TRANSTEK BLOOD PRESSURE MONITOR

{0}------------------------------------------------ ### K131395 # TRANSTEK # JUN 1 9 2013 ### Section 6 - 510(k) Summary Date of Summary Preparation: 05/08/2013 #### 1. Submitter's Identifications Submitter's Name: Guangdong Transtek Medical Electronics Co., Ltd Address: Zone A, 5/F., Investment Building, No. 12 Huizhan East Rd., Torch Development District, Zhongshan, Guangdong, China 528437 Contact Person: Ada Zhang Contact Email Address: adazhang@transtek.com Telephone: 086-760-88282982 ext. 876 Fax: 086-760-85339231 #### 2. Correspondent's Identifications Correspondent's Name: A03 Lab of BTS Address: No.1 Fanghua Street, Hi-tech Zone, Chengdu 610041, Sichuan, China Contact Person: Leo Wang Contact Email Address: leo.w@hibts.com Telephone: 086-28-86083300 Fax: 086-20-80727399 #### 3. Name of the Device Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: TRANSTEK Blood Pressure Monitor Trade Name: TRANSTEK Models: LS802-B, LS805-B, TMB-1018-BT Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classification: Class II #### 4. The Predicate Devices TRANSTEK, Blood Pressure Monitor, Model LS802-E, K123780 Section 6 -- 510(k) Summary Page 1 of 4 {1}------------------------------------------------ # TRANSTEK #### 5. Device Description Transtek Blood Pressure Monitor, LS802-B, LS805-B and TMB-1018-BT are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. Measurement 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 heartbeat rate. which is a well-known technique in the market called the "Oscillometric method". Transtek Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. ABS is jused to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22cm and 42cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject device is powered by four AA/AAA alkaline batteries or by a DC 6V 400mA adapter. 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 of irregular heartbeat when the difference of the time intervals is over 25%. Transtek Blood Pressure Monitor LS802-B, LS805-B and TMB-1018-BT embed a Bluetooth module that allows it to connect with nearby BT receiving terminal. Once measurement is over, the LCD of device displays results. And the device will start to transmit data to the paired BT terminal. Thus users can receive, display, and storage measurement data of Transtek Blood Pressure Monitor unit through their terminal devices that embedded BT module. #### 6. Intended Use of Device Transtek Blood Pressure Monitor LS802-B, LS805-B and TMB-1018-BT are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor. LS802-B, I.S805-B and TMB-1018-BT are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. Section 6 - 510(k) Summary Page 2 of 4 {2}------------------------------------------------ ## TRANSTEK #### 7. Design Control Activities and Performance Tests Summary Design control activities for this modification have been implemented and performance tests of modified devices have been done. These performance tests, risk management, and design verification tests provide demonstration that the differences do not raise any new questions of safety and effectiveness. LS802-B, LS805-B and TMB-1018-BT conform to the following standards: ISO 14971, Risk management to medical devices AAMI/ANSI/IEC 80601-2-30, Safety and performance characteristics IEC60601-1, Electrical safety; IEC60601-1-2, Electromagnetic compatibility FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations Radio-Frequency Wireless Technology in Medical Devices, Wireless coexistence Explanation: The wireless coexistence tests provide to demonstrate the reliability of wireless connection and wireless coexistence of BT data communication function. Meanwhile the BT data communication function does not affect blood pressure monitors' measurement function. Therefore we have not done the Clinical test. #### 8. Summary of Substantial Equivalence 8.1 Difference between proposed devices and the predicate device The only significant difference between LS802-B, LS805-B and TMB-1018-BT and the predicate device is that these modified devices use Bluetooth instead of RF which the original device used. More modification details are described in this submission. #### 8.2 Discussion The Transtek Blood Pressure Monitor LS802-B, LS805-B, and TMB-1018-BT have identical indication for use, fundamental scientific technology, performance specifications, energy type, Cuff type, functions, and similar dimensional specifications, environmental specifications, software/firmware, labeling to the predicate device. The only difference between LS802-B, LS805-B and TMB-1018-BT and the predicate device is that these modified devices' wireless data transmission achieved by a BT module instead of original's RF module. The Bluetooth does not raise new questions of safety and effectiveness. All required design control activities have been implemented and all applicable performance tests have been done according with demands of FDA guidance document "Non-Invasive Blood Pressure (NIBP) Monitor Guidance" FDA March 10, 1997. We found that the modified device does not create new significant risk. Section 6 - 510(k) Summary Page 3 of 4 {3}------------------------------------------------ # TRANSTEK #### 9. Conclusions . Transtek Blood Pressure Monitor LS802-B, LS805-B and TMB-1018-BT are substantially equivalent to the predicate device LS802-E, by having the identical indication for use, identical technologies, performance specification, cuff, and the similar wireless data communications, in which RF replaced by Bluetooth that does not impact the safety and effectiveness of these devices. --- End of this section --- Page 4 of 4 {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES DEPARTMENT OF HEALTH & HUMAN SERVICES • USA June 19, 2013 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Guangdong Transtek Medical Electronics Co., Ltd C/O Leo Wang No. 1 Fanghua Street, Hi-tech District Chengdu, Sichuan, 610041 CH Re: K131395 Trade/Device Name: Transtek blood pressure monitor (models: LS802-B, LS805-B, and TMB-1018-BT) Regulation Number: 21 CFR 870.1130 Regulation Name: System, Measurement, Blood-Pressure, Non-Invasive Regulatory Class: Class II Product Code: DXN Dated: May 15, 2013 Received: May 20, 2013 Dear Leo 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 Part 807); labeling (21 CFR Part 801); medical device 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ ff 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address for http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. OwenPFaris -S Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure 。 {6}------------------------------------------------ ### K131395 ### TRANSTEK ### Section 5 - Indications for Use #### 510(k) Number (if known); Device Name: Transtek Blood Pressure Monitor Models: LS802-B, LS805-B, and TMB-1018-BT Indications for Use: Transtek Blood Pressure Monitor LS802-B, LS805-B, and TMB-1018-BT are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9-17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. These Blood Pressure Monitor compare average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, LS802-B, LS805-B, and TMB-1018-BT are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use × (Part 21 CFR 801 Subpart D) (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) Owen P. Faris -S 2013.06.19 15:34:06 -04'00' #### Section 5 - Indications for Use Page 1 of 1