SCOUT MD Surgical Guidance System
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 |
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.
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)
Submission Summary (Full Text)
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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).
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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
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### 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) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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## SCOUT MD Surgical Guidance System
Traditional 510(k) Premarket Notification
## 510(k) Summary-K231468
| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Contact Person:<br>Date of Preparation:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>(510) 468-9995<br>Sandeep Saboo<br>02 February 2024<br>1721504 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Device | Trade Name:<br>Common/Usual Name:<br>Classification Name: | SCOUT MD Surgical Guidance System<br>Implantable Clip<br>Marker, Radiographic, Implantable |
| Predicate Device | Trade Name:<br>Classification Name:<br>Premarket Notification: K181007<br>Manufacturer: | SAVI Scout Reflector and SAVI Scout System<br>Marker, Radiographic, Implantable<br>Merit Medical Systems, Inc.<br>Predicate has not been a subject of a design related recall. |
| Classification | Class:<br>Regulation:<br>FDA Product Code:<br>Review Panel: | Class II<br>21 CFR 878.4300<br>NEU<br>General & Plastic Surgery |
| Intended<br>Use/Indications<br>For Use | The SCOUT MD Reflector is intended to be placed percutaneously in soft tissue (>30 days)<br>to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging<br>guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance<br>(SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with the<br>target tissue. The SCOUT MD System is intended only for the non-imaging detection and<br>localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site<br>or a soft tissue site intended for surgical removal. | |
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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).
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# 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<br>SAVI SCOUT System | Result of<br>Comparison |
| Class | II | II | No Difference |
| Regulation<br>Name | Implantable Clip | Implantable Clip | No Difference |
| Regulation<br>Number | 878.4300 | 878.4300 | No Difference |
| Product Code | NEU | NEU | No Difference |
| Product Code<br>Description | Marker, Radiographic, Implantable | Marker, Radiographic, Implantable | No Difference |
| Indications for<br>Use: | The SCOUT MD Reflector is intended<br>to be placed percutaneously in soft<br>tissue to mark (>30 days) a biopsy site<br>or a soft tissue site intended for<br>surgical removal. Using imaging<br>guidance (such as ultrasound, MRI, or<br>radiography) or aided by non-imaging<br>guidance (SCOUT MD System) the<br>SCOUT MD Reflector is located and<br>surgically removed with the target<br>tissue. The SCOUT MD System is<br>intended only for the non-imaging<br>detection and localization of the<br>SCOUT MD Reflector that has been<br>implanted in a soft tissue biopsy site or<br>a soft tissue site intended for surgical<br>removal. | The SAVI Scout Reflector is intended to<br>be placed percutaneously in soft tissue<br>to mark (>30 days) a biopsy site or a<br>soft tissue site intended for surgical<br>removal. Using imaging guidance (such<br>as ultrasound, MRI, or radiography) or<br>aided by non-imaging guidance (SAVI<br>Scout System) the SAVI Scout Reflector<br>is located and surgically removed with<br>the target tissue. The SAVI Scout<br>System is intended only for the non-<br>imaging detection and localization of<br>the SAVI Scout Reflector that has been<br>implanted in a soft tissue biopsy site or<br>a soft tissue site intended for surgical<br>removal. | No Difference<br>(other than<br>product name) |
| | | SYSTEM COMPARISON | |
| Procedure(s)<br>Used | Used in guided surgical removal of<br>soft tissue (e.g. breast tumor and<br>related tissue). | Used in guided surgical removal of<br>soft tissue (e.g. breast tumor and<br>related tissue). | No Difference |
| Use<br>environment | Intra-operative, guided surgical<br>procedure | Intra-operative, guided surgical<br>procedure | No Difference |
| Patient<br>population | Adult patient diagnosed with<br>carcinoma who are medically eligible<br>for tumor resection | Adult patient diagnosed with<br>carcinoma who are medically eligible<br>for tumor resection | No Difference |
| Tissue Type | Soft tissue, including breast | Soft tissue, including breast | No Difference |
