Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a microcontroller controlling a DC motor for vacuum and speed, with predefined modes. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.

Therapeutic

No.
The device is a breast pump used to express and collect milk, which is not considered a therapeutic function that cures or alleviates a disease.

Diagnostic

No
The device is a breast pump used to express and collect milk, not to diagnose a medical condition. Its function is purely mechanical to facilitate milk expression.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a diaphragm-type vacuum pump, DC-motor, rechargeable lithium ion battery, and AC adapter. While software is mentioned for control, the device is fundamentally a physical breast pump with integrated hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device function: The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are used to physically express and collect milk from a lactating woman's breast. This is a mechanical process performed on the body, not a test performed on a sample taken from the body.
Intended Use: The intended use is to "express and collect milk from their breasts," which aligns with a physical function, not a diagnostic test.

Therefore, the device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.

Product codes

HGX

Device Description

The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are single-user powered breast pumps capable of single pumping. The subject devices are powered by a rechargeable lithium ion battery or AC adapter. They are non-sterile. The powered breast pumps' drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over vacuum pressure and cycle speed.

Models YY-A11, YY-A21 and YY-A41 are capable of single pumping and have two modes:

Massage mode: Helps to relax the muscle around the breast and prepare for suction. .
. Normal mode: Suction patterns are characterized by low vacuum to start milk flow.

In addition to the two modes described above, Models YY-A31, YY-A103, YY-A103, YY-A104, and BF103 are capable of single pumping and have an additional mode:

. Rapid mode: Suction patterns are characterized by high vacuum to express more milk.
Model BF100 is capable of single and double pumping and has two modes only:
Letdown mode: Helps to relax the muscle around the breast and prepare for suction. ●
Expression mode: Suction patterns are characterized by high vacuum to express more milk. .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

breasts

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home

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)

Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:

a. Electromagnetic Compatibility, Electrical Safety, and Battery Safety: The subject devices were tested in compliance with the following:
- i. ANSI/AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- ii. IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- iii. IEC 60601-1-11 Medical electrical equipment Part 1-11: 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
- iv. IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
Biocompatibility: Patient contacting components were subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
Software Verification: Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
Performance Testing: Bench testing was conducted to demonstrate pump performance di (vacuum performance, speed verification, milk collection in the worst-case scenario), batterv performance, backflow protection, and overflow protection were tested using internal test protocols.

Key results: The results of the performance testing described above demonstrate that the Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are as safe and effective as the predicate device and supports a determination of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K181937

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

March 30, 2020

Guangzhou Yongyi Industrial Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou. 510000 CHINA

Re: K192640

Trade/Device Name: Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 25, 2020 Received: February 28, 2020

Dear Cassie Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192640

Device Name

Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump

Indications for Use (Describe)

The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K192640

1. Submitter Information

Sponsor Name:	Guangzhou Yongyi Industrial Co., Ltd.
Address:	B3, No.29, Qixin Road, Dongchong Town, Nansha District, Guangzhou
Guangdong China.
Contact name:	Jian Zhongrong (GM)
Tel:	+86-020-39953345
Fax:	+86-020-39953354
E-mail:	diky@kidrobaby.com

Application Correspondent:

Contact Person:	Ms. Cassie Lee
	Guangzhou GLOMED Biological Technology Co., Ltd.
Address:	2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District,
	Guangzhou, Guangdong, China
Tel:	+86-20-61099984
Email:	regulatory@glomed-info.com

Date summary was prepared: March 25, 2020

2. Subject Device Information

Trade Name:	Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
Models:	Kidro: YY-A11, YY-A21, YY-A31, YY-A41, YY-A51, YY-A103, YY-A104
	Dr. Brown's: BF103, BF100
Common Name:	Powered Breast Pump
Regulation Number:	884.5160
Product Code:	HGX (pump, breast, powered)
Class:	II
Review Panel:	Obstetrics/Gynecology

3. Predicate Device Information

510(K) Number:	K181937
Device Name:	Pump In Style® Advanced
Manufacturer:	Medela LLC

The predicate device has not been subject to a design-related recall.

4. Device Description

The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are single-user powered breast pumps capable of single pumping. The subject devices are powered by a rechargeable lithium ion battery or AC adapter. They are non-sterile. The powered breast pumps' drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over vacuum pressure and cycle speed.

Models YY-A11, YY-A21 and YY-A41 are capable of single pumping and have two modes:

Massage mode: Helps to relax the muscle around the breast and prepare for suction. .
. Normal mode: Suction patterns are characterized by low vacuum to start milk flow.

In addition to the two modes described above, Models YY-A31, YY-A103, YY-A103, YY-A104, and BF103 are capable of single pumping and have an additional mode:

4

. Rapid mode: Suction patterns are characterized by high vacuum to express more milk.
Model BF100 is capable of single and double pumping and has two modes only:
Letdown mode: Helps to relax the muscle around the breast and prepare for suction. ●
Expression mode: Suction patterns are characterized by high vacuum to express more milk. .

5. Indications for Use

The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.

6. Predicate Comparison

The following table compares the subject devices to the predicate with respect to the indications for use and technological characteristics:

| Device | Subject Device
K192640 | Predicate Device
K181937 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Guangzhou Yongyi Industrial Co.,
Ltd. | Medela LLC |
| Name and Model | Kidro Digital Electric Breast Pump
Models: YY-A11, YY-A21, YY-A31, YY-A41, YY-
A51, YY-A103, YY-A104

5

| Vacuum range
(mmHg) | YY-A11/YY-A21/YY-A41: -67.5 to -285mmHg
YY-A31/YY-A51/YY-A103/YY-A104/BF103:
-97.5 to -295mmHg
BF100: -45 to -231mmHg | -50 to -240 mmHg |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Cycle Speed | YY-A11/YYA21/YY-A41: 49-63 cycles/min
YY-A31/YY-A51/YY-A103/YY-A104/BF103: 40-
63 cycles/min
BF100: 36-63 cycles/min | 120 cycles |
| Cycling/Suction
Control | Microprocessor | Microprocessor |
| Power Supply type | AC Adapter or rechargeable lithium battery | AC Adapter, AA batteries, or
Switching vehicle power adapter |
| Battery use life | Approx.1.5h for pumping time | Unknown |
| Low battery
indicator | Yes | Unknown |
| Automatic Power
Off | Yes | Unknown |

The subject devices have similar indications for use and the same intended use as the predicate device, As noted in the table above, the subject and predicate devices have different technological characteristics. The differences in technological characteristics do not raise different questions of safety and effectiveness.

7. Summary of Non-Clinical Testing

Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:

a. Electromagnetic Compatibility, Electrical Safety, and Battery Safety: The subject devices were tested in compliance with the following:
- i. ANSI/AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- ii. IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- iii. IEC 60601-1-11 Medical electrical equipment Part 1-11: 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
- iv. IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
ﻘ Biocompatibility: Patient contacting components were subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation

6

and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).

ﻥ Software Verification: Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
Performance Testing: Bench testing was conducted to demonstrate pump performance di (vacuum performance, speed verification, milk collection in the worst-case scenario), batterv performance, backflow protection, and overflow protection were tested using internal test protocols.

Conclusion 8.

The results of the performance testing described above demonstrate that the Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are as safe and effective as the predicate device and supports a determination of substantial equivalence.