(265 days)
Not Found
No
The description mentions a microprocessor controlling a vacuum pump and user-selectable modes, but there is no mention of AI, ML, or adaptive learning based on user input or milk flow. The modes are pre-defined.
Yes
Explanation: The device is intended to express and collect milk from breasts, which is a therapeutic function for lactating women.
No
The device is an electric breast pump intended to express and collect milk from lactating women, not to diagnose a medical condition.
No
The device description clearly outlines hardware components such as a reciprocating diaphragm vacuum pump, a microprocessor, a keypad, an LCD display, an internal rechargeable battery, and an external AC power adapter. While it includes software validation, it is integral to the operation of the physical breast pump.
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 their breasts." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical pump that generates suction. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a disease or condition
- Using reagents or test kits
The device is clearly a medical device, but its function is to physically extract milk, not to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Youha electric breast pump is a single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. YH-8004 and YH-8016 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YH-8006IV and YH-8015 have a single pumping configuration only.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280mmHg. The user interface consists of a front panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure.
The device has three modes of operation:
- Massage mode: Suction patterns with fast cycles and low vacuum to start milk flowing
- Low expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.
- High expression mode: Suction patterns with slower cycles and higher vacuum to express more milk efficiently.
YH-8004, YH-8015 and YH-8016 have 3 modes including massage mode, low expression mode and high expression mode. YH-8006IV has 2 modes including massage mode and high expression mode.
The device is electrically powered from either an internal rechargeable battery or an external AC power adapter. The external adapter also charges the battery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Home use (Over-The-Counter Use)
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 Youha electric breast pump met all design specifications and is substantially equivalent to the predicate. The test results demonstrated that the proposed device complies with the following standards:
- Risk Analysis developed in accordance with ISO 14971:2007.
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3m Edition) with US ● deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- Safety Testing for use in the home in accordance with IEC 60601-1-11:2015.
- Biocompatibility Tests in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
- Software Validation Software Life Cycle Processes in accordance with IEC 62304. ●
- FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
Performance testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection. These results held under conditions of single and double pumping mode with varying power sources (e.g., AC/DC power vs. battery power).
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 seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2017
Ningbo Youhe Electrical Appliance Technology Co., Ltd. % Daniel Qiu Project Manager Shanghai Qisheng Business Consulting Co.,ltd. Room 1301, Bld 46, Jing Gu Zhong Rd., No.58, Min Hang District, Shanghai, CN Shanghai, 200240 China
Re: K163136 Trade/Device Name: Youha electric breast pump, Models: YH-8004, YH-8016, YH-8006IV, YH-8015 Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 22, 2017 Received: June 22, 2017
Dear Daniel Qiu:
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 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 (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,
Joyce M. Whang -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
Indications for Use
510(k) Number (if known) K163136
Device Name
Youha electric breast pump, Models: YH-8004, YH-8016, YH-8006IV, YH-8015
Indications for Use (Describe)
The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It 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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3
510(k) Summary
K163136
1. Submitter Information
| Name: | Ningbo Youhe Electrical Appliance Technology Co., Ltd |
|---|---|
| Address: | No.226-228 San Jiao Tian Road, Fu Hai Town, CiXi City, Zhejiang, China |
| Telephone: | +86-574-63860315 |
| Fax: | +86-574-23660066 |
Contact Person: Huang Yun Jun
-
- Date Prepared: June 30, 2017
3. Device Information
| Trade Name: | Youha electric breast pump |
|---|---|
| Common Name: | Powered breast pump |
| Models: | YH-8004, YH-8016, YH-8006IV, YH-8015 |
| Regulation Class: | Class II |
| Regulation Number: | 21CFR 884.5160, Powered breast pump |
| Review Panel: | Obstetrics/Gynecology |
| Product Code: | HGX (pump, breast, powered) |
4. Predicate Device
K162415 510(k): Device Name: Spectra 9 Plus powered breast pump Manufacturer: Uzinmedicare Company
5. Device Description
The Youha electric breast pump is a single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. YH-8004 and YH-8016 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YH-8006IV and YH-8015 have a single pumping configuration only.
A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280mmHg. The user interface consists of a front panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure.
The device has three modes of operation:
- . Massage mode: Suction patterns with fast cycles and low vacuum to start milk flowing
4
- Low expression mode: Suction patterns with slow cycles and high vacuum to . express more milk gently and efficiently.
