(39 days)
The Contour Embolization Particles are used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.
Contour Embolization Particles are artificial embolization devices. These devices are intended to provide vascular occlusion upon selective.placement via an angiographic catheter. Contour Embolization Particles are packaged sterile by gamma irradiation. Each vial is intended for single patient use only. The Contour™ Embolization particles are packaged in 1 cc dry volume per vial. The vials (glass with screw cap closure) are contained within a poly/Tyvek® pouch. The pouches are placed in boxes, in either a 2 vial/box or 5 vial/box configurations. All vials and boxes are appropriately labeled. The labels are color coded to differentiate between the different size ranges. The device is sterilized by gamma irradiation and labeled with a 26 month shelf life. The Contour Embolization Particles are available in a range of sizes as tabulated below:
| Size | Minimum Compatible Catheter ID |
|---|---|
| 45-150 µm | 0.53 mm (0.021 in) (e.g. Renegade™ 18, Renegade STC) |
| 150-250 µm | |
| 250-355 µm | |
| 355-500 µm | |
| 500-710 µm | 0.69 mm (0.027 in) (e.g. Renegade Hi-Flo) |
| 710-1000 µm | |
| 1000-1180 µm | 1.12 mm (0.044 in) (e.g. Imager™ II Selective) |
The Contour Embolization Particles are made of polyvinyl alcohol, which has been used for embolization procedures since 1972.
This document is a 510(k) summary for the Contour™ Embolization Particles. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The provided text details the submission of a medical device (Contour™ Embolization Particles) for clearance by the FDA based on substantial equivalence to a predicate device. This type of submission (510(k)) generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from clinical trials, especially for a non-AI/ML device.
Here's why the requested information cannot be extracted from the provided text:
- Non-AI/ML Device: The device described is "Contour™ Embolization Particles," which are physical artificial embolization devices made of polyvinyl alcohol. This is not an Artificial Intelligence or Machine Learning (AI/ML) device. Therefore, questions 1-9, which pertain to AI/ML device validation (acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets), are not applicable to this document.
- Substantial Equivalence: The core of this 510(k) submission is to demonstrate "substantial equivalence" to a previously cleared device (K030966). This means the manufacturer is asserting that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as the predicate device. The only change mentioned is to the labeling (contraindications).
- Lack of Performance Study Details: The document explicitly states: "This assessment is based upon identical device materials and design characteristics." It does not describe any new performance study, clinical trial, or data analysis to establish specific numerical performance metrics for the device itself against predefined acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about studies for an AI/ML device, as the provided text describes a non-AI/ML embolization particle device and focuses on substantial equivalence rather than new performance studies with specific metrics.
§ 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).