Desaturation Validation of INVSENSOR00036
Phase: NA
Conditions: Healthy
Sponsor: Masimo Corporation

 
 
Official Title: Desaturation Validation of 
INVSENSOR00036 
 
Date of Protocol: 6/9/2020 
 
NCT Number:   
 
NCT04002960 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision: A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 1 of 14 
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
Protocol/Test Procedure Title 
Desaturation Validation of INVSENSOR00036
Lead Investigator 
Tala Harake, MS
Senior Manager, Clinical Research/Laboratory 
Masimo Corporation 
52 Discovery, Irvine, CA 92618 
Other Investigators 
Steven Barker, PhD, MD
Chief Science Officer and Chairman of Scientific Advisory Board 
Masimo Corporation 
52 Discovery, Irvine, CA 92618 
 
Chelsea Frank, MS 
Clinical Research Associate II 
Masimo Corporation 
52 Discovery, Irvine, CA 92618 
Expected Start Date 
 
Expected End Date 
 
IRB 
E&I West Coast Board – IRB00007807
Protocol Version Date 
TBD 
 
Protocol Test Abstract: 
This study is designed to evaluate the trending accuracy of a noninvasive regional oximetry measurement of 
somatic oxygen saturation. One investigational sensor (INVSENSOR00036) will be placed on the somatic site of the 
volunteer. The values obtained by the test sensor will be compared to the reference value obtained from an FDA-
cleared sensor placed on the somatic site on the contralateral side. 
 
Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the 
concentration of oxygen inhaled is slowly reduced until the subject’s oxygen saturation is approximately 70%.  The 
subject will then be returned to inhaling room air. 
 
APPROVALS 
Author 
Date
Engineering
Date 
 
 
 
 
Quality Assurance 
Date
Manufacturing
Date 
 
 
 
 
 
 
 
 
 
 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 2 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
STATEMENT OF COMPLIANCE 
 
This document is a protocol for a clinical research study sponsored by Masimo Corporation.  The study will be 
conducted in compliance with all stipulations of this protocol, the conditions of IRB approval and applicable 
regulations including 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 812, ISO-14155, and International Conference on 
Harmonisation E6 Good Clinical Practice (ICH GCP). 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the 
Institutional Review Board (IRB) for review and approval.  Approval of both the protocol and the consent form must 
be obtained before any participant is enrolled.  Any amendment to the protocol will require review and approval by 
the IRB before the changes are implemented to the study.   
1. 
PURPOSE 
This study is designed to evaluate the trending accuracy of O3 system’s measurement of oxygen saturation in 
somatic sites.    
 
The INVSENSOR00036 is Masimo’s O3 system, which has been cleared by the FDA and has recived CE marking for 
rSO2 measurements in the cerebral tissue. The INVSENSOR00036 is identical to the currently cleared adult O3 
sensor and is made with with the same materials, and optical components however, it is considered an 
investigational device when placed over skeletal muscle. The values obtained by the INVSENSOR00036 will be 
compared to reference values. 
 
This is a nonrandomized study wherein all subjects receive both the somatic sensor (INVSENSOR00036) and one 
FDA-cleared device sensor.  Data using the sensors will be collected from healthy volunteers undergoing a 
desaturation procedure. Desaturation will be conducted by reducing the concentration of oxygen the study subject 
breathes in a controlled manner to obtain noninvasive regional oxygen saturation readings, rSO2, at various levels.  
Outcome Measure:  
This study will evaluate the trending accuracy of the INVSENSOR00036 relative to the reference value obtained from 
the comparative FDA-cleared device.  
 
2. 
BACKGROUND 
Masimo Corporation develops non-invasive medical technologies.  These devices have applications in the operating 
room, critical care unit, emergency room, emergency transport vehicles, as well as physician’s offices. 
 
2.1. 
Technology Background 
Regional oximetry is a noninvasive technology for measuring the level of oxygenation in deep tissue (rSO2). 
To arrive at their measurements, regional oximeters use Near Infrared Spectroscopy (NIRS), which is based 
on the Beer Lambert Law.  
For cerebral oximetry, multiple detectors and emitters are utilized to provide multiple pathways for the light 
to travel through the tissue. Software algorithms then process the received light signals to provide an 
oxygenation measurement. 
 
