(139 days)
No
The description mentions a "Single-Chip Microcomputer" for imitating sucking action and multiple levels, but there is no mention of AI, ML, or any learning or adaptive capabilities based on data. The performance studies are bench tests and safety/EMC testing, not studies related to AI/ML performance.
Yes
The intended uses of the device include alleviating engorgement of the breast and maintaining the ability of lactation, which are therapeutic functions.
No
The device's stated intended use and description are to express and collect milk, alleviate engorgement, and maintain lactation, which are functional purposes, not diagnostic ones. There is no mention of identifying, detecting, or measuring any medical condition or disease.
No
The device description explicitly states it is an "electric breast pump" and details hardware components like a Single-Chip Microcomputer, keyboard, and LCD screen, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, 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 detect diseases, conditions, or infections.
- Device Function: The electric breast pump's function is to physically express and collect milk from the breast. It does not perform any tests on biological samples to diagnose or monitor a condition.
- Intended Use: The intended use clearly states its purpose is for expressing and collecting milk, alleviating engorgement, maintaining lactation, and providing milk for feeding. None of these activities fall under the scope of in vitro diagnostics.
The device is a medical device, but it is a therapeutic/supportive device rather than a diagnostic one.
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 device is intended for a single user, not for hospital use.
Product codes
HGX
Device Description
The electric breast pump is designed and manufactured by the Shantou Xinghe Electrical Apparatuses Co., Ltd. It is intended to express and collect milk from breast 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 device is intended for a single user, not for hospital use. Model XN-2201M1, XN-2201M3, XN-2206M2, XN-2207M1, XN-2209M1, XN-2210M2 are included in this submission. The electric breast pump imitates a baby's sucking action to express milk with help of Single-Chip Microcomputer. It has multiple stimulation levels for breast massage, and multiple milk quantity of a baby's suction. The keyboard of the device control panel is soft. The screen is an LCD, and allows for process viewing.
The electric breast pump has an electric negative pressure module (one/two set of core vacuum pump) which utilizes automatic microcomputer and control procedure to set and adjust the mode, velocity and intensity of stimulation and suction. The core module vacuum pump runs discontinuously to generate periodic negative pressure, and to control another critical component, a magnetic valve, to adjust negative pressure periodically.
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
Home and not for hospital 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)
Summary of Non-Clinical Tests:
The sponsor has performed bench tests to demonstrate the electric breast pump of six models performs within specifications.
Also, the proposed device has met acceptance criteria of performance testing including biocompatibility (in vitro cytotoxicity, irritation and sensitization testing), electrical safety, and EMC testing. There are no differences between the subject and predicate devices that affect the safety and effectiveness.
Summary of clinical tests:
The subject of this premarket submission, electric breast pump, did not require clinical studies to support substantial equivalence.
Conclusion:
Shantou Xinghe Electrical Apparatuses Ltd. considers the electric breast pump to be as safe and effective as the predicate. Electric Breast Pump is therefore substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 6, 2015
Shantou Xinghe Electrical Apparatuses Co., Ltd % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services., Ltd. 7th Floor, Jingui Business Building, No. 982 Congyun Rd.,Baiyun District, Guangdong, 510420 China
Re: K143585
Trade/Device Name: Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: April 21, 2015 Received: April 23, 2015
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 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.
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
1
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 yours,
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
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Indications for Use
510(k) Number (if known) K143585
Device Name Electric breast pump
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 device is intended for a single user, not for hospital use.
