Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study, A Single Center Prospective Clinical Study
Conditions: Peripheral ICC
Sponsor: Teleflex

Clinical Study Protocol 
 
 
Title: 
Vascular Positioning System G4 Algorithm ECG Data Collection 
for Model Training Study, A Single Center Prospective Clinical 
Study 
Teleflex Product: 
Product: Arrow Vascular Positioning System G4 
Protocol Number: 
 2022-03 
Version: 
4.0 
Date: 
February 12 , 2024 
Sponsor: 
Arrow International LLC (an affiliate of Teleflex Incorporated) 
 
   ClinicalTrial.Gov NCT # 
    NCT05702515 
 
 
 
 
 
GOOD CLINICAL PRACTICE (GCP) 
This document is a protocol for a human clinical research study. This study is to be conducted in accordance with 
all applicable United States standards of Good Clinical Practice (FDA Title 21, parts 11,50,54,56 and 812) and 
International Clinical Harmonization (ICH) guidelines, applicable government regulations, institutional research 
policies and procedures and Teleflex standards, including, where applicable, the Declaration of Helsinki. 
HIPAA 
The Teleflex Incorporated is committed to protecting the privacy, security and integrity of individually identifiable 
health information provided to us. The Company follows the highest standards of integrity in the performance of its 
business to maintain compliance with the Health Insurance Portability and Accountability Act (HIPAA). 
CONFIDENTIALITY 
The information in this document is confidential and is the property of the Teleflex Medical Incorporated. The 
information may be provided only to Investigators, sub-Investigators, appropriate trial personnel, members of the 
Institutional Review Board/Institutional Ethics Committee (IRB/EC) and personnel of the authorities to whom it is 
submitted. This protocol may not be photocopied or discussed with third parties not involved in the trial with the 
prior written authorization from the Teleflex Incorporated. 

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Protocol Approval Page 
“Vascular Positioning System G4 Algorithm ECG Data Collection for Model 
Training Study, A Single Center Prospective Clinical Study” 
 
Protocol #2022-03 
V4.0 – February 12, 2024 
 
 
 
 
Approved by: 
 
 
 
 
 
Amy Bardin, Ed.D, RRT, FAARC, VA-BCTM 
Date 
Vice President, Clinical and Medical Affairs, Vascular and Interventional 
Director, Medical Affairs, Vascular 
 
 
 
 
 
Adriann Taylor – Sr. Director, 
Date 
Global Clinical Operations, CMA 
 
 
 
 
 
 
Tatiana Puga - Associate Director, 
Date 
Global Clinical Operations, CMA 
 
 
Issued by: 
 
 
 
 
 
Tolani Adebanjo, PhD – Clinical Trial Manager 
Date 
Global Clinical Operations, CMA 

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Synopsis 
Sponsor: Arrow International LLC, an 
affiliate of Teleflex Incorporated 
Protocol Number: 2022 – 03 
Product: Teleflex Arrow Vascular Positioning 
System G4 
Development Phase: Post Market 
Title: Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training 
Study, A Single Center Prospective Clinical Study
Investigators: 
Deborah Hutch Allen, PhD, RN 
Duke University Hospital 
Sponsor Management: 
Teleflex Incorporated 
Study Management: Tolani Adebanjo PhD, Clinical 
Trial Manager 
Study Monitor: Aaron Cherry, Clinical Research 
Associate
Study Design: Prospective Clinical Study 
Objective: The objective of this study is to collect and analyze intravascular and extravascular 
echocardiogram (ECG) data from subjects receiving peripherally inserted central catheters (PICC) 
while using the Vascular Positioning System G4 and a 12 lead ECG machine. The data obtained 
will be used to evaluate the correlation between intra- and extravascular ECG data and determine 
usability in updating the G4 algorithm. 
 
Primary endpoint: The primary endpoint is synchronized digital data collected from the G4 and 
ECG machines during the PICC insertion procedure, including a photographic image 
documenting ECG lead placement, and a chest x-ray (post procedure). 
Number of Subjects:30 
Number of Study Centers: 1 
Duration of Evaluation: Time required for 
PICC insertion 
Estimated Duration of Study: 4 months 

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Contents 
1. 
Introduction ..................................................................................................................................... 5 
2. 
Objective of Study and Study Design ............................................................................................ 6 
3. 
Selection of Subjects ........................................................................................................................ 6 
4. 
Study Procedures ............................................................................................................................. 7 
5. 
Assessment of Safety ..................................................................................................................... 11 
6. 
Potential Risks and Benefits .......................................................................................................... 13 
7. 
Statistical Consideration ............................................................................................................... 14 
8. 
Quality Control and Quality Assurance ...................................................................................... 14 
9. 
Study Monitoring .......................................................................................................................... 15 
10. Institutional Review Board Review .............................................................................................. 15 
11. Data Handling and Recording ...................................................................................................... 16 
12. Confidentiality ............................................................................................................................... 17 
13. Publication Policy .......................................................................................................................... 17 
References .............................................................................................................................................. 18 
 

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1. Introduction 
 
1.1. 
Background 
A peripherally inserted central catheter (PICC) is an intravenous device that can be 
successfully utilized for medium- and long-course intravenous therapy in hospitalized and 
discharged patients.i Correct positioning of a PICC is essential to avoiding complications.ii 
The Arrow Vascular Positioning System G4 (here forth referred to as G4) (Teleflex, 
Morrisville, NC, USA) is designed for PICC navigation and tip confirmation. Using a 
combination of intravascular Doppler ultrasound, intravascular electrocardiogram (ECG) 
and advanced algorithmic logic, the system measures multiple physiological parameters and 
provides real-time navigation as the PICC advances through the patient’s vasculature.iii 
 
Like all medical devices, the AI ECG (algorithms) must be carefully vetted and validated in 
real-world clinical environments.iv Machine learning creates algorithms by building a 
model from a set of data points, then verifying its accuracy. Increasing data points allows 
the device to learn various circumstances and thus the ability to compare and respond 
appropriately. 
 
This study seeks to collect and analyze synchronized digital data collected from the G4 and 
ECG machines during the PICC insertion procedure. De-identified G4 and ECG data will 
be submitted to the sponsor. Photographic data confirming ECG lead placement and 
radiographic imaging (chest x-ray) showing PICC placement will also be de-identified and 
submitted to the sponsor. Both the G4 and the ECG machine used for data collection in this 
study are FDA cleared. 
 
1.2. 
Study Rationale 
The purpose of this study is to collect and analyze synchronized intra- and extravascular 
ECG data from subjects requiring PICC insertion using the G4 system and an external 12- 
lead ECG machine. This study will serve to determine the feasibility of using the 
comparison data collected to evaluate the correlation between intra- and extravascular ECG 
data, and to determine usability of the data in refining the next generation G4 system 
algorithm. 
 
1.3. 
Hypothesis 
Data collected simultaneously from the G4 system and a 12-lead ECG machine during 
PICC insertion in adult subjects will be useful in evaluating the correlation between intra- 
and extravascular ECG recordings and refining the next generation G4 algorithm model. 
 
1.4. 
Description of Device 
The Arrow G4 system is an FDA cleared device (K123813) indicated for use as an 
alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement 
confirmation in adult patients. The system consists of a base unit powered by a proprietary 
algorithm, a touch screen interface with remote control, a Doppler enabled ultrasonic stylet, 

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and a power supply; that are used together during PICC insertion to guide the inserter 
through the anatomy of the vasculature to the proper catheter tip location in the lower 1/3 of 
the superior vena cava – cavo-atrial junction. 
 
An FDA cleared 12-lead ECG machine capable of collecting ECG data digitally with a 
sample resolution between 12-16 bit at a sample rate of 300 - 1000 Hz will be utilized 
for this study. 
 
Photo documentation will be captured using a digital camera. 
 
Radiographic image (lateral chest x-ray) will be captured using Duke Radiology services to 
document PICC tip placement. 
 
2. Objective of Study and Study Design 
 
2.1. 
Primary Objective 
The objective of this study is to collect and analyze synchronized intra- and extravascular 
ECG data from subjects receiving PICC insertion while using the G4 and a 12-lead ECG 
machine. The data will be analyzed to evaluate the correlation between intra- and 
extravascular ECG data. 
 
Primary Endpoint 
The primary endpoint is the successful collection of the following data: synchronized digital 
data collected from the G4 and ECG machines during the PICC insertion procedure, 
photographic images documenting ECG lead placement, and a chest x-ray of the inserted 
PICC (post procedure). A copy of the data will be submitted to the sponsor. 
 
