Wrist Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 11, 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: K232815 Trade/Device Name: Wrist 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) K232815 Device Name Wrist Blood Pressure Monitor Indications for Use (Describe) Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use. | 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." {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: | Wrist 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 | K223291 | |-----------------------|-----------------------------------| | Trade Name of Device: | Wrist Blood Pressure Monitor | | Regulation Number: | 21 CFR 870.1130 | | Regulation Name: | Electronic Blood Pressure Monitor | | Regulatory Class | II | | Product Code: | DXN | # IV Device Description Wrist Blood Pressure Monitor mainly consist of pressure sensor, air pump, valve, cuff, main board and plastic case. Wrist 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. The Wrist Blood Pressure Monitor include two models: YJ110, YJ111 {5}------------------------------------------------ ## V Indications for use Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure. diastolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use. ## VI Technological Characteristics Comparison VI-1: Comparison of Wrist Blood Pressure Monitor | Device<br>Characteristic | Subject Device | Predicate Device<br>(K223291) | Discussion | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Type of Blood<br>Pressure<br>Monitor | Wrist Blood Pressure<br>Monitor<br>YJ110, YJ111 | Wrist Blood Pressure Monitor<br>PG-800A18, PG-800A19,<br>PG-800A28, PG-800A51,<br>PG-800A52, PG-800A11-1,<br>PG-800A36-1 and<br>PG-800A37-1 | - | | Product Code | DXN | DXN | Same | | Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same | | Class | II | II | Same | | Indications for<br>Use | Wrist Blood Pressure<br>Monitor is used to measure<br>adult systolic blood<br>pressure. diastolic blood<br>pressure and pulse rate.<br>The values are for<br>diagnostic reference only.<br>Suitable for medical<br>institutions (such as<br>hospitals, clinics, health<br>centers, etc.) and home<br>use. | The Electronic Blood Pressure<br>Monitor is intended to measure<br>the systolie and diastolic blood<br>pressure as well as the pulse<br>rate of adult person via<br>non-invasive oscillometric<br>technique in which an inflatable<br>cuff is wrapped around the wrist.<br>It can be used at medical<br>facilities or at home. The<br>intended wrist circumference is<br>13.5-19.5 cm. The patient<br>population does not include<br>adolescents aged 12 to <18<br>years of age. The patient<br>population includes transition<br>adolescent B (18 to < 22 years<br>of age but treated like adult) and<br>adults (at least 22 years of age). | Same | | Measurement<br>Type | Wrist | Wrist | Same | | Patient<br>Population | Adult | Adult | Same | | Measurement<br>Item | Systolic Pressure, Diastolic<br>Pressure, Pulse Rate | Systolic Pressure, Diastolic<br>Pressure, Pulse Rate | Same | | Principle | Oscillometric | Oscillometric | Same | | Main<br>Component | LCD/Key/Cuff/MCU/Pump/T<br>ransducer/ Batteries | LCD/Key/Cuff/MCU/Pump/Tran<br>sducer/ Batteries | Same | | Blood Pressure<br>Range | Pressure:0~295mmHg<br>(0~39.3kPa)<br>SYS: 65 to 230 mmHg<br>DIA: 45 to 160 mmHg | 30 ~ 280 mmHg | Different 1 | | Pulse Rate<br>Range | 40~199beat/min | 40-199 bpm | Same | | Intended<br>wristcircumference | 13.5~19.5cm | 13.5cm-19.5cm | Same | | Records<br>Quantity | 60 sets of memory | Double patients mode: 90/90<br>records | Different 2 | | Power supply | d.c.3V (2 AAA size<br>batteries) | Two AAA or LR03 batteries for<br>models PG-800A18,<br>PG-800A19, PG-800A28, PG-8<br>00A52<br>3.7V for models PG-800A51,<br>PG-800A11-1,PG-800A36-1,P<br>G-800A37-1 | Different 3 | | Operation<br>condition | +5℃~+40℃,<br>15%RH~85%RH<br>80kPa~105kPa | +5°C~+40°C<br>30%RH-80%RH<br>Atmospheric pressure | Different 4 | | Storage<br>condition | -20℃~+55℃,<br>15%RH~85%RH,and no<br>condensation<br>80kPa~105kPa | -20°C~+55°C<br>10%RH-93%RH<br>Atmospheric pressure | Different 5 | | Patient Contact<br>Material | Cuff-Nylon<br>Enclosure-ABS<br>Key-ABS | Cuff-Nylon<br>Enclosure-ABS<br>Key-ABS | Same | | Biocompatibility | Comply with ISO10993<br>series standards<br>No cytotoxicity; No irritation<br>to skin; No significant<br>evidence of sensitization | Comply with ISO10993 series<br>standards<br>No cytotoxicity; No irritation to<br>skin; No significant evidence of<br>sensitization | Same | | Electrical<br>Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | | Particular<br>Performance | Comply with IEC<br>80601-2-30 and ISO<br>81060-2 | Comply with IEC 80601-2-30<br>and ISO 81060-2 | Same | {6}------------------------------------------------ {7}------------------------------------------------ # Different 1- Blood Pressure 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- Records Quantity The records quantity of subject device is 60 while for predicate device is 90/90, yet the subject device adopted same measurement principle and NIBP algorithm as predicate device, software function is justified by the software documents. This difference will not affect the safety and effectiveness. #### Different 3- Power supply The difference between subject device and predicate device (K223291) is the batteries, the predicate device use 2 x 1.5V Batteries (for models: PG-800A18, PG-800A19, PG-800A28, PG-800A52) and Rechargeable Li-ion Battery PL 552233 for model: PG-800A51, PG-800A11-1, PG-800A36-1 and PG-800A37-1 while the subject device use two AAA, 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 4- Operation condition The difference between subject device and predicate device (K223291) is the humidity, the predicate device is 30%RH-80%RH, while the subject device is 15%RH-85%RH, but the humidity of subject device is meets the requirements of IEC 80601-2-30. therefore, the difference will not affect the safety and effectiveness of the subject device. #### Different 5- Storage condition The difference between subject device and predicate device (K223291) is the humidity, the predicate device is 10%RH-93%RH, while the subject device is 15%RH-85%RH, it is included in predicate device, therefore this item is considered as substantial equivalence. {8}------------------------------------------------ # VII Summary of Non-Clinical Testing The non-clinical testing for Wrist 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.<br>Appearance<br>and<br>structure test | 1.1 The shape of the product should be correct, the surface bright and clean, there should be no obvious scratches, damage and deformation. | Pass | | | | 1.2 The text and logo on the control panel of the product should be accurate, clear and firm. | Pass | | | | 1.3 The function of the product shall be clearly marked and indicated. | Pass | | | | 1.4 The connection of each part of the product should be reliable, the key activity should be free, no card key and affect the operation phenomenon. | Pass | | | | 1.5 The display number of the product should be clearly distinguishable, and there is no missing or breaking phenomenon. | Pass | | | 2.<br>Identification<br>requirement | 2.1 Device identification a) Display enough information for easy traceability and identification. In addition, the following information should also be displayed:<br>b) Use warnings, including a statement that you need to consult a medical professional to interpret the blood pressure value measured.<br>c) Appropriate operating instructions.<br>d) Instrument performance parameters | Pass | | | | | relevant to the accuracy requirements of this standard. | | | | | e) Wrist girth for matching wristbands | | | | 2.2 External<br>packing | The outer package should include the following information:<br>a) Applicable wrist circumference (can be identified by "cm");<br>b) Any special requirements for battery-operated equipment shall also be indicated. | Pass | | | 2.3<br>Specification | Each piece of equipment should be accompanied by a manual, which should include at least the following:<br>a) Complete instructions for use, including a section summarizing warnings for use. This section should be indexable in the table of contents and direct the user to the relevant section in the information manual;<br>b) A dedicated chapter with information on: how to unpack, install, perform pre-service checks, where to get help, standard operating procedures, general maintenance, recalibration and cleaning frequency recommendations;<br>c)How to contact the manufacturer for after-sales service;<br>d)Whether the device can achieve the claimed performance when common arrhythmias such as atrial premature, ventricular premature, and atrial fibrillation occur;<br>e) Check the accuracy of the wristband pressure sensor/indicator at the time | Pass | Table VII-1: Performance testing was conducted on the subject device {9}------------------------------------------------ {10}------------------------------------------------ | | interval specified by the manufacturer, and<br>give suggestions on the validity verification<br>method; | |--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | f) The detailed measurement method<br>should be indicated, including at least the<br>location of the measurement, the<br>appropriate time to rest before the blood<br>pressure measurement, the applicable wrist<br>circumference, and a statement that the<br>blood pressure value measured should be<br>interpreted by a professional; | | | g) The user is reminded that any blood<br>pressure measurement is affected by the<br>posture of the person being measured as<br>well as his/her physical condition. Other<br>factors that interfere with blood pressure<br>measurement should also be listed; | | | h) A statement that if stored or used outside<br>the manufacturer's specified temperature<br>and humidity ranges, the system may not<br>achieve the claimed performance<br>specifications (Manufacturer's specified<br>temperature and humidity ranges should be<br>given together in the statement); | | | i) Product warranty information; | | | j) It should be indicated that the device is<br>not