A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease(LithoVue China Study)
Phase: NA
Conditions: Urinary Tract Disease
Sponsor: Boston Scientific Corporation

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Medical Device Clinical Trial Protocol 
 
Reference Number: U0628 
 
Protocol Title: 
A prospective, multi-center, single-arm study to evaluate the safety and efficacy 
of LithoVue ureteroscope system in Chinese patients with urinary disease 
 
Investigational Device: 
LithoVue Ureteroscope System (including flexscope catheter and workstation) 
 
Device Model: 
 
 
 
 
 
Class of device: 
 
    Class 3 medical device requiring clinical trials  Yes ☐  No☒ 
    Same class device within China  Yes ☐  No☒ 
 
Protocol version and date: Rev/AB, 2018, Mar 29 
 
Clinical trial sites: Peking University Third Hospital 
 
Principal Investigator: Ma Lulin 
 
Sponsor: BSC International Medical Trading (Shanghai) Co., Ltd, (“BSC China”) 
Agent: not applicable 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. It should be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
LithoVue Flexscope 
• 
LithoVue Standard 
M0067913500 
• 
LithoVue Reverse 
M0067913600 
LithoVue System Workstation 
• 
LithoVue System Workstation  
M0067911200 

 
 
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A prospective, multi-center, single-arm study to evaluate the safety and 
efficacy of LithoVue ureteroscope system in Chinese patients with urinary 
disease 
LithoVue China Study 
 
CLINICAL PROTOCOL 
 
BSC Project Number: U0628 
 
Sponsored By 
BSC International Medical Trading (Shanghai) Co., Ltd, (“BSC China”) 
Part A, 2nd Floor, No.68, Rijing Road, 
WaiGaoQiao Free Trade Zone, 
Shanghai, China 200131 
 
 
 
 
 
 
 
 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 

 
 
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Contact Information 
Role 
Contact  
Clinical Contact 
Peng, Lv  
Clinical Trial Manager 
BSC China 
12th Floor, Building 2, The World Profit Center 
16, Tianze Road, Chaoyang District 
Beijing 100125, P.R. China 
Email：Peng.Lv@bsci.com 
Cell：+86 18516830968 
Tele：+86 10 85216439 
Author 
Cathy Peng 
Sr. Medical Affairs Manager 
BSC China  
12th Floor, Building 2, The World Profit Center 
16, Tianze Road, Chaoyang District 
Beijing 100125, P.R. China 
Email: LinCathy.Peng@bsci.com 
Cell：+86 13910074711 
Tele：+86 10 85212906 
Coordinating Principal 
Investigator 
Prof. Lulin Ma 
Peking University Third Hospital 
No. 49, Huayuan North Road, Haidian District,  
Beijing 100191, P.R. China 
Vendors 
Quintiles IMS (DM、BIO、Safety) 
Investigational Sites 
See “LithoVue China Study site list and contact information”  
 
 
 

 
 
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Original Release: Jan 16, 2018 
Current Version: Mar 29, 2018 
Revision 
Version 
Protocol 
Date 
Template 
number and 
version 
Protocol 
Section 
Modified 
Existing Text 
as Written in 
Protocol, 
Version  
Revised/New 
Text as 
Written in 
Protocol, 
Version 
Justification 
for 
Modification 
AA 
Jan 16, 
2018 
90702637 
Rev/Ver AI 
N/A 
N/A 
N/A 
Initial release 
AB 
Mar 
29,2018 
90702637 
Rev/Ver AI 
17.4 
Sponsor 
Responsibilities
, AA 
Sponsor 
Responsibilities
, AB 
Comments of 
PI site’s EC. 
 

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2. Protocol Synopsis 
A prospective, multi-center, single-arm study to evaluate the safety and efficacy of 
LithoVue ureteroscope system in Chinese patients with urinary disease  
LithoVue China Study 
Objective(s) 
The aim of this study is to evaluate the safety and efficacy of LithoVue 
ureteroscope system in Chinese population, to support the regulatory 
approval by CFDA 
Planned 
Indication(s) for 
Use  
The LithoVue System is intended to be used to visualize organs, cavities 
and canals in the urinary tract (urethra, bladder, ureter, calyces and renal 
papillae) via transurethral or percutaneous access routes. It can also be 
used in conjunction with endoscopic accessories to perform various 
diagnostic and therapeutic procedures in the urinary tract 
Test Device 
LithoVue Ureteroscope System(including flexscope catheter and 
workstation) 
 
LithoVue Flexscope 
• 
LithoVue Standard 
M0067913500 
• 
LithoVue Reverse 
M0067913600 
LithoVue System Workstation 
• 
LithoVue System Workstation  
M0067911200 
Study Design 
Prospective, multicenter, single-arm, pre-market study 
Planned 
Number of 
Subjects 
LithoVue China study will enroll 60 patients. The enrolling cap for each 
participate center is 40 patients. 
All procedures in each participate center should be solely performed by 
experienced urologist who is skilled at therapeutic urology cases. 
Planned 
Number of 
Centers / 
Countries 
3 investigational sites in China.  
Primary 
Endpoint 
Procedure success rate of LithoVue ureteroscope system 
Procedure success is defined as: 
Scope condition is suitable to complete the procedure and not requiring 
immediate scope substitution; it is also considered as a procedure success 
if the clinical effect is the same as that from the LithoVue scope per 

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A prospective, multi-center, single-arm study to evaluate the safety and efficacy of 
LithoVue ureteroscope system in Chinese patients with urinary disease  
LithoVue China Study 
investigator’s judgement in the case of a scope change (non-LithoVue). 
Secondary 
Endpoints 
1. Procedure routes: transurethral or percutaneous access 
2. Target lesion’s size and location 
3. Procedure time: defined as the time between LithoVue catheter 
insertion and removal 
4. Hospitalization time: defined as the time between patient admission 
and discharge 
5. Stone clearance rate: clearance is defined as stone free or residual 
stone’s diameter≤4mm on KUB and urinary CT at 4W post 
procedure. 
6. Complication (Clavein-Dindo classification):  
a) fever(>38.5o) 
b) urinary tract infection requiring additional antibiotics (routine 
antibiotics is within 48 hours post procedure) 
c) Urinary sepsis, defined as infection and qSOFA score ≥2. 
(qSOFA score includes 
• the change of consciousness (Glasgow  score < 13) 
• systolic blood pressure ≤ 100 mmHg 
• respiratory frequency ≥22 times / min ) 
d) ureteral injury (moderate, medium and severer) 
e) bleeding requiring transfusion  
f) 
perirenal hematoma  
g) steinstrasse  
h) severe abdominal pain (requires additional hospitalization 
treatment or prolonged hospitalization time) 
7. Image quality: Very good, good, fair, poor, bad 
8. Maneuverability: Very good, good, fair, poor,  bad 
9. Surgeon’s overall satisfaction:  Very good, good, acceptable, poor, 
bad 
Method of 
This is a single arm study. 

