(269 days)
The Wearable Breast Pump, Model S18 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
The Wearable Breast Pump, Model S18 is an electrically powered breast pump to be used in home environment by a single user. The device is provided non-sterile and can be re-used by a single user. The device is electrically powered by an internal rechargeable Li-ion battery. It can be charged using 5V DC adaptor and the device is designed to be not used during charging. The device consists of the pump motor, milk collection parts, adjustment buckle and charging cable. The device functionality is controlled using an embedded firmware. The subject device has three modes of operation - Expression mode, Stimulation mode and Massage mode, and each mode of operation allows for switching between nine suction levels. The device has three buttons, a power button to turn the device on/off or switch between the modes, a '+ plus' button to increase the suction level and a '- minus' to decrease the suction level within a mode. The device includes an LED status display for the device operating mode and battery status indicator on the pump body. The operating mode LED changes to specific color based on the mode of operation. The device is designed to automatically shut down after 30 minutes of continuous operation. The device operates on a suction(vacuum) cycle that consists of an inhale (letting in air to release vacuum) and an exhaust (removal of air to create vacuum) process. When the breast pump is powered on, the vacuum pump exhausts the air inside the cavity. Once the suction strength reaches the set value, the vacuum pump stops and the valve for the milk opens and expressed milk flows into the bottle due to a pressure difference. All milk contacting components of the device are compliant with 21 CFR 177.
The provided document is a 510(k) Pre-Market Notification for a wearable breast pump (K232774). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical studies, especially those with AI components.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves a device with an AI component meets those criteria. Such information would be found in a submission for a device incorporating AI/ML, which would require performance data against defined metrics, often involving ground truth established by experts.
The document discusses performance testing relevant to a traditional electromechanical device (breast pump), such as:
- Biocompatibility Testing: Evaluating tissue-contacting components for cytotoxicity, irritation, and sensitization.
- Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with recognized standards like IEC 60601-1.
- Software Verification and Validation Testing: This is to ensure the embedded firmware functions correctly according to its specifications, not to assess AI performance. The documentation level is "Basic Documentation Level," which is typical for non-AI software in medical devices.
- Performance Testing and Use Life Verification: This includes testing vacuum level and cycle frequency, backflow, battery capacity, button performance, and automatic shutdown function over the device's 3-year use-life.
None of these tests involve AI-specific acceptance criteria, ground truth establishment by multiple experts, MRMC studies, or standalone algorithm performance.
In summary, the provided text does not contain the information necessary to answer the questions about AI device acceptance criteria and study methodology because the device in question (a breast pump) is not an AI/ML medical device.
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June 6, 2024
Ningbo Dearevery Electronic Technology Co., LTD Kelong Zhang General Manager No3-1, Gongji South Road, Hudi Village, Linshan Town Yuyao, Zhejiang 315460 CHINA
Re: K232774 Trade/Device Name: Wearable Breast Pump, Model S18 Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: May 5, 2024 Received: May 6, 2024
Dear Kelong Zhang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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
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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, PhD, 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) K232774
Device Name Wearable Breast Pump, Model S18
Indications for Use (Describe)
The Wearable Breast Pump, Model S18 is intended to express milk from lactating women in order to collect milk from their breasts. The device 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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510(k) Summary – K232774
| 1. Submitter Information: | Ningbo Dearevery Electronic Technology Co., Ltd.No3-1, Gongji South Road, Hudi Village, Linshan Town, Yuyao,Zhejiang, China.Tel :+8613858311121 Fax :+86-574-63233915Email:1020666000@qq.com |
|---|---|
| 2. Contact Person: | Kelong Zhang(General Manager) |
| 3. Date prepared: | June 5, 2024 |
| 4. Device Information: | Device Name: Wearable Breast Pump, Model S18Common Name: Powered breast pumpRegulation Number: 21 CFR 884.5160Regulation Name: Powered Breast PumpProduct Code: HGX (Pump, Breast, Powered)Regulatory Class: Class II |
| 5. Predicate DeviceInformation: | Device Name: Electric breast pump, model RH338Manufacturer: Cixi Ruihong Electric Appliance Co., Ltd.510(k) Number: K201903.The predicate device has not been subject to a design-related recall. |
| 6. Device Description: | The Wearable Breast Pump, Model S18 is an electrically powered breast pump to be used in home environment by a single user. The device is provided non-sterile and can be re-used by a single user. The device is electrically powered by an internal rechargeable Li-ion battery. It can be charged using 5V DC adaptor and the device is designed to be not used during charging.The device consists of the pump motor, milk collection parts, adjustment buckle and charging cable. The device functionality is controlled using an embedded firmware. The subject device has three modes of operation - Expression mode, Stimulation mode and Massage mode, and each mode of operation allows for switching between nine suction levels.The device has three buttons, a power button to turn the device on/off or switch between the modes, a '+ plus' button to increase the suction level and a '- minus' to decrease the suction level within a mode. The device includes an LED status display for the device operating mode and battery status indicator on the pump body. The operating mode LED changes to specific color based on the mode of operation. The device is designed to automatically shut down after 30 minutes of continuous operation.The device operates on a suction(vacuum) cycle that consists of an inhale (letting in air to release vacuum) and an exhaust (removal of air to create vacuum) process. When the breast pump is powered on, the vacuum pump exhausts the air inside the cavity. Once the suction strength reaches the set value, the vacuum pump stops and the valve for the milk opens and expressed milk flows into the bottle due to a pressure difference. |
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All milk contacting components of the device are compliant with 21 CFR 177.
