STREAMLoc- Streamlined Localization Using SCOUT® at Biopsy: An Analysis of Process Improvement, Cost Savings and Enhanced Patient Experience.
Phase: NA
Conditions: Breast Cancer
Sponsor: Merit Medical Systems, Inc.

 
 ___________________________________________________________________________________________________________  
Page 1  of 33 
 
 
 STREAMLoc v3.0 CA– 21FEB2023 
 
 
 
 
 
 
 
 
 
STREAMLoc- Streamlined Localization using SCOUT® at Biopsy: An analysis of process 
improvement, cost savings and enhanced patient experience. 
 
STREAMLoc SCOUT Registry 
 
 
 
 
Registry Plan 
Protocol Number: SCOUT2021 
 
Sponsor: 
Merit Medical Canada Ltd. 
1 Valleywood Drive, 
Unit 4 and 5 
Markham, ON L3R 5L9 
 
 
Coordinating Investigators:  
Dr. Christine Desbiens 
CHU de Québec, Hôpital St-Sacrement 
 
Dr. Isabelle Trop 
Centre hospitalier de l'Université de Montréal (CHUM) 
 
 
 
 
Version 3.0 (CA) 
21 February 2023 
(amendment to V2.0, 16JUN2021)  
 
 
 
 
CONFIDENTIAL 

STREAMLoc v3.0 (CA)- 21FEB2023 
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Protocol Signature Page – Site Principal Investigator 
Protocol Title: STREAMLoc- Streamlined Localization using SCOUT® at Biopsy: An analysis of 
process improvement, cost savings and enhanced patient experience. 
 
Protocol number: SCOUT2021 
Protocol version: v3.0 (CA) 
Protocol version date: 21FEB2023 
  
 
I have read this protocol, amendments (if any) and appendices, and agree to adhere to the requirements 
therein. 
I will provide copies of this Protocol and all pertinent information to the study personnel under my 
supervision and to the Research Ethics Board/ Institutional Review Board. I will discuss this material with 
them and ensure they are fully informed regarding the device and the conduct of the study. 
 
I will conduct the study in accordance with the protocol and the International Conference on 
Harmonization Good Clinical Practice (ICH GCP), ISO 14155:2020, national and local laws of the 
appropriate regulatory authorities, and the Declaration of Helsinki, and 21 CFR Parts 50, 54, and 56 (as 
applicable). 
 
 
 
I, the undersigned, have read and approved the protocol specified above, and agree upon the contents: 
 
 
 
Site Name___________________________ 
Principal Investigator Name _______________________ 
 
 
 
Principal Investigator (signature)____________________________ Date _______________________ 
 
 

STREAMLoc v3.0 (CA)- 21FEB2023 
Page 3  of 33 
 
Table of Contents 
1. 
Study Purpose .................................................................................................................... 10 
2. 
Background and Rationale .................................................................................................. 10 
2.1 
Breast Cancer: Clinical Background ..................................................................... 10 
2.2 
Breast Cancer & Clinical Management ................................................................ 11 
2.2.1 
Wire Localization ................................................................................................ 11 
2.2.2 
Radioactive Seed Localization ............................................................................. 11 
2.2.3 
SCOUT® Reflector ............................................................................................... 11 
2.3 
Localization at Biopsy: Rationale for the Registry ................................................ 12 
3. 
Devices ............................................................................................................................... 13 
3.1 
Device Description and Indication ....................................................................... 13 
3.2 
SCOUT® Reflector ............................................................................................... 13 
3.3 
SCOUT® Guide and Control Unit .......................................................................... 14 
3.4 
Labelling ............................................................................................................. 15 
4. 
Registry Plan ...................................................................................................................... 15 
4.1 
Objectives ........................................................................................................... 15 
4.2 
Endpoints ........................................................................................................... 15 
4.3 
Population .......................................................................................................... 15 
4.4 
Inclusion and Exclusion Criteria ........................................................................... 16 
4.5 
Design ................................................................................................................ 16 
4.6 
Inclusion Period .................................................................................................. 16 
4.6.1 
Informed Consent Process .................................................................................. 17 
4.7 
Device Period...................................................................................................... 17 
4.8 
Final Outcomes ................................................................................................... 18 
4.9 
Assessments ....................................................................................................... 19 
4.10 
Participating Centers .......................................................................................... 20 
4.11 
Sponsor responsibilities ...................................................................................... 20 
4.12 
Investigator responsibilities ................................................................................ 21 
5. 
Data Analysis & Statistics .................................................................................................... 22 
5.1 
Sample Size Calculation ...................................................................................... 22 
5.2 
Point of Inclusion ................................................................................................ 22 
5.3 
Analysis of Clinical Data ...................................................................................... 23 
5.4 
Missing, Unused & Spurious Data ....................................................................... 23 
6. 
Data Collection & Reporting ............................................................................................... 23 
6.1 
Method of Data Collection & Documentation ..................................................... 23 
6.2 
Protocol Deviations............................................................................................. 23 
6.3 
Electronic Case Report Form (eCRF) .................................................................... 23 
6.4 
Data Management .............................................................................................. 24 
6.5 
Data Quality Control & Assurance ....................................................................... 24 
6.6 
Registry Records Retention ................................................................................. 24 
7. 
Safety ................................................................................................................................. 25 
7.1 
Definition and assessment of safety related events............................................. 25 
7.2 
Reportable Events............................................................................................... 25 

STREAMLoc v3.0 (CA)- 21FEB2023 
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7.3 
Reporting of safety related events ...................................................................... 26 
7.3.1 
Severity Definition .............................................................................................. 26 
7.3.2 
Causality or Relationship to the Device and/or Procedure ................................... 27 
7.4 
Independent Physician Adjudicator ..................................................................... 27 
8. 
Measures to Minimize Bias ................................................................................................. 27 
9. 
Risks and Benefits............................................................................................................... 28 
9.1  
Risk Analysis ....................................................................................................... 28 
9.2   
Anticipated Clinical Benefits................................................................................ 28 
9.3  
Anticipated Adverse Events and Adverse Device Effects ...................................... 29 
9.4  
Steps Taken to Control or Mitigate Risks ............................................................. 29 
10. 
Quality Control & Quality Assurance ................................................................................... 30 
10.1  
Training .............................................................................................................. 30 
10.2  
Quality Assurance ............................................................................................... 30 
10.3   
Regulatory Inspections/ Audits ........................................................................... 30 
10.4  
Suspension or premature termination of the registry .......................................... 31 
11. 
Publication ......................................................................................................................... 31 
12. 
Literature References ......................................................................................................... 32 
 
 
 

STREAMLoc v3.0 (CA)- 21FEB2023 
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List of Abbreviations 
 
ADE  
Adverse Device Effect  
AE 
Adverse Event 
BCS 
Breast conserving surgery 
BI-RADS 
Breast Imaging, Reporting and Data System 
CAPA 
Corrective and preventive  actions 
CADTH 
Canadian Agency for Drugs and Technologies in Health 
CFR 
Code of Federal Regulations  
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CV 
Curriculum vitae 
DCIS 
Ductal carcinoma in situ 
DD 
Device Deficiency 
eCRF 
Electronic Case Report Form 
EMR 
Electronic Medical Record 
FDA  
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization 
ICF 
Informed Consent Form 
ICMJE 
International Committee of Medical Journal Editors 
IFU  
Instructions For Use  
ISO 
International Organization of Standardization 
IR 
Infrared                                                                                                                                                          
IRB 
Institutional Review Board 
ITT  
Intention to treat 
MRI 
Magnetic Resonance Imaging 
N 
Number (typically refers to participants) 
OR 
Operating room 
PP 
Per protocol 
REB 
Research Ethics Board 
RSL 
Radioactive Seed Localization 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis System 
SD 
Standard Deviation 
SDV 
Source Data Verification 
SM 
Safety margins 
STX 
Stereotaxis 
TOMO 
Tomosynthesis 
WL 
Wire localization 
 
 
 
 
 
 

STREAMLoc v3.0 (CA)- 21FEB2023 
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KEY ROLES AND CONTACT INFORMATION 
 
Coordinating Investigator: 
Dr. C. Desbiens, Surgeon 
Study Site: 
CHU de Québec, Hôpital St-Sacrement 
Coordinating Investigator: 
Dr. I. Trop, Radiologist 
Study Site: 
CHUM 
Sponsor: 
Merit Medical Canada 
 
