(21 days)
The Fibered IDC Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
The Fibered IDC Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature.
The provided text details a 510(k) premarket notification for a medical device and describes its intended use and regulatory status but does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.
Specifically:
- Acceptance Criteria and Reported Device Performance: This information is not present in the provided text. The document states that "All data gathered demonstrate this device as substantially equivalent" to predicate devices, but it does not specify what performance metrics were evaluated or what the acceptance thresholds for those metrics were.
- Sample size for the test set and data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable as this is a physical medical device, not an AI algorithm requiring ground truth for training or evaluation.
- Sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm with a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).