(84 days)
No
The description details a microcontroller-based system with predefined modes (stimulation and expression) and control over motor speed and solenoid. There is no mention of learning, adaptation, or complex pattern recognition that would indicate AI/ML. The software validation is based on a 2005 guidance document, predating widespread AI/ML in medical devices.
No
The device is used to express and collect milk, which is a supportive function rather than treating a medical condition or disease.
No
The device is an Electric Breast Pump used to express and collect milk, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description explicitly details hardware components such as a motor, breast shields, tubing, bottle, valve, diaphragm-type vacuum pump, DC-motor, and microcontroller. The performance studies also include testing related to electrical safety, EMC, and biocompatibility, which are associated with hardware.
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.
- Device Description: The device description details a mechanical pump that applies suction to the breast. It does not involve any reagents, test strips, or analysis of biological samples.
- Performance Studies: The performance studies focus on electrical safety, EMC, biocompatibility, software validation, and mechanical performance (vacuum pressure, battery life). These are typical tests for a medical device that interacts with the body, not for an IVD which would involve analytical performance characteristics like sensitivity and specificity.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like milk for composition or indicators), using reagents, or providing diagnostic information based on a sample.
In summary, the Electric Breast Pump is a medical device used for a physical process (milk expression), not for performing a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.
Product codes
HGX
Device Description
The Electric Breast Pump is a personal use electric breast pump capable of single pumping. The device is electrically powered from either internal batteries or an external AC powered supply and is provided non-sterile.
The Electric Breast Pump consists of the motor, breast shields, tubing, bottle and valve. The materials used are silicone (breast shield) and polypropylene (Pump body and bottle).
The electric breast pump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release).
The device has two modes of operation:
- Stimulation mode: Suction patterns with fast cycles and low vacuum to start milk flowing
- . Expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.
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 or Hospital
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)
Performance testing was conducted to validate and verify that the Electric Breast Pump met all requirements of the applicable standards, including electrical safety, EMC, and biocompatibility. Results of these tests demonstrate compliance to the following standards:
Electrical Safety and performance requirements:
-
AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment
Home-used medical equipment requirements and environmental test: -
· IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic compatibility requirements: -
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation for patient contacting components: -
Cytotoxicity ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests . for in vitro cytotoxicity
-
Sensitization ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: . Tests for irritation and skin sensitization
-
Irritation ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for . irritation and skin sensitization
Software Validation:
The software/firmware verification and validation was provided in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Bench Performance Testing:
The following bench testing was completed on the subject device:
- . Vacuum pressure range (suction)
- Maximum vacuum pressure .
- Backflow-leakage testing .
- Battery life testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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December 20, 2017
Joytech Healthcare Co., Ltd. Ren Yunhua General manager No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City, Zhejiang 311100 China
K172989 Re: Trade/Device Name: Electric Breast Pump (Models LD-202 and LD-213) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 15, 2017 Received: September 27, 2017
Dear Ren Yunhua:
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.
1
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 of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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) K172989
Device Name
Electric Breast Pump (Models LD-202 and LD-213)
Indications for Use (Describe)
The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump 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
JOYTECH HEALTHCARE CO. LTD.
510(k) Summary
K172989
1. Date Prepared: 2017.12.19
2. Submitter's Identification:
Name: JOYTECH HEALTHCARE CO., LTD.
- Address: No.365, Wuzhou Road, Yuhang Economic Development Zone,Hangzhou City, 311100 Zhejiang,China
Contact Person: Yunhua Ren
Phone: +86-571-81957767
Fax: +86-571-81957750
RENYH@SEJOY.COM Email:
3. Name of the Device:
Trade Name: Electric Breast Pump (Models LD-202, LD-213)
4. Classification Information:
| Common Name: | Electric Breast Pump |
|---|---|
| Classification name: | Powered breast pump |
| Regulation number: | 884.5160 |
| Product Code: | HGX, Powered breast pump |
| Device Class: | II |
| Panel: | Obstetrics/Gynecology |
4
Image /page/4/Picture/1 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is Chinese characters.