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A prospective, multi-center, single-arm study to evaluate the safety and efficacy of 
LithoVue ureteroscope system in Chinese patients with urinary disease  
LithoVue China Study 
Assigning 
Patients to 
Treatment 
Follow-up 
Schedule 
Follow up points are 48±24 hours post procedure, 4W±7 days post 
procedure. 
The visit points are: 
1. Baseline 
2. Study Procedure 
3. 48±24H post procedure  
4. 4W ± 7 days post procedure  
Study Duration 
The study is expected to last 9 months after first subject enrollment. 
Participant 
Duration 
The study duration for each subject is expected to be approximately 1.5 
months. 
Inclusion 
Criteria 
1. Willing and able to provide written informed consent to participate in 
the study. 
2. Willing and able to comply with the study procedures. 
3. Diagnosed as urinary disease and indicated for flexible ureteroscope 
procedures 
4. For stone cases, the diameter of stones is less than or equal to 2cm in 
order to avoid staged procedures 
Exclusion 
Criteria 
1. Surgeries are contraindicated. 
2. Flexible ureterocope procedure is contraindicated 
3. Based on doctor’s evaluation, the patient’s medical condition doesn’t 
fit for this study 
4. For stone case, the diameter of stones is greater than 2cm.  
5. Women of childbearing potential who are or might be pregnant at the 
time of this study. 
Statistical Methods  

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A prospective, multi-center, single-arm study to evaluate the safety and efficacy of 
LithoVue ureteroscope system in Chinese patients with urinary disease  
LithoVue China Study 
Primary 
Statistical 
Hypothesis 
The Procedure success rate of LithoVue ureteroscope system is the 
primary endpoint. Published literature result regarding this index is 
95.6%. Based on previous clinical experience in China, the rate should be 
more than 85%. So 85% is chosen as the objective performance value. 
The expected success rate is 95% based on investigator’s decision. 
A hypothesis testing for the primary endpoint will be performed using 
85% as the performance goal. For procedure success rate, the 90% exact 
Clopper-Pearson confidence interval of the proportion will be calculated.  
The primary objective is met if the lower bound of the confidence interval 
(LCI) is greater than the PG,   
Statistical Test 
Method 
The procedure success rate and other index for LithoVue ureteroscope 
system will be summarized descriptively. Categorical variables will be 
tabulated with frequencies, percentages and 95% confidence intervals. 
Continuous variables will be tabulated with mean, median, standard 
deviation, minimum, maximum, and 95% confidence interval of the 
mean. 
Sample Size 
Calculation 
The sample size is calculated using according to the text book “Statistic 
for medical device clinical trials” written by Prof. Li Wei. The formula 
is : 
 
n is sample size, P0 is objective performance value, P1 is expected 
technique success rate. It is designed P1 as 0.95, P0 as 0.85, one-sided 
α=0.05，β=0.20（power=80%）. As the primary endpoint is captured in 
ureteroscope procedures, it’s not necessary to consider attrition rate. So 
the final calculated sample size is 60. 
 
 
 

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3. Table of Contents 
1. 
TITLE PAGE  ........................................................................................................................ 1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................... 5 
3. 
TABLE OF CONTENTS .......................................................................................................... 9 
3.1. Table of Figures ...................................................................................................... 12 
3.2. Table of Tables ....................................................................................................... 12 
4. 
INTRODUCTION ................................................................................................................. 13 
5. 
DEVICE DESCRIPTION ....................................................................................................... 13 
6. 
OBJECTIVES ...................................................................................................................... 14 
7. 
ENDPOINTS ........................................................................................................................ 14 
7.1 
Primary endpoint: .................................................................................................. 14 
7.2 
Secondary endpoint: .............................................................................................. 14 
8. 
STUDY DESIGN .................................................................................................................. 15 
8.1 
Scale and Duration ................................................................................................. 15 
8.2 
Treatment Assignment........................................................................................... 16 
8.3 
Justification for the Study Design ......................................................................... 16 
9. 
SUBJECT SELECTION ......................................................................................................... 16 
9.1 
Study Population and Eligibility ........................................................................... 16 
9.2 
Inclusion Criteria ................................................................................................... 16 
9.3 
Exclusion Criteria .................................................................................................. 17 
10. SUBJECT ACCOUNTABILITY .............................................................................................. 17 
10.1 Point of Enrollment ................................................................................................ 17 
10.2 Withdrawal ............................................................................................................. 17 
10.3 Enrollment Controls .............................................................................................. 18 
10.4 End-of-Study Action Plan ..................................................................................... 18 
11. STUDY METHODS .............................................................................................................. 18 

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11.1 Data Collection ....................................................................................................... 18 
11.2 Study Candidate Screening ................................................................................... 20 
11.3 Informed Consent .................................................................................................. 20 
11.4 Baseline ................................................................................................................... 20 
11.5 Index procedure ..................................................................................................... 20 
11.6 48± 24 hours post procedure ................................................................................. 21 
11.7 4 Weeks± 7 days post procedure  ........................................................................... 22 
11.8 Study Completion ................................................................................................... 23 
11.9 Source Documents .................................................................................................. 23 
12. STATISTICAL CONSIDERATIONS ....................................................................................... 23 
12.1 Endpoints ................................................................................................................ 23 
12.2 General Statistical Methods .................................................................................. 25 
12.3 Data Analyses ......................................................................................................... 26 
13. DATA MANAGEMENT ........................................................................................................ 27 
13.1 Data Collection, Processing, and Review ............................................................. 27 
13.2 Data Retention ........................................................................................................ 28 
14. AMENDMENTS ................................................................................................................... 28 
15. DEVIATIONS ...................................................................................................................... 28 
16. DEVICE/EQUIPMENT ACCOUNTABILITY .......................................................................... 29 
17. COMPLIANCE ..................................................................................................................... 30 
17.1 Statement of Compliance ....................................................................................... 30 
17.2 Investigator Responsibilities ................................................................................. 31 
17.3 Institutional Review Board/ Ethics Committee ................................................... 34 
17.4 Sponsor Responsibilities ........................................................................................ 34 
17.5 Insurance ................................................................................................................. 36 
18. MONITORING ..................................................................................................................... 36 
19. POTENTIAL RISKS AND BENEFITS .................................................................................... 37 
19.1 Anticipated Adverse Events .................................................................................. 37 
19.2 Anticipated Adverse Device Effects ...................................................................... 38 

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19.3 Risks Associated with the Study Device(s) ........................................................... 38 
19.4 Risks associated with Participation in the Clinical Study .................................. 38 
19.5 Possible Interactions with Concomitant Medical Treatments ........................... 39 
19.6 Risk Minimization Actions .................................................................................... 39 
19.7 Anticipated Benefits ............................................................................................... 39 
19.8 Risk to Benefit Rationale ....................................................................................... 39 
20. SAFETY REPORTING .......................................................................................................... 39 
20.1 Reportable Events by investigational site to Boston Scientific .......................... 39 
20.2 Definitions and Classification ............................................................................... 40 
20.3 Relationship to Study Devices ............................................................................... 42 
20.4 Investigator Reporting Requirements .................................................................. 44 
20.5 Boston Scientific Device Deficiencies .................................................................... 45 
20.6 Reporting to Regulatory Authorities / ECs / Investigators ................................ 46 
21. INFORMED CONSENT......................................................................................................... 46 
22. COMMITTEES .................................................................................................................... 48 
22.1 Safety Monitoring Process ..................................................................................... 48 
23. SUSPENSION OR TERMINATION ........................................................................................ 49 
23.1 Premature Termination of the Study ................................................................... 49 
23.2 Termination of Study Participation by the Investigator or Withdrawal of EC 
Approval ................................................................................................................. 50 
23.3 Requirements for Documentation and Subject Follow-up ................................. 50 
23.4 Criteria for Suspending/Terminating a Study Center ........................................ 50 
24. PUBLICATION POLICY ....................................................................................................... 51 
25. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS .................................................. 52 
25.1 Subject Reimbursement......................................................................................... 52 
25.2 Compensation for Subject’s Health Injury ......................................................... 52 
26. BIBLIOGRAPHY .................................................................................................................. 52 
27. ABBREVIATIONS AND DEFINITIONS .................................................................................. 52 
 
 

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3.1. Table of Figures 
Figure 8.1-1: LithoVue China Study Design .......................................................................... 16 
 
3.2. Table of Tables 
Table 11.1-1: Data Collection Schedule ................................................................................. 19 
Table 11.9-1: Source Documentation Requirements .............................................................. 23 
Table 20.1-1: Safety Reporting Definitions ............................................................................ 40 
Table 20.2-1: Criteria for Assessing Relationship of Study Device to Adverse Event .......... 43 
Table 20.3-1: Investigator Reporting Requirements ............................................................... 44 
Table 27-1: Abbreviations ...................................................................................................... 53 
 

