The BR128 Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.

Device Description

The BR128 is an electrically powered breast pump that uses negative pressure to express milk from the breasts of lactating women. It adopts a Single-Chip Microcomputer to imitate a baby's suckling action and a reciprocating vacuum pump to generate the suction to extract the milk at vacuum levels between 0 and 170mmHg. It is intended for single pumping.

It is designed to mechanically interface with a mother's breast via a massage cushion and withdraw then collect the breast milk. The motor unit of the device is connected to the bottle via a silicone tube. Its suction strength is adjustable via the suction adjustment button on the device, but its cycles per minute are controlled by software and cannot be adjusted. The device can be powered by batteries or the provided mains adapter.

AI/ML Overview

The provided text is a 510(k) Summary for the BR128 Breast Pump, which is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This document is a premarket notification for a medical device submitted to the FDA, asserting substantial equivalence to a legally marketed predicate device.

Based on the provided information, here's a breakdown of the acceptance criteria and the study details:

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

The document does not explicitly state "acceptance criteria" for performance metrics like "Stimulating Velocity" or "Sucking Intensity" that would typically be defined as a required range the device must operate within to be considered safe and effective. Instead, it presents a comparison table of the subject device's specifications against a predicate device. The underlying "acceptance" is based on the device demonstrating performance within a range that is considered safe and effective for breast pumps, primarily by showing substantial equivalence to a predicate device.

Performance Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (BR128 Breast Pump)
Intended Use	Express and collect milk from a lactating woman's breasts; single user.	Express and collect milk from a lactating woman's breasts; single user.
Patient Population	Lactating women	Lactating women
Environment of Use	Home	Home
Pump Style	Reciprocating Vacuum Pump	Reciprocating Vacuum Pump
Adjustable Suction Levels	Yes	Yes
Adjustable Cycle Rates	Yes (Predicate: 30-80 cycles/min)	No
Stimulating Velocity	30-80 cycles/min (Predicate)	100-150 cycles/min
Stimulating Intensity	50-270mmHg (Predicate - single)	0-170mmHg
Sucking Velocity (Cycle Rate)	30-80 cycles/min (Predicate)	13-18 cycles/min
Sucking Intensity	50-270mmHg (Predicate - single)	0-170mmHg
Overflow Protection	Yes (Predicate)	No
Pressure Modulation Control	Microprocessor	Microprocessor
Software	Yes	Yes
Power Source	AC adaptor or 6 AA batteries (Predicate)	AC adaptor or 2 AA Batteries
Cleaning Method for Accessories	Boiling water	Boiling water
Patient Contact Material	Unknown (Predicate)	Silicone, PP, ABS (verified by ISO 10993)
Food Contact Material	Unknown (Predicate)	PP & Silicone (evaluated by 21 CFR food criteria)

The justification for "acceptance" is that "These differences do not raise different questions of safety or effectiveness."

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 focuses on non-clinical performance testing and does not report any clinical tests or studies involving a "test set" of patients or data in the way a diagnostic AI device would. The testing performed is primarily focused on engineering performance, electrical safety, EMC, biocompatibility, and software validation. Therefore, sample sizes for a test set of data or data provenance are not applicable in this context.

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. As noted above, this submission does not involve clinical data or "ground truth" established by experts in the context of diagnostic performance. The validation is against established safety and performance standards, and engineering specifications.

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

Not applicable. There is no "test set" requiring adjudication by experts.

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 device is a breast pump, not a diagnostic device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This device is a mechanical breast pump with software control, not an algorithm being evaluated for standalone performance. Its "performance" is its ability to express milk, which is assessed through engineering tests (pressure, cycle speed, etc.), not through an "algorithm-only" evaluation.

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

For this device, the "ground truth" for proving substantial equivalence relates to:

Compliance with recognized performance standards (e.g., minimum and maximum pressure, cycle speed, sound volume).
Compliance with safety standards (biocompatibility, electrical safety, EMC).
Food and patient contact material assessments against regulatory criteria (FDA 21 CFR and ISO 10993).
Software validation against FDA guidance.

The "ground truth" is therefore regulatory and engineering compliance, rather than a clinical ground truth like pathology or expert consensus on clinical outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set" of data for algorithm development.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 5, 2015

Guangzhou Jinxinbao Electronic Co.,ltd % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, No.21 Building, Kaiyu Garden, Xishan South Road Wenzhou. Zhejiang, 325000 China

Re: K150923 Trade/Device Name: BR128 Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: December 20, 2014 Received: September 8, 2015

Dear Helen Nan.