The Wearable Breast Pump, Model S18 is intended to express milk from 7. Indications for Use: lactating women in order to collect milk from their breasts. The device is intended for a single user.
8. Predicate Device Comparison
The following table compares the intended use and technological characteristics of the subject and predicate device.
| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Wearable Breast Pump,Model S18 | Electric Breast Pump,Model RH-338 | ||
| K232774 | K201903 | ||
| Product Code | HGX (pump, breast, powered) | HGX (pump, breast, powered) | Same |
| Regulation Number | 21CFR 884.5160, Poweredbreast pump | 21CFR 884.5160, Poweredbreast pump | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Wearable Breast Pump,model S18 is intended toexpress milk from lactatingwomen in order to collect milkfrom their breasts. The device isintended for a single user. | The RH-338 and RH-228electric breast pump isintended to be used bylactating women to expressand collect milk from theirbreasts. It is intended for asingle user. | Similar |
| Single/double pumping | Single | Single | Same |
| Media Separation(backflow protection) | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Patient population | Lactating women | Lactating women | Same |
| Suction modes | 3 modes - Massage mode,Stimulate mode, Expressionmode | 3 modes - Massage mode,Stimulate mode, Expressionmode | Same |
| Suction Levels | 9 levels, in each mode | 9 levels, in each mode | Same |
| Vacuum strength (mmHg) | Massage mode: 101-165Stimulate mode:108-180Expression mode: 166-270 | Massage mode: 135-255Stimulate mode: 45-165Expression mode: 110-300 | Different |
| Cycle frequency (Cycles perminute) | Massage mode: 40-72Stimulation mode: 24-40Expression mode: 31-47 | Massage mode: 56-72Stimulate mode: 115-155Expression mode: 25-52 | Different |
| Battery indication | Yes | Yes | Same |
| Pump Type | Diaphragm | Diaphragm | Same |
| Power Supply | Li-ion battery | Li-ion battery and USB | Different |
| User Interface | Power button, mode button,Gear plus button, Gear minusbutton | On/Off button,Increase/decrease vacuumbutton, Switch mode button; | Similar |
| Maximum Suction | 283.5 mmHg | 300 mmHg | Different |
Table 1 Comparison Between the Subject and Predicate Device
The subject and predicate devices have similar indications for use statements and the same intended use (i.e., for collection of breast milk from the breasts of lactating women).
The subject and predicate devices have similar technological features including suction modes and levels, pump type, user interface etc. The differences between the subject and predicate device include suction
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strength, cycle frequency and power source. These differences do not raise new questions of safety and effectiveness and these differences in technological characteristics may be evaluated through performance testing.
9. Summary of Non-Clinical Performance Testing:
Biocompatibility Testing
The biocompatibility evaluation for the Wearable Breast Pump was conducted in accordance with 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process.". The tissue-contacting components were evaluated for cytotoxicity, irritation and were found to be noncytotoxic, non-irritating, and non-sensitizing.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the Wearable Breast Pump device per the following standards:
- IEC 60601-1:2005+A1:2012+A2:2020, Medical equipment-Part 1: General requirements for basic safety, and essential performance.
- IEC 60601-1-11:2015 +A1:2020. Medical electrical equipment-Part 1-11: General reguirements ● for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014+A1:2020, Medical electrical equipment-Part 1-2: General requirements for ● basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests standard for EMC.
- IEC 62133-2 :2017 +A1:2021, Secondary cells and batteries containing alkaline or other non-● acid electrolytes - Safety requirements for portable secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
Software Verification and Validation Testing
Software verification & validation was provided in accordance with 2023 FDA guidance: Content of Premarket Submissions for Device Software Functions. The documentation level for the subject device is Basic Documentation Level.
Performance Testing and Use Life Verification
The subject device has a use-life of 3-years. The following performance testing were conducted at time T=0 and after fatigue testing equivalent to 3-years of device use to demonstrate that the device meets its performance specifications throughout its proposed use-life:
- Vacuum level and cycle frequency testing was performed for all modes and levels of operation to confirm that the device meets specifications for each mode and level.
- Backflow testing was conducted to verify that the fluid does not flow back into the tubing and to . the pump.
- . Battery capacity and service time testing was conducted to demonstrate that the battery meets its specified service time and the LED on the device accurately displays the battery charge status. The battery was also tested for its charging time.
- The button performance test was conducted to verify that the buttons maintain their functionality over proposed use-life of the device.
- Automatic shutdown function testing was conducted to demonstrate that the device shuts down automatically after 30 minutes of continuous operation.
10. Conclusion:
The results of the performance testing described above demonstrate that the Wearable Electric Breast
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Pump, Model S18 is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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).