Electronic Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 5, 2023 Zhuhai Yueja Medical Device Technology Co.,Ltd. Feng Yan Department Manager Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone Zhuhai, Guangdong 519000 China Re: K232814 Trade/Device Name: Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 30, 2023 Received: September 13, 2023 Dear Feng Yan: 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. {1}------------------------------------------------ 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" (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 QS 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. {2}------------------------------------------------ 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 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, # Stephen C. Browning -S LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232814 Device Name Electronic Blood Pressure Monitor #### Indications for Use (Describe) Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm. Type of Use (Select one or both, as applicable) | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |------------------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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." {4}------------------------------------------------ # Section 3 510(k) Summary # l 510(k) Submitter Device Submitter: Zhuhai Yueja Medical Device Technology Co.,Ltd. Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone, Zhuhai, 519000, China Contact Person: Feng yan Department Manager Phone: +86-18826906029 E-mail: fengy@myzr.com.cn # II Device | Trade Name of Device: | Electronic Blood Pressure Monitor | |-----------------------|-----------------------------------| | Regulation Number: | 21 CFR 870.1130 | | Classification Name: | Electronic Blood Pressure Monitor | | Product Code: | DXN | | Regulation Number: | Electronic Blood Pressure Monitor | | Regulatory Class | II | | Review Panel | Cardiovascular | #### III Predicate Devices | 510k Number | K222994 | |-----------------------|-----------------------------------| | Trade Name of Device: | Electronic Blood Pressure Monitor | | Regulation Number: | 21 CFR 870.1130 | | Regulation Name: | Electronic Blood Pressure Monitor | | Regulatory Class | II | | Product Code: | DXN | #### IV Device Description Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries. Electronic Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. Electronic Blood Pressure Monitor can be divided into three models (YJ320、YJ321E、 {5}------------------------------------------------ YJ326E) according to their appearance and functions. The differences among these models are shown as below: | Model | Air pumps and air<br>valves | Cuffs | Software Function | Hardware | |--------|-----------------------------|-----------|----------------------------------------------------------------|-----------------------------------| | YJ320 | Same | Same | Same | Black and white<br>backlit screen | | YJ321E | Same | Same | Removed cuff detection<br>and misoperation prompt<br>functions | Black and white<br>backlit screen | | YJ326E | Different | Different | Same | Color backlit<br>screen | # V Indications for use Electronic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. lt can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm. # VI Technological Characteristics Comparison VI-1: Comparison of Electronic Blood Pressure Monitor | Device<br>Characteristic | Subject Device | Predicate Device<br>(K222994) | Discussion<br>n | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Type of Blood<br>Pressure<br>Monitor | Electronic Blood Pressure<br>Monitor<br>YJ320、YJ321E、YJ326E | Electronic Blood Pressure<br>Monitor<br>AOJ-33 series | - | | Product Code | DXN | DXN | Same | | Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same | | Class | II | II | Same | | Indications for<br>Use | Electronic Blood Pressure<br>Monitor is a digital monitor<br>intended for use in<br>measuring blood pressure<br>and pulse rate in adult | The Arm Blood Pressure<br>Monitor is intended to measure<br>the systolic and diastolic blood<br>pressure as well as the pulse<br>rate of adult person via | Same | | patient population. It is non-invasive oscillometric intended to measure the technique in which an inflatable diastolic, systolic blood CUFF is wrapped around the pressures and pulse rate upper arm at medical facilities or through an inflatable cuff at home. wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm. | | | | | Measurement site | Upper arm | Upper arm | Same | | Patient Population | Adult | Adult | Same | | Measurement Item | SYS, DIA, Pulse Rate | SYS, DIA, Pulse Rate | Same | | Principle | Oscillometric | Oscillometric | Same | | Blood pressure measurement range | pressure:0 to 295mmHg<br>SYS: 55 to 255 mmHg<br>DIA: 25 to 200 mmHg | 30 ~ 255 mmHg | Different 1 | | Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Same | | Pulse Rate Range | 40~199beat/min | 40-199 bpm | Same | | Accuracy | $\pm$ 5% of reading | $\pm$ 5% of reading | Same | | Cuff size | 22~42cm | 22~42cm | Same | | Power