2.2. 
Study Design 
This is a single center prospective clinical feasibility study. All enrolled subjects will 
receive a 12-lead ECG during PICC insertion, a chest x-ray post insertion, and a 
photographic documentation of ECG lead placement. 
 
2.3. 
Duration of Subject Study Participation 
Each subject’s participation will start at the time of signing the informed consent and 
terminate upon completion of the x-ray. 
 
3. Selection of Subjects 
 
3.1. 
Participant Population 
Adult male patients scheduled to receive a PICC insertion using the G4 tip navigation 
system may be considered for participation in the study. 

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As this is a feasibility study, male and female patients will be recruited for participation in 
this study.  As a means to limit female exposures to photographs, Images will only be 
captured for male subjects 
 
3.2. 
Sample Size 
A sample size of up to 30 adult subjects will be enrolled to obtain 20 evaluable subjects. 
Including a maximum of 10 subjects in whom the G4 system was used for tip navigation but 
the blue bull’s eye was not achieved and 10 subjects where the blue bull’s eye served as 
confirmation for tip placement. An adult subject per The Federal Food, Drug, and Cosmetic 
Act (FD&C Act) is persons 22 years of age and older at the time of treatment.vi To be 
considered an evaluable subject, data must be collected for the duration of the PICC 
insertion procedure on both the G4 and the ECG machines, the post-insertion chest x-ray 
completed, and photographic documentation of the ECG lead placement captured.  Non- 
evaluable subjects will be replaced to meet the target sample size. 
 
3.3. 
Inclusion Criteria 
Subjects must meet the following criteria to be selected for participation in the study: 
 
22 years of age or older 
 
Scheduled for PICC insertion using the G4 system 
 
Willing to allow thoracic photos to be obtained after ECG lead placement 
 
3.4. 
Exclusion Criteria 
Subjects who meet any of the following criteria are not eligible for participation in the 
study: 
 
˂ 22 years of age 
 
Patient has a pacemaker 
 
Patient condition precludes ECG use and lead placement 
 
Patient condition precludes radiographic imaging 
 
Unwilling to allow thoracic photos to be obtained after ECG lead placement 
 
4. Study Procedures 
 
4.1. 
Informed Consent 
Subjects being scheduled to receive a PICC will be approached by clinical staff if deemed 
to meet the eligibility criteria for the study. Consent for participation in the study will be 
obtained from the subject using an Institutional Review Board (IRB) approved informed 
consent form (ICF) after study aims, methods, benefits and risks have been fully explained 
by the investigator or member of the study staff. Participation in the study is voluntary and 
the subject may withdraw at any time. Subjects will be told that electing not to participate in 
this study will not affect the care received for treatment. The subject will have a private 
room with sufficient time to read the informed consent form and ask any questions. A copy 
of the fully executed informed consent form will be given to the subject. 

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4.2. 
Screening and Enrollment 
After the informed consent document has been signed, the subject will undergo screening 
procedures. All subjects screened for the study will be entered on the Screening/Enrollment 
Log and sequentially assigned a subject identification number. Present diagnosis requiring 
PICC placement and cardiovascular disease history, including pacemaker, and/or a history 
of arrhythmic heart conditions such as: atrial fibrillation, atrial flutter, severe tachycardia, or 
pacemaker driver rhythms will be captured for all subjects enrolled. Subjects who do not 
meet all inclusion/exclusion criteria will not be enrolled in the study. The reasons for 
screening failure will be documented on the screening/enrollment log. 
 
4.3. 
ECG Lead Placement Image Capture 
ECG lead will be placed according to the standardized ECG lead placement chart below. A 
second study team member will confirm and attest to the proper placement of the ecg lead 
in accordance with the ECG lead placement chart below. For some male subjects who 
consent, the placement of thoracic ECG leads will be documented by three photographs: 
one photo capturing the chest perpendicular to the xyphoid process, and one left and right 
oblique photograph. A ruler should be placed in the photograph, not obscuring any ECG 
leads, as a scale reference. Images captured will exclude portions of the body above the 
shoulders. 
 
4.3.1. ECG Lead Placement and Procedure 
The subject identification number will be entered into the ECG machine to ensure the 
correct subject data can be identified. (See below for ECG lead placement.) 
 