 
 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 3 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
In addition to assessing brain oxygenation, the O3 system can be used to for oxygenation measurement in 
somatic sites. The oxygenation of somatic tissue can be used clinically in applicable medical, surgical, and 
trauma patients.  
2.2. 
Study Devices 
Investigational sensors: INVSENSOR00036 
The INVSENSOR00036 is a system which includes Masimo’s O3 adult sensor and Masimo’s O3 module. The 
sensor used in this study is a modification to the application of Masimo’s O3 adult line of sensors which is 
currently FDA cleared for application to the forehead. This sensor will be used in conjunction with the 
Masimo O3 module that is currently cleared for clinical use on adult and pediatric cerebral tissue in the US 
and EU countries.  The O3 module will be used with the Root monitor that will be used to collect data from 
the new application site during this study. 
 
FDA Cleared Sensors and Devices: 
Masimo Root Patient Monitoring Platform: Root is a patient monitoring and connectivity platform that 
offers rainbow® and Masimo SET® measurements with other parameters in an integrated platform. With 
docking capabilities for the Radical-7® handheld monitor and multiple networking/connectivity options, Root 
integrates multiple streams of data into one display monitor.  
 
FDA Cleared Comparator Device 
The FDA cleared comparator device provides real-time monitoring of changes in regional oxygen saturation 
(rSO2) of blood in the brain or other body tissues beneath the sensor. The system utilizes near-infrared light 
at wavelengths that are absorbed by hemoglobin. Light travels from the sensor’s light emitting diode to a 
proximal and a distal detector, permitting data processing of the optical signals.  
The output measurement is a real-time rSO2. 
 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 4 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
 
3. 
REFERENCE 
1 
R-FRM-4662 
Consent To Be A Research Subject Desaturation Validation of INVSENSOR00036 
2 
FRM-4660  
Health Assessment Questionnaire Desaturation Validation of INVSENSOR00036 
3 
FRM-4661  
Desaturation Validation of INVSENSOR00036 Recruitment Script 
4 
FRM-4659  
Desaturation Validation of INVSENSOR00036 Healthy Volunteers Needed 
Advertisement 
5 
FRM-4658 
Desaturation Validation of INVSENSOR INVSENSOR00036 Case Report Form (CRF) 
6 
R-FRM-2449  
Confidentiality Agreement 
7 
FRM-3267  
Post Care Instructions 
8 
DEO-6407  
W-9 Request for Taxpayer Identification Number and Certification  
9 
FRM-1084  
Volunteer Payment Form 
10 
DEO-5548 
Development and Validation of a Cerebral Oximeter Capable of Absolute Accuracy 
11 
DEO-1016C 
Pulse Oximeters - Premarket Notification Submissions 510k Guidance_1605 
12 
DEO-5551 
ISO 80601-2-61 Medical electrical equipment - Part 2-61_Particular requirements 
for basic safety and essential performance of pulse oximetry equipment 
 
 
 
