(60 days)
SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg, pediatric patients weighing 10-50 kg, and neonatal patients weighing no less than 3 kg.
As an accessory of the legally marketed oximeters or patient monitors in the United States, the proposed device SpO2 Sensor is intended for hospital use and continuous monitoring of functional arterial oxygen saturation and pulse rate.
The SpO2 sensor consist of a probe attached to the patient's finger. The sensor shall be connected to its corresponding pulse oximeter monitor with a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Oxygenation of blood is measured by detecting the infrared and red light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin.
Four types of sensor housings are described in this submission:
- Reusable soft tip sensor comprised of an integrated silicone rubber tip.
- Reusable finger clip sensor with rigid halves and silicone pads
- Disposable non- adhesive sensor with sponge and velcro backing.
- Disposable adhesive sensors constructed of a medical tape laminate.
Each SpO2 sensor has unique labeling and specifications designed for compatibility with the specific oximeters/monitors that have been legally marketed in the United States. The compatible oximeters/monitors are listed in the labeling of each SpO2 sensor.
This document is a 510(k) summary for a pulse oximetry sensor (SpO2 Sensor), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria and study design for an AI/ML device, such as sample size for training/test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and cannot be extracted from this document.
The document states: "The subject and predicate devices are exactly the same. The sensors are identical to the cleared version and are not modified. Therefore, the subject device is substantially equivalent to the predicate device." This indicates that the regulatory clearance is based on the device being identical to previously cleared devices, rather than on independent performance testing of a novel AI/ML algorithm.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or any of the other AI/ML specific information requested.
§ 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).