GE Cardiovascular Ultrasound Device Evaluation
Phase: NA
Conditions: Echocardiography
Sponsor: GE Healthcare

 
 
Page 1 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 
 
 
 
 
Clinical Study Protocol 
Study Title: GE Cardiovascular Ultrasound Device Evaluation 
Study Number: 217021760 
Version: 2.0; 14/Apr/2022 
NCT Number: NCT05340244 
 
Sponsor: 
General Electric Company, acting through its GE Precision Healthcare LLC 
business 
3000 N. Grandview Blvd 
Waukesha, WI 53188 
Sponsor Contact:  
See Appendix B – Administrative Structure of Investigation 
FOR QUALIFIED INVESTIGATORS, STUDY STAFF, AND THEIR 
ETHICS COMMITTEE(S) ONLY 
CONFIDENTIALITY STATEMENT 
Information in this RESEARCH STUDY PROTOCOL is for investigators, site personnel 
involved with the study, ethics committee(s), and/or their authorized representative(s) except 
as required to obtain consent from study participants or as otherwise required by law. Once 
signed, the terms of the protocol are binding for all parties. 
 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 2 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
The Sponsor and Investigator have approved this protocol version, and I confirm hereby to conduct the study 
according to the protocol and per applicable principles of the World Medical Association Declaration of Helsinki 
and Good Clinical Practice (GCP) guidelines as per ISO 14155, any conditions of approval imposed by the 
reviewing ethics committee (EC) or governing regulatory body, and applicable local and federal laws and 
regulations. The investigator should not deviate from this protocol except for emergency use. I have read and 
understood and agree to abide by all the conditions and instructions contained in this protocol. 
Local Principal Investigator at study site: 
 
Investigator Signature 
Date
 
 
 
Print Name 
 
 
 
Site Name, Department, Address 
 
 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 3 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
Table of Contents 
Document and Version Control ................................................................................................. 5 
List of Abbreviations and Terms ............................................................................................... 6 
Synopsis ...................................................................................................................................... 7 
1.  Background and Justification ............................................................................................. 9 
2.  Device Description ............................................................................................................. 10 
 
Identity, Mechanism, and Function ............................................................................................. 10 
 
Intended Use ............................................................................................................................... 10 
 
Concomitant / Ancillary Administrations...................................................................................... 11 
 
Accountability .............................................................................................................................. 11 
 
Anticipated Risks and Benefits ................................................................................................... 11 
3.  Objectives ............................................................................................................................ 12 
 
Purpose of the Study................................................................................................................... 12 
4.  Study Design ....................................................................................................................... 12 
 
Summary of Study Design .......................................................................................................... 12 
 
Study Population ......................................................................................................................... 12 
 
Number of Subjects..................................................................................................................... 12 
 
Protection of Vulnerable Subjects ............................................................................................... 13 
 
Eligibility Criteria .......................................................................................................................... 13 
 
Recruiting and Screening ............................................................................................................ 14 
 
Criteria for Withdrawal/Discontinuation ....................................................................................... 14 
5.  Study Procedures ............................................................................................................... 14 
 
Subject Preparation..................................................................................................................... 14 
 
Description of Study Procedures ................................................................................................ 14 
 
Follow-up ..................................................................................................................................... 15 
6.  Study Data Collection and Assessments ......................................................................... 15 
 
Primary Assessment ................................................................................................................... 15 
 
Safety Assessments.................................................................................................................... 15 
7.  Qualification and Training Plan ......................................................................................... 15 
 
Staff Qualifications ...................................................................................................................... 15 
 
Training Plan for the Protocol and Research Device/Product .................................................... 16 
8.  Safety ................................................................................................................................... 16 
 
Anticipated Adverse Events ........................................................................................................ 16 
 
Adverse Event Definitions ........................................................................................................... 18 
 
Documentation of Adverse Events .............................................................................................. 19 
 
Reporting of Safety Events ......................................................................................................... 20 
 
Reporting of Device Deficiencies/Complaints ............................................................................. 20 
9.  Ethical Conduct of the Study ............................................................................................. 20 
 
Ethics Committee ........................................................................................................................ 20 
 
Regulatory Agencies and Competent Authority(ies) ................................................................... 21 
 
Management of Protocol Modifications and Amendments ......................................................... 21 
 
Management of Protocol Deviations ........................................................................................... 21 
 
Subject Information and Informed Consent ................................................................................ 21 
 
Suspension/Early Termination of the Study ................................................................................ 22 
10. Statistical Methods ............................................................................................................. 22 
 
Statistical Hypothesis .................................................................................................................. 22 
 
Sample Size Determination ........................................................................................................ 22 
 
Statistical Analysis ...................................................................................................................... 22 
 
Handling of Missing Data ............................................................................................................ 22 
 
Deviation(s) from the Original Statistical Plan ............................................................................ 23 
11. Quality Assurance and Control ......................................................................................... 23 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 4 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 
Data Management....................................................................................................................... 23 
12. Monitoring Plan ................................................................................................................... 23 
 
Confidentiality and Data Protection ............................................................................................. 24 
13. Research Agreements ........................................................................................................ 24 
 
Clinical Study Report and Publication Policy .............................................................................. 24 
Appendix A – Study Site and Investigator List ...................................................................... 25 
Appendix B – Administrative Structure of Investigation ...................................................... 26 
References ................................................................................................................................ 28 
 
 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 5 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
DOCUMENT AND VERSION CONTROL 
This section records all changes made to the protocol for a specific study. In the table below, record every 
relevant change by indicating what changes have been made. 
 