4. 
LOCATION 
Masimo Corporation 
Clinical Laboratory 
52 Discovery 
Irvine, CA 92618 
The Masimo Clinical Laboratory facility is designed as a Phase 1 clinical study research center.  The laboratory is 
staffed by physicians, anesthesiologists, certified registered nurse anesthetists, registered nurses, medical assistants, 
and clinical research staff.  All personnel undergo routine required training on GCP and human research subject 
protections.  The laboratory is equipped with standard FDA-approved medical monitoring equipment including ECG 
monitors, blood pressure monitors, pulse oximeters, standard hematology analyzers, and has emergency crash carts 
available.  Hospitals and urgent care facilities are within three miles of the Masimo Clinical Laboratory. 
5. 
STUDY POPULATION  
5.1. 
Inclusion Criteria  
x 
Subject is between 18 and 50 years of age. 
x 
Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.  
x 
Must have a hemoglobin value greater than or equal to 11 g/dL. 
x 
Baseline heart rate ≥ 45 bpm and ≤ 85 bpm. 
x 
Blood Pressure (Systolic BP < 140 mmHg and Diastolic BP < 90 mmHg). 
x 
CO value d 2.0% FCOHb  
x 
Subject has a physical status of ASA I or II (American Society of Anesthesiology Class I; Healthy 
subjects without any systemic disease at all.  American Society of Anesthesiology Class II; subjects 
with mild systemic disease) as it applies to the systemic disease portion of the classification. 
x 
Subject is able to read and communicate in English and understands the study and risks involved. 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 5 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
5.2. 
Exclusion Criteria (*= Per physician discretion) 
x 
Subject is pregnant. 
x 
Subject smokes (including e-cigarette use). 
x 
Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for 
participation by a medical professional. 
x 
Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after a 
blood draw, or has a fear of blood draws. 
x 
Subject has open wounds, inflamed tattoos or piercings and/or visible healing wounds that a 
medical professional renders them at an increased risk for participation.* 
x 
Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, 
altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.  
x 
Subject has known drug or alcohol abuse and/or uses recreational drugs. 
x 
Subject has experienced a concussion or head injury with loss of consciousness within the last year. 
x 
Subject has any chronic bleeding disorders (i.e. hemophilia). 
x 
Subject has any history of a stroke, myocardial infarction, seizures or heart attack. 
x 
Subject has any cancer or history of cancer (not including skin cancer)*. 
x 
Subject has a known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, 
Multiple Sclerosis, Huntington’s disease) that interferes with the subjects’ level of consciousness. 
x 
Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received clearance by their 
physician to participate. 
x 
Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome. 
x 
Subject has taken anticoagulant medication within the last 30 days (excluding nonsteroidal anti-
inflammatory drugs (NSAIDS)).  
x 
Subject has donated blood within the past 4 weeks. 
x 
Subject has taken opioid pain medication within 24 hours before the study.  
x 
Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, 
etc.). 
x 
Subject is taking medications known to treat any type of infectious disease. 
x 
Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome. 
x 
Subject has had invasive surgery within the past year- including but not limited to major dental 
surgery*, appendix*, plastic surgery*.  
x 
Subject has had invasive surgery within the past year- including but not limited gallbladder, major 
fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ENT surgery, 
joint replacement or gynecological surgeries, heart surgery or thoracic surgery. 
x 
Subject has symptoms of congestion, head colds, flu or other illnesses. 
x 
Subject is claustrophobic and/or has generalized anxiety disorder. 
x 
Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization 
within the last 12 months.  
x 
Subject has chronic unresolved asthma, lung disease or respiratory disease. 
x 
Subject is allergic to lidocaine, latex, adhesives, or plastic. 
x 
Subject has a heart condition, insulin-dependent diabetes or uncontrolled hypertension. 
x 
Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization 
or had a C-section within the last 6 months. 
x 
Subject has any medical condition which in the judgment of the investigator and/or medical staff, 
renders them ineligible for participation in this study (Discretion of investigator/study staff). 
 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 6 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
5.3. 
Withdrawal of subjects  
Subjects must be withdrawn under the following circumstances: 
5.3.1 
The subject withdraws consent. 
 
5.3.2 
Discretion of investigator, for example:  
x 
The investigator feels that the subject is too money motivated. 
x 
The investigator feels that the subject does not fully comprehend and understand the 
consent form. 
x 
The subject is ill-mannered and/or shows aggressive behavior towards study staff. 
x 
Malfunction of the device for greater than 30 minutes that prevents accurate collection 
of optical data. 
x 
Subject displays or communicates signs of discomfort or distress so that the study may 
not be continued. 
5.4. 
Replacement of subjects 
In case a subject is withdrawn from the study, another subject may be recruited. 
6. 
EQUIPMENT AND MATERIALS  
Equipment and Materials: All lab analyzers and equipment will be maintained per manufacturer specifications and 
all study personnel will be trained on the use of relevant equipment.  Equivalent equipment and materials to those 
listed below may be used.  
Safety Equipment (FDA-Cleared) 
x 
Blood pressure monitoring system 
x 
Electrocardiogram (ECG) 
x 
Masimo Pulse Oximeters (Radical-7) 
x 
Masimo Patient Monitoring Platform (Root®) 
x 
Pulse oximeter sensors and cables (Masimo SET, Masimo rainbow, or comparable)  
x 
Medical-grade oxygen tank and mask 
x 
Crash cart  
 
Test Devices 
x 
Masimo INVSENSOR00036 
 
Reference Device 
x 
Tissue oximetry system FDA-cleared for somatic use  
 
Research Equipment 
x 
Masimo Patient Monitoring Platform (Root®) 
x 
O3 Regional Oximeter Module  
x 
Passive Data Collection Research Equipment (automated data collection software (ADC), multi-input pulse 
oximeter technology board)   
x 
Gas Blender: electro-pneumatic system intended to assist the clinical operator in setting and delivering a 
prescribed concentration of O2, CO2 and N2 gases.   
x 
Warming blanket 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 7 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
7. 
PROCEDURE 
7.1        SCHEDULE OF ACTIVITIES 
Procedures 
Phone  
Pre-Screen 
Baseline 
Visit 1 
Procedure 
Visit 1 
Brief Study Procedure Description 
X 
 
