(102 days)
HL858CP 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.
The device can accurately measure in pregnant patients including those with known or suspected in preeclampsia condition.
HL858CP 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 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 monitor by means of DailyChek® application software with the paired Bluetooth-enabled device.
HL858CP 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 can accurately measure blood pressure in pregnant patients including those with known or suspected in pre-eclampsia condition.
The device will display a symbol O-W- 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.
HL858CP is equipped with Bluetooth Data Transmission function, which can electronic transfer the measured data of HL858CP to the paired Bluetooth-enabled device. The transferable measured data includes Systolic, Diastolic, and Pulse. The Bluetooth Data Transmission is without controlling or altering the functions or parameters of HL858CP and Paired Bluetooth-enabled device. In addition, the Bluetooth Data Transmission function could transfer the battery status of HL858CP to the Paired Bluetooth-enabled device without any controlling or altering on both devices.
Besides, Bluetooth Data Transmission function could provide Date/Time synchronization for HL858CP, which simply help users set Time/ Date information. It will help users prevent from entering incorrect time information.
The provided text describes the Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP, and its clinical validation, particularly regarding its ability to accurately measure blood pressure in pregnant patients, including those with pre-eclampsia. This information is gleaned from various sections of the 510(k) Summary.
Here's a breakdown of the requested information:
Device: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858CP
1. Table of Acceptance Criteria and Reported Device Performance
The core clinical validation for non-invasive sphygmomanometers, including this device, is typically against the ISO 81060-2 standard. This standard sets specific criteria for accuracy.
| Acceptance Criteria (ISO 81060-2:2013) | Reported Device Performance (HL858CP) |
|---|---|
| For all subjects (general population): | |
| Mean difference between device and reference standard in mmHg (Systolic and Diastolic) ≤ ±5 mmHg | The results of this clinical investigation show that the required limits for mean difference... are fulfilled by the subject device HL858CP in the group of 90 subjects. (Specific numerical mean differences are not provided in the summary but stated to meet the criteria). |
| Standard deviation of differences in mmHg (Systolic and Diastolic) ≤ 8 mmHg | The results of this clinical investigation show that the required limits for ... standard deviation are fulfilled by the subject device HL858CP in the group of 90 subjects. (Specific numerical standard deviations are not provided in the summary but stated to meet the criteria). |
| For pregnant patients (including pre-eclampsia): | The same ISO 81060-2:2013 criteria are applied specifically to this sub-population. The device aimed to show equivalence to a predicate device (Microlife BP3MW1-4B, K153077) cleared for this indication. |
| Mean difference between device and reference standard in mmHg (Systolic and Diastolic) ≤ ±5 mmHg | The clinical test result of HL858CP meets criteria of ISO 81060-2:2013 and proves the safety and effectiveness of pregnancy accuracy performed as well as the predicate device Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077). (Specific numerical values for pregnant patients are not provided, but compliance is asserted). |
| Standard deviation of differences in mmHg (Systolic and Diastolic) ≤ 8 mmHg | The clinical test result of HL858CP meets criteria of ISO 81060-2:2013 and proves the safety and effectiveness of pregnancy accuracy performed as well as the predicate device Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K153077). (Specific numerical values for pregnant patients are not provided, but compliance is asserted). |
Note: While the summary states that the criteria were fulfilled, the exact numerical performance values (mean difference and standard deviation) are not explicitly given in the provided text for either the general or pregnant populations. The summary focuses on meeting the standard.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: "90 subjects with qualified distribution."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, for a clinical validation study for a medical device approval, especially an accuracy study like this, it is almost exclusively prospective and generally conducted in a controlled clinical environment (e.g., a hospital or clinic). The lack of country specification likely means it was conducted where the manufacturer is based or in a region with established clinical trial infrastructure that is recognized by the FDA (e.g., often US, Taiwan, Europe).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth. For blood pressure measurement validation according to ISO 81060-2, the ground truth is typically established by trained medical professionals (e.g., physicians or nurses) using a validated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a rigorous protocol (e.g., auscultatory method with trained independent observers). The standard prescribes specific requirements for these observers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not explicitly describe an adjudication method for the test set. For ISO 81060-2 validation, the ground truth is typically captured by two independent observers (auscultatory method), and if there's a significant discrepancy, a third observer might be involved. The standard has specific requirements for the agreement between observers (e.g., differences within certain mmHg). While not explicitly stated as "adjudication," this method ensures robust ground truth.
5. 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
This device is a blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device. The study described is a clinical validation of the device's measurement accuracy against a reference standard.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The entire clinical investigation described ("compliant to the standard of ISO 81060-2: Second Edition 2013-05-01") is a standalone algorithm (device) performance study. The device's measurements are directly compared to the clinically established ground truth, demonstrating the device's accuracy without requiring human interpretation or intervention in the measurement process beyond device operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used is based on clinically established reference measurements of blood pressure, typically using the auscultatory method with a mercury sphygmomanometer (or an equivalent validated reference device) performed by trained medical professionals, as per the ISO 81060-2 standard. This is most akin to an expert consensus method from trained individuals applying a gold standard technique.
8. The sample size for the training set
The document does not specify a training set sample size. This is common for traditional medical devices like blood pressure monitors, which are validated against standards like ISO 81060-2 based on their mechanical and algorithmic adherence to established measurement principles, rather than being "trained" like machine learning models. The 90 subjects mentioned are for the clinical validation/test set.
9. How the ground truth for the training set was established
As there is no "training set" in the context of machine learning for this device, a specific method for establishing ground truth for a training set is not applicable/not detailed. The device's internal algorithms for oscillometric blood pressure measurement are developed based on established physiological principles and engineering, not typically via a data-driven training process in the way AI models are.
§ 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).