(197 days)
Not Found
No
The description focuses on standard software control for different modes and suction levels, with no mention of adaptive learning, pattern recognition, or other AI/ML characteristics. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is intended to express and collect milk from a lactating woman, which is not a therapeutic purpose but a supportive function.
No
An electric breast pump is intended to express and collect milk, not to diagnose a condition or disease.
No
The device description explicitly states it is an "electrically powered" pump with a "vacuum pump" and physical components like a "massage cushion" and "milk bottle." While it has embedded software, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breast of a lactating woman." This is a physical process involving the body directly, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a mechanical pump that applies suction to the breast. It does not involve any reagents, test strips, or analysis of biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose any condition, measure any biomarkers, or provide any information about a patient's health status based on the milk collected.
IVDs are typically used to test blood, urine, tissue, or other bodily fluids to detect diseases, conditions, or measure levels of substances. This breast pump's function is purely mechanical and related to milk expression.
N/A
Intended Use / Indications for Use
The Electric Breast Pumps are intended to express and collect milk from the breast of a lactating woman.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Electric Breast Pump BLA8015-02 is designed and manufactured to express and collect milk from a lactating woman's breast. The subject device is electrically powered, software-controlled, digital single-user pumps.
The pump is available in 4 different modes, which are massage mode, continuous express mode, frequency conversion mode and normal express mode. The different modes can be distinguished by different keys displayed on the LCD. There are 6 expression levels for massage mode and continuous expression mode, and 9 expression levels for frequency conversion mode and normal express mode. The suction strengths are different for different working modes. The suction strength can be adjusted within 20~240mmHg by the user. When powered, the subject device starts with massage mode at level 1. The mode switch and level adjustment can be achieved by mode keys.
A suction cycle consists of an inhale process and an exhaust process. When the breast pump is powered on, the vacuum pump exhausts the air inside the cavity. When the suction strength reaches the setting value, the vacuum pump stops working and the expressed milk opens the valve and then flows into the bottle due to pressure difference.
The pump is provided in non-sterile and can be re-used by a single user. The device has embedded software and the level of concern for the software is minor. The device is powered by Li-ion battery.
The patient contact component and milk contact component are massage cushion and milk bottle. The contact duration and contact level is limited skin contact. The massage cushion and milk bottle are respectively made of polypropylene and silicone gel. The materials meet the requirements of FDA regulations concerning food contact.
The device can be used in both hospital and home environment.
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
hospital and 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 tests were conducted to verify that the proposed device met all design specifications and that the subject device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, IEC 60601-1-11:2010, IEC 60601-1-2:2014, ISO 10993-5:2009, ISO 10993-10:2010. The software was verified and validated. Vacuum pressure of proposed devices was tested and complied with design specifications. Backflow testing was conducted to ensure no liquid backflow into the tubing or pump motor, and test results showed no backflow.
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 16, 2020
Ningbo Huiyoo Baby Products Co. Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, 200120 CHINA
Re: K191802
Trade/Device Name: Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: December 19, 2019 Received: December 23, 2019
Dear Diana Hong:
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-regulatory-information/postmarketing-safety-reportingcombination-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 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 Sharon M. Andrews 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191802
Device Name Electric Breast Pump
Indications for Use (Describe)
The Electric Breast Pumps are intended to express and collect milk from the breast of a lactating woman.
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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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K191802
-
- Sponsor Identification
Ningbo Huiyoo Baby Products Co. Ltd. 523# Cizhang Road, Zhangqi Industrial Area, Cixi, 315313, Zhejiang, China
- Sponsor Identification
Contact Person: Xiaoping Liu Position: Electrical Engineer Tel: +86-0574-63679665 Email: liuxiaoping@foxmail.com
-
- Date of Preparation: January 15, 2020
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
-
- Identification of Proposed Device
Trade Name: Electric Breast Pump; Common Name: Breast Pump Models: BLA8015-02
- Identification of Proposed Device
Regulatory Information Classification Name: Pump, Breast, Powered; Classification: II Product Code: HGX; Regulation Number: 21 CFR 884.5160; Review Panel: Obstetrics/Gynecology;
-
- Identification of Predicate Device
510(k) Number: K151284 Product Name: Electric Double Breast Pumps Manufacturer: Wuxi Xinzhongrui Baby Supplies Co., Ltd.
- Identification of Predicate Device
The predicate device has not been subject to a design-related recall.
