A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 03, 2017 A&D Company, Ltd % Jerry Wang Director of Engineering 1756 Automation Parkway San Jose, California 95131 Re: K163683 Trade/Device Name: A&D Medical UA-1200BLE Ultraconnect 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: March 31, 2017 Received: April 3, 2017 Dear Jerry 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. 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, M.A. Hillemann 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 510(k) Number (if known) K163683 Device Name UA-1200BLE UltraConnect Digital Blood Pressure Monitor Indications for Use (Describe) Measure blood pressure (systolic and diastolic) and pulse rate. Type of Use (Select one or both, as applicable) _ Prescription Use (Part 21 CFR 801 Subpart D) മ Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." Page 1 of 1 Page 1 of 1. Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effective information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92. #### 1. Date Prepared December 23, 2016 #### 2. Submitter's Information A&D Engineering, Inc. Mr. Jerry Wang 1756 Automation Parkway, San Jose, CA 95131 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang@andonline.com #### 3. Device Information Proprietary Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor 21 CFR 870.1130 Noninvasive Blood Pressure Measurement System Class II DNX #### 4. Information for he 510(k) Cleared Devices (Predicate Devices) - A&D Medical UA-651 Digital Blood Pressure Monitor with 510(k) number K141160 . - A&D Medical UA-767PBT Digital Blood Pressure Monitor with 510(k) number . K043217 Both predicate devices are designed and manufactured by the same company and facilities as the modified device. #### ട. Indications for Use Measure blood pressure (systolic and diastolic) and pulse rate #### 6. Intended Use A&D LifeSource UA-1200BLE digital blood pressure monitor is designed for adult at home or clinic use. It measures systolic, diastolic, and pulse rate. UA-1200BLE uses the oscillometric method to determine blood pressure. If the user has a massive body movement or irregular heartbeats, a heart symbol will be shown on the app display. At the end of the measurement, the blood pressure results are compared with JNC VII hypertension classification. The rating is also displayed. UA-1200BLE has Bluetooth® low energy wireless (BLE) communication capability with Smart devices. UA-1200BLE fits arm size from 22 to 42 cm. #### 7. Device Description - Technological and Operational Characteristics Comparison UA-1200BLE of digital blood pressure monitor has the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. After the user starts the blood pressure measurement, the cuff is inflated automatically by an internal pump. The systolic {4}------------------------------------------------ ### K163683 and diastolic blood pressures are also determined by oscillometric method. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released immediately. There is a maximum pressure safety setting at 299 mmHg. UA-1200BLE UltraConnect Digital Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. UA-1200BLE will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the OLED and transmitted via Bluetooth wireless module to the connected app. The cuff is also deflated automatically to 0 mmHg at the same time. If the monitor receives no further action from the user for 1 minute, it will automatically turn off by itself. #### Summary of Substantial Equivalence 8. ### Modifications made from the predicate devices: - · Remove the plastic host between the cuff and main BP monitor. Basically, UA-1200BLE is a hoseless BP monitor comparing with the predicate devices. We also changed the plastic molds so the UA-1200BLE digital blood pressure monitors have a new appearance. - · Enable user ID so up to six users can use the UA-1200BLE. - · Increase the memory size to 100 per user except in the visitor mode. - · Change upper limit of the arm size from 17.7 inches (45 cm) to 16.5 inches (42 cm). - · Change pressure sensor from static electricity capacity type to semiconductor type | | Predicate Devices | | Modified Device | |------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------| | Model | UA-767PBT | UA-651 | UA-1200BLE | | Measurement<br>Method | Oscillometric Method | Oscillometric Method | No change | | Measurement<br>Range | BP : 20 - 280mmHg<br>Pulse : 40 - 200beats per<br>minute | BP : 0 - 299mmHg<br>Pulse : 40 - 180beats<br>per minute | No change from UA-651 | | Measurement<br>Accuracy | BP : +/- 3mmHg or +/-<br>2% of measured value,<br>whichever is greater<br>Pulse : +/- 5% (pulse) | BP : +/- 3mmHg<br>Pulse : +/- 5% (pulse) | No change from UA-651 | | Minimum<br>Display<br>Resolution | 1 mmHg | 1 mmHg | No change | | Pressure<br>sensor | Static electricity capacity<br>type sensor | Static electricity<br>capacity type sensor | Semiconducting type<br>sensor | | Pressurizatio<br>n Source | Automatic internal pump | Automatic internal<br>pump | No change | | Cuff<br>Deflation<br>Method | Automatic constant speed<br>mechanical exhaust valve | Automatic constant<br>speed mechanical<br>exhaust valve | Solenoid valve for rapid<br>exhaust | | Display Type | Liquid crystal display | Liquid crystal display | OLED display | | Cuff<br>Attachment<br>Method | By plastic hose connected<br>to monitor | By plastic hose<br>connected to monitor | Integrated (hoseless) | | IHB | Enabled | Enabled | No change | | %IHB | No | Enabled. %IHB is<br>displayed as frequency<br>of IHB detected | No change from UA-651 | | Power Source | 6V DC, 4x1.5V AA<br>batteries or AC adaptor<br>as an option | 6V DC, 4x1.5V AA<br>batteries or AC<br>adaptor as an option | 3.7V Li-ion batteries<br>or AC adaptor as an<br>option | | Protection<br>against<br>electrical<br>shock | Class I, Type B | Class I, Type B | No change | | Battery Life | 6 months with one<br>measurement dairy | 6 months with one<br>measurement dairy | 3 months with one<br>measurement daily | | Operating<br>Environment | 50°F(10°C) to<br>104°F(40°C)<br>at less than 85%RH | 50°F(10°C) to<br>104°F(40°C)<br>15%RH to 85%RH | No change | | Storage<br>Environment | -4°F(-20°C) to<br>140°F(60°C)<br>at less than 85%RH | -4°F(-20°C) to<br>140°F(60°C)<br>10%RH to 95%RH | No change | | Data<br>Memory Size | Last 40 measurements of<br>systolic, diastolic, and<br>pulse rate | Last 60 measurements<br>for each of the four<br>user | Last 100 measurements<br>for each of the five user | | Dimensions | 163.7(H)x111(W)x66.7(<br>L) mm | 140(W)x60(H)x105(D<br>) mm | 40(W)x126(H)x26(D)<br>mm | | Weight | 320g without batteries | 255g without batteries | 205g without batteries | | Cuff Design | D-ring cuff with plastic<br>hose | D-ring cuff with<br>plastic hose | D-ring cuff(Integrated)<br>Hoseless | | Arm Size | 13 to 45 cm | 22 to 45 cm | 22 to 42 cm | | Clock<br>(Time/Date) | Yes (By App) | Yes | No change from UA-<br>767PBT | | AM/PM | No | Yes | No change from UA-651 | | Pressure<br>Indicator | Yes | Yes | No change | | Wireless<br>Radio<br>Connectivity | Bluetooth wireless | No | No change from UA-<br>767PBT | | Field service | Not allowed | Not allowed | No change | | Automatic<br>Zero at<br>"START" | Yes | Yes | No change | | Manual Zero<br>Adjustment | Not allowed | Not allowed | No change | | Calibration | Not allowed in the field | Not allowed in the<br>field | No change | | Sterilization | Not needed | Not needed | No change | | Blood<br>Pressure<br>Reading<br>Classification<br>Criteria | USA JNC VII | WHO Classification<br>Criteria | No change from UA-<br>767PBT | ### Product Specification Comparison Table: {5}------------------------------------------------ {6}------------------------------------------------ ### Key Features Comparison | Parameter | Predicate Devices<br>(UA-651 & UA-767PBT) | Modified Device<br>(UA-1200BLE) | |-------------------------------------------|-------------------------------------------|---------------------------------| | Field service | Not allowed | No change - the same | | Automatic zero after<br>"START" operation | Yes | No change - the same | | Manual zero adjustment | Not allowed | No change - the same | | Calibration | Not allowed in the field | No change - the same | | Sterilization | Not needed | No change - the same | #### 9. Discussion of standards used in the design verification and design validation A&D Medical follows FDA recognized consensus standards and guidance documents in our medical device development and manufacturing processes. The following standards were used to for the design verification and valuation of UA-1200BLE UltraConnect Digital Blood Pressure Monitor. These standards include three major groups. First group is the general quality system requirements. Second group is the special requirements for CDRH (870.1130). The third group is related to software and app life cycle processes requirements. - AAMI/ANSI/ISO 14971:2007/(R) 2010 (Corrected 4 October 2007) ● Medical Devices - Applications Of Risk Management To Medical Devices (FDA Recognized Number 5-70) - IEC 60601-1-11 Edition 1.0 2010-04 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 [Including: Technical Corrigendum 1 (2011)] (FDA Recognized Number 19-6) - . IEC 60601-1-2 Edition 3: 2007-03 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (FDA Recognized Number 19-1) - AAMI/ANSI/IEC 60601-1-2:2007/(R)2012 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3) (FDA Recognized Number 19-2) {7}------------------------------------------------ - AAMI/ANSI/ISO 81060-2 Second Edition 2013-05-01 ● Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type (FDA Recognized Number 3-117) - . AAMI/ANSI/IEC 80601-2-30:2009 & A1:2013 Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers (FDA Recognized Number 3-130) - . AAMI/ANSI/IEC 62304:2006 Medical Device Software - Software Life Cycle Processes (FDA Recognized Number 13-32) ### 10. Substantial Equivalence Conclusion: Non-clinical Test Summary: - Safety Tests: IEC 60601-11 Edition 1.0 2010-04 - . EMC Tests: IEC 60601-1-2 Edition 3: 2007-03 - Reliability Tests: ASMI/ANSI/IEC 80601-2-30:2009 & A1:2013 ● - Risk Assessment: ISO 14971:2012 . - Software Assessment: IEC Medical Life Cycle Process & FDA "Guidance for the Content of Premarket Submissions for Software contained in Medical Devices", November 2005. . Bluetooth Tests: FCC Part 15 Subpart C : 2014 ### Clinical Test Summary based on AAMI/ANSI/ISO 81060-2 Second Edition 2013-05-01 | Item | Standard Requirements | Study Results | | Pass/Fail | |--------------------------|--------------------------------------|-----------------|-----------|-----------| | Number of Subject | 85 or more | 85 | 100% | Pass | | Number of<br>Measurement | 3 times or more | 3 times | 100% | Pass | | Observer | 2 | 2 | 100% | Pass | | Observer Difference | +/-4 mmHg or less | +/- 4 mmHg less | 100% | Pass | | Gender | Male 30% or more | 59 | 69.4% | Pass | | | Female 40% or more | 26 | 30.6% | Pass | | Age | Older than 12 years : 100% | 85 | 100.0% | Pass | | Circumference of<br>Arm | 22.0-32.0 cm : 40% or more | 49 | 57.6% | Pass | | | 32.1 - 42.0 cm : 40% or more | 36 | 42.4% | Pass | | | 22.0-27.0cm: 20% or more | 28 | 32.9% | Pass | | | 37.0-42.0 cm: 20% or more | 17 | 20.0% | Pass | | BP Range | SBP<100mmHg 5% or more | 19 | 7.5% | Pass | | | SBP>160mmHg 5% or more | 15 | 5.9% | Pass | | | SBP<140mmHg 20% or more | 51 | 20.0% | Pass | | | DBP<60mmHg 5% or more | 19 | 8.2% | Pass | | | DBP>100mmHg 5% or more | 23 | 9.0% | Pass | | | DBP >85mmHg 20% or more | 87 | 34.1% | Pass | | Measurement Result | Average : +/-5mmHg or less | SBP | -2.66mmHg | Pass | | | | DBP | +0.90mmHg | Pass | | | S.D. : 8mmHg or less<br>(Criteria 1) | SBP | 6.90mmHg | Pass | | | | DBP | 6.63mmHg | Pass | {8}------------------------------------------------ | S.D.: 8 mmHg or less<br>(Criteria 2) | SBP | 5.35 mmHg | Pass | |--------------------------------------|-----|-----------|------| | | DBP | 6.12 mmHg | Pass | UA-1200BLE of digital blood pressure monitors Digital blood pressure monitors have the following similarities to the predicate devices, UA-651 and UA-767PBT digital blood pressure monitors, which previously received the 510(k) clearance. - Same intended use. - Same oscillometric method to determine the blood pressure & pulse rate - Same inflation method - automatic internal pump - . Same fast safety deflation method - solenoid controlled exhaust valve - Same materials, no new materials used - Same manufacturing processes at the same facility - . Same Indications For Use As a conclusion. UA-1200BLE UltraConnect digital blood pressure monitor as described in its labeling and comparison analysis has not changed as a result of the modifications. The fundamental scientific technology of the modified device has not changed, either. There is no significant difference that affects the safety or effectiveness of the modified device as compared to the predicate devices.