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.

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.

AI/ML Overview

The provided document details the 510(k) summary for the Joytech Healthcare Co., Ltd. Electric Breast Pump (Models LD-202 and LD-213). It focuses on demonstrating substantial equivalence to a predicate device, the Medela Swing Breast Pump (K053052).

While the document describes performance tests conducted, it does not provide a table of specific acceptance criteria and detailed reported device performance for functional aspects (like vacuum pressure, battery life, or backflow leakage) that would be expected to demonstrate clinical effectiveness. Instead, it refers generally to "all requirements of the applicable standards" and lists the types of tests performed.

Therefore, for the information requested regarding acceptance criteria and detailed performance, I can only extract general statements and the types of tests, not specific numerical criteria or results.

Here's a summary of the information available, addressing your points as much as possible:

1. A table of acceptance criteria and the reported device performance

The document mentions that "Performance testing was conducted to validate and verify that the Electric Breast Pump met all requirements of the applicable standards." However, it does not provide a table with specific numerical acceptance criteria for functional performance (e.g., a specific vacuum range and the measured performance) nor the detailed reported device performance directly. It only lists the types of tests performed.

Acceptance Criteria Category	Reported Device Performance (General Statement/Test Type)
Electrical Safety	Compliance to 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	Compliance to 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 (EMC)	Compliance to 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 - Cytotoxicity	Compliance to ISO 10993-5:2009 "Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity"
Biocompatibility - Sensitization	Compliance to ISO10993-10:2010 "Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization"
Biocompatibility - Irritation	Compliance to ISO10993-10:2010 "Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization"
Software Validation	Verification and validation in accordance with FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Bench Performance - Vacuum pressure	Testing conducted for "Vacuum pressure range (suction)" and "Maximum vacuum pressure." Specific numerical results or acceptance criteria are not provided.
Bench Performance - Backflow-leakage	Testing conducted for "Backflow-leakage testing." Specific numerical results or acceptance criteria are not provided.
Bench Performance - Battery life	Testing conducted for "Battery life testing." The comparison table indicates "Approx. 1.5h for pumping time" for both the subject and predicate devices, suggesting this is the expected performance.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for any of the performance tests. The tests appear to be bench testing (laboratory-based) rather than clinical studies involving human subjects for performance evaluation, as indicated by the "Bench Performance Testing" section. Therefore, there is no mention of data provenance in terms of country of origin or retrospective/prospective nature for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The performance testing described is bench testing against established engineering and biocompatibility standards, not evaluation by clinical experts establishing ground truth for a diagnostic output.

4. Adjudication method for the test set

Not applicable. This is not a study involving human reader interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with or without AI assistance.

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

This device is an electric breast pump, a mechanical and electrical device, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The performance tests are for the device's physical and electrical functions.

7. The type of ground truth used

For the safety and performance tests, the "ground truth" would be established by the specifications and requirements outlined in the referenced international standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993 series) and the internal design specifications for the vacuum pressure, cycling, and battery life. There's no clinical "ground truth" like pathology or outcomes data needed for this type of device submission.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device. The performance data comes from testing the physical device.

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

Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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,

Image /page/1/Picture/6 description: The image shows the text "Charles Viviano -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are evenly spaced, and the overall impression is clean and legible.

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)

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}------------------------------------------------

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 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 DeviceK172989	PredicatedeviceK053052	Comparison
Indication for use	A powered breast pumpto be used by lactatingwomen to express andcollect milk fromtheir breasts.	A powered breast pumpto be used by lactatingwomen to express andcollect milk fromtheir 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
Adjustablesuctionlevels	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/SuctionControlMechanism	Microprocessor	Microprocessor	Identical
Breastshield size	24mm or 27mm	21mm,24mm,27mm,30mmor 36mm	Similar.
Cleaning method forAccessories	Soap and warm water	Soap and warm water	Identical
Battery type	4 AA batteries or MedicalAC Adapter (DC6.0V,1000mA)	4 AA batteries orAC Adapter (DC4.8V, 1.2A)	Similar
Battery use life	Approx.1.5h for pumping time	Approx.1.5h forpumping time	Identical
Lowbatteryindicator	Yes	Yes	Identical
AutomaticPower-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.

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).