SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor
Phase: NA
Conditions: Healthy, Hypoxia
Sponsor: Stryker Sustainability Solutions

 
 
 
 
 
 
 
 
Official Title: SpO2 Accuracy of Noninvasive 
Pulse Oximeter Sensor 
 
NCT Number: NCT05141500 
 
Date of Protocol: November 02, 2021 
 

 
Hypoxia Clinical Study Protocol for 
Reprocessed Masimo and Nellcor VHP 
Pulse Oximeters 
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CRD10302 
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1.0 
Purpose ....................................................................................................................................................... 2 
2.0 
Scope .......................................................................................................................................................... 2 
3.0 
Associated References ............................................................................................................................... 2 
4.0 
Related Documents ..................................................................................................................................... 2 
5.0 
Key Terms ................................................................................................................................................... 3 
6.0 
Roles and Responsibilities .......................................................................................................................... 3 
7.0 
Summary ..................................................................................................................................................... 4 
8.0 
Product Description ..................................................................................................................................... 6 
9.0 
Worst Case Justification .............................................................................................................................. 7 
10.0 
Sample Size Designation ............................................................................................................................ 7 
11.0 
Preliminary Investigations and Justification of the Study ............................................................................ 8 
12.0 
Study Devices .............................................................................................................................................. 8 
13.0 
Procedure .................................................................................................................................................... 8 
14.0 
Sponsor Pulse Oximeter Study Data .......................................................................................................... 9 
15.0 
Statistics ...................................................................................................................................................... 9 
16.0 
Data Analysis ............................................................................................................................................. 10 
17.0 
Subject Safety ........................................................................................................................................... 10 
18.0 
Risks and Benefits of the Investigational Device and Clinical Investigation ............................................. 10 
19.0 
Invasive Laboratory Testing on Healthy Volunteers.................................................................................. 11 
20.0 
Risk Mitigations ......................................................................................................................................... 11 
21.0 
Informed Consent ...................................................................................................................................... 11 
22.0 
Investigational Review Board (IRB)/Independent Ethics Committee (IEC) .............................................. 11 
23.0 
Monitoring Arrangements .......................................................................................................................... 11 
24.0 
Data Storage ............................................................................................................................................. 12 
25.0 
Acceptance Criteria ................................................................................................................................... 12 
26.0 
Protocol Revision History .......................................................................................................................... 12 
27.0 
Attachments ............................................................................................................................................... 12 

 
Hypoxia Clinical Study Protocol for 
Reprocessed Masimo and Nellcor VHP 
Pulse Oximeters 
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General Information 
 
1.0 Purpose 
1.1 The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability 
Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 
as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide 
supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.  
In this study, the level of oxygen within the blood will be reduced in a controlled manner by 
reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive 
pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements 
from a laboratory blood gas analyzer. 
It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse 
oximetry sensors will meet a specification of +/-3% with a target of +/-3% or better in non-motion 
conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air 
breathing and then at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for 
about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy 
performance specification. 
1.2 This study is being conducted to support regulatory body approval of pulse oximeter probes 
sterilized and/or decontaminated with Vaporized Hydrogen Peroxide.  
2.0 
Scope 
This procedure applies to the following Stryker Sustainability Solutions location(s):  
☒ Tempe    
    ☒ Tijuana                
       
2.1 This study has been designed to include the subject devices listed in Table 1. 
Study Device: 
OM 
SKU 
Minimum Quantity 
Cycle Count 
Masimo 
1859 (Adult) 
20 
4x 
Masimo 
2329 (Adult) 
20 
4x 
Nellcor 
MAX-A (Adult) 
20 
4x 
Nellcor 
MAX-N (Adult) 
20 
4x 
Table 1: Subject devices  
3.0 
Associated References 
3.1 Pulse Oximeters – Premarket Notification Submissions [510(k)s] Guidance for Industry and Food 
and Drug Administration Staff Document issued on: March 4, 2013 
3.2 ISO 80601-2-61:2017 Medical Electrical Equipment — Part 2-61: Particular requirements for basic 
safety and essential performance of pulse oximeter equipment 
4.0 
Related Documents 
4.1 DWI-CDS-109, Division Engineering Study Templates 
4.2 DWI-CDS-112, Division Engineering Study Exceptions 
4.3 DWI109.650, New Product Development Training Form  
4.4 TEM10208, Division Observation Ledger  
4.5 CRD10303 Hypoxia Clinical Study Report for Reprocessed Masimo and Nellcor VHP Pulse 
Oximeters 

