Automatic Arm Bluetooth Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 24, 2016 Truly Instrument Limited % Max Wong, Corporate Secretary Truly (U.S.A) Inc 2620 Concord Avenue, Suite 106 Alhambra, California 91803 Re: K161846 Trade/Device Name: Automatic Arm Bluetooth Blood Pressure Monitor, with models DB62, DB63 and DB85 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 27, 2016 Received: October 4, 2016 Dear Max Wong: 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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, for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### K161846 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K161846 Device Name Automatic Arm Bluetooth Blood Pressure Monitor Indications for Use (Describe) Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a noninvasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### 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." FORM FDA 3881 (8/14) PSC Publishing Services (301) 443-67 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the alphanumeric string "K161846". The string is written in a simple, sans-serif font. The characters are black against a white background, providing a clear contrast. Image /page/3/Picture/1 description: The image contains the word "TRULY" in large, red, bold letters. There is a registered trademark symbol to the right of the word. A black line is located underneath the word. # 510(k) Summary V1.1 Date of Summary Preparation: Jan.16.2015 ### 1. Submitter's Identifications | Submitter's Name: | Truly Instrument Limited | |-------------------|---------------------------------------------------------------------------| | Address: | Site 2, Truly Industrial Area, Shanwei City,<br>Guangdong Province, China | | Contact Person: | Manager Yang Jian-Hao | | Telephone: | 86-0660-3380070 | | Fax: | 86-0660-3380377 | #### 2. Name of the Device | | Device Classification Name: | System, Measurement, Blood-Pressure, Non-invasive | |------------------------|------------------------------------------------|---------------------------------------------------| | Trade Nam: | Automatic Arm Bluetooth Blood Pressure Monitor | | | Models: | DB62, DB63, DB85 | | | Classification Panel: | cardio-vascular | | | Common/Usual Name: | Automatic Arm Blood Pressure Monitor | | | Product Code: | DXN | | | Device Classification: | Class II | | | Contraindications : | N/A | | #### 3. The Predicate Devices - 3-1. YA HORNG Electronic Co., Ltd Upper Arm Blood Pressure Monitor. Model BP-700NW and Bluetooth Transmission BP-700W. K Number : K121025 - 3-2. TRULY Instrument Limited. Truly Automatic Arm Blood Pressure Monitor DB Series, Model DB62M. K Number :K091434 ### 4. Device Description Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method". The main components of the Truly Automatic Arm Blood Pressure Monitor DB series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the word "TRULY" in red, with a registered trademark symbol next to it. The word is in a bold, sans-serif font and is slightly slanted to the right. A black line is present underneath the word. single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AA alkaline batteries. The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%. The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol. . ### 5. Intended use of device Truly Automatic Arm Bluetooth Blood Pressure Monitor DB series, Models DB62, DB63, DB85 are a series devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication . ### 6. Technological Characteristics of our new DEVICE COMPARED TO THE ### PREDICATE DEVICE: 6-1:The technological characteristics of Truly Automatic Arm Bluetooth Blood Pressure Monitor, models DB62, DB63, DB85 are substantially equivalent to Truly Automatic Arm Blood Pressure Monitor DB Series, Model DB62M.( K091434). There is the same Owner, TRULY instrument Limited. Which FDA owner number is 9055362. our new devices DB62. DB63. DB85 are the upgraded version to include the Bluetooth 4.0 Wireless function. In addition, there are the same dseign specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices. | Parameter | Predicate Devices<br>DB62M(K091434) | DB62 | DB63 | DB85 | Result | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|--------| | Indications<br>for use | Measuring systolic and<br>diastolic blood pressure and<br>pulse rate of adult individual<br>by using a non-incasive<br>technique in which an<br>inflatable cuff is wrapped<br>around the upper arm,,<br>The devices features include | Truly Automatic Arm Bluetooth Blood<br>Pressure Monitor DB series, Models<br>DB62, DB63, DB85 are a series devices<br>intended to measure the systolic and<br>diastolic blood pressure and pulse rate of<br>an adult individual by using a<br>non-invasive technique in which an<br>inflatable cuff is wrapped around the | | | Same | #### Table-6-1: The comparison table {5}------------------------------------------------ | | | RULY® | |--|--|-------| |--|--|-------| | Parameter | Predicate Devices<br>DB62M(K091434) | DB62 | DB63 | DB85 | Result | |---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|--------| | | irregular pulse nrhythm<br>detection during<br>measurement, and display a<br>warning signal with the<br>reading once the irregular<br>heartbeat is detected. .<br>Over-The-Counter Use | upper arm.<br>The devices' features include irregular<br>pulse rhythm detection during<br>measurement, and will display a alert<br>signal with the reading when irregular<br>heartbeat is detected.<br>The devices' feature include Bluetooth<br>function to transmit data to an external<br>Bluetooth device with wireless<br>communication ..<br>Over-The-Counter Use | | | | | Target<br>Population | Adult | Adult | | | Same | | Anatomical<br>sites | Upper Arm | Upper Arm | | | Same | | Where used<br>(hospital,<br>home,<br>ambulance.<br>etc) | Home | Home | | | Same | | Energy used<br>and / or<br>delivered | 4x 1.5V AA Battery | 4x 1.5V AA Battery | | | Same | | Human<br>factors | Blood pressure | Blood pressure | | | Same | | Measurement<br>algorithm<br>Method | Oscillometric method | | | | Same | | Cuff | No change ,all same According to ISO-10993 | | | | Same | | Irregular<br>heartbeat<br>detection | More than ±25% to the mean interval of pulse intervals. | | | | | | Measurement<br>Pressure<br>Range | 20 ~ 280 mmHg | No change ,all same | | | Same | | Measurement<br>Pulse Range | 40 ~ 195 beats/min | No change ,all same | | | | | Mesauring<br>resolution | 1 mmHg | No change ,all same | | | | | Accuracy<br>Pressure | ±3mmHg | No change ,all same | | | | | Accuracy<br>Pulse | ±5% | No change ,all same | | | | {6}------------------------------------------------ | Truly Instrument Limited | | | | | | |------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|------|------|--------| | Parameter | Predicate Devices<br>DB62M(K091434) | DB62 | DB63 | DB85 | Result | | PCB | 1. The major PCB is all all same.<br>2. There is BLE module to direct connect to major PCB via the port RX and TX on the new Bluetooth models DB62,DB63,DB85. | | | | | | Software | Upgrade the software to include the data transmit with Uart protocol on the new Bluetooth models DB62, DB63, DB85. | | | | | | Compatibility<br>with the<br>environment<br>and other<br>devices | Operation Environment:<br>10°C~ 40°C, 15%~90%RH<br>Storage Environment:<br>-20°C~ 60°C, 10%~95%RH | | | | Same | | Electrical<br>safety | According to IEC60601-1-2<br>According to IEC60601-1 | According to IEC60601-1-2<br>According to IEC60601-1 | | | Same | | Mechanical<br>safety | Same | Same | | | Same | 6-2: Besides, the devices DB62, DB63, DB85 and the other predicate device YA HORNG Electronic Co., Ltd Upper Arm Blood Pressure Monitor. Model Bluetooth Transmission BP-700W( K121025) are also with the wireless communication function connect to an external Bluetooth enable device for data receiving and storage. Table-6-1: The comparison table | Parameter | Predicate Devices<br>BP-700W(K121025) | DB62 | DB63 | DB85 | Result | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Indications<br>for use | The YA HORNG Upper<br>Arm Blood Pressure<br>Monitor, mondel BP-700NW<br>and Bluetooth Transmission<br>BP-700W are noninvasive<br>blood pressure measurement<br>systems intended to measure<br>the systolic and diastolic<br>blood pressures and pulse<br>rate of an adult individual,<br>over age 18, at home by<br>using a non-invasive using a<br>non-invasive technique in<br>which an inflatable cuff is<br>wrapped around the upper<br>arm, The cuff circumference<br>is limited to be 9.0''~13.0''<br>for Arm type.<br>Optional models: BP-700W<br>with Bluetooth module for<br>the wireless communication | Truly Automatic Arm Blood Pressure<br>Monitor DB series, Models DB62, DB63,<br>DB85 are a series devices intended to<br>measure the systolic and diastolic blood<br>pressure and pulse rate of an adult<br>individual by using a non-invasive<br>technique in which an inflatable cuff is<br>wrapped around the upper arm. | | The devices' features include irregular<br>pulse rhythm detection during<br>measurement, and will display a alert<br>signal with the reading when irregular<br>heartbeat is detected.<br>The devices' feature include Bluetooth<br>function to transmit data to an external<br>Bluetooth device with wireless<br>communication .<br>Over-The-Counter Use | Same | | Parameter | Predicate Devices<br>BP-700W(K121025)<br>function connectes to the PC<br>for record archiving and<br>printing purposes.<br>Over-The-Counter Use | DB62 | DB63 | DB85 | Result | | Target<br>Population | Adult | Adult | | | Same | | Anatomical<br>sites | Upper Arm | Upper Arm | | | Same | | Where used<br>(hospital,<br>home,<br>ambulance.