A Comparison of Capnography Sampling Lines
Phase: NA
Conditions: Capnography
Sponsor: Medtronic - MITG

 
 
 
 
A Comparison of Capnography Sampling Lines Trial  
 
NCT03554629 
 
 
 
 
• Clinical Investigation Plan (CIP), version 2 dated 01 June 2018  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 1 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan Identifier 
MDT17063FRS 
Document Version 
2. 0    30MAY2018 
Sponsor 
Medtronic/Covidien LP, a Medtronic company 
MITG Respiratory, Gastrointestinal & Informatics (RGI) 
6135 Gunbarrel Avenue  
Boulder, Colorado     
80301  
                                           Lead Principal 
Investigator 
Thomas A. Minor MD 
Pulmonologist/Sleep Medicine 
Clinimark, LLC  
80 Health Park Drive,      
Louisville, CO 80027 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. Any distribution, 
copying, or disclosure without the prior written authorization of Medtronic is strictly prohibited. Persons to whom the 
information is disclosed must know that it is confidential and that it may not be further disclosed by them. 
                                             Covidien LP is an indirectly wholly owned subsidiary of Medtronic plc. 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 2 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
1. Investigator Statement 
Sponsor 
Medtronic/Covidien LP, a Medtronic company 
MITG Respiratory, Gastrointestinal & Informatics (RGI) 
6135 Gunbarrel Avenue  
Boulder, Colorado     
80301 
Clinical Investigation Plan Identifier 
MDT17063FRS 
 
Version Number/Date  
2.0/30MAY2018 
 
 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this study as described. I will conduct this study as outlined herein and will 
make a reasonable effort to complete the study within the time designated.   I agree to comply with 
International Conference on Harmonization Guidelines on Good Clinical Practice and United Stated 
Food and Drug Administration regulations 21 CFR 50, 21 CFR 56, 21 CFR 54 and 21 CFR 803.  
I agree to ensure that the confidential information contained in this document will not be used for any 
purpose other than the evaluation and conduct of the clinical investigation without the prior written 
consent of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
 
Investigator’s Signature: 
 
 
Investigator’s Name: 
 
 
Institution: 
 
 
Date:  
 
 
 
 
Signatures Held in the 
Study Trial Master File 
(TMF) at Medtronic 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 3 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Table of Contents  
 
1. 
Investigator Statement .................................................................................................. 2 
Table of Contents .................................................................................................................. 3 
2. 
Glossary ......................................................................................................................... 5 
3. 
Synopsis ......................................................................................................................... 7 
4. 
Introduction ................................................................................................................... 9 
4.1. Background ................................................................................................................... 9 
4.2. Purpose ....................................................................................................................... 10 
5. 
Objectives and Endpoints ............................................................................................. 11 
5.1. Objectives .................................................................................................................... 11 
5.1.1. 
Primary Objective(s) ......................................................................................................... 11 
5.1.2.   Secondary Objective(s) ....................................................................................................... 11 
6. 
Study Design ................................................................................................................ 12 
6.1. Duration ...................................................................................................................... 13 
6.2. Rationale ..................................................................................................................... 13 
7. 
Product Description ...................................................................................................... 14 
7.1. General ........................................................................................................................ 14 
7.2. Manufacturer ................................................................................................................ 14 
7.3. Packaging .................................................................................................................... 14 
7.4. Intended Population....................................................................................................... 15 
7.5. Equipment.................................................................................................................... 15 
7.6. Product Use .................................................................................................................. 18 
7.7. Product Training Requirements......................................................................................... 18 
7.8. Product Receipt and Tracking ........................................................................................... 18 
7.9.   Product Storage ........................................................................................................... 19 
7.10.  Product Return............................................................................................................ 19 
7.11.  Product Accountability .................................................................................................. 19 
8. 
Selection of Subjects .................................................................................................... 19 
8.1. Study Population ........................................................................................................... 19 
8.2. Subject Enrollment ........................................................................................................ 19 
8.3. Inclusion Criteria ........................................................................................................... 20 
8.4. Exclusion Criteria ........................................................................................................... 20 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 4 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
9. Study Procedures ............................................................................................................ 20 
9.1.  Schedule of Events ........................................................................................................ 20 
9.1.1. Enrollment Visit ........................................................................................................... 20 
9.1.2. Study Exit .................................................................................................................. 23 
9.2.  Subject Screening ......................................................................................................... 23 
9.3. Prior and Concomitant Medications ................................................................................... 23 
9.4.  Subject Consent ............................................................................................................ 23 
9.5.  Randomization and Treatment Assignment ........................................................................ 23 
9.6.  Assessment of Safety ..................................................................................................... 23 
9.7.  Recording Data ............................................................................................................. 24 
9.8.  Deviation Handling ........................................................................................................ 24 
9.9.  Subject Withdrawal or Discontinuation .............................................................................. 24 
10. Risks and Benefits ......................................................................................................... 25 
10.1.  Potential Risks ............................................................................................................ 25 
10.2.  Potential Benefits ........................................................................................................ 26 
10.3.  Risk-Benefit Rationale .................................................................................................. 26 
11. Adverse Events and Device Deficiencies ........................................................................ 27 
11.1 Definitions/Classifications................................................................................................ 27 
11.2 Reporting of Adverse Events ........................................................................................... 29 
12. Data Review Committee ................................................................................................ 30 
13.  Statistical Design and Methods ..................................................................................... 30 
14. Ethics ............................................................................................................................ 32 
14.1 Statement(s) of Compliance ............................................................................................ 32 
15. Study Administration ..................................................................................................... 32 
15.1.  Monitoring.................................................................................................................. 32 
15.2.  Data Management ....................................................................................................... 33 
15.3.  Direct Access to Source Data/Documents ........................................................................ 33 
15.4. Confidentiality .............................................................................................................. 34 
15.5. Liability ....................................................................................................................... 34 
15.6. CIP Amendments ......................................................................................................... 34 
15.7. Record Retention.......................................................................................................... 35 
15.8. Publication and Use of Information .................................................................................. 36 
15.9. Suspension or Early Termination ..................................................................................... 36 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 5 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
16. References .................................................................................................................... 38 
17. Version History .............................................................................................................. 38 
 
 
2. Glossary 
Term 
Abbreviation 
Definition 
Adverse Event  
AE 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether related to the medical 
device. 
Note: This definition includes events related to the medical device 
or the comparator. 
Note: This definition includes events related to the procedures 
involved. 
Note: for users or other persons, this definition is restricted to 
events related to the medical devices. 
Adverse Device 
Effect 
ADE 
Adverse event related to the use of a medical device.  
Note: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation or any malfunction of the 
medical device. 
Note: This definition includes any event resulting from use error or 
from intentional misuse of the medical device. 
Carbon Dioxide  
CO2 
CO2 is a colorless and odorless gas that is a by-product of animal 
cellular metabolism removed by the lungs in exhaled gas and can be 
measured by capnography during the respiratory cycle.  
Capnography 
CO2 
monitoring  
Continuous, non-invasive measurement and monitoring of carbon 
dioxide concentration of the expired and inspired breath and a 
function of time and respiration rate based the carbon dioxide 
respiration cycle. 
Capnostream®35 
CS35 
The Capnostream®35 combined capnography/pulse oximeter 
monitor and its accessories are intended to provide professionally 
trained health care providers with continuous, non-invasive 
measurement and monitoring of carbon dioxide concentration of 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 6 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Term 
Abbreviation 
Definition 
the expired and inspired breath and respiration rate, and with 
continuous non-invasive monitoring of functional oxygen saturation 
of arterial hemoglobin (SpO2) and pulse rate. The CS35 contains 
many FDA cleared smart algorithms such as IPI and ASA. 
CO2 cannula 
sampling 
filterline   
CCSF 
Products under study with variation on patient interface cannula 
designs to secure a breath gas sample to the capnography device for 
measurement of the partial pressure of CO2 in the breath gas 
mixture.  
End Tidal CO2 
EtCO2 
The numeric partial pressure of the maximum value of carbon 
dioxide in the exhaled breath over the last 20 seconds. The EtCO2 
numeric value is updated once a second. Alternative abbreviations 
used in the literature are ETCO2 and etCO2. 
Fractional 
inspired carbon 
dioxide 
FiCO2 
The numeric partial pressure of carbon dioxide present during 
inhalation. 
Nasal Cannula 
NC 
Nasal prongs in the nares for gas sampling and/or oxygen delivery 
Non-invasive 
ventilation  
NIV 
Noninvasive ventilation (NIV) refers to the administration of 
ventilatory support without using an invasive artificial airway 
(endotracheal tube or tracheostomy tube). 
Nare 
 
