(326 days)
The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained and experienced in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and guide wires should be employed.
The Medusa™ Vascular Plug is a coil-based occlusion device intended for embolization procedures in the peripheral vasculature. The Medusa™ Vascular Plug consists of an implant and a delivery system. The implant is constructed of multiple polymer coils that are pre-loaded on to the delivery system. The Medusa™ Vascular Plug coils are delivered concurrently for vascular occlusion in a single application. Like predicate embolic coils, vascular occlusion with the Medusa™ Vascular Plug is achieved by mechanical flow restriction resulting from coil pack delivery that leads to thrombus formation and rapid cessation of blood flow.
This document describes the premarket notification (510(k)) for the Medusa™ Vascular Plug, focusing on its substantial equivalence to predicate devices. The review is based on non-clinical and animal testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Medusa™ Vascular Plug) |
|---|---|
| Equivalent occlusion performance in a clinically relevant model | Exhibited performance equivalent to the predicate Cook stainless steel embolization coils through the 95-day time point. |
| Comparable stability of occlusion | Achieved comparable stability of occlusion to predicate coils. |
| Comparable occlusion times | Achieved comparable occlusion times to predicate coils. |
| Comparable or better durability of occlusion | Achieved comparable or better durability of occlusion compared to predicate coils. |
| No acute or chronic complications | Did not exhibit any acute or chronic complications. |
| No new issues of safety | Did not raise any new questions of safety. |
| Meets established specifications for consistent performance for intended use | Collective results of non-clinical testing demonstrate that the device meets established specifications necessary for consistent performance for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The study was an in-vivo animal validation study conducted in an ovine (sheep) model. The sample size for this animal study is not explicitly stated in the provided text.
The data provenance is prospective animal study data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document mentions "occlusion assessed by the physician" during the angiographic assessment. This implies clinical assessment was part of the ground truth determination. However, the number of physicians/experts and their specific qualifications are not explicitly stated.
4. Adjudication Method for the Test Set
The adjudication method for the angiographic assessment and subsequent histopathology is not explicitly detailed. It mentions "occlusion assessed by the physician," but whether this involved multiple physicians, consensus, or a specific rule (e.g., 2+1) is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focused on an animal model, not human readers assessing cases.
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 AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The performance evaluated here is the physical device's occlusive capabilities.
7. The Type of Ground Truth Used
The ground truth was established through a combination of:
- Angiographic assessment (visual assessment of occlusion by a physician).
- Gross necropsy (post-mortem examination of the animal).
- Microscopic examination.
- Histopathology (microscopic examination of tissues for disease or abnormalities).
This provides a multi-faceted biological and anatomical ground truth from the animal model.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device (vascular plug), not an AI algorithm that requires a training set. The "testing" in this context refers to performance validation of the physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device like a vascular plug. The "ground truth" (or established performance criteria) for the device's function was derived from the performance of the predicate devices.
§ 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).