TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR

{0}------------------------------------------------ K113083 Image /page/0/Picture/1 description: The image shows the word "TRULY" in bold, black letters. There is a line underneath the word. A circled "R" is to the right of the word. Truly Instrument Limited # 510(k) Summary JAN 1 9 2012 Date of Summary Preparation: August. 16.2011 ## 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: | Truly Automatic Arm Blood Pressure Monitor | | Models: | DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 | | 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 Truly Automatic Arm Blood Pressure Monitor, Model DB61M, K091434 ### 4. Device Description Truly Automatic Arm Blood Pressure Monitor DB series, Models DB33, DB81, DB83, DB85, DB91, DB92, DB93 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 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 device 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 Page 1 of 5 {1}------------------------------------------------ K||3083 #### TRULY Truly Instrument Limited of irregular pulse rhythm when the difference of the time intervals is over 25%. #### 5. Intended use of device Truly Automatic Arm Blood Pressure Monitor DB series, Models DB33, DB81, DB82, DB83. DB91, DB91, DB93 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 display a warning signal with the reading once the irregular heartbeat is detected. ## 6. Summary of Substantial Equivalence | Parameter | Predicate Devices DB61M | DB<br>33 | DB<br>81 | DB<br>82 | DB<br>83 | DB<br>85 | DB<br>91 | DB<br>92 | DB<br>93 | Result | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------|----------|----------|----------|----------|--------| | Intended use | Measuring systolic and diastolic blood pressure and pulse rate of adult individual | Measuring systolic and diastolic blood pressure and pulse rate of adult individual | | | | | | | | Same | | Indications<br>for use | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection. Over-The-Counter Use | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection. Over-The-Counter Use | | | | | | | | Same | | 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 | | design | Refer to Table-2 | | | | | | | | | Same | | performance | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection | | | | | | | | Same | | materials | Refer to Table-2 | | | | | | | | | Same | | biocompatibi | Cuff | Cuff | | | | | | | | Same | Table-1: The comparison table Page 2 of 5 {2}------------------------------------------------ K//3083 | TRULY® Truly Instrument Limited | | | | | | | | | | | |------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------|----------|----------|----------|----------|----------|----------|--------| | Parameter | Predicate Devices DB61M | DB<br>33 | DB<br>81 | DB<br>82 | DB<br>83 | DB<br>85 | DB<br>91 | DB<br>92 | DB<br>93 | Result | | lity | According to ISO-10993 | According to ISO-10993 | | | | | | | | | | Compatibility<br>with the<br>environment<br>and other<br>devices | Operation Environment:<br>10℃~ 40℃, 15%~90%RH<br>Storage Environment:<br>-20℃~ 60℃, 10%~95%RH | Operation Environment:<br>10℃~ 40℃, 15%~90%RH<br>Storage Environment:<br>-20℃~ 60℃, 10%~95%RH | | | | | | | | Same | | sterility | N/A | N/A | | | | | | | | 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 | | Chemical<br>safety | N/A | N/A | | | | | | | | Same | | Thermal<br>safety | N/A | N/A | | | | | | | | Same | ## Table-2: The comparison table in Design and Materials | Parameter | Predicate<br>Devices<br>DB61M | DB<br>33 | DB<br>81 | DB<br>82 | DB<br>83 | DB<br>85 | DB<br>91 | DB<br>92 | DB<br>93 | | |-------------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------|----------|----------|----------|----------|--| | Measurement<br>algorithm<br>Method | Oscillometric<br>method | No change,all same | | | | | | | | | | Measurement<br>site of body | Arm | No change,all same | | | | | | | | | | Pressure<br>Sensor | MSP-2107 | No change,all same | | | | | | | | | | Cuff | | No change,all same | | | | | | | | | | Software | | No change,all same | | | | | | | | | | Irregular<br>heartbeat<br>detection | | More than ±25% to the mean interval of pulse intervals.<br>About the more detailed description of the IH detection algorithm, please<br>refer to "Software validation report I-5. Algorithm description 4.