The subject Siege Vascular Plug ("Device") is a self-expanding braided Nitinol vascular embolization implant that is supplied with components used for implantation. The Device has radiopaque marker bands attached to each end and a screw attachment for connection to the Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 225 cm Delivery Wire that is provided within a hoop dispenser. The Delivery Wire has a lubricious, hydrophilic coating at its distal end (approximately 26.5cm long). A Tuohy Borst Valve is provided for flushing and maintaining hemostasis: a Torque Device is provided for releasing the Device; a Non-Vented Luer Cap is provided for device preparation.

The subject Siege Vascular Plug has been designed with a material, size, configuration, and shape that allows introduction through recommended 0.021" or 0.027" inner diameter commercial microcatheters for the embolization of arterial blood vessels in the peripheral vasculature. The Siege Vascular Plug Devices are provided in three different outer diameters (4.5 mm, 6.5 mm, 8.5 mm) to treat different artery diameter ranges (1.5 - 2.5 mm, 2.5 - 4 mm, 4 - 6 mm) in the peripheral vasculature.

AI/ML Overview

This document describes the 510(k) premarket notification for the Siege Vascular Plug, a medical device intended for arterial embolization in the peripheral vasculature. The device's manufacturer, Merit Medical Systems, Inc., demonstrated substantial equivalence to a legally marketed predicate device (Siege Vascular Plug [K212817]) through a series of non-clinical performance tests and a GLP animal study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All test results were comparable to the predicate Siege Vascular Plug and the subject Siege Vascular Plug met the predetermined acceptance criteria." However, specific numerical acceptance criteria and detailed performance results for each test are not explicitly provided in the furnished text. Instead, it lists the types of tests conducted:

Acceptance Criteria Category	Reported Device Performance
Simulated Use	Met predetermined acceptance criteria.
Set (Tensile) Strength	Met predetermined acceptance criteria.
Loader Heat Shrink Tensile	Met predetermined acceptance criteria.
Fatigue Testing	Met predetermined acceptance criteria.
Nickel Leach	Met predetermined acceptance criteria.
Radial Force	Met predetermined acceptance criteria.
Nitinol Austenite Finish Temperature	Met predetermined acceptance criteria.
MRI Compatibility	Met predetermined acceptance criteria.
Corrosion Testing	Met predetermined acceptance criteria.
Dimensional Testing/Size Designation	Met predetermined acceptance criteria.
Particulate Testing	Met predetermined acceptance criteria.
Radiopacity Testing	Met predetermined acceptance criteria.
Packaging	Met predetermined acceptance criteria.
Sterilization	Met predetermined acceptance criteria.
Pyrogenicity	Met predetermined acceptance criteria.
Shelf Life	Met predetermined acceptance criteria.
Biocompatibility	Met predetermined acceptance criteria.
GLP Animal Study	Demonstrated acute and chronic safety, performance, and handling comparable to a commercially available Reference Device in a porcine model.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of plugs tested for tensile strength or fatigue).

For the GLP Animal Study:

Sample Size: Not specified (only mentions "a porcine model").
Data Provenance: Prospective (as it's a study explicitly conducted to evaluate the subject device). The "country of origin" is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable and therefore not provided in the document. The acceptance criteria were based on "requirements outlined in guidance's and industry standards," and the performance was evaluated through physical and biological testing, not through expert-established ground truth in the context of diagnostic performance.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used for evaluating human-in-the-loop diagnostic performance, not for the technical and biological performance tests described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The evaluation focused on the physical, mechanical, and biological performance of the device itself, not on human reader performance with or without AI assistance.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical vascular plug, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests was adherence to established industry standards, guidance documents, and pre-defined specifications. For the animal study, the ground truth was the observable acute and chronic safety, performance, and handling within the porcine model, compared to a reference device. This is equivalent to performance against established benchmarks/standards and direct observation of biological safety/effectiveness.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable, as there is no training set for a physical medical device.

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.

May 2, 2024

Merit Medical Systems, Inc. James Kenny Principal Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland

Re: K240261

Trade/Device Name: Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: January 31, 2024 Received: April 8, 2024

Dear James Kenny:

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 OS regulation requires device manufacturers to review and approve changes to device design and production (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 (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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,

Misti L. Malone -S

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

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Indications for Use

510(k) Number (if known) K240261

Device Name

Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(+353) 91 651 560(+353) 91 680 104James Kenny1721504
GeneralProvisions	Correspondent Name:Address:	Merit Medical Ireland Ltd.Parkmore Business ParkParkmore, Galway, Ireland
	Telephone Number:Fax Number:	(+353) 91 703 761(+353) 91 680 104
	Contact Person:	James Kenny
	Date of Preparation:Registration Number:	26 January 20249616662
SubjectDevice	Trade Name:Common/Usual Name:Class:Product code:Classification Name:	Siege™ Vascular PlugVascular embolization plugIIKRDDevice, Vascular, For PromotingEmbolization
	Regulation Number:Regulation Medical Specialty	21 CFR 870.3300Cardiovascular
	Trade Name:	Siege™ Vascular Plug
	Class:Product code:	IIKRD
PredicateDevice	Classification Name:	Device, Vascular, For PromotingEmbolization
	Regulation Number:Regulation Medical Specialty	21 CFR 870.3300Cardiovascular
	Premarket Notification:	K212817
	Manufacturer:	Merit Medical Systems, Inc.

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	Reference Device#1:Trade Names:Premarket Notification:	Micro Vascular Plug System (MVP)MVP-3Q, MVP-5Q, MVP-7QK123803, K133282, K150108
ReferenceDevices	Reference Device#2:Trade Name:Premarket Notification:	Amplatzer Vascular Plug (AVP)K031810
	Reference Device#3:Trade Name:Premarket Notification:	Micro Plug SetK182944

Device

The subject Siege Vascular Plug has been designed with a material, Description size, configuration, and shape that allows introduction through recommended 0.021" or 0.027" inner diameter commercial microcatheters for the embolization of arterial blood vessels in the peripheral vasculature. The Siege Vascular Plug Devices are provided in three different outer diameters (4.5 mm, 6.5 mm, 8.5 mm) to treat different artery diameter ranges (1.5 - 2.5 mm, 2.5 - 4 mm, 4 - 6 mm) in the peripheral vasculature.

The subject Siege Vascular Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature. The main users are physicians trained in standard endovascular techniques.

Intended Use	The Siege Vascular Plug is intended for therapeutic embolizationto reduce or obstruct blood flow.
Indications for Use	The Siege Vascular Plug is indicated for arterial embolization in theperipheral vasculature.

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The subject Siege Vascular Plug is substantially equivalent in its intended use/indications for use, technology/principle of operation, materials, and performance specification to the predicate Siege Vascular Plug [K212817].

A comparison of the technological characteristics is summarized in the table below:

	DeviceCharacteristic	SubjectSiege Vascular Plug	PredicateSiege Vascular Plug
510(k) #		To be assigned	K212817
Product Code		KRD	KRD
Intended Use/Indicationsfor Use		The Siege Vascular Plug isindicated for arterialembolization in theperipheral vasculature.The Siege Vascular Plug isintended for therapeuticembolization to reduce orobstruct blood flow.	Indicated for arterialembolization in theperipheral vasculature.
Comparisonto Predicate	ComponentsSupplied inthe SterilePackage	Siege Vascular Plug Loader Delivery Wire Torque Device Tuohy Borst Valve Non-Vented Luer Cap	Siege Vascular Plug Loader Delivery Wire Torque Device Tuohy Borst Valves (2)
	ComponentConstructionMaterials	Plug Nitinol braid Platinum-Iridiumradiopaque markerbands Platinum-Iridium femalethreaded component atproximal end	Plug Nitinol braid Platinum-iridiumradiopaque markerbands 316 L Stainless Steelfemale threadedcomponent at proximalend
		Delivery Wire Nitinol ground core wire,stainless steel screw,gold plated tungsten coil,polymer (Pellethane)jacket with a lubricious,hydrophilic, coatingapplied at its distal end(26.5 +/- 1.5 cm long)	Delivery Wire Nitinol ground core wire,stainless steel screw,stainless steel outer coil.No lubricious coating.

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K240261

Page 4 of 7 Tuohy Borst Valve Tuohy Borst Valve • Body, Housing, Nut and • Body and Cap – Cap – polycarbonate polycarbonate · Seal - silicone rubber, · Seal - silicone, blue • Washer - PTFE • O-ring – silicone rubber • Washer & Back-Up Ring

• Lubricant - Silicone Oil
Loader• High DensityPolyethylene (HDPE)tubing with polyolefinheat shrink	Loader• Rilsan (nylon) tubing withVestamid hub and PTFEliner
Torque Device• Polycarbonate cap,polypropylene body,brass collet	Torque Device• Polycarbonate cap,polypropylene body,brass collet
Non-Vented Luer Cap• Polycarbonate• Colorant, Polycarbonate,Red
Siege Vascular Plug	Siege Vascular Plug
Diameter sizes: 4.5, 6.5, &	Diameter sizes: 3,4,5 & 6

Siege Vascular Plug	Siege Vascular Plug
Diameter sizes: 4.5, 6.5, & 8.5 mm	Diameter sizes: 3,4,5 & 6 mm
Construction:	Construction:
2 lobes 2 or 3 braid layers - each layer is comprised of 64 and/or 72 wires with diameters of 0.0008 and/or 0.001 inches Female threaded bushing with either 0.065 or 0.080" length Markerband ID 0.016" Device Diameter Device Length* 4.5 mm 6.4 mm 6.5 mm 7.3 mm 8.5 mm 7.8 mm *unconstrained – elongates when constrained with oversizing		3 lobes 2 braid layers - each layer is comprised of 72 wires with diameters of 0.0008 and/or 0.001 inches Female threaded bushing 0.052" length Markerband ID 0.016" Device Diameter Device Length* 3 mm 6.0 mm 4 mm 5.2 mm 5 mm 5.2 mm 6 mm 5.2 mm *unconstrained - elongates when constrained with oversizing
Delivery Wire Outer Diameter: 0.022" and 0.018" Length: 225 cm	Delivery Wire Outer Diameter: 0.022" Length: 180 cm

blue

– PTFE • Adhesive

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	Loader• Inner Diameter: 0.023" &0.028"• Length: 14"Touhy Valve• FLO50Torque Device• 3 Part torque device	Loader• Inner Diameter: 0.026" ID• Length: 11.2"Touhy Valve• FLO40Torque Device• 3 Part torque device
CatheterCompatibility	Delivery Catheter (notincluded)Introduction through 0.021"or 0.027" inner diametercommercially compatiblemicrocatheters up to 175cm long is recommended.	Delivery Catheter (notincluded)Introduction through 0.027"inner diametercommercially compatiblemicrocatheters up to 150cm long is recommended.
Use	Single Use	Single Use
AnatomicalSite	Peripheral vasculature	Peripheral vasculature
Sterilization	Sterile/Ethylene Oxide SAL10-6	Sterile/Ethylene Oxide SAL10-6
Shelf Life	6-months	3-years
Pyrogenicity	Non-Pyrogenic	Non-Pyrogenic
Packaging	Pouch and generallysquare box designed toaccommodate allcomponents (except amicrocatheter). Accessorypouch for torque device,Tuohy Borst Valve and non-vented luer cap. Hoopdispenser to containdelivery wire, loader andplug with a retention clip toanchor the delivery wire.	Length of backing card,pouch and box designed toaccommodate allcomponents (except amicrocatheter). Similarpackaging but will beshorter in length toaccommodate the removalof the catheter and willinclude a retention clip toanchor the delivery wire.
Principles ofoperation	The Delivery Wire withattached Siege VascularPlug is transferred into arecommended 0.021" or0.027" inner diametercommercially compatiblemicrocatheter using theprovided Loader. The Plugis advanced through arecommendedmicrocatheter to thetargeted position. TheSiege Vascular Plug isadvanced out of themicrocatheter; the SiegeVascular Plug device self-expands recovering its pre-set shape and cross-	The Delivery Wire withattached Siege VascularPlug is transferred into arecommended 0.027" innerdiameter commerciallycompatible microcatheterusing the provided Loader.The Plug is advancedthrough a recommendedmicrocatheter to thetargeted position. TheSiege Vascular Plug isadvanced out of themicrocatheter; the SiegeVascular Plug device self-expands recovering its pre-set shape and cross-sectionally occludes thevasculature. If Device
	vasculature. If Deviceposition is unsatisfactory,the device can berepositioned or removed. Ifposition is satisfactory, theDelivery Wire is rotatedcounterclockwise using theprovided Torque Device torelease the Siege VascularPlug.	position is unsatisfactory,the device can berepositioned or removed. Ifposition is satisfactory, theDelivery Wire is rotatedcounterclockwise using theprovided Torque Device torelease the Siege VascularPlug.

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No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. However, Vascular and Neurovascular Embolization Devices are subject to the Special Controls specified in "Vascular and Neurovascular Embolization Devices - Class II Special Controls Guidance Document for Industry and FDA Staff", issued in December 2004. A battery of testing was conducted, on the subject Siege Vascular Plug, in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence. The included performance testing, biocompatibility, evaluations sterilization, and animal studies.

Where appropriate, the tests were based on the requirements of the following documents:

Safetv & Performance Tests

The following is a list of all testing that was successfully completed on the subject Siege Vascular Pluq:

Performance Non-Clinical Testing

1. Simulated Use
1. Set (Tensile) Strength
1. Loader Heat Shrink Tensile
1. Fatigue Testing
1. Nickel Leach
1. Radial Force
1. Nitinol Austenite Finish Temperature
1. MRI Compatibility
1. Corrosion Testing
1. Dimensional Testing/Size Designation
1. Particulate Testing
1. Radiopacity Testing
1. Packaging
1. Sterilization

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Pyrogenicity
Shelf life
Biocompatibility
GLP Animal Study

The GLP animal study was conducted to evaluate the acute and chronic safety, performance and handling of the subject Siege Vascular Plug as compared to a commercially available Reference Device in the peripheral arteries of a porcine model.

Clinical testing was not required for the determination of substantial equivalence.

All test results were comparable to the predicate Siege Vascular Plug and the subject Siege Vascular Plug met the predeterminded acceptance criteria. This demonstrated that the subject Siege Vascular Plug is substantially equivalent to the predicate Siege Vascular Plug.

Summary of Substantial Equivalence	Based on the comparisons noted, the subject Siege Vascular Plug meets the requirements for its intended use and is substantively equivalent to the predicate Siege Vascular Plug [K212817] also manufactured by Merit Medical Systems, Inc.
------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
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.(b)
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).