- High expression mode: Suction patterns with slower cycles and higher vacuum to . express more milk efficiently.
YH-8004, YH-8015 and YH-8016 have 3 modes including massage mode, low expression mode and high expression mode. YH-8006IV has 2 modes including massage mode and high expression mode.
The device is electrically powered from either an internal rechargeable battery or an external AC power adapter. The external adapter also charges the battery.
6. Indications for Use
The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
7. Predicate Comparison
The following table compares the Youha Electric breast pump to the predicate device with respect to indications for use and technological characteristics:
| Device & Predicate Device(s): | Subject Device: | Predicate Device: |
|---|---|---|
| Youha electric breast pump | ||
| K163136 | Spectra 9plus | |
| K162415 | ||
| Indications for Use | The Youha electric breast pump is | |
| intended to be used by lactating women | ||
| to express and collect milk from their | ||
| breasts. It is intended for a single user. | The Spectra 9Plus is a single-user, | |
| powered breast pump intended to | ||
| express and collect milk from the | ||
| breasts of lactating women. | ||
| Single user | Yes | Yes |
| Provided Non-sterile | Yes | Yes |
| Re-usable | Yes | Yes |
| Direct user contact | Yes | Yes |
| Power source | AC/DC wall converter and | |
| Rechargeable | Power source | |
| Suction Strength (Expression | ||
| Mode) (mmHg) | Low | |
| YH-8004:75-250 | ||
| YH-8016:75-250 | ||
| YH-8015:115-250 | ||
| YH-8006IV:N/A | 50-270 | |
| High | ||
| YH-8004:120-280 | ||
| YH-8016:120-280 | ||
| YH-8015: 120-280 | ||
| YH-8006IV:125- | ||
| 280 | ||
| Suction Strength (Massage | ||
| Mode) (mmHg) | YH-8004:34-190 | |
| YH-8016:34-190 | ||
| YH-8015: 50-190 | ||
| YH-8006IV: 50-190 | 50-150 | |
| Adjustable Suction levels | Yes | Yes |
| Suction Settings (High/low | YH-8004:6 | 10 |
5
| Expression Mode) | YH-8016:6 | ||
|---|---|---|---|
| YH-8015:9 | |||
| YH-8006IV:10 | |||
| Suction Settings (Massage Mode) | YH-8004:6 | 5 | |
| YH-8016:6 | |||
| YH-8015:9 | |||
| YH-8006IV:10 | |||
| Cycle Speed (Expression Mode) (cycles/min) | Low | YH-8004:41-69 | 24-60 |
| YH-8016:41-69 | |||
| YH-8015:36-60 | |||
| YH-8006IV:N/A | |||
| High | YH-8004:16-33 | ||
| YH-8016:16-33 | |||
| YH-8015:16-34 | |||
| YH-8006IV:32-57 | |||
| Cycle Speed (Massage Mode) | YH-8004:94-113 | 70 | |
| YH-8016:94-113 | |||
| YH-8015:80-122 | |||
| YH-8006IV:71-100 | |||
| Backflow Protection | Yes | Yes | |
| Single or Double Pumping | YH-8004/ YH-8016: Single and Double | ||
| Pumping | Single and Double Pumping | ||
| YH-8006IV/YH-8015:Single Pumping | |||
| Only | |||
| Visual Indicator | LCD | LCD | |
| Pump Type | Diaphragm | Diaphragm |
The Youha electric breast pump has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.
8. Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the Youha electric breast pump met all design specifications and is substantially equivalent to the predicate. The test results demonstrated that the proposed device complies with the following standards:
- Risk Analysis developed in accordance with ISO 14971:2007.
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3m Edition) with US ● deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014.
- . Safety Testing for use in the home in accordance with IEC 60601-1-11:2015.
- Biocompatibility Tests in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
- Software Validation Software Life Cycle Processes in accordance with IEC 62304. ●
6
- . FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
Performance testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection. These results held under conditions of single and double pumping mode with varying power sources (e.g., AC/DC power vs. battery power).
Clinical Performance Data 9.
Not Applicable
10. Conclusion
Based on the comparison and analysis above, the Youha electric breast pump is substantially equivalent to the predicate device.