Merit Siege Vascular Plug

K212817 · Merit Medical System, Inc. · KRD · Dec 15, 2021 · Cardiovascular

Device Facts

• Record ID: K212817
• Device Name: Merit Siege Vascular Plug
• Applicant: Merit Medical System, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Dec 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.

Device Story

The Merit Siege Vascular Plug is a self-expanding, braided nitinol vascular occlusion implant used for arterial embolization in the peripheral vasculature. It is delivered via a microcatheter under fluoroscopic guidance by physicians trained in vascular embolization. The device consists of a nitinol braid with platinum-iridium radiopaque marker bands and a screw attachment for connection to a delivery wire. The system includes a loader, delivery wire, torque device, and Tuohy Borst valves. During the procedure, the plug is advanced through a microcatheter to the target site; upon deployment, it self-expands to occlude the vessel. If positioning is unsatisfactory, the device can be recaptured or repositioned. Once correctly placed, the delivery wire is detached by counterclockwise rotation using the torque device. The device provides a mechanical means to achieve vessel occlusion, aiding in the management of peripheral vascular conditions.

Clinical Evidence

No clinical data was required. Substantial equivalence was demonstrated through bench testing and a GLP animal study. Bench testing included simulated use, deployment/recapture/redeployment, fatigue testing, nickel leach, radial force, migration resistance, MRI compatibility, corrosion testing, and packaging/sterilization validation. The animal study evaluated acute and chronic performance and tissue response. All results met predetermined acceptance criteria.

Technological Characteristics

Self-expanding braided nitinol implant with platinum-iridium radiopaque markers. 316L stainless steel threaded component. Provided in 3mm, 4mm, 5mm, and 6mm diameters. Compatible with 0.027" ID microcatheters. Sterilized via ethylene oxide (SAL 10^-6). Complies with ISO 10555-1, ISO 80369-7/20, ASTM F2005, ASTM F2004, ISO 14630, ASTM F2129, ASTM F3044, ASTM G71, ASTM F2052, ASTM F2182, ASTM F2213, ASTM F2119, ASTM D4169, ASTM F1980, ASTM F88, ASTM F2096, ASTM F1929, ASTM D4332, AAMI TIR28, ISO 2233, ISO 11607-1/2, ISO 11135, and ISO 10993-1.

Indications for Use

Indicated for arterial embolization in the peripheral vasculature. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Dr. Amplatz Micro Plug (K182944)

Reference Devices

• Amplatzer® Vascular Plug (AVP) (K031810)
• Micro Vascular Plug System (MVP) (K123803)
• Micro Vascular Plug System (MVP) (K133282)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Merit Medical System, Inc. Siobhan King Senior Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland

## Re: K212817

Trade/Device Name: Merit Siege Vascular Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: November 5, 2021 Received: November 12, 2021

### Dear Siobhan King:

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/cfpmp/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 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

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K212817

Device Name Merit Siege Vascular Plug

Indications for Use (Describe)

The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.

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

| General<br>Provisions | Submitter Name: | Merit Medical Systems, Inc. | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 | |
| | Telephone Number: | ([phone] (Ext. 3061) | |
| | Fax Number: | ([phone] | |
| | Contact Person: | Mark Mullaney | |
| | Registration Number: | 1721504 | |
| | Correspondent Name: | Merit Medical Ireland Ltd. | |
| | Address: | Parkmore Business Park<br>Parkmore, Galway, Ireland | |
| | Telephone Number: | ([phone] (Ext. 3052) | |
| | Fax Number: | ([phone] | |
| | Contact Person: | Siobhan King | |
| | Date of Preparation: | 31 August 2021 | |
| | Registration Number: | 9616662 | |
| Subject<br>Device | Trade Name: | Merit Siege Vascular Plug | |
| | Common/Usual Name: | Vascular Device for promoting<br>embolization | |
| | Classification Name: | Vascular Embolization Device | |
| Predicate<br>Device | Premarket Notification Predicate: | | |
| | Trade Name: | Dr. Amplatz Micro Plug | |
| | Classification Name: | 21 CFR 870.3300 Vascular<br>Embolization Device | |
| | Premarket Notification: | K182944 | |
| | Manufacturer: | KA Medical | |
| | Premarket Notification Reference Device#1: | | |
| | Trade Name: | Amplatzer® Vascular Plug (AVP) | |
| | Classification Name: | 21 CFR 870.3300 Vascular<br>Embolization Device | |
| | Premarket Notification: | K031810 | |
| | Manufacturer: | Abbott | |
| Premarket Notification Reference Device#2: | | | |
| | Trade Name: | Micro Vascular Plug System<br>(MVP) | |
| | Classification Name: | 21 CFR 870.3300 Vascular<br>Embolization Device | |
| | Premarket Notification: | K123803 | |
| | Manufacturer: | Medtronic | |
| | Premarket Notification Reference Device#3: | | |
| | Trade Name: | Micro Vascular Plug System | |
| | | (MVP) | |
| | Classification Name: | 21 CFR 870.3300 Vascular<br>Embolization Device | |
| | Premarket Notification: | K133282 | |
| | Manufacturer: | Medtronic | |
| | | | |
| Classification | Class II | | |
| | 21 CFR § 870.3300 | | |
| | Product code: KRD | | |
| | Division of Cardiovascular Devices | | |
| | | | |
| Intended Use | The Siege Vascular Plug is indicated for arterial embolization<br>in the peripheral vasculature. | | |
| | | | |
| Device<br>Description | The Siege™ Vascular Plug (“Device”) is a self-expanding<br>braided nitinol vascular occlusion implant that is supplied with<br>components used for implantation. The Device has radiopaque<br>marker bands attached to each end and a screw attachment for<br>connection to a Delivery Wire. The Device is packaged<br>collapsed within a Loader and attached to a 180cm Delivery<br>Wire that is provided within a hoop dispenser. Touhy Borst<br>Valves are provided for flushing and maintaining hemostasis. A<br>Torque Device is provided for releasing the Device. | | |
| | The Siege™ Vascular Plug has been designed with a material,<br>size, configuration and shape that allows introduction through<br>recommended 0.027" inner diameter commercial<br>microcatheters for the occlusion of blood vessels in the<br>peripheral vasculature. The Siege™ Vascular Plug Devices are<br>provided in four different diameters (3mm, 4mm, 5mm, 6mm) to<br>treat different sized blood vessels in the peripheral vasculature.<br>The Siege™ Vascular Plug is designed to be used under<br>fluoroscopy for delivery and implantation in the peripheral<br>vasculature. The main users of the device are physicians trained<br>in vascular embolization. | | |
| Comparison<br>to Predicate | Device<br>Characteristic | Subject Merit<br>Siege™ Vascular Plug | Predicate KA Medical,<br>Micro Plug Set<br>(K182944) |
| | 510(k) # | K212817 | K182944 |
| | Product Code | KRD | Same |
| | Indications<br>for<br>Use/Intended<br>Use | indicated for arterial<br>embolization in the<br>peripheral vasculature | Same |
| | Components<br>Supplied in<br>the Sterile<br>Package | Siege Vascular Plug Loader Delivery Wire Torque Device Tuohy Borst Valves | Micro Plug Device Loader Delivery Wire Torque Device Tuohy Borst Valves Delivery Catheter |
| | Component<br>Construction<br>Materials | Plug Nitinol braid Platinum-iridium radiopaque marker bands 316 L Stainless Steel female threaded component at proximal end | Plug Same |
| | | Delivery Wire Nitinol ground core wire, stainless steel screw, stainless steel outer coil. Tuohy Borst Valve Body and Cap – polycarbonate Seal – silicone, blue Washer - PTFE Loader Rilsan (nylon) tubing with Vestamid hub and PTFE liner | Delivery Wire Same Tuohy Borst Valve Same Loader Rilsan (nylon) tubing with Pebax hub, LDPE strain relief and PTFE liner |
| | | Torque Device Polycarbonate cap, polypropylene body, brass collet Delivery Catheter No longer supplied – compatible with commercially available 0.027" inner diameter microcatheters | Torque Device Polybutylene Terephthalate (PBT) Delivery Catheter Nylon, Pebax, Stainless steel braid, PTFE, Grilamed, platinum-iridium, Hydrophilic coating |
| Dimensions | Siege Vascular Plug | Micro Plug Set | |
| | Diameter sizes: 3,4,5 & 6 mm<br>Construction:<br>• 3 lobes<br>• 2 braid layers - each layer is comprised of 72 wires with diameters of 0.0008 and/or 0.001 inches<br>• Female threaded bushing 0.052" length<br>• Markerband ID 0.016" | Diameter sizes: 3,4,5 & 6 mm<br>Construction:<br>• 3 lobes<br>• 2 braid layers - each layer is comprised of 72 wires with diameter of 0.001 inches<br>• Female threaded bushing 0.047" length<br>• Markerband ID 0.018" | |
| | Device<br>Diameter | Device<br>Diameter | |
| | Device<br>Length* | Device<br>Length* |…