Transtek Wrist Blood Pressure Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 6, 2020 Guangdong Transtek Medical Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China Re: K202599 Trade/Device Name: Transtek Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 2, 2020 Received: September 8, 2020 Dear Kevin 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202599 Device Name Transtek Wrist Blood Pressure Monitor Indications for Use (Describe) The Transtek Blood Pressure Monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 23cm. It is intended for adult, indoor use only. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) Summary ### Prepared in accordance with the requirements of 21 CFR Part 807.92 # Prepared Date: 2020/09/02 ### 1. Submission sponsor Name: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone B, No.105, Dongli Road, Torch Development District, Zhongshan, Guangdong, China Contact person: Nicole Hu Title: RA Engineer E-mail: nicole.hu(@transtekcorp.com ### 2. Submission correspondent Name: Chonconn Medical Device Consulting Co., Ltd. Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067 Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160 | Trade/Device Name | Transtek Wrist Blood Pressure Monitor | |-------------------|---------------------------------------| | Model | TMB-2072 | | Common Name | Automatic Blood Pressure Monitor | | Regulatory Class | Class II | | Product Code | DXN | | Submission type | Traditional 510(K) | ### Subject Device Information 3. ### 4. Predicate Device Guangdong Transtek Medical Electronics Co., Ltd., Transtek Wrist Blood Pressure Monitor, Model TMB-1014-BT under K123669. ### ട്. Device Description Transtek Wrist Blood Pressure Monitor, TMB-2072 is 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 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 wellknown technique in the market called the "Oscillometric method". Transtek Wrist Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. The preformed cuff unit, which is applicable to {4}------------------------------------------------ wrist circumference approximately between 13.5 and 23 cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump and the electromagnetic deflation control valve. The subject device is powered by 3.7V Built-in rechargeable lithium-ion battery. 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 Wrist Blood Pressure Monitor TMB-2072 embeds a Bluetooth module that allows it to connect to nearby BT receiving end. The mobile application displays results. And once measurement is over, the device will start transmission data by BT. Thus, users can receive, and display/storage, measurement data from TMB-2072 unit through their end devices that embedded BT module. #### Intended use & Indication for use 6. The Transtek Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate with a wrist circumference ranging from 13.5cm to 23 cm. It is intended for adult indoor use only. | Features | Subject Device<br>TMB-2072 | Predicate Device K123669<br>Model: TMB-1014-BT | Remark | |---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Applicant | Guangdong Transtek Medical<br>Electronics Co., Ltd. | Guangdong Transtek Medical<br>Electronics Co., Ltd. | / | | Classification<br>Regulation | 21CRF 870.1130 | 21CRF 870.1130 | Same | | Classification<br>and Code | Class II,<br>DXN | Class II,<br>DXN | Same | | Common<br>name | Automatic Arm Blood Pressure<br>Monitor | Automatic Arm Blood Pressure<br>Monitor | Same | | Intended use | The Transtek Blood Pressure<br>Monitor is a digital monitor<br>intended for use in measuring<br>blood pressure and heartbeat rate<br>with a wrist circumference<br>ranging from 13.5cm to 23 cm.<br>It is intended for adult indoor use<br>only. | Transtek Wrist Blood Pressure<br>Monitor TMB-1014-BT is a<br>digital monitor intended for use in<br>measuring blood pressure and<br>heartbeat rate in adult patient<br>population with wrist<br>circumference<br>ranging from 13.5 cm to 21.5 cm<br>(about 5 1/4-S8 1/2 inches).<br>This device detects the<br>appearance of irregular heartbeats<br>during measurement and gives a<br>warning | Different<br>1) | | Features | Subject Device<br>TMB-2072 | Predicate Device K123669<br>Model: TMB-1014-BT | Remark | | | | signal with readings.<br>The Wrist Blood Pressure<br>Monitor compares average blood<br>pressure results to pre-established<br>AHA (American Heart<br>Association) hypertension<br>guideline of 135/85 mmHg.<br>Transtek Wrist Blood Pressure<br>Monitor, TMB-1014-BT is not<br>intended to be a diagnostic<br>device. Contact your physician if<br>hypertensive values are indicated. | | | Principle | Oscillometric method | Oscillometric method | Same | | Target<br>population | Adult | Adult | Same | | Anatomical sites | Wrist | Wrist | Same | | Where used<br>(hospital, home,<br>ambulance, etc.) | Home | Home | Same | | Energy used and<br>/ or delivered | 3.7V 420mAH Built-in<br>rechargeable lithium-ion battery,<br>5V 1A USB AC Adaptor | 2 × 1.5V AA Battery | Different<br>2) | | Human factors | Blood pressure | Blood pressure | Same | | Performance | Measuring systolic and diastolic<br>blood pressure and pulse rate of<br>adult individual, Including<br>irregular pulse rhythm detection | Measuring systolic and diastolic<br>blood pressure and pulse rate of<br>adult individual, Including<br>irregular pulse rhythm detection | Same | | Biocompatibility | Cuff, according to ISO-10993 | Cuff, according to ISO-10993 | Same | | Compatibility<br>with the<br>environment and<br>other devices | Operation Environment:<br>5°C~40°C,15%~90%RH<br>Storage Environment:<br>-20°C~60°C, <93%RH | Operation Environment:<br>5°C~40°C,15%~90%RH<br>Storage Environment:<br>-20°C~60°C, ≤93%RH | Same | | Electrical safety | According to IEC60601-1-2<br>According to IEC60601-1 | According to IEC60601-1-2<br>According to IEC60601-1 | Same | | Blood Pressure<br>Measurement | 0mmHg-299mmHg, ±3mmHg | 0mmHg-300mmHg, ±3mmHg | Different<br>3) | | Pulse rate<br>measurement | 40-199 beats/minute, ±5% | 40-199 beats/minute, ±5% | Same | | Cuff Deflation | Automatic deflation | Automatic deflation | Same | | Features | Subject Device<br>TMB-2072 | Predicate Device K123669<br>Model: TMB-1014-BT | Remark | | Wireless | Bluetooth | Bluetooth | Same | #### 7. Comparison to the Predicate Device {5}------------------------------------------------ {6}------------------------------------------------ Justification of difference: Different 1): The wrist circumference is different. The clinical study of blood pressure can demonstrate the subject device can meet the requirement on this wrist range. The clinical study was conducted by ISO 81060-2. So, the different does not raise different questions of safety and effectiveness. Different 2): The power supply is different. The subject device was tested accordance with IEC 60601-1. The clinical study can demonstrate the subject device can meet the requirement on this power supply. So, the different does not raise different questions of safety and effectiveness. Different 3): The subject device's blood pressure is restricted to 299 mmHg for safety purpose. So, the different does not raise different questions of safety and effectiveness. #### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests: - Cytotoxicity . - . Sensitization - Irritation . The subject device is considered surface contacting for a duration of not exceed 24 hours. # Non-clinical data The subject device has been tested according to the following standards: - IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance - IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - IEC 80601-2-30: Medical electrical equipment - Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. - IEC 60601-1-11: Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment {7}------------------------------------------------ - IEC 60601-1-6: Medical Electrical Equipment Part 1-6: General requirements for safety -● Collateral Standard: Usability. - IEC 62366-1: Medical devices – Application of usability engineering to medical devices. - FDA Guidance for Non-Automated Sphygmomanometer. # Wireless testing: - Bluetooth test according to FCC CFR Title 47 Part 15 Subpart C. - ANSI C63.27L: 2017: American National Stand for Evaluation of Wireless Coexistence. - AAMI TIR69: 2017 Risk management of radio-frequency wireless coexistence for medical devices and systems. - Radio Frequency Wireless Technology in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (August 14, 2013) # Reprocessing validation: - AAMI TIR12: 2010-designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufactures - AAMI TIR30: 2011-A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff # Clinical data This device was tested to ISO 81060-2: 2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The study population consisted of 85 qualified healthy adult subjects. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018, and the accuracy of subject device is better than predicate device. No adverse effect and/or complication is found in this study. #### 9. Conclusion It has been shown in this 510(k) submission that the difference between the proposed devices and the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.