 
Hypoxia Clinical Study Protocol for 
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4.6 TP16204 Sample Preparation Protocol for Reprocessed Pulse Oximeter Sensors for Clinical 
Study 
4.7 CQD-CCA-001 Conducting Clinical Research 
4.8 CQP-CCA-002 Approval of Clinical Research Proposals, Protocols, Study Design Documents and 
Publications  
4.9 DSOP587 Division Conducting Clinical Research  
4.10 D0000065949 Investigator Initiated Studies 
5.0 
Key Terms 
Refer to CQM-02, Stryker Corporation Quality and Regulatory Master Glossary, for definitions to the 
Key Terms used within this document. 
5.1 Allocation: A method used to assign participants to an arm of a clinical study. The types of 
allocation are randomized allocation and nonrandomized. 
5.2 Arm: A group or subgroup of participants in a clinical trial that receives a specific 
intervention/treatment, or no intervention, according to the trial's protocol. 
5.3 Eligibility criteria: The factors that allow someone to participate in a clinical study are called 
inclusion criteria, and the factors that disqualify someone from participating are called exclusion 
criteria. They are based on characteristics such as age, gender, the type and stage of a disease, 
previous treatment history, and other medical conditions. 
5.4 Intervention/treatment: A process or action that is the focus of a clinical study. Interventions 
include drugs, medical devices, procedures, vaccines, and other products that are either 
investigational or already available. Interventions can also include noninvasive approaches, such 
as education or modifying diet and exercise. 
5.5 Masking: A clinical trial design strategy in which one or more parties involved in the trial, such as 
the investigator or participants, do not know which participants have been assigned which 
interventions. Types of masking include: open label, single blind masking, and double-blind 
masking. 
5.6 Primary outcome measure: In a clinical study's protocol, the planned outcome measure that is 
the most important for evaluating the effect of an intervention/treatment. Most clinical studies have 
one primary outcome measure, but some have more than one. 
5.7 Study type: Describes the nature of a clinical study. Study types include interventional studies 
(also called clinical trials), observational studies (including patient registries), and expanded 
access. 
6.0 
Roles and Responsibilities 
6.1 Divisional 
 
R&D Engineering in collaboration with Regulatory Affairs is responsible for the 
preparation and execution of this protocol, analysis of the test results, and the 
preparation of the summary report. 
 
R&D Engineering, Regulatory Affairs and Principal Investigators are responsible for 
ensuring adherence to the Clinical Trial Agreement associated with the study outlined 
in the protocol.    
 
The external facilities that may be used in the execution of this protocol are listed in 
Table 1. 
Service 
Name and Location 
Clinical Study 
UCSF (University of California San Francisco) 
490 Illinois Street, 5th Floor 
San Francisco, CA 94143-1209 

 
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Table 1 – External facility information  
Study Design 
7.0 
Summary 
Study Design: 
Study Type: 
Interventional  Non-significant Risk Lab Test 
Enrollment: 
A typical study will include at least 10 subjects (up to 24 if needed to reach the 200 
necessary data points to meet the ISO 80601-2-61:2019). 
Allocation: 
Non-randomized 
Intervention Model: 
Parallel Assignment 
Intervention Model Description: 
Subjects will recline for the study. Reference sensors will be placed on each subject 
to evaluate the SpO2 accuracy and performance. Shield material may be used 
between any adjacent finger sensors to prevent optical crosstalk. Simultaneous 
data collection will be set up for devices under test. The data from the test devices 
will be collected by the sponsor or trained UCSF staff. Data will be collected for 1 
second intervals data analysis. The SpO2 accuracy of the test devices will be 
evaluated over the oxygen saturation range between 70-100%. 
Masking: 
None (Open Label) 
Primary Purpose: 
Device Validation 
Study Start Date: 
November 2021 
Arms and Interventions: 
Experimental: Masimo and Nellcor SpO2 Adhesive 
Sensors, Adult 1859, 2329, MAX-A, & MAX-N 
 
