(92 days)
No
The device description focuses on the physical characteristics and materials of the vascular plug and its delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies described are standard biocompatibility, sterilization, and animal studies, not studies evaluating the performance of an AI/ML algorithm.
Yes
The device is described as being indicated for "therapeutic embolization to reduce or obstruct blood flow," which falls under the definition of a therapeutic device.
No
The device is indicated for "therapeutic embolization to reduce or obstruct blood flow," which is a treatment, not a diagnostic purpose.
No
The device description clearly states it is a physical implant (self-expanding braided Nitinol vascular embolization implant) and includes hardware components for implantation and delivery.
Based on the provided information, the Siege Vascular Plug is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "arterial embolization in the peripheral vasculature" and "therapeutic embolization to reduce or obstruct blood flow." This describes a therapeutic intervention performed within the patient's body.
- Device Description: The device is a "self-expanding braided Nitinol vascular embolization implant." This is a physical implant designed to be placed inside blood vessels.
- Mechanism of Action: The device works by physically obstructing blood flow.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other information. The Siege Vascular Plug is a therapeutic device used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
Peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained in standard endovascular techniques.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K123803, K133282, K150108, K031810, K182944
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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.
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).
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 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
2
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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3
| | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(+353) 91 651 560
(+353) 91 680 104
James Kenny
1721504 |
|-----------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| General
Provisions | Correspondent Name:
Address: | Merit Medical Ireland Ltd.
Parkmore Business Park
Parkmore, 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 2024
9616662 |
| Subject
Device | Trade Name:
Common/Usual Name:
Class:
Product code:
Classification Name: | Siege™ Vascular Plug
Vascular embolization plug
II
KRD
Device, Vascular, For Promoting
Embolization |
| | Regulation Number:
Regulation Medical Specialty | 21 CFR 870.3300
Cardiovascular |
| | Trade Name: | Siege™ Vascular Plug |
| | Class:
Product code: | II
KRD |
| Predicate
Device | Classification Name: | Device, Vascular, For Promoting
Embolization |
| | Regulation Number:
Regulation Medical Specialty | 21 CFR 870.3300
Cardiovascular |
| | Premarket Notification: | K212817 |
| | Manufacturer: | Merit Medical Systems, Inc. |
4
| | Reference Device#1:
Trade Names:
Premarket Notification: | Micro Vascular Plug System (MVP)
MVP-3Q, MVP-5Q, MVP-7Q
K123803, K133282, K150108 |
|----------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Reference
Devices | Reference Device#2:
Trade Name:
Premarket Notification: | Amplatzer Vascular Plug (AVP)
K031810 |
| | Reference Device#3:
Trade Name:
Premarket Notification: | Micro Plug Set
K182944 |
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.
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 embolization
to reduce or obstruct blood flow. |
|---------------------|-------------------------------------------------------------------------------------------------------|
| Indications for Use | The Siege Vascular Plug is indicated for arterial embolization in the
peripheral vasculature. |
5
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:
| | Device
Characteristic | Subject
Siege Vascular Plug | Predicate
Siege Vascular Plug |
|-----------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | | To be assigned | K212817 |
| Product Code | | KRD | KRD |
| Intended Use/
Indications
for Use | | The Siege Vascular Plug is
indicated for arterial
embolization in the
peripheral vasculature.
The Siege Vascular Plug is
intended for therapeutic
embolization to reduce or
obstruct blood flow. | Indicated for arterial
embolization in the
peripheral vasculature. |
| Comparison
to Predicate | Components
Supplied in
the Sterile
Package | 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) |
| | Component
Construction
Materials | Plug Nitinol braid Platinum-Iridium
radiopaque marker
bands Platinum-Iridium female
threaded component at
proximal end | Plug Nitinol braid Platinum-iridium
radiopaque marker
bands 316 L Stainless Steel
female threaded
component at proximal
end |
| | | Delivery Wire Nitinol ground core wire,
stainless steel screw,
gold plated tungsten coil,
polymer (Pellethane)
jacket with a lubricious,
hydrophilic, coating
applied 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. |
6
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 Density | |
| Polyethylene (HDPE) | |
| tubing with polyolefin | |
| heat shrink | Loader |
| • Rilsan (nylon) tubing with | |
| Vestamid hub and PTFE | |
| liner | |
| 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 |
| Dimensions | 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
7
| | Loader
• Inner Diameter: 0.023" &
0.028"
• Length: 14"
Touhy Valve
• FLO50
Torque Device
• 3 Part torque device | Loader
• Inner Diameter: 0.026" ID
• Length: 11.2"
Touhy Valve
• FLO40
Torque Device
• 3 Part torque device | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Catheter
Compatibility | Delivery Catheter (not
included)
Introduction through 0.021"
or 0.027" inner diameter
commercially compatible
microcatheters up to 175
cm long is recommended. | Delivery Catheter (not
included)
Introduction through 0.027"
inner diameter
commercially compatible
microcatheters up to 150
cm long is recommended. | |
| Use | Single Use | Single Use | |
| Anatomical
Site | Peripheral vasculature | Peripheral vasculature | |
| Sterilization | Sterile/Ethylene Oxide SAL
10-6 | Sterile/Ethylene Oxide SAL
10-6 | |
| Shelf Life | 6-months | 3-years | |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | |
| Packaging | Pouch and generally
square box designed to
accommodate all
components (except a
microcatheter). Accessory
pouch for torque device,
Tuohy Borst Valve and non-
vented luer cap. Hoop
dispenser to contain
delivery wire, loader and
plug with a retention clip to
anchor the delivery wire. | Length of backing card,
pouch and box designed to
accommodate all
components (except a
microcatheter). Similar
packaging but will be
shorter in length to
accommodate the removal
of the catheter and will
include a retention clip to
anchor the delivery wire. | |
| Principles of
operation | The Delivery Wire with
attached Siege Vascular
Plug is transferred into a
recommended 0.021" or
0.027" inner diameter
commercially compatible
microcatheter using the
provided Loader. The Plug
is advanced through a
recommended
microcatheter to the
targeted position. The
Siege Vascular Plug is
advanced out of the
microcatheter; the Siege
Vascular Plug device self-
expands recovering its pre-
set shape and cross- | The Delivery Wire with
attached Siege Vascular
Plug is transferred into a
recommended 0.027" inner
diameter commercially
compatible microcatheter
using the provided Loader.
The Plug is advanced
through a recommended
microcatheter to the
targeted position. The
Siege Vascular Plug is
advanced out of the
microcatheter; the Siege
Vascular Plug device self-
expands recovering its pre-
set shape and cross-
sectionally occludes the
vasculature. If Device | |
| | vasculature. If Device
position is unsatisfactory,
the device can be
repositioned or removed. If
position is satisfactory, the
Delivery Wire is rotated
counterclockwise using the
provided Torque Device to
release the Siege Vascular
Plug. | position is unsatisfactory,
the device can be
repositioned or removed. If
position is satisfactory, the
Delivery Wire is rotated
counterclockwise using the
provided Torque Device to
release the Siege Vascular
Plug. | |
8
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
-
- Simulated Use
-
- Set (Tensile) Strength
-
- Loader Heat Shrink Tensile
-
- Fatigue Testing
-
- Nickel Leach
-
- Radial Force
-
- Nitinol Austenite Finish Temperature
-
- MRI Compatibility
-
- Corrosion Testing
-
- Dimensional Testing/Size Designation
-
- Particulate Testing
-
- Radiopacity Testing
-
- Packaging
-
- Sterilization
9
-
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. |
|---|---|
| ------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |