(184 days)
No reference devices were used in this submission.
No
The description mentions a "single-chip microcomputer" and "electronic memory" mimicking rhythm, which are standard features of electronic devices and do not indicate the use of AI or ML. There is no mention of AI, ML, or related concepts like training or test sets.
Yes
The intended use mentions alleviating engorgement of the breast and maintaining the ability of lactation, which are therapeutic actions.
No
Explanation: The device is an Electric Breast Pump used to express and collect milk, alleviate engorgement, and maintain lactation. Its intended uses do not involve diagnosing any medical conditions.
No
The device description explicitly states it comprises a pump unit and expression collection kit made of physical materials (polypropylene, silicone, thermoplastic elastomer) and includes hardware components like a negative pressure module, keyboard, and screen.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The Electric Breast Pump's intended use is to physically express and collect milk from the mother's breast. It is a mechanical device that interacts with the body externally to collect a bodily fluid, but it does not perform any diagnostic testing on that fluid or any other sample.
- Intended Use/Indications for Use: The description clearly states its purpose is for milk expression, alleviating engorgement, maintaining lactation, and providing milk for feeding. None of these are diagnostic activities.
- Device Description: The description focuses on the mechanical and electronic components of the pump, not on any analytical or testing capabilities.
- Performance Studies: The performance studies listed are related to the safety and functionality of the pump itself (biocompatibility, electrical safety, software validation, technical parameters), not to the analysis of a biological sample.
Therefore, based on the provided information, the Electric Breast Pump is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Electric Breast Pump 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. The Electric Breast Pump is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting for a single user. It comprises of a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer.
This electric breast pump has a negative pressure module that utilizes a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk expression speed intensities. The keyboard of the control panel is soft. The screen is an LCD or LED screen, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 30 to 247.5 mmHg with cycle rates up to 100 cycles per minute.
The Electric Breast Pump provides the following user features:
. Closed system with anti-backflow
. LCD or LED screen touch button operation
. 2-phase expression: Stimulation and Expression phases
Stimulation Phase: Expression pattern with fast cycles (70100 Cycles/min) and low vacuum (30 ~ 112.5 mmHg) to start milk flowing, 9 levels90Cycles/min) and higher vacuum (75 ~ 247.5 mmHg) to express milk, 9 levels
Phase: Expression cvcles (24
Double-pumping ability: single or double pumping
. Dual power source: it can be operated by A/C adapter or batteries
Built-in rechargeable li-ion polymer battery or additional AA battery power option
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
lactating women in a home setting
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)
Performance testing was conducted on the Electric Breast Pump. Technical parameters of stimulation mode and expression mode, including working current, pressure, cycle rate and noise, backflow protection mechanism, and battery specification were evaluated in the performance testing. In addition, the stability of vacuum level and shelf life were evaluated. All of the tested parameters met the predefined acceptance criteria.
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.
No reference devices were used in this submission.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 7, 2019
Guangdong Horigen Mother & Baby Products Co., Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co.,Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K182413
Trade/Device Name: Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 1, 2019 Received: February 4, 2019
Dear Mike Gu:
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 mav, 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.
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.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -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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Indications for Use
510(k) Number (if known) K182413
Device Name Electric Breast Pump
Models: XN-2212M2, XN-2219M1, XN-2219M2, XN-2223M2, XN-2223M2, XN-2233M1, XN-2233M2
Indications for Use (Describe)
The Electric Breast Pump 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. The Electric Breast Pump is 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
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Guangdong Horigen Mother & Baby Products Co., Ltd. NO.8, Yi Road, Pingbei Industrial Zone, Chaoyang District, Shantou, 515100, Guangdong, China Phone: +86-754-83613668 Fax: +86-754-83843338
| Primary Contact | Mike Gu |
|---|---|
| Person: | Regulatory Affairs Manager |
| Guangzhou Osmunda Medical Device Technical Service | |
| Co., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86) -20-8633 0253 | |
| Secondary Contact | Jun Deng |
| Person: | General Manager |
| Guangdong Horigen Mother & Baby Products Co., Ltd. | |
| Tel: (+86)-754-83613668-866 | |
| Fax: (+86)-754-83843338 | |
| Date prepared | March 6, 2019 |
| 2. DEVICE | |
| Device Name: | Electric Breast Pump |
| Common/Usual Name: | Powered breast pump |
| Model: | XN-2212M2, XN-2219M1, XN-2219M2, XN-2223M1, |
| XN-2223M2, XN-2233M1 and XN-2233M2 | |
| Regulation number | 21 CFR 884.5160 Powered breast pump |
| Regulation Class: | II |
| Product Code: | HGX Pump, Breast, Powered |
3. PREDICATE DEVICE
Predicate device: K143585, Electric Breast Pump
4
This predicate and the referenced have not been subject to a design-related recall. No reference devices were used in this submission.
4. DEVICE DESCRIPTION
The Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting for a single user. It comprises of a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer.
This electric breast pump has a negative pressure module that utilizes a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk expression speed intensities. The keyboard of the control panel is soft. The screen is an LCD or LED screen, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 30 to 247.5 mmHg with cycle rates up to 100 cycles per minute.
The Electric Breast Pump provides the following user features:
- . Closed system with anti-backflow
- . LCD or LED screen touch button operation
- . 2-phase expression: Stimulation and Expression phases
- Stimulation Phase: Expression pattern with fast cycles (70~100 Cycles/min) and low vacuum (30 ~ 112.5 mmHg) to start milk flowing, 9 levels
- Phase: Expression cvcles (24~90Cycles/min) and higher vacuum (75 ~ 247.5 mmHg) to express milk, 9 levels
- Double-pumping ability: single or double pumping
- . Dual power source: it can be operated by A/C adapter or batteries
- Built-in rechargeable li-ion polymer battery or additional AA battery power option
5. INDICATIONS FOR USE
The Electric Breast Pump 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. The Electric Breast Pump is intended for a single user.
5
The indications for use statement for the subject device is similar to that of the predicate, with minor alterations in text; however, the intended use of the subject and predicate devices is the same (express and collect milk from breasts of lactating women).
6
| Device & Predicate Device(s): | K182413 | K143585 |
|---|---|---|
| General Device Characteristics | ||
| Environment of Use | Home | Home, institutions and |
| hospital | ||
| Single or Multiple-User | Single | Single |
| Pump Type | diaphragm pump | diaphragm pump |
| Adjustable Vacuum Levels | 9 levels | 9 levels |
| Maximum Expression Intensity | 247.5 | 270 |
| Stimulation Intensity range | 30-112.5 | 15.2-144.4 |
| Stimulation Velocity | 70 – 100 cycles/min | 95-105 |
| Expression Velocity | 24 – 90 cycles/min | 20-65 |
| User Interface | Hardware interface | Hardware interface |
| Backflow Protection (prevention | ||
| of backflow of liquid into | ||
| pump/tubing) | Yes | Yes |
| Overflow Protection (stops | ||
| pumping when the bottle is full | ||
| to prevent overflow) | No | No |
| Power Source | AC Mains 100-240 VAC, | |
| 50/60Hz, 1.5A/1A | ||
| 4AA Alkaline battery | ||
| Rechargeable Li-Ion | ||
| Battery (7.4 V / 1750 | ||
| mAh) | 4AA battery or AC/DC | |
| adapter |
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
7
The subject device is different from the predicate and the referenced in suction pressure range, cycle speed, maximum suction pressure and the power source. However, these differences do not raise different questions of safety and effectiveness. The technological differences can be evaluated through the software, performance and EMC/electrical safety testing provided.
PERFORMANCE DATA 7.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Electric Breast Pump 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 Electric Breast Pump. The device complies with the IEC 60601-1:2012, standard for electrical safety and the IEC 60601-1-2:2014 standard for EMC. Software Validation was performed per the FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
Performance testing
Performance testing was conducted on the Electric Breast Pump. Technical parameters of stimulation mode and expression mode, including working current, pressure, cycle rate and noise, backflow protection mechanism, and battery specification were evaluated in the performance testing. In addition, the stability of vacuum level and shelf life were evaluated. All of the tested parameters met the predefined acceptance criteria.
8. CONCLUSION
The indications for use statement for the subject device is similar to that of the predicate. The differences between the Electric Breast Pump and its predicate device
8
do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the Electric Breast Pump should perform as intended in the specified use conditions.
From the results of non-clinical data including the performance testing described, Guangdong Horigen concludes that the Electric Breast Pump is as safe and as effective as the predicate device.