<br>Determination method of irregular heartbeat". | | | | | | | | | | Memory Size | 4 x 99 | 2X60 | 1X40 | 1X40 | 4X99 | 4X99 | 4X99 | 4X99 | 4X99 | | | Measurement<br>Pressure<br>Range | 20 ~ 280 mmHg | No change,all same | | | | | | | | | | Measurement<br>Pulse Range | 40 ~ 195 beats/min | No change,all same | | | | | | | | | | Mesauring<br>resolution | 1 mmHg | No change,all same | | | | | | | | | | Accuracy | ±3mmHg | No change,all same | | | | | | | | | Page 3 of 5 {3}------------------------------------------------ K//3083 | Parameter | Predicate<br>Devices<br>DB61M | DB<br>33 | DB<br>81 | DB<br>82 | DB<br>83 | DB<br>85 | DB<br>91 | DB<br>92 | DB<br>93 | | |--------------------------|-------------------------------|---------------------------------------------|----------|----------|----------|----------|----------|----------|----------|--| | Pressure | | | | | | | | | | | | Accuracy<br>Pulse | $\pm5%$ | No change,all same | | | | | | | | | | Pressurization Source | Automatic<br>internal pump | No change,all same | | | | | | | | | | Cuff<br>Deflation | Automatic<br>deflation | No change,all same | | | | | | | | | | Operating<br>Environment | 10~40℃<br>15~90%RH | No change,all same | | | | | | | | | | Power<br>Voltage | 4X 1.5V | No change,all same | | | | | | | | | | Hardware<br>circuit | | No change,all same | | | | | | | | | | Electronic<br>element | | No change,all same | | | | | | | | | | PCB | | No change,all same | | | | | | | | | | Display Type | Liquid crystal<br>display | Liquid crystal display,Only difference size | | | | | | | | | | Cover | | Difference | | | | | | | | | ## Truly Instrument I imited ## 7. Summary of Clinical study l ). Subjects: Ninety subjects including 15 hypertensive patients 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 ANSI/AAMI SP10 Standard recommended : - a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg A. between test device and reference method. - Between-observer agreement should be:95% or more of readings made B. simultaneously by observers agree to within x10mmHg and 85% or more agree to within x5 mmHg. 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. | Table-1 Between test device and reference method | | | |--------------------------------------------------|-------------------|--------------------| | Criteria | Test Result | | | | Systolic Pressure | Diastolic Pressure | blog 1 Pativan toot daving and reference a {4}------------------------------------------------ K//3083 Image /page/4/Picture/1 description: The image shows the word "TRULY" in bold, black letters. To the right of the word is a circled "R", indicating that the word is a registered trademark. The word is simple and clear, making it easily readable. Truly Instrument Limited | Mean differences | x 5 mmHg | 3.3 mmHg | 4.5 mmHg | |------------------|----------|----------|----------| | SD differences | x 8 mmHg | 5.2 mmHg | 4.6 mmHg | | Table-2 Betwee-observer agreement | | | | |-----------------------------------|--|--|--| |-----------------------------------|--|--|--| | Criteria | Test Result | | |------------------------------------------------------|-------------------|--------------------| | | Systolic Pressure | Diastolic Pressure | | At least 95% of readings agree to<br>within x 10mmHg | 100% | 100% | | At least 85% of readings agree to<br>within x 5mmHg | 95% | 99% | ## 8. Conclusions The new subject series devices of Truly Automatic Arm Blood Pressure Monitor continue to follow principles of hardware and software design of the predicate device DB61M(K091434), and the feature, safety, effectiveness are also as same as DB61M., just only in case and LCD''s size changes. Thus, the subject devices are substantially equivalent to the predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Truly Instrument Co., Ltd. c/o: Mr. Jack Lee Truly (USA) INC 2620 Concord Avenue, Suite 106 Alhambra, CA 91803 JAN 1 9 2012 Re: K113083 Truly Automatic Arm Blood Pressure Monitor (DB33, DB81, DB82, DB83, DB91, DB92, DB93) - 8 models Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II Product Code: DXN Dated: January 13, 2012 Received: January 13, 2012 Dear Mr. Lee: 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 for ass based of 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 {6}------------------------------------------------ Page 2 - Mr. Jack Lee 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) of brovisions (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 17 you active pov.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. Director Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ K113083 # Truly Instrument Limited # Indications for Use 510(K) Number (if Known) Device Name: Truly Automatic Arm Blood Pressure Monitor DB Series: Models DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 Indication For Use: Truly Automatic Arm Blood Pressure Monitor, Models DB33, DB81, DB82, DB83, DB85, DB91, DB92, DB93 are a series device 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 display a warning signal with the reading once the irregular heartbeat is detected. AND/OR -Prescription Use _______________ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | |------------------------------------| | Division of Cardiovascular Devices | | 510(k) Number | K113083 | |---------------|---------| |---------------|---------| Page 1 of 1