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. 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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the TRANSTEK Wrist Blood Pressure Monitor Model TMB-1014-BT, which is a modification of a previously cleared device (TMB-1014). The key difference is the addition of a Bluetooth module. The document focuses on demonstrating substantial equivalence to the predicate device and does not contain a standalone study proving the device meets specific acceptance criteria for blood pressure measurement accuracy. Instead, it relies on the predicate device's performance and the argument that the added Bluetooth function does not affect the core measurement function.

Therefore, many of the requested details about a study evaluating the device's performance against acceptance criteria are not present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with AAMI/ANSI SP10, which sets performance criteria for non-invasive blood pressure monitors. However, it does not explicitly state specific numerical acceptance criteria or report the device's performance against those criteria within this submission.

The document claims:

"TMB-1014-BT conforms to the following standards: AAMI/ANSI SP10, Safety and performance characteristics"
"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."

This indicates that the device is expected to meet the AAMI/ANSI SP10 criteria, but the specific performance results are not provided in this 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "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."

This means:

Sample size for the test set: Not applicable, as no new clinical test (involving a test set of human subjects) was performed for this modified device.
Data provenance: Not applicable, as no new clinical data was generated for the TMB-1014-BT in this submission. The substantial equivalence relies on the predicate device's data and the non-impact of the modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No new clinical test was performed with a human test set. Establishing ground truth for blood pressure measurement typically involves simultaneous measurements by trained human observers using auscultation (e.g., two observers) or a reference device. Since no clinical study was conducted, this information is not available.

4. Adjudication Method for the Test Set

Not applicable. As no new clinical test was performed, there was no test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not relevant for a blood pressure monitor, which measures a physiological parameter rather than interpreting images or other complex data requiring multiple human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a standalone blood pressure monitor. However, the study referenced (compliance with AAMI/ANSI SP10) would be a performance study of the device itself, not an "algorithm-only" study in the typical AI/software sense where a human-in-the-loop comparison is the alternative. The entire device's accuracy is evaluated against a reference standard. The document states "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," implying that such a standalone performance evaluation against accepted standards was done for the predicate device. No new standalone clinical performance study was done for this modified device.

7. The Type of Ground Truth Used

For the initial clearance of the predicate device (TMB-1014), the ground truth for blood pressure measurements would typically be established using a standard reference method, most commonly auscultation by trained observers with a mercury sphygmomanometer, in accordance with standards like AAMI/ANSI SP10. The document does not provide details on how the ground truth was established for the predicate device, only that the new device relies on the predicate's performance.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-based device that would typically have a "training set" in the context of machine learning. The algorithms used are likely well-established signal processing techniques.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI/ML sense for this device.

Summary

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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

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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

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

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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 ---

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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.

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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

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Indications for Use

Regulation Number and Section

§ 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).