Version 
Date 
Author 
Comments/Changes 
1.0 
23/Aug/2021 
Emmaly Schwartz Lead Medical Writer – Initial version.  
2.0 
14/Apr/2022 
Tracy 
Grzendzielewski 
Lead Research Program Integrator, Ultrasound 
During review of the IDE application for this study, 
FDA requested modifications to the eligibility 
criteria, which are detailed in Appendix C 
(Amendment of Protocol Version 1.0 to 2.0) 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 6 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
LIST OF ABBREVIATIONS AND TERMS 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
AFAP 
As Far As Possible 
AMA 
American Medical Association 
CA 
Competent Authority 
CCG 
Case Report Form Completion Guidelines 
CFR 
Code of Federal Regulations 
CHF 
Clinical History File (synonymous with e-Trial Master File) 
CRF 
Case Report Form 
DCF 
Data Clarification Form 
DMP 
Data Management Plan 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
EU 
European Union 
FDA 
United States Food and Drug Administration 
GCP 
Good Clinical Practice (see ISO 14155) 
GDP 
Good Documentation Practices  
GE 
General Electric 
HCP 
Health Care Provider 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
IFU 
Instructions for use 
ISO 
International Standards Organization 
IQ 
Image quality  
LAR 
Legally authorized representative 
MWS 
GE Healthcare MyWorkshop Internal Documentation System 
PI 
Principal Investigator 
RPI 
Research Program Integrator 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SPR 
System Problem Report 
UADE 
Unanticipated Adverse Device Effect 
US 
United States 
USADE 
Unexpected Serious Adverse Device Effect 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 7 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
SYNOPSIS 
Sponsor: 
General Electric Company, acting through its GE Healthcare (GE Healthcare) 
Business 
Research Type: 
This is an open label, prospective, non-randomized clinical research study at a 
single site. 
Regulatory Status: 
This is a pre-market – pilot stage research study of the following devices/products: 
Pre-market: Vivid E95 v206 ultrasound system; 9VT-D transesophageal 
echocardiography (TEE) probe 
Background and 
Rationale: 
GE Healthcare (GEHC) manufactures the Vivid E95 – a general purpose 
ultrasound system, specialized for use in cardiac imaging. Feedback from real 
clinical use cases is required to optimize medical devices prior to device 
finalization and commercialization. The goal of this study is to collect user 
feedback and de-identified images from the investigational Vivid E95 v206 
system and probes during transthoracic echocardiogram (TTE) and TEE 
exams. The results of this study are intended primarily for use in engineering 
evaluation and optimization of the device.  
Procedures/ 
Methods: 
Eligible subjects will be enrolled into the study and positioned for their 
ultrasound exam. Standard clinical practice procedures will be followed using 
the standard of care device at the site to complete the clinically indicated 
exams. 
After the clinically indicated exam, portions of the TTE and/or TEE exam will be 
repeated with the investigational Vivid E95 ultrasound device. Ultrasound 
scans in this study will take a similar amount of time and be performed in a 
similar manner as standard of care ultrasound exams at the site. 
The device operator will store images from both ultrasound exams conducted 
with the standard of care device and the investigational device. Images 
collected with the investigational device will not be used for patient 
management. 
Objectives: 
The primary objective of this study is to collect user feedback and de-identified 
images from the Vivid E95 v206 ultrasound system and probes in TTE and 
TEE exams in a clinical setting. User feedback will include workflow, 
performance, user preference, image quality (IQ), device features, and open-
ended feedback. 
 
The safety objective of this study is to collect safety information, including type 
and number of AEs, SAEs, and device issues. No clinical efficacy endpoints 
will be assessed. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 8 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
Eligibility Criteria: 
Inclusion criteria: 
1) Has a clinical indication for a 
TEE and/or TTE procedure 
with an ultrasound device; 
2) Has a weight of at least 5kg; 
3) Is able and willing to comply 
with study procedures; 
4) If less than 7 years old, has 
two parents or legally 
authorized representatives 
able and willing to provide 
written consent to 
participate. 
5) If 7-17 years old, is able and 
willing to provide written 
assent to participate AND 
has two parents or legally 
authorized representatives 
able and willing to provide 
written consent to 
participate. 
6) If 18 years old or older, is 
able and willing to provide 
written consent to 
participate.  
Exclusion criteria: 
1) Pregnant or suspected to be 
pregnant based on the opinion 
of a clinician investigator; 
2) Expected to be at increased 
risk due to study participation 
(e.g. due to sensitivities, 
relative or absolute 
contraindication to TEE), in the 
opinion of a clinician 
investigator; 
3) Previously participated in this 
study or are enrolled in 
another research study that 
could be expected to interfere 
with participation in study 
procedures;  
4) History of esophageal surgery 
or known vascular ring; OR 
5) Experiences any complications 
or difficulty with the initial TEE 
procedure performed using the 
standard device. 
 
Sample Size and 
Sites: 
Up to 100 subjects from one site will be included. This number is based on 
prior engineering development and testing experience of the Sponsor. This 
study will enroll the minimum number of subjects necessary to complete 
Sponsor engineering requirements for this stage of development and 
optimization of the device, which may be less than the maximum enrollment 
set forth in this protocol.  
Expected Subject 
Participation 
Duration: 
The duration of subject participation is the time it takes to complete the 
ultrasound exam(s) (less than one day). 
Study Duration: 
The study is expected to last approximately 6 months. 
Estimated start date (first subject in): January 2022 
Estimated end date (last subject out): June 2022  
Study Completion: 
The study will be considered complete when subject enrollment requirements 
are met per the Sponsor’s determination. 
 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 9 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
1. BACKGROUND AND JUSTIFICATION 
Echocardiography, or ultrasound imaging of the heart, provides real time imaging of the blood flow and heart 
functioning. Transthoracic echocardiography (TTE) is a form of non-invasive imaging where a sonographer uses 
an ultrasound probe on the chest to view the heart. While this type of echocardiography has only minor risks, 
such as discomfort, and does not require extensive preparation, body tissues and organs may prevent clear or 
complete visualization of the target area. 
To avoid obstructions to imaging associated with TTE, transesophageal echocardiography (TEE) may be used 
to better image the heart. This type of ultrasound places the transducer in the esophagus, close to the heart. 
TEE has been shown to outperform TTE1,2 and change patient management when used to evaluate cardiac 
etiology.2 Beyond regular two-dimensional (2D) TEE imaging, three-/four-dimensional (3D/4D) TEE allows the 
user to see better see the depth of image and change over time. Imaging for mitral valve3,4, aortic valve5, 
tricuspid valve4, left and right ventricles6, and masses7 have shown to be equal to or improved compared to 
regular 2D imaging strategies. 
The current study will investigate a small TEE probe, called the 9VT-D TEE (4D Micro TEE) probe, intended for 
use on smaller patients, such as children. Currently, the only post-market 4D TEE probes available are 
designed for adult patients and are only approved for use in adults. This is considered a semi-invasive imaging 
application and is typically optimized through simulations and phantom imaging. To optimize live or moving 
images, simulation data and phantom images may not be adequate. Porcine (pig) and canine (dog) models 
have similar anatomical structures to humans, making porcine and canine models optimal for pre-clinical 
testing.8,9 GE Healthcare previously conducted an animal study which tested the 9VT-D TEE probe in one 
medium canine and one small porcine model. GE Healthcare obtained image data and user feedback to 
optimize probe image quality based on this in vivo animal testing. 
The goal of this study is to collect user feedback and de-identified images from investigational Vivid E95 v206 
system and probes during TTE and TEE exams. The results of this study are intended primarily for use in 
engineering evaluation and optimization of the device and may be used for augmenting design verification and 
design validation. This evaluation may generate reference images/data to support regulatory filings but will not 
generate clinical evidence to support regulatory claims. Results may be used to help commercialize the product 
in other global regions in the future, at the discretion of the Sponsor. Funding for this study will be provided by 
GE Healthcare. 
 
 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 10 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
2. DEVICE DESCRIPTION 
 Identity, Mechanism, and Function 
Name:  
Vivid E95 v206 system, 9VT-D TEE probe 
Modality/Type: 
Cardiovascular Ultrasound 
Manufacturer:  
GE Healthcare 
Software version: The most current version available will be used. 
Regulatory Status: Pre-market – pilot stage 
Note: A record of number of devices issued, along with applicable identification numbers (e.g., serial/lot/batch) and 
components/accessories used in this study will be retained by the Sponsor as part of the clinical history file (CHF), 
as required by applicable laws and regulations. 
The Vivid E95 v206 is a pre-market diagnostic ultrasound system that provides digital acquisition, processing, 
analysis and display capability. It consists of a mobile console with a control panel, touch panel, and display 
monitor. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal 
processing, software computing, hardware for image storage, hard copy printing, and network access to the 
facility. The Vivid E95 v206 employs the same fundamental scientific technology as the commercially available 
predicate Vivid E95. 
The 9VT-D TEE probe is a pre-market probe that functions primarily by supporting real time 3D imaging for 
pediatric use cases. Currently approved 4D TEE probes are available for adult patients, which are too large to 
use for pediatrics. Only 2D TEE probes are available for pediatric patients. The 9VT-D TEE probe will be used 
with the pre-market Vivid E95 v206 cardiovascular ultrasound system. Commercially available probes may also 
be provided for use with the Vivid E95 v206 system for TTE exams in this study. 
The research device, instructions for use, or packaging shall indicate that the research device is for use in a 
research investigation, per FDA 21 CFR §812.5 and other applicable laws and regulations. 
The investigational device will be exclusively used for research purposes. Routine accessories necessary to 
perform ultrasound, such as ultrasound gels, may be provided by the site and used according to the site 
standard of care during this study. Additionally, software may be used for post processing of images. Results of 
this study may be used in current and future technology development and scientific evaluation. 
 Intended Use 
The Vivid E95 ultrasound system is intended to be used for a variety of diagnostic cardiovascular procedures on 
pediatric and adult patients. Vivid E95 is a general purpose ultrasound system, specialized for use in cardiac 
imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging, 
measurement, display and analysis of the human body and fluid. The 9VT-D TEE probe is intended for use by a 
duly licensed physician who has received appropriate training in endoscopic techniques as dictated by current 
relevant medical practices. It is intended to be used on pediatrics; the minimum recommended patient weight 
limit is 5kg. It may also be used on smaller patients, based upon the physician’s clinical judgement of benefit/risk 
for the individual patient. 
The procedures conducted in this study are intended for device development purposes. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 11 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 Concomitant / Ancillary Administrations 
 Medications and Biologic Products 
No medications or biologic products will be administered as part of study procedures. As part of the standard of 
care at the site, subjects may receive anesthesia. Clinically necessary medications for the subjects’ prescribed 
medical procedure shall be administered per the site standard care and participation in this study will not alter 
their standard care. 
 Laboratory Tests and Sample Processing 
No laboratory tests or sample processing is planned as part of the study procedures. 
 Accountability 
Accurate and adequate records will be maintained for all devices, from time of shipment to the site until return or 
disposal of all devices issued by the Sponsor as part of this study, as required by applicable laws and 
regulations. The Principal Investigator will be responsible for the security and integrity of research devices at the 
investigational site during the study. 
 Issuance 
The research device will be provided by the Sponsor. No calibration/maintenance procedures are planned for 
this study. Software updates may be made during the study. 
 Disposition 
The device will be dispositioned after the study and returned to the Sponsor, per applicable laws and 
regulations. 
 Anticipated Risks and Benefits 
The device under study has undergone risk assessment, per International Standards Organization (ISO) 14971, 
and risks have been mitigated to levels as far as possible (AFAP). Verification of the system will be completed, 
including mitigation of hazards and functional changes impacting the study, and that the system device features 
operate as expected. Additionally, electromagnetic interference testing will have been completed to ensure the 
investigational device does not impact other electronic medical devices, and acoustic output verification testing 
will be completed to ensure that the energy output from the system is within acceptable ranges. The measures 
ensure that the devices used in the study are equivalent to systems that already meet the requirements for CE 
mark and are used for diagnosis outside of the USA. Validation of user requirements and expectations will be 
completed for the device. 
The risks associated with the investigational device are not expected to be greater than those of similar 
procedures routinely conducted in clinical practice. Subjects will undergo procedures with both the standard of 
care device and the investigational device, so there may be an incremental risk associated with the double 
procedure. Post-trial care or follow-up is not required by this study. 
Subjects are not expected to benefit directly from study participation. The results may benefit future patients by 
helping to optimize the device, accessories, and software. This may provide better imaging for pediatric patients 
in the future. 
 Risk Category and Rationale 
The 9VT-D TEE probe, as used in this study, is considered a significant risk device per 21 CFR §812.3(m) 
because it does present a potential for serious risk to the health, safety, or welfare of a subject. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 12 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
3. OBJECTIVES 
 Purpose of the Study 
The purpose of the study is to collect user feedback on the Vivid E95 v206 ultrasound system and probes during 
clinical procedures on the device’s intended population in order to optimize the device. 
 Primary Objective 
The primary objective of this study is to collect user feedback and de-identified images from the Vivid E95 v206 
ultrasound system and probes in TTE and TEE exams in a clinical setting. User feedback will include workflow, 
performance, user preference, IQ, device features, and open-ended feedback. 
 Safety Objective 
The safety objective of this study is to collect safety information, including type and number of AEs, SAEs, and 
device issues. No clinical efficacy endpoints will be assessed. 
4. STUDY DESIGN 
 Summary of Study Design 
This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in 
the United States. The study will be considered complete when subject enrollment requirements are met per the 
Sponsor’s determination. The duration of subject participation is the time it takes to complete the ultrasound 
exam(s) (less than one day). 
This study is not intended to support a comparative claim or test any hypotheses, such as superiority or non-
inferiority, so no control group is necessary. All reasonable attempts will be made to control and minimize bias 
during the study. The study will not impact the clinically indicated scan used for clinical care. Subjects will be 
consecutively enrolled in this study as they present at the site for standard of care procedures. This type of 
sampling reduces, but does not eliminate, some risks of sampling bias. Additionally, site and Sponsor 
responsibilities are clearly defined to reduce additional biases during the conduct of study procedures. 
 Study Population 
Subjects will be enrolled who meet all of the inclusion criteria and none of the exclusion criteria and are 
prescribed a standard of care procedure using an ultrasound device for a TEE exam, including either diagnostic 
or perioperative TEE, and/or a Transthoracic Echocardiography (TTE) exam. This population is representative 
of the general population that is expected for the device in clinical practice. 
 Number of Subjects 
Up to 100 subjects may be enrolled in this study. This study will enroll the minimum number of subjects 
necessary to complete Sponsor engineering requirements for this stage of development and optimization of the 
device, which may be less than the maximum enrollment set forth in this protocol. 
4.3.1 Enrollment Schedule 
After the first 5 subjects are enrolled and complete study procedures, subject enrollment will pause. A progress 
update will be submitted to the EC, which will include safety-related information such as any adverse events, 
device deficiencies, or any other relevant issues that have occurred during the initial enrollment period. Subject 
enrollment will resume upon receipt of favorable opinion from EC. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 13 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 Protection of Vulnerable Subjects 
Vulnerable subjects are individuals whose willingness to volunteer in a clinical investigation could be unduly 
influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory 
response from senior members of a hierarchy in case of refusal to participate. 
The Sponsor shall avoid improper influence on, or inducement of, the subject, monitor, any investigator(s), or 
other parties participating in, or contributing to, the clinical investigation. 
All investigators shall avoid improper influence on, or inducement of, the subject, Sponsor, monitor, other 
investigator(s), or other parties participating in, or contributing to, the clinical investigation. 
Neonates, children, or minor subjects: Neonates, children, and minor subjects under the age of 18 years old 
will be subjects in this study. These subjects are considered members of a vulnerable research population who 
are not legally competent to provide valid informed consent. This research will be approved by an EC, and  two 
parents or legally authorized representatives (LARs), such as health care surrogate, attorney in fact, judicially 
appointed guardian, or proxy, must provide written informed consent for the child’s participation. Assent will be 
obtained from minor subjects aged 7-17 years old. 
The study activities cannot otherwise be performed without the use of vulnerable populations. Children have 
anatomical and physiological differences compared to adults, such as smaller and less developed anatomy, 
faster heart rate, and faster breathing rate, which affect ultrasound image acquisition. Children may also behave 
and move differently than adults during scans, which introduces additional challenges and variables. It is 
important to evaluate the device’s performance in the intended population so it can be optimized for actual 
clinical use. 
 Eligibility Criteria 
 Inclusion Criteria 
Subjects who meet all the following inclusion criteria may be enrolled: 
1) Has a clinical indication for a TEE and/or TTE procedure with an ultrasound device; 
2) Has a weight of at least 5kg; 
3) Is able and willing to comply with study procedures; 
4) If less than 7 years old, has two parents or legally authorized representatives able and willing to provide 
written consent to participate. 
5) If 7-17 years old, is able and willing to provide written assent to participate AND has two parents or 
legally authorized representatives able and willing to provide written consent to participate; 
6) If 18 years old or older, is able and willing to provide written consent to participate. 
 Exclusion Criteria 
Subjects who meet any of the following exclusion criteria will be excluded: 
1) Pregnant or suspected to be pregnant based on the opinion of a clinician investigator; 
2) Expected to be at increased risk due to study participation (e.g. due to sensitivities, relative or absolute 
contraindication to TEE), in the opinion of a clinician investigator; 
3) Previously participated in this study or are enrolled in another research study that could be expected to 
interfere with participation in study procedures; 
4) History of esophageal surgery or known vascular ring; OR 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 14 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
5) Experiences any complications or difficulty with the initial TEE procedure performed using the standard 
device. 
Note: It is not possible to assess exclusion criterion #5 prior to the point of enrollment; this exclusion 
criterion will be assessed during the initial standard care TEE procedure. 
 Recruiting and Screening 
Subjects will be recruited for potential enrollment in this study according to the standard procedures of the 
investigational site, unless otherwise specified by the Sponsor in this study protocol. All participation will be 
voluntary. 
Subjects will be screened for enrollment in this study against the inclusion and exclusion criteria according to the 
standard procedures of the investigational site. 
Following recruitment, a subject will be considered enrolled (the point of enrollment) once the subject or the 
subject’s parents or LARs sign and date the informed consent form (ICF), including the informed assent form as 
applicable. Once enrolled, the subject will be assigned a unique subject number, which will not contain 
information that could identify the subject (such as subject name or date of birth). The unique subject number 
will be used to label case report form (CRF) data for the subject throughout his/her participation in the study. 
 Criteria for Withdrawal/Discontinuation 
A subject may withdraw from study participation at any time, for any reason. The Investigator may withdraw a 
subject at any time, for any reason. The reasons for withdrawal and discontinuation for any subject shall be 
recorded on a CRF. These will be reported to the Sponsor. The EC should be notified per their notification of 
subject withdrawal policy. 
5. STUDY PROCEDURES 
 Subject Preparation 
Study staff will confirm that the subject is eligible and complies with applicable site requirements prior to starting 
study procedures. No preparation beyond that required by the investigational site is required before procedures. 
 Description of Study Procedures 
Eligible subjects will be enrolled into the study and positioned for their ultrasound exam. Standard clinical 
practice procedures will be followed using the standard of care device at the site to complete the clinically 
indicated exams. 
After the clinically indicated exam, portions of the TTE and/or TEE exam will be repeated with the investigational 
Vivid E95 ultrasound device. Ultrasound scans in this study will take a similar amount of time and be performed 
in a similar manner as standard of care ultrasound exams at the site. The additional investigational TTE and 
TEE scans will add no more than about 15 minutes to the procedure time. For subjects having TEE in 
conjunction with surgery or an interventional catheterization procedure, the additional investigational scans will 
occur simultaneously while the hospital staff are preparing for or performing the procedure to avoid any delay in 
care. Images collected with the investigational device will not be used for patient management. 
The device operator will store images from both ultrasound exams conducted with the standard of care device 
and the investigational device.  
After completion of the investigational ultrasound exam, the ultrasound system and associated probes will be 
cleaned and disinfected as applicable, according to site standard of care and specifications in Sponsor 
instructions provided to the site. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 15 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
The subject will be followed for adverse events (AEs) from the time the ultrasound exam begins with the 
investigational device to the time the subject leaves the scan room. Subjects may also contact the PI if they 
experience any additional symptoms after the study. Subjects will, if necessary, be provided with emergency 
care. In the event of any device issues, the event will be recorded. 
Any AEs or device deficiencies/complaints observed by the operator will be reported to GEHC. 
 Follow-up 
Study enrollment will end after the subject has completed his/her investigational ultrasound exam. AEs reported 
to the site will be followed until resolution. No other follow-up procedures will be conducted. 
Any data, including de-identified images, collected for the subject, up until the time of withdrawal or 
discontinuation, may still be provided to GEHC, unless the subject requests that their data not be used. The site 
shall document all requests by subjects regarding their data use. 
6. STUDY DATA COLLECTION AND ASSESSMENTS 
Only data relevant to the conduct of the study shall be collected by the Sponsor. 
 Primary Assessment 
The device user will save the images (raw DICOM) during the conduct of the procedures. Device users 
performing the scans will periodically be asked to provide feedback on User Survey forms prepared by the 
Sponsor. 
Minimal data will also be collected per subject on a CRF, including: 
 
Date of consent/assent; 
 
Confirmation of eligibility, including age and weight; 
 
Investigational exam information [device user, procedure(s) completed (TTE and/or TEE), start/stop 
times, and probes used]. 
 Safety Assessments 
The description, severity, and device relatedness of any AE or SAE during the study will be recorded. In the 
event of any device issues, the event will be recorded. Safety reporting will be conducted as described in this 
protocol. 
7. QUALIFICATION AND TRAINING PLAN 
 Staff Qualifications 
All members of the study staff participating in the conduct of the investigation shall be qualified by education, 
training and/or experience to perform their tasks, and this shall be documented appropriately, per ISO 14155. If 
study staff or PI qualification lapses, the Sponsor will work with the site to requalify the respective role or ensure 
the duties are reassigned appropriately by the site. The Sponsor reserves the right to disqualify a PI with 
appropriate justification, such as repeated issues that impact participant safety and data integrity. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 16 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 Training Plan for the Protocol and Research Device/Product 
Before starting the study, the study staff will be trained on the clinical investigation requirements set forth in this 
study protocol. 
The following training information will be collected in the training log prior to study enrollment: 
 
Title of Training 
 
Target audience (who will be trained) 
 
Training content (including device operation, protocol review and understanding) 
Study staff directly operating or maintaining the research device or product will be trained based on the current 
available operator manual and Device Training provided by the Sponsor. 
The Principal Investigator will be ultimately responsible for execution of this study per the protocol and for device 
use in this study by members of the study staff. 
8. SAFETY 
 Anticipated Adverse Events 
 Non-invasive, or transcutaneous, ultrasound exams 
Non-invasive diagnostic ultrasound involves minimal risk because it does not utilize X-rays or other types of 
ionizing radiation. Even though manifestation of risks during diagnostic ultrasound is rare, diagnostic ultrasound 
can produce effects on the body, such as: 
Risk 
Description 
Likelihood 
Tissue warming 
In transcutaneous ultrasound, the probe may heat up slightly, 
causing sensation of warmness or heat of the skin at the site of the 
contact with probe. 
Rare. 
Cavitation 
Formation of small pockets of gas in body fluids or tissues.  
Rare.  
Skin/tissue irritation 
or injury  
Reddening, scraping, stretching, pulling, or other sensations of the 
skin/tissue that may cause minor discomfort. 
Contact with gel or disinfectants may cause allergic reactions or 
skin irritations. 
Uncommon.  
Bruising or Abrasion 
(tears) in skin or 
tissue 
Skin bruising or abrasion/tearing caused by probe placement and 
movement across the tissue.  
Uncommon. 
Infection 
There is a very low risk of infection from cross contamination of 
probe surface or gel, which is mostly theoretical in case of intact 
skin. 
Rare. 
The risk of these adverse effects is not expected to be greater for subjects in this study than those encountered 
during routine diagnostic ultrasound procedures conducted outside of the study. 
The formation of an ultrasound image necessarily requires the exposure of regions of interest to ultrasonic 
energy, part of which is absorbed in the tissue through which it propagates, and part is reflected back to the 
transducer (probe) and forms the image. Biological effects of diagnostic ultrasound include heating of the 
tissues by absorbed ultrasound energy and the risk of cavitation from pressure gradient passing through the 
tissue (such as lung tissue and bowels with gas that may enter the ultrasound field of view during cardiac 
exams). The cavitation effects of acoustic energy are most pronounced at lower than diagnostic ultrasound 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 17 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
frequencies (in kHz range, not MHz range) and the human tissues have less nucleation sites and higher 
viscosity than water and the negative pressures from diagnostic ultrasound are lower than most testing done to 
evaluate cavitation. 
 TEE Ultrasound Imaging 
TEE probes are optimized to ensure acceptable safety in terms of external atraumatic smoothness, probe size, 
trackability, steerability and maneuverability-stiffness while allowing adequate diagnostic imaging performance. 
The probes are also designed for robustness to foreseeable mishaps and reprocessing throughout their service 
life. User attentiveness is still essential for safe operation of the TEE probes. 
Invasive ultrasound scans carry inherent risks associated with invasive nature of the procedure, such as: 
Risk 
Description 
Likelihood 
Perforation 
Injury to the esophagus, throat and mouth could occur if the users are not 
appropriately trained in endoscopic procedures and familiar with the probe at 
hand. There are varied mechanisms for an esophageal perforation during a 
TEE exam. Direct mechanical trauma can cause an esophageal perforation; 
from a blind insertion and advancement of the probe; size discrepancy of the 
probe tip relative to the esophagus, and from a wide range of probe tip 
flexion and manipulation required to obtain certain images. Mechanical injury 
to esophageal tract is therefore an inherent risk due to the nature of the TEE 
procedure. The incidence, nature and severity of esophageal 
tears/perforations associated with endoscopic procedures are well 
characterized. 10Injuries vary from self-resolving (local minor bleeding), to 
life-threatening (perforation, major bleeding, infection or death) requiring 
surgery or medical treatment. Significant injuries are uncommon when 
patient is low-risk, underlying the importance of careful assessment of 
suitability of the TEE procedure for a particular patient. 
Indirect trauma of the GI tract may be related to excessive or prolonged, 
continuous pressure at the TEE probe-mucosal interface, resulting in tissue 
ischemia and necrosis. The risk can be minimized by relaxing the pressure 
and moving the probe tip to a less sensitive area. This may occur particularly 
during cardiac surgical procedures, when the TEE probe is stationed in the 
thoracic esophagus, for long durations.  
Rare. 
Bleeding 
Overstimulation of mucosa by manipulations of the TEE probe necessary to 
perform the examination may lead to tears ranging from minor to serious. 
The external surface of the probe could be damaged through impact, which 
could expose sharp edges and lead to bleeding. Pre-procedure inspection of 
the probe for defects is essential to minimize this risk, as these conditions 
are easily noticeable by user. 
Rare. 
Infection 
Cross contamination could occur if the probe is not properly reprocessed or 
is damaged or worn in such a way that micro-organisms or disinfection 
chemicals could collect inside the probe to be released when intubated. 
Requirements for high-level disinfection must be met for patient contact 
areas. 
Note, there is no adequate means to disinfect a probe that has been 
contaminated by prions, such as Creutzfeldt Jacob’s disease. In such case, 
Rare. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 18 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
the contaminated device/probe MUST BE discarded in accordance with local 
biologic waste hazard procedures. 
Bruising 
Irritation and discomfort of the throat due to placement and movement of the 
probe. 
Uncommon. 
Tissue 
warming 
In case of invasive ultrasound, the probe may heat internal tissue (e.g. 
esophageal wall), but this would not be detectable to the subject. The 
system continuously monitors probe temperature and shuts the probe down 
automatically if unsafe temperature is detected well before a burn is 
expected. 
Rare. 
Chemical 
burns 
Chemical burns can occur if the probe is not completely rinsed from residue 
of harsh disinfectants. 
Rare. 
Electric 
shock 
There are electric currents present inside the TEE probe. In extremely rare 
cases of loss of integrity of the probe the patient may get exposed to the risk 
of electric shock. Structural integrity check using leakage current are 
incorporated as part of reprocessing, thus this risk is minimized. 
Rare. 
Damage to 
dental 
fixtures 
Damage to teeth and dental prosthetics is also a concern when removing the 
probe or using bite guards. 
Uncommon. 
 