 
AMENDMENT HISTORY 
 
Protocol 
Version No. 
Date Issued 
Author(s) of 
Changes 
Details of Changes Made 
v1 
5MAR2021 
Linnea Aasen-
Johnston 
Original; pre-market registry 
V2 
16JUN2021 
Linnea Aasen-
Johnston 
Change to post-market registry 
V2.0 (US) 
20SEP2022 
Linnea Aasen-
Johnston / Vicky 
Brunk 
Country specific amendment for US 
sites only 
V3.0 (CA) 
21FEB2023 
Linnea Aasen-
Johnston  
Canadian specific amendment to 
include US sites, add physician 
adjudication, include additional 
device models 
 
 
 

STREAMLoc v3.0 (CA)- 21FEB2023 
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REGISTRY SYNOPSIS 
 
Sponsor:  
Merit Medical Canada Ltd. 
1 Valleywood Drive, 
Unit 4 and 5 
Markham, ON L3R 5L9 
 
Study Title: 
Streamlined Localization using SCOUT® at Biopsy: An analysis of 
process improvement, cost savings and enhanced patient experience. 
Short Title / Study ID: 
STREAMLoc 
Protocol Version and Date:  Version 3.0 (CA) 21FEVB2023 
Trial Registration: 
NCT04815291 
Phase of Development:  
Post-market registry (Canada & US) 
Background and Rationale: 
SCOUT® has been identified as an alternative to other localization 
options, providing maximum flexibility in patient visit scheduling. In the 
COVID-19 era, it would follow that improved efficiencies, leading to a 
decrease in patient visits to the breast center, as well as reduced 
contact with the technicians prior to surgery, is the preferred treatment 
option for patient and clinician safety and reduced logistical burden. 
Taveh et al.1 showed that by deploying the SCOUT® Reflector at the 
time of tumor biopsy, the need for a second procedure to localize the 
tumor was eliminated, thus reducing the number of patient visits and 
potential COVID- 19 exposure. The authors demonstrated that wireless 
localization using the SCOUT® System was an effective and time-
efficient alternative to wire localization, resulting in excellent physician 
and patient acceptance. Parkinson et al.2 found insertion of the 
SCOUT®Reflector at biopsy resulted in at least one (1) less patient visit 
to the breast center.  
This post-market registry is intended to assess the utility of SCOUT® in 
the Canadian public and US healthcare systems with fixed resources and 
a conservative approach to patient and clinician exposure to harm (i.e., 
radiation, COVID-19 exposure, patient emotional trauma). By assessing 
the utility of reflector insertion at the time of biopsy, this study will be 
able to measure the impact on patient visits to the breast center for 
invasive procedures between biopsy and surgery, and quantify this 
value to the public healthcare system. The efficacy and safety of this 
system will be further assessed, as well as the acceptance of clinicians 
and patients.  

STREAMLoc v3.0 (CA)- 21FEB2023 
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Objective: 
Primary (Efficiency Endpoint): To demonstrate the utility of the SCOUT® 
Surgical Guidance system to improve workflow and efficiency in centers 
treating breast cancer. 
Secondary: To further evaluate the safety and performance of the 
SCOUT® Surgical Guidance system in 500 consented BI-RADS 4C/5 
patients according to the instructions for use. 
 
Endpoints:  
Primary (Efficiency Endpoint): The number of patient visits to the breast 
center for invasive procedures from the time of biopsy to surgery. 
Secondary:  
1. Device success: percent successful localization, detection and 
retrieval; 
2. Device safety: rate of device-related adverse events; 
3. Procedural success: absence of close margins (DCIS: <2mm), 
positive margins (tumor on ink) or requirement for re-excision. 
4. Duration (days) from assessment to surgery and biopsy to 
surgery;  
5. Radiologist assessment: ease of placement; ability to position 
reflector in desired location; scheduling flexibility; visibility on 
ultrasound/ mammography (immediate and late); artifact 
(Tomo/MRI if applicable). 
6. Surgeon assessment: ease of detection; ease of device retrieval. 
7. Participant satisfaction questionnaire: anxiety; convenience; 
pain; overall experience compared to expectation 
8. Process improvement with implementation of same-day biopsy 
and SCOUT® Reflector placement. 
Study Design:  
A single-arm, multicenter, non-randomized cohort study. 
The registry is divided into three periods:  
1. Inclusion Period: from registry eligibility screening until reflector 
insertion; 
2. Device Period: from reflector insertion at biopsy to removal at 
surgery; 
3. Outcomes Period: from completion of surgery to pathology 
report of outcomes. 
Inclusion / Exclusion 
Criteria: 
Inclusion Criteria: 
1. Woman >18 years and <80 years of age; 
2. Classified as BI-RADS 4C or 5; 
3. Lesion depth is <6 cm from skin surface;  
4. Non-palpable lesions; 
5. Informed consent obtained. 
Exclusion Criteria: 
1. Multicentric breast cancer; 
2. Pregnant or lactating patient; 
3. Known or suspected nickel-titanium allergy. 

STREAMLoc v3.0 (CA)- 21FEB2023 
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Study Product / 
Intervention: 
SCOUT® Reflector, SCOUT® Console, SCOUT® Handpiece -all 
components of the SCOUT® Surgical Guidance System. 
Control Intervention 
(if applicable):  
The primary endpoint of this cohort will be compared to historical 
standard of care. 
Number of Participants: 
Five hundred (500) BI-RADS 4C/5 patients undergoing biopsy of a breast 
lesion at a participating study center. 
Study Duration:  
12 -18 months 
Study Schedule: 
Reflector Insertion: Device (Reflector) will be inserted in eligible, 
consented participants at the time of biopsy as per the instructions for 
use. 
Surgery:  Reflector will be detected and retrieved at the time of breast 
surgery. Reflector performance and safety will be assessed based on 
detection and retrieval success and the rate of adverse events.  
Pathology report: Results from the pathology report will be recorded. 
Procedural success defined as the absence of close margins (DCIS: 
<2mm), positive margins (tumor on ink) or requirement for re-excision.  
 
No post-operative participant follow-up will be required. 
 
 
 

STREAMLoc v3.0 (CA)- 21FEB2023 
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1. Study Purpose 
 
The purpose of this post-market registry is to demonstrate the utility of the SCOUT® Surgical Guidance 
system to improve workflow and efficiency in Canadian and US centers treating breast cancer by reducing 
the number of patient visits for invasive procedures required from biopsy to surgery. 
To further evaluate the safety and performance of the SCOUT® Surgical Guidance system in 500 consented 
Breast Imaging, Reporting and Data System (BI-RADS) 4C/5 patients according to the instructions for use 
(IFU).  
Patient selection for biopsy will be performed according to current clinical practice at participating sites. 
2. Background and Rationale 
2.1  Breast Cancer: Clinical Background  
Breast cancer continues to be a consequential disease posing a considerable burden on patients, families 
and the healthcare system. One in eight women are expected to develop breast cancer in their lifetime.3,4 
In Canada, it is estimated that 28,600 women will be diagnosed with breast cancer in 2022. In the United 
States (US), 281,550 new cases of breast cancer were estimated in 2021.5 
Due to increased utilization of mammographic screening and improved imaging techniques, there has 
been a rapid increase in the detection of palpable and non-palpable breast lesions. This increased 
detection rate of non-palpable breast lesions has increased the need for imaging-guided localization 
before surgery. Localization plays an important role in conservative surgical excision, with or without 
neoadjuvant therapy.6,7 The goal of breast conserving surgery (BCS) is to safely remove the target tissue 
with adequate surgical margins (SM), avoid unnecessary resection of healthy breast tissue, providing a 
good cosmetic outcome without compromising survival. 8  Re-excision rates in Canada have been 
previously reported as high as 23%9 and in the US 22.6%.10 
Currently lesions are classified based on the Breast Imaging, Reporting and Data System (BI-RADS, 
American College of Radiology). Lesion categorization provides an estimated risk of malignancy based on 
imaging findings. BI-RADS classification of 4C or 5 estimate risk of malignancy to be >50% and >95% 
respectively. These patients are considered highly likely to receive surgical intervention.11  
 
