Using SCOUT Bx Delivery System, 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 intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

Device Description

The SCOUT Bx Delivery System (including the SCOUT Reflector) is a sterile, single use device composed of a SCOUT Reflector preloaded in a delivery system. The SCOUT Reflector, when used in conjunction with the SCOUT Handpiece and SCOUT Console, can be used as a guide for the surgeon to follow in the excision of tissue. The SCOUT Reflector is visible using ultrasound and radiography. The SCOUT® Console, SCOUT Handpiece and SCOUT Reflector are components of the SCOUT Surgical Guidance System. The SCOUT Bx Delivery System is intended to be used with compatible Hologic® Biopsy Devices (Eviva® 0913-20, Eviva 1213-20, BREV09 (20mm aperture) and ATEC® ILS 0914-20).

AI/ML Overview

The provided text is a 510(k) summary for the SCOUT Bx Delivery System. It outlines the device description, indications for use, comparison to a predicate device, and the performance testing conducted. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study that proves the device meets the criteria in the context of an AI/ML medical device performance study.

The relevant sections are focused on bench testing and biocompatibility for a physical medical device (implantable marker delivery system), not on software performance, diagnostic accuracy, or human reader effectiveness with AI assistance.

Therefore, many of the requested items, such as expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and AI training/test set details, are not applicable or present in this document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document mentions various bench tests and biocompatibility tests. While it states "Performance Testing-Bench" and lists categories like "Compatibility with legally marketed 3rd party Biopsy Device," "Deployment Accuracy," "Cannula Effective Length & OD," etc., it does not provide the specific quantitative acceptance criteria or the reported performance values for these tests. It only lists that these tests were conducted as part of the substantial equivalence determination.

2. Sample sizes used for the test set and the data provenance:

Sample sizes: Not specified for any of the performance tests.
Data provenance: Not applicable in the context of clinical data for AI testing, as this document describes bench and biocompatibility testing of a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as typically understood for AI/ML diagnostic devices (e.g., expert interpretation of images) is not relevant to the described physical device testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No expert-based adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states: "No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device." This confirms that no clinical studies involving human readers or AI assistance were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the physical device, ground truth would be based on engineering specifications and physical measurement standards (e.g., ISO, ASTM standards listed). Not expert consensus or pathology in the diagnostic sense.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable.

In summary:

The provided text documents the 510(k) clearance for a physical medical device (SCOUT Bx Delivery System) and outlines the bench and biocompatibility testing performed to demonstrate substantial equivalence to a predicate device. It does not contain any information related to AI/ML device performance studies, diagnostic accuracy, or human reader interaction with AI, which are the typical contexts for the requested acceptance criteria and study details.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

April 8, 2022

Merit Medical Systems, Inc. Sari Stevens Senior Regulatory Affairs Specialist 1600 W Merit Parkway South Jordan, Utah 84095

Re: K212882

Trade/Device Name: SCOUT BX Delivery System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: September 8, 2021 Received: September 10, 2021

Dear Sari Stevens:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212882

Device Name SCOUT Bx Delivery System

Indications for Use (Describe)

