(207 days)
No
The summary describes standard electric breast pump functionality with Bluetooth connectivity for remote control, but no mention of AI or ML for data analysis, pattern recognition, or adaptive behavior.
No.
The device is intended to express and collect milk from the breasts of lactating women, which is a supportive function rather than a treatment for a disease or condition.
No
Explanation: The device is an electric breast pump intended to express and collect milk. Its function is not to diagnose any condition.
No
The device description clearly states it is a "powered breast pump" and describes physical components like a diaphragm, tubing, and pump unit, indicating it is a hardware device with some software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Electric Breast Pumps are designed to physically express and collect milk from the breasts of lactating women. They do not perform any diagnostic tests on biological samples.
- Intended Use: The intended use is solely for expressing and collecting breast milk. There is no mention of analyzing or testing the milk or any other bodily fluid for diagnostic purposes.
Therefore, the function and intended use of these electric breast pumps clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Electric Breast Pumps are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
Product codes
HGX
Device Description
The subject devices are intended to be used by lactating women to express and collect milk from their breasts. The devices are intended for a single user in the home environment or hospital setting. When properly connected, the pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination.
The Electric Breast Pumps contain 4 models, YY-A203, YY-A204 and YY-TC201. The YY-A46 model operates in single pumping mode only; models YY-A203, YY-A204 and YY-TC201 can be operated in single or double pumping modes. Models YY-A203 and YY-A204 have an LED panel and model YY-TC201 has an LCD panel to display working mode, cycle, timer, battery level, and Bluetooth symbol to user. While YY-A46 has an LED indicator to indicate the working status of the device, models YY-A46, YY-A203, and YY-A204 can be wirelessly operated via Bluetooth connection to a smart device. Users can select the working mode, adjust the suction level and cycle speed, and start or pause the device from a smart device. Model YY-TC201 can only be operated on the pump unit itself. All models have massage and expression mode and have a maximum working time of 30 minutes.
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
Single user, Home environment or hospital 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)
Non-clinical tests were conducted to verify that the subject devices met all design specifications and that the subject devices are substantially equivalent to the predicate device. The subject devices were tested as follows:
- Electromagnetic Compatibility and Electrical Safety
- ANSI AAMI ES 60601-1:2005/(R)2012 & A1:2012, Medical electrical equipment Part 1: . General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)] (Recognition Number 19-46)
- . IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical equipment and medical electrical systems used in the home healthcare environment (Recognition Number 19-38)
- . IEC 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
- Software Validation
The software documentation of the subject device was provided in accordance with FDA guidance document, "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005. - Biocompatibility
The pumping kits of the subject devices are identical to K192640 in formulation, processing, and cleaning. Therefore, biocompatibility information from K192640 can be leveraged to support the biocompatibility of patient-contacting components of the subject device. - Performance Testing
- . Vacuum and cycle performance testing were conducted at all settings and demonstrated that the device met its specifications.
- . Backflow protection testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- . Use life testing was conducted to demonstrate that the device maintains its performance specification throughout its proposed use-life.
- . Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- . Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
Key results: The results of the testing described above demonstrate that the subject device is 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)
Reference Device(s)
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/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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 26, 2023
Guangzhou Yongyi Industrial Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biologcial Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 523000 China
K223329 Re:
Trade/Device Name: Electric Breast Pumps (model: YY-A203, YY-A203, YY-A204, YY-TC201) Regulation Number: 21 CFR$ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: April 24, 2023 Received: April 24, 2023
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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Monica D. Garcia -S
Monica D. Garcia, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K223329
Device Name
Electric Breast Pumps (model: YY-A46, YY-A203, YY-A204, YY-TC201)
Indications for Use (Describe)
The Electric Breast Pumps are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
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
510(k) Summary - K223329
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter
Sponsor Name: Guangzhou Yongyi Industrial Co., Ltd. Address: No. 4, Majun Rd., Dongchong Town, Nansha District, Guangzhou, Guangdong, China Contact Person: Wei Hu Establishment Registration Number: 3016562061 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
2. Date of the summary prepared: May 25, 2023
3. Subject Device Information
Device/Trade Name: Electric Breast Pumps (Models: YY-A46, YY-A203, YY-A204, YY-TC201) Common or Usual Name: Powered breast pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX (Pump, Breast, Powered)
4. Predicate Device
CIMILRE F1 and CIMILRE S3, K162870 This predicate device has not been subject to a design-related recall.
5. Device Description
4
The subject devices are intended to be used by lactating women to express and collect milk from their breasts. The devices are intended for a single user in the home environment or hospital setting. When properly connected, the pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination.
The Electric Breast Pumps contain 4 models, YY-A203, YY-A204 and YY-TC201. The YY-A46 model operates in single pumping mode only; models YY-A203, YY-A204 and YY-TC201 can be operated in single or double pumping modes. Models YY-A203 and YY-A204 have an LED panel and model YY-TC201 has an LCD panel to display working mode, cycle, timer, battery level, and Bluetooth symbol to user. While YY-A46 has an LED indicator to indicate the working status of the device, models YY-A46, YY-A203, and YY-A204 can be wirelessly operated via Bluetooth connection to a smart device. Users can select the working mode, adjust the suction level and cycle speed, and start or pause the device from a smart device. Model YY-TC201 can only be operated on the pump unit itself. All models have massage and expression mode and have a maximum working time of 30 minutes.
