(35 days)
Transtek Blood Pressure Monitor LS802-B, LS805-B, and TMB-1018-BT are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9-17 inches).
These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings.
These Blood Pressure Monitor compare average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg.
Transtek Blood Pressure Monitor, LS802-B, LS805-B, and TMB-1018-BT are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Transtek Blood Pressure Monitor, LS802-B, LS805-B and TMB-1018-BT are 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 arm.
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 Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. ABS is jused to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22cm and 42cm, 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 four AA/AAA alkaline batteries or by a DC 6V 400mA adapter.
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 Blood Pressure Monitor LS802-B, LS805-B and TMB-1018-BT embed a Bluetooth module that allows it to connect with nearby BT receiving terminal. Once measurement is over, the LCD of device displays results. And the device will start to transmit data to the paired BT terminal. Thus users can receive, display, and storage measurement data of Transtek Blood Pressure Monitor unit through their terminal devices that embedded BT module.
The provided text describes a 510(k) submission for a blood pressure monitor, focusing on substantial equivalence to a predicate device. It contains very limited information regarding the performance study that would typically establish acceptance criteria and device performance. The device is a "TRANSTEK Blood Pressure Monitor" (Models: LS802-B, LS805-B, and TMB-1018-BT).
Here's an analysis based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Device Performance Study for TRANSTEK Blood Pressure Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria or specific reported device performance metrics for blood pressure measurement accuracy. It primarily focuses on the substantial equivalence of the new models to a predicate device, with the key difference being the use of Bluetooth instead of RF for wireless data transmission.
The document states compliance with standards, notably:
- AAMI/ANSI/IEC 80601-2-30, Safety and performance characteristics
- ISO 14971, Risk management to medical devices
Compliance with AAMI/ANSI/IEC 80601-2-30 would imply that the device meets the performance requirements for blood pressure monitors as outlined in that standard. This standard typically defines accuracy requirements (e.g., mean difference and standard deviation of blood pressure readings compared to a reference method). However, the specific results from a study demonstrating this compliance are not presented in this document.
The document states: "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." This indicates that performance testing was conducted, but the results are not explicitly detailed.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any clinical or performance test set related to blood pressure measurement accuracy.
It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical data because it explicitly states that a clinical test for blood pressure measurement accuracy was not done for this submission.
The document includes the following crucial statement: "Explanation: The wireless coexistence tests provide to demonstrate the reliability of wireless connection and wireless coexistence of BT data communication function. Meanwhile the BT data communication function does not affect blood pressure monitors' measurement function. Therefore we have not done the Clinical test."
This indicates that the submission relies on the substantial equivalence of the core measurement technology to the predicate device (TRANSTEK, Blood Pressure Monitor, Model LS802-E, K123780), and the performance of the blood pressure measurement function itself was not re-evaluated clinically for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since a clinical test for blood pressure measurement accuracy was not conducted for this submission (as stated in the document), there is no information provided regarding experts or ground truth establishment for a clinical test set.
4. Adjudication Method for the Test Set
As no clinical test set for blood pressure measurement accuracy was established for this submission, there is no information regarding an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC multi-reader comparative effectiveness study was done. This device is an automated blood pressure monitor, not an imaging or diagnostic device that typically involves human readers interpreting results. The comparison is between automated measurements and a "reference" (likely auscultatory or invasive arterial pressure, as per NIBP standards), not between human readers.
- Therefore, no effect size for human readers improving with AI vs. without AI assistance is applicable or reported.
6. Standalone (Algorithm Only) Performance
The device itself is a standalone algorithm-based device for measuring blood pressure using the oscillometric method. The discussion implies that the basic measurement function (algorithm for detecting systolic and diastolic pressure) is identical to the predicate device. However, specific standalone performance metrics are not reported in this summary. The focus of the current submission is the change in wireless transmission technology.
7. Type of Ground Truth Used
For non-invasive blood pressure monitors, the "ground truth" in performance studies typically involves comparison with either:
- Auscultatory measurements performed simultaneously by trained observers using a mercury sphygmomanometer, often with double or triple auscultation for observer bias reduction.
- Invasive arterial pressure monitoring (intra-arterial catheter), considered the most accurate reference but less common for routine device validation.
Given the statement that an AAMI/ANSI/IEC 80601-2-30 compliant test would be expected, the ground truth would likely be established through one of these methods at the time the predicate device (K123780) was validated. For this submission, no new ground truth was established for blood pressure measurement accuracy, as no clinical test was performed.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set for the device's algorithms. As the device uses the "oscillometric method," which is a well-established technology, the core algorithm was likely developed and validated prior to the predicate device's clearance. The current submission is for a modification (Bluetooth) to an already cleared device.
9. How the Ground Truth for the Training Set Was Established
The document does not describe how the ground truth for any training set was established. This information would typically be part of the original development and validation of the oscillometric algorithm, which predates this specific 510(k) submission.
§ 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).