TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995

{0}------------------------------------------------ TRANSTEK # Section 5 - 510(k) Summary Date of Summary Preparation: 11/09/2010 #### 1. Submitter's Identifications Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONIC CO., LTD. Address: Jinbiao Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Guo Zhiping Contact Email Address: gzp@transtek.cn Telephone: 086-760-88282982 ext. 231 Fax: 086-760-85339231 #### 2. Correspondent's Identifications Correspondent's Name: A03 Lab of BTS Address: No.1 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: 086-4006070050 ext. 8 #### 3. Name of the Device Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: Blood Pressure Monitor Trade Name: Transtek Models: TMB-986, TMB-987, TMB-995 Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classification: Class II Contraindications: None #### 4. The Predicate Devices OMRON, Automatic Blood Pressure Monitor, Model HEM 780N3, K061822 #### 5. Device Description Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 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. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses ### MAY 2 7 2011 {1}------------------------------------------------ # TRANSTE 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 used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 - 42cm). Product package will contains only one cuff and which size is decide by business requirement. 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 AAA or AA alkaline batteries or by a DC 6V 400mA adapter. I 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 Blood Pressure Monitor, Models TMB 986, TMB987, and TMB995 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, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. #### 7. Summary of Substantial Equivalence Table 1: The difference between Transtek Blood Pressure Monitor | | The Similarities and Difference among TMB-986, TMB-987 and TMB-995 | | | | | | |----|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--| | | Feature | TMB-986 | TMB-987 | TMB-995 | Comparison | | | 1 | Power supply | Battery powered mode: | | | | | | | | 6VDC 4*AAA<br>alkaline batteries | 6VDC 4*AAA<br>alkaline batteries | 6VDC 4*AA<br>alkaline batteries | similar | | | | | AC adaptor powered mode: | | | | | | | | AC 100-240V,<br>50-60Hz, 400mA | AC 100-240V,<br>50-60Hz, 400mA | AC 100-240V,<br>50-60Hz, 400mA | similar | | | | Feature | TMB-986 | TMB-987 | TMB-995 | Comparison | | | 2 | Display mode | Digital LCD<br>V.A.128*50mm | Digital LCD<br>V.A.150*34mm | Digital LCD<br>V.A.128*50mm | TMB-986, and<br>TMB-995:<br>128*50mm<br>TMB-987:<br>150*34mm | | | 3 | Measurement<br>mode | Oscillographic<br>testing mode | Oscillographic<br>testing mode | Oscillographic<br>testing mode | similar | | | 4 | Accuracy | Pressure:<br>$15℃~25℃$ :<br>within±0.4kpa /<br>3mmHg<br>$10℃~40℃$ (out of<br>$15℃~25℃$ ):<br>Within ±0.65kpa /<br>5mmHg<br>Heartbeat:<br>value:±5% | Pressure:<br>$15℃~25℃$ :<br>within±0.4kpa /<br>3mmHg<br>$10℃~40℃$ (out of<br>$15℃~25℃$ ):<br>Within ±0.65kpa /<br>5mmHg<br>Heartbeat:<br>value:±5% | Pressure:<br>$15℃~25℃$ :<br>within±0.4kpa /<br>3mmHg<br>$10℃~40℃$ (out of<br>$15℃~25℃$ ):<br>Within ±0.65kpa /<br>5mmHg<br>Heartbeat:<br>value:±5% | similar | | | 5 | Normal<br>working<br>condition | Temperature: $10℃$<br>$~40℃$<br>Relative humidity<br>≤80% | Temperature: $10℃$<br>$~40℃$<br>Relative humidity<br>≤80%<br>Barometric pressure: 105~80 kPa (790~600 mmHg) | Temperature: $10℃$<br>$~40℃$<br>Relative humidity<br>≤80% | similar | | | 6 | Storage &<br>transportation<br>condition | Temperature: - $20℃~60℃$ | | | | | | | | Relative<br>humidity:10~93% | Relative<br>humidity: 10~93% | Relative<br>humidity:10~93% | similar | | | 7 | Measurement<br>perimeter<br>of upper arm | 22cm~42cm | 22cm~42cm | 22cm~42cm | similar | | | 8 | Weight | Approx.300g<br>(Excluding the<br>batteries) | Approx.300g<br>(Excluding the<br>batteries) | Approx.300g<br>(Excluding the<br>batteries) | similar | | | 9 | External<br>dimensions | Approx.<br>180*100*39mm | Approx.<br>200*60*56mm | Approx.<br>180*100*39mm | TMB-986,<br>and<br>TMB-995:<br>Approx.<br>180*100*39mm<br>TMB-987:<br>Approx.<br>200*60*56mm | | | 10 | Mode of<br>operation | Continuous<br>operation | Continuous<br>operation | Continuous<br>operation | similar | | ર-2 {2}------------------------------------------------ # TRANSTEK 北 5-3 {3}------------------------------------------------ TRANSTEK | Feature | TMB-986, TMB-987,<br>TMB-995 | Predicate: HEM 780N3 | Comparison | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Device name | Blood Pressure Monitor | Automatic Blood Pressure<br>Monitor | Similar | | Indication for use | Measure the blood pressure<br>and heartbeat rate.<br>Irregular heartbeat detection. | Measure the blood pressure<br>and heartbeat rate. | Add new<br>features | | Components | Main Unit, Cuff, Adapter,<br>Instruction Manual, 4*AAA<br>/4*AA batteries, Storage<br>Case and Warranty Card | Main Unit, Cuff, Adapter,<br>Instruction Manual,<br>4"AA"batteries, Storage<br>Case and Warranty Card | Similar<br>components<br>and materials | | Performance Tests | Biocompatibility<br>Electromagnetic<br>Compatibility and Electrical<br>Safety | Biocompatibility<br>Electromagnetic<br>Compatibility and Electrical<br>Safety | Similar | | Labeling | Company name and address<br>Specification<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 | Company name and address<br>Specification<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 | | Energy used | Battery (4*AAA/4*AA) or<br>AC adapter (DC 6V Output) | Battery (4*AA) or AC<br>adapter (DC 6V Output) | Similar | | Display | Liquid crystal digital display | Liquid crystal digital display | Similar | | Dimensions | TMB-986, TMB-995:<br>180(W)*100(D)*39(H)mm<br>TMB-987:<br>200(W)*60(D)*56(H)mm | 131(W)*155(D)*85(H)mm | Similar | | Applicable cuff | Wrap around cuff | Wrap around cuff | Similar | | Accuracy of<br>pressure indicator | Within ±3mmHg(15~25℃)<br>Within ±5mmHg<br>(10°C~40°C(out of<br>15℃~25℃)) | Within ±3mmHg or 2% of<br>reading | Similar | | Accuracy of<br>heartbeat rate | Within ±5% of reading | Within ±5% of reading | Similar | | Feature | TMB-986, TMB-987,<br>TMB-995 | Predicate: HEM 780N3 | Comparison | | Cuff inflation | Automatic inflation with air<br>pump | Automatic inflation with air<br>pump | Similar | | Deflation of<br>pressure | Automatic air release | Deflation rate is controlled by<br>an active electronic control<br>valve by 4 to 11 mmHg/s<br>depending on pulse rate | Similar | | Operating voltage | DC 6V | DC 6V | Similar | | Measurement<br>perimeter<br>of upper arm | 22cm~42cm | 22cm~42cm | Similar | | Operation<br>environment | Temperature: 10℃~40℃<br>Relative humidity: ≤80%<br>Barometric pressure:<br>105~80 kPa<br>(790-600 mmHg) | Temperature: 10℃~40℃<br>Relative humidity: 30-80%<br>Barometric pressure:<br>105~80 kPa<br>(790-600 mmHg) | Similar | | Transport and<br>storage environment | Temperature: -20℃~60℃<br>Relative humidity:10~93% | Temperature: -20℃~60℃<br>Relative humidity: 10~95% | Similar | Table 2: The difference between Transtek Blood Pressure Monitor and Predicate HEM 780N3 4/5 {4}------------------------------------------------ S/C #### 8. Conclusions The subject devices have all features of the predicate device HEM 780N3 except the new features of irregular heartbeat detection, some specification of arm cuff and battery. These differences do not affect the safety and effectiveness of the subject devices. Irregular heartbeat detection technology is same as what is used in Automatic Blood Pressure Monitor with Com Fit™ Cuff Model HEM-780. Thus, the subject devices are substantially equivalent to the predicate device. --- End of this section -- {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol with three curved lines forming the body and wings. Below the bird, there are wavy lines that represent water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zhongshan Transtek Electronic Co., Ltd. c/o Mr. Leo Wang A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District Chengdu City, Sichuan CHINA MAY 2 7 2011 Re: K101681 Trade/Device Name: Transtek Blood Pressure Monitor Models TMB-986, TMB-987 and TMB-995 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Monitoring System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: May 13, 2011 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 10 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. 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/CDRH0ffices/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.fdagov/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, D. Zahariev, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # TRANSTEK # Section 4 - Indications for Use 510(k) Number (if known): K101681 Device Name: Blood Pressure Monitor Models: TMB-986, TMB-987, TMB-995 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 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, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) メ (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 | | 11/0168