Reference sensors from the reprocessed oximeter 
device will be placed on each subject to evaluate the 
SpO2 accuracy and performance. 
Device: STRYKER SUSTAINABILITY SOLUTIONS Masimo and 
Nellcor PULSE OXIMETRY SENSORS 
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. Pulse oximetry monitoring is considered a standard 
physiological measurement and is used by clinicians in 
everyday situations to estimate arterial oxygen saturation. 
Because an arterial sample of blood is not required to make the 
measurement, the pulse oximeter can provide non-invasive 
real time information. 
Sham Comparator: Covidien Nellcor SpO2 Sensor, 
MAX-A and MAX-N 
A whole blood analyzer (CO-Oximeter) is used as the 
reference standard device for obtaining the 
functional SaO2 value from arterial blood samples 
obtained during the study. 
Device: CO-OXIMETRY SENSORS 
A whole blood analyzer (CO-Oximeter) is used as the reference 
standard device for obtaining the functional SaO2 value from 
arterial blood samples obtained during the study. 
Primary Outcome Measures: 
1. Accuracy of Sensor by Arms 
Calculation [ Time Frame: 1-5 
hours ] 
 
Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the 
Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over 
the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-
Oximetry. 

 
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The Accuracy root mean square (ARMS) between measured SpO2 and reference 
SaO2 (arterial oxygen saturation) must meet the 3% specification for each Stryker 
Sustainability Reprocessed pulse oximetry sensor style. 
 
Accuracy will be determined by comparing the noninvasive blood oxygen 
saturation measurement of the pulse oximeter to that obtained from a blood 
sample and calculating the arithmetic root mean square error (Arms) value. In 
order to obtain the Arms value, the blood oxygen saturation measurement is 
subtracted from the pulse oximeter oxygen saturation measurement for a number 
of samples, the average of this difference is computed as the bias. The standard 
deviation of the differences is computed as the precision. The square root of the 
sum of the squares of bias and precision is computed as the Arms Error value. 
 
For each range specified, SpO2 ACCURACY of the PULSE OXIMETER EQUIPMENT 
shall be stated in terms of the root-mean‐square (rms) difference between 
measured values (SpO2i) and reference values (SRi), as given by the following 
formula. 
 
 
 
 
Eligibility Criteria: 
Ages Eligible for Study: ≥18 and <50   (Adult) 
Sexes Eligible for Study: All 
Accepts Healthy Volunteers: Yes 
Inclusion and Exclusion Criteria 
Inclusions:  
• 
The subject is male or female, aged ≥18 and <50 
• 
The subject is in good general health with no evidence of any medical 
problems. 
• 
The subject is fluent in both written and spoken English 
• 
The subject has provided informed consent and is willing to comply with the 
study procedures 
Exclusions:    
• 
The subject is obese (BMI>30) 
• 
The subject has a known history of heart disease, lung disease, kidney or liver 
disease 
• 
Diagnosis of asthma, sleep apnea, or use of CPAP 
• 
Subject has diabetes 
• 
Subject has a clotting disorder 
• 
The subject a hemoglobinopathy or history of anemia, per subject report or 
the first blood sample, that in the opinion of the investigator, would make 
them unsuitable for study participation 
• 
The subject has any other serious systemic illness 
• 
The subject is a current smoker 