 
Informed consent 
X 
 
Demographics (including skin tone) 
X 
X 
 
Medical history (subject-reported) 
X 
X 
 
Concomitant medication review  
X 
X 
 
Vital Signs (ECG, Blood Pressure Cuff, Pulse Ox) 
X 
X 
Height  
X 
X 
 
Weight  
X 
X 
 
ASA Status Assessment  
 
X 
 
Pregnancy test1 
 
X 
 
Allen’s Test 
 
X 
 
Venous sample (via needle stick or IV placement)  
 
X 
Local anesthetics (lidocaine, ethyl chloride spray, or pain ease skin 
refrigerant) as needed2 
 
X 
X 
Peripheral Venous Line (IV)2 
 
X 
X 
Placement of test sensors  
 
 
X 
Data collection 
 
 
X 
Desaturation 
 
 
X 
Post Care Instructions Given 
 
X 
X 
Discharge 
 
X 
X 
Adverse Event Review and Evaluation3 
X 
X 
1) hCG (urine) pregnancy test (all female subjects) 
2) IV may be placed during screening/baseline to obtain qualifying venous sample at discretion of medical staff.  If 
the IV is placed during screening/baseline, medical staff will offer to use local anesthetics. 
3) Adverse events may be reported by the subject after their visit.  See section 10 for additional details. 
 
7.2. 
RECRUITMENT AND PRESCREENING 
Subjects will be recruited using IRB-approved advertisements.  Subjects may be referred to the 
study by previous subjects.  Subjects are contacted via phone call to conduct a prescreening 
interview to determine their initial eligibility for the study.  Potential eligible subjects are scheduled 
for a study visit to the clinical laboratory. 
7.3         CONSENTING AND SCREENING 
7.3.1. Study staff will discuss the informed consent process and the study with the potential 
subjects.  The subjects will be provided with enough time to read and understand the 
informed consent document and their questions will be answered by study staff prior to the 
subject signing the informed consent form.  No study related activities will be conducted 
until consent is signed. If the subject fails to provide proper documentation on their 
individual consent form for any study, Masimo has the right to re-contact the subject and 
ask them to return to the clinical lab in order to properly complete the consent form or 
subject bill of rights. 
7.3.2. The subject’s weight and height are self-reported, however the subject may be weighed on 
a scale for verification. 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 8 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
7.3.3. Subjects will be asked to provide a copy of their valid government photo ID and/or Social 
Security Number (SSN) card to verify subject identity.  The copies of these forms of 
identification will be stored along with the subject’s consent.  The confidentiality and 
retention of these documents will be protected to the extent provided and required by law.  
7.3.4. Subjects will be asked a brief series of health questions to ensure their eligibility for this 
study.  Subjects must meet all the inclusion criteria and none of the exclusion criteria in 
order to participate in the study.   
7.3.5. Subject demographic information including age, sex, skin tone, ethnicity, height and weight 
will be collected.  These may be recorded for data analysis purposes. 
7.3.6. In addition, a medical history will be recorded after the initial screening questionnaire. 
7.3.7. Pre-procedure vital signs will be recorded for subject safety monitoring.  Spikes in blood 
pressure and heart rate can be expected during line placement, needle sticks, blood draws 
etc. and may also be attributed to anxiety/nervousness relating to a new environment.  Only 
the initial recorded blood pressure and/or heart rate determines a subject’s qualification for 
the study. 
7.3.8. Female subjects will be required to take a pregnancy test.  Results will be noted in study 
documentation.  If the pregnancy test is positive, the subject will be notified and removed 
from the study.  
7.3.9. A venous sample will be obtained via needle stick or by placement of an IV and analyzed to 
verify that the subject meets the inclusion criteria for hemoglobin level and FCOHb.  The 
subject will be excluded from the study if the values from the blood draw fall outside the 
ranges stated in the inclusion criteria. 
7.3.10. Subjects may have a blanket placed on them or hot water bottles placed under their hands 
(per request of subject or staff) for their comfort.  
7.3.11. Subjects may be offered a snack (e.g., granola bar) and/or beverage (e.g., water, juice) due 
to the amount of time their involvement in this study may take.  
7.4. 
PROCEDURES 
7.4.1. Standard hospital-type monitors will be placed on the subject, including ECG, blood 
pressure, and a reference pulse oximeter for safety monitoring by medical staff. 
7.4.2 
Proprietary Masimo data collection software will be used to verify all oximeters are reading.  
If not, proper sensor positioning will be checked and sensors may be repositioned, as 
needed.  
7.4.2.1 Pulse oximeter output values (e.g., SpO2, Pulse rate) will be recorded using the 
proprietary Masimo data collection software.  These values match the values 
calculated by the instrument at runtime. 
7.4.2.2 Raw absorbance data from the noninvasive device(s) will also be recorded using the 
data collection software. 
7.4.3 
A peripheral venous line(s) will be placed in the subject’s arm.  One or more venous 
sampling catheters may be placed and used for the qualifying venous blood draw and/or for 
safety or clinical intervention required during the study.  

