Feasibility and Performance Evaluation for INVSENSOR00024

Feasibility and Performance Evaluation of INVSENSOR00024

This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.

Inclusion Criteria:

• Less than or equal to 1 month of age
• Weight <3kg
• Subjects admitted with standard of care (SOC) arterial blood sampling line already in place

Exclusion Criteria:

• Subjects with underdeveloped skin
• Subjects with abnormalities at the planned application sites that would interfere with system measurements
• Subjects with known allergic reactions to foam/rubber products and adhesive tape
• Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator