The Proture Double Electric Breast Pump to be used by lactating women in a home setting to express and collect milk from their breasts. This device is intended for a single user.

Device Description

The Proture Double 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 and is for a single user. It comprises 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 imitates baby's sucking rhythm with help of a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk suction speed intensities to imitate rhythm of a baby's suction. The keyboard of the control panel is soft. The screen is an LCD, 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 15 to 247 mmHg with cycle rates up to 107 cycles per minute.

The Proture Double Electric Breast Pump provides the following user features:

Closed system with anti-backflow
LCD screen touch button operation
2-phase expression: Stimulation and Expression phases
Stimulation Phase: Suction pattern with fast cycles (53-107 cycles/min) and low vacuum (15-120mmHg) to start milk flowing, 5 levels
Expression Phase: Suction pattern with slower cycles (19~47T/min) and higher vacuum (82-247mmHg) 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

All parts of the device that directly contact with breast and milk are to be sanitized by boiling in water for 5 minutes, followed by drying with a clean towel. After use, all parts that directly contact the breast and milk are to be cleaned in warm, soapy water.

AI/ML Overview

This document provides a 510(k) summary for the Proture Double Electric Breast Pump. Let's extract the requested information based on the provided text.

Based on the provided document, the device in question is a Proture Double Electric Breast Pump. The studies conducted are primarily focused on safety and performance, comparing the device to a predicate device (Naya Breast Pump System). There is no mention of a study involving AI, human readers, or a ground truth established by medical experts for diagnostic purposes, as this is a breast pump, not a diagnostic imaging device.

Therefore, many of the requested categories (like sample size of test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, and how ground truth for training set was established) are not applicable to the type of device and study described here.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document mentions that "All of the tested parameters meet the predefined acceptance criteria" for performance testing, but it does not explicitly list these criteria in a table format alongside the reported device performance. It mainly discusses the types of tests conducted.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility
Cytotoxicity	Complied with ISO 10993-5:2009/(R)2014; non-cytotoxic
Sensitization	Complied with ISO 10993-10:2010; non-sensitizing
Skin Irritation	Complied with ISO 10993-10:2010; non-irritating
Electrical Safety	Complies with IEC 60601-1:2012
EMC	Complies with IEC 60601-1-2:2007
Performance Testing
Working Current	Met predefined acceptance criteria
Pressure	Met predefined acceptance criteria
Cycle Rate	Met predefined acceptance criteria
Noise	Met predefined acceptance criteria
Stability of Vacuum Level	Met predefined acceptance criteria
Use-life	Met predefined acceptance criteria
Software Verification and Validation	Functions as specified in software requirement specifications

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

Sample Size: Not specified. The document states "Performance testing was conducted on the Proture Double Electric Breast Pump" but does not give a sample size (e.g., number of units tested).
Data Provenance: Not specified. The manufacturer is Guangdong Horigen Mother & Baby Products Co., Ltd. in China, implying testing was likely done in China, but this is not explicitly stated. The studies are non-clinical (laboratory testing), not patient data.

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):

Not Applicable. This is a physical device (breast pump) and the "ground truth" is based on engineering and safety standards, not expert medical opinion on a diagnostic image or patient outcome.

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

Not Applicable. As the "ground truth" is based on compliance with international standards (ISO, IEC) and engineering specifications, an adjudication method for expert consensus is not relevant.

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:

No. This is a breast pump, not a diagnostic AI device. MRMC studies are not relevant here.

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

Not Applicable. This is not an algorithm or AI device.

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

For biocompatibility: Ground truth is defined by compliance with International Standards (ISO 10993-1, ISO 10993-5, ISO 10993-10) demonstrating non-cytotoxicity, non-sensitization, and non-irritation.
For electrical safety and EMC: Ground truth is defined by compliance with International Standards (IEC 60601-1, IEC 60601-1-2).
For performance testing: Ground truth is defined by predefined acceptance criteria based on technical parameters (working current, pressure, cycle rate, noise, vacuum level stability, use-life).
For software: Ground truth is defined by software requirements specifications.