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 9 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
7.4.4 
Local anesthetics such as lidocaine, ethyl chloride spray, or Pain Ease skin refrigerant spray 
may be used in the event that an IV is placed to numb the site.  Subjects will be given the 
option to have lidocaine or numbing spray be used during IV placement for the purpose of 
making catheter placement more comfortable for the subjects. 
7.4.5 
Sensor of the control device will be placed on one somatic site and INVSENSOR00036 will be 
placed on the other side of the somatic site. Subjects may be asked to shave the area prior 
to sensor placement. If the subject declines to shave they may be kept from participating in 
the study.   
7.4.6 
Subjects will wear a nose clip or nose plugs during the desaturation procedure.  A 
mouthpiece will be placed in the subject’s mouth.  Upon indication the subject is 
comfortable, a gas mixture will be administered through the mouthpiece.  The proportion of 
oxygen in this mixture will be decreased in a controlled manner to lower the subject’s blood 
oxygen saturation.  The lowest targeted value will be 70% oxygen saturation as measured by 
the FDA cleared pulse oximeter on the subject’s finger.  Note: At any point in the study, if 
the subject feels uncomfortable, the subject will be given 100% oxygen through either the 
mouthpiece or a supplemental mask.  
7.4.7 
Subjects may undergo the desaturation procedure up to 2 times.  
7.4.14 The study will end with several minutes at a FiO2 greater than room air (>21%) to help the 
subject re-saturate after the procedures.  
7.4.16 At the conclusion of the procedure, the sensors/devices, and IV(s) will be removed and the 
subject will be allowed to leave after medical personnel determine it is safe to do so.  
7.4.17 Study staff may take one final blood draw 1-4cc to verify the subjects blood values are 
within normal range (eg. pH, Glucose, etc.). These values will be assessed by a physician and 
the subject will then be cleared to leave the study space. 
7.4.18 The total procedure time will be approximately 180 minutes. 
7.4.19 All subjects will be encouraged to remain in the study area until they feel fit to leave. 
7.4.20 Subjects will be given instructions on wound care.  All subjects will be instructed to contact 
the principal investigator or study staff in the event of any potential complication. 
7.4.21 Subjects will be paid for their time. 
7.4.22 Subjects will be provided with information related to any significant new findings that 
develop at any time during the study which may relate to their willingness to continue their 
participation. 
7.4.23 After the study has ended subjects will be offered a snack (eg. Granola bar) and something 
to drink (eg. water or juice). Subjects are asked to consume food and/or liquid prior to 
leaving the clinical lab area for their safety. Subjects may also be asked to wait in the clinical 
lab or lobby waiting area for an additional 30 minutes (estimate) before leaving to allow for 
their body to continue adjusting after the study has completed.   
7.5. 
RE-CONTACTING SUBJECTS 
If the subject fails to provide proper documentation on their individual consent form for any study, 
Masimo has the right to re-contact the subject and ask them to return to the clinical lab in order to 
properly complete the consent form or subject bill of rights. Subject will be compensated for travel.  

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 10 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
Other than the IRB approved consent form, the subject will also fill out Masimo study documents. 
Masimo study documents aid in the collection of data, tracking subject count, etc. and do not affect 
subject safety or the consenting process. If the subject fails to provide proper documentation on 
Masimo documents the subject will not need to return to the laboratory in order to complete these 
specific forms.  
The subject will be re-contacted via phone or email and be asked to return within 1 week from their 
last appointment or from the point in which the missing documentation was identified. 
 
8. 
ACCEPTANCE CRITERIA (JUSTIFY IF NOT APPLICABLE) 
There are no gold standards for tissue oximetry on somatic sites, therefore an acceptance criterion for 
absolute accuracy is not available. In this study the acceptance criterion for INVSENSOR00036 is a Trending 
Accuracy of ≤ 5 rSO2% when compared to the reference values obtained from the FDA-cleared device.  
9. 
SAMPLE SIZE JUSTIFICATION AND DATA ANALYSIS PROCEDURE TO BE USED 
9.1. 
Sample size determination 
For a paired samples with one sided comparison, the study sample size is given by 
 ൌቀ
ሺ୲ಉା୲ಊሻ൉஢
ஔ
ቁ
ଶ
  
where:  
tα is the t distribution score with tail area α (one sided comparison) 
tβ is the t distribution score with tail area β 
σ is the estimate of the standard deviation 
δ is the desired detection limit  
 