| Principle of<br>Operation<br>(localization<br>technique) | Implantable reflector (marker) used<br>in conjunction with proprietary<br>location detection system which<br>measures relative strength of RF<br>reflective energy and provides<br>proximity/location and distance<br>information to the user | Implantable reflector (marker) used<br>in conjunction with proprietary<br>location detection system which<br>measures relative strength of RF<br>reflective energy and provides<br>proximity/location information to<br>the user | Minor<br>Difference |
| System<br>components | • Reflector (marker)<br>• Reflector Delivery System<br>• Guide (handpiece)<br>• Console | • Reflector (marker)<br>• Reflector Delivery System<br>• Guide (handpiece)<br>• Console | No Difference |
| REFLECTOR COMPARISON<br>(Reflector is a component of the Delivery System) | | | |
| How provided | Sterile, assembled within the Delivery<br>System | Sterile, assembled within the Delivery<br>System | No Difference |
| SAL | SAL 10-6 | SAL 10-6 | No Difference |
| Implant<br>Duration | > 30 days | > 30 days | No Difference |
| Reflector body | • 4mm (length) x 1.3.mm (dia),<br>• Loctite 3922 (Fully encases<br>electronics) | • 4mm (length) x 1.3.mm (dia),<br>• Loctite 3922 (Fully encases<br>electronics) | No Difference |
| Reflector length<br>(end to end) | Two Length Options<br>• 12mm<br>• 8mm | 12mm | Similar:<br>A smaller<br>Reflector is<br>available to<br>meet clinician<br>needs. |
| Reflector<br>tissue<br>contacting<br>materials | • Nitinol SE508, light oxide [ASTM<br>F2063-D]<br>• Loctite 3922 | • Nitinol SE508, light oxide [ASTM<br>F2063-D]<br>• Loctite 3922 | No Difference |
| Reflector<br>shapes | Four (4) | One (1) | Similar:<br>4 unique<br>shapes allow<br>clinicians to<br>distinguish<br>when multiple<br>marker(s) are<br>implanted |
| Reflector<br>activity | Responsive (in presence of IR light)<br>marker; passive marker (in absence<br>of IR light) | Responsive (in presence of IR light)<br>marker; passive marker (in absence<br>of IR light) | No Difference |
| Reflector<br>visibility | Visible under radiography, MR and<br>ultrasound | Visible under radiography, MR and<br>ultrasound | No Difference |
| DELIVERY SYSTEM COMPARISON<br>(see above for comparison of Reflector, a component of the Delivery System) | | | |
| How provided<br>Use | Sterile (SAL ≥ 10-6)<br>Single-use | Sterile (SAL ≥ 10-6)<br>Single-use | No Difference<br>No Difference |
| Sterilization<br>Method | EO | EO | No Difference |
| MR<br>Compatibility | MR Unsafe | MR Unsafe | No Difference |
| Delivery of<br>Reflector | Needle delivery system for<br>percutaneous placement of Reflector<br>(marker) | Needle delivery system for<br>percutaneous placement of Reflector<br>(marker) | No Difference |
| Working<br>Length | 5cm, 7.5cm and 10cm | 5cm, 7.5cm and 10cm | No Difference |
| | GUIDE/HANDPIECE COMPARISON | | |
| How provided | Non-sterile for Reuse and Sterile,<br>Single-Use Configurations | Non-sterile for Reuse and Sterile,<br>Single-Use Configurations | No Difference |
| Primary<br>functions | • Receives micro impulse radar signal<br>(RF electromagnetic wave signals)<br>from Console.<br>• Delivers RF electromagnetic wave<br>signal and infrared light pulses to<br>soft tissue.<br>• Receives reflected signal back from<br>the detected Reflector and<br>transmits data to the connected<br>Console. | • Receives micro impulse radar signal<br>(RF electromagnetic wave signals)<br>from Console.<br>• Delivers RF electromagnetic wave<br>signal and infrared light pulses to<br>soft tissue.<br>• Receives reflected signal back from<br>the detected Reflector and<br>transmits data to the connected<br>Console. | No Difference |
| Guide<br>Handpiece<br>Length | Handpiece Length: 140 mm length | Handpiece Length: 140 mm length | No Difference |
| Guide/Console<br>interface | Cable | Cable | No Difference |
| Cables | • Flexible, instant signal processing<br>• Tether probe to surgical Field | • Flexible, instant signal processing<br>• Tether probe to surgical Field | No Difference |
| | CONSOLE COMPARISON | | |
| Console<br>calibration | At Factory | At Factory | No Difference |
| Reflector<br>Localization | • Delivers micro impulse radar signal (RF<br>electromagnetic wave signals) to Guide.<br>• Provides power to the Guide to enable<br>Guide to output infrared light.<br>• Receives reflected RF electromagnetic<br>wave signal from the Reflector through<br>the Guide.<br>• The time delay between the<br>transmitted signal and the true<br>reflected signal is used to determine the<br>distance between the distal surface of<br>the Guide Handpiece and the Reflector. | • Delivers micro impulse radar signal (RF<br>electromagnetic wave signals) to Guide.<br>• Provides power to the Guide to enable<br>Guide to output infrared light.<br>• Receives reflected RF electromagnetic<br>wave signal from the Reflector through<br>the Guide.<br>• The time delay between the<br>transmitted signal and the true<br>reflected signal is used to determine the<br>distance between the distal surface of<br>the Guide Handpiece and the Reflector. | No Difference |
| User interface | Touchscreen Display with volume<br>control, start/stop, mode selection | LCD Display. Separate buttons for<br>volume control, start/stop…