The nose nostril airway. 
Oxygen  
O2 
A colorless, odorless gas that provided to the body via inhalation 
and is required for metabolic creation of energy to sustain life. 
Pulse Oximetry 
SpO2 
Depends on pulsatile blood flow and measures only the 
oxyhemoglobin in arterial blood as it leaves the heart. 
Respiration Rate 
RR 
The count of breaths per minute based upon the carbon dioxide 
cycle as measured by capnography. 
Septum  
 
The osseo-cartilaginous midline structure in the nose that divides 
the now into two (2) similar halves.    
Serious Adverse 
Device Effect 
SADE 
Adverse device effect that has resulted in any of the 
consequences characteristic of a Serious Adverse Event. 
Serious Adverse 
Event 
SAE 
Adverse event that  
1. led to death,  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 7 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Term 
Abbreviation 
Definition 
2. led to serious deterioration in the health of the subject, that 
either resulted in  
a. a life-threatening illness or injury, or  
b. a permanent impairment of a body structure or a    body 
function, or  
c. in-patient or prolonged hospitalization, or  
d. medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body 
structure or a body function,  
3. 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 protocol, without serious deterioration 
in health, is not considered a serious adverse event. 
 
3. Synopsis 
Title 
A Comparison of Capnography Sampling Lines  
Clinical Study Type 
 Interventional Comparative Study 
Product Names 
Study carbon dioxide (CO2) cannula sampling filterline (CCSF) disposable products with 
variations on the cannula patient interface designs all FDA cleared  
1. Medtronic (MDT) Microstream™ CO2 FilterLine™   nasal cannula 
2. Salter Labs® nasal cannula 
3. Hudson RCI®/Teleflex® nasal cannula 
4. flexicare® nasal cannula 
5. Westmed oral nasal cannula  
6. DispoMed® oral nasal cannula with reflective monitor end connection 
7. Medtronic (MDT) Microstream™ CO2 FilterLine™   oral nasal cannula  
8. Salter Labs® oral nasal cannula 
Note details of product name and 510K numbers is in Section 7.1 
Sponsor/Local 
Sponsor  
Medtronic/Covidien LP, a Medtronic company 
MITG Respiratory, Gastrointestinal & Informatics (RGI) 
6135 Gunbarrel Avenue  
Boulder, Colorado     
80301  
Indication under 
investigation  
A CO2 cannula sampling filterline (CCSF) is designed to collect breath gas samples 
via the cannula interface from the nose or nose and mouth. The gas sample is sent 
to a capnography monitor for CO2 partial pressure measurement in millimeters 
(mm) of mercury (Hg).  There are many variations on the cannula patient interface 
design. 
The Medtronic Microstream™ CO2 FilterLine™ cannula sampling lines 
(Microstream™ CCSF) are designed for use with Microstream™ enabled 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 8 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
capnography monitors to capture quality breath samples without effecting CO2 
measurement when supplemental O2 flow up to 5 liters/minute.  
All the cleared CCSF products under study will be used within the approved 
intended use.  
Investigation 
Purpose 
To collect CO2 measurements on human subjects as a function of the carbon 
dioxide (CO2) cannula sampling filterline (CCSF) during simulated patient activity to 
provide guidance on filterline selection in the clinical setting for Microstream™ 
enabled monitors.  There is no human data on variations of CCSF performance to 
provide an adequate breath sample when connected to the Microstream™ enable 
monitor. 
Product Status 
All devices are USA FDA Cleared products and will be used within the intended 
use. 
Primary Objective(s) To compare the performance of the Medtronic Microstream™ FilterLine™ 
compared to the non-Medtronic CCSF products during predefined expected 
patient activities to provide a quality sample of breath gas to the Microstream™ 
enabled capnography monitor.  
Secondary 
Objectives(s) 
To score non- Microstream™ CCSFs performance against the Medtronic (MDT) 
Microstream™ FilterLine™   performance. 
Study Design 
Prospective, Interventional, Single Center, comparative product study on a 
convenience sample of out-of-hospital volunteers.  Subject enrollment not to 
exceed 3 hours of study procedure participation. No follow-up is required.  
Randomization 
Subjects are not randomized to any treatment or procedure group.  
Sample Size 
Up to 50 consented subjects at one clinical site in USA to secure a minimum of 30 
complete subject data sets.  
A subject may be re-consented to collect data on the two additional CCSF that 
have been added to this version of the CIP. These re-consented subjects will not 
be included in the total sample size of 50. 
Inclusion/Exclusion 
Criteria 
 
 
 
Inclusion: 
1. Non-hospitalized adults ≥ 18 years old.  
2. Willing and able to give informed consent.  
Exclusion:  
1. Lack of an informed consent.  
2. Subjects not able to accommodate the proper application of the cannula. 
3. Subject not willing or able to comply fully with the study procedures.  
4. Subjects with sensitivity to nasal cannula in both nares. 
5. Subject with skin allergies to medical adhesives. 
6. Subjects with runny nose the day of the study participation. 
7. Subject, who in the opinion of the Principal Investigator, should not be 
enrolled.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 9 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Study Procedures 
and Assessments 
 
 
The sequence of the carbon dioxide (CO2) cannula sampling filterlines (CCSF) 
disposable products under test for the sequential scripted activities will be 
randomized by subject ID.  
 The Procedure scripted activity case report form (CRF) record with and without 
Supplemental O2 may include: 
1.   Variation of mouth position (open/close) 
2.   Partial and full unilateral nasal obstruction by subject finger as directed  
         3.  Oral/ nasal shifting pattern with variations of mouth position. 
         4.  Variation in respiratory effort and rate 
         5. Variation of head position  
         6. Body position changes (sitting, standing, lying on a bed) 
The above CRF procedure list of potential scripted activities may not extend 
beyond the three hours of consented enrollment. With the three-hour limit on 
subject enrollment, the targeted list of scripted activities will be prioritized in 
terms of those activities that would most likely lead to sampling difficulties as per 
PI/Sub-I in consultation with MDT. The initial list of scripted activities maybe 
reduced after the high frequency measured device data is collected and reviewed 
on an ongoing basis on the first 5 up to 10 subjects to eliminate those activities 
that provide no significant differences in sampling performance without a much 
larger sample size.  Scripted activities will not be added to the CRF only removed.   
Safety Assessments 
 Subjects will be monitored for Adverse Events, Serious Adverse Events, and 
Device-Related Adverse Events continuously during study execution by the Study 
Coordinator via visual and verbal assessment of the subject and observation of 
device data notifications on measured non-invasive arterial oxygen saturation 
(SPO2).   
 Statistics 
Statistical analyses will be conducted by Medtronic or its designee as outlined in 
the Statistical Analysis Plan (SAP). Any changes in statistical methods will be 
detailed in the SAP.  
 
Demographic information and baseline characteristics data will be summarized 
using descriptive statistics. Cross-over comparison of each CCSF design by subject 
and in aggregate using the endpoints will be used to meet the primary and 
secondary objectives.  Multiplicity adjustments will be done using the method of 
Tukey-Kramer multiple comparisons.   
 
4. Introduction  
4.1. 
Background  
 
The Medtronic (MDT) Microstream™ enabled monitors offer a unique and highly specific measurement 
technology using Molecular Correlation Spectroscopy™ (MCS™) for the measurement of the partial 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 10 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
pressure of carbon dioxide (CO2) in any gas mixture.  The technology has allowed for an extremely small 
sample cell (15 microliter) within the monitor, which in turn, permits the use of a very low sample flow 
rate (50 ml/min) for CO2 partial pressure measurement. Capnography is the monitoring of the 
concentration or partial pressure of carbon dioxide (CO2) in the respiratory gases. The peak CO2 partial 
pressure during the respiratory cycle is at the end of expiration is called end tidal carbon dioxide (EtCO2).  
A key to obtaining an accurate EtCO2 measurement and quality waveforms with any capnograph is the 
sampling line.   Measurement technology can only report what is being delivered, so if the sampling line is 
not providing a representative CO2 sample, the accuracy of the measurement is impacted.  The MDT 
Microstream™ FilterLine™ designs are designed for use with Microstream™ enabled capnography 
monitors to capture quality breath samples for measurement with an integrated supplemental O2 
delivery design.  
There is no human subject evidence on the performance of cleared non- Microstream™ CO2 cannula 
sampling filterline (CCSF) designs when they are connected to the Microstream™ enabled capnography 
monitors.   
There is one published manuscript on the performance of CO2 sampling filterline cannula design with 
adult subjects at rest using on a non- Microstream™ capnography monitor and one publication on nasal 
cannula design in laboratory simulation. 1,2   Literature search on Ovid and PubMed failed to identity any 
additional published evidence on the performance of any CO2 sampling filterline performance during 
expected patient activity such as variation of RR, variations of respiration patterns/efforts or positional 
changes when connected to any capnography monitor.  
4.2. 
Purpose  
The purpose of this study is to provide guidance on filterline selection in the clinical setting for 
Microstream™ enabled monitors.  There is no human data on variations of CCSF performance to provide 
an adequate breath sample when connected to the Microstream™ enabled monitor. 
 
1 See Ebert, T; The Effectiveness of Oxygen Delivery and Reliability of Carbon Dioxide Waveforms: A Crossover Comparison of 4 Nasal Cannulae.  
 
2 See Marshall, G; Right Versus Left Prong Nasal Cannula Flow Delivery and the Effects of Nasal Cycling on Inspired FIO2 in an Adult Anatomic 
Model.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 11 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
All the CCSF (CO2 cannula sampling filterlines) in this comparative study were cleared by FDA with the 
integrated connection option for the provision of low flow supplemental oxygen. 
The rational to conduct this study is the lack of human data on variations of CCSF performance to provide 
an adequate breath sample when connected to the Microstream™ enabled monitor. 
This data collected in this study may guide filterline selection in a variety of clinical settings for 
Microstream™ enabled monitors. 
5. Objectives and Endpoints 
5.1. 
Objectives 
5.1.1. 
Primary Objective(s) 
The primary objective of this clinical study is to compare the performance of the Medtronic 
Microstream™ FilterLine™ compared to the non-Medtronic CCSF products during predefined expected 
patient activities to provide a quality sample of breath gas to the Microstream™ enabled capnography 
monitor.  
The primary endpoints will be the frequency and duration of false physiological alarms, device 
notifications regarding a reduction in CO2 Waveform device messages/notifications such as filterline 
blockage, performing auto zero, clearing the filterline and CO2 error. 
5.1.2.   Secondary Objective(s) 
The secondary objective is to score the performance of the non- Microstream™ CCSFs compared to the 
Medtronic (MDT) Microstream™ FilterLine™.   The primary endpoints will be the foundation to score 
sampling performance per activity by subject and in aggregate.  
The need to score performance by the scripted simulated patient activities will provide information on 
optimal filterline selection based upon end use clinical setting and expected patient activity.   

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 12 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
6. Study Design  
Prospective, interventional, single center, comparative product study design on a convenience sample of 
out-of-hospital volunteers.  Intervention assignments (CCSF sequence) for each subject will be based 
upon a randomized sequence by subject ID.  Subjects will serve as their own control within each of the 
repeated scripted activity periods (such as variations on mouth positions, partial and full unilateral nasal 
obstruction, nasal/oral respiration shifting pattern, variations in respiratory effort and rate, variations of 
head position, variations of body position) in the study design. 
Subject consented enrollment will not exceed 50 to secure device data on up to 30 subjects. Subject 
enrollment will not exceed 3 hours of study procedure participation. If a subject is withdrawn before 
completing the study procedures, an additional subject will be recruited to obtain up to 30 subject 
complete device data sets.  Enrollment will end when up to 30 complete subject data have been 
collected, transferred to Medtronic and device data is verified as valid.  No study procedure follow-up is 
required.  
The FDA cleared CO2 cannula sampling filterline (CCSF) products for performance comparison when 
connected to the Medtronic Microstream™ vary in the patient interface cannula design for breath 
sampling from the nose or from the nose and mouth.  The products will be used according to the 
manufacturer instructions for use to collect and provide a breath sample to a capnography monitor and 
will not be modified.   
Each subject will wear up to eight (8) CO2 cannula sampling filterline (CCSF) in a randomized block 
sequence for repeated targeted scripted activities with and without supplemental O2 up to 5lpm with 
capnography device data collected.  The prioritization of the scripted activities will be based upon 
physiological conditions that would contribute to challenging sampling of exhaled gas to keep enrollment 
time at less than 3 hours/day. The sequence of each of the 8 CO2 sampling filterline cannula to be worn 
by each subject will be randomized by subject ID to reduce sequence bias.  The low impact activities will 
not be randomized but a minute washout break between each activity will be included in the case report 
form to acquire baseline data. Due to the time limit it may be possible that not all 8 filterlines are utilized 
by each subject during enrollment. 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 13 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
During the study procedures, the study case report form will be used to record subject ID, randomization 
of cannula sequence assigned by subject ID and the CS35 device time for each activity to link procedure 
activity time to the timed electronic device data.  The CS35 device data will be collected at 20 data 
points/second via a USB per the CS35 instructions for use with subject ID recorded in the device data file 
name.  
Foreseeable factors that may compromise the outcome of the study include lack of recognizing and 
including patient activities that might affect breath sampling. Every effort was made to include activities 
known to effect sampling in the clinical environment.  
6.1. 
Duration 
The duration of the study for first enrollment to end of enrollment will be no more than eight months.  
Each subject will be actively enrolled for study procedure for not more than three hours/day.  With the 
update to the CCSF under test list, the six subjects that did not wear the two replaced filterlines (#5 and 
#6) will be re-consented and will undergo the study procedures for the 2 replaced filterlines that are 
introduced with this CIP version. 
Subjects can be withdrawn without penalty and be compensated for their time at a rate of 37.50 USD per 
30 minutes of enrollment in study procedures, as defined in Section 9.0 
No follow-up for any subject is required for this study.  
6.2. 
Rationale  
There is a clinical need to understand the performance of non- Microstream™ CO2 cannula sampling 
filterline (CCSF) designs to provide a representative quality respiration gas sample for monitoring of 
ventilation on a Microstream™ enabled capnography monitor in the clinical setting.  
There is a need to provide a comprehensive guideline on CO2 cannula sampling filterline selection in the 
clinical setting to include non-Microstream™ CCSF products for end-users of Microstream™ enabled 
monitors. The chosen study design was based on similar comparative human interface product design 
models where each subject serves as their own control with facial anatomy a constant by subject.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 14 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
7. Product Description 
7.1. 
General 
Medtronic will provide the FDA cleared disposable CO2 cannula sampling filterlines, pulse oximeter 
probes and the Capnostream®35 (CS35) as the Microstream™ enabled monitor for use in this study along 
with the manufacturer instructions for use.  
Below is a list of commercially available products that will be used in this study with manufacturer: 
product name/sampling method (K number):  
    A. Study carbon dioxide (CO2) cannula sampling filterline (CCSF): 
 1. Medtronic (MDT) Microstream™ CO2 FilterLine™: O2/CO2 FilterLine™   /nasal cannula(K010024) 
 2. Salter Labs®: ETCO2/O2 nasal sampling line/ one nare sampling cannula (K151421) 
 3. Hudson RCI®/Teleflex®: Softech® Bi-Flo ETCO2 Sampling Cannula/nasal cannula (K961150) 
 4. flexicare®: Dual Nare Nasal Cannula with O2/CO2 Combination Monitoring/ nasal cannula (K140113) 
 5.Westmed:  Adult CO2 /O2 Oral/Nasal Cannula/ oral nasal(K162343) 
        6. Dispo-MED®: Nasal/Oral CO2 Sampling Cannula w/O2 Delivery with reflective connection (K143127) 
        7. Medtronic (MDT) Microstream™: Smart CapnoLine™ Plus/oral nasal cannula(K010024) 
     8. Salter Labs®: Oral-Trac®/ oral nasal cannula (K151421) 
      
B.  Medtronic Nellcor™ SpO2 Adhesive Disposable Sensors, Adult >30 kg, Max-A (K051271) 
   C. Medtronic Capnostream®35 (CS35) a Microstream™ enabled capnography medical device (K150272).              
7.2. 
Manufacturer 
The Manufacturer of the cleared medical devices are listed above with the 510(k) numbers.  
7.3. 
Packaging 
The disposable CCSF products are single patient, packaged singly in non-sterile packaging with expiration 
date on use marked on the packaging.  Supplied CCSF products provided for the study will not be beyond 
the expiration date if an expiration date is on the packaging. 
The disposable Nellcor™ SpO2 Adhesive Sensors are single patient, packaged singly in non-sterile 
packaging with expiration data on use marked on the packaging. Supplied SpO2 sensors provided for the 
study will not be beyond the expiration date. 
The Capnostream®35 (CS35) dual parameter portable monitor will be hand carried to the site and be in 
calibration for use.   

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 15 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
7.4. 
Intended Population 
The Capnostream™ 35 combined capnograph/pulse oximeter monitor and its accessories are intended to 
provide professionally trained health care providers with continuous, non-invasive measurement and 
monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and 
with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) 
and pulse rate. 
The required accessory to non-invasively measure of the partial pressure of CO2 in the provided breath 
sample (ventilation) is a CO2 cannula sampling filterline (CCSF) to be placed on the subject face.  The 
variations of cannula design for breath sampling and delivery of supplemental oxygen are under 
investigation in this study.  
The required accessory to non-invasively measure arterial oxygen saturation is a sensor to be wrapped 
around one finger.  
7.5. 
Equipment 
A. Microstream™ capnography enabled monitor 
A calibrated CS35 dual parameter monitor (Figure 1) will be provided to measure capnography via the 
CO2 cannula sampling filterlines under investigation and pulse oximetry.  Should the CS35 device fail 
during the conduct of the study a new monitor will be provided. Failure history will be reported to 
Medtronic.  
 
 
 
 
 
 
 
 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 16 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Figure 1. Capnostream 35 
 
B. CCSF cannulas under investigation 
Eight different CO2 cannula sampling filterlines will provided for investigation for quality of the breath 
sample provided.  Figure 2, The Microstream™ CO2 FilterLine™, provides a graphic of the long -term 
duration version of the Smart CapnoLine™ Plus which is one of the MDT reference cannula for 
comparison. The Non - Microstream™ CCSF designs are variation on sampling port(s) and supplemental 
O2 delivery ports.  
The inline Nafion® on the long duration version Smart CapnoLine™ Plus increases the duration of 
sampling use by managing the inline humidity (H) via water vapor diffusion.  The absence or presence of 
the Nafion® does not compromise CO2 gas partial pressure measurement in the Microstream™ enabled 
monitor. 
 
 
 
 
 
 
 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 17 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
  Figure 2. Microstream™ Smart CapnoLine™ H Plus (H means humidity management) 
 
Any failure of the disposable CO2 cannula sampling (CCSF) device under investigation to measure CO2 will 
be identified by the CS35 device electronic data which will also contain all device and alarm notifications 
with the time of the event.  Any failure of a MDT medical device noted on the device deficiency log will 
be processed within MDT as a product complaint.  
C. MDT Nellcor Max A disposable pulse oximeter finger sensor 
Pulse oximetry finger sensor will non-invasively measure the amount of hemoglobin saturated with 
oxygen or SpO2.  Light emitting diodes (LEDs) emit red and infrared light.  Changes in light absorption 
during the pulsatile cycle determine the SpO2.  
 
 
 
 
 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 18 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Figure 3. Medtronic Nellcor MAX A disposable pulse oximeter.  
 
7.6. 
Product Use 
Product provided to the site by the study sponsor is for study subject use only.  Study use of the CS35 and 
the accessories (disposable CO2 sampling filterlines and disposable SpO2 probes) will be according to the 
IFUs provided to Clinimark.  
7.7.    Product Training Requirements 
Product information will be included in the study training material with hand-on use of the devices.  The 
device data transfer process will be tested and verified during the site initiation process and training will 
be provide on transfer of the device data to MDT via an encrypted and password protect MDT Box site.  
All the training material will be based upon the IFU with a focus on the study needs to collect device date 
with the accessories used as per IFUs. A copy of study medical device IFUs will be provided to the site 
prior to the IRB submission.  
7.8. Product Receipt and Tracking 
Shipment/delivery and receipt of all study medical devices and equipment provided per the contract will 
be tracked and signed records maintained in the MDT trial master file (TMF). The records will include 
dates, quantities, lots/serial numbers and equipment descriptions.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 19 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
7.9.   Product Storage 
Storage of the cleared study product will reside at Clinimark and only be available to the study staff for 
study enrollment. Clinimark is an external physiological lab with restricted work hours and access.  
7.10.  Product Return 
The return of the CS35 dual parameter monitor and unused disposable CO2 sampling line will be 
documented on the MDT product Shipment Form with product details which includes product name, 
serial or Lot# and quantify returned. This record will be filed in the Medtronic TMF.  
7.11.  Product Accountability  
The investigator will store the study product. The storage area should be locked/secure with access 
limited only to approved study staff. Devices will be stored at Clinimark LLC, a human performance 
laboratory with limited access within a hospital facility.  
 
     Records will be maintained of product delivery to the study site. This includes dates, quantities 
received, lot/serial numbers, and expiration dates if noted on the product packaging. 
 
     Use of the study device by each participant will be recorded in a device accountability log. 
8. Selection of Subjects 
8.1. 
Study Population 
The target population consists of non-hospitalized volunteer subjects of adult age (≥18).  
8.2. 
Subject Enrollment 
Subjects will be considered enrolled once the informed consent has been signed.  If a subject is 
withdrawn after signing the informed consent, the subject will be replaced by increasing the enrollment.  
The minimum number of subjects to be consented is 30 with a maximum of 50 with an expected 
withdrawal rate to 10%.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 20 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
8.3. 
Inclusion Criteria 
1. Non-hospitalized Adults ≥ 18 years old  
2. Willing and able to give informed consent 
8.4. 
Exclusion Criteria 
1. Lack of an informed consent  
2. Subjects not able to accommodate the proper application of the cannula 
3. Subject not willing or able to comply fully with the study procedures 
4. Subjects with sensitivity to nasal cannula in both nares 
5. Subjects with skin allergies to medical adhesives 
6. Subjects with a runny nose the day of the study participation   
7. Subject, who in the opinion of the Principal Investigator, should not be enrolled. 
  
9. Study Procedures  
9.1.  Schedule of Events 
Study duration per subject is up to three hours with no study follow-up visits.  
Data will only be collected on the enrollment visit unless a follow-up phone call is required to close an AE.  
Data collection requirements are summarized in Table 1.  The study site personnel must report all study 
specific Adverse Events (AE) and changes in status of these Adverse Events from time of enrollment until 
the AE is closed by the Principal Investigator.  
9.1.1. Enrollment Visit 
The point of enrollment is when written informed consent is obtained after meeting criteria for 
enrollment.  Removal from the study after consent will be considered a withdrawal.  
Information for enrolled subjects will be captured on the Health Assessment section of the CRF Form. 
 