 
FIGURE 1: RISK OF BREAST CANCER: BI-RADS 

STREAMLoc v3.0 (CA)- 21FEB2023 
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2.2 Breast Cancer & Clinical Management  
2.2.1 Wire Localization 
The most common technique for pre-operative localization of breast lesions has historically been wire 
localization (WL). Under imaging guidance, and through a co-axial needle introducer, a thin 3-15 cm wire 
is guided through the skin to the lesion and the surgeon uses the wire to help guide the excision. This 
technique has several problematic features including: patient discomfort, vasovagal symptoms (in up to 
7-10% of patients), wire rupture, wire migration or scheduling difficulties due to the necessity of prior-
day or same-day insertion.  
In response, wireless technologies have been developed to address the limitations of wire localization. 
Advantages of wireless devices include: avoiding wire dislodgement or migration, increased flexible with 
surgical scheduling, improved options for surgical access resulting in improved cosmesis.8,12 
2.2.2 Radioactive Seed Localization 
Radioactive seed localization (RSL) is an alternative to WL and was first described in 2001. RSL utilizes a 
small 5-mm titanium seed containing iodine-125 placed in the center of the breast lesion under ultrasound 
or mammographic guidance. The half- life of the I-125 seed is 59.4 days, and pre-operative localization 
can be performed several days before the surgical excision, which allows flexibility in scheduling operative 
procedures. A study reporting on RSL noted a mean time from RSL insertion to surgery of 4.0 + 2.8 days 
(range 1-17 days).13  Bloomquist et al.14 reported a median duration of localization to surgery of 2 days 
(range 0-5 days). Importantly, the RSL cannot be placed in patients who may undergo neoadjuvant 
chemotherapy or patients whose surgery may be delayed more than 5 days. Therefore, it is not advisable 
to place it at the time of biopsy. 
Overall, RSL has been reported as a more convenient and less painful option to WL14 and has been 
purported to reduce operative time, increase surgeon and radiologist satisfaction and reduce excised 
tissue volume.15 However, disadvantages include radiation exposure and related safety precautions. 7,8 
Zang et al.12 performed a cost comparison analysis between RSL and WL and found that RSL was less costly 
than WL due to a reduction in operating room (OR) delays (RSL: WL=120 vs 254 min; p < 0.001) and fewer 
vasovagal reactions at insertion, allowing for more efficient use of radiology scheduling and shorter wait 
times for patients on their day of surgery. 
2.2.3 SCOUT® Reflector 
The SCOUT® System aids in the detection and excision of soft tissue lesions during various surgical 
procedures. The SCOUT® System is a sophisticated wide band radar-based technology. The technology 
consists of a Console, handheld Guide and the implantable Reflector. The Guide simultaneously transmits 
infrared (IR) light and Ultra-Wide Band Micro Impulse RADAR signal at 50 million pulses per second. IR 
light activates an electronic switch in the Reflector to create a unique, modulating signal. The Reflector 
“reflects” a unique RADAR ECHO back to the Guide.  The Console receives the unique radar signal (Echo 
return), processes the data, and detects and locates the reflector in real-time based on the signal cadence. 
The SCOUT® Console provides an audible cadence signal and a visual representation of distance. During 
surgery, the surgeon uses the Guide, which emits pulses of radar and IR light. Upon the Guide contacting 
the skin, 50 million pulses per second are transmitted into the breast, allowing the system to directionally 
“lock in” on the exact location of the reflector within +/- 1mm of accuracy. 

STREAMLoc v3.0 (CA)- 21FEB2023 
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The SCOUT® Reflector is placed percutaneously at the time of or subsequent to biopsy to mark the lesion. 
Using imaging guidance (such as ultrasound, MRI or radiography) or aided by non-imaging guidance 
(SCOUT® System), the SCOUT® Reflector is located and surgically removed along with the target tissue. 
The SCOUT® System is required for the non-imaging detection and localization of the SCOUT® Reflector 
that has been inserted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.  
Studies comparing SCOUT® to RSL or WL have shown comparable clear margin rates and re-excision 
rates.16,17,18 
Clinical investigation data has demonstrated the SCOUT® system is safe and effective for guiding the 
excision of palpable and non-palpable breast lesions and is a viable alternative to standard localization 
options.18,19,20,21  Similar to RSL, SCOUT® allows flexibility in placing the reflector from any direction 
without impacting the surgical approach.19 Further, use of SCOUT® has resulted in improved efficiencies 
in scheduling radiology and surgery independent of one another.16,17,19 SCOUT® is an accurate, reliable 
method to localize and excise breast lesions with acceptable incidence of positive margins and re- excision 
rates.18 
In a multisite study,20 a surgeon survey on workflow including ability to start cases earlier, patient wait 
times and reduction in surgery schedule delays, the responses for SAVI SCOUT® were significantly better 
than WL.  
2.3 Localization at Biopsy: Rationale for the Registry 
The SCOUT® System has been identified as an alternative to other localization options, providing 
maximum flexibility in patient visit scheduling. In the COVID-19 era, it would follow that improved 
efficiencies, leading to a decrease in patient visits to the breast center, as well as reduced contact with 
the technician prior to surgery, is the preferred treatment option for patient and clinician safety and 
reduced logistical burden. Taveh et al.1 showed that by deploying the SCOUT® Reflector at the time of 
tumor biopsy, the need for a second procedure to localize the tumor was eliminated, thus reducing the 
number of patient visits and potential COVID- 19 exposure. The authors demonstrated that wireless 
localization using the SCOUT® System is an effective and time-efficient alternative to WL, resulting in 
excellent physician and patient acceptance. Parkinson et al.2 found insertion of the SCOUT® Reflector at 
biopsy resulted in at least one (1) less patient visit to the breast center. If the reflector is placed at the 
time of the diagnostic work-up, two (2) patient visits could be eliminated. 
This post-market registry is intended to assess the utility of the SCOUT® System in the Canadian public 
and US healthcare system with fixed resources and a conservative approach to patient and clinician 
exposure to harm (i.e., radiation, COVID-19 exposure, patient emotional trauma). By assessing the utility 
of reflector insertion at the time of biopsy, this study will be able to measure the impact on patient visits 
to the breast center for invasive procedures between biopsy and surgery, and it will quantify this value to 
the healthcare system. The efficacy and safety of this system will be further assessed, as well as the 
acceptance of clinicians and patients.  

STREAMLoc v3.0 (CA)- 21FEB2023 
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3. Devices  
3.1 Device Description and Indication 
The SCOUT® Console, SCOUT® Guide, SCOUT® Handpiece and SCOUT® Reflector are components of the 
SCOUT® Surgical Guidance System (Merit Medical). This same system was previously marketed as the SAVI 
SCOUT® Surgical Guidance System. The SCOUT® Console is a medical device that provides control 
operations for detecting the presence of the SCOUT® Reflector within soft tissue during surgery. The 
SCOUT® Handpiece and SCOUT® Reflector are available separately.  Inclusion of devices for use in this 
post-market registry are limited to those that are cleared/approved in the regions where the study is 
conducted. 
The SCOUT® System employs micro-impulse radar and IR light technology to determine the location of 
the Reflector, which is placed into the soft tissue during a prior procedure. The Console provides the 
micro-impulse radar signal to the Handpiece along with power for the IR light sources. The Handpiece 
delivers the micro-impulse radar signal and IR light into the soft tissue and, in turn, receives signals 
reflected back from the Reflector. The Console processes the reflected radar signals to provide the 
surgeon with Reflector proximity and location information via audible and visual feedback.  
The numeric display provides real-time distance between the Handpiece and Reflector. The audible 
feedback produced by the Console increases in cadence as Handpiece is placed in closer proximity to the 
Reflector. The Console provides a maximum detection range of 60mm from the Handpiece to the 
Reflector. Excision of the lesion is then performed using standard surgical techniques.  
The Console and Guide are provided non-sterile. The Handpiece and Reflector (available separately) are 
provided as sterile.  
The SCOUT® Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy 
site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, 
or radiography) or aided by non-imaging guidance (SCOUT® System), the SCOUT® Reflector is located and 
surgically removed with the target tissue. The SCOUT® System is required for the non-imaging detection 
and localization of the SCOUT® Reflector that has been inserted in a soft tissue biopsy site or a soft tissue 
site intended for surgical removal. 
3.2 SCOUT® Reflector 
The SCOUT® Reflector is delivered via a delivery system to a pre-determined site in close proximity or 
within the identified tissue lesion. The Reflector is designed to be highly reflective to radio frequency 
(electromagnetic wave/micro- impulse radar) signals allowing it to be easily identified and located within 
soft tissue by the electromagnetic wave signal. The Reflector is delivered percutaneously. The SCOUT® 
Reflector is preloaded into either the SCOUT® Delivery Device or SCOUT® Bx Delivery Device. The standard 
SCOUT® Delivery Device contains a 16G introducer needle which retracts into the handle when a release 
button is actuated, thereby deploying the SCOUT® Reflector. The SCOUT® Bx Delivery Device consists of a 
plastic molded handle and a 15G rigid cannula, and it is designed for insertion through the biopsy 
introducer sheath utilized with the following biopsy devices (Hologic Eviva 0913-20; 1213-20 (STX), 
Hologic BREV09 (STX), ATEC ILS 0914-20 (MRI)). The SCOUT® Reflector is deployed by actuating a 

STREAMLoc v3.0 (CA)- 21FEB2023 
Page 14  of 33 
deployment plunger. Availability of these different delivery device configurations within this post-market 
registry study is dependent upon regional regulatory licensing/clearance. The SCOUT® Reflector and 
delivery systems are provided as sterile single-use devices.  
 
Part no. 
Description 
SSR05-01 
SCOUT® 5cm Delivery Needle and Reflector 
SSR75-01 
SCOUT® 7.5cm Delivery Needle and Reflector 
SSR75S-01 
SCOUT® 7.5cm Delivery Needle and Reflector, Single-handed 
SSR75SM-01 
SCOUT® 7.5cm Delivery Needle and MINI Reflector, Single-handed 
SSR10-01 
SCOUT® 10cm Delivery Needle and Reflector 
SSR13B-01 
SCOUT® Bx Delivery System 
TABLE 1: LISTING OF SCOUT® REFLECTOR AND DELIVERY SYSTEM MODELS  
All future models that are regulatory licensed/cleared for the same indication in the region of the 
participating site will be allowed in this registry. Note: Please refer to the Instructions for Use of the device 
for complete information.  
3.3 SCOUT® Guide and Control Unit 
A handheld probe (SCOUT® Guide or Handpiece) is placed in direct contact with the skin overlying the 
target tissue, and is used to deliver the electromagnetic wave signal. It receives the return signal which is 
reflected back from the previously implanted marker.  
A control unit (SCOUT® Surgical Guidance Console) processes the reflected electromagnetic wave signals, 
providing  the surgeon with marker proximity information via audible and visual feedback.  
Part no. 
 Description 
SSC-01 
SCOUT® Surgical Guidance Console 
SSC-01L 
SCOUT® Surgical Guidance Console, Loaner Unit 
HPSU-01 
SCOUT® Single-Use Handpiece 
SG-01 
SCOUT® Surgical Guide18mm 
SG-02 
SCOUT® Surgical Guide 12mm 
CHK-01  
SCOUT® Check Console  with 1 handpiece 
CHK-01L 
SCOUT® Check Console with 1 handpiece, Loaner Unit 
CHKHP-01 
SCOUT® Check Handpiece 
SH-01 
Sterile Sheath for reusable handpieces 
TABLE 2: LISTING OF  SCOUT® GUIDE AND CONTROL UNIT MODELS 

STREAMLoc v3.0 (CA)- 21FEB2023 
Page 15  of 33 
All future models that are regulatory licensed/cleared for the same indication in the region of the 
participating site will be allowed in this registry. Note: Please refer to the Instructions for Use of the device 
for complete information.   
3.4 Labelling 
The model number and lot number of the implantable reflector(s) will be identified and recorded on the 
participant case report form (CRF). 
4. Registry Plan 
4.1 Objectives 
The primary objective of this registry is to demonstrate the utility of the SCOUT® Surgical Guidance system 
to improve workflow and efficiency in centers diagnosing and treating breast cancer. The secondary 
objective is to further evaluate the safety and performance of the SCOUT® Surgical Guidance system in 
500 consented BI-RADS 4C/5 patients according to the IFU.  
4.2 Endpoints 
The primary endpoint is the number of patient visits to the breast center for invasive procedures from the 
time of biopsy to surgery. The primary endpoint will be compared to historical controls. It is expected that 
there will be a mean reduction of at least one (1) visit for invasive procedures. 
 
The secondary endpoints are defined below: 
1. Device success: percent successful localization, detection and retrieval. 
2. Device safety: rate of device-related adverse events. 
3. Procedural success: absence of close margins (<2mm), positive margins (tumor on ink) or requirement 
for re-excision. 
4. Duration (days) from diagnosis to surgery and biopsy to surgery. 
5. Radiologist assessment: ease of placement; ability to position reflector in desired location; scheduling 
flexibility; visibility on ultrasound/ mammography (immediate and late); artifact (Tomo/MRI if 
applicable). 
6. Surgeon assessment: ease of detection; ease of device retrieval. 
7. Participant satisfaction questionnaire: anxiety; convenience; pain; overall experience compared to 
expectation 
8. Process improvement with implementation of same-day biopsy and SCOUT® Reflector placement. 
4.3 Population 
Five hundred (500) BI-RADS 4C/5 patients undergoing biopsy of a breast lesion at a participating study 
center. 

STREAMLoc v3.0 (CA)- 21FEB2023 
Page 16  of 33 
It is expected that 3-7 centers will participate in this registry, so enrollment per center is estimated as 
approximately 100-150 per center. 
4.4 Inclusion and Exclusion Criteria 
The inclusion criteria are as follows: 
1. Woman >18 years and < 80 years of age; 
2. Classified as BI-RADS 4C or 5; 
3. Lesion depth is  < 6 cm from skin surface; 
4. Non-palpable lesions; 
5. Informed consent obtained. 
The exclusion criteria are as follows: 
1. Multicentric breast cancer; 
2. Pregnant or lactating; 
3. Known or suspected nickel-titanium allergy. 
4.5 Design 
This is a single-arm, multicenter, non-randomized cohort study that will include five hundred (500) 
participants scheduled to undergo a biopsy of a breast lesion at participating Canadian and US study 
centers.  
The expected duration of the trial is 12-18 months. Enrollment is expected to take approximately 12 
months. 
The primary endpoint of this cohort will be compared to historical controls (standard of care visits). 
The registry is divided into three periods:  
1. Inclusion Period: from registry eligibility screening until reflector insertion; 
2. Device Period: from reflector insertion at biopsy to removal at surgery; 
3. Outcomes Period: from completion of surgery to pathology report of outcomes. 
4.6 Inclusion Period 
Patients meeting all inclusion criteria and no exclusion criteria will be considered for inclusion into the 
registry.  Each eligible patient will be informed about the registry by the Investigator or designate. 
Prior to any data collection, the patient must be thoroughly informed about all aspects of the registry and 
must have signed the Research Ethics Board (REB) or Institutional Review Board (IRB) approved Informed 
Consent Form (ICF). Participants will be assigned a unique identifier for the registry upon enrollment.  
No patient data, including adverse events will be collected in this period. A patient will be considered 
enrolled in the registry at the time of reflector insertion. 

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4.6.1 Informed Consent Process 
Written Informed Consent with the REB/IRB  approved consent form will be obtained for all subjects prior 
to conducting any study-related assessments and prior to administration of any pre-procedure 
medications or sedation. The principal investigator, or qualified designee, will explain to each patient all 
aspects of the clinical study that are relevant to the patient’s decision to participate in the clinical study 
including, but not limited to, the following: purpose and nature of the study, study procedures, expected 
study duration, available alternative therapies, the benefits and risks involved with study participation 
and the potential treatment.  The principal investigator, or qualified designee, shall avoid any coercion or 
undue improper influence on, or inducement of, the patient to participate and will not waive or appear 
to waive the patient’s legal rights. Patients will be given a copy of the informed consent form and will be 
provided ample time to read and understand the document and be given the opportunity to ask questions. 
Patients will be informed of their right to withdraw from the study at any time without prejudice; consent 
forms will use non-technical language and be provided in a language understandable to the patient.  After 
this explanation, and before any study-specific procedures have been performed, the patient and the 
principal investigator, or qualified designee, responsible for conducting the informed consent process will 
voluntarily sign and personally date the ICF.  The patient will receive a copy of the signed and dated written 
informed consent. 
The informed consent process may be completed during an in-person meeting or through remote consent 
procedures. All procedures of remote consent must be in compliance with institutional requirements for 
remote consent. 
The principal investigator or qualified designee will document in the medical records on the informed 
consent document the informed consent process, including the date of consent and name of the person 
conducting the consent process.  Documentation of the time of consent is required if the informed 
consent process occurs on the same day as the index procedure.  The principal investigator or qualified 
designee shall ensure important new information is provided to new and existing participants throughout 
the clinical investigation. 
4.7 Device Period 
Insertion of the SCOUT® Reflector shall be conducted according to the IFU at the time of biopsy. The 
physician will follow regular clinical practice before and during the biopsy procedure.  
SCOUT® Reflector may be inserted in a soft tissue biopsy site or a soft tissue site intended for surgical 
removal as per IFU and clinician decision. Additionally, as per clinician decision, more than one (1) SCOUT® 
Reflector may be inserted in a participant (bracketing) ensuring a minimum distance of 25 mm between 
Reflectors.  
The data collected during the biopsy and reflector insertion will consist of the following: 
• 
Patient demographic: age, weight, height and diagnosis 
• 
Date of assessment 
• 
Date of biopsy and insertion 
• 
Reflector insertion data: success, deployment within lesion or distance from lesion, depth of 
reflector, type of guidance used, number of reflectors used, type of lesion 
• 
Lot number(s) and model of the SCOUT® Reflector 

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• 
Reflector detection (if performed) 
• 
Adverse events (if applicable) 
 
The data collected during the surgery will consist of the following: 
• 
Date of surgery 
• 
Neoadjuvant therapy (if applicable): start and stop date 
• 
Reflector detection: success before or after incision 
• 
Reflector retrieval data: success, identification and retrieval duration 
• 
Operative time: Time from beginning the detection to the time the lesion is removed from the 
breast. 
• 
Participant satisfaction questionnaire: 1 this may be completed by/collected from the participant 
up to 2 weeks after the surgery.  
• 
Adverse events (if applicable) 
4.8 Final Outcomes 
The assessment of procedure success is determined by the pathology report. This will not require an 
additional participant visit for the purposes of the registry. Participation will be considered complete 
following collection of the final outcomes and Participant satisfaction questionnaire. 
The following data points will be recorded from the report: 
• 
Excised tissue information 
• 
Specimen size  
• 
Margins: (positive, close, negative)  
• 
Re-excision required (after surgery) 
• 
Radiologist assessment (collected once per radiologist at completion of study) 
• 
Surgeon assessment (collected once per surgeon at completion of study) 
 
 
 
 
                                               
1 Romanoff A, Schmidt H, McMurray M, et al. Physician preference and patient satisfaction with radioactive seed 
versus wire localization. J Surg Res. 2017; 210: 177-180. 

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4.9 Assessments 
All assessments will be conducted according to the standard practice applicable at each participating site.  
Assessments to be collected during the registry are found below: 
Schedule of Assessments 
 
Consent* 
Biopsy** 
Surgery 
Final 
Outcomes*** 
Patient Data 
Informed Consent 
X 
 
 
 
Demographic information (age, height, weight, diagnosis) 
 
X 
 
 
Neoadjuvant therapy (start and stop date) 
 
 
X 
 
Device and Procedural Data 
Reflector insertion data (success, deployment within lesion 
or distance from lesion, depth of reflector, type of guidance 
used, number of reflectors used, type of lesion, reflector 
detection) 
 
X 
 
 
Reflector detection (before incision or after incision) 
 
Xi 
X 
 
Reflector retrieval (success, identification and retrieval 
duration) 
 
 
X 
 
Operative time  
 
 
X 
 
Adverse events (including device deficiencies) 
 
X 
X 
 
Scheduling Data 
Date of assessment 
 
X 
 
 
Date of biopsy and insertion 
 
X 
 
 
Date of surgery 
 
 
X 
 
Satisfaction Assessments 
Radiologist assessment: ease of placement; ability to 
position reflector in desired location; scheduling flexibility; 
visibility on ultrasound/mammography; artifact (Tomo/MRI 
if applicable) 
 
 
 
Xii 
Surgeon assessment: ease of detection; ease of reflector 
removal 
 
 
 
Xii 
Participant satisfaction questionnaire 
 
 
 
Xiii 
 

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Pathology Report data 
Margins (positive; close <2mm; negative >2mm) 
 
 
 
X 
Re-excision required (after surgery) 
 
 
 
X 
Excised tissue information 
 
 
 
X 
 
*Performed prior to biopsy  
 
**Reflector insertion performed at time of biopsy 
***No additional participant visit; data recorded from pathology report 
i If performed 
ii Collected once per clinician at completion of registry 
iii Window up to 2 weeks post-surgery (remote completion) 
4.10 Participating Centers 
Participating centers will be selected by the Sponsor. All required approvals will be confirmed by the 
Sponsor prior to initiation of a participating site [i.e., REB/IRB, ISO 14155:2020 requirements and 21 CFR 
Parts 50, 54 and 56 requirements (US centers only)]. 
It is anticipated that there will be 3-7 centers participating in this registry. 
4.11 Sponsor responsibilities 
Merit Medical Canada has the overall responsibility for the conduct of the study, including assurance that 
the study satisfies international standards and the regulatory requirements of the relevant regulatory 
authorities. 
The Sponsor will be responsible for: 
• Selection of clinical investigators and sites: The Sponsor will select qualified investigators and 
facilities which have adequate study population to meet the requirements of the investigation. 
• Training of investigators and site personnel and site monitoring: The training of the Investigator 
and clinical site personnel will be the responsibility of the Sponsor, or designee, and may be 
conducted during an investigator meeting, a site initiation visit, or other training sessions. Periodic 
monitoring visits will be conducted frequently enough to ensure that all clinical participant data 
are properly documented and that the study is properly conducted. 
• Documentation: The Sponsor will collect, store, guard and ensure completion of all study relevant 
documents by the relevant parties. 
o Signed and dated CRFs 
o Records of any Serious Adverse Events (SAEs) reported to the Sponsor during the clinical 
investigation 
• Any statistical analyses and underlying supporting data 
• Final report of the clinical investigation 
• Submitting Reports 

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• Maintaining Records: The Sponsor will maintain copies of correspondence, data, SAEs and other 
records related to the clinical study according to requirements set forth by ISO 14155:2020 and 
regulations.  
• Monitoring: The Sponsor is responsible for monitoring the study to ensure compliance with ISO 
14155:2020 and regulatory requirements.  
4.12 Investigator responsibilities 
• 
Protocol acceptance: Prior to starting enrolment of participants, the Investigator must read and 
understand this study protocol, and must sign and date the Protocol Signature page. The Site 
Agreement documents agreement to all conditions of the study protocol and agreement to 
conduct the study accordingly. This study will be conducted in accordance the Declaration of 
Helsinki and other applicable regulatory requirements and standards, and any conditions of 
approval imposed by the REB/IRB or regulatory authorities. 
• Required documents: The following documents must be submitted to the Sponsor, or designee 
prior to participant enrolment: 
1. 
Signed Protocol Signature Page 
2. 
Recent (≤ 2 years old) signed and dated English Curriculum Vitae (CV) of the Principal 
Investigator and co-investigators of the clinical site. The CV should clearly show the 
Investigator/co-investigators’ qualifications and experience. 
3. 
Copy of the written confirmation of the REB/IRB regarding approval of the protocol including 
version number and date, ICF (including version and date) and other adjunctive participant 
material. 
4. 
List of  voting REB/IRB members 
5. 
Signed Clinical Trial Agreement 
 
• REB/IRB approvals and notifications: According to the local requirements, the Investigator must 
have all necessary approvals, including written approval from the REB/IRB of the clinical site prior 
to enrolling participants in the study. A copy of the written approval must be provided to the 
Sponsor. 
o Serious Adverse Event (SAE) reports as well as annual and final reports will be submitted 
to the REB/IRB as required. 
• 
Obtaining informed consent: The Principal Investigator, or qualified designee, will obtain 
informed consent in accordance with the procedure described in this study protocol and the 
requirements of the REB/IRB. 
• 
Medical care of participants 
• 
Reporting requirements 
• 
Audits / Inspections: In the event that audits/inspections are initiated by the Sponsor (or its 
designee) or national/international regulatory authorities, the Investigator must allow access to 

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the original medical records and must provide all requested information. In the event that audits 
are initiated by regulatory authorities, the Investigator will immediately notify the Sponsor. 
5. Data Analysis & Statistics 
5.1 Sample Size Calculation 
No formal sample size calculation has been performed. Five hundred (500) participants will be included 
in this registry. This sample size has been selected to adequately support a multi-center experience 
reflective of the Canadian and US healthcare system and associated workflow.  
Further, the Canadian Agency for Drugs and Technologies in Health (CADTH) assessed the evidence of a 
competitive device and noted the requirement for a cohort size greater than 200 in order to draw 
conclusions of effectiveness.22 It is estimated that this sample size will result in a robust data set. 
5.2 Point of Inclusion 
A patient is considered enrolled in the registry as soon as they: 
1. Have provided signed consent agreeing to be part of this registry; and  
2. Undergo the insertion of the SCOUT® Reflector at the time of biopsy 
Note- If a patient has given consent but the Reflector is not inserted at biopsy, the patient will not receive 
a participant number and will not be considered as enrolled in the registry. No patient data will be 
collected. 
 