JOYTECH HEALTHCARE CO. LTD.
5. Predicate Device Information:
Medela Swing Breast Pump (K053052); Medela AG
The predicate device has not been subject to a design-related recall.
6. Indications for Use:
The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The electric breast pump is intended for a single user.
7. Device Description:
The Electric Breast Pump is a personal use electric breast pump capable of single pumping. The device is electrically powered from either internal batteries or an external AC powered supply and is provided non-sterile.
The Electric Breast Pump consists of the motor, breast shields, tubing, bottle and valve. The materials used are silicone (breast shield) and polypropylene (Pump body and bottle).
The electric breast pump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release).
The device has two modes of operation:
- Stimulation mode: Suction patterns with fast cycles and low vacuum to start ● milk flowing
- . Expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.
| | Subject Device
K172989 | Predicate
device
K053052 | Comparison |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------|
| Indication for use | A powered breast pump
to be used by lactating
women to express and
collect milk from
their breasts. | A powered breast pump
to be used by lactating
women to express and
collect milk from
their breasts. | Identical |
| Patient Population | Lactating women | Lactating women | Identical |
| Environment of Use | Home | Home or Hospital | Similar |
| Single/double pump | Single pump | Single pump | Identical |
| Re-usable | Yes | Yes | Identical |
| Direct user contact | Yes | Yes | Identical |
| Adjustable
suction
levels | Yes | Yes | Identical |
8. Predicate Device Comparison:
5
| JOYTECH HEALTHCARE CO. LTD. | |||
|---|---|---|---|
| Visual indicator | LCD Screen | LED | Similar |
| Vacuum range | |||
| (mmHg) | -60~-250mmHg | -50~-250mmHg | Similar |
| Cycling/Suction | |||
| Control | |||
| Mechanism | Microprocessor | Microprocessor | Identical |
| Breastshield size | 24mm or 27mm | 21mm,24mm,27mm,30mm | |
| or 36mm | Similar. | ||
| Cleaning method for | |||
| Accessories | Soap and warm water | Soap and warm water | Identical |
| Battery type | 4 AA batteries or Medical | ||
| AC Adapter (DC6.0V, | |||
| 1000mA) | 4 AA batteries or | ||
| AC Adapter (DC4.8V, 1.2A) | Similar | ||
| Battery use life | Approx.1.5h for pumping time | Approx.1.5h for | |
| pumping time | Identical | ||
| Low | |||
| battery | |||
| indicator | Yes | Yes | Identical |
| Automatic | |||
| Power- | |||
| Off | Yes | Yes | Identical |
The Electric Breast Pump has the same intended use but minor differences in technological characteristics compared to the predicate device. These minor differences in technological characteristics do not raise different questions of safety and effectiveness.
9. Performance data
The following performance data were provided in support of the substantial equivalence determination.
Performance testing was conducted to validate and verify that the Electric Breast Pump met all requirements of the applicable standards, including electrical safety, EMC, and biocompatibility. Results of these tests demonstrate compliance to the following standards:
Electrical Safety and performance requirements:
-
AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment
Home-used medical equipment requirements and environmental test: -
· IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic compatibility requirements: -
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation for patient contacting components: -
Cytotoxicity ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests . for in vitro cytotoxicity
-
Sensitization ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: . Tests for irritation and skin sensitization
6
JOXTEC-11116
JOYTECH HEALTHCARE CO. LTD.
- Irritation ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for . irritation and skin sensitization
Software Validation
The software/firmware verification and validation was provided in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Bench Performance Testing
The following bench testing was completed on the subject device:
- . Vacuum pressure range (suction)
- Maximum vacuum pressure .
- Backflow-leakage testing .
- Battery life testing .
10. Conclusions:
The performance testing provided is sufficient to support substantial equivalence determination. Based on the information provided in this submission, the Joytech Electric Breast Pump is as safe and effective as the predicate Medela Swing Breast Pump.