Consent Process  
1. Explain the procedure to the subject. Have them read the Informed Consent Form (ICF), and review 
the information answering all questions.  
2. Assign a subject ID number and record that number on the CRFs and the enrollment log.  Ask the 
subject to provide the information to complete the Health Assessment CRF for subject demographics, 
history of oral & nasal surgery, sleeping and/or breathing difficulties, sinus problems and inhalation 
medications. 
3. Each subject will be given a copy of the signed ICF prior to leaving Clinimark.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 21 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Study Procedure Process 
1. Have the subject sit comfortably.  
2. Identify the sequence of the CCSF (CO2 cannula sampling filterline) design sequence linked to the 
subject ID per the MDT CCSF sequence randomization table and obtain the CCSF products.  
3. Setup the CS35 medical device and verify that the communication between the CS35 and the USB for 
electronic device data extraction is working via the CS35 messaging per the MDT study device 
training material. The USB device election data will leave Clinimark on an encrypted USB at the end of 
the study and be provided ongoing via the encrypted and password protected Box site. The device 
data will contain serial number of the device, date and time, subject ID and all the device measured 
physiological data with device notifications. 
4. Enroll the subject ID into the CS35 device so the electronic data will be saved by subject ID with the 
date and device serial number as per the MDT study device training material. 
5. Apply the assigned CO2 sampling filterline cannula (CCSF) per randomization sequence. 
6. Record the assigned CCSF code name (A – F) on the CRF printed activity list.  
7. Adjust subject interface cannula as appropriate and record that the cannula was on properly. 
8. Start CS35 electronic device data collection on USB per the data output menu on the CS35 and enter 
the CCSF code name as free test using the event marker. This electronic device data will be correlated 
to the CRF with the listed sequence of activities and posted time.  It is essential to link the CRF to the 
electronic device data by time and CCSF code name for data analysis. 
9. Record CS35 monitor start time for each scripted activity on the procedure CRF with the posted 
EtCO2 under the CCSF code name in current use.  The scripted activities may include any of the 
following with or without supplemental O2 up to 5lpm:  
       A.   Variation of mouth position (open/close) 
       B.   Partial and full unilateral nasal obstruction by subject finger as directed  
       C.  Oral/ nasal shifting pattern with variations of mouth position. 
              D.  Variation in respiratory effort and rate 
              E. Variation of head position  
       F. Body position changes (sitting, standing, lying on a bed) 
10. Respiration rate will be coached using a metronome by the study staff and document if a subject is 
not in sync with the metronome.  
11. The study staff will monitor the subject’s well-being through-out the test confirming that the subject 
is doing ok and SpO2 ≥ 90. Should the subject’s SpO2 drop below 85%, for a duration of 30 seconds, 
the study activities including the provision of supplemental O2 will be paused as needed to maintain 
SpO2 > 90%.  The purpose of the low flow supplemental O2 provided in this study is to measure the 
effect on breath sample gas dilution and not as a treatment for subject low oxygenation.  
12. Subject will be advised during the study that he/she may stop the test at any time. 
13. The test may be stopped at any time by the subject, the clinician or study coordinator. 
14. Once each activity has been performed, the subject will remove the CO2 cannula sampling filterline 
with the CS35 monitor time recorded on the CRF with any comments on comfort or discomfort.  
15.  Repeat 5 – 14 until all the CCSF device interface models have been worn per the assigned sequence 
of activities not to exceed the three-hour limit and unless the study is terminated. There may be 
situations where not all 8 filterlines may be worn by each subject due to the time constraint.  The 
activity list will be reduced over time in this adaptive CRF process such that only those activities that 
demonstrate difficulties in sampling in any CCSF device will remain. 
16. All equipment will be removed from the subject. 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 22 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
 
A study coordinator will be with subject during enrollment and will determine subject compliance to the 
procedures.  If a subject is not compliant, the subject will be withdrawn.  
 
  Table 1. Data Collection Requirements and Source  
Data 
Screening 
evaluation  
Enrollment Visit, 
Study 
Procedures, Exit 
After Day One   
 Follow-up to 
close any open 
AEs 
Source 
Document  
Location  
Phone using the 
Clinimark 
recruitment 
pool 
Clinimark 
Phone and 
Clinimark if 
required by PI 
 
Informed Consent 
 
X 
 
ICF at the Site  
Inclusion/Exclusion Criteria 
Evaluation 
X 
X 
 
Health 
Assessment CRF 
Medical History and Demographic 
via the Health Assessment CRF 
 
X 
 
Health 
Assessment CRF 
-Self reported  
Nasal Deviated Septum Self-Exam 
Score 
 
X 
 
Health 
Assessment CRF 
-Self reported 
Adverse Events (AE) 
 
X 
X 
AE CRF  
CS35 Device Memory Data 
 
X 
 
 USB  
Device Deficiencies (DD) 
 
X 
x 
DD CRF  
Protocol Deviations (PD) 
 
X 
x 
PD CRF  
 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 23 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
The list of CO2 sampling cannula filterline under test to be used in an assigned CCSF code name 
randomized sequence by subject ID is in Section 7.1.  
9.1.2. Study Exit 
Before the subject is discharged from the study, the study coordinator/clinician will review any final 
questions with the subject and ask if there were any effects from the study. The subject will be released 
with no further follow up required. 
9.2.  Subject Screening  
Subjects will be screened and recruited from the Clinimark volunteer recruitment pool meeting the 
criteria for enrollment in this study by phone.   
9.3. Prior and Concomitant Medications 
No restriction on existing medication and/or treatments before and/or during the study. If the subject is 
on a prescription aerosol inhaler (corticosteroid inhaler or bronchodilator) or uses non-invasive positive 
pressure ventilation (CPAP or other) at night that will be recorded on the Health Assessment Case Report 
Form (HACRF) after informed consent has been provided by the subject. A subject will provide self-
reported information to complete the pre-procedure Health Assessment section of the CRF.  
9.4.  Subject Consent 
The investigator or authorized designee must obtain written informed consent on subjects meeting the 
inclusion criteria and none of the exclusion criteria before any clinical study related activity takes place. 
Written informed consent must be obtained prior to participation in any procedure scripted activities.   
9.5.  Randomization and Treatment Assignment 
There is no blinding or randomization to subject procedure. A Medtronic statistician will provide a 
cannula sequence randomization table by subject ID for use for the repeated assigned sequence of 
procedure activates. The assignment of each filterline to a CCSF code name will be done by Clinimark and 
will not be shared with MDT until the device data has been evaluated by CCSF code name to reduce bias.  
9.6.  Assessment of Safety 
Assessing, recording and analyzing safety parameters, including adverse events may occur thought out 
the study and after each subject enrollment.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 24 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
9.7.  Recording Data 
Consent will be confirmed on the case report form (CRF) by a person identified on the delegation of 
authority as a site monitor to share the device data with the unsigned/unmonitored CRF. The 
unmonitored/unsigned CRF will be stamped “uncontrolled” by Clinimark before sharing with MDT.  
Subject’s medical historical information will be as supplied by the subject to complete the Health 
Assessment CRF which will be considered the source in this volunteer out-of-hospital study.  
Subject ID CS35 electronic device data recorded on a MDT supplied USB will be transferred to the 
enterprise MDT Box site after each subject enrollment.  MDT has requested that the 
unsigned/unmonitored CRF stamped by Clinimark as “Uncontrolled” with date be shared with the device 
data to review the device data.  The CRF will be monitored at the end of the study and if a subject did not 
meet the inclusion/exclusion criteria, subject data will be removed with this protocol deviation. The study 
device data transferred to the MDT enterprise encrypted and password protected Box site will be 
considered the source data for data analysis.  
9.8.  Deviation Handling  
Deviations are instance(s) of failure to follow, intentionally or unintentionally, the requirements of the 
CIP. Intentional deviations are not permitted, except where necessary to protect the life or physical well-
being of a subject in an emergency. All deviations must be documented and explained, regardless of the 
reason for the deviation. Deviations will be documented on the MDT deviation log and escalated to 
Medtronic within 10 days of identification of the deviation by the site and/or site monitor.  
Medtronic is responsible for reviewing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. additional training and vendor contracts).   
If consent was not obtained prior to active enrollment this deviation event will be reported to Medtronic 
immediately and the IRB as per IRB requirement.  
9.9.  Subject Withdrawal or Discontinuation  
Consented subjects may be withdrawn from the study at any time by the subject or PI with the reason 
documented on the case report form (CRF).  No follow-up post withdrawal is required.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 25 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Subject data will be withdrawn from the data pool if insufficient CRF and electronic device data is 
collected.  
Each subject withdrawn before the end of the study will increase enrollment by one but not to exceed 
total consented at 50 subjects. 
10. Risks and Benefits 
10.1.  Potential Risks 
This study will be conducted in accordance with the Declaration of Helsinki and good clinical practice. The 
study will not commence until the approval has been received from the IRB. 
All medical devices used in this clinical study are FDA Cleared products and Medtronic is not aware of any 
significant problems with these products. In the clinical study, the products will be used in accordance 
with their labeling/IFU, therefore no risks other than the risks typically associated with routine device use 
are anticipated.   
Risks will be minimized with subject assessment by the Principal Investigator during study procedures. In 
addition, study risks during the study execution will be minimized by monitoring pulse oximetry in 
parallel with careful visual assessment of the subject by the study coordinator prior to, during, and after 
the scripted procedure activates.  Should the subject’s SpO2 drop below 85% for a duration of 30 
seconds, the study activities including the provision of supplemental O2 will be paused as needed to 
maintain SpO2 > 90%.  Low flow supplemental O2 will be supplied to measure the dilution effect on the 
breath sample provided to the CS35 for measurement not as any treatment.  The subject will be advised 
during the study that he/she may stop the test at any time.  
Subjects may withdraw at any time with no consequence. 
 
