Digital Blood Pressure Monitor

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In the center of the logo is an abstract symbol that resembles an eagle or bird with three human profiles incorporated into its design. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 24, 2016 Suzhou Sunspiri Co., Ltd. % Long Yang Coo Shenzhen Hlongmed Biotech Company Limited R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District Shenzhen, 518054 CN Re: K153033 Trade/Device Name: 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: May 13, 2016 Received: May 19, 2016 Dear Long Yang: 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. 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 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) #### Device Name Digital Blood Pressure Monitor Models: JWS Series, including: JDS-189, JDS-500A, IDS-500E, JDS-600, JDS-700, IDS-703, IDS-704, JDS-800, BM20 Indications for Use (Describe) This device is intended to measure the blood pressure and pulse rate on upper arms of adults. 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}------------------------------------------------ # 510(k) Summary #### Date Prepared: June 22, 2016 #### 1. Submitter SUZHOU SUNSPIRIT CO., LTD. No.72, Hengshan Rd., Suzhou New District, P. R. China, 215009 Establishment Registration Number: 3010271644 Tel: 0086-512-68238996 Fax: 0086-512-68234280 #### 2. Submission Correspondent 1) Ms. Jing Zhang (QA manager) SUZHOU SUNSPIRIT CO., LTD. No.72, Hengshan Rd., Suzhou New District, P. R. China, 215009 2) Mr. Long Yang (COO) Shenzhen Hlongmed Biotech Company Limited R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P.R. China,518054 Tel: 0086-755-86664986 Fax: 0086-755-86664933 E-mail: yanglong@hlongmed.com ## 3. Proposed Device Information Trade name: Digital Blood Pressure Monitor Model: JDS Series, including: JDS-189, JDS-500, JDS-500A, JDS-500E, JDS-600, JDS-700, JDS-703, JDS-704, JDS-800, BM20 Common name: Digital Blood Pressure Monitor Classification name: Noninvasive Blood Pressure Measurement System Review Panel: Cardiovascular System Devices Panel (74) Product Code: DXN Regulation Class: II Regulation Number: 870.1130 {4}------------------------------------------------ ## 4. Predicate Device Information Company Name: Shenzhen Pump Medical System Co., Ltd. Device Name: Arm Automatic Blood Pressure Monitor, model BF1115 510(k) number: K130325 ## 5. Device Description The Digital Blood Pressure Monitor is Arm-type fully automatic Digital Blood Pressure Monitor and used the oscillometric method for non-invasive measurement of blood-pressure at home. The equipment is non-transit-operable, portable equipment, not used at the conditions of patient movement in normal use. The unit is powered by internal dry battery. Digital Blood Pressure Monitor is based on pressure vibration method. Blood pressure cuff use the air pump to inflate, then the arteries are extruded by the cuff with pressure. Pressure sensor collects the pressure in the cuff, and then converts it to digital signal to the CPU. Then the software calculates the systolic and diastolic blood pressure and pulse rate. Digital Blood Pressure Monitor, JDS-189, JDS-500A, JDS-500E, JDS-600, JDS-700, JDS-703, JDS-704, JDS-800, BM 20 in term of intended use measurement method, structure, and specifications are totally same, only the appearance, memory space has difference. #### 6. Intended use/Indications for use: This device is intended to measure the blood pressure and pulse rate on upper arms of adults. ## 7. Testing data and clinical study Laboratory testing was conducted to validate and verify that Digital Blood Pressure Monitor met all requirements of related international standards, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of the bellow consensus standards. Clinical study has been evaluated according to ANSI/AAMI/ISO 81060-2. #### Applied Standard: {5}------------------------------------------------ - Electrical Safety requirement: AAMI / ANSI ES 60601-1:2005 - Performance requirement: IEC80601-2-30 ● - Electromagnetic Compatibility Requirements: IEC 60601-1-2 ● - Home-used medical equipment requirements: IEC 60601 -1 -11 - Biocompatibility Evaluation for NIBP Cuff: ISO 10993-5, ISO 10993-10 ● - Clinical Evaluation: ANSI/AAMI/ISO 81060-2 # 8. Comparison to Predicate Device | Trade Name | Digital Blood Pressure Monitor | Arm Automatic Blood Pressure Monitor | |--------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Model | JDS-189, JDS-500, JDS-500A, JDS-500E, JDS-600, JDS-700, JDS-703, JDS-704, JDS-800, BM 20 | BF1115 | | Indications for use | This device is intended to measure the blood pressure and pulse rate on upper arms of adults. | It is intended for measuring adult blood pressure and pulse rate. | | Target population | Adult | Adult | | Environment of use | Home | Home | | Technology | Oscillometric method | Oscillometric method | | Measurement Method | Non-invasive | Non-invasive | | Measurement localization | Upper arm | Upper arm | | Memory Space | 2×30(BM20, JDS-189, JDS-500, JDS-500A, JDS-500E, JDS-600) / 1×99(JDS-700)/ 2×60(JDS-703, JDS-704)/ 2×50(JDS-800) | 50 sets of measurement values( blood pressure and pulse rate) for each user( Memory 1 and Memory 2) | | Measuring parameters | blood pressure (systolic and diastolic) and heart rate | blood pressure (systolic and diastolic) and heart rate | {6}------------------------------------------------ | Measurement<br>range | Pressure: 0 – 300 mmHg<br>Pulse: 40 –180 beats/min | Pressure: 0 to 280 mmHg<br>Pulse: 40 to 180 pulses/min | |-----------------------------|----------------------------------------------------------|----------------------------------------------------------| | Measurement<br>accuracy | Pressure: ± 3 mmHg<br>Pulse: ± 5% of the displayed value | Pressure: ± 3 mmHg<br>Pulse: ± 5% of the displayed value | | Inflation Mode | Automatic by Internal Pump | Automatic by Internal Pump | | Deflation<br>Mode | Automatic by Valve | Automatic by Valve | | Measurable<br>circumference | 22-32cm | 22-36cm | | Display | LCD, digital display | LCD, digital display | | Energy source | 4 AA Alkaline batteries | 4 AA Alkaline batteries or AC<br>adaptor(AC 100~ 240V) | | Operating<br>environment | +10~+40 °C , ≤85% RH | +5~+40°C , ≤93%RH | | Storage<br>environment | -5 ~ +50 °C, ≤85% RH | -25~+70°C,10~95%RH | The subject device is Substantially Equivalent (SE) to the predicate device which is US legally market device. # 9. Conclusion Digital Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate device. Moreover, non-clinical testing & clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness. In a word, Digital Blood Pressure Monitor is substantial equivalent to the predicate device.