(89 days)
Not Found
No
The description details the use of the oscillometric method and a microprocessor to analyze pressure signals and calculate blood pressure and heart rate. It mentions comparing time intervals for irregular heartbeat detection. There is no mention of AI, ML, or any learning algorithms used in the device's operation or data analysis. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a blood pressure monitor intended for measuring blood pressure and heartbeat rate, which is a diagnostic function rather than a therapeutic one.
Yes
The device is intended for measuring blood pressure and heartbeat rate, and it can also detect irregular heartbeats. These are indications that fall under diagnostic purposes as they help in identifying potential health conditions.
No
The device description clearly outlines hardware components such as an inflatable cuff, pressure sensor, microprocessor, pump, and deflation control valve. While it has a Bluetooth module and a mobile application for data display, the core measurement functionality relies on physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure blood pressure and heartbeat rate. This is a physiological measurement taken directly from the body, not a test performed on a sample of biological material (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a non-invasive method using a cuff and electronic sensor to measure pressure and heart rate. This is a physical measurement technique, not a diagnostic test performed on a sample.
- No mention of biological samples: The entire description focuses on the physical interaction with the wrist and the measurement of physical parameters. There is no mention of collecting or analyzing any biological samples.
IVD devices are specifically designed to perform tests on biological samples to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This blood pressure monitor does not fit that definition.
N/A
Intended Use / Indications for Use
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 23cm. It is intended for adult, indoor use only.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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. 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
1
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) 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)
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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
TMB-2072 | Predicate Device K123669
Model: TMB-1014-BT | Remark |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Applicant | Guangdong Transtek Medical
Electronics Co., Ltd. | Guangdong Transtek Medical
Electronics Co., Ltd. | / |
| Classification
Regulation | 21CRF 870.1130 | 21CRF 870.1130 | Same |
| Classification
and Code | Class II,
DXN | Class II,
DXN | Same |
| Common
name | Automatic Arm Blood Pressure
Monitor | Automatic Arm Blood Pressure
Monitor | Same |
| Intended use | 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. | Transtek Wrist Blood Pressure
Monitor TMB-1014-BT is a
digital monitor 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-S8 1/2 inches).
This device detects the
appearance of irregular heartbeats
during measurement and gives a
warning | Different
- |
| Features | Subject Device
TMB-2072 | Predicate Device K123669
Model: TMB-1014-BT | Remark |
| | | signal with readings.
The Wrist Blood Pressure
Monitor compares average blood
pressure results to pre-established
AHA (American Heart
Association) hypertension
guideline of 135/85 mmHg.
Transtek Wrist Blood Pressure
Monitor, TMB-1014-BT is not
intended to be a diagnostic
device. Contact your physician if
hypertensive values are indicated. | |
| Principle | Oscillometric method | Oscillometric method | Same |
| Target
population | Adult | Adult | Same |
| Anatomical sites | Wrist | Wrist | Same |
| Where used
(hospital, home,
ambulance, etc.) | Home | Home | Same |
| Energy used and
/ or delivered | 3.7V 420mAH Built-in
rechargeable lithium-ion battery,
5V 1A USB AC Adaptor | 2 × 1.5V AA Battery | Different - |
| Human factors | Blood pressure | Blood pressure | Same |
| Performance | Measuring systolic and diastolic
blood pressure and pulse rate of
adult individual, Including
irregular pulse rhythm detection | Measuring systolic and diastolic
blood pressure and pulse rate of
adult individual, Including
irregular pulse rhythm detection | Same |
| Biocompatibility | Cuff, according to ISO-10993 | Cuff, according to ISO-10993 | Same |
| Compatibility
with the
environment and
other devices | Operation Environment:
5°C~40°C,15%90%RH60°C,
Storage Environment:
-20°C