Arm Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue. March 24, 2019 Xuzhou Yongkang Electronic Science Technology Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 608. No. 738. Shangcheng Rd., Pudong Shanghai, 200120 Cn Re: K183491 Trade/Device Name: Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 17, 2018 Received: December 17, 2018 Dear Boyle Wang: We have reviewed vour 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. 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 {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shawn W. Forrest -S 2019.03.24 22:04:34 -04'00' Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K183491 Device Name Arm Blood Pressure Monitor Indications for Use (Describe) The Arm blood pressure monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy. | 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}------------------------------------------------ # Tab #06 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. #### 1.0 submitter's information Name: Xuzhou Yongkang Electronic Science Technology Co., Ltd Address: 4F Building C8, 40 Jingshan Road, Economic and Technological Development Zone, Xuzhou, Jiangsu,221000,China Tel: 86-516- 87892766-601 Fax: 86- 516-87892766 -606 Contact: Kai Li Date of Preparation: Mar.24.2019 ## Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn #### 2.0 Device information Trade name: Arm Blood Pressure Monitor Common name: Noninvasive Blood Pressure Measurement System Classification name: Noninvasive Blood Pressure Measurement System Model(s): YK-BPA1 #### 3.0 Classification Production code: DXN Regulation number: 21 CFR 870.1130 Class II Classification: Panel: Cardiovascular #### 4.0 Predicate device information Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Device: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D {4}------------------------------------------------ #### 510(k) number: K170605 #### 5.0 Indication for Use Statement The Arm Blood Pressure Monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy. #### 6.0 Device description The proposed device, Arm Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven both battery and AC power supply. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy. The measuring method for the Arm Blood Pressure Monitor is oscillation mensuration. And all values can be read out in one LCD panel. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data.The blood pressure storing 2x99 set memory value, each measurement it will automatically stored. When it stored 2x99 set memory value, the old value will be covered by the new one. It can show the latest 3 times average value. User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result: User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure, diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power. Cuff supporting the use of Xuzhou Yongkang electronic sphygmomanometer: M5303(small adult)/M5304(adult)/ M5305(big adult) provided by Xuzhou Maikang Science and Technology Ltd., and cleared by the CE(Declaration of Conformity for Class I)/ISO and FDA(k151290). #### 7.0 Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance. IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General {5}------------------------------------------------ requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. IEC 80601-2-30:2013, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers. IEC 62304:2015 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard. #### 8.0 Clinical Test Conclusion Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The clinical trials for YK-BPA1 were performed according the standard of ISO 81060-2:2013, Non-Invasive Sphygmomanometers - Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement. There were 150 subjects been selected to participate in the trial, and Auscultation was applied as gold standard with the qualified calibrated mercurial sphygmomanometer used as control group for comparison with the proposed device. The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2013 within the ±5mmHg.And the proposed device comply with the standard requirements and the accuracy the manufacture declared. | Table1-General Comparison | | | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Item | Proposed device | Predicated device<br>K170605 | Remark | | Product Code | DXN | DXN | SE | | Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | SE | | Class | II | II | SE | | Intended Use | The Arm blood pressure<br>monitor is used for<br>measuring blood<br>pressure and pulse rate.