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4. Introduction 
The development of reusable flexible ureteroscopes is a novel innovation to diagnose or treat 
upper urinary tract. Comparing open surgery, during the past two decades, flexible 
ureteroscopes provided major diagnostic and treatment advantages concerning most upper 
urinary tract (UUT) pathologies, with reduction of associated morbidity. Flexible 
ureteroscopy has allowed for visual inspection of the entire collecting system.[1,2] 
The designs of traditional reusable ureteroscopes, however, result in progressive deterioration 
of scope performance. Sterilization requires dedicated equipment, staff, and time. 
Decontamination has failed in the past and confers a risk of transmitting infection.[3,4] 
As re-usable flexible fiber-optic or digital ureteroscope which has the potential increased risk 
for scope damage and repair costs compared to single-use scopes, LithoVue system, a 
single-use, digital, disposable flexible ureteroscope, was introduced to market. 
This study aimed to evaluate the safety and efficacy of LithoVue ureteroscope system in 
Chinese population, to support the regulatory approval by CFDA. 
5. Device Description 
The LithoVue System is a software-controlled digital flexible ureteroscope system that 
consists of the LithoVue System Workstation (Touch PC and Cart) and the LithoVue Single-
Use Digital Flexible Ureteroscope (sterile, single-use disposable) catheter.  
The LithoVue Single-Use Digital Flexible Ureteroscope catheter is a sterile, single-use 
device comprised of two main components: a handle with articulation controls and accessory 
access ports, and a flexible shaft portion. The LithoVue Single-Use Digital Flexible 
Ureteroscope catheter is also referred to as the LithoVue Flexscope or ureteroscope in these 
instructions. The LithoVue Flexscope catheter is used by physicians to access, visualize, and 
perform procedures in the urinary tract. The ureteroscope enables delivery and use of 
accessories such as biopsy forceps, laser fibers, guidewires, graspers and retrieval baskets at 
a surgical site. The distal tip of the ureteroscope articulates to 270 degrees in two directions, 
and the distal tip can be rotated a total of 360 degrees by rotating the handle. In addition, the 
shaft of the ureteroscope features a secondary deflection that is passive. 
The LithoVue System Workstation is referred to as the System Workstation, and the 

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LithoVue Single-Use Digital Flexible Ureteroscope is referred to as the LithoVue Flexscope 
in these instructions. 
The LithoVue Flexscope connects to the System Workstation via the Flexscope Connector 
Cable Plug Receptacle (hereafter referred to as Workstation Receptacle) on the front of the 
System Workstation. 
The LithoVue System is designed to allow physicians to access, visualize, and perform 
procedures in the urinary tract, using appropriate accessory devices (e.g., baskets, laser fibers, 
and forceps). 
6. Objectives 
The aim of this study is to evaluate the safety and efficacy of LithoVue ureteroscope system 
in Chinese population, to support the regulatory approval by CFDA. 
7. Endpoints 
7.1 Primary endpoint: 
Procedure success rate of LithoVue ureteroscope system. 
Procedure success is defined as: 
Scope condition is suitable to complete the procedure and not requiring immediate scope 
substitution; it is also considered as a procedure success if the clinical effect is the same as 
that by the LithoVue scope per investigator’s judgement in the case of a scope change (non-
LithoVue). 
7.2 Secondary endpoint: 
1. Procedure routes: transurethral or percutaneous access 
2. Target lesion’s size and location 
3. Procedure time: defined as the time between LithoVue catheter insertion and removal 
4. Hospitalization time: defined as the time between patient admission and discharge 
5. Stone clearance rate: clearance is defined as stone free or residual stone’s diameter≤4mm 
on KUB and urinary CT at 4W post procedure 

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6. Complication(Clavein-Dindo classification):  
a) fever(>38.5o) 
b) urinary tract infection requiring additional antibiotics (routine antibiotics is within 
48 hours post procedure) 
c) Urinary sepsis, defined as infection and qSOFA score ≥2. (qSOFA score includes  
• 
the change of consciousness (Glasgow  score < 13) 
• 
systolic blood pressure ≤ 100 mmHg 
• 
respiratory frequency ≥22 times / min ) 
d) ureteral injury (moderate, medium and severer) 
e) bleeding requiring transfusion 
f) 
perirenal hematoma 
g) steinstrasse 
h) severe abdominal pain (requires additional hospitalization treatment or prolonged 
hospitalization time) 
7. Image quality: Very good, good, fair, poor, bad 
8. Maneuverability: Very good, good, fair, poor, bad 
9. Surgeon’s overall satisfaction:  Very good, good, acceptable, poor, bad 
8. Study Design 
This study is a prospective, multicenter, single-arm, pre-market study. 
8.1 Scale and Duration 
This study will be conducted at 3 centers in China.  Data will be collected at least 60 patients. 
All participating patients will sign the informed consent form approved at the participating 
center per local requirements. 
 
 
 
 
 
 

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Figure 3.2-1: LithoVue China Study Design 
 
ICF & Screening 
 
       
Index Procedure 
  
48±24 Hours follow up Visit 
 
4 weeks ±7 days Visit  
 
Study Exit 
8.2 Treatment Assignment 
Subjects in this trial will not be randomized. Eligible subjects will be considered as enrolled 
into LithoVue China Study at the time of sheath is accessed into the urinary tract or 
percutaneous route is established. 
8.3 Justification for the Study Design 
This study is designed to evaluate the safety and efficacy of LithoVue ureteroscope system in 
Chinese population, to support the regulatory approval by CFDA. 
9. Subject Selection  
9.1 Study Population and Eligibility  
The study population is all patients who need diagnostic or therapeutic flexible ureteroscopy 
procedures. 
9.2 Inclusion Criteria 
Subjects who meet all of the following criteria may be given consideration for inclusion in 
this clinical investigation, provided no exclusion criteria are met (see 9.3).  
1. Willing and able to provide written informed consent to participate in the study 
2. Willing and able to comply with the study procedures 

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3. Diagnosed as urinary disease and indicated for flexible ureteroscope procedure 
4. For stone cases, the diameter of stones is less than or equal to 2cm in order to avoid 
staged procedures 
9.3 Exclusion Criteria 
Subjects who meet any one of the following criteria will be excluded from this clinical study. 
1. Surgeries are contraindicated 
2. Flexible ureterocope procedure is contraindicated 
3. Based on doctor’s evaluation, the patient’s medical condition doesn’t fit for this study 
4. For stone cases, the diameter of stones is greater than 2cm 
5. Women of childbearing potential who are or might be pregnant at the time of this study 
10. Subject Accountability 
10.1 Point of Enrollment 
The point of enrollment is the time when sheath is accessed into the urinary tract or 
percutaneous route is established. 
10.2 Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented. The Investigator may 
discontinue a subject from participation in the trial if the Investigator feels that the subject 
can no longer fully comply with the requirements of the trial or if any of the trial procedures 
are deemed potentially harmful to the subject. If any subjects withdraw from the study, the 
replaced subjects shall be enrolled, to meet study designed sample size. If a subject 
withdraws from the clinical investigation, the reason(s) shall be recorded. If such withdrawal 
is due to problems related to investigational device safety or performance, the investigator 
shall ask for the subject’s permission to follow his/her status/condition outside of the clinical 