The intent-to-treat (ITT) population includes all participants in whom the SCOUT® Reflector has been 
inserted. Any participants who have a reflector inserted and do not undergo surgery will be exited from 
the registry using a study completion form. The occurrence of this scenario is expected to be low (< 10%). 
Reasons may include: 
1. Benign concordant biopsy results. 
2. Participant death prior to surgery due to metastases. 
3. Lesion is metastatic from another location. 
4. Participant declines surgery. 
5. Participant is ineligible for surgery. 
 
The per protocol (PP) population will include all participants in whom a SCOUT® Reflector has been 
inserted and who subsequently undergo breast surgery.  
Participation in the registry will be considered complete after surgery, documentation of surgical 
outcomes and completion of the Participant Assessment Questionnaire. This will be documented on a 
study completion form. It is expected the duration of each participant will be approximately <7 months  
and will vary based on each participant’s treatment plan. 

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5.3 Analysis of Clinical Data 
This registry is not hypothesis driven. The limitation of the design for this registry is that there are no 
pass/fail criteria from a statistical hypothesis testing.  
Descriptive statistics will be generated for all endpoints using a 1-sided 95% confidence interval. 
Participant data will be quantified. For quantitative parameters, descriptive statistics will be reported: 
number, mean, standard deviation (SD), minimum, median and maximum values. For categorical 
variables, frequency and percentage will be reported. The primary endpoint will be compared to historical 
data using one-way analysis of variance. 
Subset analysis may be performed for participants who have undergone neoadjuvant therapy. 
Endpoint analysis will be performed on the PP analysis set.  Descriptive data and adverse event analysis 
will be performed on the ITT analysis set.  
Full analysis will be described in the statistical analysis plan and specified in the final report. No interim 
analysis is planned. 
The Sponsor will perform data management and statistical analysis. Statistical analyses will be performed 
using the Statistical Analysis System (SAS) or other widely accepted statistical software. 
5.4 Missing, Unused & Spurious Data 
Attempts will be made to complete any missing data. In addition, the means and ranges of all variable 
distributions and outlying data or improbable combinations of variables will be examined before analysis 
is undertaken. Queries will be sent to investigators for inconsistent or missing data. Endpoint analysis will 
be performed with and without using imputation of missing data (where applicable) to estimate the effect 
of missing data on ITT and PP population. Differences between their results will be summarized and 
discussed. 
6. Data Collection & Reporting 
6.1 Method of Data Collection & Documentation 
The Sponsor will provide the center with the Registry Plan, electronic Case Report Forms (eCRF) and all 
other necessary documentation to perform the registry.  
6.2 Protocol Deviations 
Investigators may not deviate from the registry plan, unless to protect the health and safety of a 
participant. Any deviations from the protocol must be reported to the Sponsor as soon as possible and no 
later than 10 calendar days. Deviations will be assessed by the Sponsor and corrective and preventive  
action plans (CAPA) may be implemented to avoid future deviations. Deviations will be reported to the 
REB/IRB according to reporting guidelines.  
6.3 Electronic Case Report Form (eCRF) 
Registry data will be documented on a web-based eCRF. The eCRF is provided by the Sponsor and will be 
used to record data that are integral to the registry and subsequent reports. The Sponsor will obtain 

STREAMLoc v3.0 (CA)- 21FEB2023 
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evidence of verification, validation and security of the eCRF platform. All collected data will be de-
identified and reside in Canada.   
The eCRF must be accurate and complete. All participant data entered onto the eCRF should be supported 
by source documents (e.g., medical records). The eCRFs are completed for each enrolled participant and 
signed by the Investigator. 
Because of the potential for errors, inaccuracies, and illegibility in transcribing data onto eCRF, originals 
of all relevant procedural records and reports, post-procedural examinations, laboratory and other test 
results should be kept on file in each participant’s medical file as permissible by each site’s record keeping 
policy. The eCRF must be kept current to reflect participant’s status during the course of the registry.    
The Sponsor will train each participating center in this registry on the proper use of the eCRF. 
6.4 Data Management 
The Investigator shall enter all participant data into a web-based registry database. Only de-identified 
participant data will be collected to ensure and maintain participant privacy. The database will be 
maintained within Canada and will comply to all relevant privacy laws. 
6.5 Data Quality Control & Assurance  
Data entry will be reviewed on a regular basis. Quality control audits of all key performance and safety 
data in the database will be made after the sites complete enrollment and prior to database lock. 
The Sponsor (or delegate) will oversee all aspects of data quality. The data will be monitored according to 
the Monitoring Plan through central and remote monitoring strategies. Outlier data will be queried and 
remote access to electronic medical records (EMR) may be requested for source data verification (SDV).  
Each clinical site will be monitored according to the study monitoring plan to ensure to verify that: 
• 
The rights and well-being of the participants are protected 
• 
The reported study data are accurate, complete and verifiable from source documents 
• 
The conduct of the study is in compliance with the currently approved Clinical Investigation Plan 
(CIP)/ amendment(s), ICH GCP, ISO 14155:2020, 21 CFR parts 50, 54 and 56, and applicable 
requirements of the REB/IRB 
• 
There is adequate participant enrollment 
6.6 Registry Records Retention 
It is the responsibility of the investigator to maintain a comprehensive and centralized filing system of all 
relevant study documentation. Investigators will be instructed to retain all study records required by the 
Sponsor in a secure and safe facility with limited access for one of the following time periods based on 
sponsor notification: 
• A period of at least two years after completion of the registry 
• Or longer as required by local regulations 

STREAMLoc v3.0 (CA)- 21FEB2023 
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The investigator will be instructed to consult with the Sponsor before disposal of any study records and 
to provide written notification to the Sponsor of any change in the location, disposition, or custody of the 
registry documentation. 
7. Safety 
7.1 Definition and assessment of safety related events 
Information on safety related events will be collected during the Device Period of the registry by the 
investigators or their designate. Classification of events is based on ISO 14155:2020.23  
• 
Adverse Event (AE): any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in participants, users or other persons, 
whether or not related to the device. This definition includes events related to the procedures 
involved. 
• 
Serious Adverse Events (SAE): An adverse event that led to death or led to serious deterioration 
in the health of the participant, that either resulted in: 
o Death 
o A life-threatening illness of injury, or 
o A permanent impairment of a body structure of a body function, or 
o In-patient or prolonged hospitalization, or 
o Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, or 
o Fetal distress, fetal death or a congenital abnormality of birth defect. 
Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigation plan without serious deterioration in health, is not considered a serious adverse event. 
• 
Adverse Device Effect (ADE): An adverse event related to the use of the device. This definition 
includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation or operation, or any malfunction of the device. This 
definition includes any event resulting from use error or from intentional misuse of the medical 
device. 
• 
Serious Adverse Device Effect (SADE): Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
• 
Device Deficiency (DD): inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, usability, safety or performance. Device deficiencies include malfunctions, 
use errors, and inadequacy in the information supplied by the manufacturer including labelling.  
7.2 Reportable Events 
For the purpose of this post market registry and per the study AE CRF, the following adverse events of 
interest and device deficiencies will be collected: 
• 
Adverse reaction to material 

