(273 days)
Not Found
No
The summary describes a standard electric breast pump with a chip controlling vacuum and solenoid valve. There is no mention of AI, ML, or any features that would suggest adaptive learning or intelligent processing of data beyond basic control functions.
Yes
The device is intended to alleviate engorgement of the breast and maintain the ability of lactation, which are therapeutic claims.
No
The device's intended use and description focus on expressing and collecting breast milk, alleviating engorgement, and maintaining lactation, which are functional and supportive, not diagnostic, purposes.
No
The device description explicitly lists physical components like a pump unit, tubing, and milk collection kit, indicating it is a hardware device with potentially embedded software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to express and collect milk from the mother's breast, alleviate engorgement, maintain lactation, and provide milk for feeding. This is a physical process involving the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a mechanical pump system for extracting milk. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a disease, condition, or state of health. The device's function is purely mechanical and related to milk expression.
In summary, the device is a medical device, specifically a breast pump, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) are electric breast pumps that are intended for lactating women to express and collect breast milk. The Electric Breast Pump and Electric Double Breast Pump are intended for a single user and are to be used in the home environment.
The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053_01) are Li-ion-battery powered breast pumps that include following main components: the expressed milk collection kit, the pump unit, and tubing. The expressed milk collection kit includes a funnel cover, silicone cushion, funnel adapter, membrane, valve body, valve membrane cap, and milk bottle. The pump unit contains a chip that controls the work of the vacuum pump and solenoid valve to draw air inside of the funnel adapter to form negative pressure. The tubing has two connectors on the two ends. The user attaches the connector to the air vent of the membrane cap and the connector to the pump unit separately to ensure a tight fit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mother's 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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility: A biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests: Cytotoxicity - (ISO 10993-5: 2009), Sensitization - (ISO 10993-10:2010), Skin Irritation - (ISO 10993-10:2010).
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the subject device in accordance with IEC 60601-1:2012 (electrical safety) and IEC 60601-1-2:2014 (EMC).
Software: Software verification and validation for the subject device was conducted as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005).
Performance testing: Performance testing was conducted on the subject device, including the following assessments:
- Minimum and maximum vacuum pressure testing in single and double pumping mode
- Assessment of technical specifications for stimulation mode and expression mode at all cycle and vacuum settings
- Assessment of working current, pressure, cycle rate and noise
- Backflow protection mechanism testing
- Battery specification validation and performance
- Use life testing of vacuum level and battery performance
Key Results: All of the tested parameters met the predefined acceptance criteria. The nonclinical performance data described above demonstrate that the Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
September 11, 2020
Guangdong Horigen Mother & Baby Products Co., Ltd Jun Deng Vice President No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District Shantou, 515100 China
Re: K193449
Trade/Device Name: Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053_01) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: August 8, 2020 Received: August 10, 2020
Dear Jun Deng:
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,
Monica D. Garcia, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K193449
Device Name Electric Breast Pump (model KP033 01)
Electric Double Breast Pump (model KP053 01)
Indications for Use (Describe)
The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended for a single user.
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 - K193449
I. SUBMITTER:
510(k) Owner:
Guangdong Horigen Mother & Baby Products Co., Ltd. No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District, 515100 Shantou, Guangdong, PEOPLE'S REPUBLIC OF CHINA
Primary Contact Person: Jun Deng Title: Vice president Phone: +86 (754) 83613668 EXT.836 Email: dengjun@horigen.cn
Date summary prepared: September 8, 2020
II. DEVICE
Device Name: Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053 01) Common Name: Powered Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Product Code: HGX (Pump, Breast, Powered) Regulatory Class: II
PREDICATE DEVICE III.
The predicate device is the Electric Breast Pump (K182413).
This predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) are electric breast pumps that are intended for lactating women to express and collect breast milk. The Electric Breast Pump and Electric Double Breast Pump are intended for a single user and are to be used in the home environment.
The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053_01) are Li-ion-battery powered breast pumps that include following main components: the expressed milk collection kit, the pump unit, and tubing. The expressed milk collection kit includes a funnel cover, silicone cushion, funnel
4
adapter, membrane, valve body, valve membrane cap, and milk bottle. The pump unit contains a chip that controls the work of the vacuum pump and solenoid valve to draw air inside of the funnel adapter to form negative pressure. The tubing has two connectors on the two ends. The user attaches the connector to the air vent of the membrane cap and the connector to the pump unit separately to ensure a tight fit.
DEVICE MODELS:
- KP033_01: Single pump ●
- KP053_01: Double pump
INDICATIONS FOR USE V.
The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053 01) are intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended for a single user.
| DEVICE | Subject Device | Primary Predicate Device |
|---|---|---|
| Product Name | Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) | Electric Breast Pump |
| Indications for Use | The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) are intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) are intended for a single user. | The Electric Breast Pump (K182413) is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. |
VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICE
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| K1934- | ||
|---|---|---|
| Classification Product | ||
| Code | HGX | HGX |
| Single User | Yes | Yes |
| Single/Double Pump | Single or Double Pump | Single |
| Environment of Use | Home | Home |
| Pump Type | Diaphragm pump | Diaphragm pump |
| Adjustable Vacuum | ||
| Levels | 9 Levels | 9 Levels |
| Backflow Protection | ||
| (prevention of | ||
| backflow of liquid into | ||
| pump/tubing) | Yes | Yes |
| Maximum Expression | ||
| Pressure | 247.5mmHg | 247.5mmHg |
| Stimulation Pressure | ||
| range | KP033_01 (30-120, mmHg) | |
| KP053_01 (37.5-112.5mmHg ) | 30-120 mmHg | |
| Stimulation Velocity | 100 Cycles/min | 100 cycles/min |
| Expression Velocity | 26-60 Cycles/min | 20 – 90 cycles/ min |
| Expression Pressure | ||
| Range | 120 -247.5 mmhg | 75-247.5mmhg |
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The intended use of the subject and predicate devices is the same (express and collect milk from breasts of lactating women). The subject device has different adjustable stimulation levels and a different power source as compared to the predicate device. There are minor differences in stimulation and expression pressure ranges and cycle speeds of stimulation and expression. However, these differences do not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
A biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
- Cytotoxicity - (ISO 10993-5: 2009)
- Sensitization - (ISO 10993-10:2010)
- . Skin Irritation - (ISO 10993-10:2010)
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device in accordance with IEC 60601-1:2012 (electrical safety) and IEC 60601-1-2:2014 (EMC).
Software
Software verification and validation for the subject device was conducted as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005).
Performance testing
Performance testing was conducted on the subject device, including the following assessments:
- . Minimum and maximum vacuum pressure testing in single and double pumping mode
- Assessment of technical specifications for stimulation mode and expression mode at ● all cycle and vacuum settings
- . Assessment of working current, pressure, cycle rate and noise
- Backflow protection mechanism testing
- Battery specification validation and performance .
- . Use life testing of vacuum level and battery performance
7
All of the tested parameters met the predefined acceptance criteria.
VIII. CONCLUSION
The nonclinical performance data described above demonstrate that the Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is as safe and effective as the predicate device and supports a determination of substantial equivalence.