ECG 12 lead placement: 
Standardized placement of ECG leads is important. ECG lead placement must be 
consistent between subjects and performed according to the directions provided in this 
section below. Primary and secondary ecg lead placement attestation will be used to 
document the lead placement for each subject, to confirm the accuracy of the lead 
placement with the requirements of the protocol. Some consenting male subjects will 
undergo photographic documentation of ECG leads. 
 
 
ECG Lead 
Anatomical Placement 
Lead 1 
Fourth intercostal space on the right sternum 
Lead 2 
Fourth intercostal space on the left sternum 
Lead 3 
Midway between placement of Lead 2 and Lead 4 fifth intercostal 
space at the midclavicular line 
Lead 4 
Fifth intercostal space at the left and mid clavicular line 
Lead 5 
Anterior axillary line on the same horizontal level as Lead 4 
Lead 6
Mid axillary line on the same horizontal level as Lead 4 and Lead 5
Right Arms (RA) 
Anywhere between the right shoulder and right elbow 
Right Leg (RL) 
Anywhere between the right torso and the right ankle 
Left Arm (LA) 
Anywhere between the left shoulder and the left elbow 
Left Leg (LL) 
Anywhere between the left torso and the left ankle 
 
 Note: There will be three "duplicate" electrodes (RA / LA and RL) between the two 
systems (G4 and 12-lead ECG). Duplicate electrodes should be placed as close together 
as possible without interfering with the other electrode. 

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4.4. 
PICC Insertion, ECG, Chest X-ray, and Data Collection 
The ECG recording and chest x-ray will be performed as described in the sections below. 
The ECG machine should start recording data prior to the first skin puncture and continue 
recording through  catheter tip placement.  
The study staff will defer to the institution’s policy for confirming proper tip placement. 
After successful PICC tip placement , ECG data collection can be terminated. Up to a 
maximum of 10 subjects in whom the blue bull’s eye was not achieved during PICC 
navigation will be included as evaluable subjects. Beyond, these 10 subjects, if the blue 
bull’s eye is not achieved the subject’s participation in the study will be terminated and no 
additional study procedures will be performed. If an ECG lead should fall off during the 
data collection period, the lead can be replaced, as long as, the G4 system is not displaying 
the orange caution indicator on the screen. If the caution indicator is displayed refrain from 
replacing the lead. If the ECG stops recording during the data collection period, it will not 
be resumed. 
 
Data Collection Procedures 
4.4.1. G4 and ECG Synchronization 
The minutes and hour display on the G4 and the ECG clocks must be synchronized to 
within 1 second of variation prior to the start of PICC insertion data collection. This 
synchronization must be performed prior to each subject use. 
 
4.4.2. PICC Placement Using G4 
Standard PICC placement and G4 operating procedures will be followed according to 
institutional policy. The G4 data will be de-identified by replacing the MRN number with 
the subject ID number before transferring the data to the sponsor. The catheter selected, the 
final length inserted, exposed length of catheter, and location of lead placement for both 
devices will be recorded. Anatomical location of access site, including arm and vessel used 
for PICC insertion as well as the procedure start and stop time will also be documented. 
The data for each subject will be submitted to the sponsor. 
 
4.4.3. Chest X-Ray: Image Capture and Radiology Review 
 
PICC tip location in the lower one third of the superior vena cava/cavo-atrial junction will 
be documented by radiograph. Any patient items that may interfere with visualization, 
including jewelry, and ECG patches/wires, should be removed prior to capturing the 
image. Replace ECG patches/wires prior to the start of the data collection period. The 
image acquired should keep the arm with the PICC at the same angle from the patient’s 
midline as performed during PICC insertion. Provide support for the arm during the X-ray 
procedure. X-ray beam should be 90° perpendicular to the film. Verify angle. The distance 
between the beam and the film should be maintained at 48 inches. Measure this to ensure 
that it is correct. X-ray should be shot at end-expiration during normal breathing. Do not 

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ask the patient to take a deep breath as this will move the PICC line and will not provide a 
proper assessment of the catheter tip. 
 
ECG and G4 recording should be terminated before the x-ray. A de-identified copy of the 
x-ray image will be transferred to the study sponsor. 
 
A designated radiologist will be selected to review and provided interpretation for all 
radiographs for this study to ensure consistency. The radiologist interpretation will be 
submitted to the sponsor. 
 
4.4.4. Demographic and Procedural Data Collection 
 
The following demographic data will be collected: gender, age (in years), height in 
cm, weight in kg, and race/ethnicity will be collected. 
 
