Search Results

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.

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.

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.

Ask a specific question about this device