The investigational device is being used in addition to the standard of care device, so there is an increased risk 
of AEs associated with this extended procedure. The additional scan does not have risks beyond the standard 
of care procedure, but the secondary intubation may increase the overall likelihood of events occurring. 
The Vivid E95 v206 ultrasound system is investigational and has not been cleared by the FDA. However, it has 
been developed based on technologies that are well understood and used in commercial ultrasound systems 
developed and marketed by GEHC. 
There is always a chance of unexpected risks. Throughout the study, the Sponsor will evaluate and update 
safety information in study documents. 
 Adverse Event Definitions 
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 or not related to the 
investigational medical device and whether anticipated or unanticipated. This includes events related to the 
investigational device or the comparator and to the procedures involved. For users or other persons, this is 
restricted to events related to the use of investigational medical devices or comparators. 
Serious Adverse Event (SAE): an AEs that led to death; led to a serious deterioration in the health of the 
subject, users, or other persons as defined by one or more of the following: a life-threatening illness or injury, a 
permanent impairment of a body structure or a body function including chronic disease, or in-patient or 
prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to body structure or a body function; or led to fetal distress, fetal death or a congenital 
abnormality or birth defect including physical or mental impairment. Planned hospitalization for a pre-existing 
condition, or a procedure required by the protocol without serious deterioration in health, is not considered a 
SAE. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 19 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
Adverse Device Effect (ADE): an AEs related to the use of an investigational or comparator medical device. 
This includes any AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, 
installation, or operation, or any malfunction of the investigational medical device. This includes any event that is 
a result of a user error or intentional misuse of the investigational device. 
Serious Adverse Device Effect (SADE): an adverse device effect that has resulted in any of the 
consequences characteristic of a SAE. 
Unanticipated serious adverse device effect (USADE): a serious adverse device effect, which by its nature, 
incidence, severity, or outcome has not been identified in the current risk assessment. (Note, the ISO14155 
term USADE encompasses the FDA term Unanticipated Adverse Device Effect or UADE, and shall be reported 
in accordance with FDA requirements.) 
Serious health threat: signal from any AE or device deficiency that indicates an imminent risk of death or a 
serious deterioration in the health of subjects, users or other persons, and that requires prompt remedial action 
for other subjects, users or other persons. 
 Documentation of Adverse Events 
All AEs, including all SAEs, are required to be collected, investigated, and documented. AEs will be collected 
from the time the ultrasound exam begins with the investigational device to the time the subject leaves the scan 
room. All AEs will be followed through to their resolution. Documentation will include: 
 
Description of Event 
 
Date of onset 
 
Outcome, including date of resolution, unless resolution does not occur during study reporting period. In 
the instance that resolution does not occur, the status of the AE will be documented 
 
Severity (mild, moderate, or severe) 
 
Mild: Symptom(s) barely noticeable to the subject or does not make the subject uncomfortable. 
The AE does not influence performance or functioning. Prescription drugs are not ordinarily 
needed for relief of symptom(s). 
 
Moderate: Symptom(s) of a sufficient severity to make the subject uncomfortable. Performance 
of daily activities is influenced. Treatment of symptom(s) may be needed. 
 
Severe: Symptom(s) of a sufficient severity to cause the subject severe discomfort. Treatment 
for symptom(s) may be given. 
 
Serious (yes/no) 
 
Causal relationship to investigational or comparator medical device? (not related, possibly related, or 
related) 
 
Not related: The AEs is reasonably expected to be related to (or caused by) a concurrent 
illness, effect of another device/drug or other cause, and is unlikely related to the investigational 
product. 
 
Possibly related: The AEs is reasonably expected to be related to the investigational product, 
and an alternative etiology is equally or less likely compared to the potential relationship to 
investigational product. 
 
Related: There is a strong relationship to investigational product or recurs on re-challenge, and 
another etiology is unlikely or there is no other reasonable medical explanation for the event. 
 
Causal relationship to investigational procedure? (not related, possibly related, or related) 
 
Treatment given and/or action taken 
 
Anticipated (yes/no) 
 
Signals from AE that might indicate a serious health threat. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 20 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 Reporting of Safety Events 
The following events are to be reported to the Sponsor within 72 hours of the event occurrence and to the EC 
per their policy: 
 
All SAEs and USADEs 
 
All device issues that could possibly lead to an SAE 
 
Any signal from an AE that might indicate a serious health threat 
 
Unanticipated AE and unanticipated ADEs 
Additional follow-up information may be requested by the Sponsor. In addition, safety information may be 
shared with regulatory agencies and other participating sites, as required by applicable law and regulation. 
The Sponsor contact for reporting safety events: 
Research Program Integrator (see Appendix B) 
E-mail: SAE@ge.com 
 Reporting of Device Deficiencies/Complaints 
Device deficiency: an inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
usability, safety, or performance, such as malfunctions, use errors, and inadequacy in the information supplied 
by the manufacturer including labelling. 
The primary objective of this study is to collect user feedback about the investigational device. User feedback 
about the device that is provided to meet the objective of this study will not be considered device deficiencies. 
Device deficiencies/complaints should be reported to the study Sponsor contact identified on the cover page of 
this protocol. All device deficiencies/complaints will to be collected, fully investigated, and documented in the 
source document during the study reporting period. The Principal Investigator is responsible for notifying the 
Sponsor if there is any device issue that could potentially lead to a SAE. 
9. ETHICAL CONDUCT OF THE STUDY 
The study will be carried out per the protocol and with principles enunciated in the current version of the 
Declaration of Helsinki; the guidelines of GCP for medical devices, as set forth by ISO 14155 and ISO 14971; 
applicable sections of US FDA 21 Code of Federal Regulations (CFR); and applicable regulatory authority’s 
requirements of the United States. 
The study will be conducted and reported per applicable policies of the EC and governing regulatory authorities. 
If national or regional EC requirements are less strict than the requirements of GCP, such as ISO 14155 for 
medical devices, the Sponsor shall apply the requirements of this International Standard to the greatest extent 
possible, irrespective of any lesser requirements, and shall record such efforts. 
 Ethics Committee 
The responsible Principal Investigator at each site will ensure that approval from an appropriately constituted EC 
is attained for the clinical study prior to enrolling subjects, and the Principal Investigator will ensure that 
documentation of approval is maintained for the duration of the study. 
The Principal Investigator will ensure that the Sponsor is notified of any withdrawal of EC approval within 5 
working days of such occurrence. If approval is terminated or suspended, the Principal Investigator will notify the 
Sponsor and provide written explanation. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 21 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 Regulatory Agencies and Competent Authority(ies) 
The Sponsor will obtain approval from the local regulatory agency or competent authority before the start of the 
clinical trial, if necessary, per applicable local laws and regulations. Any additional requirements imposed by the 
EC or regulatory authority shall be followed, if applicable. 
 Management of Protocol Modifications and Amendments 
Substantial amendments will only be implemented after approval of the EC. Non-substantial modifications may 
be made during the normal course of device optimization, maintenance, and feasibility testing. Non-substantial 
modifications will be communicated to the competent authority (CA) as soon as possible, if applicable, and to 
the EC per their policy. 
 