<br>The monitor can be used<br>in hospitals, families,<br>schools and medical<br>centers. It is suitable for<br>adult, not for neonate or<br>pregnancy. | Electronic blood pressure<br>monitor is intended to<br>measure the blood<br>pressure and pulse rate<br>of adult at household or<br>medical center. (Not<br>suitable for neonate,<br>pregnancy or<br>pre-eclampsia). | SE | | Application | Upper Arm | Upper Arm | SE | #### Table1-General Comparison 9.0 Technological Characteristic Comparison Table {6}------------------------------------------------ | Site | | | | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----| | Patients<br>Contacting<br>Materials | Patient contact materials<br>of the cuff supporting the<br>use of Xuzhou Yongkang<br>electronic<br>sphygmomanometer:<br>M5303(small<br>adult)/M5304(adult)/<br>M5305(big adult)<br>provided by Xuzhou<br>Maikang Science and<br>Technology Ltd., and<br>cleared by the<br>CE(Declaration of<br>Conformity for Class<br>I)/ISO and<br>FDA(K151290). | Patient contact materials<br>of the cuff have been<br>tested in accordance with<br>ISO10993 and FDA<br>guidance. | SE | | Patient<br>Population | Adult | Adult | SE | | Measurements<br>Item | SYS,DYS,Pulse | SYS,DYS,Pulse | SE | | Display | LCD Digital Display | LCD Digital Display | SE | | Design<br>Method | Oscillometric<br>Method | Oscillometric<br>Method | SE | | Main<br>Component | LCD / Key / Cuff / MCU /<br>Pump / Batteries<br>(optional) / AC<br>Adapter(optional) | LCD / Key / Cuff / MCU /<br>Pump / Batteries<br>(optional) / AC<br>Adapter(optional) | SE | # Table2 Performance Comparison | Item | Proposed Device | Predicate Device<br>K170605 | Remark | |------------------------|---------------------------------------|---------------------------------------------|----------| | BP Range | 20-280 mmHg | 0-280 mmHg | Analysis | | BP Accuracy | $\pm$ 5mmHg | $\pm$ 3 mmHg | Analysis | | PR Range | 40-199 beats/min | 40 ~ 200 beats/min | Analysis | | Pulse<br>Accuracy | $\pm$ 5% of reading<br>value | $\pm$ 5% of reading<br>value | SE | | Operation<br>Condition | 5-40 °C<br>15%-80% RH<br>86kPa~105kPa | 10-40 °C<br>15%-90% RH (no<br>condensation) | Analysis | | Storage<br>Condition | -20-55 °C<br>$\le$ 95% RH | -20-55 °C<br>15%-90% RH (no | Analysis | {7}------------------------------------------------ | | 50kPa $\sim$ 105kPa | condensation) | | |-------------------------|----------------------------------------|----------------------------------------|----------| | Data Storage | SYS, DIA, PR,<br>Measurement Time, No. | SYS, DIA, PR,<br>Measurement Time, No. | SE | | Performance<br>Standard | Comply with IEC<br>80601-2-30 | Comply with IEC<br>80601-2-30 | SE | | Cuff<br>Circumference | 220mm $\sim$ 320mm | 220mm $\sim$ 320mm | Analysis | | Power Supply | 4 AA batteries or<br>AC Adapter | 4 AA batteries | SE | #### Analysis The proposed device is substantially equivalent to the predicate device. The differences between both devices are insignificant in terms of safety and effectiveness. Based on the nonclinical and clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. | Item | Proposed Device | Predicate Device<br>K170605 | Remark | |----------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------| | Electrical Safety | Comply with IEC<br>60601-1 | Comply with IEC 60601-1 | SE | | Home Use | Comply with IEC<br>60601-1-11 | Comply with IEC<br>60601-1-11 | SE | | EMC | Comply with IEC<br>60601-1-2 | Comply with IEC<br>60601-1-2 | SE | | Biocompatibility | Comply with ISO<br>10993-1, FDA<br>Guidance | Comply with ISO<br>10993-1, FDA Guidance,<br>Tests included<br>Cytotoxicity, Sensitization<br>and Intracutaneous<br>Reactivity | SE | | Label and<br>Labeling | Conforms to FDA<br>Regulatory<br>Requirements | Conforms to FDA<br>Regulatory Requirements | SE | | Level of<br>Concern of the<br>Software | Moderate | Moderate | SE | #### Table3 Safety Comparison #### 10.0 Conclusion The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety {8}------------------------------------------------ or effectiveness.The differences between both devices are insignificant in terms of safety and effectiveness.