TRANSTEK WRIST BLOOD PRESSURE MONITOR

{0}------------------------------------------------ ## (122482 OCT 2 2 ### TRANSTEK ### Section 5 - 510(k) Summary Date of Summary Preparation: 07/25/2012 ### 1. Submitter's Identifications Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Lisa Li Contact Email Address: lisha!@transtek.cn Telephone: 086-760-88282982 ext. 876 Fax: 086-760-85339231 ### 2. Correspondent's Identifications Correspondent's Name: A03 Lab of BTS Address: No. I Fanghua Street, Hi-tech Zone, Chengdu City, 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: Wrist Blood Pressure Monitor Trade Name: Transtek Models: TMB-895, TMB-988, TMB-1014, TMB-1117 Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classitication: Class II Contraindications: None ### 4. The Predicate Devices omron, digital wrist blood pressure monitor, MODEL HEM-609N, K042505 Page 1 of 5 {1}------------------------------------------------ ### TRANSTEK ### 5. Device Description Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 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 wrist. Measurement method to define systolic and diastolic pressure is similar to the auscultatory melhod 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 Wrist Blood Pressure Monitor is single-mounted device of the main unit and cuff unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 13.5 and 21.5 cun, includes the inflatable bladder and nylon shell. All four models of the wrist blood pressure monitor use the same size of cuff. The subject devices consist 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 two AAA 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 of irregular heartbeat when the difference of the time intervals is over 25%. #### 6. Intended Use of Device Transtek Wrist Blood Pressure Monitor, Models TMB-895, TMB-988, TMB-1014, TMB-1117 are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4 - 8 1/2 inches). The subject devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AHA (Anierican Heart Association) hypertension guideline of 135/85 mmHg. Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-1014, TMB-1117 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. 7. Summary of Substantial Equivalence (Continued on next page) Section 5 -- 510(k) Summary {2}------------------------------------------------ K122482 ## TRANSTEK ### Table I : The difference between Transtek Wrist Blood Pressure Monitors | Feature | TMB-895/TMB-988/TMB-1014/TMB-1117 Performance Data | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Power | 2*AAA alkaline batteries (3V DC) | | Display mode | Digital LCD V.A.<br>TMB-895: 41*44mm<br>TMB-988: 35*40mm<br>TMB-1014: 36*41mm<br>TMB-1117: 31.5*44mm | | Measurement method | Oscillographic testing mode | | Measurement range | Pressure: 0 to 300mmHg (0 to 40kPa)<br>Pulse value: 40 to 199 times/minute | | Accuracy | Pressure: 5°C~40°C within ±3mmHg<br>0°C~45°C (out of 5°C~40°C) within ±5mmHg<br>Pulse value: ±5% | | Normal working condition | Temperature: 5°C~40°C<br>Relative humidity: ≤80% | | Storage and transportation<br>condition | Temperature: -20°C~60°C;<br>Relative humidity: 10%~93% | | Measurement perimeter of<br>the wrist | About 13.5cm~21.5cm | | Main unit weight | Approx. (Excluding the batteries)<br>TMB-895: 150g<br>TMB-988: 95g<br>TMB-1014: 120g<br>TMB-1117: 120g | | Main unit dimensions | Approx. (Not including the wrist cuff)<br>TMB-895: 73*70*32mm<br>TMB-988: 68*75*22mm<br>TMB-1014: 80*65*22mm<br>TMB-1117: 68*75*31mm | | Degree of protection | Internal type B powered equipment | | Air Release | Exhaust valve | | Pressure method | Motor pump | | Pressure Detection | Semiconductor sensor | | Pulse Detection | Semiconductor sensor | 3/5 {3}------------------------------------------------ # 长122482 . ". . ### TRANSTEK | Feature | TMB-895 /TMB-988<br>/TMB-1014 /TMB-1117 | Predicate: HEM-609N | Comparison | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Device name | Wrist Blood Pressure Monitor | Digital Wrist Blood Pressure<br>Monitor | Similar | | Indication for<br>use | Measure the blood pressure and<br>heartbeat rate.<br>Irregular heartbeat detection. | Measure the blood pressure and<br>heartbeat rate.