(103 days)
No
The device description and performance studies focus on the mechanical properties and delivery system of a physical vascular plug, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for "arterial embolization in the peripheral vasculature," which is a medical procedure aimed at treating a health condition (e.g., stopping bleeding or blocking blood flow to a tumor), thus it serves a therapeutic purpose.
No
This device is an occlusive implant used for arterial embolization, meaning it blocks blood vessels. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines a physical implant (braided nitinol vascular occlusion implant) and associated hardware components (Delivery Wire, Loader, Touhy Borst Valves, Torque Device).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Siege Vascular Plug is a physical implant designed to occlude blood vessels within the body. It is used in vivo (within a living organism) during a medical procedure.
- Intended Use: The intended use is "arterial embolization in the peripheral vasculature," which is a therapeutic procedure performed directly on the patient's circulatory system.
- Device Description: The description details a physical implant and delivery system, not a test or reagent for analyzing biological samples.
- Input: The input is fluoroscopy, which is an imaging technique used during the procedure, not a biological specimen.
The Siege Vascular Plug is a therapeutic medical device, specifically an implantable device used for embolization.
N/A
Intended Use / Indications for Use
The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.
Product codes
KRD
Device Description
The Siege™ Vascular Plug (“Device”) is a self-expanding braided nitinol vascular occlusion 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 a Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 180cm Delivery Wire that is provided within a hoop dispenser. Touhy Borst Valves are provided for flushing and maintaining hemostasis. A Torque Device is provided for releasing the Device.
The Siege™ Vascular Plug has been designed with a material, size, configuration and shape that allows introduction through recommended 0.027" inner diameter commercial microcatheters for the occlusion of blood vessels in the peripheral vasculature. The Siege™ Vascular Plug Devices are provided in four different diameters (3mm, 4mm, 5mm, 6mm) to treat different sized blood vessels in the peripheral vasculature. The Siege™ Vascular Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature. The main users of the device are physicians trained in vascular embolization.
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 vascular embolization.
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 Merit Siege Vascular Plug, in accordance with protocols based on requirements outlined in guidance's and Performance industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence. The evaluations included performance testing, biocompatibility, sterilization, and animal studies.
Performance Testing included: Simulated Use Loader Flushing, Device Handoff, Device Advancement, Deployment, Apposition, Recapture, Redeployment, Device Release, Set Strength, Delivery Wire Proximal Weld Strength, Loader Fluid Leakage Under Pressure, Loader Hub to Loader Tube Peak Tensile Force, Luer Testing, Fatigue testing, Nickel leach, Radial Force, Migration resistance, Nitinol Austenite Finish Temperature, MRI Testing, Corrosion Testing, Size Designation.
Packaging testing included: Visual, Dye penetration testing, Bubble Leak Test, Seal peel strength, Burst Test.
Other tests included: Sterilization, Shelf life, Biocompatibility, GLP Animal Study (Acute performance, Chronic performance, Tissue response).
All test results were comparable to the predicate devices and the subject Merit Siege™ Vascular Plug met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate device, K182944.
Clinical testing was not required for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary
| General
| Provisions | Submitter Name: | Merit Medical Systems, Inc. | |
|---|---|---|---|
| Address: | 1600 West Merit Parkway | ||
| South Jordan, UT 84095 | |||
| Telephone Number: | (+353) 91 703700 (Ext. 3061) | ||
| Fax Number: | (+353) 91 680104 | ||
| Contact Person: | Mark Mullaney | ||
| Registration Number: | 1721504 | ||
| Correspondent Name: | Merit Medical Ireland Ltd. | ||
| Address: | Parkmore Business Park | ||
| Parkmore, Galway, Ireland | |||
| Telephone Number: | (+353) 91 703700 (Ext. 3052) | ||
| Fax Number: | (+353) 91 680104 | ||
| Contact Person: | Siobhan King | ||
| Date of Preparation: | 31 August 2021 | ||
| Registration Number: | 9616662 | ||
| Subject | |||
| Device | Trade Name: | Merit Siege Vascular Plug | |
| Common/Usual Name: | Vascular Device for promoting | ||
| embolization | |||
| Classification Name: | Vascular Embolization Device | ||
| Predicate | |||
| Device | Premarket Notification Predicate: | ||
| Trade Name: | Dr. Amplatz Micro Plug | ||
| Classification Name: | 21 CFR 870.3300 Vascular | ||
| 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 | ||
| Embolization Device | |||
| Premarket Notification: | K031810 | ||
| Manufacturer: | Abbott | ||
| Premarket Notification Reference Device#2: | |||
| Trade Name: | Micro Vascular Plug System | ||
| (MVP) | |||
| Classification Name: | 21 CFR 870.3300 Vascular | ||
| 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 | ||
| 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 | ||
| in the peripheral vasculature. | |||
| Device | |||
| Description | The Siege™ Vascular Plug (“Device”) is a self-expanding | ||
| braided nitinol vascular occlusion 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 a Delivery Wire. The Device is packaged | |||
| collapsed within a Loader and attached to a 180cm Delivery | |||
| Wire that is provided within a hoop dispenser. Touhy Borst | |||
| Valves are provided for flushing and maintaining hemostasis. A | |||
| Torque Device is provided for releasing the Device. | |||
| The Siege™ Vascular Plug has been designed with a material, | |||
| size, configuration and shape that allows introduction through | |||
| recommended 0.027" inner diameter commercial | |||
| microcatheters for the occlusion of blood vessels in the | |||
| peripheral vasculature. The Siege™ Vascular Plug Devices are | |||
| provided in four different diameters (3mm, 4mm, 5mm, 6mm) to | |||
| treat different sized blood vessels in the peripheral vasculature. | |||
| The Siege™ Vascular Plug is designed to be used under | |||
| fluoroscopy for delivery and implantation in the peripheral | |||
| vasculature. The main users of the device are physicians trained | |||
| in vascular embolization. | |||
| Comparison | |||
| to Predicate | Device | ||
| Characteristic | Subject Merit | ||
| Siege™ Vascular Plug | Predicate KA Medical, | ||
| Micro Plug Set | |||
| (K182944) | |||
| 510(k) # | K212817 | K182944 | |
| Product Code | KRD | Same | |
| Indications | |||
| for | |||
| Use/Intended | |||
| Use | indicated for arterial | ||
| embolization in the | |||
| peripheral vasculature | Same | ||
| Components | |||
| Supplied in | |||
| the Sterile | |||
| 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 | |||
| Construction | |||
| 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 | |||
| Construction: | |||
| • 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" | Diameter sizes: 3,4,5 & 6 mm | ||
| Construction: | |||
| • 3 lobes | |||
| • 2 braid layers - each layer is comprised of 72 wires with diameter of 0.001 inches | |||
| • Female threaded bushing 0.047" length | |||
| • Markerband ID 0.018" | |||
| Device | |||
| Diameter | Device | ||
| Diameter | |||
| Device | |||
| Length* | Device | ||
| Length* | |||
| 3 mm | |||
| 6.0 mm | 3 mm | ||
| 5.2 mm | |||
| 4 mm | |||
| 5.2 mm | 4 mm | ||
| 5.2 mm | |||
| 5 mm | |||
| 5.2 mm | 5 mm | ||
| 5.2 mm | |||
| 6 mm | |||
| 5.2 mm | 6 mm | ||
| 5.2 mm | |||
| *unconstrained - elongates when constrained with oversizing | *unconstrained - elongates when constrained with oversizing | ||
| Delivery Wire | |||
| • Reduction in OD to 0.022" outer HHS | Delivery Wire | ||
| • OD 0.024" outer HHS | |||
| Loader | |||
| • 0.026" ID with tapered distal tip geometry, length increased to 11.2" | Loader | ||
| • 0.029" ID with chamfered distal tip geometry, length 8.75" | |||
| Touhy Valve | |||
| • FLO40 | Touhy Valve | ||
| • Same | |||
| Torque Device | |||
| • 3 Part torque device | Torque Device | ||
| • 2 part torque device | |||
| Delivery Catheter (not included) | |||
| Introduction through 0.027" inner diameter commercially compatible microcatheters up to 150 cm long is recommended. | Delivery Catheter included: | ||
| 2.9F, 125 cm long, .028-inch inner diameter with hydrophilic coating | |||
| Single Use | Yes | Same | |
| Anatomical | |||
| site | Peripheral vasculature | Same | |
| Sterilization | Sterile/Ethylene Oxide SAL 10-6 | Same | |
| Shelf Life | 1 year | 3 years | |
| Pyrogenicity | Yes | Same | |
| Packaging | 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 | Length of backing card, pouch and box designed to accommodate all components and included catheter. | |
| 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 0.027" 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 | The Delivery Wire with | ||
| attached Micro Plug Set | |||
| Device is transferred into | |||
| the Delivery Catheter | |||
| using the provided | |||
| Loader. The plug is | |||
| advanced through the | |||
| supplied Delivery | |||
| Catheter to the targeted | |||
| position. The Micro Plug | |||
| Set Device is advanced | |||
| out of the Delivery | |||
| Catheter; the Micro Plug | |||
| Set Device self-expands | |||
| Vascular Plug device self- | |||
| expands recovering its pre- | |||
| set shape and cross- | |||
| sectionally occludes the | |||
| 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 | recovering the pre-set | ||
| shape and cross- | |||
| sectionally occludes the | |||
| vasculature. If Device | |||
| position is unsatisfactory, | |||
| the Device can be | |||
| repositioned, redeployed | |||
| or removed. If position is | |||
| satisfactory, the Delivery | |||
| Wire is rotated | |||
| counterclockwise using | |||
| the provided Torque | |||
| Device to release the | |||
| Micro Plug Set Device |
4
The subject equivalent MEN
TIN Slege"" Vascu its intended ar Plug is substantially
use/indications 11 use,
5
technology/principle of operation, materials and performance specification to the predicate KA Medical Micro Plug Set (K182944).
A comparison of the technological characteristics is summarized in the table below:
6
7
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 on December 29, 2004. A battery of testing was conducted, on the subject Merit Siege™ Vascular Plug, in accordance with protocols based on requirements outlined in guidance's and Performance industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence. The evaluations included performance testing, biocompatibility, sterilization, and animal studies.
Where appropriate, the tests were based on the requirements of the following documents:
FDA Guidance documents:
Safety &
Tests
- · Vascular and Neurovascular Embolization Devices Class II Special Controls Guidance Document for Industry and FDA Staff (December 29, 2004)
8
- · Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Guidance for Industry and FDA Staff (July 09, 2021)
- Q3D(R1) Elemental Impurities Guidance for Industry (March 2020)
- · Applying Human Factors and Usability Engineering to Medical Devices to Optimize Safety and Effectiveness in Design (February 2016)
- · MRI Compatibility Testing and Labelling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 2021)
- · Select updates for Non-Clinical Engineering Tests and Recommended Labelling for Intravascular Stents and Associated Delivery Systems (August 2015)
Recognized Standards
- · ISO 10555-1:2013 Intravascular Catheters-Sterile and Single-use Catheters
- · ISO 80369-7:2016 Small bore connectors for liquids and qases in healthcare applications - Part 7: connectors for intravascular or hypodermic applications
- · ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications- Part 20: Common test methods
- · ASTM F2005 Standard Terminology for Nickel-Titanium Shape Memory Alloy
- · ASTM F2004 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
- · ISO 14630:2012 Non-active surgical implants General requirements
- · ASTM F2129-19a Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small implants
- ASTM F3044-20 Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
- · ASTM G71-81 2014 Standard quide for conducting and evaluating galvanic corrosion tests in electrolytes
- · ASTM F2052-15 Standard Test Method for the Measurement of Magnetically Induced Displacement Force on medical Devices in the Magnetic Resonance Environment
- · ASTM F2182-19e Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
- · ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the
Maqnetic Resonance Environment
9
- · ASTM · F2119-07(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- · ASTM D4169-16 Standard Practice For Performance Testing Of Shipping Containers And Systems
- · ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- · ASTM F88 / F88M 15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- · ASTM F2096 11(2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- · ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- · ASTM · D4332-14 Standard Practice for Conditioning Containers. Packages, or Packaging Components for Testing
- AAMI TIR28:2016 Product adoption and process equivalence for ethylene oxide sterilization
- · ISO 2233:2001 Packaging Complete, filled transport packages and unit loads - Conditioning for testing
- · ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- · ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- · ISO 11135:2014 Sterilization of health care products-Ethylene oxide-: Requirements for the development, validation and routine control of a sterilization process for medical devices
- · ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Guidance for Industry, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
The subject Merit Siege™ Vascular Plug was compared to the predicate device for various performance attributes that support substantial equivalence of the device.
The following testing was successfully completed: Performance Testing
- Simulated Use Loader Flushing. Device Handoff. ● Device Advancement, Deployment, Apposition, Recapture, Redeployment, Device Release
- Set Strength ●
10
- Delivery Wire Proximal Weld Strength ●
- Loader Fluid Leakage Under Pressure ●
- Loader Hub to Loader Tube Peak Tensile Force ●
- Luer Testing ●
- Fatique testing
- Nickel leach ●
- Radial Force
- Migration resistance ●
- Nitinol Austenite Finish Temperature
- MRI Testing
- Corrosion Testing ●
- Size Designation ●
- Packaging
- Visual o
- O Dye penetration testing
- Bubble Leak Test O
- Seal peel strength o
- o Burst Test
- Sterilization
- Shelf life
- Biocompatibility ●
- GLP Animal Study ●
- o Acute performance
- Chronic performance o
- Tissue response o
Clinical testing was not required for the determination of substantial equivalence.
All test results were comparable to the predicate devices and the subject Merit Siege™ Vascular Plug met the predetermined acceptance criteria. This has demonstrated that the subject device is substantially equivalent to the predicate device, K182944.
Based on the Indications for Use, design, safety and Summary of performance testing, the subject Merit Siege™ Vascular Plug Substantial meets the requirements that are considered essential for its Equivalence intended use and is substantially equivalent to the predicate device, KA Medical, Micro Plug Set (K182944).