 
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• 
Any injury, deformity, or abnormality at the sensor sites that in the opinion of 
the investigators would interfere with the sensors working correctly 
• 
The subject has a history of fainting or vasovagal response 
• 
The subject has a history of sensitivity to local anesthesia 
• 
The subject has a diagnosis of Raynaud’s disease 
• 
The subject has unacceptable collateral circulation based on exam by the 
investigator (Allen’s test) 
• 
The subject is pregnant, lactating or trying to get pregnant 
• 
The subject is unable or unwilling to provide informed consent, or is unable or 
unwilling to comply with study procedures 
• 
The subject has any other condition, which in the opinion of the investigators 
would make them unsuitable for the study 
Contacts and Locations: 
Locations 
United States, California 
University of California San Francisco 
Sponsors and Collaborators 
Stryker Sustainability Solutions, Mike Bernstein (study monitor) 
Investigators 
Principal Investigator:  
Dr. Bickler CA License # is G64031 
Co-Principal Investigator: 
John R Feiner 
8.0 
Product Description 
8.1 Intended Use: Reprocessed Masimo and Nellcor Adhesive Pulse Oximeter Sensors are indicated 
for single patient use for continuous noninvasive arterial oxygen saturation and pulse rate 
monitoring.  
8.2 Principle of Operation: The principle of operation of pulse oximetry is based upon the 
fundamental principle that hemoglobin bound to oxygen (oxyhemoglobin) and hemoglobin 
unbound to oxygen (deoxyhemoglobin) vary in the absorption of different wavelengths of the light 
and the absorptions can be used to estimate SpO2 and PR.  The mechanism by which this 
process occurs is the use of red and infrared wavelengths of light delivered by an emitter and the 
detection of the signal from the light absorption of oxygenated blood and deoxygenated blood to 
determine functional oxygen saturation of hemoglobin (SpO2). 
8.3 Mechanism of Action for Achieving the Intended Effect: The Reprocessed Pulse Oximeter 
Sensor provides the intended effect equivalent to the previously cleared pulse oximeter sensor in 
that it utilizes an optical sensor that is applied to the patient’s finger or toe through which light is 
transmitted to the photodetector that detects the signal transmission.  The signal transmission is 
processed by the Pulse Oximeter to provide SpO2 and PR. 

 
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Reprocessed Masimo LNCS Pulse Oximeter 
Sensor 
1859 
 
Reprocessed Masimo LNCS Pulse Oximeter Sensor  
2329 
 
 
 
Reprocessed Nellcor Pulse Oximeter Sensor 
Max-A 
Reprocessed Nellcor Pulse Oximeter Sensor 
Max-N 
9.0 
Worst Case Justification 
9.1 The pulse oximeter sensors which are identified in table 1 as subject devices are pending FDA 
clearance for a maximum of four (4) reprocessing cycles.  Sensors used in this study will be 
subjected to the maximum number of reprocessing cycles.  Catalog number 1859 and Max-A 
consists of a non-woven tape and catalog number 2329 and Max-N consists of a woven tape.  
There is no worse case model in that the characteristics of both tape types are equivalent within 
the model family and do not present different challenges during the tape removal process when 
reprocessing.   
10.0 
Sample Size Designation 
10.1 A typical study will include at least 10 subjects (up to 24 if needed to reach the 200 necessary 
data points to meet the ISO 80601-2-61:2019). 
 
10.2 Each study subject will have four reprocessed sensors attached to their fingers. Two VHP Masimo 
sensors will be placed on one side and two VHP Nellcor sensors will be placed on the other. Digits 

 
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selected should be two of the three middle fingers on each hand avoiding the thumb or pinky 
fingers as test sites.   
11.0 
Preliminary Investigations and Justification of the Study 
11.1 Stryker Sustainability Solutions has developed a process to reprocess pulse oximeters that cleans 
and disinfects the devices active element components and device cord and replaces all patient 
contacting tapes. 
11.2 The manufacturing process for reprocessing includes 100% visual inspection and functional 
assessment.  
11.3 As part of the product development and validation phases of this project, Stryker performed the 
following studies: 
• 
Cleaning 
• 
Disinfection 
• 
Biocompatibility  
• 
Performance 
• 
Functionality 
12.0 
Study Devices 
Masimo and Nellcor SpO2 Adhesive Sensors, Adult 1859, 2329, MAX-A, & MAX-N 
12.1 Device Accountability  
 
Receipt of Device will be conducted by the study monitor. 
12.1.1.1 
 
 
Use of Study Device 
12.1.2.1 
Use of devices will be documented electronically as case reports for each 
subject.  
12.2 Packaging and Labeling 
 
Research conducted for this study will utilize investigational devices. The Sponsor is 
responsible for packaging and labeling of the devices for delivery to the study site. 
Investigational devices or its immediate package shall bear a label with the following 
information:  
“CAUTION – Investigational device. Limited by Federal (or United States) law to 
investigational use”. 
 
