TRANSTEK BLOOD PRESSURE MONITOR

{0}------------------------------------------------ # ittk # Section 5 - 510(k) Summary Date of Summary Preparation: 12/21/2011 ## 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: lishal@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: 086-028-86083300 Fax: 086-4006070050 ext. 8 ## 3. Name of the Device Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: TRANSTEK Blood Pressure Monitor Trade Name: TRANSTEK Models: LS-802, TMB-1018, TMB-1018-A, TMB-1112, TMB-1112-A Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classification: Class II Contraindications: Do not use the Analyzer if you have a pacemaker or other internal medical device. ### 4. The Predicate Devices TRANSTEK, Blood Pressure Monitor, Model TMB-986, K101681 Section 5 - 510(k) Summary {1}------------------------------------------------ ### 5. Device Description Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112 and TMB-1112-A 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 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. 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 LS-802, TMB-1018-A, TMB-1018-A, TMB-1112 and TMB-1112-A are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 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 tesults to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, LS-802, TMB-1018-A, TMB-1112 and TMB-1112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. {2}------------------------------------------------ . . ・・・ . . . . : ·· # RANSTEK # 7. Summary of Substantial Equivalence | Feature | LS-802 | TMB-1018 | TMB-1018-A | TMB-1112 | TMB-1112-A | Comparison | | | |------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|------------|--------------|------------------| | Power supply | Battery powered mode | | | | | Similar | | | | | 6VDC 4*AA<br>alkaline<br>batteries | 6VDC 4*AAA<br>alkaline<br>batteries | 6VDC 4*AAA<br>alkaline<br>batteries | 6VDC 4*AA<br>alkaline<br>batteries | 6VDC 4*AA<br>alkaline<br>batteries | | | | | Power supply | AC adaptor powered mode | | | | | Similar | | | | | AC 100~240V<br>50-60 Hz<br>400mA | AC 100~240V<br>50-60 Hz<br>400mA | AC 100~240V<br>50-60 Hz<br>400mA | AC 100~240V<br>50-60 Hz<br>400mA | AC 100~240V<br>50-60 Hz<br>400mA | | | | | Display mode | Digital LCD<br>V.A. 78*92mm | Digital LCD<br>V.A. 140*36mm | Digital LCD<br>V.A. 140*36mm | Digital LCD<br>V.A. 61*93mm | Digital LCD<br>V.A. 41*60mm | Similar | | | | Measurement<br>mode | Oscillographic<br>testing mode | Oscillographic<br>testing mode | Oscillographic<br>testing mode | Oscillographic<br>testing mode | Oscillographic<br>testing mode | Similar | | | | Accuracy | Pressure:<br>15°C~25°C:<br>within ±3mmHg | Pressure:<br>15°C~25°C:<br>within ±3mmHg | Pressure:<br>15°C~25°C:<br>within ±3mmHg | Pressure:<br>15°C~25°C:<br>within ±3mmHg | Pressure:<br>15°C~25°C:<br>within ±3mmHg | Similar | | | | | 10°C~40°C(out<br>of 15°C-25°C): | 10°C~40°C(out<br>of 15°C-25°C): | 10°C~40°C(out<br>of 15°C-25°C): | 10°C~40°C(out<br>of 15°C-25°C): | 10°C~40°C(out<br>of 15°C-25°C): | | | | | | within ±5mmHg<br>Heartbeat:<br>within ±5% of<br>reading | within ±5mmHg<br>Heartbeat:<br>within ±5% of<br>reading | within ±5mmHg<br>Heartbeat:<br>within ±5% of<br>reading | within ±5mmHg<br>Heartbeat:<br>within ±5% of<br>reading | within ±5mmHg<br>Heartbeat:<br>within ±5% of<br>reading | | | | | Measurement<br>range | Pressure: 0~<br>300mmHg<br>Heartbeat:<br>40~199<br>Pul/min | Pressure: 0~<br>300mmHg<br>Heartbeat:<br>40~199<br>Pul/min | Pressure: 0~<br>300mmHg<br>Heartbeat:<br>40~199<br>Pul/min | Pressure: 0~<br>300mmHg<br>Heartbeat:<br>40~199<br>Pul/min | Pressure: 0~<br>300mmHg<br>Heartbeat:<br>40~199<br>Pul/min | Similar | | | | | Measurement<br>perimeter of<br>upper arm | 22cm~42cm | 22cm~42cm | 22cm~42cm | 22cm~42cm | | 22cm~42cm | Similar | | | Net weight | Approx. 