Search Results
Found 1 results
510(k) Data Aggregation
(89 days)
The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.
The Automatic Arm Electronic Blood Pressure Monitor, including LBP70C and LBP70D, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult patient with arm circumference ranging from 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches) by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The device has irregular heat beat (IHB) indicator which can indicate a rhythm 25% less or 25% more than the average rhythm detected while measuring the systolic and diastolic blood pressure. The subject device consists of the PCBA, pressure sensor, operation keys, pump, control valve, LCD screen, cuff, batteries and optional accessory AC adapter. The two models have same intended use, working principle, measuring range, accuracy, cuff, component and appearance. They are only different in power supply. Model LBP70C is powered by 4 AA alkaline batteries or AC adapter, while model LBP70D is powered by rechargeable lithium-polymer battery or AC adapter. The device has a memory function that can automatically store up to 90 sets of data for each user. It can also display the latest measurement result.
The provided text describes the acceptance criteria and a clinical study conducted for the Automatic Arm Electronic Blood Pressure Monitor (K210435).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Standard / Requirement) | Reported Device Performance (Subject Device) | Compliance |
|---|---|---|---|
| Blood Pressure Accuracy | ISO 81060-2 (Mean Difference $\pm 5$ mmHg, Standard Deviation $\leq 8$ mmHg) | Mean Difference $\pm 3$ mmHg / $\pm 0.4$ kPa | Meets |
| Pulse Rate Accuracy | Not explicitly stated in table, but generally $\pm 5$% is accepted | $\pm 5$% | Meets (implied) |
| Systolic BP Range | IEC 80601-2-30: At least 60~230 mmHg | 60~255 mmHg | Meets |
| Diastolic BP Range | IEC 80601-2-30: At least 40~130 mmHg | 30~195 mmHg | Meets |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10 | No cytotoxicity, no sensitization, negligible irritation | Meets |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11 | Meeting requirements | Meets |
| EM Compatibility | IEC 60601-1-2 | Meeting requirements | Meets |
| Software | IEC 62304, FDA Guidance for Software | Developed, documented, and validated accordingly | Meets |
| Operating Temperature | 5°C~40°C | 5°C~40°C | Meets |
| Operating Humidity | 15%RH~85%RH | 15%RH~85%RH | Meets |
| Operating Atmospheric Pressure | IEC 80601-2-30 requirements (not explicitly listed for this range in tables) | 70 kPa | Meets (after verification) |
| Storage Temperature | -20°C~55°C | -20°C~55°C | Meets |
| Storage Humidity | ≤93%RH | ≤93%RH (compared to predicate 10%RH~93%RH) | Meets (after verification) |
| Storage Atmospheric Pressure | IEC 80601-2-30 requirements (not explicitly listed for this range in tables) | 50 kPa | Meets (after verification) |
Note on Measurement Range: While the table indicates $\pm 3$ mmHg accuracy for blood pressure, the full ISO 81060-2 standard typically defines acceptance based on the mean difference and standard deviation of differences between the device and reference measurements. The text states "the results showed the accuracy of the subject device is within acceptable scope specified in ISO 81060-2," implying these statistical criteria were met.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 85 patients (46 males, 39 females).
- Data Provenance: The document does not explicitly state the country of origin. The study was conducted as a "clinical study," which implies it was a prospective collection of data for the purpose of validating the device.
3. Number of Experts and Qualifications for Ground Truth
- The document implies the use of a manual Mercury Sphygmomanometer as a reference sphygmomanometer. This suggests that human operators (who would be skilled in using such a device) were involved in generating the reference measurements.
- Number of Experts: Not explicitly stated. For ISO 81060-2, a minimum of two trained observers are typically required, but the document does not specify this detail.
- Qualifications of Experts: Not explicitly stated. For a standard like ISO 81060-2, trained observers are required, typically with experience in auscultatory blood pressure measurement using a mercury sphygmomanometer.
4. Adjudication Method for Test Set
The document states, "Same arm sequential method was adopted during the clinical study." This method involves taking measurements on the same arm sequentially using both the test device and the reference device. There is no mention of an adjudication process (e.g., 2+1, 3+1) for discrepancies, as the ground truth is established by the direct measurements from the reference standard. If multiple human observers were used, the ISO standard would typically dictate an averaging or specific agreement criteria, but this is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study focuses on validating the accuracy of the automated blood pressure monitor against a reference standard, not on comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance
The study directly assesses the performance of the Automatic Arm Electronic Blood Pressure Monitor, which is a standalone device. While it contains "intelligent" components (Automatic Arm Electronic Blood Pressure Monitor, Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.), the intent of the clinical study is to validate the accuracy of the device itself (algorithm + hardware) in producing blood pressure measurements. Therefore, the reported performance is effectively the standalone performance of the device without explicit human-in-the-loop assistance for the measurement process (beyond the human placing the cuff).
7. Type of Ground Truth Used
The ground truth was established using measurements from a manual Mercury Sphygmomanometer. This is considered a reference standard for blood pressure measurement in clinical validation studies as per ISO 81060-2.
8. Sample Size for Training Set
The document does not provide any information regarding the training set size or how the device's algorithms were developed. The information provided pertains solely to the clinical validation (test set).
9. How Ground Truth for Training Set Was Established
As no information about a training set is provided, no details on how its ground truth was established can be given. The document focuses on the validation of the finished device.
Ask a specific question about this device
Page 1 of 1