Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

Accuracy Performance Verification of the INVOS™ PM7100 System by Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers

Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard

Study Overview

• Status: Completed
• Conditions: Oxygen Saturation
• Intervention / Treatment: Device: Observational

Detailed Description

The purpose of this study is to provide data for verification of the INVOS™ PM7100 System paired with the Adult Sensor (PMSENS71-A). Medtronic evaluates the performance and/or feasibility of non-invasive optical devices over a clinically relevant range of arterial saturations. This study evaluates rSO2 accuracy of tissue oximetry equipment compared directly to the actual saturation of arterial and jugular blood samples (SaO2) and (SjvO2) and the composite of the two (SavO2) as measured by co-oximetry.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria

Description

Inclusion Criteria:

1. Subjects between the ages of 18 to 50 years
2. Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
3. Minimum weight 40kg
4. BMI within range 18.0 - 29.9

Exclusion Criteria:

1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported]
2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
3. Subjects taking medication(s) beyond birth control may be excluded from participating at the PI discretion [self-reported]
4. Any interventional study within 30 days that, in the opinion of the PI, electrocardiogram (ECG) may interfere with study participation (i.e., drug, biologic)
5. Negative Allen's test for radial and ulnar patency
6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure [self-reported]
7. Is pregnant
8. Has anemia as measured by co-oximetry [values specific for sex]
9. Has a history of sickle cell trait or thalassemia [self-reported]
10. Has an abnormal hemoglobin electrophoresis test [lab measurement]
11. Has a positive urine cotinine test or urine drug screen or oral ethanol test [Point of Care (POC) testing]
12. Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate]
13. Has a clinically significant abnormal ECG [assessment by PI or delegate]
14. Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate]
15. Has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co-oximetry]

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational; Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria

Device: Observational; The study objective requires placement of a jugular venous bulb catheter in the right or left jugular venous bulb with ultrasound guidance. A venous and radial arterial line will be placed. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead. The INVOS™ device will be evaluated for a targeted range of 70-100% SpO2 levels. Hypoxic mixtures of gas are delivered, and data are collected at approximately (~) 5-minute intervals during steady periods of increasing and decreasing oxygen concentration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy root mean square	Accuracy root mean square is the square-root of the average squared distances between regional oxygen saturation (rSO2) as measured by INVOS and and field saturation (fSO2) as measured by blood sampling	rSO2 and fSO2 data are recorded every 5-minutes during the procedure

Collaborators and Investigators

• Sponsor: Medtronic - MITG

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): July 22, 2025

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MDT23038INSENS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes