(22 days)
Not Found
No
The description details standard oscillometric blood pressure measurement technology and a simple algorithm for detecting irregular heartbeats based on time intervals. There is no mention of AI or ML.
No.
The device's intended use clearly states that "Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is not intended to be a diagnostic device," and it only measures and monitors blood pressure, not treat it.
No
The "Intended Use / Indications for Use" section explicitly states, "Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is not intended to be a diagnostic device."
No
The device description explicitly details hardware components such as an inflatable cuff, pressure sensor, microprocessor, pump, valve, and LCD, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "measuring blood pressure and heartbeat rate" and is "not intended to be a diagnostic device."
- Device Description: The description details a non-invasive method of measuring blood pressure using a cuff and electronic sensor, which is a physical measurement, not an in vitro test.
- Lack of IVD Characteristics: IVD devices typically involve testing samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health status. This device does not perform any such testing.
The device is a medical device used for physiological measurement, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 - 8 1/2 inches). This device detects the appearance of irregular heartbeats during measurement and gives a warning 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 mmHz. Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Transtek Wrist Blood Pressure Monitor, TMB-1014-BT 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 well-known 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 21.5 cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject device is 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%. Transtek Wrist Blood Pressure Monitor TMB-1014-BT embeds a Bluetooth module that allows it to connect to nearby BT receiving end. The LCD of device 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-1014-BT 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 patient population
Intended User / Care Setting
Not Found
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)
Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the difference does not raise any new questions of safety and effectiveness. TMB-1014-BT conforms to the following standards: ISO14971, Risk management to medical devices AAMI/ANSI SP10, Safety and performance characteristics IEC60601-1, Electrical safety; IEC60601-1-2, Electromagnetic compatibility FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations.
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
K123669
TRANSTEK
Section 5 - 510(k) Summary
Date of Summary Preparation: 11/23/2012
DEC 2 1 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: lisha1@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.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: 086-20-80727399
3. Name of the Device
Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: TRANSTEK Wrist Blood Pressure Monitor Trade Name: TRANSTEK Models: TMB-1014-BT Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classification: Class II Contraindications: None.
4. The Predicate Devices
TRANSTEK, Wrist Blood Pressure Monitor, Model TMB-1014, K122482
5. Device Description
Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which
1
TRANSTEK
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 well-known 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 21.5 cm, includes the inflatable bladder and nylon shell. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject device is 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%.
Transtek Wrist Blood Pressure Monitor TMB-1014-BT embeds a Bluetooth module that allows it to connect to nearby BT receiving end. The LCD of device 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-1014-BT unit through their end devices that embedded BT module.
6. Intended Use of Device
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 - 8 1/2 inches).
This device detects the appearance of irregular heartbeats during measurement and gives a warning 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 mmHz.
Transtek Wrist Blood Pressure Monitor, TMB-1014-BT is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
7. Design Control Activities and Performance Tests Summary
Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the difference does not raise any new questions of safety and effectiveness.
TMB-1014-BT conforms to the following standards:
ISO14971, Risk management to medical devices
2
TRANSTEK
AAMI/ANSI SP10, Safety and performance characteristics
IEC60601-1, Electrical safety; IEC60601-1-2, Electromagnetic compatibility
FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations
Explanation: The cuff of TMB-1014-BT is identical to the predicate's cuff, and the new wireless function does not affect blood pressure monitor measurement function. Therefore we have not done the ISO10993 test and Clinical test.
8. Summary of Substantial Equivalence
8.1 Difference between proposed device and the predicate device
The only difference between the two devices is that TMB-1014-BT add-on a Bluetooth data communication, what user option, which can transmit measurement results to those end devices that embedded a BT module.
8.2 Discussion
The Transtek Wrist Blood Pressure Monitor TMB-1014-BT has identical indication for use, fundamental scientific technology, cuff, energy type, environmental specifications, dimensional specifications, performance specifications, and similar software/firmware, functions, labeling to the predicate device.
The only function difference between TMB-1014-BT and the predicate device is that the TMB-1014-BT provides user an optional wireless (Bluetooth) data transmission. It is an add-on function that is entirely independent from the blood pressure monitor measurement function, which does not reply on the wireless connection to carry out a blood pressure measurement and heartbeat rate analysis and display its results. Thus the BT data transmission does not affect the safety and effectiveness of the wrist blood pressure monitor function.
All required design control activities have been implemented and all applicable performance tests have been done according with demands of FDA guidance document "Non-Invasive Blood Pressure (NIBP) Monitor Guidance" FDA March 10, 1997. We found that the modified device does not create new significant risk.
9. Conclusions
The Transtek Wrist Blood Pressure Monitor TMB-1014-BT is substantially equivalent to the predicate device TMB-1014 by having the identical indication for use, identical technologies, and an add-on function which does not impact the safety and effectiveness of the device.
--- End of this section ---
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 2 1 2012
Zhongshan Tranktek Electronics Co., LTD. c/o Leo Wang A03 Lab of BTS No. 1 Fanghua Street Hi-Tech District Chengdu, Sichuan CHINA 610041
Re: K123669
Trade/Device Name: TRANSTEK Wrist Blood Pressure Monitor Model TMB-1014-BT Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: October 30, 2012 Received: November 29, 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.
4
Page 2 - Mr. Leo Wang
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 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.htm.
Sincerely vours,
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
ection 4 - Indications for
10(k) Number (if known):
:
4
Device Name: 3
Transtek Wrist Blood Pressure Monitor Model: TMB-1014-BT -
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Concurrence of CDRH, Office of Device Evaluation (ODE
Owen P. Faris -S
2012.12.21
13:15:47 -05'00'
Indications for Use