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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.

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.

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:

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.

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

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.

This document is a 510(k) summary for the Merit Siege Vascular Plug. It states that clinical testing was not required for the determination of substantial equivalence. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information is not applicable to this submission.

The summary focuses on comparing the subject device to predicate devices (KA Medical Micro Plug Set K182944, Amplatzer® Vascular Plug K031810, Micro Vascular Plug System K123803, and Micro Vascular Plug System K133282) based on technological characteristics and performance testing.

Here's what can be extracted from the provided text regarding acceptance criteria and performance, although it doesn't fit the requested table format precisely due to the lack of quantitative criteria:

Acceptance Criteria and Reported Device Performance (Qualitative)

Since no specific quantitative acceptance criteria are provided in the document beyond meeting "predetermined acceptance criteria" and being "comparable to predicate devices," this table is formed qualitatively based on the tests performed and the general statement of meeting criteria.

The document explicitly states that clinical testing was not required for the determination of substantial equivalence (page 10). Therefore, the following requested information is not applicable in this context:

2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. "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." These tests were likely in vitro or in vivo (animal study).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there was no clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a vascular plug, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a vascular plug, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be the engineering specifications, industry standards, and biological responses observed in biocompatibility and animal studies, rather than a clinical ground truth. For the animal study, outcomes such as acute performance, chronic performance, and tissue response were evaluated.
8. The sample size for the training set: Not applicable as no machine learning algorithm was involved.
9. How the ground truth for the training set was established: Not applicable as no training set for a machine learning algorithm was involved.

In summary, this 510(k) submission for the Merit Siege Vascular Plug demonstrates substantial equivalence through non-clinical testing (performance, biocompatibility, sterilization, and animal studies) rather than clinical studies requiring human data, expert review, or AI performance metrics.

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