(475 days)
The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/ or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.
The circul™ pro Ring is a small, wearable, non-invasive, wireless device that the user wears on one finger. The ring features an adjustable fit (by means of multiple ring sizes (S, L, XL) and a spring fit) for comfort and can be worn on any finger on either hand. The circul pro Ring relies on an optical sensor to detect oxygen saturation (SpO2) and pulse rate (PR). The sensor uses two wavelengths of LEDs: Red: with a wavelength of 660 nm ± 10 nm, Infrared: with a wavelength of 940 nm ± 20 nm. The blood oxygen percentage is calculated based on measuring the passage of the two wavelengths of light (with different absorption rates) through the body, also known as Reflective Oximetry. The integrated sensor technology works to determine the blood oxygen content by determining the light absorption when the skin is illuminated. The circul pro Ring features a spring mechanism, and the elastic structure of the embedded sensor and inner arch of the ring are ergonomically shaped to offer a snug fit, preventing it from slipping off the finger, stabilizing the sensor on the 'belly' of the finger, and minimizing twisting of the ring on the wearer's finger. This also helps to reduce the likelihood of poor SpO2 readings in patients with darker skin pigments.
Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) summary for the circul™ pro Ring:
Acceptance Criteria and Device Performance
The primary performance metrics for this device are oxygen saturation (SpO2) and pulse rate (PR) accuracy. The acceptance criteria are largely derived from the ISO 80601-2-61:2017 standard for pulse oximeters, as well as the device's intended use and comparison with predicate devices.
Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (from ISO 80601-2-61:2017 or internal protocol) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (ARMS) | $\le$ 3.5% (SpO2 within 70% - 100% range) | 1.85% (within the range of |
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).