(66 days)
iHealth BP3L Wireless Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
iHealth BP3L Wireless Blood Pressure Monitors are designed and manufactured according to IEC 80601-2-30.
The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. The new devices achieves its function by an iOS or Andriod devices.
The provided document describes the iHealth BP3L Wireless Blood Pressure Monitor and its premarket notification to the FDA. The relevant information for acceptance criteria and the study proving the device meets them is scattered across several sections.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference: ISO 80601-2-30) | Reported Device Performance (iHealth BP3L) |
|---|---|
| Accuracy (Pressure): Mean difference between device measurement and reference measurement should be $\leq \pm 5$ mmHg with a standard deviation $\leq 8$ mmHg. | Pressure: $\pm 3$ mmHg (Stated "Accuracy" in paragraph 7.0 and "Range of measurement" in paragraph 7.0) |
| Accuracy (Pulse): Mean difference between device measurement and reference measurement should be $\leq\pm 5%$ | Pulse: $\pm 5%$ (Stated "Accuracy" in paragraph 7.0) |
| Cuff Pressure Range: 0 ~ 295 mmHg (Predicate device) | Cuff Pressure Range: 0 ~ 300 mmHg (Subject device) |
| Determination Range: 30 ~ 280 mmHg (Predicate device) | Determination Range: 40 ~ 260 mmHg (Subject device) |
| Operating Environment: 0~35°C, |
§ 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).