8. The sample size for the training set:

Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not Applicable. There is no mention of a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 8, 2016

Guangdong Horigen Mother & Baby Products Co., Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor. R&D Building. No. 26 Oinglan Street Panyu District, Guangzhou, 510006 China

Re: K162747 Trade/Device Name: Proture Double Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: Class II Product Code: HGX Dated: October 9, 2016 Received: October 11, 2016

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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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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.

For Division

Douglas Silverstein -S 2016.12.08 10:57:16 -05'00'

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) K162747

Device Name Proture Double Electric Breast Pump

Indications for Use (Describe)

The Proture Double Electric Breast Pump to be used by lactating women in a home setting to express and collect milk from their breasts. This device is intended for a single user.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image features a logo for "HORIGEN". The logo consists of a red square with rounded corners. Inside the square, there is a white graphic that resembles a crescent moon with a profile of a face within it. Below the square, the word "HORIGEN" is written in a bold, serif font, also in red.

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 Person:	Jun Deng
	General Manager
	Guangdong Horigen Mother & Baby Products 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)-20-6231 6262
	Fax: (+86) -20-8633 0253
Date prepared	Sep 27, 2016

2. DEVICE

Device Name:	Proture Double Electric Breast Pump
Common/Usual Name:	Powered breast pump
Regulation number	21 CFR 884.5160 Powered breast pump
Regulation Class:	II
Product Code:	HGX Pump, Breast, Powered

3. PREDICATE DEVICE

K160511, Naya Breast Pump System This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

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Image /page/4/Picture/0 description: The image is a logo featuring a red square with rounded corners. Inside the square, there's a white crescent moon shape with a profile of a face looking towards the right. Below the square, there is a word that appears to be a brand name, but the text is cut off at the bottom of the image.

DEVICE DESCRIPTION

The Proture Double Electric Breast Pump provides the following user features:

. Closed system with anti-backflow
. LCD screen touch button operation
2-phase expression: Stimulation and Expression phases
- Stimulation Phase: Suction pattern with fast cycles (53-107 cycles/min) and low vacuum (15-120mmHg) to start milk flowing, 5 levels
- Expression Phase: Suction pattern with slower cycles (19~47T/min) and higher vacuum (82-247mmHg) 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

5. INDICATIONS FOR USE

The Proture Double Electric Breast Pump is a powered breast pump to be used by lactating women in a home setting to express and collect milk from their breasts. This device is intended for a single user.

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Image /page/5/Picture/0 description: The image contains the logo for HORIGEN. The logo features a red square with rounded corners. Inside the square is a white graphic of a crescent moon shape with a silhouette of a face looking towards the right. Below the square, the word "HORIGEN" is written in red, with a serif font.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Specification	Predicate Device	Proposed Device	Discussion of Differences
Device name	Naya Breast PumpSystem	Proture Double ElectricBreast Pump
K number	K160511	K164727
Product code	HGX	HGX	Identical
Indication for Use	The Naya Breast PumpSystem is a poweredbreast pump to be usedby lactating women inthe hospital or homesetting to express andcollect milk from theirbreasts.	The Proture Double ElectricBreast Pump is a poweredbreast pump to be used bylactating women in a homesetting to express andcollect milk from theirbreasts. This device isintended for a single user.	Different.The proposed device is only forsingle users in a homeenvironment.Same Intended Use
PatientPopulation	Lactating women	Lactating women	Identical
Environment ofUse	Home and Hospital	Home	Different.The proposed device is onlyintended for a homeenvironment.Same Intended Use
Pump Style	Reciprocating Pump	Reciprocating Pump	Identical
Single/doublepump	both	both	Identical
Adjustablesuction levels	10 levels	9 levels	Similar.Less suction levels.This difference does not raisedifferent questions of safetyand effectiveness.
Cycle speed(cycles/min)	34–120	19-107	Similar.Lower cycle speed.This difference does not raisedifference questions of safetyand effectiveness.
Visual indicator	a mobile App	LCD Screen	Different.Different user interface.This difference does not raisedifferent questions of safetyand effectiveness.
HORIGEN
510(k) Premarket Notification Submission
Specification	Predicate Device	Proposed Device	Discussion of Differences
Vacuum range(mmHg)	50-260	15-247	Similar.Lower vacuum levels.This difference does not raisedifference questions of safetyand effectiveness.
Cycling/SuctionControlMechanism	Microprocessor	Microprocessor	Identical
Power source	Input: 100-240 VAC,50/60Hz,2.1A	Input: 100-240 V, 50/60Hz,1.6A	Similar.Different batteries.Complied with IEC 60601-1
	Rechargeable Li-ionBattery	Battery or A/C Adapter	and IEC 60601-1-2.This difference does not raisedifferent questions of safetyand effectiveness.
Software	Yes	Yes	Identical
Anatomical Sites	breast	breast	Identical
Cleaning methodfor Accessories	Soap and warm water	Soap and warm water	Identical
Materials incontact with userand expressedmilk tested perISO 10993-1	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Identical
Electrical Safety	IEC 60601-1IEC 60601-1-2	IEC 60601-1IEC60601-1-2	Identical