The Instructions for Use (IFUs) are provided as separate (electronically) from this 
protocol.  
13.0 
Procedure 
13.1 After injection of a local anesthetic, a 22-gauge catheter is inserted in one radial artery. Pulse 
oximeters are attached to fingers. Subjects are in a comfortable semi-recumbent position.  
Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired 
level of hypoxemia. Stable, safe and controlled hypoxia is adjusted manually by an 
anesthesiologist that permits the inspired gas mixture to be adjusted to achieve a level of lung 
alveolar gas that will achieve the desired degree of saturation.   
13.2 Typically, saturation levels involve one period with air breathing and then at one of 6 levels with 
reduced oxygen, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation.  Each level of saturation is 

 
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held for 30-60 seconds. At appropriate intervals and when oxygen levels are stable, arterial blood 
samples are obtained from the radial arterial catheter.   The operator then changes the inspired 
oxygen concentration to attain the next desired stead-state level of hypoxia.  A "run" consists of 
several stable steady-state hypoxia levels and together takes 10-15 minutes. Each run is 
terminated by a breath of 100% O2 followed by room air.  Two runs together enable obtaining a 
total of 20-25 blood samples, 2 samples at each plateau.  Saturation of each arterial blood sample 
is determined by direct oximetry in a Radiometer ABL-90 multi-wavelength oximeter. The precise 
target levels of saturation can be adjusted to suit the sponsor, but typical testing is done to satisfy 
ISO and FDA standards for testing, which is 70% to 100%.  
13.3 The study takes about 1 hour of each subject's time.  Analysis of the data requires several days. 
Manufacturer’s representatives (Stryker) will be present for these tests, and to mount the probes. 
14.0 
Sponsor Pulse Oximeter Study Data 
14.1 Data from test pulse oximeters for comparison to blood values can be obtained in several ways.  
In every case, the goal is to obtain a reading from the oximeter that corresponds to the associated 
blood sample or a reference oximeter.  Because of circulation delays and instrument averaging 
time, attempts will be made to create steady state conditions at each level of oxygenation.  
Therefore, a means should be provided to record the instrument reading at each blood sample.  
This instrument reading may be obtained with several different approaches. Some instruments 
have no digital or analog output and the instrument reading may be recorded manually or 
recorded by a video of the instrument display.  Other instruments may have an analog output.  
The laboratory can record analog data by use of LabView.  Digital recording of output can also be 
obtained via LabView but his requires information from the sponsor concerning the structure of the 
digital signal.   
14.2 If a manufacturer prefers to collect and analyze the data, the continuous digital signal of each 
oximeter should be read, for comparison with the blood sample, 9 seconds before the record 
shows a sudden fall or rise in oxygen saturation, not at the time of blood sampling.  This 
procedure accounts for the delays of finger circulation and uses the estimated delay from the lung 
to the sample site.  There is no useful correlation between the actual time of blood sampling and 
the oximeter recording because of the variability of tissue blood flow lag.  As mentioned, steady-
state hypoxia avoids the concern that oximeter reading is not aligned with a blood sample reading. 
15.0 
Statistics 
15.1 The number of subjects and the number of comparisons (paired pulse oximeter readings and 
arterial saturation values) is determined by current FDA guidance requirements. This is a 
minimum of 200 data points and 10 subjects. In the course of this type of study, some subjects 
may drop out, some readings can be lost due to motion or other interference and occasionally 
some do not consent.   
15.2 The following demographic data will be collected on the subjects: 
 
Gender (male, female, other) 
 
Age  
 
Skin tone (dark, medium, light) preferably 1-6 using the Fitzpatrick scale 
 
Height (cm) 
 
Weight (kg) 
 
Wrist circumference (cm) 
 
Dominant hand (left or right) 
 

 
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16.0 
Data Analysis 
16.1 In all cases, the blood analysis data are provided, including the SaO2, MetHb, COHb and Hgb 
concentration. 
16.2  The data analysis report will consist of the following: 
 
A Table of the oximeter readings versus corresponding blood SaO2 values.  
 