STREAMLoc v3.0 (CA)- 21FEB2023 
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• 
Device Migration 
• 
Inaccurate location detection 
• 
Inaccurate deployment 
• 
Infection 
• 
Tissue/vascular trauma 
• 
Other: any AE that, in the opinion of the investigator, has a causal relationship (probable or 
definite) to the device or procedure, or any device deficiency, whether or not associated with an 
adverse event.  
7.3 Reporting of safety related events 
Adverse events and DD will be collected from the time the reflector is inserted into the participant (at 
biopsy) to the time the reflector is removed at surgery (Device Period) or until a study completion form is 
completed. Any AE in this period, either serious, non-serious, whether deemed device-related or not, 
must be reported to the Sponsor immediately after the investigator or coordinator has become aware of 
its occurrence. Reporting of an AE or DD to the Sponsor should take place within 24 hours upon becoming 
aware of the event, but not later than 3 calendar days. All AE (serious or non-serious) and DD will be 
documented in the eCRF. The AE/DD eCRF page should be submitted to the Sponsor within 24 hours even 
if all of the information is not available at the time of the initial contact. Sponsor contact for reporting: . 
The investigator will evaluate (S)AEs with regard to causality and seriousness.  
Reporting of serious incidents to the regulatory authorities will be reported per local regulations: 
• 
Incident means any malfunction or deterioration in the characteristics and/or performance of the 
SCOUT® Surgical Guidance system, including use-error due to ergonomic features, any inadequacy 
in the information supplied by the manufacturer and any undesirable side-effect. 
• 
Serious incident means any incident that directly or indirectly led, might have led or might lead to 
any of the following: 
o Death of a participant, user or other person, 
o Temporary or permanent serious deterioration of the participant’s, user’s or other 
person’s state of health, 
o Serious public health threat; 
Safety related events, which require preventive or corrective measurements intended to protect 
participants, may have to be reported to the local REBs/IRBs. The Sponsor will notify all other involved 
sites to report to their respective REBs/IRBs according to their requirements. The Sponsor will report any 
(S)ADEs and DD(s) to Health Canada and US FDA as required and within stipulated timelines. 
7.3.1 Severity Definition 
• 
Mild: Generally transient & not interfering with daily activities; 
• 
Moderate: Sufficiently discomforting to interfere with usual activities; 
• 
Severe: AE that prevents normal daily activities. 

STREAMLoc v3.0 (CA)- 21FEB2023 
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The investigator will document their assessment of the relationship of the AE to the device using the 
criteria outlined below. 
7.3.2 Causality or Relationship to the Device and/or Procedure 
• 
Unrelated: The AE has no temporal relationship to the device or to the procedure, and/or there 
is evidence of alternative cause such as concurrent medication or illness; 
• 
Possibly related: A temporal relationship with the device or the procedure is not clear, alternative 
causes are also possible; 
• 
Reasonable Causal Related: The AE is associated with the device or with procedures beyond 
reasonable doubt when: 
o The event is a known side effect of the product category the device belongs to or of similar 
devices and procedures;  
o The event has a temporal relationship with the device use/application or procedures;  
o The event involves a body-site or organ that the device or procedures have an effect on; 
o The AE follows a known response pattern to the medical device (if the response pattern 
is previously known);  
o 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);  
o 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;  
o Harm to the participant is due to error in use;  
o The event depends on a false result given by the device used for diagnosis, when 
applicable;  
o 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 AE. 
7.4 Independent Physician Adjudicator 
An independent Physician Adjudicator (IPA) will be responsible for review and adjudication of all serious 
and potentially device-related adverse events, at minimum.  Other events may be reviewed as defined in 
the IPA Charter.  
In order to enhance objectivity and reduce the potential for bias, the IPA shall be independent of the 
Sponsor as well as the investigational sites and investigators. The methodology for performing these 
responsibilities shall be developed and outlined in the IPA Charter. Operational provisions shall be 
established to minimize potential bias. 
8. Measures to Minimize Bias 
The following measures will be implemented to minimize the potential for bias in this single arm Registry: 

STREAMLoc v3.0 (CA)- 21FEB2023 
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• 
Sites are requested to screen and enroll consecutive subjects, as far as possible, and enrollment 
activities will be documented in a screening/enrollment log. 
• 
Multiple sites will be included to ensure a representative sample of physicians performing the 
procedure and to provide a reasonable enrollment period. 
• 
Site selection will be performed using predefined parameters to ensure Investigators are 
appropriately qualified to conduct registry. 
• 
Site training will be performed to assure full understanding and engagement to comply with the 
study design and all protocol requirements. 
• 
A sample of adverse events will be reviewed and assessed by an independent Physician. 
• 
Any known or foreseeable factors that may compromise the outcome of the Registry or the 
interpretation of results are covered by the Inclusion and Exclusion criteria. 
• 
Financial disclosures will be collected from all investigators to document any potential for bias or 
conflict of interest. 
9. Risks and Benefits 
9.1 Risk Analysis 
Risks associated with the SCOUT® Surgical Guidance System are managed in accordance with ISO 14971, 
Medical Devices- Application of risk management to medical devices. Risks associated with localization 
devices are well-understood and have been documented in the risk analysis, published clinical 
literature,19,20,22,24,25  as well as post-market surveillance data available for the benchmark devices. The 
nature of the SCOUT® System procedure carries the same clinical risks to the intended patient population 
as other localization technologies.19,20,21,24,25,26 The risk analyses for these devices included objective 
reviews of published and available unpublished medical and scientific data. The sections below provide 
an overview of residual risks identified in the risk management reports and anticipated benefits of the 
medical device. 
The safety and performance aspects of the SCOUT® System have been evaluated using risk analysis 
techniques. The risks associated with the use of the SCOUT® System are considered reasonable in 
comparison to the anticipated benefits to patients. There were no reports of morbidity/mortality 
attributable to use of the SCOUT® System in any study.2,18,19,20,24,25 
The risks associated with the SCOUT® System are the same as existing benchmark localization 
technologies used in the intended patient population, as such the SCOUT® System poses an acceptable 
level of risk for its intended use.25,26 
9.2  Anticipated Clinical Benefits 
All information supplied with the SCOUT® System clearly indicates the intended purpose of the device, 
namely use as a localization system for the identification of a soft tissue biopsy site or soft tissue site 
intended for surgical removal. The intended clinical benefit of use of a localization system is to facilitate 
identification (e.g., location) of target tissue in patients medically indicated for excision of soft tissue due 
to suspected or confirmed carcinoma. 

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These same benefits were assessed for the SCOUT® device where the investigators concluded that the 
SCOUT® System is safe and effective for guiding the excision of palpable and non-palpable breast lesions 
and a viable alternative to standard localization options.18,19,22,26,27  
While there is no guaranteed clinical benefit associated with participation in this registry, it is expected 
that participants will have similar benefits as other commercially available localization systems. Compared 
to other available localization systems, registry participants may benefit from a streamlined clinical 
pathway resulting in reduced number of invasive procedures.  
9.3 Anticipated Adverse Events and Adverse Device Effects 
The nature of the SCOUT® System procedure carries the same clinical risks to the intended patient 
population as other localization technologies. Namely anticipated ADEs included:  
• 
infection- there have been no instances of reported infection from the reflector. Incidence of 
infection from other localization systems have been reported between 1.56-4.61%.25 
• 
adverse reaction to materials- Using the highest values (worst case observed), a total of 
approximately 0.0075 µg of nickel was released, from each device, over a 30-day period. This 
translates to about 0.00025 μg per day released per reflector . Nickel potentially released from 
the reflector is less than 0.0004% of nickel absorbed by adults during the normal course of each 
day. Complaint rates range from 0-0.02% annually with no adverse events associated.25 
• 
tissue/vascular trauma- Complaint rates ranges from 0-0.08% annually in the global market. 25 
• 
inaccurate location detection- Complaint rates range from 0-0.48% annually in the global market. 
25 
• 
inaccurate deployment- complaint rates range from 0-0.22% annually in the global market. 25 
• 
device migration-complaint rates range from 0-0.02% annually in the global market. 25 
 
Risks associated with the SCOUT® System and localization procedure, together with their likely incidence, 
are described in the IFU. 
There may be risks related to the device under investigation that are unknown at present. Likewise, the 
exact frequency of the risk may be unknown. However, the SCOUT® System has been commercially 
available and utilized extensively in the US market since 2014 (K141318) and Europe since 2020. The risks 
associated with the use of the SCOUT® System are considered reasonable in comparison to the anticipated 
benefits to patients. There were no reports of morbidity/mortality attributable to use of the SCOUT® 
System in any study.2,18,19,20,24,25 
Possible risks associated with participating in this registry are not anticipated to be any different from 
risks associated with undergoing procedures with the commercially available SCOUT® System 
(globally). Protocol required assessments are aligned with standard of care for treating non-palpable 
breast lesions using localization and as such do not pose any additional risks. 
9.4 Steps Taken to Control or Mitigate Risks 
In-depth recommendations, special precautions and instructions regarding patient selection, device 
handling, and device placement are included in the IFU for the SCOUT® System. It is also stated in the IFU 

