Electric Breast Pump

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December 1, 2021 Zhejiang Carebao Co., Ltd. % Iris Wang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue Xili Town Shenzhen, Guangdong 518000 CHINA Re: K211755 Trade/Device Name: Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: October 15, 2021 Received: November 1, 2021 Dear Iris Wang: 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. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K211755 Device Name Electric Breast Pump Indications for Use (Describe) The electric breast pump is intended to be used by lactating women to express and collect milk from their breast. It 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}------------------------------------------------ # 510(k) Summary – K211755 # 1. Submitter Information | Prepared Date | November 30, 2021 | |---------------|-------------------------------------------------------------| | Manufacturer | Zhejiang Carebao Co., Ltd. | | | Address: | | | 3, No.1, Chuangye 4th Road, Ningbo Free Trade Zone, Ningbo, | | | Zhejiang, China. | | | | | | Contact person: Yan Xie | | | TEL: +86-574-87902421 | | | E-Mail: xie.yan@unibono.com | | | | | Submission | Shenzhen Joyantech Consulting Co., Ltd. | | Correspondent | 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | | | Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | | | Province, China. | | | Contact person: Mr. Field Fu; Ms. Iris Wang; | | | E-Mail: field@cefda.com; iris@cefda.com | | | | | Image: Logo | | # 2. Device Information | Type of 510(k): | Traditional | |-------------------------|-----------------------------| | 510(k) Number: | K211755 | | Device Name/Trade Name: | Electric Breast Pump | | Common Name: | Powered breast pump | | Model: | YD-1130S, YD-1132S, YD-1168 | | Regulation Name: | Powered breast pump | | Regulation Number: | 884.5160 | | Product Code: | HGX (Pump, Breast, Powered) | | Regulatory Class: | II | # 3. Predicate Device Information {4}------------------------------------------------ | Manufacturer: | Shenzhen Bosidin Technology Co. Ltd. | |----------------|--------------------------------------| | Device Name: | Youha electric breast pump | | Model: | YH-8004, YH-8016, YH-8006IV, YH-8015 | | 510(k) Number: | K163136 | | Product Code: | HGX | The predicate device has not been subject to a design-related recall. ## 4. Device Description The electric breast pump is an over-the-counter powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment by a single user. The electric breast pump includes three models: YD-1132S, and YD-1168. YD-1130S and YD-1132S has a double pumping from both breasts at the same time) configuration only. YD-1168 has both single pumping (pumping from one breast) and double pumping (pumping from both breasts at the same time) configurations. The electric breast pump is comprised of the pump unit, system parts (including connector body, silicone shield, dust cap, top cover, diaphragm, valve, airway tube, bottle, nipple, bottle cap set, bottle stand), and USB cable. The electric breast pump provides the following features: - 1) Models YD-1130S and YD-1168 have two suction modes, as listed below: - o Massage mode: Suction patterns with fast cycles and low vacuum to start milk flowing. o Five vacuum levels from level L1-L5 for massage mode - . Expression mode: Suction patterns with slower cycles and higher vacuum to express milk gently and efficiently. - o Nine vacuum levels from level L1-L9 for expression mode. - 2) Model YD-1132S has two suction as listed below: - Massage mode: Suction patterns with fast cycles and low vacuum to start milk . flowing. - o Six vacuum levels from level L1-L6 for massage mode - o Vacuum level L6 of massage mode is called "Let-down control", which operates as follows: Quickly suck 3 times to start milk flowing (massage mode) and then slowly suck 1 time (expression mode). - Expression mode: Suction patterns with slower cycles and higher vacuum pressure . {5}------------------------------------------------ to express milk gently and efficiently. - o Nine vacuum levels from level L1-L9 for expression mode The electric breast pump has user-adjustable controls for turning the device on/off, switching between massage mode and expression mode, controlling vacuum level within each of the modes, and selecting between single pumping and double pumping model YD-1168 only). The electric breast pump is capable of providing a vacuum pressure up to 280 mmHq. The device is electrically powered from either an internal rechargeable battery or an external AC power adapter. The external adapter also charges the battery. The Micro USB port of the pump unit is for connection of the AC power adapter through USB cable, and the AC power adapter is connected to AC mains for charging. ## 5. Indications for Use The electric breast pump is intended to be used by lactating women to express and collect mills from their breasts. It is intended for a single user. ## 6. Comparison with Predicate Device A comparison of the intended use and technological characteristics of the subject and predicate device is provided in the table below: | Items | Subject Device | Predicate Device (K163136) | Comparison | |------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------| | Device name and<br>model | Electric Breast Pump,<br>Models: YD-1130S, YD-<br>1132S, YD-1168 | Youha electric breast pump,<br>Models: YH-8004, YH-8016 | N/A | | Product code | HGX | HGX | Same | | Regulation<br>number | 884.5160 | 884.5160 | Same | | Device class | 2 | 2 | Same | | Location for use | OTC | OTC | Same | | Indications for use | The electric breast pump is<br>intended to be used by<br>lactating women to express | The Youha electric breast<br>pump is intended to be used<br>by lactating women to | Same | | | and collect milk from their<br>breasts. It is intended for a<br>single user. | express and collect milk from<br>their breasts. It is intended for<br>a single user. | | | Single user | Yes | Yes | Same | | Provided non-sterile | Yes | Yes | Same | | Re-usable | Yes | Yes | Same | | Direct user<br>contact | Yes | Yes | Same | | Power source | Micro USB: 5V, 2A<br>(supplied by an AC adapter<br>with a USB port) or internal<br>rechargeable battery | AC/DC wall converter and<br>Rechargeable | Similar | | Vacuum range<br>(Massage mode) | YD-1130S: 34~190 mmHg | 34-190 mmHg | Different | | | YD-1132S: 34~280 mmHg | | | | | YD-1168:<br>Single pumping:<br>34~190 mmHg | | | | | Double pumping:<br>89~190 mmHg | | | | | | | | | Vacuum range<br>(expression<br>mode) | YD-1130S: 67~280 mmHg | Low: 75-250mmHg<br>High: 120-280mmHg | Different | | | YD-1132S: 97~280 mmHg | | | | | YD-1168:<br>Single pumping:<br>87~280 mmHg | | | | | Double pumping:<br>96~280 mmHg | | | | | | | | | Cycle speed<br>(Massage mode) | YD-1130S:<br>40 ~140 cycles/min | 94-113 cycles/minute | Different | | | YD-1132S:<br>10~140 cycles/min | | | | | YD-1168:<br>Single pumping:<br>52~140 cycles/min | | | | | | | | | | | | | | | | | | | Cycle speed<br>(expression<br>mode) | Double pumping:<br>63~105 cycles/min | | Different | | | YD-1130S:<br>24~70 cycles/min | | | | | YD-1132S:<br>21~68 cycles/min | Low: 41-69 cycles/minute<br>High: 16-33 cycles/minute | | | | YD-1168:<br>Single pumping:<br>25~78 cycles/min | | | | | Double pumping:<br>28~83 cycles/min | | | | | | | | | Adjustable suction<br>levels | Yes | Yes | Same | | Suction settings<br>(Massage mode) | YD-1130S: 5 | 6 | Different | | | YD-1132S: 6 | | | | | YD-1168: 5 | | | | Suction settings<br>(expression<br>mode) | YD-1130S: 9 | 6 | Different | | | YD-1132S: 9 | | | | | YD-1168: 9 | | | | Overflow<br>protection | Yes | Yes | Same | | Pumping options | YD-1130S/YD-1132S:<br>Double pumping | Single and double pumping | Similar | | | | | | | | YD-1168: Single or Double<br>pumping | | | | | | | | | Visual indicator | LED indicators | LCD | Different | | Pump type | Diaphragm | Diaphragm | Same | {6}------------------------------------------------ {7}------------------------------------------------ The electric breast pump has the same intended use as the predicate device – to express and collect milk from lactating women. The subject and predicate device have different technological characteristics, including different pumping options, modes, suction strengths, cycle speeds, visual indicator, and power source. However, the differences in technological characteristics do not raise different questions of safety and effectiveness. {8}------------------------------------------------ # 7. Non-Clinical Test Summary Non-clinical tests were conducted to verify that the proposed device met all design specifications and that the subject device is substantially equivalent to the predicate device, as follows: #### 7.1. Electromagnetic Compatibility and Electrical Safety The subject device has been tested in accordance with and found to comply with the following standards: - 1) ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - 2) 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 - 3) IEC 60601-1-11:2015 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 ### 7.2. Biocompatibility Biocompatibility testing in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments: - 1) Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity - 2) Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization - 3) Irritation per ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization The results of these test demonstrated that the patient-contacting components of the subject device are non-cytotoxic, non-sensitizing, and non-irritating. ### 7.3. Performance Testing - 1) Vacuum performance testing, cycle performance testing, and backflow protection testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. The specifications were met for vacuum level, cycle rate, and backflow protection. These results held under {9}------------------------------------------------ conditions of single and double pumping mode with varying power sources (i.e., AC adapter power and battery power). - 2) Use life testing was conducted to demonstrate that the device maintains its performance specifications throughout its proposed use-life - 3) Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life - 4) Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life #### 7.4. Software 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. ## 8. 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.