Management of Protocol Deviations 
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of the 
protocol. Under emergency circumstances, deviations from the protocol to protect the rights, safety, and 
wellbeing of human subjects may proceed without prior approval of the Sponsor and the EC/CA. Such 
deviations shall be documented and reported to the Sponsor and the EC/CA as soon as possible. Deviations will 
be reported as: 
 
Critical Deviations: Deviations that significantly affect the safety, efficacy, integrity, or conduct of the 
study. These deviations must be reported to the Sponsor no later than 5 working days from awareness 
of occurrence and reported to the EC per the deviation reporting policy. 
 
Non-Critical Deviations: Protocol deviations that do not significantly affect the safety, efficacy, 
integrity, or conduct of the trial. These deviations must be documented on the CRF Protocol Deviation 
page and will be reviewed by the study monitor. 
The Sponsor will assess and implement any corrective or preventative actions necessary, such as retraining the 
study staff and PI. 
 Subject Information and Informed Consent 
The investigator or designee will explain to each subject based on their consenting/assenting age group the 
nature of the study, its purpose, the procedures involved, the expected duration of exposure to the 
investigational device (if applicable), the potential risks and benefits, and any potential discomforts. If the subject 
is too young to undergo the assent process, their parents or LARs will provide consent for the subject. Each 
subject will be informed that participation in the study is voluntary, that he/she may withdraw from the study at 
any time, and that withdrawal of consent will not affect his/her subsequent medical assistance and treatment. 
The subject and/or parents or LARs must be informed that his/her medical records may be examined by 
authorized individuals other than their treating physician. 
All potential subjects 18 years or older, and parents/LARs for minor subjects, will be provided an ICF describing 
the study and providing sufficient information to allow the subject (i) to make an informed decision about 
participation in the study, and (ii) to be fully aware of subjects’ rights under the applicable. Informed consent 
documents will be subject to approval by the EC prior to enrolling subjects in the study. Minor subjects will be 
provided an assent based on their ability to comprehend information. 
The subject, or parents/LARs, should read and consider the statement before signing and dating the ICF and 
shall be given a copy of the signed document. The ICF must also be signed and dated by the investigator (or 
his/her designee), and it shall be retained as part of the study records. 
For minor subjects, written assent will be documented in addition to written informed consent from the parents or 
LARs, such as health care surrogate, attorney in fact, judicially appointed guardian, or proxy. An assent form will 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 22 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
be provided in language appropriate for eligible subjects, and the study staff will read or explain the assent form 
to the subject, per EC policy. 
 Suspension/Early Termination of the Study 
The Sponsor, PI, EC, or regulatory authority may suspend or terminate the study prematurely for various 
significant and documented reasons. Reasons for suspension or termination may include but are not limited to 
insufficient participant recruitment, updated risk profile impacting subject safety, alterations in accepted clinical 
practice impacting study procedures, updates to software or improvement of product technology, early evidence 
of benefit or harm of the research product, or serious or repeated deviations by the investigator. 
The decision to suspend or terminate the study should be shared in writing with all parties described above. 
If the reason for study suspension is resolved, the deciding party shall inform all appropriate parties of the 
decision and actions to resume study procedures. 
10. 
STATISTICAL METHODS 
  Statistical Hypothesis 
No statistical hypothesis is being tested in this study. 
  Sample Size Determination 
Sample size is based on the Sponsor’s previous clinical experience and the number of user surveys required by 
engineering. This number is based on prior engineering development and testing experience of the Sponsor. 
Each ultrasound exam may utilize different combinations of features and probes, so multiple exams are 
necessary to assess all features. In addition, enrolling multiple subjects will allow the device to be evaluated 
across various characteristics (such as age, body habitus, and pathology), which is important to optimize the 
device for its intended use in a diverse patient population. 
  Statistical Analysis 
No statistical analysis is prospectively planned. 
 General Statistical Methods 
The study data will be presented in tables, listings, and figures, as applicable. Categorical variables will be 
described with counts, percentages, and sample size. User Surveys consist of Likert scales and qualitative 
feedback and this data will not follow a statistical analysis plan. 
 Safety Analysis 
The number of AEs, SAEs, and device issues will be reported. 
 Interim Analysis 
No interim analyses are intended to be conducted as part of this study. 
  Handling of Missing Data 
Only collected data will be included, and no imputation will be done for missing data. 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 23 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 Deviation(s) from the Original Statistical Plan 
 No statistical analysis is planned for this study. 
11. 
QUALITY ASSURANCE AND CONTROL 
  Data Management 
Data management processes for handling study data will be maintained by the Sponsor. 
  Completion of CRFs 
Paper CRFs will be used to collect data. The Sponsor will provide CRFs and train study staff on completion of 
CRFs using Good Documentation Practices. CRF Completion Guidelines (CCG) may be provided by the 
Sponsor to help facilitate training. 
CRFs are to be completed as information becomes available at the site. CRFs should be signed by indicated 
parties, in indicated area(s), to certify the contents of the form. The Principal Investigator is ultimately 
responsible for ensuring completion of CRFs. 
If discrepancies are discovered on paper CRFs during monitoring, the Sponsor’s representative will ensure that 
the study staff makes necessary corrections directly to the CRF(s) prior to collection. 
Following CRF collection, the Sponsor will review the data. A Data Clarification Form (DCF) may be provided to 
the site to correct or clarify discrepancies. 
If a site discovers discrepancies after CRF collection, the site may notify the Sponsor and request data 
modification. 
 Data Handling and Record Keeping 
All documents and data shall be produced and maintained in a manner that assures control and traceability. 
 Source Data and Documents 
Source data includes information in original records, certified copies of original records of clinical findings, 
observations, or other activities for the study. Source documents for each subject must be retained throughout 
the investigation, including printed or electronic documents containing source data. Elements should include: 
 
Source data and documentation relevant to data recorded for subject screening and CRF 
corroboration. 
 