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that the devices can only be used by physicians who have received appropriate training on how to use the 
device. Physician users are expected to be aware of the known and foreseeable safety risks associated 
with the use of the device including the surgical and/or non-surgical treatment of these conditions.  
Risks associated with the use of the device under investigation are minimized through device design, 
investigator selection and training, pre-specified participant eligibility requirements, and risk-based 
monitoring to ensure adherence to the protocol. All AEs will be reported to the Sponsor as summarized 
in Section 7.3 and will be monitored internally for safety surveillance purposes. 
10.Quality Control & Quality Assurance 
10.1 Training 
Sponsor will ensure that Investigators and site staff are trained in the study protocol, including consent 
requirements and data collection procedures.  Training may be completed by on-site visit or remote/web-
based training.  No additional device training or case support is required for Study Participation, device 
training will be in accordance with Merit requirements for commercial use applicable to the country 
where site is located.   
Canadian sites are required to complete the Merit Medical Canada Training plan.  Prior to use of the 
device, radiologists and surgeons will complete didactic and hands-on product training. Clinicians will 
complete proctor sign-off prior to enrolling participants in this registry. 
US sites will be selected from established device users and no additional device training is required. 
The Principal Investigator will be responsible for ensuring that all subsequent personnel involved in the 
study are trained and receive proctor sign-off, where applicable. 
10.2 Quality Assurance  
The Sponsor will implement and maintain quality systems defined by written procedures to ensure that 
study is conducted and data are generated, documented and reported in compliance with this CIP, Good 
Clinical Practices (ISO 14155:2020) and the applicable regulatory requirements. Included in these 
procedures will be quality control measures to ensure that all data are reliable and have been processed 
correctly at each stage of handling.  
The Sponsor will secure agreement with the Investigator to ensure direct access to the site and source 
data/documents and reports, for the purpose of monitoring and auditing by the Sponsor and/or 
regulatory authorities and/or REBs/IRBs.  
10.3  Regulatory Inspections/ Audits 
The registry may be inspected by regulatory agencies or audited by the Sponsor. These inspections may 
take place at any time during or after the registry. In the event that audits are initiated by the Sponsor (or 
its designee) or national/international regulatory authorities, the Investigator must allow access to the 
original medical records and must provide all requested information. In the event that audits are initiated 
by a regulatory authority, the Investigator will immediately notify the Sponsor. 

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10.4 Suspension or premature termination of the registry 
In the case that the registry must be suspended or prematurely terminated, investigational sites will be 
notified and arrangements will be made with the highest regard for participant safety.   
11.Publication 
The registry will be registered in a publicly accessible database prior to participant inclusion, and the 
results of the registry will be made publicly available upon conclusion in accordance with the Declaration 
of Helsinki.   At the conclusion of the registry, a report will be prepared for presentation and for 
publication. Authorship is based on the ICMJE (International Committee of Medical Journal Editors) 
guidelines. 
All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well 
as positive results must be published or otherwise made publicly available. Sources of funding, 
institutional affiliations and conflicts of interest must be declared in the publication. 
 
 

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12.  Literature References 
1 Tayeh S, Muktar S, Heeney J, et al. Reflector-Guided Localization of Non-palpable Breast Lesions: The 
First Reported European Evaluation of the SAVI SCOUT® System. Anticancer Research. 2020;  40:3915-
3924. 
2 Parkinson B, McKeown R. Finding Allies, Building Alliances: An Alliance Building Story About Improving 
Cancer Protocols With The One Intermountain Breast Care Services Team. 2019. 
3 Canadian Cancer Society. Incidence and mortality. Accessed 19 August 2022.  
https://cancer.ca/en/cancer-information/cancer-types/breast/statistics 
4 American Cancer Society. Key Statistics for Breast Cancer. Accessed 19 August 2022. 
https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html 
5 Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. Jan 2021;71(1):7-33. 
doi:10.3322/caac.21654 
6 Bick U, Trimboli RM, Athanasiou A, et al. Image-guided breast biopsy and localisation: 
recommendations for information to women and referring physicians by the European Society of 
Breast Imaging. Insights Imaging. 2020; 11(1):12 
7 Cheang E, Ha R, Thornton CM, Mango VL. Innovations in image- guided preoperative breast lesion 
localization. Br J Radiol. 2018; 91(1085): 20170740.  
8 Hayes MK. (2017) Update on preoperative breast localization. Radiol Clin North Am 55:591–603.  
9 Canadian Institute for Health Information (CIHI), 2012: Breast Cancer Surgery in Canada, 2007–2008 to 
2009–2010. Ottawa, ON, CIHI. 
10 Chavez-MacGregor M, Lei X, Tamirisa N, Caudle AS, Giordano SH. Re-excision rates among older breast 
cancer patients undergoing breast-conserving surgery (BCS): Impact of the SSO-ASTRO consensus 
guideline on margins. J Clin Oncol. 2020;38(15_suppl):576-576. doi:10.1200/JCO.2020.38.15_suppl.576 
11 Magny SJ, Shikhman R, Keppke AL. Breast Imaging Reporting and Data System. 2020 Sep 5. In: 
StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan–. PMID: 29083600. 
12 Zhang Y, Seely J, Codeiro E, et al. Radioactive Seed Localization Versus Wire-Guided Localization for 
Nonpalpable Breast Cancer: A Cost and Operating Room Efficiency Analysis. Ann Surg Oncol. 2017; 24 
(12): 3567-3573. 
13 Jumaa K, Al Johani BA, Brackstone M, Kornecki A. A Single-Institute Experience With Radioactive Seed 
Localization of Breast Lesions—A Retrospective Study. Can Assoc Radiol J. 2020; 71(1): 58-62. 
14 Bloomquist EV, Ajkay N, Patil S, et al. A Randomized Prospective Comparison of Patient- Assessed 
Satisfaction and Clinical Outcomes with Radioactive Seed Localization versus Wire Localization. Breast 
J. 2015; 22(2): 151-157. 
15 Burroughs J, Fenci JL, Wakefield MC. Radioactive Seed Localization Program for Patients With 
Nonpalpable Breast Lesions. AORN J. 2017; 105(6): 593-604. 
 
                                               

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16 Srour MK, Kim S, Amersi F, et al. Comparison of wire localization, radioactive seed, and Savi SCOUT® 
radar for management of surgical breast disease. Breast J. 2019; 26(3): 406-413. 
17 Lee MK, Sanaiha Y, Kusske AM, et al. A Comparison of two non-radioactive alternatives to wire for the 
localization of non-palpable breast cancers. Breast Cancer Res Treat. 2020; 182(2): 299-303. 
18 Mango VL, Wynn RT, Feldman S, et al. Beyond Wires and Seeds: Reflector-guided Breast Lesion 
Localization and Excision. Radiology. 2017; 365-371. 
19 Cox CE, Russell S, Prowler V, et al. A Prospective, Single Arm, Multi-site, Clinical Evaluation of a 
Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during 
Excision. Ann Surg Oncol. 2016; 23(10): 3168-3174. 
20 Cox CE, Garcia-Henriquez N, Glancy MJ, et al. Pilot Study of a New Nonradioactive Surgical Guidance 
Technology for Locating Nonpalpable Breast Lesions. Ann Surg Oncol. 2016; 23(6): 1824-1830.  
21 Mango V, Ha R, Gomberawalla A, et al. Evaluation of the SAVI SCOUT® Surgical Guidance System for 
Localization and Excision of Nonpalpable Breast Lesions: A Feasibility Study. AJR Am J Roentgeno. 
2016; W1-w4. 
22 CADTH, 2019: CADTH rapid response report: summary with critical appraisal. Magnetic seed 
localization for soft tissue lesions in breast patients: Clinical effectiveness, cost- effectiveness, and 
guidelines. 
23 ISO 14155, 2020: Clinical investigation of medical devices for human subjects — Good clinical practice. 
24 Patel SN, Mango VL, Jadeja P, et al. Reflector-guided breast tumor localization versus wire localization 
for lumpectomies: A comparison of surgical outcomes. Clin Imaging. 2018; 14-17. 
25 Clinical Evaluation Report, 2020: SCOUT® Surgical Guidance System. Rev C. 
26 Kasem I and Mokbel K. Savi Scout® Radar Localisation of Non-palpable Breast Lesions: Systematic  
Review and Pooled Analysis of 842 Cases. Anticancer Res. 2020; 40(7): 3633-3643. 
 
27 Tingen JS, McKinley BP, Rinkliff JM, Cornett WR, Lucas C. Savi Scout Radar Localization Versus Wire 
Localization for Breast Biopsy Regarding Positive Margin, Complication, and Reoperation Rates. Am 
Surg. 2020; 86(8):1029-1031.