(199 days)
HL858CL automatically measures human's Systolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.
HL858CL detects the appearance of irregular heartbeats during measurement; an indicated symbol will appear with measuring reading. And the Risk Category Indicator will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, the device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device. Also, users could simply synchronize the current date and time, and check the battery status of blood pressure montor by means of DailyChek® application software with the paired Bluetooth-enabled device.
HL858CL automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's upper arm. The intended use of this over-the-counter device is for adults aged 18 years and older with arm circumference ranging from 9 inches to 22 inches (approx.23 cm to 56 cm) and for home use.
The device will display a symbol O-+-, to indicate the detection of irregular heartbeat rhythm as defined as a rhythm is more than or less than 25% from the average heartbeat intervals during the measurement. Additionally, after measurement, the Risk Category Indicator function will show the information with the readings on the screen for the user tracking their blood pressure level.
Besides, when Triple Check mode is turned on by user, the symbol ( ) will display on the LCD. Then press Start/Stop button the device will take three consecutive measurements automatically at 1 minute intervals. After measurements are completed LCD will display the average values of the three measurements. And user can use the Bluetooth Data Transmission function, which provides users an optional choice to log, track and store their measurement data. Also synchronize the current date and time, and check the battery status of blood pressure monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
The provided text describes the 510(k) submission for the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CL. The key study proving its performance is a clinical investigation conducted to demonstrate compliance with the standard ISO 81060-2: Second Edition 2013-05-01, "Non-invasive sphygmomanometers- Part 2: Clinical validation of automated measurement type."
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria for blood pressure monitors, as per ISO 81060-2, relate to the accuracy of BP measurements. While the exact numerical criteria for mean difference and standard deviation are not explicitly stated in the provided text, the document confirms that the device did meet these criteria. The text states: "The results of this clinical investigation show that the required limits for mean difference and standard deviation are fulfilled by the subject device HL858CL in the group of 90 subjects with qualified distribution."
| Acceptance Criteria (from ISO 81060-2) | Reported Device Performance |
|---|---|
| Mean Difference (Systolic) | Fulfilled required limits |
| Standard Deviation (Systolic) | Fulfilled required limits |
| Mean Difference (Diastolic) | Fulfilled required limits |
| Standard Deviation (Diastolic) | Fulfilled required limits |
(Note: The exact numerical values for 'mean difference' and 'standard deviation' were not provided in the document, only the statement that the 'required limits' were fulfilled.)
2. Sample Size and Data Provenance
- Sample Size for Test Set: 90 subjects.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical validation studies for medical devices are typically prospective.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish ground truth. For clinical validation of blood pressure monitors according to ISO 81060-2, the ground truth is typically established by trained human observers using a reference sphygmomanometer, often with simultaneous auscultation and standardized procedures, but no details are provided on the specific experts involved.
4. Adjudication Method for the Test Set
The document does not explicitly detail an adjudication method. In ISO 81060-2 studies, blood pressure measurements are typically taken by multiple observers (often two) and averaged or compared against a standardized reference, but specific adjudication processes (e.g., 2+1, 3+1) are not mentioned in this summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a blood pressure monitor, which is typically validated for its standalone accuracy against a reference standard, not for human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, the study described is essentially a standalone performance study. The device's accuracy in measuring blood pressure is assessed against a reference standard (as per ISO 81060-2), which means it's evaluating the algorithm and hardware without human interpretation of ambiguous readings.
7. Type of Ground Truth Used
The ground truth for the clinical validation was established by comparison to a reference standard as dictated by ISO 81060-2. This typically involves simultaneous measurements by the device under test and trained observers using a calibrated auscultatory method.
8. Sample Size for the Training Set
The document does not provide information about a training set size. For blood pressure monitors validated to ISO 81060-2, the primary clinical study is a validation study, not a deep learning model's training. The device's algorithm would have been developed and refined using internal data, but details of that process (including training set size) are not part of this 510(k) summary for clinical validation.
9. How the Ground Truth for the Training Set Was Established
As noted above, information about a "training set" and its ground truth is not provided in this regulatory summary, as the primary focus is on the clinical validation against the ISO standard.
§ 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).