Subject records containing the completed ICFs, assent, and CRFs. 
The study staff will maintain a regulatory binder containing the protocol and any subsequent amendments, EC 
submissions and approvals, blank ICF(s) and assent forms, and site logs. 
Operator’s manuals or written training materials may be provided by Sponsor throughout study. The Principal 
Investigator or institution shall provide direct access to source data during and after the clinical investigation for 
monitoring, audits, EC review, and regulatory authority inspections. 
  Archiving 
All study data must be archived for a minimum of 3 years after study completion or premature termination of the 
clinical trial. 
12. 
MONITORING PLAN 
In collaboration with the site, the Sponsor will ensure proper monitoring of the study to confirm that all the 
research requirements are met. Monitoring visits will oversee the progress of a clinical investigation and ensure 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 24 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
that it is conducted, recorded, and reported per the protocol, written procedures, GCP ISO 14155, and the 
applicable regulatory requirements. 
 Confidentiality and Data Protection 
The investigator affirms and upholds the principle of the participant's right to privacy, and the investigator shall 
comply with applicable privacy laws. Especially, data privacy will be ensured when presenting the data at 
scientific meetings or publishing data in scientific journals. 
Individual subject medical information obtained as a result of this study will be considered confidential, and 
disclosure to third parties will be prohibited. Subject confidentiality will be further ensured by utilizing subject 
identification code numbers. For data verification purposes, authorized representatives of the Sponsor, a CA, or 
an EC may require direct access to parts of the medical records relevant to the study, including subject medical 
history. 
 Storage of Images and Associated Health Data 
Ultrasound images and associated data will be collected and disclosed to the Sponsor as part of this study. 
Fully de-identified data, which has had all personal identifying information removed, may be stored and used by 
the Sponsor. The Sponsor and/or its authorized representatives may use any de-identified data collected in this 
study for future technology and engineering development, marketing purposes, education, regulatory 
submissions, publications, or other possible uses. 
13. 
RESEARCH AGREEMENTS 
GE Healthcare will fund this clinical investigation, which will be conducted under contractual agreements 
between the investigational sites and the Sponsor, GE Healthcare. 
  Clinical Study Report and Publication Policy 
Prior to recruitment, a description of this clinical investigation will be registered in a publicly accessible 
database. This database will be updated per regional or national requirements throughout the conduct of the 
clinical investigation. 
A clinical study report will be generated upon completion of the study. 
The results of this study may be used in future publications, per conditions described in any contractual 
agreement(s) between the investigational sites and the Sponsor. 
 
 
 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 25 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
 
APPENDIX A – STUDY SITE AND INVESTIGATOR LIST 
The following investigators at each study site will be responsible for the conduct of this study: 
Principal 
Investigator: 
 
Dr. Sanket Shah 
Principal Investigator 
Tel: (816) 302-3612 
 
e-mail: ssshah@cmh.edu 
 
The Children's Mercy Hospital 
Address:  2401 Gillham Road 
Kansas City, MO 64108-4619 
1 The role of the Principal Investigator is to implement and manage the conduct of the investigation as well as ensure data 
integrity and the rights, safety, and wellbeing of humans involved in the study. Co-Investigators or Sub-Investigators share 
only those responsibilities designated by the Principal Investigator. 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 26 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
APPENDIX B – ADMINISTRATIVE STRUCTURE OF INVESTIGATION 
 
Research 
Program 
Integrator 
(Sponsor 
Contact):  
Tracy Grzendzielewski 
Telephone: +1-414-218-6167 
E-mail: tracy.grzendzielewski@ge.com  
GE Healthcare 
Address: 9900 Innovation Drive 
 
  RP2139 
 
  Wauwatosa, WI 53226 
 
Medical 
Monitor:  
Tibor Duliskovich, MD, Medical Director 
Telephone: +1-262-391-6852 
E-mail: Tibor.Duliskovich@ge.com  
GE Healthcare 
Address: 3000 N. Grandview Blvd 
               Waukesha, WI 53188 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 27 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
APPENDIX C – AMENDMENT (PROTOCOL VERSION 1.0 TO 2.0) 
A detailed amendment is provided for version 1.0 to version 2.0. Version 1.0 was the first version to receive EC 
approval but was not implemented at the site. 
Purpose of Amendment: To incorporate changes to eligibility criteria that were requested by FDA during 
review of the Investigational Device Exemption (IDE) application for this study. 
The changes are not expected to increase subject or operator risk, affect study endpoints, or to adversely 
impact the scientific integrity or conduct of the study. 
 
Item 
Section 
Revision or Clarification 
Justification 
1 
 Synopsis; 4.5: Eligibility 
Criteria  
Updated inclusion criteria #4 and #5: “has a 
parent or legally authorized representative able 
and willing to provide written consent to 
participate” changed to “has two parents or 
legally authorized representatives able and 
willing to provide written consent to participate.”
To clarify requirement for two 
parental/LAR signatures.  
2 
 Synopsis; 4.5: Eligibility 
Criteria 
Added exclusion criteria #5 with clarifying note. 
To add exclusion criterion required by 
FDA during IDE review. 
3 
 4.4 Protection of Vulnerable 
Subjects; 4.6 Recruiting 
and Screening; 9.5 Subject 
Informed Consent 
Multiple instances where parent or LAR is 
described in the singular were changed to two 
parents/LARs. 
To clarify requirement for two 
parental/LAR signatures. 
 
 
  

Study Title: GE Cardiovascular Ultrasound Device 
Evaluation 
Study Number: 217021760 
 
 
Page 28 of 28 
DOC2608524 
 
Version 2.0; 14/Apr/2022 
Property of GE Healthcare – Confidential 
REFERENCES 
1. 
Pearson AC, Labovitz AJ, Tatineni S, Gomez CR. Superiority of transesophageal 
echocardiography in detecting cardiac source of embolism in patients with cerebral ischemia 
of uncertain etiology. J Am Coll Cardiol. 1991;17(1):66-72. 
2. 
Blum A, Reisner S, Farbstein Y. Transesophageal echocardiography (TEE) vs. transthoracic 
echocardiography (TTE) in assessing cardio-vascular sources of emboli in patients with acute 
ischemic stroke. Med Sci Monit. 2004;10(9):CR521-523. 
3. 
Salcedo EE, Quaife RA, Seres T, Carroll JD. A framework for systematic characterization of 
the mitral valve by real-time three-dimensional transesophageal echocardiography. J Am Soc 
Echocardiogr. 2009;22(10):1087-1099. 
4. 
Sugeng L, Weinert L, Lang RM. Real-time 3-dimensional color Doppler flow of mitral and 
tricuspid regurgitation: feasibility and initial quantitative comparison with 2-dimensional 
methods. J Am Soc Echocardiogr. 2007;20(9):1050-1057. 
5. 
Houck RC, Cooke JE, Gill EA. Live 3D echocardiography: a replacement for traditional 2D 
echocardiography? AJR Am J Roentgenol. 2006;187(4):1092-1106. 
6. 
Lang RM, Badano LP, Tsang W, et al. EAE/ASE recommendations for image acquisition and 
display using three-dimensional echocardiography. Eur Heart J Cardiovasc Imaging. 
2012;13(1):1-46. 
7. 
Muller S, Feuchtner G, Bonatti J, et al. Value of transesophageal 3D echocardiography as an 
adjunct to conventional 2D imaging in preoperative evaluation of cardiac masses. 
Echocardiography. 2008;25(6):624-631. 
8. 
Kesisoglou F. Use of preclinical dog studies and absorption modeling to facilitate late stage 
formulation bridging for a BCS II drug candidate. AAPS PharmSciTech. 2014;15(1):20-28. 
9. 
Nakamura K, Takagi S, Sasaki N, et al. Contrast-enhanced ultrasonography for 
characterization of canine focal liver lesions. Vet Radiol Ultrasound. 2010;51(1):79-85. 
10. 
R. V. Romero KLG. Esophageal perforation: Continuing challenge to treatment. 
Gastrointestinal Intervention. 2013;2(1):1-6. 
 
 
 
End of Document