Procedure Risk for scripted activities: 
The potential study activities require minimal physical effort that will repeated for each CO2 cannula 
sampling filterline (CCFS) design so risk might be related to boredom more than physical exhaustion. 
Subjects will be encouraged to take a break as needed to relieve the boredom.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 26 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Low flow supplemental oxygen maybe provided at up to 5 lpm to measure CO2 sample dilution effects as 
a function of cannula design and/or procedure actives.  A subject may refuse supplemental O2 and/or 
request to stop the O2 if uncomfortable and or feeling lightheaded.  The reason will be recorded on the 
CRF. 
Insertion and removal of a nasal cannula may cause nasal irritation, discomfort, pain or nasal bleeding. 
Subject will be visually assessed before and after each cannula change for any adverse events and may be 
withdrawn if an AE occurs and/or subject request to stop the study.  
Medical Device Risk for cleared on label use per IFU includes: 
1. Pulse oximetry disposable sensor: Mild to moderate skin irritation or discomfort (redness, itching, 
rash, pressure) related to the disposable pulse oximetry sensor. The skin will be assessed before and 
after the application for a potential adverse event. Pulse oximetry will measure the subject’s 
oxygenation saturation during the procedure activities to identify any respiratory compromise 
adverse event. 
2. CO2 sampling cannula filterlines: Mild to moderate skin irritation or discomfort involved in wearing 
a nasal cannula with and without an oral scoop/tube above the mouth to collect a gas sample. 
Designs of the nasal only and oral/nasal cannula interface designs and low pump suction pressure for 
sampling within the CS35 monitor are means to reduce risk of discomfort. 
10.2.  Potential Benefits 
Volunteer subjects will have no direct benefit for study participation.  
The information gained from this study might result in clinical evidence to aid in capnography CO2 
sampling cannula filterline selection for Microstream™   enabled monitors in the clinical setting.  
10.3.  Risk-Benefit Rationale 
Medtronic believes that the potential risks associated with the conduct of this study are minimal and 
reasonable in relation to the anticipated benefit to provide clinical evidence and guidance on filterline 
selection.  
All the devices used in the study are commercially available and used within their intended use.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 27 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
11. Adverse Events and Device Deficiencies 
Clinimark, an approved clinical vendor with a service agreement for this study, will track all AEs and 
device deficiencies/failures and report them to MDT as they occur throughout the study.  
 
In this study the following Adverse Events (AE) will be collected: 
• All AEs related to the use of the pulse oximeter sensor  
• All AEs related to the use of any of the CO2 sampling filterline  
• All AEs related to the procedures of the study  
• All Serious Adverse Events  
11.1 Definitions/Classifications 
Where the definition indicates “device”, it refers to any medical device product used in the study. See 
product description Section 7 for product information. 
 
Table 1. Definition of Adverse Events and Device Deficiency 
Term 
Abbreviation 
Definition 
Adverse Event 
AE 
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether related to the investigational medical device. 
Note 1: This definition includes events related to the investigational 
medical device or the comparator. 
Note 2: This definition includes events related to the procedures 
involved. 
Note 3: For users or other persons, this definition is restricted to 
events related to investigational medical devices. 
Adverse Device Effect 
ADE 
Adverse event related to the use of a medical device.  
Note 1: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation or any malfunction of 
the medical device. 
Note 2: This definition includes any event resulting from use 
error or from intentional misuse of the medical device. 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 28 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Term 
Abbreviation 
Definition 
Serious Adverse 
Device Effect 
SADE 
Adverse device effect that has resulted in any of the 
consequences characteristic of a Serious Adverse Event.   
Serious Adverse 
Event 
SAE 
An adverse event that  
a) led to death, 
b) led to serious deterioration in the health of the subject, 
that either resulted in  
1) 
a life-threatening illness or injury, or 
2) 
a permanent impairment of a body structure or a body 
function, or 
3) 
in-patient or prolonged hospitalization, or  
4) 
medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment 
to a body structure or a body function, 
c) led to fetal distress, fetal death or a congenital 
abnormality or birth defect.   
Note 1:  Planned hospitalization for a pre-existing condition, 
or a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event. 
Device Deficiency 
DD 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. 
Note 1: Device deficiencies include malfunctions, use errors, 
and inadequate labelling. 
 
The list of expected Adverse Events that may be associated with the conduct of the study includes: 
               1. As subjects will be changing their body position throughout the study it is expected that there 
will be transient decreases in SpO2 below 90%. Should the subject’s SpO2 drop below 85%, for a 
duration of 30 seconds, the study activities including the provision of supplemental O2 will be 
paused as needed to maintain SpO2 > 90%. For this reason, events will only be recorded as an AE 
if they go unresolved after stopping the study activity.   
2.  Minor to moderate discomfort at finger sensor site and/or oral/nasal cannula site 
3. Itching (pruritis) around or near the location of the sensor and/or cannula site  
4. Pain around or near the location for the sensor and/or cannula site 
5. Nose bleeds (epistaxis)  
               6. Dizziness or light headiness  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 29 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
11.2 Reporting of Adverse Events 
Adverse Event (AE) information will be collected throughout the study and report to Medtronic on the AE 
CRF form and recorded on the AE log for each adverse event. It is the responsibility of the investigator to 
identify the occurrence of adverse events to ensure that the information is accurately documented on 
the subject AE CRF. The reported AE will be updated with a second AE CRF for the AE 
closure/reconciliation date if the AE is still open at the time of the initial AE CRF report.  
Medtronic medical device deficiencies (DD) will be collect throughout the study and reported to 
Medtronic on the DD form and recorded on the DD log.  Any DDs related to the products not 
manufactured by MDT would have to be reported to the appropriate manufacturer but will be noted on 
the DD log to track study device failures in one location.  
DDs related to our products will be reported to us in an appropriate amount of time (within 48 hours). 
Any DDs related to products that we don’t make would have to be reported to those manufacturers. 
Other manufacturer DD will be noted on the subject CRF with the time and description of the failure. 
AE documentation will include the following information at a minimum: 
• Date of event 
• Time of the event 
• Description of the event  
• Actions taken / treatment  
• Assessment of seriousness 
• Relatedness to the event (procedure or device) 
• Outcome or resolution and date of the resolution 
 
For AEs that require immediate reporting, initial reporting may be done by phone or e-mail.  The 
completed AE CRF must be sent to Medtronic as soon as possible. 
Any serious adverse event related to the study procedure or medical device must be report to the 
sponsor and the IRB per the IRB guidelines as soon as possible, but no later than 10 working days after 
the investigator learns of the effect.   
 