Graphic plots of the bias between the oximeter reading and the SaO2 measured by 
the hemoximeter (on the blood sample, i.e Modified Bland-Altman plots for each 
instrument or instrument probe combination. 
 
Regression equations for the bias of each instrument. 
 
Tables of the mean error or bias, its standard deviation, standard error, 95% 
confidence interval, maximum and minimum and root mean square error, all 
computed both overall and by several sub-ranges of desaturation. 
 
A table of the demographics of the subject population is provided. 
17.0 
Subject Safety 
17.1 Pulse oximeter sensors are typically considered non-significant risk medical devices. The LED 
light energy utilized in typical test measurements is within the same range as other cleared 
marketed devices and introduces no further risks. An LED light emits light that passes through the 
tissue. A light detector then measures how much light was absorbed by the tissue. Based on the 
ratio of absorbance of different wavelengths of light, the device calculates the oxygen saturation. 
18.0 
Risks and Benefits of the Investigational Device and Clinical Investigation 
18.1 Breathing a very low oxygen mixture may cause dizziness and might cause loss of consciousness 
for a few seconds. It may make one feel very short of breath during the test and for a few seconds 
afterwards. There is a remote possibility that if the subject loses consciousness he/she might have 
muscular twitching or convulsions. This study will not seek to reach saturations below 70%. 
Hypoxia may cause tachycardia and increased blood pressure during the test, and might cause 
headache. In all the years of the lab conducting the study no subject has mentioned headache. 
Much more severe and prolonged lack of oxygen could cause brain injury or death, but the 
duration and depth of hypoxia is limited by the test protocol to short intervals. The needle catheter 
used to take blood may hurt when it is inserted despite the use of local anesthesia, and there may 
be a black and blue spot afterward. It is remotely possible the artery might be damaged or clot, or 
a tendon sheath near it be injured by the needle, resulting in some soreness. These risks are 
unlikely because none of the enrolled 2000+ subjects has ever had a serious complication. 
Hyperventilating during the part of the study requiring reduced PCO2 may make subjects 
lightheaded or dizzy. Breathing air with added CO2 may make subjects feel short of breath and 
cause a headache. Some subjects feel faint when they arrive for the study, apparently related to 
the thought of having an arterial line. These subjects will likely be excluded from the study. 
18.2 Currently the FDA defines pulse oximeters as Class II devices which 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 and may be used alone or in conjunction with a fiberoptic oximeter 
catheter. All oximeters being used in this study work by transmittance of radiation at known 
wavelength(s) through tissue to measure blood oxygen saturation based on the amount of 
reflected and scattered radiation. The devices under test and this study procedure are considered 
Non-Significant Risk (NSR). 
The device and use of the device under test does not meet the definition of a significant risk 
device. Under 21 CFR 812.3(m), an SR device means an investigational device that: 

 
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information herein may be reproduced, used or disclosed to any third party without the prior 
written consent of Stryker Corporation. 
 
