Automatic Digital 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. September 23, 2020 AVICHE Shandong Medical Technology Co, Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China Re: K210152 Trade/Device Name: Automatic Digital 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 18, 2021 Received: August 25, 2021 Dear Boyle 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. 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/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, # 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K210152 Device Name Automatic Digital Blood Pressure Monitor Indications for Use (Describe) The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia). | Type of Use (Select one or both, as applicable) | Day-to-Day Use (49 CFR 391 Subpart E) One-Time Contract Use (49 CFR 391 Subpart G) | |-------------------------------------------------|-----------------------------------------------------------------------------------------| |-------------------------------------------------|-----------------------------------------------------------------------------------------| __ 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 (K210152) This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92. #### 1.0 Submitter's Information Name: AVICHE Shandong Medical Technology Co, Ltd. Address: Floor 26, Building A, A2-1 Jinan Pharm Valley, Gangxingsan Road,High-tech District, Jinan City, Shandong Province, China Tel: 86-15689734848 Contact: Zhike Song Date of Preparation: Aug.11,2021 #### Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn #### 2.0 Device Information Trade name: Automatic Digital Blood Pressure Monitor Common name: Noninvasive Blood Pressure Measurement System Classification name: Noninvasive Blood Pressure Measurement System Model(s): HD10,HD20 #### 3.0 Classification Production code: DXN Regulation number: 21 CFR 870.1130 Classification: Class II Panel: Cardiovascular #### 4.0 Predicate Device Information - Manufacturer: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Device: Electronic Blood Pressure Monitor: YE620B, YE620D, YE660E, YE660F and YE680B {4}------------------------------------------------ #### 510(k) number: K200939 #### 5.0 Indication for Use Statement The Automatic Digital Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of adult at household. (Not suitable for neonate, pregnancy or pre-eclampsia). #### 6.0 Device Description The subject device, Automatic Digital Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven by 4 AA batteries or AC adapter (optional). 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 at household, not for neonate or pregnancy. This blood pressure monitor has the memory function of 60 reading of measuring data of two groups, which can save the data separately. It can display the average reading of the latest 3 groups of measurement results. This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function (optional). During measurement and recall the memory, there will be voice operation tips. Cuff supporting the use of Automatic Digital Blood Pressure Monitor is M5402(small adult)/M5403(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 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. 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 {5}------------------------------------------------ IEC 80601-2-30:2018, 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 intended use. The clinical trials for the Automatic Digital Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, 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 subject device. The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±3mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared. | Table1-General Comparison | | | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Item | Subject Device<br>K210152 | Predicate Device<br>K200939 | Remark | | Product Code | DXN | DXN | SE | | Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | SE | | Class | II | II | SE | | Intended Use | The Automatic Digital Blood<br>Pressure Monitor is<br>intended to measure the<br>blood pressure and pulse<br>rate of adult at household.<br>(Not suitable for neonate,<br>pregnancy or<br>pre-eclampsia). | Electronic blood pressure<br>monitor is intended to<br>measure the blood<br>pressure and pulse rate of<br>adult at household or<br>medical center. (Not<br>suitable for neonate,<br>pregnancy or<br>pre-eclampsia). | SE | | Application Site | Upper Arm | Upper Arm | SE | | Cuff<br>Circumference | 22-36cm or 22-42cm<br>(optional) | Type A (22cm~32cm,<br>22-45cm optional)<br>Type B (22cm~ 32cm,<br>22-45cm optional) | SE | | Patients | Arm Cuff - M5402(small | Patient contact materials of | SE | #### 9.0 Technological Characteristic Comparison Table {6}------------------------------------------------ | Contacting<br>Materials | adult)/M5403(adult)<br>provided by Xuzhou<br>Maikang Science and<br>Technology Ltd., and<br>cleared by FDA<br>(K151290). | the cuff have been tested<br>in accordance with<br>ISO10993 and FDA<br>guidance. | | |-------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|----| | Patient<br>Population | Adult | Adult | SE | | Measurements<br>Item | SYS, DIA,Pulse | SYS, DIA,Pulse | SE | | Display | LCD Digital Display | LCD Digital Display | SE | | Design Method | Oscillometric<br>Method | Oscillometric<br>Method | SE | | Main<br>Component | LCD / Key / Cuff / MCU /<br>Pump / Batteries | LCD / Key / Cuff / MCU /<br>Pump / Batteries | SE | #### Table 2 Performance Comparison | Item | Subject Device<br>K210152 | Predicate Device<br>K200939 | Remark | |------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------| | BP Range | 0-280 mmHg | 0-300 mmHg | SE | | BP Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | SE | | PR Range | 40-199 beats/min | 40 ~ 200 beats/min | SE | | Pulse<br>Accuracy | $\pm$ 5% of reading value | $\pm$ 5% of reading value | SE | | Inflation<br>Method | Automatic by<br>electronic pump | Automatic by<br>electronic pump | SE | | Deflation<br>Method | Automatic Pressure<br>Release Valve | Automatic Pressure<br>Release Valve | SE | | Memory Size | 2x60 set of data | Up to 60x2 sets of data<br>or<br>Up to 99 sets of Data<br>or<br>Up to 99x2 sets of data | SE | | Operation<br>Condition | Temperature +5~+40°C<br>Humidity $\leq$ 80%RH<br>Air pressure<br>80.0kPa-105.0kPa | Temperature +5°C ~ +40 °C<br>Humidity 15%-90% RH<br>(no condensation)<br>Air pressure:<br>Not publicly available | Analysis | | Storage<br>Condition | Temperature -20-55 °C<br>Humidity 10%~90% RH<br>Air pressure<br>80.0kPa-105.0kPa | Temperature -20-+55 °C<br>Humidity 15%-90% RH<br>(no condensation)<br>Air pressure: Not publicly<br>available | Analysis | {7}------------------------------------------------ | 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 | | Power Supply | 4 AA batteries or 5V/1.0A<br>AC adapter | 4 AA batteries or 6V/600mA<br>AC adapter | Analysis | #### Analysis: The subject device is substantially equivalent to the predicate device. The differences in Operation Condition and Storage Condition between both devices are insignificant in terms of safety and effectiveness. Also, the little difference in power supply according to the Electrical Safety and EMC test result, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. | Item | Proposed Device<br>K210152 | Predicate Device<br>K200939 | Remark | |-------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------| | Electrical Safety | Comply with IEC 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 60601-1-2 | SE | | Biocompatibility | Comply with ISO<br>10993-1, FDA Guidance | Comply with ISO 10993-1,<br>FDA Guidance, Tests<br>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 Concern<br>of the Software | Moderate | Moderate | SE | #### Table 3 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 or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.