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study. Data that have already been collected on withdrawn subjects will be retained and used 
for analysis but no new data will be collected after withdrawal. 
10.3 Enrollment Controls 
The enrolling cap for each participate center is 40 patients.  
10.4 End-of-Study Action Plan 
After end of the study, subjects will continue receiving routine clinical practice. 
11. Study Methods 
11.1 Data Collection 
This study will collect data on: 
1. Procedure success rate of LithoVue ureteroscope system 
Procedure success is defined as: 
Scope condition is suitable to complete the procedure and not requiring immediate scope 
substitution; it is also considered as a procedure success if the clinical effect is the same 
as that by the LithoVue scope per investigator’s judgement in the case of a scope change 
(non-LithoVue). 
2. Procedure routes: transurethral or percutaneous access 
3. Target lesion’s size and location 
4. Procedure time: defined as the time between LithoVue catheter insertion and removal 
5. Hospitalization time: defined as the time between patient admission and discharge 
6. Stone clearance rate: clearance is defined as stone free or residual stone’s diameter≤4mm 
on KUB and urinary CT at 4W post procedure. 
7. Complication (Clavein-Dindo classification):  
a) fever(>38.5o) 
b) urinary tract infection requiring additional antibiotics (routine antibiotics is within 
48 hours post procedure) 

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c) Urinary sepsis, defined as infection and qSOFA score ≥2. (qSOFA score includes 
• the change of consciousness (Glasgow  score < 13) 
• systolic blood pressure ≤ 100 mmHg 
• respiratory frequency ≥22 times / min ) 
d) ureteral injury (moderate, medium and severer) 
e) bleeding requiring transfusion 
f) 
perirenal hematoma 
g) steinstrasse 
h) severe abdominal pain (requires additional hospitalization treatment or prolonged 
hospitalization time) 
8. Image quality: Very good, good, fair, poor, bad 
9. Maneuverability: Very good, good, fair, poor, bad 
10. Surgeon’s overall satisfaction:  Very good, good, acceptable, poor, bad 
Table 3.2-1: Data Collection Schedule 
Procedure/Assessment 
Screening 
(Base Line) 
LithoVue 
Procedure 
Follow-up Visits 
48(±24)hours 
Visit  
4 weeks 
(± 7 Days) 
Visit  
Informed consent 
X 
-- 
-- 
-- 
Demographics 
X 
-- 
-- 
-- 
Physical assessment  
X 
-- 
-- 
-- 
Pregnancy test(Women of reproductive 
age) 
X 
-- 
-- 
-- 
Medical history 
X 
-- 
-- 
-- 
Procedure information 
-- 
X 
-- 
-- 
Image quality, maneuverability, Irritation 
-- 
X 
-- 
-- 
Complication and treatment 
-- 
X 
X 
X 
Hospitalization time 
-- 
-- 
-- 
X 
Urinary CT and KUB 
-- 
-- 
-- 
X 
Stone clearance 
-- 
-- 
-- 
X 
Surgeon’s satisfaction 
-- 
-- 
-- 
X 
Adverse events 
-- 
X 
X 
X 

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11.2 Study Candidate Screening 
The investigator(s) are to follow local standard of care medical practice to diagnose urinary 
system disease and determine the eligibility for flexible ureteroscope procedures. 
This will be an open-label, single-arm study. All patients who are evaluated and scheduled to 
have flexible ureteroscope procedures will be approached prior to flexible ureteroscope 
treatment to see if they are willing to participate in the study. 
11.3 Informed Consent 
Patients who are interested in participating in the study will sign an Informed Consent prior 
to undergoing flexible ureteroscope procedures. 
11.4 Baseline 
1. Age and gender 
2. Medical history including diagnosis  
3. Physical examination including blood pressure and pulse 
4. Pregnancy test(Women of reproductive age) 
5. Indication for flexible ureteroscope procedures 
11.5 Index procedure 
1. Procedure date 
2. Side: left, right, bilateral 
3. Location: bladder, ureter (proximal, middle, distal), kidney (pelvis, upper calyx, middle 
calyx, lower calyx) 
4. Size of the stone/tumor: single, multiple; diameter(mm)  
5. Angle between ureter and stone/tumor(degrees) 
6. Procedure routes: transurethral or percutaneous access 
7. Procedure time: defined as the time between LithoVue catheter insertion and  removal 

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8. Insertion of the device up to the stone/tumor 
9. Image quality vision: Very good, good, fair, poor, bad 
10. Maneuverability: Very good, good, fair, poor, bad 
11. Irrigation：Very good, good, fair, poor, bad 
12. Breakage of scope: if yes, indicate reason 
13. Procedure success:  
Procedure success defined as:  
Scope condition is suitable to complete the procedure and not requiring immediate scope 
substitution; it is also considered as a procedure success if the clinical effect is the same 
as that by the LithoVue scope per investigator’s judgement in the case of a scope change 
(non-LithoVue). 
14. Complications and treatment 
Include immediate bleeding and perforation and the corresponding the treatment(s). If 
immediate bleeding occurs, the following information needs to be collected: hemoglobin 
value, the hemostasis method and whether transfusion is used; the amount of the blood 
transfusion if applicable; and whether it is result in hemorrhagic shock. 
15. AE and treatment 
11.6 48± 24 hours post procedure 
1. Complications and treatment 
Complication (Clavein-Dindo classification):  
a) fever(>38.5o) 
b) urinary tract infection requiring additional antibiotics (routine antibiotics is within 
48 hours post procedure) 
c) Urinary sepsis, defined as infection and qSOFA score ≥2. (qSOFA score includes 
• the change of consciousness (Glasgow  score < 13) 
• systolic blood pressure ≤ 100 mmHg 

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• respiratory frequency ≥22 times / min ) 
d) ureteral injury (moderate, medium and severer) 
e) bleeding requiring transfusion  
f) 
perirenal hematoma  
g) steinstrasse  
h) severe abdominal pain (requires additional hospitalization treatment or prolonged 
hospitalization time) 
2. AE and treatment 
11.7 4 Weeks± 7 days post procedure 
1. Complications and treatment 
Complication (Clavein-Dindo classification):  
a) fever(>38.5o) 
b) urinary tract infection requiring additional antibiotics (routine antibiotics is within 
48 hours post procedure) 
c) Urinary sepsis, defined as infection and qSOFA score ≥2. (qSOFA score includes 
• the change of consciousness (Glasgow  score < 13) 
• systolic blood pressure ≤ 100 mmHg 
• respiratory frequency ≥22 times / min ) 
d) ureteral injury (moderate, medium and severer) 
e) bleeding requiring transfusion  
f) 
perirenal hematoma  
g) steinstrasse  
h) severe abdominal pain (requires additional hospitalization treatment or prolonged 
hospitalization time) 
2. Stone clearance rate: clearance is defined as stone free or residual stone’s diameter≤4mm 
on KUB and urinary CT at 4W post procedure 
3. Hospitalization time: defined as the time between patient admission and  discharge 
4. Surgeon’s overall satisfaction:  Very good, good, acceptable, poor, bad 
5. AE and treatment 

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11.8 Study Completion 
Data collection for the patient will be completed at the 4 weeks follow up evaluation. The 
patient will be exited from this study following the successful completion 4 weeks follow-up 
evaluation. 
In the event of a safety concern, the physician may continue follow-up with the 
participating patient. 
11.9 Source Documents 
Table 11.9-1 summarizes the source documents required for data collection and verification.   
Where copies of the original source document as well as printouts of original electronic 
source documents are retained, these shall be signed and dated by a member of the 
investigation center team with a statement that it is a true reproduction of the original source 
document. 
Table 3.2-1: Source Documentation Requirements 
Requirement 
Disposition 
Index procedure record 
Retain at center 
Video data 
Retain at center 
Urinary CT and KUB 
Retain at center 
Adverse   Event   summary: hospitalization   records as applicable 
Retain at center 
 
12. Statistical Considerations 
12.1 Endpoints 
12.1.1. Primary Endpoint 
Procedure success rate of LithoVue ureteroscope system. 
Procedure success is defined as: 
Scope condition is suitable to complete the procedure and not requiring immediate scope 
substitution; it is also considered as a procedure success if the clinical effect is the same as 

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that by the LithoVue scope per investigator’s judgement in the case of a scope change (non-
LithoVue). 
12.1.1.1. Hypotheses 
The Procedure success rate of LithoVue ureteroscope system is the primary endpoint. 
Published literature result regarding this index is 95.6% [5]. Based on previous clinical 
experience in China, the rate should be more than 85%. So 85% is chosen as the objective 
performance value. The expected success rate is 95% based on the investigator’s decision. 
A hypothesis testing for the primary endpoint will be performed using 85% as the PG. For 
procedure success rate endpoint, the 90% exact Clopper-Pearson confidence interval of the 
proportion will be calculated.  The primary objective is met if the lower bound of the 
confidence interval (LCI) is greater than the PG. 
12.1.1.2. Sample Size  
The sample size is calculated using according to the text book “Statistic for medical device 
clinical trials” written by Prof. Li Wei. The formula is: 
 
n is sample size, P0 is objective performance value, P1 is expected technique success rate. It 
is designed P1 as 0.95, P0 as 0.85, one-sided α=0.05，β=0.20（power=80%）. As the 
primary endpoint is captured in ureteroscope procedures, it’s not necessary to consider 
attrition rate. So the final calculated sample size is 60. 
12.1.1.3. Statistical Methods 
The procedure success rate and other endpoints for LithoVue ureteroscope system will be 
summarized descriptively. Categorical variables will be tabulated with frequencies, 
percentages and 95% confidence intervals. Continuous variables will be tabulated with mean, 
median, standard deviation, minimum, maximum, and 95% confidence interval of the mean. 
12.1.2. Secondary Endpoints 
1. Procedure routes: transurethral or percutaneous access 

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2. Target lesion’s size and location 
3. Procedure time: defined as the time between LithoVue catheter insertion and removal 
4. Hospitalization time: defined as the time between patient admission and discharge 
5. Stone clearance rate: clearance is defined as stone free or residual stone’s diameter≤4mm 
on KUB and urinary CT at 4W post procedure 
6. Complication (Clavein-Dindo classification):  
a) fever(>38.5o) 
b) urinary tract infection requiring additional antibiotics (routine antibiotics is within 
48 hours post procedure) 
c) Urinary sepsis (defined as infection and qSOFA score ≥2. (qSOFA score includes 
• 
the change of consciousness (Glasgow  score < 13) 
• 
systolic blood pressure ≤ 100 mmHg 
• 
respiratory frequency ≥22 times / min ) 
d) ureteral injury (moderate, medium and severer) 
e) bleeding requiring transfusion 
f) 
perirenal hematoma 
g) steinstrasse 
h) severe abdominal pain (requires additional hospitalization treatment or prolonged 
hospitalization time) 
7. Image quality: Very good, good, fair, poor, bad 
8. Maneuverability: Very good, good, fair, poor, bad 
9. Surgeon’s overall satisfaction:  Very good, good, acceptable, poor, bad 
12.2 General Statistical Methods 
12.2.1. Analysis Sets 
Safety analysis set will be comprised of all subjects that sheath is accessed into the urinary 
tract or percutaneous route is established.  

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Efficacy analysis set will be comprised of all subjects that sheath is accessed into the urinary 
tract or percutaneous route is established. 
12.2.2. Number of Subjects per Investigative Site 
The enrollment cap for each participating center is 40 patients. 
12.3 Data Analyses 
1. The following endpoints will be summarized at index procedure: 
(1) Procedure success rate 
(2) Procedure route 
(3) Procedure time 
(4) Target lesion’s size and location 
(5) Image quality 
(6) Maneuverability 
(7) Complication 
2. The following endpoints will be summarized at 48 hours post procedure: 
(1) Complication 
3. The following endpoints will be summarized at 4 weeks post procedure: 
(1) Complication 
(2) Stone clearance 
(3) Hospitalization time 
(4) Surgeon’s overall satisfaction 
12.3.1. Interim Analyses  
No formal interim analyses are planned for this study. 

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12.3.2. Justification of Pooling 
This study will be conducted under a common protocol for each investigational site with the 
intention of pooling the data for analyses. Every effort  will  be  made  to  promote  
consistency in  study  execution  at  each investigational site. 
12.3.3. Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan approved prior to performing the 
analyses. Changes from the planned statistical methods after performing the analyses will be 
documented in the clinical study report along with a reason for the deviation. 
13. Data Management 
13.1 Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) system.  
The clinical database will reside on a production server hosted by EDC. All changes made to 
the clinical data will be captured in an electronic audit trail and available for review by 
Boston Scientific Corporation (BSC) or its representative. The associated RAVE software 
and database have been designed to meet regulatory compliance for deployment as part of a 
validated system compliant with laws and regulations applicable to the conduct of clinical 
studies pertaining to the use of electronic records and signatures. Database backups are 
performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data discrepancies. 
Manual and/or automatic queries will be created in the EDC system and will be issued to the 

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site for appropriate response. Site staff will be responsible for resolving all queries in the 
database. 
13.2 Data Retention 
The Investigator and site will maintain, at the investigative site, in original format all 
essential study documents and source documentation that support the data collected on the 
study subjects in compliance with ISO 14155 or International Conference on Harmonization 
(ICH)/Good Clinical Practice (GCP) guidelines, China related regulation and guideline. For 
institute, documents must be retained for at least 10 years after the end of study. For sponsor, 
documents must be retained until the study device is no longer used in market. last approval 
of a marketing application or until at least 5 years have elapsed since the formal 
discontinuation of the clinical investigation of the product. These documents will be retained 
for a longer period of time by agreement with BSC or in compliance with pertinent 
individual country laws and regulations.  
It is BSC’s responsibility to inform the Investigator and site when these documents no longer 
need to be maintained. The Investigator and site will take measures to ensure that these 
essential documents are not accidentally damaged or destroyed. If for any reason the 
Investigator and site withdraw responsibility for maintaining these essential documents, 
custody must be transferred to an individual who will assume responsibility and BSC must 
receive written notification of this custodial change. 
14. Amendments  
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals (e.g., 
IRB/EC/FDA/CA) of the revised protocol must be obtained prior to implementation. 
15. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC of any deviation from the investigational plan to protect 
the life or physical well-being of a subject in an emergency, and those deviations which 

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affect the scientific integrity of the clinical investigation. Such notice shall be given as soon 
as possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using EDC. Sites may also be 
required to report deviations to the IRB/EC, per local guidelines and government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, site re-training, or site 
discontinuation/termination) will be put into place by the sponsor. 
Deviations will be classified by BSC according to the following definitions:  
• 
Type A - Deviation to protect the life or physical well-being of a patient in an 
unforeseen emergency.  
• 
Type B - Deviation based on medical judgment.  
• 
Type C - Deviation due to misunderstanding of protocol requirements.  
• 
Type D - Deviation due to a situation that is beyond control.  
• 
Type E - Deviation due to an oversight, error or protocol non-compliance. 
Also, a major PD is a protocol deviation that directly or potentially disrupts the study 
progress (i.e., the study design, study data and results can be compromised), OR a protocol 
deviation that compromises the safety and welfare of study participants. A minor PD is a 
protocol deviation that does not disrupt study progress (i.e., the study design, study data and 
results will not be compromised), AND does not compromise the safety and welfare of study 
participants.  
16. Device/Equipment Accountability 
The investigational devices/equipment shall be securely maintained, controlled, and used 
only in this clinical study. The current BSC processes will be used to track subjects and 
device allocations during the study. 

