Electronic Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. August 20, 2020 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd % Giselle Zhang Technical Consultant Emergo Global Consulting . LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746 Re: K200939 Trade/Device Name: Electronic Blood Pressure Monitor: YE620B, YE620D, YE660E, YE660F and YE680B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 21, 2020 Received: July 23, 2020 Dear Giselle 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 (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. {1}------------------------------------------------ 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 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 (OS) 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. LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K200939 Device Name Electronic Blood Pressure Monitor: YE620B, YE620D, YE660E, YE660F and YE680B Indications for Use (Describe) Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia) | 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}------------------------------------------------ # Special 510(k) Summary Upper Arm Type Electronic Blood Pressure Monitor Series #### 1. Submission Sponsor Jiangsu Yuyue Medical Equipment& Supply Co., Ltd Yunyang Industrial Park Danyang Jiangsu China Rui Li, Regulatory Assurance Email: lirui@yuyue.com.cn Phone number: 025-85582701-6225 #### 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX78746 Office Phone:(512) 327-9997 Contact: Giselle Zhang Title: Technical Consultant #### 3. Date Prepared 07/21/2020 #### 4. Device Identification | Trade/Proprietary Name: | Electronic Blood Pressure Monitor: YE620B, YE620D, YE660E, YE660F and<br>YE680B | |-------------------------|---------------------------------------------------------------------------------| | Common/Usual Name: | Non-Invasive Blood Pressure Monitor | | Classification Name: | Noninvasive blood pressure measurement system | | Regulation Number: | 870.1130 | | Product Code: | DXN | | Class: | II | Classification Panel: Cardiovascular #### 5. Legally Marketed Original Device | Trade/Proprietary Name: | Upper Arm Type Electronic Blood Pressure Monitor Series Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------| |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ | Common/Usual Name: | Non-Invasive Blood Pressure Monitor | |-----------------------|-----------------------------------------------| | Classification Name: | Noninvasive blood pressure measurement system | | Regulation Number: | 870.1130 | | Product Code: | DXN | | Class: | II | | Classification Panel: | Cardiovascular | | 510(k) Number: | K170605 | #### 6. Indication for Use Statement Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult in household or medical facilities. (Not suitable for neonate, pregnancy or pre-eclampsia). #### 7. Device Description The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The subject devices will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; the time, date, blood pressure value and pulse value are included. The record maybe revisited. #### 8. Substantial Equivalence Discussion The following table compares the modified device series to the original device series by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. {5}------------------------------------------------ | Device/Model | YE620B | YE620D | YE660E | YE660F | YE680B | Predicate: YE650A, YE650D, YE660B, YE670A and YE670D (K170605) | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | | | | | | | Product Code | DXN | | | | | | | Regulation No. | 870.1130 | | | | | | | Classification | II | | | | | | | Intended Use | Electronic blood pressure monitor is intended to measure the blood pressure and pulse rate of adult in household or medical facilities.<br>(Not suitable for neonate, pregnancy or pre-eclampsia) | | | | | | | | | | | | | Performance | | Design Method | Oscillometric | | | | | | | Patient<br>Population | Adult | | | | | | | Measurement<br>Site | Upper Arm | | | | | | | Cuff<br>Circumference | Type A (22cm~32cm, 22-45cm optional)<br>Type B (22cm~ 32cm, 22-45cm optional) | | | Type A (22cm~ 32cm)<br>Type B (22cm~ 32cm) | | | | Inflation Method | Automatic by electronic pump | | | | | | | Deflation Method | Automatic Pressure Release Valve | | | | | | | Display | Backlight LCD<br>Digital Display | Backlight LCD<br>Digital Display | LCD Digital<br>Display | Backlight LCD<br>Digital Display | Backlight LCD<br>Digital Display | Backlight LCD Digital Display | | Patients<br>Contacting<br>Materials | Patient contact materials are not changed. | | | | | | | Device/Model | YE620B | YE620D | YE660E | YE660F | YE680B | Predicate: YE650A, YE650D, YE660B, YE670A and YE670D (K170605)<br>YE670A:74 sets, YE670D: 60 sets, YE650A: 60 sets, YE650D: 80 sets, YE660B: 74 sets | | Memory Size | Up to 99 sets of data | Up to 60x2 sets of data | Up to 99 sets of data | Up to 90 sets of data | Up to 99x2 sets of data | | | Blood Pressure Indication Range | Measuring range: Diastolic:20 – 210 mm Hg<br>Systolic:40 - 260 mmHg | | | | | | | Measurement Pressure Range | | 0 ~ 300 mmHg (0 kPa ~ 40 kPa) | | | | 0~280mmHg (0-37.3kPa) | | Range Accuracy | ±3 mmHg (±0.4kPa) | | | | | | | Measurement Pulse Range | 40 ~ 200 beats/min | | | | | | | Pulse Accuracy | ±5% of reading value | | | | | | | Pressurization Source | Automatic Internal Pump | | | | | | | Pressure Sensor | Semiconductor Pressure Sensor | | | | | | | Operating Environment | Temperature: +5ºC ~ +40 °C<br>Humidity: 15% RH ~ 90% RH (no condensation) | | | | | Temperature: +10 °C ~ +40 °C<br>Humidity: 15% RH ~ 90% RH (no condensation) | | Storage Environment | Temperature: -20 °C ~ +55 °C<br>Humidity: 15% RH ~ 90% RH (no condensation) | | | | | | | Energy Source | 4 AA batteries or 6V/600mA AC adapter | | | | | 4 AA batteries | | Display Content | Cuff Pressure, Pulse, Date, Time, Systolic/Diastolic Pressure, error message. | Cuff Pressure, Pulse, Date, Time, Systolic/Diastolic Pressure, error message. | Cuff Pressure, Pulse, Date, Time, Systolic/Diastolic Pressure, error message. | Cuff Pressure, Pulse, Date, Time, Systolic/Diastolic Pressure, error message. | Cuff Pressure, Pulse, Date, Time, Systolic/Diastolic Pressure, error message. | Cuff Pressure, Pulse, Date, Time, Systolic/Diastolic Pressure, error message, measurements results in memory, Irregular Heart Beat Feature, Body movement detection. Cuff Wrapping Detection | | Device/Model | YE620B | YE620D | YE660E | YE660F | YE680B | K###<br>Predicate: YE650A, YE650D, YE660B,<br>YE670A and YE670D (K170605) | | | measurements | measurements | measurements | measurements | measurements | | | | results in | results in | results in | results in | results in | | | | memory, | memory, | memory, | memory, | memory, | | | | Irregular Heart | Irregular Heart | Irregular Heart | Irregular Heart | Irregular Heart | | | | Beat Feature, | Beat Feature, | Beat Feature, | Beat Feature, | Beat Feature, | | | | Body movement | Body movement | Body movement | Body movement | Body movement | | | | detection, Cuff | detection, Cuff | detection, Cuff | detection, Cuff | detection, Cuff | | | | Wrapping | Wrapping | Wrapping | Wrapping | Wrapping | | | | Detection | Detection, Dual | Detection | Detection | Detection, Dual | | | | | user switching | | | user switching | | | Controls | Memory Button,<br>START/PULSE<br>Button | START/PULSE<br>Button, Memory<br>Button, Member<br>Button | Memory Button,<br>START/PULSE<br>Button | Memory Button,<br>START/PULSE<br>Button | Memory Button,<br>START/PULSE<br>Button, Member<br>Button | SET Button, Plus/Minus Button,<br>START/PULSE Button | | Performance | ANSI/IAAMI/ISO81060-2:2013 | | | | | | | Performance | IEC80601-2-30 | | | | | | | Biocompatibility | ISO 10993-1, FDA Guidance, Tests included Cytotoxicity, Sensitization and Intracutaneous Reactivity | | | | | | | Electrical Safety | IEC60601-1 | | | | | | | EMC | IEC60601-1-2 | | | | | | | Usability | IEC 60601-1-6 | | | | | | | Home Use | IEC 60601-1-11 | | | | | | ### Table 5A – Comparison of Characteristics {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 9. Non-Clinical Performance Data To demonstrate safety and effectiveness of Electronic Blood Pressure Monitor: YE620B, YE660E, YE660F and YE680B and to show substantial equivalence to the original device, Jiangsu Yuyue Medical Equipment& Supply Co., Ltd completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The device passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device: - . ANSI AAMI ES60601-1:2005/ (R)2012 And A1:2012, C1:2009/ (R)2012 And A2:2010/ (R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD) – Passed - . ANSI AAMI IEC60601-1-2:2014Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: ElectromagneticDisturbances -- Requirements And Tests – Passed - IEC 60601-1-6 Edition 3.1 2013-10 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability – Passed - 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 – Passed - . ANSI AAMI IEC80601-2-30:2009 & A1:2013 (R2016) Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers – Passed - ISO 81060-2 Third Edition 2018-11Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type - Passed #### 10. Clinical Performance Data A clinical validation was conducted to evaluate safety and effectiveness of the Electronic Blood Pressure Monitor: YE620B, YE620D, YE660E, YE660F and YE680Bwhen used according to the indications for use. The study is an auscultatory study conducted with Model YE680B (representative model) according to ISO 81060-2. Eighty-five(85) participants were involved in the study, and three valid blood pressure values are taken for each participant by nurses and the reference device used is a mercury sphygmomanometer. A total 255 blood pressure values are being collected. Results of the clinical evaluation support the indications for use of the Electronic Blood Pressure Monitor: YE620B, YE620D, YE660E, YE660F and YE680B.The results confirm that the device is safe and effective when used according to the instructions for use. {9}------------------------------------------------ #### 11. Statement of Substantial Equivalence The Electronic Blood Pressure Monitor: YE620B, YE620D, YE660F and YE680B has the same intended use as the original device, and the same or similar technological characteristics. The minor differences in technological characteristics do not raise new or different questions of safety and effectiveness, as determined through a risk assessment and well-established test methods. Therefore, the Upper Arm Electronic Blood Pressure Monitor: YE620B, YE660E, YE660F and YE680B is substantially equivalent to the original Upper Arm Type Electronic Blood Pressure Monitor Series Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D.