Table 6.1 Comparison with Predicate Device

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Image /page/6/Picture/0 description: The image is a logo with a red square background. Inside the square is a white crescent moon shape. Within the crescent moon shape are two faces facing each other in profile. The faces are also white and appear to be in a silhouette style.

According to the above comparison, the proposed device is comparable to the predicate device in pump style, single/double pump, cycling/suction control mechanism, anatomical sites, cleaning method for accessories, biocompatibility and electrical safety.

Compared with the predicate device, the proposed device is indicated for single users in a home environment, while the predicate device is indicated for use by single or multiple users in a home or hospital environment. These differences in physical location of use do not impact the intended use (expressing and collecting milk from breasts), which is the same for the proposed and predicate devices.

In terms of technology compared with the predicate device, the proposed device has less suction levels, different cycle speeds, different vacuum range, a different device interface, and type of batteries. However, as noted in the table above, these differences in technological characteristics do not raise different questions of safety and effectiveness as compared to the predicate device.

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PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Double Electric Breast Pump was conducted in accordance with the International Standard ISO 10993-1:2009/(R)2013, "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
Sensitization
Skin Irritation

The breast shield body and silicone cushion of the Proture Double Electric Breast Pump are considered to contact directly with the human body and breast milk for a duration of less than 24 hours. Testing for cytotoxicity, sensitization and skin irritation complied with ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Testing demonstrates that the materials are non-cytotoxic, non-sensitizing, and non-irritating.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Proture Double Electric Breast Pump. The device complies with the IEC 60601-1:2012, standard for electrical safety and the IEC 60601-1-2:2007 standard for EMC. It demonstrates substantial equivalences to the predicate device.

Performance testing

Performance testing was conducted on the Proture Double Electric Breast Pump. Technical parameters of stimulation mode and suction mode, including working current, pressure, cycle rate and noise were evaluated in the performance testing, as well as the stability of vacuum level and use-life. All of the tested parameters meet the predefined acceptance criteria. The performance parameters were compared with the predicate device in Table 6.1, and it is concluded that the proposed device is substantially equivalent to the predicate device.

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Image /page/8/Picture/0 description: The image features the logo for HORIGEN. The logo consists of a rounded square with a pink background. Inside the square is a white graphic that appears to be a stylized representation of a human face in profile, possibly a mother and child. Below the square, the word "HORIGEN" is written in a serif font, also in pink.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern. Software validation demonstrated that the software functions as specified in the software requirement specifications. It demonstrates substantial equivalences to the predicate device.

Animal Study

The subject of this premarket submission, Proture Double Electric Breast Pump, does not require animal studies to support substantial equivalence.

Clinical Study

The subject of this premarket submission, Proture Double Electric Breast Pump, did not require clinical studies to support substantial equivalence.

8. CONCLUSION

The differences between the Proture Double Electric Breast Pump and its predicate device 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 Proture Double 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 Proture Double Electric Breast Pump is as safe and as effective as 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).