For Type I error rate or α = 5%,                                    tα = 1.86  
For Type II error rate or β = 20% or power = 80%,    tβ = 0.89 
Assuming detection limit equal to one standard deviation, δ = σ, we get  
 ൌ ൬ሺͳǤͺ͸ ൅ͲǤͺͻሻ൉ɐ
ɐ
൰
ଶ
ൌͺǤ 
The required sample size comes out at 9 or more subjects, which is consistent with the ISO-80601-2-
61 guidelines for pulse oximeter desaturation studies (10 subjects and 200 points).   
This study will consist of a minimum of 9 subjects  to fulfill gender and range of measurement 
requirements. 
 
9.2. 
Statistical Analysis 
INVSENSOR00036 is placed on the somatic site. Reference sensor from the control device is placed 
on the somatic site on the contralateral side. 
Relative rSO2 is computed on a sensor by sensor basis. Relative error is defined to be the relative 
rSO2 difference of the test sensor and reference sensor. 
9.3. 
Trending Accuracy is defined as root-mean-squared relative error of all data points across all 
subjects. 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 11 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
9.4. 
Measures taken to minimize/avoid bias: 
Sensors and devices will be provided to operators in a way that minimizes the operator bias. Sensors 
and devices will be provided at random when deemed necessary.   
9.5. 
Expected drop out rates 
Subjects may not complete the study for various reasons, such as a clinical screening test failure, 
unable to complete desaturation (less than 90 %SpO2).   
Expected drop out rate for this study is approximately 50% of the total number of subjects enrolled. 
10. 
ADVERSE EVENTS 
Definitions: 
Adverse event:  Any untoward medical occurrence in a subjects, users or other persons, whether or not 
related to the medical device under study. 
Device-related adverse event:  Adverse event related to, associated with, or caused by, the use of a medical 
device under study, including but not limited to events that may have been attributed to the device because 
of device failure or malfunction, improper or inadequate design, manufacture or user error. 
Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance.  Device deficiencies include malfunctions, use errors and inadequate labeling. 
Device deficiencies will be reported according to department procedures. 
Serious adverse event:  Adverse event that: a) led to death, b) led to serious deterioration in the health of 
the subject, that resulted in: (i) a life-threatening illness or injury,  (ii) a persistent or significant impairment 
of a body structure or a body function, (iii) in-patient or prolonged hospitalization, or (iv) medical or surgical 
intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a 
body function, or c) led to fetal distress, fetal death or a congenital abnormality or birth defect.  NOTE:  
Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational 
plan, without serious deterioration in health, is not considered a serious adverse event. 
All adverse events, including inter-current illnesses will be reported and documented as described below. 
10.1. 
Adverse Events 
All adverse events that occur during the study shall be recorded on the Case Report Form even if the 
investigator/study staff assess the adverse event as unlikely to be causally related to the test device 
or study procedures. 
10.2. 
Serious Adverse Events 
The investigator/study staff shall promptly report both serious adverse events and unanticipated 
adverse device effects to the sponsor within 48 hours.  All serious adverse events will also be 
reported to the IRB per IRB reporting requirements. 
At the time of discharge from the study, any unresolved serious adverse event(s) will be followed up 
by the investigator/study staff until the event(s) are resolved, stabilized or the patient is lost to 
follow-up or the adverse event is otherwise explained.  The investigator and/or study staff  will also 
instruct the subject to report any subsequent events occurring in the next 30 days, which the 
subject or the subject’s physician believes might reasonably be regarded as caused by or have a 
reasonable possibility of being caused by the test device or procedures involved in the study. 
10.3. 
Unanticipated Problems 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 12 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
Any unanticipated problem involving subjects will be reported to the IRB, such as protocol violations 
or deviations as required by the IRB reporting procedures. 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
11.1 
Measures Taken to Protect the Rights and Welfare of subjects 
11.1.1 All subjects will be monitored closely throughout the study.  There will be an ACLS certified 
medical doctor present in the study area throughout the study. 
11.1.2 The following measures will be taken to ensure the confidentiality of the subjects: 
11.1.2.1 A code (identification) number for each subject will be kept on file. 
11.1.2.2 Only their corresponding identification number will identify subjects. 
11.1.2.3 Access to identifying documents (IC, SSN, photo ID) and data will only be made to 
the principal investigators in the study and study staff. 
11.1.2.4 The confidentiality and retention of these documents will be protected to the 
