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510(k) Data Aggregation
(493 days)
This Handheld Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult patients in hospitals, clinics, or home. This device is not intended for continuous monitoring, use during motion or use with low perfusion.
The Handheld Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Handheld Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Handheld Pulse Oximeter is powered by 3 AA batteries. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The Handheld Pulse Oximeter is compatible with S0010B-S sensor. The device is a spot-check Handheld Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
The provided text describes the 510(k) summary for a Handheld Pulse Oximeter (WIT-S100, WIT-S300) and its substantial equivalence determination. The document primarily focuses on non-clinical and clinical performance data to support the device's accuracy and safety.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criteria for a pulse oximeter revolve around its accuracy in measuring functional oxygen saturation (SpO2) and pulse rate (PR). The standards cited provide these.
| Acceptance Criteria (from ISO 80601-2-61) | Reported Device Performance |
|---|---|
| SpO2 Accuracy (70-100%) | ±2% (for 70-100%) |
| **SpO2 Accuracy ( |
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(435 days)
This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Fingertip Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Fingertip Pulse Oximeter is powered by 2 AAA batteries. The device mainly composed of PCB board, one key, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check Fingertip Pulse Oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
Here's a breakdown of the acceptance criteria and study information for the Fingertip Pulse Oximeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (as per ISO 80601-2-61:2017) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Accuracy (70-100%) | ≤ 3.5% Arms (Root Mean Square) for SpO2 values between 70-100% | The document states "70~100%, ±2%." This likely refers to the error tolerance claimed by the manufacturer which is tighter than the ISO standard. The clinical study section states "Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range." implying that the device met acceptable accuracy within the specified range. |
| SpO2 Accuracy ( |
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