SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061

This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.

Study Overview

• Status: Completed
• Conditions: Spo2
• Intervention / Treatment: Device: Masimo INVSENSOR00061

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • National City, California, United States, 91950
      • Bailony Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • Subject is a full-term newborn (37 weeks) to 18 months of age.

Exclusion Criteria:

• • Subject has underdeveloped skin.

  • Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
  • Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
  • Subject is not suitable for the investigation at the discretion of the Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Masimo INVSENSOR00061; Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.	Device: Masimo INVSENSOR00061; Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2 Accuracy of INVSENSOR00061	SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.	Approximately 15 minutes
Pulse Rate Accuracy of INVSENSOR00061	Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.	Approximately 15 minutes

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BAIL0003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes