HD BLOOD PRESSURE MONITOR

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 DEPARTMENT OF HEALTH & HUMAN SERVICES - USA September 8, 2014 BioCare Asia Corporation Ltd. c/o Dr. Ke-Min Jen Official Correspondent No. 260, Mayun Road New District Suzhou. Jiangsu. 215129 P.R.C. Re: K141924 > Trade/Device Name: HD Blood Pressure Monitor, Upper Arm Type: 3161 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 5, 2014 Received: July 16, 2014 Dear Dr. Ke-Min Jen: 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 {1}------------------------------------------------ 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 of medical devicerelated 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 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 vours Arthell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K141924 Page __1__ of __1__ 510(k) Number (if known): K141924 Device Name: __ HD Blood Pressure Monitor, Upper Arm Type: 3161 Indications For Use: HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over. This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cm〜43cm). #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use X {3}------------------------------------------------ K141924 Page 1 of 4 ## Summary of Safety and Effectiveness (According to 21 CFR 807.92) # 510(k) Summary for ____K141924_____ | | Submitter's information | | | | | |--|-------------------------|--|--|--|--| | | | | | | | | Name | : | BioCare Asia Corporation Ltd. | |-----------------------|---|---------------------------------------------------------------------------------------------| | Address | : | No.260, Mayun Road, New District, Suzhou, Jiangsu, 215129, P.R.C | | Phone number | : | +86 (512) 6809-1772 | | Fax number | : | +86 (512) 6809-7761 | | Representative person | : | Albert Chen / Administrator | | FDA Registration | : | # 3003979308 | | 510k Contact person | : | Dr. Jen, Ke-Min<br>Tel: +886-3-5208829 Fax:+886-3-5209783<br>Email: ceirs.jen@msa.hinet.net | | Date of preparation | : | July 1, 2014 | | Device name | | | | Trade name | : | BioCare Asia HD 3161 Blood Pressure Monitor | | Device name | : | HD Blood Pressure Monitor, Upper Arm Type: 3161 | | Common name | : | Blood Pressure Monitor | | Classification | | | | Classification name | : | Non-Invasive Blood Pressure Monitoring System | | Regulation number | : | 21CFR Section 870.1130 | | Class | : | II (Two) performance standards | | Specialty | : | Cardiovascular | | Product code | : | DXN | {4}------------------------------------------------ #### Predicate devices U-RIGHT TD-3127 Blood Pressure Monitoring System (K100658) TaiDoc Technology Corporation #### Device Information - Device description: HD 3161 Blood Pressure Monitor measures both systolic and diastolic blood pressure and heart pulse rate via a standard oscillometric method. The oscillometric method senses the vibrating signal via the closed air pipe system and utilizes a microcomputer to automatically sense the characteristics of the pulse signal. Unlike with the traditional measuring method, based on the Korotkov sound, with the oscillometric method the use of a stethoscope is not required. Through simple calculations, this method provides accurate blood pressure readings: the systolic pressure is defined as the blood pressure when the cuff pressure oscillating amplitude begins to increase, while the diastolic blood pressure is defined as the pressure when the cuff pressure oscillating amplitude stops decreasing. Indication for use: HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over. > This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cm~43cm). #### Test Summary: - 1. ELECTRIC SAFETY, EMC and Biocompatibility test reports, | General safety | IEC 60601-1:2005 | PASS | |--------------------|--------------------------------|------| | | IEC 60601-1-11:2010 | PASS | | | EN 1060-1:2002, EN 1060-3:2005 | PASS | | EMC conformity | IEC 60601-1-2: 2007 | PASS | | Biocompatibility | ISO 10993-5:2009 | PASS | | | ISO 10993-10:2010 | PASS | | FCC 47 CFR Part 18 | ANSI C63.4: 2009 | PASS | {5}------------------------------------------------ K141924 Page 3 of 4 ### 2. PERFORMANCE & CLINICAL TEST IEC 80601-2-30:2013 AAMI / ANSI / ISO 81060-2:2013 #### Comparison with predicate device and conclusion Similarities: | Comparison item | Proposed device | Predicate device | |---------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Applicant | BioCare Asia Corporation Ltd. | TaiDoc Technology Corporation | | Trade name | BioCare Asia HD 3161 Blood Pressure<br>Monitor | U-RIGHT TD-3127 Blood Pressure<br>Monitoring System | | Model name | HD 3161 | TD-3127 | | 510K number | New listing | K100658 | | Technological<br>characteristics | Oscillometric method | Oscillometric method | | Measuring method | Oscillometric method, automatic<br>inflation and measurement | Oscillometric method, automatic<br>inflation and measurement | | Sensor | Semiconductor gauge sensor | Semiconductor gauge sensor | | Rapid air release | By an active electronic control valve | By an active electronic control valve | | System<br>anatomical sites | Upper arm | Upper arm | | Display and user<br>interaction | LCD monitor | LCD monitor | | Power source | Batteries or AC adapter | Batteries or AC adapter | | Measurement range | Systolic 50 - 250 mmHg<br>Diastolic 30 - 180 mmHg<br>Pulse 40 – 199 beats per minute | Systolic 50 - 250 mmHg<br>Diastolic 30 - 180 mmHg<br>Pulse 40 - 199 beats per minute | | Pressure accuracy | Pressure: ±3mmHg or ±2% of readout<br>value | Pressure: ±3mmHg or ±2% of readout<br>value | | Pulse accuracy | ±4% of reading value | ±4% of reading value | | Operating temperature<br>and humidity | Temperature: 32~104°F (0~40°C)<br>RH:15% to 90% | Temperature: 32~104°F (0~40°C)<br>RH:15% to 90% | | Storage temperature<br>and humidity | Temperature: 23~122°F (-5~50°C)<br>RH:15% to 95% | Temperature: 23~122°F (-5~50°C)<br>RH:15% to 95% | | Cuff material | Cuff: nylon (PVC bladder, non-latex)<br>Biocompatibility:<br>ISO 10993-5:2009, ISO 10993-10:2010 | Cuff: nylon (PVC bladder, non-latex)<br>Biocompatibility:<br>ISO 10993-5:2009, ISO 10993-10:2010 | {6}------------------------------------------------ K141924 Page 4 of 4 #### Differences: | Comparison item | Proposed device | Predicate device | |--------------------------|---------------------------------|----------------------------------| | Dimensions<br>(L*W*H) mm | 134.8(L)x94.6(W)x31.5(H) mm | 150(L) × 96(W) × 66(H)mm | | Weight | 425g (w batteries) | 250g | | Memory | 2 * 90 measurements | 100 measurements | | Auto shutoff | 90 sec after last key operation | 180 sec after last key operation | #### Summary with predicate device and conclusion The new device, HD 3161 Blood Pressure Monitor is substantially equivalent to the U-RIGHT TD-3127 Blood Pressure Monitoring System (K100658) and they are the same upper arm type of the blood pressure monitor. The intended use and the indications for use of the HD 3161 Blood Pressure Monitor as described in its labeling are the same as the predicate device and the two devices are intended to be used in the same measurement range; in addition, there are the same operating and storage environments. The HD 3161 Blood Pressure Monitor and the predicate devices are substantially equivalent in all of the technological characteristics of patient contact materials, performance, biocompatibility function, mechanical safety, standards met, electrical safety, and EMC. The main differences for the two devices are overall dimensions, including dimensions, weight, memory, and the time of auto shutoff. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate devices in this aspect. BioCare Asia Corporation Ltd. believes this information and the referred documentation to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.