Who is the manufacturer of SCOUT MD Surgical Guidance System?

Merit Medical System, Inc. filed the 510(k) submission for SCOUT MD Surgical Guidance System (K231468).

What is the FDA product code for SCOUT MD Surgical Guidance 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 MD Surgical Guidance System?

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

What are the predicate devices for SCOUT MD Surgical Guidance System?

SAVI Scout Reflector and SAVI Scout System (K181007).

Who can help prepare an FDA 510(k) submission like SCOUT MD Surgical Guidance 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 MD Surgical Guidance System

K231468 · Merit Medical System, Inc. · NEU · Feb 12, 2024 · General, Plastic Surgery

Device Facts

Record ID	K231468
Device Name	SCOUT MD Surgical Guidance System
Applicant	Merit Medical System, Inc.
Product Code	NEU · General, Plastic Surgery
Decision Date	Feb 12, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4300
Device Class	Class 2

Intended 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.

Device Story

System consists of implantable reflector, delivery device, guide handpiece, and console. Reflector is percutaneously implanted into soft tissue using imaging guidance (ultrasound, MRI, radiography) to mark biopsy/surgical sites. During surgery, surgeon uses handpiece connected to console to detect reflector. Console transmits micro-impulse radar (RF) and infrared light pulses through handpiece to tissue. Reflector reflects RF signal; console measures time delay between transmitted and reflected signals to calculate distance. Console provides audible feedback (cadence increases as proximity to reflector increases) and displays distance in millimeters. System facilitates precise localization and removal of target tissue. Used intraoperatively by surgeons. Benefits include improved surgical accuracy and tissue removal efficiency.

Clinical Evidence

Bench testing only. Evidence includes software verification/validation (IEC 62304), functional testing (deployment, detection, accuracy), dimensional inspection, simulated use, MR compatibility (ASTM F2503), biocompatibility (ISO 10993-1), sterilization validation (ISO 11135), packaging validation (ASTM D4169), accelerated aging (ASTM F1980), and electrical safety/EMC (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

Reflector: Nitinol SE508 (ASTM F2063-D), Loctite 3922. Dimensions: 4mm x 1.3mm (body), 8mm or 12mm (length). Sensing: Micro-impulse radar (RF) and infrared light. Connectivity: Wired (cable) between handpiece and console. Sterilization: Ethylene Oxide (EO). Software: Rule-based signal processing for distance calculation.

Indications for Use

Indicated for adult patients diagnosed with carcinoma who are medically eligible for tumor resection, requiring percutaneous placement of a reflector in soft tissue (including breast) to mark a biopsy or surgical site for subsequent removal.

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

SAVI Scout Reflector and SAVI Scout System (K181007)

Related Devices

K252892 — SCOUT MD Surgical Guidance System · Merit Medical Systems, Inc. · Dec 19, 2025
K223682 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit · Sirius Medical Systems B.V. · Nov 9, 2023
K181007 — Cianna Medical SAVI Scout Reflector and SAVI Scout System · Cianna Medical, Inc. · Aug 2, 2018
K193189 — RFID Localization System · Health Beacons, Inc. · May 6, 2020
K171767 — Cianna Medical SAVI Scout Reflector and SAVI Scout System · Cianna Medical, Inc. · Oct 31, 2017

Submission Summary (Full Text)

{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) | ### 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}------------------------------------------------ ## 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 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…