Using SCOUT Bx Delivery System, 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 Reflector is located and surgically removed with the target tissue. The SCOUT System is intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in 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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510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Contact Person:Date Prepared:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4674Sandeep Saboo04/01/20221721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel:	SCOUT Bx™ Delivery SystemImplantable ChipMarker, Radiographic, Implantable2NEU878.4300General & Plastic Surgery
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	SCOUT Surgical Guidance SystemMarker, Radiographic, ImplantableK181007Merit Medical Systems, Inc.
ReferenceDevice		No reference devices were used in this submission.
DeviceDescription	The SCOUT Bx Delivery System (including the SCOUT Reflector) is asterile, single use device composed of a SCOUT Reflector preloaded ina delivery system. The SCOUT Reflector, when used in conjunctionwith the SCOUT Handpiece and SCOUT Console, can be used as aguide for the surgeon to follow in the excision of tissue. The SCOUTReflector is visible using ultrasound and radiography. The SCOUT®Console, SCOUT Handpiece and SCOUT Reflector are components ofthe SCOUT Surgical Guidance System. The SCOUT Bx DeliverySystem is intended to be used with compatible Hologic® BiopsyDevices (Eviva® 0913-20, Eviva 1213-20, BREV09 (20mm aperture)and ATEC® ILS 0914-20).
Indications forUse	Using SCOUT Bx Delivery System, the SCOUT Reflector is intended tobe placed percutaneously in soft tissue (>30 days) to mark a biopsy siteor a soft tissue site intended for surgical removal. Using imagingguidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT System) the SCOUT Reflector is locatedand surgically removed with the target tissue. The SCOUT System isintended only for the non-imaging detection and localization of theSCOUT Reflector that has been implanted in a soft tissue biopsy site ora soft tissue site intended for surgical removal.
Comparison toPredicateDevice		The SCOUT Bx Delivery Device has the similar design andtechnological characteristics as the predicate SCOUT Delivery Device.Both devices are used with the SCOUT Surgical Guidance System toimplant the SCOUT Reflector to the target tissue. The subject devicediffers from the predicate device in.• Blunt cannula compared to the sharp cannula

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No depth marks on the blunt cannula ●
Compatible with legally marketed 3rd party biopsy devices ●
Plunger for deplovment instead of a trigger ●
. Allows for Stereotactic (X-ray) and MRI deployment imaging instead of X-ray and ultrasound imaging
Longer Length
Change in grade of stainless steel for tube and plunger ●
Change in non-patient contacting materials in device handle
. 15G instead of 16G
. Indications for Use statement has minor updates due to updated branding and readability; removal of word "SAVI", capitalization of "SCOUT", moved "(>30 days)" from after word "mark" to after "tissue"

The comparison between the subject and reference devices is based on the following:

Same intended use ●
Same Indications for Use ●
Same sterilization methods
Same fundamental technology/principle of operation between ● the subject and predicate devices

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject SCOUT Bx Delivery System was conducted based on the risk analysis and based on the requirements of the following international standard:

. ISO 7864 Fourth edition 2016-08-01, Sterile hypodermic needles for single use - Requirements and test methods
ISO 9626:2016. Stainless steel needle tubing for the manufacture of . medical devices - Requirements and test methods
JIS T 3228, Biopsy needles for single use ●
ISO 10993-1:2018, Biological Evaluation of Medical Devices Part ● 1: Evaluation and testing within a risk management process
. ISO 10993-5:2009. Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Data

. ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
USP 43-NF38:2020 <151> Pyrogen Test
ISO 11607-1: 2019, Packaging for terminally sterilized medical ● devices
ASTM D4169-16, Standard Practice for Performance Testing of ● Shipping Containers and Systems
EN ISO 2233: 2001 Packaging Complete, Filled Transport ● Packages and Unit Loads - Conditioning for Testing
ISO 11135 Second edition 2014-07-15 Sterilization of health-care . products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]

Performance

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ISO 10993-7:2008, Biological Evaluation of Medical Devices Part ● 7: Ethylene Oxide Sterilization Residuals.
ASTM F88-15, Standard Test Method for Seal Strength of Flexible • Barrier Materials

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the SCOUT Bx Delivery System was conducted in accordance with ISO 10993-1:2018. The battery of testing included the following tests:

Cytotoxicity ●
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity .

The SCOUT Bx Delivery System is considered tissue contacting for a duration of less than 24 hours.

	Performance Testing-Bench
	Compatibility with legally marketed 3rd party Biopsy Device Deployment Accuracy Cannula Effective Length & OD Plunger to Handle Tensile Plunger to Rod Tensile Handle to Cannula Tensile Resistance to Corrosion Design Validation Packaging Qualification
PerformanceData cont.	No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device.
	Summary ofSubstantialEquivalence

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.