The following medical information will be collected: present diagnosis requiring 
PICC placement and cardiovascular disease history, including pacemaker, and/or a 
history of arrhythmic heart conditions such as: Atrial fibrillation, atrial flutter, 
severe tachycardia, or pacemaker driver rhythms will be captured for all subjects 
enrolled. 
 
The following procedural data will be collected: anatomic location of the access 
site (right/left arm and vein), catheter selected (number of lumens, length, and 
manufacturer), PICC insertion procedure start and stop times, lead placement (G4 
and ECG machine), and final catheter length inserted and exposed. 
 
4.5. 
Adverse Events (AE) Assessment 
Adverse events will be assessed, documented, and reported to the Sponsor as outlined in 
Section 5. 
 
4.6. 
End of Study Status: Subjects will be categorized based upon their end of study status as 
described below. 
 
4.6.1. Completed Study 
Subject is considered to have completed the study after completion of all study procedures. 
 
4.6.2. Subject Initiated Early Termination from Study: 
A subject’s participation in the study will be immediately terminated upon subject 
withdrawal of consent. Upon termination a final AE assessment should be performed by 
the study staff. 
 
4.6.3. Investigator Initiated Early Termination from Study: 
If the Investigator feels that the subject can no longer fully comply with the requirements of 
the study, if any of the study procedures would not be in the best interest of the subject, or if 
any of the study procedures cannot be completed on the subject (data collection on 12-lead 

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ECG and/or chest x-ray) the investigator should withdraw the subject from the study. Upon 
termination a final AE assessment should be performed by the study staff. 
 
5. Assessment of Safety 
 
5.1. 
General 
The safety of the subjects will be prioritized for this clinical study. Each participating 
Investigator has the responsibility for the safety of the subjects under their care. Since the 
only study procedures are the use of ECG during the PICC insertion and the chest x-ray 
post-insertion, only AEs related to the study procedures will be reported in the case report 
form (CRF) as described below. Incidences of device malfunction and adverse events 
related to the PICC device and G4 system should be reported to Teleflex in accordance with 
institutional policy and procedure and regulatory requirements. 
 
5.2. 
Adverse Events 
An adverse event (AE) is any unfavorable medical occurrence affecting a clinical 
investigation Subject, which does not necessarily have a causal relationship with the 
treatment or procedure. An AE can therefore be any unfavorable and unintended sign, 
symptom, or diagnosis associated with the use of the study device, whether or not it is 
considered related to the device. Adverse events should be reported in accordance with 
International Conference on Harmonization (ICH) guidelines. 
For all adverse events, the investigator must pursue and obtain information adequate to 
determine the severity, causality (e.g., study procedure or other cause), and outcome of the 
event and to assess whether it meets the criteria for classification as a serious adverse event. 
Follow-up of the event is required until the event or its sequelae resolve or stabilize at a 
level acceptable to the investigator and the study sponsor/monitor. Adverse event evaluation 
will begin from the start of data collection through completion of the chest x-ray. Adverse 
events reported to the investigator subsequent to the subject’s participation will also be 
evaluated. 
 
5.2.1. Relationship to Study Device/ Procedure 
Adverse events will be assessed for relationship to the study procedures and categorized as 
follows: 
Not Related 
Possibly Related 
Definitely Related 
 
5.2.2. Unanticipated Adverse Device Effect 
An unanticipated adverse device effect (UADE) is a serious adverse effect that is possibly 
caused by or related to a study device or procedure not previously identified in nature, 
severity or degree, or any other unanticipated serious problem associated with a device. 
UADEs associated with use of the 12-lead ECG should be reported to the sponsor on the 
eCRF and to the ECG manufacturer in accordance with institutional policy and procedure 
and regulatory requirements. 

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5.2.3. Non-serious Adverse Events 
Non-serious adverse events determined by the principal investigator (PI) to have at least a 
possible relationship to the 12-lead ECG use, or the chest x-ray study procedures will be 
reported to the sponsor on the eCRF. 
 