6. Indications for Use
The Electric Breast Pumps are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
7. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
| Elements of
| Comparison | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Sponsor | Guangzhou Yongyi | ||
| Industrial Co., Ltd. | Cimilre Co., Ltd. | -- | |
| Device Name and | |||
| Model | Electric Breast Pump, | ||
| Models: YY-A46, YY-A203, | |||
| YY-A204, YY-TC201 | CIMILRE F1 and CIMILRE | ||
| S3 | -- | ||
| 510(k) Number | K223329 | K162870 | -- |
| Product Code | HGX | HGX | Same |
| Device Class | II | II | Same |
| Indications for | |||
| Use | The Electric Breast Pumps | ||
| are single-user, powered | |||
| breast pumps intended to | |||
| express and collect milk | |||
| from the breasts of lactating | |||
| women. | The CIMILRE F1 and | ||
| CIMILRE S3 are single- | |||
| user, powered breast | |||
| pumps intended to express | |||
| and collect milk from the | |||
| breasts of lactating women. | Same | ||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Comparison |
| Intended use | |||
| population | Single user | Single user | Same |
| Intended use | |||
| environment | Home environment | Home environment | Same |
| Power Supply | AC adapter: | ||
| Input 100-240 VAC, | |||
| 50/60Hz and output of 5V | |||
| 1A DC | |||
| Battery: | |||
| YY-A46: 3.7V, 760mAh | |||
| YY-A203, YY-A204, YY- | |||
| TC201: 3.7V, 3000mAh | AC/DC Converter (12 VDC) | ||
| Rechargeable Lithium | |||
| Polymer Battery (only for | |||
| CIMILRE F1) | Similar | ||
| Pump type | Diaphragm | Diaphragm | Same |
| Pump options | YY-A46: single | ||
| YY-A203, YY-A204, YY- | |||
| TC201: single or double | Single or double | Same | |
| Black flow | |||
| protection | Yes | Yes | Same |
| Modes | 2 modes (massage mode, | ||
| expression mode) | 2 modes (massage mode, | ||
| expression mode) | Same | ||
| Vacuum levels | YY-A46 | ||
| Massage model: 6 levels | |||
| Expression mode: 12 levels | |||
| YY-A203, YY-A204, YY- | |||
| TC201: | |||
| Massage model: 5 levels | |||
| Expression mode: 12 levels | CIMILRE F1 | ||
| Massage model: 5 levels | |||
| Expression mode: 10 levels | |||
| CIMILRE S3 | |||
| Massage model: 5 levels | |||
| Expression mode: 12 levels | Similar | ||
| Suction Strength | YY-A46: | ||
| Massage model: 60- | |||
| 185mmHg | |||
| Expression mode: 45- | |||
| 260mmHg | |||
| YY-A203, YY-A204, YY- | |||
| TC201: | |||
| Massage model: 65- | |||
| 200mmHg | |||
| Expression mode: 75- | |||
| 265mmHg | 40-280mmHg | Similar | |
| Cycle range | |||
| (Cycles/min) | Massage mode: | ||
| YY-A46: 59/65/72/78/85/92 | |||
| YY-A203, YY-A204: 50 | |||
| YY-TC201: 45/50 | |||
| Expression mode: | |||
| YY-A46: | |||
| 38/46/53/58/64/68/72 | |||
| YY-A203, YY-A204, YY-TC201: 38/46/53/58/64/68/72 | 25-60 (F1) | ||
| 30-60 (S3) | Similar | ||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Comparison |
| User | |||
| interface/control | TC201: 20/24/28/32 | ||
| YY-A46: power button, | |||
| mode button, suction | |||
| increase, suction decrease, | |||
| mode switch, indicator | |||
| YY-A203, YY-A204: power | |||
| button, nightlight button, | |||
| expression mode, massage | |||
| mode, suction increase, | |||
| suction decrease, cycle up, | |||
| cycle down, LCD Display |
YY-TC201: power button,
suction increase, suction
decrease, mode button,
night light, LCD Display | Tact switch control
Power, Vacuum/Cycle Up
or Down; Mode switch
LCD Display | Similar |
| Mobile application
and wireless
functionality | YY-A46, YY-A203, YY-
A204: Bluetooth
connectivity | None | Different |
| | YY-TC201: None | | |
5
6
The subject and predicate device have similar indications for use statements and have the same intended use (i.e., to express and collect milk from the breasts of lactating women). The subject and predicate device have different technological characteristics, including different power supplies, vacuum strengths, cycle speeds, and user interfaces. However, these differences in technological characteristics do not raise different questions of safety and effectiveness.
8. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the subject devices met all design specifications and that the subject devices are substantially equivalent to the predicate device. The subject devices were tested as follows:
1) Electromagnetic Compatibility and Electrical Safety
- ANSI AAMI ES 60601-1:2005/(R)2012 & A1:2012, Medical electrical equipment Part 1: . General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)] (Recognition Number 19-46)
- . IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical equipment and medical electrical systems used in the home healthcare environment (Recognition Number 19-38)
7
- . IEC 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
2) Software Validation
The software documentation of the subject device was provided in accordance with FDA guidance document, "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005.
3) Biocompatibility
The pumping kits of the subject devices are identical to K192640 in formulation, processing, and cleaning. Therefore, biocompatibility information from K192640 can be leveraged to support the biocompatibility of patient-contacting components of the subject device.
4) Performance Testing
- . Vacuum and cycle performance testing were conducted at all settings and demonstrated that the device met its specifications.
- . Backflow protection testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- . Use life testing was conducted to demonstrate that the device maintains its performance specification throughout its proposed use-life.
- . Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
- . Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
9. Conclusion
The results of the testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.