Who is the manufacturer of SCOUT BX Delivery System?

Merit Medical Systems, Inc. filed the 510(k) submission for SCOUT BX Delivery System (K212882).

What is the FDA product code for SCOUT BX Delivery System?

NEU. It is classified under 21 CFR 878.4300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for SCOUT BX Delivery System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SCOUT BX Delivery System?

SCOUT Surgical Guidance System (K181007).

Who can help prepare an FDA 510(k) submission like SCOUT BX Delivery System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SCOUT BX Delivery System

K212882 · Merit Medical Systems, Inc. · NEU · Apr 8, 2022 · General, Plastic Surgery

Device Facts

Record ID	K212882
Device Name	SCOUT BX Delivery System
Applicant	Merit Medical Systems, Inc.
Product Code	NEU · General, Plastic Surgery
Decision Date	Apr 8, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4300
Device Class	Class 2

Intended Use

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.

Device Story

SCOUT Bx Delivery System is a sterile, single-use device for percutaneous implantation of a SCOUT Reflector into soft tissue to mark biopsy or surgical sites. The system consists of a delivery cannula preloaded with a reflector. It is designed for use with compatible third-party biopsy devices (e.g., Hologic Eviva, ATEC ILS). The device features a blunt cannula, 15G diameter, and a plunger-based deployment mechanism. It supports deployment under stereotactic (X-ray) and MRI guidance. Once implanted, the reflector remains in the tissue for >30 days. Surgeons subsequently use the SCOUT Surgical Guidance System (console and handpiece) to non-invasively detect and localize the reflector, guiding the excision of the target tissue. This process assists in precise surgical removal of marked lesions, potentially improving surgical outcomes by ensuring accurate tissue targeting.

Clinical Evidence

Bench testing only. No clinical or pre-clinical animal testing was conducted. Performance data included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity per ISO 10993), deployment accuracy, tensile strength, corrosion resistance, and packaging/sterilization validation.

Technological Characteristics

Sterile, single-use delivery system. Materials: stainless steel (ISO 9626) and various handle materials. Dimensions: 15G cannula. Principle: mechanical plunger-based deployment of an implantable reflector. Sterilization: Ethylene Oxide (ISO 11135). Connectivity: None (mechanical delivery system). Standards: ISO 7864, ISO 9626, JIS T 3228, ISO 10993 series, ISO 11607-1, ASTM D4169, ASTM F88.

Indications for Use

Indicated for percutaneous placement in soft tissue to mark biopsy sites or sites intended for surgical removal in patients requiring localization for excision.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

SCOUT Surgical Guidance System (K181007)

Related Devices

K102608 — SECURMARK BIOPSY SITE MARKING SYSTEM · Suros Surgical Systems, Inc. A Hologic Company · Oct 8, 2010
K240429 — Trilogy Tissue Marker · Inrad, Inc. · Nov 7, 2024
K102768 — SECRMARK BIOPSY SITE MARKING SYSTEM · Hologic, Inc. · Dec 2, 2010
K171767 — Cianna Medical SAVI Scout Reflector and SAVI Scout System · Cianna Medical, Inc. · Oct 31, 2017
K153189 — Beacon Tissue Marker (SE) · Scion Medical Technologies, LLC · Dec 17, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | General Provisions | Submitter Name: Address: Telephone Number: Contact Person: Date Prepared: Registration Number: | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 (801) 208-4674 Sandeep Saboo 04/01/2022 1721504 | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name: Common/Usual Name: Classification Name: Regulatory Class: Product Code: 21 CFR §: Review Panel: | SCOUT Bx™ Delivery System Implantable Chip Marker, Radiographic, Implantable 2 NEU 878.4300 General & Plastic Surgery | | Predicate Device | Trade Name: Classification Name: Premarket Notification: Manufacturer: | SCOUT Surgical Guidance System Marker, Radiographic, Implantable K181007 Merit Medical Systems, Inc. | | Reference Device | | No reference devices were used in this submission. | | 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). | | | Indications for Use | 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. | | | Comparison to Predicate Device | | The SCOUT Bx Delivery Device has the similar design and technological characteristics as the predicate SCOUT Delivery Device. Both devices are used with the SCOUT Surgical Guidance System to implant the SCOUT Reflector to the target tissue. The subject device differs from the predicate device in. • Blunt cannula compared to the sharp cannula | {4}------------------------------------------------ - 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 {5}------------------------------------------------ - 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 | | Performance Data cont. | No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device. | | | Summary of Substantial Equivalence |