б. Device Description
The Electric Breast Pump BLA8015-02 is designed and manufactured to express and collect milk from a lactating woman's breast. The subject device is electrically powered, software-controlled, digital single-user pumps.
The pump is available in 4 different modes, which are massage mode, continuous express mode, frequency conversion mode and normal express mode. The different modes can be distinguished by different keys displayed on the LCD. There are 6 expression levels for massage mode and continuous expression mode, and 9 expression levels for frequency conversion mode and normal expression mode. The suction strengths are different for different working modes. The suction strength can be adjusted within 20~240mmHg by the user. When powered, the subject device starts with massage mode at level 1. The mode switch and level adjustment can be achieved by mode keys.
A suction cycle consists of an inhale process and an exhaust process. When the breast pump is powered on, the vacuum pump exhausts the air inside the cavity. When the suction strength reaches the setting value, the vacuum pump stops working and the expressed milk opens the valve and then flows into the bottle due to pressure difference.
5
The pump is provided in non-sterile and can be re-used by a single user. The device has embedded software and the level of concern for the software is minor. The device is powered by Li-ion battery.
The patient contact component and milk contact component are massage cushion and milk bottle. The contact duration and contact level is limited skin contact. The massage cushion and milk bottle are respectively made of polypropylene and silicone gel. The materials meet the requirements of FDA regulations concerning food contact.
The device can be used in both hospital and home environment.
7. Indication for Use
The Electric Breast Pumps are intended to express and collect milk from the breast of a lactating woman.
| Subject Device | Predicate Device |
|---|---|
| The Electric Breast Pumps are intended to | |
| express and collect milk from the breast of a | |
| lactating woman. | The powered Electric Double Breast Pumps are |
| intended to express and collect milk from the | |
| breast of a lactating woman. They are double | |
| pumps with a single pumping option and intended | |
| for single user. |
The indications for use of the subject device are similar to that of the predicate. The subject device is indicated for single pumping and for a single user, while the predicate is indicated for single and double pumping in a single user. The differences in the indications statements do not alter the intended use of the subject device as compared to the predicate.
-
- Comparison of Technological Characteristics
| ITEM | Proposed Device | Predicate Device, K151284 |
|---|---|---|
| Product Code | HGX | HGX |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Class | II | II |
| Indication for Use | The Electric Breast Pumps are intended to express and collect milk from the breast of a lactating woman. | The powered Electric Double Breast Pumps are intended to express and collect milk from the breast of a lactating woman. They are double pumps with a single |
Table 1 Comparison of Technological Characteristics
6
| pumping option and intended for | ||
|---|---|---|
| single user. | ||
| Patient | Breastfeeding women | Breastfeeding women |
| Population | ||
| Anatomical Sites | Breast | Breast |
| Pump Type | Reciprocating Diaphragm | Reciprocating Diaphragm |
| Pumping Options | Single | Single or Double |
| Cycling/Suction | ||
| Control | ||
| Mechanism | Microprocessor | Microprocessor |
| Suction Levels | 6 and 9 | 7 and 9 |
| Suction Strength | 20~240 mmHg | 60 -240 mmHg |
| Cycle Speed | 6.5~92.3 cycle/min | Single: 36 – 103 cycles / min |
| Double: 25 – 76 cycles / min | ||
| Power Supply | 3.7V 2200mAh Li-ion | 6V DC Adaptor or batteries |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Back Flow | ||
| Protection | Yes | Yes |
| Patient Contact | ||
| Material | Silicone gel | Silicone gel |
| Biocompatibility | No cytotoxicity, irritation or | |
| sensitization | No cytotoxicity, irritation or | |
| sensitization |
The differences between proposed device and predicate include suction levels, suction strength, cycle speed and power supply. These differences do not raise any question its safety and effectiveness. The differences in technological characteristics may be evaluated through performance testing.
-
- Summary of Non-clinical Performance Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications and that the subject device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Summary of Non-clinical Performance Testing
IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance.
IEC 60601-1-11:2010, 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.
7
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility
ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
The software was verified and validated. Software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, published on May 11, 2005 for a minor level of concern.
Additionally, the following non-clinical tests were conducted:
Vacuum pressure of proposed devices was tested. All the tests results complied with the design specifications of the proposed devices.
Backflow testing was conducted to ensure that even if the bottle is over-filled, no liquid will backflow into the tubing, and therefore no liquid can backflow into the pump motor. The test results showed that there was no backflow during the test.
10. Conclusion
The performance testing demonstrate that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.