ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with the letters J, X, B, and D. The letters are in a bold, sans-serif font. The letters J, X, and B are solid black, while the letter D is black with white dots inside. There is a small, abstract design to the right of the letter D. K130232 Jinxinbao Electronic Co., Ltd ## Section 5 510(k) Summary ## (As required by 21 CFR 807.92(a)) ### 5.1 Submitter Information SEP 17 2013 - · Company: Jinxinbao Electronic Co.,Ltd · Address: No.38, Huanzhenxi Road, Dagang Town, Nansha, Guangzhou, China · Phone: 086-20-34938449 - · Fax: 086-20-22865301 - · Email: xhoucc@jxb-htb.net · Contact: Jiacheng Guo, General Manager · Date: November 15, 2012. #### 5.2 Device Information · Trade/Proprietary Name: Electronic Blood Pressure Monitor for Upper Arm, Model BPA-002 · Common Name: Blood Pressure Monitor · Classification: Device Class: 2 Review Panel: Cardiovascular Name: Non-invasive Blood Pressure Measurement System Regulation Number: 21 CFR 870.1130 Product Code: DXN · Predicate Device: Fully Automatic Digital Blood Pressure Monitor, Model BP-1307. #### K120554 · Device Description: BPA-002 Electronic Blood Pressure Monitor for Upper Arm uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The Page 1 of 5 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with the letters J, X, and B in a bold, sans-serif font. The letters are arranged horizontally, with J on the left, X in the middle, and B on the right. The letter B has a design element on the top right that resembles a chain or a series of connected circles. The logo is in black and white. #### K130232 Jinxinbao Electronic Co., Ltd pressure of the cuff is completely released automatically at the end of measurement. At the same time, the measurements are displayed on the LCD display for 60 seconds. There is a maximum pressure safety setting at 280mmHg. The device will not inflate the cuff higher than 280mmHg. It will display an irregular heartbeat symbol if an irregular heartbeat was detected during the measurement process. In addition, it has LCD backlight. After 60 seconds without operation, the blood pressure monitors turn off automatically · Intended Use: BPA-002 Electronic Blood Pressure Monitor for Upper Arm is intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel. It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia. | Item | Subject Device | Predicate Device | | |----------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------| | Device Name | Electronic Blood Pressure<br>Monitor for Upper Arm<br>Model BPA-002 | Fully Automatic Digital<br>Blood Pressure Monitor<br>Model BP-1307<br>(K120554) | | | | Method of Measurement | Oscillometric | Oscillometric | | | Inflation Method | Automatic Internal Pump | Automatic Internal Pump | | | Deflation Method | Preset Mechanical Valve at<br>a Constant Rate | Preset Mechanical Valve at<br>a Constant Rate | | Anatomical Site | | Upper Arm | Upper Arm | | Range of Measurement | Pressure:<br>0mmHg~280mmHg<br><br>Pulse:<br>30~160 Beats/minute | Pressure:<br>0mmHg~300mmHg<br><br>Pulse:<br>30~180 Beats/minute | | ## 5.3 Comparison of Required Technology Characteristics {2}------------------------------------------------ | Portugues of | Jinxinbao Electronic Co., Ltd | K130232 | |------------------------|-------------------------------|--------------------------| | Accuracy | Pressure: ±3mmHg | Pressure: ±3mmHg | | | Pulse: ≤5% | Pulse: ±5% | | Operating Conditions | Temperature: 5℃~40℃ | Temperature: 5°C ~40°C | | | RH: 15%-85% | RH: <85% | | Storage Conditions | Temperature: - 10 ℃~60 ℃ | Temperature: - 10°C~55°C | | | RH: 15%~85% | RH: <95% | | Power Supply | 4 Batteries Size AA | 4 Batteries Size AA | | Display | Liquid Crystal Digital | Liquid Crystal Digital | | | Display | Display | | Cuff Size | Arm Circumference: | Arm Circumference: | | | 22~30cm | 22-36cm | | Unit Weight | About 430g ( Without | About 395g ( Without | | | Batteries) | Batteries) | | Sets of Memory | 99 Memories in three | 120 Memories in two | | | groups | groups | | Irregular Heart Beat | Yes | Yes | | Detection | | | | Low Battery Indicator | Yes | Yes | | Last 3 Results Average | Yes . | Yes | #### Brief Summary: The BPA-002 Electronic Blood Pressure Monitor for Upper Arm incorporates the same fundamental technology characteristics and design with the predicate device, such as measurement method, inflation and deflation method, anatomical site, power supply, display, irregular heart beat detection, low battery indicator and last 3 results average. Though they differ in the concrete parameters of measurement range, accuracy, cuff size and sets of memory, such differences will not influence the intended use of the subject device and will not lead to safety and effectiveness concerns. {3}------------------------------------------------ #### 5.4 Discussion of Tests Performed #### · Clinical Tests: Subject device BPA-002 is compliant to the SP10:2002/(R) 2008&ANSI/AAMI SP10:2002/A1:2003/( Manual, electronic or automated sphygmomanometers. All the relevant activities were performed by designate individual(s) and the results demonstrated that the predetermined acceptance criteria were fully met. #### · Non-Clinical Tests The subject device was tested to evaluate its safety and effectiveness according to the following standards: a. Electrical Safety Test according to IEC 60601-1, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance. b. Electromagnetic Compatibility Test according to IEC 60601-1-2:2007, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests. c. Biocompatibility Test according to ISO 10993-5: 2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10: 2010, Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization. d. Performance Effectiveness Test according to SP10:2002/(R) 2008&ANSI/AAMI SP 10: 2002/A 1: 2003/ (Manual, electronic or automated sphygmomanometers. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the letters J, X, B, and D. The letters are in a bold, sans-serif font. The letters are black and the background is white. The letters are arranged horizontally, with the J on the left and the D on the right. 5.5 Conclusion: First, the subject device BPA-002 Electronic Blood Pressure Monitor for Upper Arm enjoys the same intended use and similar technological characteristics with the predicate device. Besides, the performance safety and effectiveness of the subject device has been verified in accordance with the above FDA recognized standards, thus being considered to be as safe and effective as the predicate device. In a word, it is reasonable for us to conclude that the subject device is substantially equivalent to the predicate device according to the above analysis. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of a human figure. ### 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 September 17, 2013 Jinxinbao Electronic Co., Ltd c/o Ms. Helen Nan, General Manager Wenzhou Cytech Information Service Co., Ltd. RM-404, Bldg. 7, Jinhuichang Homeland, Liuhongqiao Rd. Wenzhou City, 325000, Zhejiang Province. CHINA K130232 Re: > Electronic Blood Pressure Monitor for Upper Arm, Model BPA-002 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: Undated Received: August 7, 2013 Dear Ms. Nan: 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 {6}------------------------------------------------ Page 2 - Ms. Helen Nan 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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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/ResourcesforYou/Industry/default.htm Sincerely yours. # Owen P. Faris -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with the letters J, X, and B. The letters are in a bold, sans-serif font and are arranged horizontally. The letters are filled with a textured pattern, giving them a slightly rough appearance. There is a small symbol to the right of the letter B. Jinxinbao Electronic Co., Ltd ## Section 4 Indications for Use Statement 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ BPA-002 Electronic Blood Pressure Monitor for Upper Arm_ Device Name: ### Indications for Use: BPA-002 Electronic Blood Pressure Monitor for Upper Arm is intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel. It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia. Prescription Use AND/OR (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 4 Clwez Digitally signed by Owen P. Faris -S Date: 2013.09.19 14:21:12 -04'00' Page _1_ of _ 1_