extent provided and required by the law. 
11.2 
Vulnerable Populations 
11.2.1 Employees are considered to be a vulnerable population. 
Participation is not a condition of employment.  There will be no repercussions in the 
workplace in the case that the employee refuses to participate in the study or withdraws at 
any point during the study.  Neither supervisors nor superiors will be involved in the 
recruitment of employees for participation in the study. 
11.2.2 Economically disadvantaged or unemployed and educationally disadvantaged. 
Reasonable compensation will be provided for economically disadvantaged subjects to 
eliminate possibility of undue influence due to financial incentive.  Educationally 
disadvantaged subjects will be provided ample time to ask questions and comprehend 
information.  
11.3 
Documents and Database 
11.3.1 Documents will be kept a minimum of 5 years after the specific product/tested for is no 
longer being made.  If destroyed, these documents will be shredded and done by a certified 
company used for destroying medical and clinical data. 
11.3.2 Documents and information stored electronically will be protected using a multi-faceted 
procedure including, but not limited to the following steps: 
x 
Two layers of endpoint security and one layer of DLP (Data loss prevention) running on 
all company machines. 
x 
Premier firewalls/Network monitoring appliances and log collection systems (SIEM) 
protecting the network.  
x 
4 layers of email security systems for protecting against phishing attacks. 
x 
Security policies to limit access to specific folders. 
12. 
DEVICE ACCOUNTABILITY 
12.1 
Receipt of Study Device 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 13 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
Upon receipt of the study device supplies, an inventory must be performed and the device 
accountability log filled out and signed by the person accepting the shipment.  It is important that 
the designated study staff counts and verifies that the shipment contains all the items noted in the 
shipment inventory.  Any damaged or unusable study devices in a given shipment will be 
documented in the study files.   
12.2 
Use of Study Device 
Use of devices and sensors will be documented on Case Report Forms for each subject. 
12.3 
Return or Destruction of Study Device 
At the completion of the study, there will be a final reconciliation of study devices and sensors 
shipped, devices/sensors used, and devices/sensors remaining.  This reconciliation will be logged on 
the device accountability log.  Any discrepancies noted will be investigated, resolved, and 
documented prior to return or destruction of unused study devices.  Devices destroyed on site will 
only be upon written instruction from the sponsor and will be documented in the study files. 
13. 
RISKS AND BENEFITS 
13.1. 
Benefits: There will be no benefit to the subject.  Other possible benefits would be to society as a 
whole.  Evaluation of the trend accuracy of this new device could enable healthcare workers to 
more appropriately treat potentially life threatening conditions. 
13.2. 
Device Risks: The noninvasive devices used in this study are similar in technology and design to 
some commercially available regional oximeters and other non-invasive devices and hence have the 
same risks.  Regional oximiters oximeters and other non-invasive devices are commonly used and 
are considered to be minimal risk.  There is an extremely small risk of damage to the subject’s skin 
including temporary skin irritation or discomfort associated with exposure to the sensor as well as 
potential temporary mechanical irritation or discomfort.  There is a remote, yet possible, risk of a 
burn from the sensor. In the case of a sensor burn there is the potential for permanent skin damage 
(scar/discoloration). 
13.3. 
Venous Cannulation Risks: swelling, infection, infiltration of fluids/ blood into area surrounding IV, 
bruising, hematoma, lightheadedness, fainting, feeling flush/warm, feeling nauseated, throwing up, 
sudden drop in blood pressure/sudden increase in blood pressure, sudden drop in heart 
rate/sudden increase in heart rate, tingling sensation of face, arms and/or legs, sweating, mouth 
dryness, damage to the blood vessel and surrounding nerves or tissue. 
13.4. 
Other anticipated adverse events that may occur, include but are not limited to: vasovagal (passing 
out/fainting), infection to the skin or area right below the skin, lightheadedness, feeling flush/ warm, 
feeling nauseated, throwing up, seizures, sudden drop in blood pressure/ sudden increase in blood 
pressure, sudden drop in heart rate/ sudden increase in heart rate, tingling sensation of face/arms 
and/or sweating, and mouth dryness.  These anticipated adverse events are expected to be 
temporary. 
13.5. 
Risk From Oxygen Administration:  There are no risks associated with high oxygen/oxygen 
administration for less than 24 hours as long as subjects do not have any cardiac conditions, COPD 
or any other lung diseases.  Subject’s answers on the health questionnaire will help the medical staff 
decide if they can safely participate in this study; subjects are encouraged to let the study staff know 