<br>etc) | Home | Home | | | Same | | Energy used<br>and / or<br>delivered | 4x 1.5V AA Battery | 4x 1.5V AA Battery | | | Same | | Human<br>factors | Blood pressure | Blood pressure | | | Same | | Measurement<br>algorithm<br>Method | Oscillometric method | No change ,all same | | | Same | | Cuff | Size: 9"~13"<br>(228mm~330mm)<br>According to ISO-10993 | Size: 220mm~340mm | | | Slightly<br>different | | Irregular<br>heartbeat<br>detection | More than ±25% to the mean interval of pulse intervals. | | | | | | Measurement<br>Pressure<br>Range | 20 ~ 280 mmHg | No change ,all same | | | Same | | Measurement<br>Pulse Range | 40 ~ 200 beats/min | 40 ~ 195 beats/min | | | Slightly<br>different | | Mesauring<br>resolution | 1 mmHg | No change ,all same | | | Same | | Accuracy<br>Pressure | ±3mmHg | No change ,all same | | | Same | | Accuracy<br>Pulse | ±5% | No change ,all same | | | Same | | Electrical<br>safety | According to IEC60601-1-2<br>According to IEC60601-1 | According to IEC60601-1-2<br>According to IEC60601-1 | | | Same | | Parameter | Predicate Devices<br>BP-700W(K121025) | DB62 | DB63 | DB85 | Result | | Mechanical<br>safety | Same | Same | | | Same | {7}------------------------------------------------ {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the word "TRULY" in red, bold letters. To the right of the word is a small red circle with the letter R inside, indicating a registered trademark. The word is displayed in a simple, sans-serif font, and the overall design is clean and straightforward. ### 7. Summary of Clinical study - 1). Subjects: Eighty-five subjects in the hospital were participated in clinical study. - 2). Method: A standard mercury sphygmomanometer was used as a reference standard. Simultaneous and blinded blood pressure determinations were performed by two doctors. - 3). Criteria: The ISO81060-2 Standard recommended : - A. a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg between test device and reference method. B. For the systolic and diastolic blood pressures for each of the m subjects, the standard Sm, of the averaged paired determinations per subject of the deviation, sphygmomanometer-under-test and of the reference sphygmomanometer shall meet the criteria listed in Tab 1 when calculated according to Equation(3). | $\overline{x}_n$ | Maximum permissible standard deviation, $s_m$ , as function of mean error, $\overline{x}_n$<br>mmHg | | | | | | | | | | |--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------|------|------|------|------|------|------|------|------| | | 0,0 | 0,1 | 0,2 | 0,3 | 0,4 | 0,5 | 0,6 | 0,7 | 0,8 | 0,9 | | ± 0, | 6,95 | 6,95 | 6,95 | 6,95 | 6,93 | 6,92 | 6,91 | 6,90 | 6,89 | 6,88 | | ± 1, | 6,87 | 6,86 | 6,84 | 6,82 | 6,80 | 6,78 | 6,76 | 6,73 | 6,71 | 6,68 | | ± 2, | 6,65 | 6,62 | 6,58 | 6,55 | 6,51 | 6,47 | 6,43 | 6,39 | 6,34 | 6,30 | | ± 3, | 6,25 | 6,20 | 6,14 | 6,09 | 6,03 | 5,97 | 5,89 | 5,83 | 5,77 | 5,70 | | ± 4, | 5,64 | 5,56 | 5,49 | 5,41 | 5,33 | 5,25 | 5,16 | 5,08 | 5,01 | 4,90 | | ± 5, | 4,79 | - | - | - | - | - | - | - | - | - | | EXAMPLE For mean error of ± 4,2, the maximum permissible standard deviation is 5,49. | | | | | | | | | | | Table 1 - Averaged subject data acceptance (criterion 2) #### 4). Result Through clinical research, we can convinced that the clinical device is safe and effective. The results of the clinical data refer the follow two tables. | | Criterion 1 | | | Criterion 2 | | |------|----------------|------------------|------|----------------|------------------| | | Diff(Systolic) | Diff (diastolic) | | Diff(Systolic) | Diff (diastolic) | | Mean | 2.5mmHg | 1.8mmHg | Mean | 2.5mmHg | 1.8mmHg | | Std. | 3.45mmHg | 3.30mmHg | Std | 2.56mmHg | 2.10mmHg | | | | | | | | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "TRULY" in large, bold, red letters. To the right of the word, there is a small, circular "R" symbol, indicating that the word is a registered trademark. The font of the word is sans-serif and the letters are closely spaced together. Test Summary: 8-1. Electric Safety , EMC and FCC test reports. | | IEC/EN 60601-1:2007 | |----------------|----------------------------------| | General safety | IEC/EN60601-1-11 | | | EN60950-1:2011 | | EMC conformity | IEC/EN 60601-1-2:2010 | | FCC conformity | FCC 47 part 15 subject B class B | | ERM conformity | EN30148-1:2008, | | | EN30148-17:2009 | | RF conformity | EN300328:2006 | | Health | EN62479:2010 | 8-2. Performance & Clinical Test ANSI/AAMI SP10:2002 ANSI/AAMI ISO 81060-2:2009 #### 9. Conclusions The new subject series devices of Truly Automatic Arm Bluetooth Blood Pressure Monitor continue to follow principles design of the predicate device DB62M(K091434), only upgraded to include the Bluetooth module . for the wireless communication function connects to an external Bluetooth enable device for data receiving and storage purposes . and the addition function Bluetooth substantially is equivalent to the predicate produce YA HORNG Electronic Co., Ltd Upper Arm Blood Pressure Monitor. Model Bluetooth Transmission BP-700W(K121025) .