 to -300 mmHgM12 Single: -60 to -297 mmHgM12 Double: -64 to -297 mmHg	Different: The differencein specification does notraise different questionsof safety andeffectiveness. Differencein maximum suctionpressure weresubstantiated byperformance testingbelow.
Vacuum range:Expression	1162: -105 to -300 mmHg1183: -105 to -300 mmHg	M5 Single: -120 to -304 mmHgM7 Single & Double: -68 to -300mmHgM10 Single: -60 to -297 mmHgM10 Double: -60 to -300 mmHgM12 Single: -60 to -297 mmHgM12 Double: -64 to -297 mmHg	Different: The differencein specification does notraise different questionsof safety andeffectiveness. Differencein maximum suctionpressure weresubstantiated byperformance testingbelow.
Cycle Speed:Stimulation	1162: 72 to 117 cycles/min1183: 69 to 114 cycles/min	M5: 26 to 80 cycles/minM7: 15 to 68 cycles/minM10: 38 to 139 cycles/minM12: 13 to 48 cycles/min	Different: The differencein specification does notraise different questionsof safety andeffectiveness. Differencein cycle speed weresubstantiated byperformance testingbelow.
Cycle Speed:Expression	1162: 23 to 86 cycles/min1183: 24 to 92 cycles/min	M5: 26 to 80 cycles/minM7: 15 to 68 cycles/minM10: 38 to 139 cycles/minM12: 13 to 48 cycles/min	Different: The differencein specification does notraise different questionsof safety andeffectiveness. Differencein cycle speed weresubstantiated byperformance testing
			below.
Controls	On/Off button:Increase/decrease vacuum button;Switch mode button;(1183 only) Switch betweendouble/single pumping mode;	Manual Controls	Similar: The subject andpredicate have similarcontrols. Differences incontrols do not raisedifferent questions ofsafety and effectiveness.
Indicators	Yes, LCD	Yes	Similar: The subjectdevice has an LCDdisplay. Differences invisual indicators do notraise different questionsof safety andeffectiveness.
Power Supply	In: 100 - 240 VAC 50/60 Hz0.4AMains Out: 5VDC, 1.5ABatt Out: 3.7VDC 2200mAh	M5, M7, and M12: 6V DCAdaptor or 4 1.5V BatteriesM10: 6V DC Adaptor	Different: The subjectdevice has a differentpower supply.Differences in powersupply are substantiatedby ES/EMC testing anddo not raise differentquestions of safety andeffectiveness.
Accessories	Pump bodyMilk collection containerCushionTubeMilk valveDiaphragmMotor unitFlange	Pump BodySealing CoverBottleCylinderNippleMembrane	Different: The subjectdevice has differentpackaged components.Differences in onboardaccessories do not raisedifferent questions ofsafety and effectiveness.

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K202802

Page 3 of 5

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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

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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.

Regulation Number and Section

§ 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).