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The sponsor shall keep records to document the physical location of all investigational 
devices from shipment of investigational devices to the investigation sites until return or 
disposal. 
Records shall be kept by the principal investigator or an authorized designee to document the 
physical location and conditions of storage of all investigational devices/equipment.  
The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the investigational devices/equipment, which shall include 
the following 
• Date of receipt 
• Manufacture date of investigational device 
• Batch number of investigational device 
• Identification of each investigational device/piece of equipment (batch number or unique 
code) 
• Expiry date, as applicable 
• Date or dates of use 
• Subject identification 
• Date on which the investigational device/piece of equipment was returned/explanted from 
subject, if applicable 
• Date of return of unused, expired, or malfunctioning investigational devices/equipment, if 
applicable. 
17. Compliance 
17.1 Statement of Compliance 
This study will be conducted in accordance with ISO 14155:2011 (2nd Edition; 2011-02-01) 
Clinical Investigation of Medical Devices for Human Subjects- GCP, or the relevant parts of 
the ICH Guidelines for GCP, ethical principles that have their origins in the Declaration of 

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Helsinki, and applicable China’s laws and regulations. The study shall not begin until the 
required approval/favorable opinion from the IRB/EC and/or regulatory authority has been 
obtained, if appropriate. Also, the study shall not begin prior to issuance of the site 
Authorization to Enroll, as provided by the sponsor. Any additional requirements imposed by 
the IRB/EC or regulatory authority shall be followed, if appropriate. 
17.2 Investigator Responsibilities 
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with the Clinical Study Agreement, the investigational 
plan/protocol, ISO 14155, ethical principles that have their origins in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing IRB/EC, and prevailing local 
and/or country laws and/or regulations, whichever affords the greater protection to the 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• Prior to beginning the study, sign the Clinical Study Agreement and Protocol Signature 
page documenting his/her agreement to conduct the study in accordance with the protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the center team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 

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• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event and observed device deficiency; and provide analysis report, which 
includes the causality assessed by both investigator and BSC and decision on study 
continuance, to IRB/EC per local and/or country requirements. 
• Report to sponsor, per the protocol requirements, all SAEs and device deficiencies that 
could have led to a SAE and potential/USADE or UADE. 
• Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
could have led to a SADE and potential/USADE or UADE, if required by applicable laws 
or regulations or this protocol or by the IRB/EC, and supply BSC with any additional 
requested information related to the safety reporting of a particular event; provides all 
required source documents related to a death event to BSC and the IEC per local 
requirements. 
• Maintain the device accountability records and control of the device, ensuring that the 
investigational device is used only by authorized/designated users and in accordance with 
this protocol and instructions/directions for use. 
• Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
monitor and respond to questions during monitoring visits. 
• Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the investigational device when it is used/ operated by the subject. 

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• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
• Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
17.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the investigator is responsible for providing appropriate 
training, are competent to perform the tasks they have been delegated and adequate 
supervision of those to whom tasks are delegated. Where there is a sub-investigator at a site, 
the sub-investigator should not be delegated the primary supervisory responsibility for the 

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site.  The investigator is accountable for regulatory violations resulting from failure to 
adequately supervise the conduct of the clinical study.  
17.3 Institutional Review Board/ Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational center will provide to the 
sponsor documentation verifying that their IRB/EC is registered or that registration has been 
submitted to the appropriate agency, as applicable according to national/regulatory 
requirements.   
A copy of the written IRB/EC and/or competent authority approval of the protocol (or 
permission to conduct the study) and Informed Consent Form, must be received by the 
sponsor before recruitment of subjects into the study and shipment of investigational 
product/equipment. Prior approval must also be obtained for other materials related to subject 
recruitment or which will be provided to the subject. 
Any amendment to the protocol will require review and approval by the IRB before the 
changes are implemented to the study.  All changes to the ICF will be IRB approved; a 
determination will be made regarding whether a new ICF needs to be obtained from 
participants who provided consent, using a previously approved ICF. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the study 
as required by local/country or IRB/EC requirements. Copies of the Investigator’s reports 
and the IRB/EC continuance of approval must be provided to the sponsor.  
17.4 Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative including Contract Research Organization (CRO) will have access to this 
information. Authorized regulatory personnel have the right to inspect and copy all records 
pertinent to this study. Study data collected during this study may be only used by BSC for 
the purposes of this study. All data used in the analysis and reporting of this study will be 
without identifiable reference to specific subject name. 

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Boston Scientific will keep subjects’ health information confidential in accordance with all 
applicable laws and regulations.  Information received during the study will not be used to 
market to subjects; subject names will not be placed on any mailing lists or sold to anyone 
for marketing purposes.  
17.4.1. Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed during implant, testing required by the protocol, 
and follow-ups. Support may include HCP training, addressing HCP questions, or providing 
clarifications to HCPs concerning the operation of BSC equipment/devices (including 
programmers, analyzers, and other support equipment). 
Typical tasks may include the following. 
• Interrogating the device or programming device parameters to investigator-requested 
settings as well as operating investigational equipment 
• Performing lead diagnostic testing using a Pacing System Analyzer or programmer to 
obtain pacing and sensing thresholds and impedance measurements 
• Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel 
• Assisting with the collection of study data from Pacing System Analyzers, programmers, 
and other equipment 
In addition, BSC personnel may perform certain activities to ensure study quality. These 
activities may include the following. 
• Observing testing or medical procedures to provide information relevant to protocol 
compliance 
• Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following.  
• Practice medicine 

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• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject without the approval and 
presence of the HCP 
• Independently collect critical study data (defined as primary or secondary endpoint data) 
• Enter data in electronic data capture systems or on paper case report forms 
17.5 Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
18. Monitoring 
Monitoring will be performed during the study, according to the study Monitoring Plan, to 
assess continued compliance with the current, approved protocol/amendment(s) and 
applicable regulations. In addition, the monitor verifies that informed consent is obtained 
from all enrolled study subjects, study records are adequately maintained, that data are 
reported in a satisfactory manner with respect to timeliness, adequacy, and accuracy, and that 
the Investigator continues to have sufficient staff and facilities to conduct the study safely 
and effectively. Pre-defined thresholds for protocol deviation and compliance once met or 
exceeded, can also trigger increased monitoring frequency and/or the implementation of 
corrective action plans at clinical sites. For the  LithoVue China trial, source documents 
include, at a minimum but not limited to, the ICF; patient medical records, including nursing 
records and laboratory records; treatment records; reports of SAEs; and device accountability 
logs. Data documented in the eCRF relevant to device deficiencies, relationship of AE to 
study device(s), procedure, and anticipatedness assessment of ADEs, may be considered 
source data for the study.  
The Investigator/institution guarantees direct access to original source documents (electronic 
or paper) by BSC personnel, their designees, and appropriate regulatory authorities. In the 
event that the original medical records cannot be obtained for a subject that is seen by a non-
study physician at a non-study institution, photocopies of the original source documents must 
be made available for review. Photocopies of original source documents related to SAEs 

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(from either the study site or a non-study institution, if applicable) must also be made 
available for submission to the BSC Safety Office as described in Section 20. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Investigator and 
relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
19. Potential Risks and Benefits 
19.1 Anticipated Adverse Events  
The following anticipated adverse events (AE) have been identified for this study, including 
but not limited to: 
• 
Bleeding  
• 
Fever 
• 
Avulsion  
• 
Sepsis 
• 
Stenosis / Stricture  
• 
Renal failure 
• 
Inflammation  
• 
Perforation (ureter, renal pelvis or bladder) 
• 
Laceration  
• 
Hematuria 
• 
Pain  
• 
Ureteral Reflux 
• 
Discomfort  
• 
Hematoma 
• 
Urinoma  
• 
Urothelial damage 
•  Infection 

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19.2 Anticipated Adverse Device Effects  
From the Anticipated Adverse Events listed above, the following anticipated adverse device 
effects (ADE) have been identified for this study, but not limited to:  
• Bleeding  
• Fever 
• Avulsion  
• Sepsis 
• Stenosis / Stricture  
• Renal failure 
• Inflammation  
• Perforation (ureter, renal pelvis or bladder) 
• Laceration  
• Hematuria 
• Pain  
• Ureteral Reflux 
• Discomfort  
• Hematoma 
• Urinoma  
• Urothelial damage 
•  Infection 
19.3 Risks Associated with the Study Device(s)  
No incremental risks that are associated with the study device and are above those of market 
available products.  
19.4 Risks associated with Participation in the Clinical Study 
Subjects participating in this study will be exposed to similar risks shared by all subjects who 
undergo flexible ureteroscope procedure with similar device but are not in this study. 

