(69 days)
No reference devices were used in this submission.
No
The description mentions a "single-chip microcomputer" and "electronic memory" to imitate sucking rhythms, but there is no mention of AI or ML algorithms, training data, or performance metrics typically associated with such technologies. The device appears to use pre-programmed patterns and user-selectable levels.
No.
A therapeutic device is typically used to treat a disease, injury, or other medical condition. A breast pump is used to express milk and does not treat a medical condition.
No
The device is a breast pump, intended for expressing and collecting milk. It does not perform any diagnostic function.
No
The device description explicitly states it comprises a pump unit and expression collection kit including tubing, made of physical materials like polypropylene and silicone. It also mentions hardware components like a single-chip microcomputer, keyboard, LCD screen, and dual power source options (A/C adapter or batteries). While it includes software for control, it is fundamentally a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Breast Pump Function: The Proture Double Electric Breast Pump is used to physically express and collect milk from a lactating woman's breast. It does not analyze or test any biological sample to diagnose or monitor a medical condition.
- Intended Use: The intended use clearly states it's for "expressing and collecting milk from their breasts." This is a mechanical function, not a diagnostic one.
The information provided about the device's performance studies (biocompatibility, electrical safety, performance testing) and software validation are typical for a medical device, but they do not indicate that it is an IVD. These tests ensure the device is safe and functions correctly for its intended purpose of milk expression.
N/A
Intended Use / 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.
Product codes
HGX
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.
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
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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
1
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
2
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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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:
-
- 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
- SUBMITTER
| 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.
4
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 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.
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.
5
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 Pump | ||
| System | Proture Double Electric | ||
| Breast Pump | |||
| K number | K160511 | K164727 | |
| Product code | HGX | HGX | Identical |
| Indication for Use | The Naya Breast Pump | ||
| System is a powered | |||
| breast pump to be used | |||
| by lactating women in | |||
| the hospital or home | |||
| setting to express and | |||
| collect milk from their | |||
| breasts. | 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. | Different. | ||
| The proposed device is only for | |||
| single users in a home | |||
| environment. | |||
| Same Intended Use | |||
| Patient | |||
| Population | Lactating women | Lactating women | Identical |
| Environment of | |||
| Use | Home and Hospital | Home | Different. |
| The proposed device is only | |||
| intended for a home | |||
| environment. | |||
| Same Intended Use | |||
| Pump Style | Reciprocating Pump | Reciprocating Pump | Identical |
| Single/double | |||
| pump | both | both | Identical |
| Adjustable | |||
| suction levels | 10 levels | 9 levels | Similar. |
| Less suction levels. | |||
| This difference does not raise | |||
| different questions of safety | |||
| and effectiveness. | |||
| Cycle speed | |||
| (cycles/min) | 34–120 | 19-107 | Similar. |
| Lower cycle speed. | |||
| This difference does not raise | |||
| difference questions of safety | |||
| and effectiveness. | |||
| Visual indicator | a mobile App | LCD Screen | Different. |
| Different user interface. | |||
| This difference does not raise | |||
| different questions of safety | |||
| and 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 raise | |||
| difference questions of safety | |||
| and effectiveness. | |||
| Cycling/Suction | |||
| Control | |||
| Mechanism | 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-ion | |||
| Battery | Battery or A/C Adapter | and IEC 60601-1-2. | |
| This difference does not raise | |||
| different questions of safety | |||
| and effectiveness. | |||
| Software | Yes | Yes | Identical |
| Anatomical Sites | breast | breast | Identical |
| Cleaning method | |||
| for Accessories | Soap and warm water | Soap and warm water | Identical |
| Materials in | |||
| contact with user | |||
| and expressed | |||
| milk tested per | |||
| ISO 10993-1 | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-5 | ||
| ISO 10993-10 | Identical | ||
| Electrical Safety | IEC 60601-1 | ||
| IEC 60601-1-2 | IEC 60601-1 | ||
| IEC60601-1-2 | Identical |
Table 6.1 Comparison with Predicate Device
6
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.
7
Image /page/7/Picture/0 description: The image is a logo for a company or organization. The logo features a red square with rounded corners. Inside the square, there is a white crescent shape with a profile of a face looking towards the right. Below the square, there is text that appears to be the name of the company or organization, but the text is blurry and difficult to read.
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.
8
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.