if they have any concerns. 
13.6. 
Low Oxygen Concentration Risks: Risks associated with hypoxia include dizziness, shortness of 
breath, drowsiness, or headache. If or when this occurs, the study can be stopped. There is an 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 14 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
extremely small risk of loss of consciousness, damage to vital organs, or death from lack of oxygen. 
The study shall be stopped by the subject or clinical staff long before this could occur.  Other 
anticipated adverse events that may occur, include but are not limited to:  vasovagal (passing 
out/fainting), lightheadedness, feeling nauseated, throwing up, seizures, sudden drop in blood 
pressure/sudden increase in blood pressure, sudden drop in heart rate/sudden increase in heart 
rate, tingling sensation of face, arms and/or legs, sweating, mouth dryness.  These anticipated 
adverse events are expected to be temporary. 
13.7. 
Nose Clip Risks: It is expected that some people will have discomfort/ pinching/ scratches from 
wearing a nose clip. If this occurs, adjustments can be made and/or the study can be stopped. 
13.8. 
Risk from Inflicted Knowledge: The risk of inflicted medical knowledge to subjects is negligible since 
we deidentify all associated sample information including those relevant to our clinical and 
engineering parameter studies.  The monitoring and test results are not examined for diagnostic 
purposes and do not reflect an attempt to ascertain any subject's medical condition.  The attending 
physician's role during this study is to ensure the safety of the subject during the study. Subjects are 
informed that these are not diagnostic tools, if observations are made using FDA cleared devices we 
will refer them to their primary care physician. 
13.9. 
Risk From Loss of Confidentiality: Masimo upholds the highest standards to protect hard and 
electronic data however, a complete promise for confidentiality cannot be guaranteed due to 
unforeseeable events. 
13.10. Risk From Additional Testing: 
13.11.1. During the conduct of the study, it is possible, but not likely, that someone could become 
exposed to the sample of blood drawn from the subject through an inadvertent needle 
stick or by contact with an open cut. In such circumstances, it will be important to the 
exposed individual to know whether the blood to which he or she was exposed contained 
Hepatitis B virus (HBV), Human immunodeficiency virus (HIV), or Hepatitis C virus (HCV) 
and additional testing of the sample will be performed. 
13.11.2. Within the consent, subjects will agree to permit the company to test the blood sample 
(or samples) by signing the consent.  The test results will be maintained as confidential 
and will only be used by healthcare professionals for the diagnosis and treatment of the 
exposed individual as appropriate.  
13.11.3. In the case that Masimo needs to contact a subject regarding additional testing they will be 
contacted by a Masimo employee and medical personnel can be available for further 
counsel if requested.  
13.11.4. The cost for the initial testing and compensation for their time/travel to the testing facility 
will be the only things paid for by Masimo. 
13.11. Although not common, it is also possible to have an allergic reaction to injectable lidocaine.  
Subjects should not take part in this study if they are allergic to lidocaine injection or other types of 
numbing medicine, or if they have a heart rhythm disorder such as Wolff-Parkinson-White 
Syndrome or Stokes-Adams syndrome.  Subjects are instructed to tell the study staff right away if 
they experience hives; difficulty breathing; swelling of your face, lips, tongue or throat. 
13.12. Ethyl Chloride (Lidocaine Spray): Ethyl Chloride is a topical anesthetic which is used to prevent pain 
by cooling the skin. Although unlikely, the anticipated adverse events that may occur, include but 

PROTOCOL/TEST PROCEDURE 
R-TP-19901 
Desaturation Validation of INVSENSOR00036 
Revision:  A 
CO-051527 
 
CONFIDENTIAL AND PROPRIETARY 
Page 15 of 15  
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. F 
All Rights Reserved 
CO-041789 
 
are not limited to: changes in skin color (i.e. Flushing or redness of the skin), delayed wound healing, 
rash, itching and swelling.  These adverse events are expected to be temporary. 
14. 
EMERGENCY RESPONSE PLAN FOR MEDICAL EMERGENCIES  
The physician and nurse present during the study will be ACLS certified and will respond to any medical 
emergency involving a subject with the ACLS approved protocol for intervention.  A crash cart is on site and 
full emergency services are within 3 miles. 
15. 
MONITORING PLAN 
A separate document for the study monitoring plan will be developed and followed to ensure subject safety 
and GCP compliance.   
16. 
PROTOCOL DEVIATIONS AND AMENDMENTS 
Deviations to the protocol will be documented on the Case Report Form or a separate document.  Protocol 
deviations will be reported to the sponsor and IRB per IRB reporting guidelines. 
Modifications to the protocol, informed consent materials, recruitment materials, or any other materials 
provided to subjects must be reviewed and approved by the IRB.