(346 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, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 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%.
This looks like a 510(k) submission for a non-invasive blood pressure monitor. Here's an analysis of the acceptance criteria and the study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate or general standards for oscillometric BP monitors) | Reported Device Performance (Transtek Models TMB-986, TMB-987, TMB-995) |
|---|---|---|
| Accuracy (Pressure) | Predicate: Within ±3mmHg or 2% of reading | Transtek: |
- Within ±0.4kpa / 3mmHg (at 15℃ to 25℃)
- Within ±0.65kpa / 5mmHg (at 10℃ to 40℃, out of 15℃ to 25℃) |
| Accuracy (Heartbeat Rate) | Predicate: Within ±5% of reading | Transtek: Within ±5% of reading |
| Cuff Inflation | Automatic inflation with air pump | Automatic inflation with air pump |
| Deflation of Pressure | Deflation rate controlled by an active electronic control valve (4-11 mmHg/s) | Automatic air release |
| Measurement Perimeter of Upper Arm | 22cm42cm | 22cm42cm |
| Operating Voltage | DC 6V | DC 6V |
| Operating Environment (Temperature) | 10℃40℃ | 10℃80 kPa (790-600 mmHg) |40℃ |80 kPa (790-600 mmHg) | 105
| Operating Environment (Relative Humidity) | 30-80% | ≤80% |
| Operating Environment (Barometric Pressure) | 105
| Transport and Storage Environment (Temperature) | -20℃60℃ | -20℃93% |60℃ |95% | 10
| Transport and Storage Environment (Relative Humidity) | 10
Note: The document explicitly states that the Transtek devices' accuracy for pressure and heartbeat rate are "similar" to the predicate device (HEM 780N3), implying they meet the predicate's acceptance criteria. The specific numerical values for temperature ranges and humidity are slightly different but considered "similar."
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not contain details about a specific clinical study conducted for the Transtek Blood Pressure Monitor models TMB-986, TMB-987, and TMB-995 regarding the sample size, data provenance (country of origin, retrospective/prospective), or the specific methodology used to validate the accuracy.
The submission relies heavily on demonstrating substantial equivalence to the OMRON Automatic Blood Pressure Monitor, Model HEM 780N3 (K061822). The "Performance Tests" section vaguely mentions "Biocompatibility, Electromagnetic Compatibility and Electrical Safety" tests, which are typically bench/engineering tests, not clinical performance studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. As there's no detailed clinical study described, there's no mention of experts establishing ground truth. For blood pressure monitors, ground truth is typically established using a reference standard like a mercury manometer or another validated oscillometric device, with measurements taken by trained technicians.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done or at least not described in this submission. This type of study is more common for imaging devices where human interpretation is a critical component and AI is introduced to assist. For a blood pressure monitor, the performance is primarily based on the accuracy of its direct measurements against a reference standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study of the algorithm's measurement accuracy would have implicitly been done as part of the overall device validation (to ensure it meets the accuracy criteria). However, the document does not detail a specific standalone study separate from the overall device performance claim, nor does it explicitly state the methodology for such a study. The "Oscillometric method" is a known technique, and the device's accuracy is reported, which implies direct measurement capability.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for validating the Transtek device's accuracy. However, for blood pressure monitors of this type, the established ground truth for accuracy testing typically involves:
- Reference standard measurements: Usually performed by trained professionals using a validated auscultatory method (e.g., using a mercury sphygmomanometer or another clinically validated device) against which the test device's readings are compared. This is implied by the accuracy criteria (e.g., ±3mmHg).
8. Sample Size for the Training Set
The document does not provide any information regarding a training set. This is not surprising as these blood pressure monitors typically rely on established "Oscillometric method" algorithms rather than deep learning models that require extensive training data. The algorithms are usually developed based on physiological principles and validated through clinical testing rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (as per point 8), the method for establishing its ground truth is also not applicable/provided.
§ 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).