<br>Irregular heartbeat detection. | Similar | | Components | Main Unit, Cuff, Instruction<br>Manual, 2*AAA batteries,<br>Storage Case and Warranty Card | Main Unit, Cuff, Instruction<br>Manual, 2*AAA batteries,<br>Storage Case and Warranty Card | Similar<br>components<br>and materials | | Measurement<br>method | Oscillographic | Oscillographic | Similar | | Labeling | Company name and address<br>Specifications<br>Product description<br>Indication for use<br>Contraindications for use<br>Precautions<br>Warnings | Company name and address<br>Specifications<br>Product description<br>Indication for use<br>Contraindications for use<br>Precautions<br>Warnings<br>Safety terms and conditions<br>Safety alert descriptions<br>Safety and performance<br>standards and so on | Similar | | | Safety terms and conditions<br>Safety alert descriptions<br>Safety and performance<br>standards and so on | | | | Energy used | Battery (2*AAA, 3V DC) | Battery (2*AAA, 3V DC) | Similar | | Display | Liquid crystal digital display | Liquid crystal digital display | Similar | | Main unit<br>dimensions | Approx. (Not including the wrist<br>cuff)<br>TMB-895: 73*70*32mm<br>TMB-988: 68*75*22mm<br>TMB-1014: 80*65*22mm<br>TMB-1117: 68*75*31mm | Approx. (Not including the wrist<br>cuff)<br>70*54*37mm | Similar | | Applicable<br>cuff | Wrap around cuff | Wrap around cuff | Similar | | Measurement<br>range | Pressure: 0 to 300 mmHg<br>Pulse value: 40 to 199 beats/min | Pressure: 0 to 299 mmHg<br>Pulse Rate: 40 to 180 beats/min | Similar | | Feature | TMB-895 /TMB-988<br>/TMB-1014 /TMB-1117 | Predicate: HEM-609N | Comparison | | Accuracy of<br>pressure<br>indicator | 5°C~40°C within ±3mmHg<br>0°C~45°C (out of 5°C~40°C)<br>within ±5mmHg | Within ±3mmHg | Similar | | Accuracy of<br>pulse rate | Within ±5% of reading | Within ±5% of reading | Similar | | Cuff inflation | Automatic inflation with air<br>pump | Automatic inflation with air<br>pump | Similar | | Deflation of<br>pressure | Automatic air release | Automatic rapid deflation | Similar | | Operating<br>voltage | 3V DC | 3V DC | Similar | | Measurement<br>perimeter<br>of wrist | 13.5cm~21.5cm | 13.5cm~21.5cm | Similar | | Operation<br>environment | Temperature: 5°C~40°C<br>Relative humidity: ≤80%<br>Barometric pressure:<br>86~106 kPa | Temperature: 10°C~40°C<br>Relative humidity: 30~85%<br>Barometric pressure:<br>80~105 kPa | Similar | | Transport and<br>storage<br>environment | Temperature: -20°C~60°C<br>Relative humidity: 10%~93% | Temperature: -20°C~60°C<br>Relative humidity: 10~95% | Similar | I able 2: The difference between Transtek Wrist Blood Pressure Monitor and Predicate HEM 609N Section 5 -- 510(k) Summary . {4}------------------------------------------------ K122482 ### TRANSTEK ### 8. Conclusions The subject devices have all similar features of the predicate device HEM-609N. Those subtle I the subject es if performance parameter do not affectiveness of the subject devices. In other sections of this submission, those performance testing and assessment proved that the subject devices are safe and effective. Thus, the subject devices are substantially equivalent to the predicate device. ### --- End of this section --- Section 5 - 510(k) Summary {5}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 OCT 22 2012 Zhongshan Transtek Electronics Co., Ltd. c/o Mr. Leo Wang Senior Consultant No.1 Fanghua Street, Hi-Tech Zone Chengdu, Sichuan 610041 (China) Re: K122482 > Trade/Device Name: Transtek Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: September 22, 2012 Received: September 25, 2012 ### Dear Mr. 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. {6}------------------------------------------------ ### Page 2 - Mr. Leo Wang 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 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.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/ResourcesforYou/Industry/default.htm1. Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # 122682 ### TRANS TEK ### Section 4 - Indications for Use 510(k) Number (if known): Device Name: Transtek Wrist Blood Pressure Monitor Model Numbers: TMB-895, TMB-988, TMB-1014, TMB-1117 Indications for Use: This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with wrist circumference ranging from 13.5 cm to 21.5 cm (about 5 1/4 -- 8 1/2 inches). This series of devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Wrist Blood Pressure Monitor compares average blood pressure results to pre-established AFIA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Wrist Blood Pressure Monitor, TMB-895, TMB-988, TMB-1014, TMB-1117 models 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) for B Zuckermain (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K122482 Page 1 of 1 Section 4 -- Indications for Use