(179 days)
The Fingertip Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
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 Pulse Oximeter is powered by 2 AAA alkaline batteries. The device mainly composed of PCB board, On/Off button, OLED or LED or LED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study proving the device meets them:
The document is a 510(k) Premarket Notification for a Fingertip Pulse Oximeter (Model LT-F20 and LT-F21). It seeks to demonstrate substantial equivalence to a legally marketed predicate device. The core of the performance data revolves around meeting established standards for pulse oximeters.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the ISO 80601-2-61:2017 standard for pulse oximeter equipment, which the subject device claims compliance with. The reported performance is directly stated.
| Parameter | Acceptance Criteria (from ISO 80601-2-61) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | 70% ~ 100%, Arms ± 3%. |
§ 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).