• 
Is intended as an implant and presents a potential for serious risk to the health, safety, or 
welfare of a subject; 
• 
Is purported or represented to be for use supporting or sustaining human life and presents a 
potential for serious risk to the health, safety, or welfare of a subject; 
• 
Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health and presents a potential for serious risk to 
the health, safety, or welfare of a subject; or 
• 
Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 
19.0 
Invasive Laboratory Testing on Healthy Volunteers 
19.1 The risk determination is based on the use of the device in an investigation in addition to the 
device itself. Generally, the FDA believes pulse oximeters as addressed in the FDA Guidance 
Document for Pulse Oximeters (March 4, 2013) are non-significant risk devices. Further, the 
recommendation is to conduct the study in accordance with Clause 201.12.1.101.2 and Annex 
EE.2 of ISO 80601-2-61:2011, where Annex EE.2 describes the procedure for invasive laboratory 
testing on healthy volunteers. 
20.0 
Risk Mitigations 
Subjects are all monitored with accurate reference oximeters and continuous end-tidal gas 
analysis to prevent the risk of more profound hypoxia than desired. Investigators are experienced 
anesthesiologists adept at assessing breathing and in maintaining appropriate airway conditions. 
The study room is set up like an OR with all resuscitation equipment immediately available.  
21.0 
Informed Consent 
21.1 Written informed consent is obtained before any study interventions. In discussions with the study 
coordinator before the day of the study, potential subjects will be offered the consent form to 
review. On the day of the study subjects are given the consent form which they read and sign if 
they wish to participate. A study doctor is present to answer questions.  
21.2 Only subjects clearly able to understand and read English will be enrolled. Subjects will be asked 
if they have any questions and are told they can withdraw at any time.  
22.0 
Investigational Review Board (IRB)/Independent Ethics Committee (IEC) 
22.1 Prior to the start of subject enrollment, the investigator will be responsible for obtaining approval 
from the authorized IRB/IEC for the institution at which the proposed clinical investigation is to be 
conducted. Written approval from the IRB/IEC should specifically refer to the investigator, the 
protocol title and date, and subject informed consent date. 
22.2 Written IRB/IEC approval and any conditions of approval imposed by the IRB/IEC was obtained by 
the sponsor/investigator. 
22.3 Protocol amendments must also undergo IRB/IEC review and approval at each clinical site. The 
written approval from the IRB/IEC for the amendment should specifically refer to the investigator, 
the protocol version number and title, and any amendment numbers that are applicable. 
23.0 
Monitoring Arrangements 
23.1 A representative from the sponsor and study monitor will provide all monitoring. The Monitor shall 
be responsible for maintaining a record of the findings, conclusions, and actions taken for the 
results of monitoring the study ensuring that: 
23.2 The monitoring requirements for an NSR device study is identified in 21 CFR 812.2(b) 
Abbreviated requirements. For monitoring an NSR device investigation, the requirement is to 

 
Hypoxia Clinical Study Protocol for 
Reprocessed Masimo and Nellcor VHP 
Pulse Oximeters 
Document No: 
CRD10302 
Revision: 
A 
Page: 
12 of 12 
 
 
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STRYKER CONFIDENTIAL – This document contains confidential and proprietary 
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information herein may be reproduced, used or disclosed to any third party without the prior 
written consent of Stryker Corporation. 
 
comply with 21 CFR 812.46 with respect to monitoring investigations: (a) Securing Compliance, 
(b) Unanticipated adverse device effects, (c) Resumption of terminated studies 
• 
Compliance to the signed agreement between the Investigator and sponsor 
• 
The study follows the protocol and any amendments that apply 
• 
Compliance to any conditions of the approval imposed by' the IRB or FDA 
23.3 Sponsor will assess any new hazards/harms identified during a clinical investigation (i.e., pre- or 
post-market study) as part of the risk management process per DPCDS-013, Risk Management 
and the complaint handling process per DP-MCF-001, Division Complaint Handling Process, as 
applicable. 
24.0 
Data Storage 
24.1 Identifiable subject information is always stored securely following all applicable rules and 
regulations.  Consent forms and other study related documents are retained following UCSF data 
retentions policy. 
25.0 
Acceptance Criteria 
25.1 The statistical results of the data will be reviewed for the following pass/fail criteria: 
 
Sp02 Accuracy for the range of 70-100%, 3 (ARMs) is a Pass. 
26.0 
Protocol Revision History 
Revision 
Change Order 
Number 
Description 
A 
ECO132226 
Establishment of a new protocol. 
27.0 
Attachments  
27.1 Attachment 1: Non-significant Risk Determination 
27.2 Attachment 2: IRB Approval 
27.3 Attachment 3: Informed Consent Forms 
27.4 Attachment 4: Executed Contrac

 
 
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Sustainability Document Template 
UNCONTROLLED WHEN PRINTED 
STRYKER CONFIDENTIAL – This document contains confidential and proprietary 
information that is the property of Stryker Corporation.  Neither this document nor the 
information herein may be reproduced, used or disclosed to any third party without the prior 
written consent of Stryker Corporation.