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.

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.

AI/ML Overview

The document provided is a 510(k) premarket notification for an Electric Breast Pump (K143585). It details the device's substantial equivalence to a predicate device, rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical or algorithm validation study.

Therefore, the requested information elements related to clinical studies, algorithmic performance (standalone, MRMC), ground truth establishment, expert adjudication, and sample sizes for test and training sets are not applicable (N/A) in this context, as this submission did not involve such studies.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating that the proposed device's specifications (technology, performance parameters, etc.) are substantially equivalent to the predicate device and meet general safety and performance standards through bench testing.

Feature/Test	Acceptance Criteria (Predicate Device K122474)	Reported Device Performance (Proposed Device K143585)	Acceptance Status
Specifications (Comparative Equivalence)
Device name	LANSINOH Powered Electric Breast Pump	Electric Breast Pump	Equivalent¹
Indications for Use	Express and collect breast milk for feeding. Single user.	Express and collect milk, alleviate engorgement, maintain lactation, provide milk for future feedings. Single user, not for hospital use.	Equivalent²
Patient Population	Breastfeeding women	Breastfeeding women	Equivalent
Pump Style	Diaphragm-type vacuum pump	Diaphragm-type vacuum pump	Equivalent
Stimulation velocity	93~144 T/min	95~105 T/min	Within range³
Stimulation intensity	-0.007~-0.019MPa	-0.002~-0.019MPa	Comparable⁴
Sucking velocity	36.6~91.2 T/min	20~65 T/min	Comparable⁵
Suction intensity	-0.011~-0.029 MPa	-0.011~-0.033 MPa	Comparable⁶
Backflow protection	Yes	Yes	Equivalent
Overflow protection	No	No	Equivalent
Adjustable Suction Levels	Yes	Yes	Equivalent
Software	Yes	Yes	Equivalent
Anatomical Sites	Breast	Breast	Equivalent
Environment of Use	Hospital, institutions, home	Home and not for hospital use	Subset/Different⁷
Non-Clinical Tests (Regulatory Compliance)
Performance within specifications	Device performs within specifications	Performed within specifications	Met
Biocompatibility (in vitro cytotoxicity, irritation, sensitization)	Met acceptance criteria (no adverse biological reactions)	Met acceptance criteria	Met
Electrical safety	Met acceptance criteria	Met acceptance criteria	Met
EMC testing	Met acceptance criteria	Met acceptance criteria	Met

Footnotes for Table:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: N/A (No clinical test set was required or presented for substantial equivalence).
Data Provenance: N/A. The non-clinical tests were bench tests performed by the sponsor (Shantou Xinghe Electrical Apparatuses Co., Ltd.) in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A (No ground truth established by experts for a test set in this context).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is a physical medical device, not an AI/software as a medical device (SaMD) requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This is not an AI/SaMD.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission largely relies on established engineering standards for performance, electrical safety, EMC, and biocompatibility, as well as the specifications and performance of the legally marketed predicate device (K122474). Therefore, the ground truth is derived from regulatory standards, predicate device characteristics, and internal bench test results demonstrating compliance with specifications.

8. The sample size for the training set

N/A (No training set for an AI/ML algorithm was involved).

9. How the ground truth for the training set was established

N/A.

The device names are different, but the fundamental function is the same, indicating equivalence in purpose. ↩
The proposed device's indications extend to alleviating engorgement and maintaining lactation, which are considered consistent with and an elaboration of the predicate's general use for breast milk expression. The "not for hospital use" is a difference in the environment of use, but not in the core indication. ↩
The proposed device's stimulation velocity (95~~105 T/min) falls within the range of the predicate (93~~144 T/min), indicating technical equivalence for this parameter. ↩
The proposed device's stimulation intensity (-0.002~-0.019MPa) overlaps significantly with the predicate's (-0.007~-0.019MPa), indicating comparable functionality. The slightly shallower minimum (less intense) could be a design choice but doesn't preclude substantial equivalence. ↩
The proposed device's sucking velocity (20~~65 T/min) is within a similar order of magnitude as the predicate's (36.6~~91.2 T/min), indicating comparable performance. The lower end of the range is different, but not noted as a safety or effectiveness concern in this type of submission. ↩
The proposed device's suction intensity (-0.011~-0.033 MPa) largely overlaps with and extends slightly beyond the predicate's (-0.011~-0.029 MPa) on the more intense end. This is considered comparable or an improvement not raising new safety/effectiveness concerns. ↩
The predicate mentions "Hospital, institutions and home" while the proposed device specifies "Home and not for hospital use." This is a difference in environment of use, which the FDA implicitly accepts as not affecting substantial equivalence based on the final decision. ↩

Summary

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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

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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)

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 DengGeneral ManagerShantou Xinghe Electrical Apparatuses Co., Ltd.Tel: +86-754-83613668-866Fax: +86-754-83843338
	Secondary Contact Person:	Mike GuRegulatory Affairs ManagerGuangzhou Osmunda Medical Device Technical Service Co., Ltd.Tel: (+86)-20-6232 1333Fax: (+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 SwingThe reference device is used as a reference for suction intensity.It has a 0~-0.033 MPa range of suction intensity, which is thesame as the range of the proposed device.
	Device Description:	The electric breast pump is designed and manufactured by theShantou Xinghe Electrical Apparatuses Co., Ltd. It is intended toexpress and collect milk from breast from the mother's breast,to alleviate engorgement of the breast, maintain the ability oflactation, and provide mother's milk for future feedings whenseparation of mother and baby occurs. The device is intended fora single user, not for hospital use. Model XN-2201M1,XN-2201M3, XN-2206M2, XN-2207M1, XN-2209M1, XN-2210M2are included in this submission.The electric breast pump imitates a baby's sucking action toexpress milk with help of Single-Chip Microcomputer. It hasmultiple 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.

Regulation Number and Section

§ 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).