 
 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 30 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
Emergency sponsor contact information for reporting serious adverse events related to the conduct of 
the study procedures and serious adverse device effects is the following:  
       Kathleen H. Niebel RN BSN 
       Capnography Clinical Project Manager 
      +1- 978-549-9325 
       Kathleen.h.niebel@medtronic.com 
                       Or 
       
        Lisa Curtis, CCRP 
Senior Clinical Research Specialist  
Office 303.305.2826 | Mobile 720.216.4670 
Lisa.curtis@medtronic.com 
The sponsor will ensure timely Adverse Event reporting to meet USA regulatory requirements. 
12. Data Review Committee 
A data review committee will not be used in this study. 
13.  Statistical Design and Methods 
Medtronic or its designee will conduct statistical analyses of the study data as outlined in the Statistical 
Analysis Plan (SAP). Any changes in statistical methods will be detailed in the SAP. 
The study hypothesis is that the Medtronic (MDT) solution of pairing the Microstream™ 
FilterLine to the Microstream™ enabled device provides a more reliable gas sample for 
measurement across many of the patient simulated scripted activities.  Performance reliability 
of each CCSF for sampling breath gas will be measured using the mean and standard deviation 
for EtCO2, the frequency of false physiological alarms, the frequency of CS35 device 
notifications, and the frequency of missing CO2 data (drop-outs) as a function of both the CCSF 
variable and activity variable by subject and in aggregate.  
This hypothesis is based upon the CS35 IFU that recommends that Microstream® EtCO2 consumables 
(FilterLine) should be used to ensure the monitor functions properly. 
The statistical design is a randomized CCSF sequence assignment with each subject serving as their own 
control within each scripted activity period with the up to 8 CO2 sampling cannula filterline designs worn 
in each separate activity period.  The randomized sequence by subject is by CCSF code name letters from 
A – F with the CCSF product assignment to the code name letters done by Clinimark and blinded to MDT 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 31 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
until after the device data has been evaluated.  A total of 30 evaluable subject data sets are expected for 
this study. Based upon a previous study on cannula design investigating both CO2 sampling and O2 
delivery (Ebert & Novalija, 2015), a sample size of 30 will provide more than 90% power to test a 
normalized effect size of 5 or more using the Tukey-Kramer multiple comparison test at the 0.05 
significance level.        
 
Statistical evaluation of the device data after the first 5 -10 subjects may result in a reduction in the CRF 
scripted activities for the remaining subjects to remove those activities that would need more than a 
total of 30 subjects to detect a statistically significant difference in EtCO2 mean as a function of the CCSF 
for each activity period. This adaptive filtering of the CRF activities purpose is to reduce enrollment time 
down to activities that may be identified as a potentially statistically significant difference in the sample 
size and not include those activities that would require an unnecessarily larger sample size for 
significance.  
 
Descriptive statistics and exploratory data analysis will be used to generate measures of central tendency 
and to perform data distribution diagnostics. Statistical analysis will entail using the Tukey- Kramer 
honest significant difference test for multiple mean comparisons. All corresponding P values and 
confidence intervals for pairwise mean differences will be Tukey corrected as appropriate. Analysis of 
variance (ANOVA) will be used to compare across multiple groups. Moreover, multivariate regression 
models will be used to explore the relationship between EtCO2 and supplemental O2   flow rate after 
adjusting for factors including cannula type, subject activity and O2 flow rate.  
 
 
 
 
 
 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 32 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
14. Ethics 
14.1 Statement(s) of Compliance  
The study will be conducted in accordance with: 
• This clinical investigation plan/protocol, good clinical practices and ethical principles that have 
origins in the Declaration of Helsinki  
• International Conference on Harmonization Guidelines on Good Clinical Practice (GCP), local 
guidelines, and regulatory requirement(s) including 21 CFR 50, 21 CFR 56, 21 CFR 54, and 21 
CFR 803. 
 
The study will not commence until IRB approval is received and all required regulatory documents 
required by the sponsor are complete and up to date including a signed CV, signed financial disclosure, 
copy of PI medical license. Any additional requirements imposed by the IRB or regulatory authority shall 
be followed, if appropriate.  
Subjects will be compensated 75 USD/hour not to exceed three hours of enrollment for their time as per 
the informed consent form. Should a subject be withdrawn during the procedures he/she will be 
compensated up to the closest half hour (37.5 USD/30 minutes). Compensation will be tracked by 
Clinimark. The 6 previously consented subjects maybe re-consented to perform study activities with the 2 
new filterlines (number 5 and 6 on the CCSF list).  These 6 subjects will be compensated for their 
additional time required. 
No subject follow-up after discharge from the study will be required.  A subject will not be discharged 
from the study after all study procedures have ended if an adverse event related to the procedures or 
study devices is not closed as per Section 11.  Follow-up on an open AE may include a phone call next day 
and /or visit to Clinimark by the subject for the PI to assess and recommend medical intervention as 
needed.  
15. Study Administration 
15.1.  Monitoring  
Per the addendum to the master service agreement for this study, Clinimark will monitor the study 
according to their SOP and provide an electronic copy of the completed signed copies of each enrolled 
subject CRF and device data file via the Medtronic encrypted and password protected BOX site.  

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 33 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
15.2.  Data Management 
Details of the Data Management are contained in the study specific Data Management Plan.   
 
It is the policy of Clinimark to ensure the confidentiality, integrity, and availability of all Protected Health 
Information that they create, receive, maintain, or transmit. As such, Medtronic agrees that they will 
protect against any reasonably anticipated threats or hazards to the security or integrity of such 
information, and to protect against any reasonably anticipated uses or disclosures of such information 
that are not permitted or required under the HIPAA Privacy regulation.  
 
Medtronic agrees that all data transmission from Clinimark to Medtronic will be conducted via an 
encrypted and password protected MDT enterprise Box site.  Electronic device data will be compared to 
subject CRF to verify the match in CCSF code name and time for activity effect on the device measured 
data.  A subject will be withdrawn from the final data pool if there is missing electronic device data for 
that subject.  
15.3.  Direct Access to Source Data/Documents  
Clinimark and Principal Investigator will permit study-related monitoring, audits, IRB review, and 
regulatory inspection(s), providing direct access to source data/documents should be included.  
Electronic copies of the CS35 device data and both unsigned/uncontrolled and final signed CRFs will be 
provided to MDT by subject ID via an encrypted and password protected MDT BOX site under the control 
of MDT clinical engineering.  Initial unsigned/stamped uncontrolled CRFs are requested before site 
monitoring to correlate the activities with the electronic device data for adapting the CRF activity list.  
The date stamped “uncontrolled” CRF with the subject de-identified device data will not be transferred to 
MDT until the Clinimark monitor has verified that informed consent has been conducted for that subject 
and signed the CRF confirmation signature line with date. This data will also be saved in a MDT clinical 
repository with copies available for data analysis. The electronic de-identified device data will also be 
returned to MDT on a USB at the end of the study.  
               

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 34 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
15.4. Confidentiality 
All records and other information about subjects participating in this study will be treated as 
confidential. The identity of a subject will never be disclosed in the event study data are published. 
Subject confidentiality will be maintained throughout the clinical study in a way that ensures 
the information can always be tracked back to the source data. For this purpose, a unique subject 
identification number will be assigned and used to allow identification of all data reported for each 
subject.  Clinimark will maintain the enrollment log with subject information that will not be shared with 
the sponsor.  
Study data may be made available to third parties, e.g. in the case of an audit performed by regulatory 
authorities, provided the data are treated confidentially and that the subject’s privacy is guaranteed.  
15.5. Liability 
Covidien LP is a wholly owned subsidiary of Medtronic, which as the parent company of such entity 
maintains appropriate clinical study liability insurance coverage as required under applicable laws and 
regulations and will comply with applicable local law and custom concerning specific insurance coverage. 
Upon request, a copy of the Medtronic “CERTIFICATE OF LIABILITY INSURANCE” will be provided. 
Clinimark LLC is an approved Medtronic clinical vendor with a current Master Service Agreement.  
15.6. CIP Amendments 
The investigator may propose any appropriate modification(s) of the Clinical Investigation Plan. 
Medtronic will review this proposal and decide whether the modification(s) will be implemented. 
Medtronic will submit any significant amendment to the Clinical Investigation Plan to documentation 
control, including a justification for this amendment, to the appropriate regulatory authorities and to the 
investigators to obtain approval from their IRB, if applicable. Administrative amendments to the Clinical 
Investigation Plan will be submitted to the IRB and appropriate regulatory authorities for notification, if 
applicable. 
 
 
 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 35 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
15.7. Record Retention 
Investigator records at Clinimark 
At a minimum, the following records must be kept by the investigator for two years: 
• 
Clinical Investigation Plan and, if applicable, any amendments 
• 
Medtronic and IRB approved Informed Consent, if applicable 
• 
Regulatory Authority approval or notification, if applicable 
• 
Fully signed clinical investigation agreement and confidentiality agreement (if not 
included in the clinical investigation agreement) 
• 
Financial disclosures 
• 
Insurance certificates, if applicable 
• 
Completed Delegated Task List and Curriculum Vitae of Primary Investigator and Sub 
Investigators 
• 
Training documentation of all investigation site personnel 
• 
Copies of the medical device IFUs provided by MDT 
• 
Relevant communications 
• 
Fully executed CRFs and corrections 
• 
Electronic copy of the CS35 de-identified device data on a USB 
• 
Randomization table with CCSF code name key  
The investigator must retain the Investigator Site File, subject medical files and eCRF data in accordance 
with local law and regulations for a minimum period of 2 year (or longer if local laws require) after study 
completion. 
The investigator should take measures to prevent accidental or early destruction of the clinical study 
related materials. 
MDT Sponsor records 
At a minimum, the sponsor will keep the following records: 
• 
All essential study documents and correspondence that pertains to the clinical study. 
• 
CIP and, if applicable, any amendments. 
• 
Curriculum vitae of Primary investigators and Sub Investigators Delegated Task. 
Lists and training records of investigators and site staff. 
• 
IRB approvals/notifications and regulatory approvals/notifications. 
• 
Signed addendums to the Mater Service Agreement for study responsibilities and study 
execution. 
• 
Medtronic and IRB approved Informed Consent. 
• 
Site selection reports, site initiation reports and monitoring visit reports. 
• 
Copies of the CCSF IFUs provided to the site 
• 
Adverse event reports. 
• 
Financial disclosures. 
• 
Final monitored and approved CRFs. 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 36 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
• 
Electronic copy of the CS35 device data on an encrypted USB and/or encrypted MDT 
repository. 
 
15.8. Publication and Use of Information 
The results of this clinical study are planned for publication. Publication/Presentation statements will be 
included in the clinical study agreement between Medtronic and Clinimark. 
The study will be registered on www.clinicaltrials.gov before enrollment begins and the informed consent 
will disclose that information.  
The following publication policy will have to be adhered to by all participating investigation sites. 
Authorship on any publication(s) resulting from this clinical study will be assigned according to substantial 
contributions to conception and design, acquisition of data, or analysis and interpretation of data, 
drafting the article or revising it critically for important intellectual content and final approval of the 
version to be published.  Names of the participating investigators will appear in the Acknowledgment of 
the paper. 
Medtronic as the owner of the data can use the data and/or any results derived from the data or 
publications based on that data for marketing purposes, further research and development of devices or 
educational use. The use of the study data information may support MDT clinical recommendations to 
customers on filterline selection for Microstream™ enabled monitors.  
The study sponsor will collect data in such way that no subject can be identified, and monitor study 
records. 
Participating subjects will not be identified by name in any published reports about the clinical study. 
15.9. Suspension or Early Termination 
Early termination results when the study is closed prior to the end of the study. A study suspension is a 
temporary postponement of the study activities related to enrollment. Both are possible for the study.  
If the study is terminated or suspended, no additional enrollment will be allowed unless otherwise 
informed by the sponsor. The current subjects will be followed according to the protocol. 
Medtronic or Regulatory Authority may decide to suspend or prematurely terminate the clinical study. If 
the clinical study is terminated prematurely or suspended, Medtronic shall promptly inform the clinical 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 37 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
investigators of the termination or suspension and the reason(s) for this. The investigator shall then 
promptly inform the reviewing IRB and the study subjects or their legal representative. 
Medtronic, IRB or Regulatory Authority may decide to suspend or prematurely terminate an investigation 
site (e.g. in case of expiring approval of the reviewing IRB, non-compliance to the Clinical Investigation 
Plan, or lack of enrollment). If an investigation site is suspended or prematurely terminated, Medtronic 
shall promptly inform the investigator(s) of the termination or suspension and the reason(s) for this. The 
investigator shall then promptly inform the reviewing IRB, if required, the study subjects or their legal 
representative. 
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definite 
outcomes, investigators must assess whether to continue, modify or immediately stop the clinical study 
in the respective investigation site and immediately inform the sponsor and IRB, if applicable. 
If the investigator (or IRB) terminates or suspends the investigation without prior agreement of the 
sponsor, the investigator will promptly inform the sponsor, the institution (if required) and the IRB, and 
provide a detailed written explanation of the termination or suspension. The sponsor will inform the 
regulatory authorities (if required). 
In case of early termination of the study, all study subjects should be followed until the resolution of any 
pending adverse event(s). 
Medtronic reserves the right to discontinue the study at any time for administrative or other reasons. 
Written notice of study termination will be submitted to the investigator in advance of such termination. 
Termination of a specific site can occur because of, but not limited to, inadequate device data collection, 
low subject enrollment, or non-compliance with the protocol or other research requirements. 
In case of close out, the investigators will be notified and notification/report to Medtronic and Regulatory 
Authority will be done, if required. 
 
 

A Comparison of Capnography Sampling Lines 
Clinical Investigation Plan  
 
MDT17063FRS 
Version 2 
Page 38 of 38 
 
Medtronic Confidential 
This document is electronically controlled  
 
056-F275, v3.0 Clinical Investigation Plan Template 
 
 
 
 
16. References 
 
1. Ebert, T. J., & Novaliia, J. M. (2015, February ). The Effectivieness of Oxygen Delivery and Reliability of 
Carbon Dioxide Waveforms: A Crossover Comparison of 4 Nasal Cannula. Anesthesia & Analgesia, 
120(2), 342-248. 
2. Marshall, S. G., Henry, N. R., & Russian, C. (2016, April ). Right Versus Left Prong Nasl Annula FLow 
Delivery and the Effects of Nasal Cycling on INspired FiO2 in an Adult Anatomical Model. 
Respiratory Care, 61(4), 397-404. 
 
 
17. Version History 
 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
Not Applicable, New Document 
Kathleen H. Niebel RN BSN 
2.0  
Rename the CCSF list to be numbers since the 
randomization table is alphabetic to maintain 
blind for analysis, replaced two CCSF 
filterlines, clarified an SpO2 AE, adjusted the 
sample size based upon volume of data 
collected (7200 data points per activity), 
added request to reconsent six to test just the 
two CCSF devices replaced and clarified 
conditions for transfer of data to MDT. 
Kathleen H. Niebel RN BSN