Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a passive reflector and a system that detects its presence and distance using non-imaging guidance and audible/visual feedback. There is no mention of AI/ML in the device description, intended use, or performance studies.

Therapeutic

No.
A therapeutic device is one that treats or cures a disease or condition. This device is a marker to aid in the location and removal of tissue, not to treat or cure a condition.

Diagnostic

No

The device is a marker (reflector) and a system for locating that marker, primarily for guiding surgical removal of tissue. While imaging guidance is used for initial placement of the reflector, the device itself (reflector and detection system) does not perform any diagnostic function such as identifying diseases or conditions. Its purpose is localization for surgical removal, not diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including the SCOUT MD Delivery System, the SCOUT MD Reflector (a passive implant), the SCOUT MD Surgical Guidance System (including a Guide/Handpiece and Console), and the SCOUT Guide Sheath. The performance studies also include testing for hardware-related aspects like electrical safety, EMC, biocompatibility, and sterilization.

IVD (In Vitro Diagnostic)

Based on the provided information, the SCOUT MD Reflector and the SCOUT MD System are not In Vitro Diagnostic (IVD) devices.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
SCOUT MD Function: The SCOUT MD Reflector is an implantable marker placed within the body. The SCOUT MD System is used to locate this marker within the body during a surgical procedure.
Intended Use: The intended use is to mark a biopsy site or a soft tissue site for surgical removal and to aid in the surgical removal of the target tissue. This is a surgical guidance and localization function, not an in vitro diagnostic test.

The device description and intended use clearly indicate that this system is used for in vivo localization and surgical guidance, not for analyzing samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SCOUT MD 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 MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

Product codes

NEU

Device Description

The SCOUT MD Surgical Guidance System consists of the following components:

. SCOUT MD Delivery System, which includes two components:
- o SCOUT MD Reflector
  - o SCOUT MD Delivery Device
SCOUT MD Guide
SCOUT MD Handpiece
. SCOUT MD Console

The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are always used while inside the SCOUT Guide Sheath. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide is placed closer to the Reflector. The distance between the distal end of the Guide and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound, MRI, or radiography

Anatomical Site

soft tissue, including breast

Indicated Patient Age Range

Adult patient

Intended User / Care Setting

Intra-operative, guided surgical procedure

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software Verification and Validation Testing performed per IEC 62304 and documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." · Other Tests were performed per approved test protocols which included: Integrity: System withstands operating pressures O O Functional Testing: Deployment, detection, accuracy Dimensional Inspection and Testing: For each component of the system O Safety & Functional Testing for each component of the system and the entire system O Performance Simulated Use: Deployment and detection test O Tests MR Compatibility Testing per ASTM F2503 O O Biocompatibility Evaluation per ISO 10993-1 Sterilization Validation per ISO 11135 O Packaging Validation per ASTM D4169 O Accelerated Aging per ASTM F1980 O O Electrical Safety & EMC: In accordance with IEC 60601-1 and IEC 60601-1-2. The results of safety and performance tests demonstrate that the SCOUT MD Surgical Guidance System (subject device) is substantially equivalent to the predicate device (SAVI Scout Reflector and SAVI Scout System cleared per K181007). Based on the comparison of intended/indications for use and technological characteristics, the subject device is substantially equivalent to the predicate device. The performance tests for each system component and the hardware and software verification and validation testing demonstrate that the subject device meets its performance specifications and will perform as intended in the specified use conditions and that any differences between the subject device and predicate device do not raise new questions of safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K181007

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2024

Merit Medical System, Inc. Saboo Sandeep Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095

Re: K231468

Trade/Device Name: SCOUT MD Surgical Guidance System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: May 19, 2023 Received: May 22, 2023

Dear Saboo Sandeep:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Tek Tek N. N. Lamichhane -S Lamichhane -S Date: 2024.02.12 07:53:58 -05'00' Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K231468

Device Name SCOUT MD Surgical Guidance System

Indications for Use (Describe)

The SCOUT MD 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 MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

510(k) Summary-K231468

| General
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(510) 468-9995
Sandeep Saboo
02 February 2024
1721504 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | SCOUT MD Surgical Guidance System
Implantable Clip
Marker, Radiographic, Implantable |
| Predicate Device | Trade Name:
Classification Name:
Premarket Notification: K181007
Manufacturer: | SAVI Scout Reflector and SAVI Scout System
Marker, Radiographic, Implantable
Merit Medical Systems, Inc.
Predicate has not been a subject of a design related recall. |
| Classification | Class:
Regulation:
FDA Product Code:
Review Panel: | Class II
21 CFR 878.4300
NEU
General & Plastic Surgery |
| Intended
Use/Indications
For Use | The SCOUT MD 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 MD System) the SCOUT MD Reflector is located and surgically removed with the
target tissue. The SCOUT MD System is intended only for the non-imaging detection and
localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site
or a soft tissue site intended for surgical removal. | |

4

The SCOUT MD Surgical Guidance System consists of the following components:

. SCOUT MD Delivery System, which includes two components:
- o SCOUT MD Reflector
  - o SCOUT MD Delivery Device
SCOUT MD Guide
SCOUT MD Handpiece
. SCOUT MD Console

Device Description The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are always used while inside the SCOUT Guide Sheath. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide is placed closer to the Reflector. The distance between the distal end of the Guide and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.

When compared to the predicate device (SAVI Scout System), the SCOUT MD Surgical Guidance System:

Has the same indications for use;
Has the same intended use;
Has the same mechanism of action and principles of operation.

The fundamental scientific technology, use and materials/design of the subject device, SCOUT MD Surgical Guidance System, are the same as those of the predicate SAVI Scout Comparison to System. The principle of operation and mechanism of action are the same. As with the Predicate predicate device SAVI Scout System, the SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector while the SCOUT MD Guides/Handpieces and the SCOUT MD Console are used to detect the SCOUT MD Reflector.

Provided in the table below is a comparison of the subject and the predicate devices. Based on the comparison, the intended/indications for use and technological characteristics of the SCOUT MD Surgical Guidance System are substantially equivalent to the predicate device (SAVI Scout Reflector and SAVI SCOUT System cleared per K181007).

5

SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

Device Type →	SUBJECT Device (K231468)	PREDICATE Device (K181007)
Manufacturer →	Merit Medical Systems, Inc.	Merit Medical Systems, Inc.
Device Name →	SCOUT MD Surgical Guidance System	SAVI Scout Reflector and
SAVI SCOUT System	Result of
Comparison
Class	II	II	No Difference
Regulation
Name	Implantable Clip	Implantable Clip	No Difference
Regulation
Number	878.4300	878.4300	No Difference
Product Code	NEU	NEU	No Difference
Product Code
Description	Marker, Radiographic, Implantable	Marker, Radiographic, Implantable	No Difference
Indications for
Use:	The SCOUT MD Reflector is intended
to be placed percutaneously in soft
tissue to mark (>30 days) 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 MD System) the
SCOUT MD Reflector is located and
surgically removed with the target
tissue. The SCOUT MD System is
intended only for the non-imaging
detection and localization of the
SCOUT MD Reflector that has been
implanted in a soft tissue biopsy site or
a soft tissue site intended for surgical
removal.	The SAVI Scout Reflector is intended to
be placed percutaneously in soft tissue
to mark (>30 days) 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 (SAVI
Scout System) the SAVI Scout Reflector
is located and surgically removed with
the target tissue. The SAVI Scout
System is intended only for the non-
imaging detection and localization of
the SAVI Scout Reflector that has been
implanted in a soft tissue biopsy site or
a soft tissue site intended for surgical
removal.	No Difference
(other than
product name)
		SYSTEM COMPARISON
Procedure(s)
Used	Used in guided surgical removal of
soft tissue (e.g. breast tumor and
related tissue).	Used in guided surgical removal of
soft tissue (e.g. breast tumor and
related tissue).	No Difference
Use
environment	Intra-operative, guided surgical
procedure	Intra-operative, guided surgical
procedure	No Difference
Patient
population	Adult patient diagnosed with
carcinoma who are medically eligible
for tumor resection	Adult patient diagnosed with
carcinoma who are medically eligible
for tumor resection	No Difference
Tissue Type	Soft tissue, including breast	Soft tissue, including breast	No Difference
Principle of
Operation
(localization
technique)	Implantable reflector (marker) used
in conjunction with proprietary
location detection system which
measures relative strength of RF
reflective energy and provides
proximity/location and distance
information to the user	Implantable reflector (marker) used
in conjunction with proprietary
location detection system which
measures relative strength of RF
reflective energy and provides
proximity/location information to
the user	Minor
Difference
System
components	• Reflector (marker)
• Reflector Delivery System
• Guide (handpiece)
• Console	• Reflector (marker)
• Reflector Delivery System
• Guide (handpiece)
• Console	No Difference
REFLECTOR COMPARISON
(Reflector is a component of the Delivery System)
How provided	Sterile, assembled within the Delivery
System	Sterile, assembled within the Delivery
System	No Difference
SAL	SAL 10-6	SAL 10-6	No Difference
Implant
Duration	> 30 days	> 30 days	No Difference
Reflector body	• 4mm (length) x 1.3.mm (dia),
• Loctite 3922 (Fully encases
electronics)	• 4mm (length) x 1.3.mm (dia),
• Loctite 3922 (Fully encases
electronics)	No Difference
Reflector length
(end to end)	Two Length Options
• 12mm
• 8mm	12mm	Similar:
A smaller
Reflector is
available to
meet clinician
needs.
Reflector
tissue
contacting
materials	• Nitinol SE508, light oxide [ASTM
F2063-D]
• Loctite 3922	• Nitinol SE508, light oxide [ASTM
F2063-D]
• Loctite 3922	No Difference
Reflector
shapes	Four (4)	One (1)	Similar:
4 unique
shapes allow
clinicians to
distinguish
when multiple
marker(s) are
implanted
Reflector
activity	Responsive (in presence of IR light)
marker; passive marker (in absence
of IR light)	Responsive (in presence of IR light)
marker; passive marker (in absence
of IR light)	No Difference
Reflector
visibility	Visible under radiography, MR and
ultrasound	Visible under radiography, MR and
ultrasound	No Difference
DELIVERY SYSTEM COMPARISON
(see above for comparison of Reflector, a component of the Delivery System)
How provided
Use	Sterile (SAL ≥ 10-6)
Single-use	Sterile (SAL ≥ 10-6)
Single-use	No Difference
No Difference
Sterilization
Method	EO	EO	No Difference
MR
Compatibility	MR Unsafe	MR Unsafe	No Difference
Delivery of
Reflector	Needle delivery system for
percutaneous placement of Reflector
(marker)	Needle delivery system for
percutaneous placement of Reflector
(marker)	No Difference
Working
Length	5cm, 7.5cm and 10cm	5cm, 7.5cm and 10cm	No Difference
	GUIDE/HANDPIECE COMPARISON
How provided	Non-sterile for Reuse and Sterile,
Single-Use Configurations	Non-sterile for Reuse and Sterile,
Single-Use Configurations	No Difference
Primary
functions	• Receives micro impulse radar signal
(RF electromagnetic wave signals)
from Console.
• Delivers RF electromagnetic wave
signal and infrared light pulses to
soft tissue.
• Receives reflected signal back from
the detected Reflector and
transmits data to the connected
Console.	• Receives micro impulse radar signal
(RF electromagnetic wave signals)
from Console.
• Delivers RF electromagnetic wave
signal and infrared light pulses to
soft tissue.
• Receives reflected signal back from
the detected Reflector and
transmits data to the connected
Console.	No Difference
Guide
Handpiece
Length	Handpiece Length: 140 mm length	Handpiece Length: 140 mm length	No Difference
Guide/Console
interface	Cable	Cable	No Difference
Cables	• Flexible, instant signal processing
• Tether probe to surgical Field	• Flexible, instant signal processing
• Tether probe to surgical Field	No Difference
	CONSOLE COMPARISON
Console
calibration	At Factory	At Factory	No Difference
Reflector
Localization	• Delivers micro impulse radar signal (RF
electromagnetic wave signals) to Guide.
• Provides power to the Guide to enable
Guide to output infrared light.
• Receives reflected RF electromagnetic
wave signal from the Reflector through
the Guide.
• The time delay between the
transmitted signal and the true
reflected signal is used to determine the
distance between the distal surface of
the Guide Handpiece and the Reflector.	• Delivers micro impulse radar signal (RF
electromagnetic wave signals) to Guide.
• Provides power to the Guide to enable
Guide to output infrared light.
• Receives reflected RF electromagnetic
wave signal from the Reflector through
the Guide.
• The time delay between the
transmitted signal and the true
reflected signal is used to determine the
distance between the distal surface of
the Guide Handpiece and the Reflector.	No Difference
User interface	Touchscreen Display with volume
control, start/stop, mode selection	LCD Display. Separate buttons for
volume control, start/stop	Minor
Difference
Audible
location
information
(Cadence)	Higher click rate = closer proximity to
site of Reflector (marker)	Higher click rate = closer proximity to
site of Reflector (marker)	No Difference
Distinct
Audible
location
information
(Tone)	Provides for all compatible Reflectors
(up to four) unique click tones	Provides for a single-compatible
Reflector a unique click tone.	No Difference

6

SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

7

SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

8

SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

The following performance data have been provided in support of the substantial equivalence determination. • Software Verification and Validation Testing performed per IEC 62304 and documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." · Other Tests were performed per approved test protocols which included: Integrity: System withstands operating pressures O O Functional Testing: Deployment, detection, accuracy Dimensional Inspection and Testing: For each component of the system O Safety & Functional Testing for each component of the system and the entire system O Performance Simulated Use: Deployment and detection test O Tests MR Compatibility Testing per ASTM F2503 O O Biocompatibility Evaluation per ISO 10993-1 Sterilization Validation per ISO 11135 O Packaging Validation per ASTM D4169 O Accelerated Aging per ASTM F1980 O O Electrical Safety & EMC: In accordance with IEC 60601-1 and IEC 60601-1-2 The results of safety and performance tests demonstrate that the SCOUT MD Surgical Guidance System (subject device) is substantially equivalent to the predicate device (SAVI Scout Reflector and SAVI Scout System cleared per K181007). Based on the comparison of intended/indications for use and technological characteristics, the subject device is substantially equivalent to the predicate device. The performance tests for each system component and the hardware and software Summary of verification and validation testing demonstrate that the subject device meets its Substantial performance specifications and will perform as intended in the specified use Equivalence conditions and that any differences between the subject device and predicate device do not raise new questions of safety and effectiveness. Therefore, the subject device can be found to be substantially equivalent to the predicate device (SAVI Scout Reflector and SAVI Scout System cleared per K181007).