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
| Date: | 2014/11/20 | |
|---|---|---|
| Submitter: | Shantou Xinghe Electrical Apparatuses Co., Ltd. | |
| Add: NO.8, Yi Road, Pingbei Industrial Zone, Chaoyang District, | ||
| Shantou, 515100, Guangdong, China | ||
| Primary Contact Person: | Jun Deng | |
| General Manager | ||
| Shantou Xinghe Electrical Apparatuses Co., Ltd. | ||
| Tel: +86-754-83613668-866 | ||
| Fax: +86-754-83843338 | ||
| Secondary Contact Person: | Mike Gu | |
| Regulatory Affairs Manager | ||
| Guangzhou Osmunda Medical Device Technical Service Co., Ltd. | ||
| Tel: (+86)-20-6232 1333 | ||
| Fax: (+86) -20-8633 0253 | ||
| Device Trade Name: | Electric Breast Pump, Model XN-2201M1, XN-2201M3, | |
| XN-2206M2, XN-2207M1, XN-2209M1, XN-2210M2 | ||
| Common/Usual Name: | Powered breast pump | |
| Classification Names: | Powered breast pump | |
| Regulation number | CFR 884.5160 | |
| Product Code: | HGX | |
| Predicate Device(s): | K122474, LANSINOH Powered Electric Breast Pump | |
| Reference Device(s): | K053052, Medela Swing | |
| The reference device is used as a reference for suction intensity. | ||
| It has a 0~-0.033 MPa range of suction intensity, which is the | ||
| same as the range of the proposed device. | ||
| Device Description: | The electric breast pump is designed and manufactured by the | |
| Shantou Xinghe Electrical Apparatuses Co., Ltd. It is intended to | ||
| express and collect milk from breast 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 device is intended for | ||
| a single user, not for hospital use. Model XN-2201M1, | ||
| XN-2201M3, XN-2206M2, XN-2207M1, XN-2209M1, XN-2210M2 | ||
| are included in this submission. | ||
| The electric breast pump imitates a baby's sucking action to | ||
| express milk with help of Single-Chip Microcomputer. It has | ||
| multiple stimulation levels for breast massage, and multiple milk |
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Image /page/4/Picture/0 description: The image shows a logo with a blue oval shape at the top, containing four white stars of varying sizes and three curved lines underneath them. Below the oval is the text "星河" in a stylized, dark blue font. The logo appears to represent a company or organization, possibly related to space, technology, or a similar field, given the star and wave imagery.
510(k) Premarket Notification Submission
quantity of a baby's suction. The keyboard of the device control panel is soft. The screen is an LCD, and allows for process viewing.
- 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 device is intended for a single user, not for hospital use.
- Technology: The electric breast pump has an electric negative pressure module (one/two set of core vacuum pump) which utilizes automatic microcomputer and control procedure to set and adjust the mode, velocity and intensity of stimulation and suction. The core module vacuum pump runs discontinuously to generate periodic negative pressure, and to control another critical component, a magnetic valve, to adjust negative pressure periodically.
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Image /page/5/Picture/0 description: The image shows a logo with a blue oval shape at the top. Inside the oval, there are three white stars of varying sizes and two curved lines. Below the oval, there are two Chinese characters in blue. The logo appears to represent a company or organization, possibly related to space or technology.
Determination of Substantial Equivalence:
Table 5.1 Comparison with Predicate Device
| Specification | Predicate Device | Proposed Device |
|---|---|---|
| Device name | LANSINOH Powered Electric Breast Pump | Electric Breast Pump |
| K number | K122474 | K143585 |
| Indications for Use | The powered breast pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user. | 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 device is intended for a single user, not for hospital use. |
| Patient Population | Breastfeeding women | Breastfeeding women |
| Pump Style | Diaphragm-type vacuum pump | Diaphragm-type vacuum pump |
| Stimulation velocity | 93~144 T/min | 95~105 T/min |
| Stimulation intensity | -0.007~-0.019MPa | -0.002~-0.019MPa |
| Sucking velocity | 36.6~91.2 T/min | 20~65 T/min |
| Suction intensity | -0.011~-0.029 MPa | -0.011~-0.033 MPa |
| Backflow protection | Yes | Yes |
| Overflow protection | No | No |
| Adjustable Suction Levels | Yes | Yes |
| Software | Yes | Yes |
| Anatomical Sites | breast | breast |
| Environment of Use | Hospital, institutions and home | Home and not for hospital use |
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Image /page/6/Picture/0 description: The image shows a logo with a dark blue oval shape at the top, containing three wavy lines and four stars of varying sizes. Below the oval, there are two Chinese characters, also in dark blue. The overall design suggests a celestial or cosmic theme, possibly representing a company or organization related to space, technology, or culture.
Summary of Non-Clinical Tests:
The sponsor has performed bench tests to demonstrate the electric breast pump of six models performs within specifications.
Also, the proposed device has met acceptance criteria of performance testing including biocompatibility (in vitro cytotoxicity, irritation and sensitization testing), electrical safety, and EMC testing. There are no differences between the subject and predicate devices that affect the safety and effectiveness.
Summary of clinical tests:
The subject of this premarket submission, electric breast pump, did not require clinical studies to support substantial equivalence.
Conclusion: Shantou Xinghe Electrical Apparatuses Ltd. considers the electric breast pump to be as safe and effective as the predicate. Electric Breast Pump is therefore substantially equivalent to the predicate device.