supply | 4 "AA" batteries(d.c.6v) or<br>USB-C INPUT 5V d.c~6V d.c/600mA | Lithium-ion battery, D.C. 3.7V | Different 2 | | Operation condition | +5°C~+40°C,<br>15%RH~85%RH<br>80kPa~105kPa | +5°C~+40°C<br>15%RH-90%RH<br>70 kPa -106 kPa | Different 3 | | Storage condition | -20°C~+55°C,<br>15%RH~85%RH,<br>80kPa~105kPa | -20°C~+55°C<br>10%RH-93%RH<br>70 kPa -106 kPa | Different 4 | | Patient Contacting | Surface-contacting,<br>Less than 24 h | Surface-contacting,<br>Less than 24 h | Same | | Biocompatibility evaluation | Cytotoxicity, skin sensitization and irritation | Cytotoxicity, skin sensitization and irritation | Same | | Electrical<br>Safety | IEC 60601-1<br>IEC 60601-1-11<br>ISO 80601-2-30 | IEC 60601-1<br>IEC 60601-1-11<br>ISO 80601-2-30 | Same | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same | | Biocompatibility | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Different 5 | | Clinical data | ISO 81060-2: 2018 | ISO 81060-2: 2018 | Same | {6}------------------------------------------------ {7}------------------------------------------------ #### Different 1- Blood pressure measurement range The Blood Pressure Range of the subject device includes the blood pressure range of predicate devices and meets the requirements of IEC 80601-2-30. Therefore, the difference will not affect the safety and effectiveness of the subject device. #### Different 2- Power supply The difference between subject device and predicate device (K222994) is the batteries, the predicate device use Lithium-ion battery, D.C. 3.7V while the subject device use 4 "AA" batteries (d.c.6v) or USB-C INPUT 5V d.c-6V d.c/600mA, but the power supply safety of subject device is justified by the IEC60601-1 electricity test reports. Thus this difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence. #### Different 3- Operation condition The difference between subject device and predicate device (K222994) is the humidity and Atmospheric pressure, the predicate device is 15%RH-90%RH, 70 kPa -106 kPa, while the subject device is 15%RH-85%RH, 80kPa~105kPa, it is included in predicate device. Therefore, this item is considered as substantial equivalence. #### Different 4- Storage condition The difference between subject device and predicate device (K222994) is the humidity Section 3-4 {8}------------------------------------------------ #### K232814 and Atmospheric pressure, the predicate device is 15%RH-90%RH, 70 kPa -106 kPa, while the subject device is 15%RH-85%RH, 80kPa~105kPa, it is included in predicate device. Therefore, this item is considered as substantial equivalence. #### Different 5- Biocompatibility The predicate device (K222994) was tested by ISO 10993-5, ISO 10993-10, and the testing part included the battery. While the main part of subject device that comes into contact with the patient is the cuff, the part that comes into contact with the operator is mainly the cover and cuff. The material of cover is ABS, which is a commonly used material in the market. It has Limited contact with intact skin. Per FDA's 2020 guidance document, Use of International Standard ISO 10993-1, ABS materials are exempt from biological testing. In addition, the cuff has tested by ISO 10993-5 and ISO 10993-10. Based on the above description, these differences do not affect the achievement of the product's intended use, nor do they compromise the safety of patients and operators. {9}------------------------------------------------ # VII Summary of Non-Clinical Testing and Clinical Testing # Non-Clinical Data: Non-clinical testing for Electronic Blood Pressure Monitor was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below. | Inspecting item | Inspection content and acceptance standard | Conclusion | | |------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. Identification requirement | Meets the requirements of IEC 60601-1:2005 in 7.2 | Pass | | | 2. life span | After at least 10,000 full scale cycles, the sphygmomanometer should still meet the safety requirements and performance requirements in the standard. | Pass | | | | A full scale cycle is when the pressure rises from 2.67kPa(20mmHg) or less to a maximum pressure value and then falls to 2.67kPa(20mmHg) or less. | | | | 3. Safety requirements | The sphygmomanometer should have overpressure protection function. When the pressure display exceeds 39.33kPa(295mmHg), the sphygmomanometer's vent valve should be opened, and the gas path pressure should be reduced to less than 2kPa(15mmHg) within 10s. In addition, the equipment should | Pass | | | | 3.1 Maximum cuff pressure | | | | 4.<br>Performance<br>index | | | | | | | ensure that the cuff pressure is<br>above 2kPa(15mmHg) for no more<br>than 3 minutes. | | | | 3.2 venting | The sphygmomanometer should<br>provide a simple and clearly<br>marked measure allowing the user<br>to deflate the cuff. When the valve<br>of the charging system is fully open<br>and quickly deflated, the time for<br>the pressure to drop from<br>34.67kPa(260mmHg) to<br>2kPa(15mmHg) should not exceed<br>10s. | Pass | | | 4.1 Range | A blood pressure monitor has a<br>range of at least 0kPa(0mmHg) to<br>39.3kPa(295mmHg). | Pass | | | 4.2 Resolution<br>ratio | The display resolution of the<br>sphygmomanometer should be<br>0.1kPa/1mmHg. | Pass | | | 4.3<br>Repeatability | For a sphygmomanometer,<br>measured at static continuous low<br>pressure, the difference between<br>repeated readings measured at<br>each point within the scale range<br>should be no greater than 0.533<br>kPa(4mmHg). All readings shall<br>comply with the requirements in 4.4 | Pass | | | 4.4 Pressure<br>sensor<br>accuracy | The maximum error of the pressure<br>measurement in the cuff should be<br>$\pm$ 0.4kPa( $\pm$ 3mmHg) at any<br>measuring point in the range,<br>regardless of whether the pressure<br>is increased or decreased. | Pass | | | | (a) The pulse measurement range | Pass | | | 4.5 Pulse | of the sphygmomanometer should | | | | | be (40 ~ 199) times/min, and the | | | | | resolution should be 1 time/min. | | | | | | (b) Pulse accuracy: ±5%. | | | 5.1 Aeration<br>source | The sphygmomanometer inflation | Pass | | | | source should provide enough air | | | | | within 10 seconds to reach | | | | | 40kPa(300mmHg) in a 200(12 | | | | | cubic inch) container. | | | 5<br>Requirements<br>for charging<br>sources and<br>pressure<br>control<br>valves. | 5.2 Pressure<br>controlled air<br>valve | 5.2.1 air leakage | Pass | | | | The sphygmomanometer valve is | | | | | closed, and the maximum pressure | | | | | drop in a container with a volume | | | | | not exceeding 80 at initial | | | | | pressures of 33.33kPa(250mmHg), | | | | | 20kPa (150 MMHG) and | | | | | 6.67kPa(50mmHg) should not | | | | | exceed 0.133kPa(1mmHg) for 10s. | | | | | 5.2.2 Valve/cuff bleed rate | | | | | When the valve is in the pressure<br>control position, the pressure drop<br>rate from 33.33kPa(250mmHg) to<br>6.67kPa(50mmHg) should not be<br>less than 0.267kPa/s (2mmHg/s);<br>5.2.3 Venting<br>The rapid venting of a gas-filled | | | | | system when the valve is fully open<br>should not take longer than 10s for<br>the pressure to drop from<br>34.67kPa(260 mmHg) to<br>2kPa(15mmHg). | | | | | | | | | | | | | 6 Cuff with air<br>bag | 6.1 Size | The length of the cuff air bag is<br>about 0.8 times the circumference<br>of the limb measured at the median<br>line of the cuff's intended use area,<br>and the width of the cuff air bag is<br>about half the length; | Pass | | | 6.2<br>compression<br>resistance | The cuff, the integrated air bag and<br>the entire pipeline should be able to<br>withstand the internal pressure<br>equal to the maximum pressure<br>expected to be used by the cuff; | Pass | | | 6.3 Cuff<br>interface,<br>structure | After 1,000 opening and closing<br>cycles and 10,000<br>40kPa(300mmHg) pressure cycles,<br>the closure and sealing off the cuff<br>and the integrated airbag shall<br>remain intact enough to meet the<br>other requirements of this standard. | Pass | | | 7 System air leakage | | The rate of pressure drop caused<br>by air leakage of the entire system<br>of the sphygmomanometer should<br>not be greater than<br>0.133kPa/s(1mmHg/s). | | | | | | | 8 function | | 8.1 display<br>function | The liquid crystal display of the<br>sphygmomanometer should be<br>able to display systolic blood | | | | | | | | pressure, diastolic blood pressure<br>and pulse rate, and there should be<br>"kPa" or "mmHg" blood pressure<br>display form. | | | | | 8.2 Automatic<br>zeroing<br>function | The sphygmomanometer should be<br>able to automatically return to zero<br>after each turn on, and<br>automatically open to test blood<br>pressure. | Pass | | | 8.3 Error<br>prompt<br>function | The sphygmomanometer should<br>display an incorrect indication if it<br>fails to measure blood pressure<br>correctly or fails to measure pulse<br>rate correctly. | Pass | | 8.4 Low<br>voltage<br>prompt<br>function | When the sphygmomanometer is<br>turned on, when the battery voltage<br>is low to 4.2V±0.2V, the battery<br>symbol "☐" should flash on the<br>display screen. | Pass | | | 8.5 Automatic<br>shutdown<br>function | The sphygmomanometer will<br>automatically shut down if no<br>operation is performed within 2<br>minutes after the measurement is<br>completed. | Pass | | | 8.6 memory<br>function | The sphygmomanometer can<br>memory store 2*99 groups of<br>measurement data, 99 groups of<br>users A and B, in the memory state,<br>press the [Start/Stop] key and the<br>[memory/read] key at the same<br>time, 3 seconds later the screen will<br>display CLR, release the double<br>key can clear all the memory data. | Pass | | | 8.7 Clock<br>setting<br>function | The sphygmomanometer should be<br>able to display time and set time,<br>including year, month, day, hour<br>and minute. | Pass | | | 8.8 | The sphygmomanometer should be | Pass | | | | Arrhythmia<br>prompt<br>function<br>8.9<br>Voice<br>broadcast<br>prompt<br>function | able to indicate the irregular<br>heartbeat of the human body and<br>can display the "♥" symbol.<br>In the "mmHg" unit display mode,<br>sphygmomanometer should<br>the<br>have a voice broadcast prompt<br>function. | Pass | | | Cuff<br>8.10<br>detection<br>prompt<br>function…