(163 days)
EmboCube Embolization Gelatin is indicated for use in embolization of hypervascular tumors.
EmboCube Embolization Gelatin is a hydrophilic medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.
The provided text is a 510(k) summary for the EmboCube Embolization Gelatin and does not contain information about the acceptance criteria and study proving a device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) studies, or ground truth establishment for a test or training set.
The document describes a medical device, EmboCube Embolization Gelatin, and its substantial equivalence to a predicate device based on various non-AI performance tests and an animal study. Therefore, I cannot address most of the points in your request based on the provided text.
However, I can extract information related to the device itself and the general summary of testing:
Device Information:
- Trade/Device Name: EmboCube Embolization Gelatin
- Regulation Name: Vascular Embolization Device
- Regulatory Class: Class II
- Product Code: KRD
- Intended Use: For use in embolization of hypervascular tumors.
- Device Description: Hydrophilic medical device consisting of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. Available in 2 cube sizes and 3 weight configurations. Once rehydrated, deformable cubes can be injected to provide a mechanical barrier to blood flow.
Study Information (Non-AI related):
- A table of acceptance criteria and the reported device performance:
The document lists the types of tests performed to demonstrate that the device meets "critical design specifications" and "clinical performance attributes," but it does not provide a table of
specific quantitative acceptance criteria (e.g., "rehydration time must be
§ 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).