5.2.4. Serious Adverse Events (SAE) 
A serious adverse event is any adverse event that: 
• Results in death 
• Is life-threatening: A life-threatening adverse event is defined as any adverse 
experience that places the subject at immediate risk of death from the reaction as it 
occurred. 
• Results in inpatient hospitalization or prolongation of existing hospitalization: 
Hospitalization is defined as any inpatient or outpatient/short-stay admission as a 
result of a precipitating, device or treatment-related emergent adverse event. For chronic or 
long-term patients, inpatient admission also includes transfer within the hospital to an 
intensive care inpatient unit. 
• Hospitalization for administrative reasons or a non-worsening pre-existing 
condition should not be considered adverse events (e.g., admission for workup of 
a persistent pretreatment lab abnormality, yearly physical exam, protocol- 
specified admission, elective surgery). Preplanned treatments or surgical 
procedures should be noted in the baseline documentation. However, if a 
hospitalization due to an unknown event occurs, it should be considered as a 
serious adverse event. 
• Prolongation of hospitalization is defined as any extension of an inpatient 
hospitalization beyond the stay anticipated/required for the original reason for 
admission, as determined by the investigator or treating physician. 
• Results in persistent or significant disability/incapacity: Disability is a substantial 
disruption of a person’s ability to conduct normal activities of daily living. 
 An adverse event that is not fatal, life-threatening, or requires hospitalization may be 
considered medically significant and therefore serious when, in the opinion of the 
investigator, it could jeopardize the subject and may require medical or surgical 
intervention to prevent any of the above outcomes. 
 
5.2.5. SAE Reporting 
Serious adverse events must be reported to the sponsor immediately, within 24 hours of 
knowledge of the event, if it occurs or comes to the attention of the investigator any time a 
subject is on study or reported to the investigator subsequent to the subject’s participation. 
SAEs may be reported by emailing the SAE documents to: 
 
Teleflex Incorporated 
Global Clinical Operations 
Email: TeleflexVPSstudy@teleflex.com 
 
An SAE report form and relevant documentation (if any) should be submitted 
electronically to Teleflex and to the IRB, in accordance with IRB reporting requirements. 
The initial report should include at minimum the following information: 
• Subject ID number, sex, age 
• Study device/procedure suspected relationship to the SAE 

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• SAE term and date of event 
Follow-up information including causality, severity, outcome, action taken, and 
concomitant medications should be communicated to the sponsor as soon as possible. 
 
 
6. Potential Risks and Benefits 
 
For the purpose of this study, subjects will have continuous 12-lead ECG tracings 
performed during PICC insertion and one chest x-ray of the inserted catheter at the end of 
the procedure. The chest x-ray and 12-lead ECG are not part of the routine PICC insertion 
procedures. These risks are outlined further but are considered to be minimal risk 
procedures. There is no perceived clinical benefit to subjects from participation in this 
study. 
 
There are standard risks of participating in a research study, for example given the 
potential of accidental disclosure of subject’s confidential information. Every effort will 
be made to ensure that subject personal information remains confidential at all times, 
including application of Subject ID and redacting personally identifying information before 
submitting to the Sponsor. 
 
Since subjects participating in the study will be receiving PICC insertion per standard of 
care, and the G4 is within the standard procedures for use during PICC device placement at 
this institution, these are not considered study procedures. Consent for PICC placement 
will be obtained as part of the standard of care and will not be associated with this study. 
 
The internal G4 device records ECG data during the central catheter line insertion that is 
used to detect correct placement. This ECG recording will be de-identified of the subject 
PHI and replaced with subject number prior to being sent to Teleflex. 
 
Risks associated with 12-lead ECG: 
The risks associated with use of the ECG machine include: 
Minor discomfort during electrode removal 
Skin irritation, itching, rash or redness from the ECG electrode pads. 
Hair that may prevent an adequate tracing will be removed via shaving, pending the subject 
approval. 
No PHI will be inputted into the ECG machine (only subject number) to maintain subject 
confidentiality. 
 
Risks associated with photographic images: 
A thoracic photograph will be taken to document the placement of the ECG leads. The risk 
associated with the photographic images is the risk of loss of privacy. Pictures of the body 
above the shoulder i.e., the face will not be included in the photographic images. Stored 
images will not contain PHI (only subject number) to maintain subject confidentiality. 
 

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Risks associated with chest x-rays: 
Radiation exposure from the x-rays needed for this study is about the same as the average 
person receives from normal radiation sources, such as sunlight and TV during a 10-day 
period. There is a slight chance of cancer from excessive exposure to radiation from x-rays. 
 
Minimization of risk 
There are no significant risks associated with the study related procedures of this clinical 
protocol. 
 
7. Statistical Consideration 
 
7.1. 
Sample Size Justification 
The sample size is not intended to be statistically justified. Data will be collected from 20 
evaluable subjects and analyzed to support the determination of feasibility of this 
synchronized data for the algorithm refinement process. 
 
7.2. 
Study Populations for Analysis 
7.2.1. Safety Analysis Population (Intent to Treat/ITT) 
All subjects on whom the G4/ECG data collection procedure was started shall be included 
in the assessment of safety (ITT population). Subjects who withdraw or are withdrawn 
from the study prior to study completion will be included through the point that they exited 
the study. All available data will be included in the analysis. 
 
7.2.2. Feasibility Analysis Population 
Non-evaluable subjects will be excluded from the feasibility analysis population. See 
Section 3.2 - Sample Size for definition of evaluable subject. 
 
7.3. 
Outcome Analysis 
Data collected for this study will be used to assess the feasibility of refining the next 
generation G4 algorithm model. 
 
8. Quality Control and Quality Assurance 
 
8.1. 
Sponsor 
The Sponsor will confirm that the study meets GCP guidelines and all applicable regulatory 
requirements. The Sponsor will be allowed direct access to all study related sites, source 
documents, and reports for the purpose of monitoring and auditing by the Sponsor, and the 
inspection by regulatory agencies. 
 
8.2. 
Investigators 
Investigators will be responsible for implementing and maintaining quality assurance and 
quality control systems to ensure that the data is generated, recorded, and reported 
appropriately. Additionally, investigators are responsible for ensuring that the study is 
conducted according to this clinical study protocol. Investigators assume full responsibility 
for performance of the clinical study in accordance with this protocol, Good Clinical 
Practice, and all regulatory requirements applicable to the jurisdiction in which the study 

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sites are located. The Investigators will apply quality control measures to all stages of data 
handling to ensure reliability and accuracy and will confirm that the data is processed 
correctly. 
 
9. Study Monitoring 
 
9.1. 
General 
Both the Investigators and the Sponsor of this study are responsible for taking all reasonable 
steps to ensure the proper conduct of the study regarding ethics, protocol compliance, 
integrity, and validity of the data recorded on the CRFs. At regular intervals during the 
study, the Investigator and Sponsor will communicate, through site visits, letters, or 
telephone calls to review study progress, compliance to protocol requirements, and any 
problems or issues. 
 
Onsite Monitoring visits will be made periodically during the study to ensure that all 
aspects of the current, approved protocol are being followed. Original source documents 
will be reviewed for verification of selected data captured on the eCRF. Digital files will be 
reviewed and submitted to the sponsor. 
 
The Investigator and site personnel will guarantee direct access to original source 
documents by Sponsor and their designees. In the event original medical records cannot be 
obtained for a subject who is seen by a non-study physician at a non-study institution, 
copies of original source documents must be made available for review. Copies of original 
source documents related to SAEs (from either the study site or a non-study institution, if 
applicable) must also be made available for submission to the Sponsor. 
 
 
9.2. 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical study protocol. As a result of 
deviations, corrective actions are to be developed by the site and implemented promptly. 
The study site is responsible for assuring that the protocol is followed, that subjects are 
included and assessed in accordance with the inclusion and exclusion procedures and that 
the subjects are seen and followed at designated times. 
 
10. Institutional Review Board Review 
 
10.1. 
Ethical Principals 
This study will be conducted in accordance with GCP, as defined by the International 
Conference on Harmonization (ICH) guidelines, and all applicable regulations. 
 
10.2. 
Institutional Review Board/Independent Ethics Committee 
This study protocol will be reviewed and approved by an IRB prior to study 
implementation. A copy of the approval will be collected by the Sponsor. 
 
10.3. 
Protocol Amendments 

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During the clinical trial, any amendment or modification to the protocol must be reviewed 
and approved by the IRB prior to implementation. The board or committee should also be 
informed of any event likely to affect the safety of subjects or the conduct of the study, in 
particular any change in safety and all updates to the IRB. 
 
10.4. 
Progress Reports 
As applicable, Investigator must send a report to the IRB, at least annually. A study closure 
report, including a summary of the trial’s outcome will be reported at the end of the study. 
 