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. 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 mav 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150923

Device Name BR128 Breast Pump

Indications for Use (Describe)

The BR128 Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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510(k) Summary

(As required by 21 CFR 807.92(a))

1.0 Submitter Information

· Company: Guangzhou Jinxinbao Electronic Co.,Ltd
· Address: No.38 Huanzhen Xi Road, Dagang Town, Panyu, Guangzhou,

Guangdong, 511470, CHINA

・ Phone: 086-20-34938449
・ Fax: 086-20-22865301
· Contact: Jiacheng Guo, General Manager
· Date: November 5, 2015

2.0 Device Information

· Trade/Device Name: BR128 Breast Pump
Image /page/3/Picture/14 description: The image shows the word "Trademark" preceded by a bullet point. The text is written in a clear, serif font. The bullet point is slightly offset to the left of the word "Trademark".

Image /page/3/Picture/15 description: The image features the word "Rycom" in a stylized logo. The "R" is in blue, while the "ycom" portion is in green. A blue line underlines the entire word, and a registered trademark symbol appears to the right of the word.

· Common Name: Powered Breast Pump
· Classification: Device: Pump, Breast, Powered

Regulation Description: Powered breast pump

Review Panel: Obstetrics/Gynecology

Product Code: HGX

Submission Type: 510(K)

Regulation Number: 21 CFR 884.5160

Device Class: II

3.0 Predicate Device Information

Evenflo Advanced Double Electric Breast Pump

submitted by Evenflo Feeding, Inc.

510K Number: K131153

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4.0 Device Description

5.0 Indications for Use

The BR128 Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.

6.0 Comparison with the Predicate Device

Comparison Table of Technological Characteristic with the Predicate Device

Device & Predicate Device(s):	Subject Device:BR128 Breast Pump	Predicate Device:Evenflo AdvancedDouble ElectricBreast Pump
	(K150923)	(K131153)
Intended Use

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Intended Use	An electrically poweredsuction device intendedto express and collectmilk from a lactatingwoman's breasts. Thisis for a single user.	An electrically poweredsuction device intendedto express and collectmilk from a lactatingwoman's breasts. Thisis for a single user.
Patient Population	Lactating women	Lactating women
Environment of Use	Home	Home
Prescription	OTC	OTC
Designation
Single User	Yes	Yes
General Device Characteristics
Pump Style	Reciprocating VacuumPump	Reciprocating VacuumPump
Single/Double	Single	Double/Single
Adjustable SuctionLevels	Yes	Yes
Adjustable Cycle Rates	No	Yes
Stimulating Velocity	100-150 cycles/min	30-80 cycles/min
Stimulating Intensity	0-170mmHg	50-270mmHg (single)
Sucking Velocity(Cycle Rate)	13-18 cycles/min	30-80 cycles/min
Sucking Intensity	0-170mmHg	50-270mmHg (single)
Overflow Protection	No	Yes
Pressure ModulationControl	Microprocessor	Microprocessor
Software	Yes	Yes
Power Source	AC adaptor or 2 AABatteries	AC adaptor or 6 AAbatteries

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Image /page/6/Picture/0 description: The image shows a logo with the letters JXB. The letters are in different colors, with J and X in black and B in blue. There are some pixelated designs on the top right of the letter B. The logo is simple and modern.

Cleaning Method forAccessories	Boiling water	Boiling water
Patient ContactMaterial	Silicone, PP, ABS(have been verified byrelevant ISO 10993standards)	Unknown
Food Contact Material	PP & Silicone(have been evaluatedby relevant food criteriaas set forth in 21 Codeof Federal Regulations)	Unknown

The subject device has the same intended use as the predicate device.

The subject and predicate device have the following technological

characteristics in common:

Both use reciprocating vacuum pump
Both have adjustable suction levels ●
Both are controlled by software .
. Both have the same power source

However, the subject and predicate device have the following differences

in technological characteristics.

Pumping Options (single vs. sing/double) ●
Suction Pressure ●
Cycle Speed ●
Overflow Protection .
Patient Contacting Material

These differences do not raise different questions of safety or effectiveness.

7.0 Discussion of Tests Performed

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7.1 Clinical Tests

Clinical testing was not performed for BR128 Breast Pump as part of the submission.

7.2 Non-Clinical Tests

The subject device was tested/analyzed according to the following standards in order to ensure its safety:

Biocompatibility according to AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro Cytotoxicity (L929 Assay) and AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. (Vaginal Irritation and Guinea Pig Maximization Sensitization)

Electrical Safety according to AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, Mod). (General II (ES/EMC))

Electromagnetic Compatibility according to AAMI / ANSI / IEC

60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (Edition 3). (General II (ES/EMC))

Safety of Food Contact Materials according to FDA 21 CFR 177.2600 and FDA 21 CFR 177.1520

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Software Validation per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

Use Life based on evaluation of device specifications following simulated use testing.

Performance Testing including minimum and maximum pressure testing, cycle speed, sound volume, and low voltage alert testing.

8.0 Conclusion:

The subject device - BR128 Breast Pump is substantially equivalent to the predicate device – Evenflo Advanced Double Electric Breast Pump (K131153).

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).