385g | Approx. 300g | Approx. 270g | Approx. 305g | | Approx. 305g | Similar | | Software | Ver. 1.0 | Ver. 1.0 | Ver. 1.0 | Ver. 1.0 | Ver. 1.0 | Similar | | | | Feature | LS-802 | TMB-1018 | TMB-1018-A | TMB-1112 | TMB-1112-A | Comparison | | | | Normal<br>working<br>condition | Temperature:<br>10℃~40℃ | Temperature:<br>10℃~40℃ | Temperature:<br>10℃~40℃ | Temperature:<br>10℃~40℃ | Temperature:<br>10℃~40℃ | Similar | | | | | Relative<br>humidity:<br>15%~90% | Relative<br>humidity:<br>15%~90% | Relative<br>humidity:<br>15%~90% | Relative<br>humidity:<br>15%~90% | Relative<br>humidity:<br>15%~90% | | | | | | Barometric<br>pressure:<br>105~80kPa | Barometric<br>pressure:<br>105~80kPa | Barometric<br>pressure:<br>105~80kPa | Barometric<br>pressure:<br>105~80kPa | Barometric<br>pressure:<br>105~80kPa | | | | | Storage &<br>transportation<br>condition | Temperature:<br>-20~60℃ | Temperature:<br>-20~60℃ | Temperature:<br>-20~60℃ | Temperature:<br>-20~60℃ | Temperature:<br>-20~60℃ | Similar | | | | | Relative<br>humidity:<br>≤90% | Relative<br>humidity:<br>≤90% | Relative<br>humidity:<br>≤90% | Relative<br>humidity:<br>≤90% | Relative<br>humidity:<br>≤90% | | | | | | External<br>dimensions | 120*160*69mm | 180*100*40mm | 180*100*40mm | 120*140*70mm | | 120*140*70mm | Little different | | Mode of<br>operation | Continuous<br>operation | Continuous<br>operation | Continuous<br>operation | Continuous<br>operation | Continuous<br>operation | Similar | | | Table 1: The difference between subjects Transtek Blood Pressure Monitor : Section 5 - 510(k) Summary ・ . . . ・ Page 3 of 5 - {3}------------------------------------------------ , ' . : : + . 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Table 2: The difference between subject Transtek Blood Pressure Monitor and the predicate device, Transtek Blood Pressure Monitor, TMB-986 | | Feature | LS-802, TMB-1018, TMB-1018-A,<br>TMB-1112, TMB-1112-A | Predicate: TMB-986 | Comparison | |--|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | Device name | Blood Pressure Monitor | Blood Pressure Monitor | Similar | | | Indication for use | Measure the blood pressure and<br>heartbeat rate.<br>Irregular heartbeat detection.<br>These models are not intended to be a<br>diagnostic device. | Measure the blood pressure and<br>heartbeat rate.<br>Irregular heartbeat detection.<br>These models are not intended to be a<br>diagnostic device. | Similar | | | Components | Main Unit, Cuff, Adapter, Instruction<br>Manual, 4*AAA/4*AA batteries,<br>Storage Case and Warranty Card | Main Unit, Cuff, Adapter, Instruction<br>Manual, 4*AAA batteries, Storage<br>Case and Warranty Card | Similar | | | Energy used | Battery (4*AAA/4*AA) or AC<br>adapter (DC 6V Output) | Battery (4*AAA) or AC adapter (DC<br>6V Output) | Similar | | | Display | Liquid crystal digital display | Liquid crystal digital display | Similar | | | Software | Ver. 1.0 | Ver. 1.0 | Similar | Section 5 -- 510(k) Summary . . . . . . ・ ・ . : : : : : : . 、 {4}------------------------------------------------ | Feature | LS-802, TMB-1018, TMB-1018-A,<br>TMB-1112, TMB-1112-A | Predicate: TMB-986 | Comparison | |---------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------| | External dimensions | LS-802: 120*160*69mm<br>TMB-1018 & TMB-1018-A:<br>180*100*40mm<br>TMB-1112 & TMB-1112-A:<br>120*140*70mm | 180*100*39mm | Similar | | Applicable cuff | Wrap around cuff<br>(Model numbers, 22/32, 22/42) | Wrap around cuff<br>(Model numbers, 22/32, 22/42) | Similar | | Accuracy of pressure<br>indicator | Within±3mmHg (15℃~25℃)<br>Within ±5mmHg (10℃~40℃ [out of<br>15℃~25℃]) | Within±3mmHg (15℃~25℃)<br>Within ±5mmHg (10℃~40℃ [out of<br>15℃~25℃]) | Similar | | Accuracy of heartbeat<br>rate | Within ±5% of reading | Within ±5% of reading | Similar | | Measurement range | Pressure: 0~300mmHg<br>Heartbeat: 