(88 days)
The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm.
The intended arm circumference includes 22 cm~32 cm.
The proposed device, Electronic Blood Pressure Monitor, is a battery driven non-invasive blood pressure monitor. It can complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHq or KPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the WHO (World Health Organization) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2. The proposed electronic blood pressure monitor has 13 models, including PG-800B30, PG-800B39, PG-800B45, PG-800B46, PG-800B48, PG-800B48, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61. All models follow the same software, measurement principle and NIBP algorithm. The main differences are product appearance and key numbers.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
The provided document is a 510(k) summary for an Electronic Blood Pressure Monitor (Model: PG-800B30, etc.) from Shenzhen Pango Medical Electronics Co., Ltd. This document does not contain information about software algorithms for intelligent analysis or AI assistance. Therefore, it does not provide the details requested for acceptance criteria and study proving device performance for such AI-based systems.
The document discusses the substantial equivalence of the new device to a predicate device (K170151), focusing on non-clinical tests (electrical safety, EMC, software verification/validation, human factors/usability) and stating that no clinical measurement performance test was needed because the blood pressure measurement function, principle, and NIBP algorithm are identical to the legally marketed predicate device.
Specifically, the document lacks the following:
- Acceptance criteria table and reported device performance for an AI/ML algorithm. The "Accuracy" row in the comparison table refers to the device's accuracy for blood pressure measurement (3mmHg), not an AI algorithm's performance metrics.
- Sample size and data provenance for an AI test set.
- Number of experts and their qualifications used for ground truth establishment for an AI algorithm.
- Adjudication method for an AI test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone (algorithm-only) performance data.
- Type of ground truth used for an AI algorithm.
- Training set sample size for an AI algorithm.
- Method for establishing ground truth for an AI training set.
The document states that the device's software was considered a "Moderate" level of concern, and software verification and validation testing were conducted as per FDA guidance. However, this is for the device's core functionality (non-invasive blood pressure measurement using an oscillometric technique), not an AI-driven diagnostic or analytical tool.
In summary, this document is for a standard electronic blood pressure monitor, not a device incorporating a novel AI/ML algorithm that would require the detailed performance study and acceptance criteria you've asked for.
§ 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).