intended for neonates; | | | k) Risks that may exist when the airbag is<br>overinflated for a prolonged period of time; | | | l) Method of determining display device<br>failure; | | | m) Recommended disinfection procedures; | | | n) A statement regarding the correlation | {11}------------------------------------------------ | | | between blood pressure measurements<br>(including systolic, diastolic and mean blood<br>pressure) obtained by this product and<br>measurements obtained using one or two<br>other different independent methods<br>mentioned in this standard; | | |----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | 2.4<br>Low<br>voltage<br>prompt<br>function | 2.4.1 Label of the battery powered device<br>The device should be marked with the<br>correct battery model.<br><br>2.4.2 Wristband identification<br>The wrist strap should indicate or indicate<br>the range of wrist girth to which it applies. | Pass | | 3.<br>Safety<br>index | 3.1 Maximum<br>band<br>pressure | 1) Wrist pressure should not exceed 40kPa<br>(300mmHg);<br><br>2) The device should ensure that the<br>wristband pressure is kept above 2kPa<br>(15mmHg) for no more than 3 minutes. | Pass | | | 3.2<br>Aerofluxus | The device shall provide a simple and<br>clearly marked measure allowing the user<br>to deflate the wristband.<br><br>When the valve of the charging system is<br>fully open and quickly deflated, the time for<br>the pressure to drop from 34.67kPa<br>(260mmHg) to 2kPa (15mmHg) should not<br>exceed 10s. | Pass | | 4.<br>Performance<br>index | 4.1 Range | Pressure measurement range: 0kPa<br>(0mmHg) ~39.3kPa (295 mmHg), the<br>maximum pressure does not exceed 40kPa<br>(300mmHg).<br><br>Pulse measurement range: 40~199<br>times/min. | Pass | | | 4.2<br>Resolution<br>ratio | The pressure display resolution should be<br>0.133kPa (1mmHg).<br>The pulse display resolution should be 1 | Pass | | | time/min. | | | | 4.3<br>Repeatability | When measured at static continuous low pressure, the difference between the readings measured repeatedly at each point within the scale range should not be greater than 0.533kPa (4mmHg). All readings shall comply with the requirements in 4.4. | Pass | | | 4.4 Pressure<br>sensor and<br>pulse<br>measurement<br>accuracy | 4.4.1 The maximum error of the pressure measurement in the wristband should not be greater than ±0.4kPa (±3mmHg) at any measuring point in the range, whether the pressure is increased or decreased.<br>4.4.2 Pulse measurement error: ±5%. | Pass | | | 4.5<br>Requirements<br>for charging<br>sources and<br>pressure<br>control valves | 4.5.1 Aeration source<br>The aeration source should provide enough air to reach a pressure of 40kPa (300mmHg) in a 200cm3 (12 cubic inches) container within 10 seconds.<br>4.5.2 Pressure controlled air valve<br>4.5.2.1 air leakage<br>When the valve is closed and the initial pressure is 33.33kPa (250mmHg), 20kPa (150mmHg) and 6.67kPa (50mmHg) respectively, the maximum pressure drop in a container with a volume not exceeding 80cm3 should not exceed 0.133kPa (1mmHg) within 10s.<br>4.5.2.2 Valve/wristband bleed rate<br>When the valve is in the pressure control position (using the accompanying wristband), the pressure reduction rate from 33.33kPa (250mmHg) to 6.67kPa | Pass | | | | (50mmHg) should not be less<br>than<br>0.267kPa/s (2mmHg/s).<br>4.5.2.3 blow-by<br>The rapid venting of a gas-filled system<br>when the valve is fully open should not take<br>longer than 10s for the pressure to drop<br>from 34.67kPa (260 MMHG) to 2kPa<br>(15mmHg). | | | | 4.6<br>Airbag<br>and wristband<br>requirements | 4.6.1 size<br>The length of the airbag is about 0.4 times<br>that of the covering wrist, and the width of<br>the airbag is about half the length.<br>4.6.2 compression resistance<br>It should be able to withstand an internal<br>pressure equal to the maximum pressure of<br>39.3kPa (295mmHg) expected to be used<br>by the wristband. | Pass | | | 4.7<br>Wrist<br>strap<br>port/Structure | After 1,000 opening and closing cycles and<br>10,000 40kPa (300mmHg) pressure cycles,<br>the closure and sealing of the wristband<br>and integrated airbag should still be intact<br>enough to meet other requirements. | Pass | | | 4.8<br>System<br>air leakage | The rate of pressure drop caused by air<br>throughout<br>leakage<br>the<br>sphygmomanometer system should not be<br>greater than 0.133kPa/s (1mmHg/s). | Pass | | | 4.9 Lifetime | After at least 10,000 full scale cycles, the<br>equipment should still meet the safety and<br>performance requirements of the standard.<br>A full scale cycle is when the pressure rises<br>from 2.67 kPa (20 mmHg) or less to a<br>maximum pressure value and then falls to<br>2.67 kPa (20 mmHg) or less. | Pass | | | | 4.10 Prompt | 4.10.1 Low battery prompt | Pass | | | facility | When<br>the<br>voltage<br>of of<br>the | | | | | sphygmomanometer is d.c. (2.2-2.5) ± | | | | | 0.1V, there should be a battery symbol | | | | | indicating that there is one grid of electricity | | | | | left. When it is lower than 2.2V±0.1V, the | | | | | battery symbol displays empty power and | | |…