(22 days)
This series of devices 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. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112, and TMB-1112-A models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Transtek Blood Pressure Monitor, LS-802, TMB-1018, TMB-1018-A, TMB-1112 and TMB-1112-A 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. Our 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 used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 -42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA or AA 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%.
Here's a breakdown of the acceptance criteria and study information for the Transtek Blood Pressure Monitor, based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria for the Transtek Blood Pressure Monitor models (LS-802, TMB-1018, TMB-1018-A, TMB-1112, TMB-1112-A) are based on their accuracy for pressure and heartbeat rate, as well as the measurement range. The reported performance for all these models is identical.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Pressure): | |
| 15°C~25°C | Within ±3mmHg |
| 10°C~40°C (outside 15°C-25°C) | Within ±5mmHg |
| Accuracy (Heartbeat): | Within ±5% of reading |
| Measurement Range (Pressure): | 0~300mmHg |
| Measurement Range (Heartbeat): | 40~199 Pul/min |
Note: The document states that "These differences do not affect the safety and effectiveness of the subject devices," implying that the performance reported meets the necessary standards for substantial equivalence to the predicate device.
Study Information
The provided 510(k) summary is for a premarket notification submission for substantial equivalence. It primarily focuses on comparing the new devices to a legally marketed predicate device (Transtek Blood Pressure Monitor, Model TMB-986, K101681). This type of submission generally relies on comparison to a predicate device that has already established its safety and effectiveness through prior studies (which are not detailed in this document).
Therefore, many of the requested details about a specific clinical study (like sample size for test sets, ground truth establishment for a training set, MRMC studies) are not typically included in this type of 510(k) summary as they refer to a primary clinical validation study. The document does not describe an independent clinical study performed specifically for these new models to prove they meet the stated acceptance criteria beyond asserting their similarity in features and performance specifications to the predicate device.
However, based on the context of blood pressure monitor regulation, devices of this type are generally validated against established standards (e.g., ISO 81060-2 or AAMI standards) which often involve clinical studies. If such a study were conducted, these are the details that would usually be provided:
- Sample size used for the test set and the data provenance: Not explicitly stated for these specific models. For blood pressure monitor validation studies (e.g., following ISO 81060-2), a typical sample size would be around 85 subjects with specific demographic and blood pressure range distributions. Data provenance would likely be from a clinical setting, potentially in China (country of the manufacturer) or another region where the validation study was conducted, and it would be prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For blood pressure monitor validation, ground truth (reference blood pressure measurements) is typically established by trained clinical observers (e.g., physicians, nurses, or technicians) using a standardized auscultatory method, often with mercury sphygmomanometers, following strict protocols. Usually, at least two independent observers are involved for each measurement series.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated. In blood pressure monitor validation studies, if multiple observers are used for ground truth, their readings are compared. Differences beyond a certain threshold often require a third observer or a predefined averaging/exclusion rule.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. These are standalone blood pressure monitors and do not involve human readers interpreting results with or without AI assistance in the way a diagnostic imaging AI would. They provide direct readings.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, indirectly. The performance specifications mentioned are for the device itself (algorithm and hardware combined) to measure blood pressure. The "oscillometric method" is an algorithmic approach. The comparison to the predicate device implies that the standalone performance is considered similar and acceptable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood pressure monitors, the ground truth for accuracy validation is typically expert consensus/clinical reference measurements obtained using a validated auscultatory method (e.g., using a mercury sphygmomanometer by trained observers).
- The sample size for the training set: Not applicable and not mentioned. These devices use the "oscillometric method," a well-established technique that generally doesn't involve a separate "training set" in the context of deep learning AI. The underlying algorithms are developed and refined based on engineering principles and physiological data, not typically machine learning training on a large dataset for each new model.
- How the ground truth for the training set was established: Not applicable, as no dedicated training set in the AI sense is described. The "ground truth" for the development of the oscillometric method itself would stem from extensive physiological studies and comparisons to direct arterial pressure measurements or established auscultatory methods.
§ 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).