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19.5 Possible Interactions with Concomitant Medical Treatments 
No additional medical treatments are prescribed for participation in the study. Patients are 
undergoing flexible ureteroscope procedure that is prescribed by their surgeon. 
19.6 Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject selection 
criteria, close monitoring of the subject's physiologic status during research procedures and/or 
follow-ups and by promptly supplying BSC with all pertinent information required by this 
protocol. 
19.7 Anticipated Benefits 
The participation of subject contributes to expand the knowledge base with respect to 
LithoVue ureteroscope system in Chinese population, which may assist Investigators in their 
device choice of treating any future patients with urinary disease in flexible ureteroscope 
procedure. 
19.8 Risk to Benefit Rationale 
The therapeutic effectiveness of LithoVue ureteroscope system is proven using the evaluated 
literature.   
The use of LithoVue ureteroscope system does not involve any incalculable risks for the 
experienced user.  The risk/benefit assessment is positive. 
20. Safety Reporting 
20.1 Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
• All Adverse Events 
• All Serious Adverse Events 
• All Investigational Device Deficiencies  

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• Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
• New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Any AE event required by the protocol, experienced by the study subject after informed 
consent and once considered enrolled in the study (as defined in study subject classification 
section), whether during or subsequent to the procedure, must be recorded in the eCRF. 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the investigation. Death should not be recorded as an AE, but 
should only be reflected as an outcome of one (1) specific SAE (see Table 3.2-1 for AE 
definitions). 
Refer to Section 19 for the known risks associated with the study device(s). 
20.2 Definitions and Classification 
Adverse event definitions are provided in Table 3.2-1. Administrative edits were made on the 
safety definitions from ISO 14155 and MEDDEV 2.7/3for clarification purposes. 
Table 3.2-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, whether or not related to the investigational 
medical device.  
NOTE 1: This includes events related to the investigational medical device 
or comparator. 
NOTE 2: This definition includes events related to the procedures involved 
(any procedure in the clinical investigation plan). 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the investigational medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155 
Adverse event related to the use of an investigational medical device 
NOTE 1: This definition includes any adverse event resulting from 

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Table 3.2-1: Safety Definitions 
Term 
Definition 
 
Ref: MEDDEV 2.7/3 
insufficient or inadequate instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the investigational medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse event that: 
a) Led to death, 
b) Led to  serious deterioration in the health of the subject, that either 
resulted in: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient  or prolonged hospitalization of existing hospitalization, 
or 
4) medical or surgical intervention to prevent life-threatening illness 
or injury or permanent impairment to a body structure or a body 
function 
c) Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
 
Unanticipated Adverse Device 
Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree 
of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare 
of subjects.   
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
 
 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current version of the risk analysis 
report. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect 
which by its nature, incidence, severity or outcome has been identified in the 
risk analysis report. 
Device Deficiency 
 
Ref: ISO 14155 
A device deficiency is any inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. 
NOTE 1: Device deficiencies include malfunctions, misuse or use errors, 

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Table 3.2-1: Safety Definitions 
Term 
Definition 
 
Ref: MEDDEV 2.7/3  
and inadequate labeling. 
 
 
Device deficiencies and other device issues should not be reported as AEs. Instead, they 
should be reported on the appropriate eCRF per the study CRF Completion Guidelines. If an 
AE results from a device deficiency or other device issue, the AE should be reported on the 
appropriate eCRF. 
In-patient hospitalization is defined as the subjects being admitted to the hospital, with the 
following exceptions. 
• A hospitalization that is uncomplicated and elective/planned (i.e., planned prior to 
enrollment) does not have to be reported as an SAE. 
• If complications or AEs occur during an elective/planned (i.e., planned prior to 
enrollment) hospitalization after enrollment, the complications and AEs must be reported 
as AEs or SAEs if they meet the protocol-specified definitions. However, the original 
elective/planned hospitalization(s) itself should not be reported as an SAE. 
20.3 Relationship to Study Devices 
The Investigator must assess the relationship of the reportable AE to the study device or 
procedure. See criteria in  Error! Reference source not found.: 

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Table 3.2-1: Criteria for Assessing Relationship of Study Device/Procedure to Adverse 
Event 
Classification 
Description 
Not Related 
 
Relationship to the device or procedures can be excluded when: 
- the event is not a known side effect of the product category the 
device belongs to or of similar devices and procedures; 
- the event has no temporal relationship with the use of the 
investigational device or the procedures; 
- the serious event does not follow a known response pattern to the 
medical device (if the response pattern is previously known) and is 
biologically implausible; 
- the discontinuation of medical device application or the reduction of 
the level of activation/exposure - when clinically feasible – and 
reintroduction of its use (or increase of the level of 
activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ not expected to be 
affected by the device or procedure; the serious event can be attributed 
to another cause (e.g. an underlying 
or concurrent illness/ clinical condition, an effect of another device, 
drug, treatment or other risk factors); 
- the event does not depend on a false result given by the 
investigational device used for diagnosis, when applicable; harms to 
the subject are not clearly due to use error; 
- In order to establish the non-relatedness, not all the criteria listed 
above might be met at the same time, depending on the type of 
device/procedures and the serious event. 
Unlikely Related 
 
The relationship with the use of the device seems not relevant and/or 
the event can be reasonably explained by another cause, but additional 
information may be obtained. 
Possibly Related 
 
The relationship with the use of the investigational device is weak but 
cannot be ruled out completely. Alternative causes are also possible 
(e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment). Cases were relatedness 
cannot be assessed or no information has been obtained should also be 
classified as possible. 
Probably Related 
 
The relationship with the use of the investigational device seems 
relevant and/or the event cannot reasonably explained by another 
cause, but additional information may be obtained. 
Causal 
Relationship 
The serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 

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Table 3.2-1: Criteria for Assessing Relationship of Study Device/Procedure to Adverse 
Event 
Classification 
Description 
 
- the event is a known side effect of the product category the device 
belongs to or of similar devices and procedures; 
- the event has a temporal relationship with investigational device 
use/application or procedures; 
- the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical 
device (if the response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the 
level of activation/exposure) and reintroduction of its use (or increase 
of the level of activation/exposure), impact on the serious event (when 
clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or 
treatment) have been adequately ruled out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the investigational 
device used for diagnosis, when applicable; 
- In order to establish the relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of 
device/procedures and the serious event. 
 
20.4 Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 3.2-1. 
The study will collect all adverse events for participating subjects and analyze 
procedure/device related adverse events for participating subjects.  
Table 3.2-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
Unanticipated Adverse Device 
Effect / Unanticipated Serious 
Adverse Device Effect  
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 24 hours of first 
becoming aware of the 
event  
Serious Adverse Event 
Complete AE eCRF page 
• Within 24 hours of first 

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Table 3.2-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
with all available new and 
updated information.  
becoming aware of the 
event  
Provide all relevant source 
documentation of the reported 
event 
d) When documentation is 
available 
Serious Adverse Device 
Effects 
Complete AE eCRF page 
with all available new and 
updated information.  
• Within 24 hours of first 
becoming aware of the 
event  
Provide all relevant source 
documentation of the reported 
event 
e) When documentation is 
available 
Device Deficiencies (including 
but not limited to failures, 
malfunctions, and product 
nonconformities) 
Note: Any Investigational 
Device Deficiency that might 
have led to a serious adverse 
event if a) suitable action had 
not been taken or b) 
intervention had not been 
made or c) if circumstances 
had been less fortunate is 
considered a reportable event. 
Complete AE eCRF page 
with all available new and 
updated information. 
f) Within 24 hours of first 
becoming aware of the 
event  
Adverse Event including 
Adverse Device Effects 
Complete AE eCRF page, 
which contains such 
information as date of AE, 
treatment of AE resolution, 
assessment of seriousness and 
relationship to the device. 
Within 10 business days 
after becoming aware of 
the information  
 
