(28 days)
The LNOPv Ad-L and Pd-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) (measured by an SpO2 sensor) for use with Masimo SET pulse oximeters for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The LNOPv Ad L and Pd L Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET pulse oximeter monitors. They represent a design change to the Masimo LNOPv Oximetry Sensors. The LNOPv Ad L and Pd L disposable sensors are similar in construction to the predicate devices LNOPv In and LNOPv Ne except that the LNOPv Ad L and Pd L have a shorter tail and the emitter and detector position is switched. The LNOPv Ad-Land Pd-L use the same emitters (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) as used in Masimo's LNOPv In and Ne sensors. The patient contacting materials in the LNOPv Ad-L and Pd-L disposable sensors are the same that is used in Masimo's LNOPv In and Ne sensors. The LNOPv Ad-L and Pd-L disposable sensors are supplied non sterile for single patient use. The LNOPv Ad L and Pd-L disposable sensors have the same electrical, optical, and material components as the LNOPv In and Ne disposable sensors.
The provided text describes the performance testing of the LNOPv Ad-L and Pd-L Oximetry Sensors. Here's a breakdown of the acceptance criteria and study details based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Biocompatibility: | |
| Non-toxic | Demonstrated non-toxic |
| Non-irritating | Demonstrated non-irritating |
| Non-sensitizing | Demonstrated non-sensitizing |
| Environmental Testing: | |
| Electrical | All tests passed |
| Mechanical | All tests passed |
| Environmental | All tests passed |
| Clinical Accuracy (SpO2): | |
§ 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).