40~199 Pul/min | Pressure: 0~300mmHg<br>Heartbeat: 40~199 Pul/min | Similar | | Cult inflation | Automatic inflation with air pump | Automatic inflation with air pump | Similar | | Dellation of pressure | Automatic air release | Automatic air release | Similar | | Operating voltage | DC 6V | DC 6V | Similar | | Measurement<br>perimeter of upper arm | 22cm~42cm | 22cm~42cm | Similar | | Operating<br>environment | Temperature: 10℃~40℃<br>Relative humidity: 15%~90%<br>Barometric pressure: 105~80kPa | Temperature: 10℃~40℃<br>Relative humidity: 15%~90%<br>Barometric pressure: 105~80kPa | Similar | | Transport and storage<br>environment | Temperature: -20~60℃<br>Relative humidity: ≤90% | Temperature: -20~60℃<br>Relative humidity: ≤90% | Similar | # 8. Conclusions The subject devices have all features of the predicate device TMB-986 except display and external dimensions. These differences do not affect the safety and effectiveness of the subject devices. Thus, the subject devices are substantially equivalent to the predicate device. --- End of this section --- Section 5 - 510(k) Summary Page 5 ol 5 {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 eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JAN 3 1 2012 Zhongshan Transtek Electronics Co., Ltd. c/o Mr. Leo Wang Consulting Manager A03 Lab of BTS No. 1 Fanghua Street Hi-Tech District Chengdu, CHINA 610041 K120058 Re: K120036 Trade/Device Name: Transtek Blood Pressure Monitor Models: LS-802, TMB-1018, TMB-1018-A, TMB-1112, and TMB-1112-A Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: January 7, 2012 Received: January 9, 2012 Dear Mr. Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intersate for use stated in the encrosule) to regars mant date of the Medical Device Ameral Food Drug commerce prof to May 20, 1970, the enacified in accordance with the provisions of the Federation (DMA) devices that have been reclassified in accordance while as proval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval organisms of and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Y ou may, therefore, market the devices, bayers to usements for annual registration, listing of the col general controls provisions of the Feet mends as a prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Scc above) into existing major regulations affecting your device can be {6}------------------------------------------------ Page 2 -- Mr. Leo Wang 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 i lease be advised that I Drivedants over device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any I edital statutes and regenments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CPN i art 607); adocing (21 CFR 803); good manufacturing practice requirements as set de rice-related daverse overse) (2 regulation (7) CFR Part 820); and if applicable, the electronic forth in the quality bytellio (Ques (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 11 you desire specific acrisboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to intep://www.radiological Health's (CDRH's) Office of Compliance. Also, please the Center 101 Devices and note the regulation onlined, "Thisstanding 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 I ou may other built belief generational 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 Bram D Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Renstek # Section 4 - Indications for Use #### 510(k) Number (if known): Device Name: Transtek Blood Pressure Monitor Models: LS-802, TMB-1018, TMB-1018-A, TMB-1112, TMB-1112-A 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, LS-802, TMB-1018, TMB-1018-A, TMB-1112, and TMB-1112-A 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) .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . consider Devices 21200 S Section 4 - Indications for Use Page 1 of 1