(22 days)
To measure systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.
Full Auto Wrist Blood Pressure Monitor (Models BP1600, BP1650, BP1700 and BP1750) is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement. The user interface panel of the device has power button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure and pulse rate. The device has memory capacity to store 10, 20, 60 and 90 most recent measurement results (respectively for BP1600, BP1650, BP1700 and BP1750). The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. Iower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.
This 510(k) premarket notification (K071523) by GENEXEL-SEIN, INC. for the Full Auto Wrist Digital Blood Pressure Monitor (Models BP1600, BP1650, BP1700, and BP1750) references substantial equivalence to a predicate device (K012054) rather than providing specific acceptance criteria and a standalone study for the new device. The provided text indicates that the performance of the new device is "Identical" to the predicate device. Therefore, the details about acceptance criteria, specific performance metrics, and the study proving compliance are derived from the overall claim of substantial equivalence and the listed characteristics.
Given the information provided, a direct table of acceptance criteria with reported device performance of the new device in a standalone study is not explicitly present. The submission relies on the established safety and effectiveness of the predicate device.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the "Performance" of the new device is "Identical" to the predicate device (510(k) # K012054). Therefore, the implied acceptance criteria would be those met by the predicate device, and the reported performance is that it matches the predicate. Specific numerical criteria are not provided for the new device in isolation.
| Acceptance Criteria Category | Reported Device Performance (vs. Predicate K012054) |
|---|---|
| Performance (Accuracy of systolic, diastolic pressure, and pulse rate measurement using oscillometric method and wrist cuff) | Identical to predicate device |
| Mechanical safety | Identical to predicate device |
| Biocompatibility | Identical to predicate device |
| Electrical safety | Identical to predicate device |
| Thermal safety | Identical to predicate device |
| Design | Similar to predicate device |
| Human factors | Similar to predicate device |
| Standards Met | Identical to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new, separate clinical study with a test set conducted for this 510(k) submission (K071523). Instead, it claims substantial equivalence based on the technological characteristics being identical or similar to the predicate device. Details on sample size or data provenance for a test set for the new device are therefore not provided. It's implied that the predicate device would have undergone such testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As no specific test set study for K071523 is described, there's no information about the number or qualifications of experts used to establish ground truth.
4. Adjudication Method for the Test Set
Since no specific test set study for K071523 is described, there's no information about an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned for this device. Blood pressure monitors typically do not involve multi-reader multi-case studies, as their function is to provide an objective measurement.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
The document does not describe a standalone performance study for the K071523 device. The basis for clearance is substantial equivalence to a predicate device, meaning its performance characteristics are considered to be effectively the same as the predicate, which would have undergone performance validation. The device itself is an automated measurement system, so "algorithm only" performance would be synonymous with its standalone performance.
7. Type of Ground Truth Used
For blood pressure monitoring devices, the "ground truth" for accuracy studies typically involves comparison against a reference standard, such as auscultatory measurement by trained observers using a mercury sphygmomanometer or an invasive arterial line. However, the document does not specify the ground truth method for this submission, instead relying on the predicate device's validation.
8. Sample Size for the Training Set
This submission does not discuss a training set, as it is not a machine learning or AI-based device in the common sense that would require a distinct training and test set with ground truth labeling for its development. It's a medical device with an oscillometric measurement algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not describe a machine learning training set in the context typically seen for AI/ML devices.
§ 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).