(207 days)
Caremed Disposable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric and infant patient populations.
The proposed device, Disposable SpO2 Sensors are accessories to the patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is Nihon Kohden BSM-5135A. The sensor shall be connected to its corresponding monitor through Caremed adapter cable model SZ30-36. Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light lit alternately according to certain sequence, when the fingertips of capillary repeatedly with the heart pumps blood congestion, light emitting diode after blood vessels and projected onto a photodiode, photodiode can be induced to change with pulse light intensity, the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
This document describes the performance data and acceptance criteria for the Disposable SpO2 Sensor (K191279).
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Predicate Device K142832) | Reported Device Performance (Subject Device) | Comparison |
|---|---|---|---|
| SpO2 Range | 70%-100% | 70%-100% | Same |
| SpO2 Accuracy | ±3% | ±3% | Same |
| PR Range | 30 bpm - 250 bpm | 30 bpm - 250 bpm | Same |
| PR Accuracy | ±3 | ±3 | Same |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Same |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Same |
| Performance | Complied with ISO 80601-2-61 | Complied with ISO 80601-2-61 | Same |
| Biocompatibility: Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Same |
| Biocompatibility: Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
| Biocompatibility: Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Same |
2. Sample size used for the test set and the data provenance:
The document states that "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Caremed Disposable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry."
For the expanded indication to include infants (3 kg
§ 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).