(130 days)
LC Bead LUMI are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
LC Bead LUMI™ is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g. fluoroscopy and CT). The beads are non-resorbable microspheres with calibrated size ranges. LC Bead LUMI™ are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVM).
LC Bead LUMI™ are supplied in a saline buffer solution within a sealed glass vial. A vial access device is also provided within the secondary packaging. LC Bead LUMI™ is provided sterile (moist heat sterilization).
LC Bead LUMI™ consist of a macromer derived from a sulphonate modified polyvinyl alcohol (PVA) macromer which contains a radiopaque moiety that is covalently bound within the hydrogel structure. The incorporation of this radiopaque moiety into the co-polymer imparts Xray imageability by rendering the microspheres radiopaque.
LC Bead LUMI™ has been designed as a radiopaque version of the LC Bead™. Currently embolization with LC Bead™ lacks post-procedural imaging feedback on exact bead location. The embolization process with LC Bead™ is monitored by detecting changes in antegrade flow of soluble iodinated contrast in which the beads are diluted. The embolization is continued until a desired embolization endpoint is reached. This process is completed without specific feedback on the bead location. In order to address this limitation, the manufacturer has developed an imageable spherical embolic bead that can be visualised by X-ray based imaging.
At the time of use, LC Bead LUMI™ is mixed with non-ionic contrast agent in order to monitor the delivery of the product during the embolization procedure. LC Bead LUMI™ is delivered via typical microcatheters to physically block the target vessel. Once the product has been delivered the iodine moiety allows for visualization of the microspheres. LC Bead LUMI™ is a single use, tissue contacting, implantable device available only for prescription use.
The provided document does not contain information regarding traditional acceptance criteria or a study design that outlines specific performance metrics for a diagnostic device. Instead, this document is a 510(k) premarket notification for a medical device called "LC Bead LUMI™," which is a vascular embolization device, not a diagnostic one.
The document focuses on demonstrating substantial equivalence to a predicate device (LC Bead™) by comparing various characteristics and providing performance data relevant to safety and effectiveness for its intended use as an embolization agent.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC study details and effect size with AI assistance.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These elements are typically found in submissions for diagnostic or AI-powered devices that assess a specific outcome or condition, often requiring metrics like sensitivity, specificity, accuracy, etc., against a defined ground truth.
What the document does provide in terms of "performance data" for LC Bead LUMI™ is:
- Bench testing data: To show that the device performs as expected in controlled laboratory settings.
- Verification and validation studies: To confirm that the device meets its design specifications and user needs.
- In vitro and in-vivo biocompatibility studies: To assess the safety of the material in biological systems.
- In-vivo safety and performance studies: To evaluate the device's safety and how it functions within living organisms.
- The conclusion is that these studies demonstrate equivalent safety and performance to the predicate device (LC Bead™), especially considering the key difference is the added radiopaque moiety for visualization.
The studies were conducted in accordance with "FDA Guidance - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices, December 29, 2004".
§ 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).