20.5 Boston Scientific Device Deficiencies 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and labeling errors) will be documented and reported to BSC. If 
possible, the device(s) should be returned to BSC for analysis. Instructions for returning the 
investigational device(s) will be provided. If it is not possible to return the device, the 

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investigator should document why the device was not returned and the final disposition of the 
device. Device failures and malfunctions should also be documented in the subject’s medical 
record. 
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are not to be reported as adverse events. However, if there is an adverse 
event that results from a device failure or malfunction, that specific event would be recorded 
on the appropriate eCRF. 
And, any Investigational Device Deficiency that might have led to a serious adverse event if 
a) suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate is considered a reportable event, and should be 
reported according to Table 3.2-1. 
20.6 Reporting to Regulatory Authorities / ECs / Investigators 
Boston Scientific Corporation will notify all participating study centers if 
UADE/USADE/SAEs/SADEs or device deficiency occur which imply a possible increase in 
the anticipated risk of the procedure or use of the device or if the occurrence of certain 
SAEs/SADEs demands changes to the protocol or the conduct of the study in order to further 
minimize the unanticipated risks. 
Boston Scientific Corporation is responsible for reporting AE and device deficiencies 
information to all participating investigators, IRBs/IECs, and regulatory authorities as 
applicable according to China local reporting requirements. 
According to China local reporting requirements, Boston Scientific Corporation will report 
all SAEs  and device deficiencies that could lead to SAEs to the local regulatory authorities 
within 5 business days of BSC first becoming aware of the event, and notify all participating 
investigators/sites and IRBs/ECs in a timely manner.  
21. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
all subjects or their legally authorized representative. The Investigator is responsible for 

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ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable. The ICF must be 
approved by BSC or its delegate (e.g. CRO), the center’s IRB/EC, or central IRB, if 
applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative center’s IRB/EC.  Any modification requires approval from BSC prior to use of 
the form.  The ICF must be in a language understandable to the subject and if needed, BSC 
will assist the center in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC approval prior to their use.  Privacy language shall be included in the 
body of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study.  

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 The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the center and a copy of the signed and dated document and 
any other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements (e.g., FDA requirement is within 5 working days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Boston Scientific approval is required if changes to the revised ICF are 
requested by the center’s IRB/EC. The IRB/EC will determine the subject population to be 
re-consented. 
22. Committees 
22.1 Safety Monitoring Process 
To promote early detection of safety issues, BSC safety team and its delegated CRO Safety 
team will provide review, process, monitor and evaluations of safety events as defined in the 
study-specific safety plan. Success of this program requires dynamic collection of 
unmonitored data as soon as the event is reported. 

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 During regularly scheduled monitoring visits, clinical research monitors will support the 
dynamic reporting process through their review of source document information and other 
data information. The BSC Medical Safety group includes physicians with expertise in 
urinary surgery and with the necessary therapeutic and subject matter expertise to evaluate 
and classify the events into the categories outlined above. 
23. Suspension or Termination 
23.1 Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or business reasons and reasons related 
to protection of subjects.  Investigators, associated IRBs/ECs, and regulatory authorities, as 
applicable, will be notified in writing in the event of study termination. 
23.1.1. Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
• Important information that impacts the progression of the study (e.g. safety or production 
performance). 
• Regulatory authorities decide to terminate the study. 
• A decision on the part of Boston Scientific to suspend or discontinue development of the 
device.  
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
Note: According to requirements in section20, even if the LithoVue China study is 
terminated, subjects with study device(s) shall be followed up for AE, SAE, SADE and 
device deficiency, which are to be assessed and reported. 

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23.2 Termination of Study Participation by the Investigator or Withdrawal of 
EC Approval 
Any investigator, or IRB/ EC/ REB in the LithoVue China study may discontinue 
participation in the study or withdrawal approval of the study, respectively, with suitable 
written notice to Boston Scientific. Investigators, associated ECs, and regulatory authorities, 
as applicable, will be notified in writing in the event of these occurrences. 
23.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating centers by Boston Scientific. 
The IRB/EC and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB or EC terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by Boston Scientific. 
In the event an investigator terminates participation in the study, study responsibility will be 
transferred to a co-investigator, if possible. In the event there are no opportunities to transfer 
investigator responsibility; detailed information on how enrolled subjects will be managed 
thereafter will be provided by Boston Scientific. 
The investigator must return all documents and investigational product to Boston Scientific, 
unless this action would jeopardize the rights, safety, or welfare of the subjects. 
23.4 Criteria for Suspending/Terminating a Study Center 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
site at any time after the study initiation visit if no subjects have been enrolled for a period 
beyond 3 months after site initiation, or if the site has multiple or severe protocol 
deviations/noncompliance without justification and/or fails to follow remedial actions. 

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In the event of termination of site participation, all study devices and testing equipment, as 
applicable, will be returned to BSC unless this action would jeopardize the rights, safety or 
well-being of the subjects. The EC and regulatory authorities, as applicable, will be notified. 
All subjects enrolled in the study at the site will continue to be followed till end of the study. 
The Principal Investigator at the site must make provision for these follow-up visits unless 
BSC notifies the investigational site otherwise. 
According to section20, all subjects with study device(s) shall be followed up for AEs, which 
are to be assessed and reported. The Principal Investigator at the site must make provision for 
these follow-up visits unless BSC notifies the investigational site otherwise. 
24. Publication Policy 
In accordance with the Corporate Policy on the Conduct of Human Subject Research, BSC 
requires disclosure of its involvement as a sponsor or financial supporter in any publication 
or presentation relating to a BSC study or its results. In accordance with the Corporate Policy 
for the Conduct of Human Subject Research, BSC will submit study results for publication 
(regardless of study outcome) following the conclusion or termination of the study. Boston 
Scientific Corporation adheres to the Contributorship Criteria set forth in the Uniform 
Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed. 
• All authorship and contributorship requirements as described above must be followed. 
• BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  

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25. Reimbursement and Compensation for Subjects 
25.1 Subject Reimbursement 
Travel and other expenses incurred by subjects as a result of participation in the study will be 
reimbursed in accordance with pertinent country laws and regulations and per the study site’s 
regulations. 
25.2 Compensation for Subject’s Health Injury 
Boston Scientific Corporation will purchase an insurance policy to cover the cost of potential 
health injury for study subjects, if required by applicable law. 
26. Bibliography 
1. De la Rosette J, Denstedt J, Geavlete P, et al. The clinical research office of the 
endourological society ureteroscopy global study: Indications, complications, and 
outcomes in 11,885 patients. J Endourol 2014; 28:131–139. 
2. Turk C, Petrik A, Sarica K, et al. EAU guidelines on interventional treatment for 
urolithiasis. Eur Urol 2016; 69: 475–482. 
3. Carey RI, Gomez CS, Maurici G, et al. Frequency of ureteroscope damage seen at a 
tertiary care center. J Urol 2006; 176:607–610; discussion 610. 
4. Carey RI, Martin CJ, Knego JR. Prospective evaluation of refurbished flexible 
ureteroscope durability seen in a large public tertiary care center with multiple surgeons. 
Urology 2014; 84:42–45. 
5. Manint U, et al. A Prospective Case–Control Study Comparing LithoVue, a Single-Use, 
Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-
Optic Ureteroscopes. Journal of Endourology. 2017;0027 
27. Abbreviations and Definitions  
Abbreviations are shown in Table 3.2-1.   
 
 

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Table 3.2-1: Abbreviations 
Abbreviation/Acronym 
Term 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BSC 
Boston Scientific 
CFDA 
China Food and Drug Administration 
CRF 
Case Report Form 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic data capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
KUB 
Kidney, Ureter, Bladder X-ray 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect