(170 days)
The Cordis Endovascular Systems, Inc. Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
The Vascular Occlusion System consists of straight and shaped TRUFILL Pushable Coils (made from platinum allow and synthetic fibers) and the TRUPUSH Coil Pusher (with 1 or 2 radiopaque markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" inner diameter.
This document, K983483, is a 510(k) premarket notification for the Cordis Endovascular Systems, Inc. Vascular Occlusion System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not applicable or not provided in this type of regulatory document. 510(k) submissions primarily rely on comparison to previously cleared devices.
Here's a breakdown of what is and is not present based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | All applicable biocompatibility testing was successfully performed for the Vascular Occlusion System. (Implied acceptance criterion is successful performance) |
| Substantial Equivalence | The Vascular Occlusion System is substantially equivalent in design, materials, sterilization, and indications for use as other commercially available occlusion devices, specifically: |
- Hilal Embolization Microcoil (Cook, Inc., K901337)
- Helix Shaped Coils with Dacron Fibers (Target Therapeutics, K901721)
- Vascular Occlusion System (Cordis Endovascular Systems, Inc., K964367, K972881) (The core acceptance criterion for a 510(k) is demonstrating substantial equivalence.) |
| Performance Standards | The FDA has not established performance standards under Section 514 of the Food, Drug and Cosmetic Act for this device type. (No specific performance acceptance criteria are mentioned beyond biocompatibility and equivalence). |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. This document does not describe a clinical or performance study with a "test set" in the context of an algorithm or device performance study. The "testing" referred to is biocompatibility, which typically involves laboratory assays, not human subject data sets in the way implied by the question. The substantial equivalence argument relies on comparison to existing devices, not a new performance study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable / Not provided. As no "test set" for performance evaluation is described, there's no mention of experts establishing ground truth for such a set.
- The "experts" involved are the FDA reviewers and the manufacturer's regulatory affairs personnel.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided. No test set requiring adjudication in the context of performance metrics is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not done or described in this 510(k) premarket notification. These studies are typically for evaluating the impact of AI on human reader performance, which is not the focus of this device (a physical embolization coil system).
6. Standalone (Algorithm Only) Performance Study:
- No. This is a physical medical device (embolization coils), not an algorithm or software device. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used:
- Not applicable / Not provided directly. For biocompatibility, the "ground truth" would be the established safety profiles and recognized standards for biological compatibility. For substantial equivalence, the "ground truth" is the established regulatory clearance and safety/effectiveness of the predicate devices. There's no clinical "ground truth" (e.g., pathology, outcomes data) presented from a de novo study.
8. Sample Size for the Training Set:
- Not applicable / Not provided. This is not an AI/ML device where a "training set" would be used.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. As this is not an AI/ML device, there's no training set or ground truth establishment for such a set.
In summary: This 510(k) submission primarily focuses on demonstrating that the "Vascular Occlusion System" is "substantially equivalent" to predicate devices already on the market, as opposed to presenting novel clinical study data against defined acceptance criteria. The only performance detail provided is the successful completion of biocompatibility testing.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).