11. Data Handling and Recording 
 
11.1. 
Record Storage and Retention 
The F.D.A. requires that essential documents be retained at the site for at least 2 years after 
the latter of the following two dates: The date on which the investigation is terminated or 
completed, or the date that the records are no longer required for purposes of supporting a 
premarket approval application, a notice of completion of a product development protocol, 
a humanitarian device exemption application, a premarket notification submission, or a 
request for De Novo classification.v 
 
11.2. 
Investigator Responsibilities 
The Investigator will maintain all study documentation and institute measures to prevent 
accidental or premature destruction of any data and/or documents related to the study. After 
the formal discontinuation of the clinical study, the Investigator will retain the study 
documentation produced by the investigator for at least 2 years after the completion of the 
study (see 10.1). The Investigator will allow Sponsor and/or Sponsor’s representatives to 
have access to the essential study documents. 
 
11.3. 
Sponsor 
The Sponsor will maintain all study documentation and institute measures to 
prevent accidental or premature destruction of any data and/or documents related to the 
study. The Sponsor will retain the study documentation permanently in accordance with 
Teleflex Record Control Global S.O.P. D0003064. 
 
11.4. 
Data ownership 
The Sponsor shall retain sole ownership of all data, results, reports, findings, and any other 
information collected during this study. 
 
11.5. 
Early Termination of Study 
This study may be terminated earlier than anticipated if, in the opinion of the investigator or 
the sponsor, there is sufficient reasonable cause. Written notification, documenting the 
reason for study termination, will be provided to the investigator or sponsor by the 
terminating party. Circumstances that may warrant termination include, but are not limited 
to: 
• Insufficient adherence to protocol requirements 
• Data that is not sufficiently complete and/or evaluable 
• Plans to modify, suspend, or discontinue the study 

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If the study is terminated earlier than anticipated, the IRB will be informed promptly and 
provided the reason(s) for the early termination. 
 
12. Confidentiality 
 
All materials, information (oral or written) and unpublished documentation provided to the 
Investigators (or any company/institution acting on their behalf), inclusive of this protocol and the 
Subject CRFs, are exclusive property of the Sponsor and may not be given or disclosed, either in part 
or in whole, by the Investigator or by any person under his/her authority to any third party without 
written approval from the Sponsor. The submission of this protocol and other necessary 
documentation to the IRB is expressly permitted. The IRB members have the same obligation of 
confidentiality. 
 
The Investigator will consider all information, results, discoveries, records accumulated, 
acquired, or deduced in the course of the study, other than that information to be disclosed by 
law, as confidential and will not disclose any such results, discoveries, records to any third party 
without written notification to the Sponsor. 
 
13. Publication Policy 
 
The Sponsor and Investigator agree that it is not anticipated that any publication will result from the 
Study, however each party retains the right to publish the Study Data and results of the Study in a 
manner compliant with the Protocol and the International Committee of Medical Journal Editors 
Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in 
Medical Journals in effect as of the date of initiation of the Study. 

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References 
 
 
 
 
 
i Santolim TQ, Baptista AM, Giovani AMM, Zumárraga JP, Camargo OP. Peripherally inserted central catheters in 
orthopedic patients : Experience from 1023 procedures. Acta Ortop Bras. 2018;26(3):206-210. doi:10.1590/1413- 
785220182603189368 
ii Smith B, Neuharth RM, Hendrix MA, McDonnall D, Michaels AD. Intravenous electrocardiographic guidance for 
placement of peripherally inserted central catheters. J Electrocardiol. 2010;43(3):274-278. 
doi:10.1016/j.jelectrocard.2010.02.003 
iii Teleflex. Teleflex Arrow VPS G4 Vascular Positioning System Information for Hospital Radiology Department 
Product Page. https://www.arrowvascular.com/vpseducation/pre-trial/documents/2013-2070%20- 
%20Trial%20Radiology%20Information%20Aid%20FINAL.pdf 
iv Attia ZI, Harmon DM, Behr ER, Friedman PA. Application of artificial intelligence to the electrocardiogram. Eur 
Heart J. 2021;42(46):4717-4730. doi:10.1093/eurheartj/ehab649 
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https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=812.140 
vi Center for Devices and Radiological Health. Pediatric medical devices treat or diagnose diseases and conditions fr. 
U.S. Food and Drug Administration. Published 2019. https://www.fda.gov/medical-devices/products-and-medical- 
procedures/pediatric-medical-devices