(214 days)
Not Found
No
The description mentions a "Single-Chip Microcomputer to imitate a baby's suckling action" and software controlling cycles per minute, but there is no mention of AI, ML, or any learning/adaptive capabilities based on data. The functionality appears to be pre-programmed and not based on algorithms that learn or improve over time.
No.
A breast pump is intended to express and collect milk, which is not considered a therapeutic function.
No.
The device's intended use and description clearly state its function as expressing and collecting milk, not diagnosing any condition.
No
The device description explicitly details hardware components such as a reciprocating vacuum pump, motor unit, silicone tube, massage cushion, and a Single-Chip Microcomputer, indicating it is a physical device with integrated software control, not a software-only device.
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 (in vitro).
- BR128 Function: The BR128 Breast Pump is a mechanical device that physically extracts milk from a lactating woman's breast. It does not perform any tests on biological samples to diagnose or monitor a medical condition.
The description clearly states its purpose is to "express and collect milk from a lactating woman's breasts," which is a physical process, not a diagnostic test.
N/A
Intended Use / 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.
Product codes
HGX
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.
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
Intended User / Care Setting
Home
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)
Clinical testing was not performed for BR128 Breast Pump as part of the submission.
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
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
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
1
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
2
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."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows a logo with the letters JXB in a stylized font. The letters are arranged horizontally, with the 'J' and 'X' in black and the 'B' in blue. The 'B' has a pixelated effect on the upper right corner, giving it a digital or tech-related feel. The logo appears to be for a company or organization with the initials JXB.
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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Image /page/4/Picture/1 description: The image shows a logo with the letters JXB. The letters are stylized and connected. The J and X are in black, while the B is in blue. There are some pixelated graphics to the right of the B.
4.0 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.
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 Advanced
Double Electric
Breast Pump |
|-------------------------------|--------------------------------------|-------------------------------------------------------------------------|
| | (K150923) | (K131153) |
| Intended Use | | |
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Image /page/5/Picture/0 description: The image shows a logo with the letters J, X, B, and D. The letters J and X are in black, while the letters B and D are in blue. The letter D has a pixelated design on the upper right side.
| Intended Use | An electrically powered
suction device intended
to express and collect
milk from a lactating
woman's breasts. This
is for a single user. | An electrically powered
suction device intended
to express and collect
milk from a lactating
woman's breasts. This
is 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 Vacuum
Pump | Reciprocating Vacuum
Pump |
| Single/Double | Single | Double/Single |
| Adjustable Suction
Levels | 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 Modulation
Control | Microprocessor | Microprocessor |
| Software | Yes | Yes |
| Power Source | AC adaptor or 2 AA
Batteries | AC adaptor or 6 AA
batteries |
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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 for
| Accessories | Boiling water | Boiling water |
|---|---|---|
| Patient Contact | ||
| Material | Silicone, PP, ABS | |
| (have been verified by | ||
| relevant ISO 10993 | ||
| standards) | Unknown | |
| Food Contact Material | PP & Silicone | |
| (have been evaluated | ||
| by relevant food criteria | ||
| as set forth in 21 Code | ||
| of 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
7
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
8
Image /page/8/Picture/0 description: The image contains a logo with the letters "JXB" in a stylized font. The "J" and "X" are in black, while the "B" is in blue. There is a pixelated design element extending from the top right of the "B", also in blue. The logo appears to be for a company or organization with the initials "JXB".
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).