(196 days)
The subject device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-42 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings.
Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique in which an inflatable cuff is wrapped around the upper 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 pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor are the main unit and cuff unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Polyester shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the power on/off key, the rubber bulb, exhaust valve, bluetooth tranismision and cuff. The subject devices are powered by Li-ion Polymer Battery.
The device has irregulae heart beat (IHB) indicator which is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
The subject device includes bluetooth tranismision which can tranfer data to APP installed in smart phone. The APP can display, store and review the measurement data including the systolic and diastolic blood pressure and pulse rate.
The provided document is a 510(k) summary for a Blood Pressure Monitor, seeking clearance from the FDA. It compares the device to a predicate device and outlines the testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this blood pressure monitor is its accuracy. The standard referenced is ISO 81060-2:2013, which specifies requirements for the clinical validation of automated non-invasive sphygmomanometers.
The document states the following for the subject device:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Pressure Accuracy (based on clinical validation) | "The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2." (Page 7) |
| Pressure Accuracy (bench test specification) | ± 3mmHg (Page 6) |
| Pulse Accuracy (bench test specification) | ± 2 bpm (Page 6) |
| Operating Temperature Range | 5~40°C (validated for full claimed range) (Page 6, 7) |
| Storage Temperature Range | -25~70°C (validated for full claimed range) (Page 6, 7) |
| Cuff Circumference Range | 22-42 cm (validated by ISO 81060-2) (Page 5, 6) |
Note: The document only provides a high-level statement for clinical accuracy (meeting ISO 81060-2 requirements). It does not provide the specific numerical results of the clinical endpoints for systolic and diastolic blood pressure differences required by ISO 81060-2 (e.g., mean difference and standard deviation, or cumulative percentages within 5, 10, 15 mmHg for individual differences). It only indicates that the device passed the tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: 85 patients (38 males and 47 females) (Page 7)
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. However, given the manufacturer's location (Shenzhen, China) and the consultants' locations (Shenzen, China), it is highly probable the study was conducted in China. The study was a prospective clinical investigation as it involved patients participating in a study to collect data for the device's validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided document does not explicitly state the number or qualifications of experts involved in establishing the ground truth for the clinical test set.
For ISO 81060-2 validation: "The manual Mercury Sphygmomanometer was used as a reference device." This implies measurements were taken by trained operators, but their specific qualifications (e.g., physicians, nurses, technicians) and their adjudication process (if any, beyond simultaneous measurement) are not detailed.
4. Adjudication Method for the Test Set
The document states: "Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device." (Page 7)
This describes a direct comparative measurement method for ground truth, where the device under test and the reference manual sphygmomanometer are used on the same arm, sequentially. This method inherently reduces inter-arm variability but relies on the accuracy of the sequential measurements and the operator's technique. There is no indication of an "adjudication method" in the sense of multiple independent expert readers reviewing data and resolving discrepancies (e.g., 2+1 or 3+1 consensus), as this typically applies to image-based diagnostic systems, not direct physiological measurement devices like blood pressure monitors.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their performance. A blood pressure monitor is a direct measurement device; its performance is validated against a reference standard, not against human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the core of the clinical validation (ISO 81060-2) is a standalone performance test for the device's accuracy. The device (algorithm) measures blood pressure, and this measurement is directly compared to a reference standard (manual mercury sphygmomanometer). This is an "algorithm only" performance, as the human interaction is primarily in operating the device and the reference, not in interpreting the device's output and making a diagnosis.
7. The Type of Ground Truth Used
The ground truth used was comparative measurements against a validated reference device: "The manual Mercury Sphygmomanometer was used as a reference device." (Page 7). This method is specified by the ISO 81060-2 standard for clinical validation of automated blood pressure devices, which compares the device's readings to those obtained by a "gold standard" auscultatory method.
8. The Sample Size for the Training Set
The document does not mention any training set or its sample size. This is typical for direct measurement devices validated against a known standard. AI/ML-based diagnostic devices often have explicit training sets, but this device appears to rely on a traditional oscillometric method and its validation is based on direct clinical comparison, not a machine learning model developed with a large training dataset.
9. How the Ground Truth for the Training Set was Established
As no training set is discussed or mentioned, the method for establishing its ground truth is not applicable or detailed in this document.
§ 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).