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The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:

• Hypervascular tumors
• Blood vessels to occlude blood flow for controlling bleeding/hemorrhaging in the peripheral vasculature

The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.

The provided document is a 510(k) summary for a medical device called OBSIDIO™ Conformable Embolic. It states that this 510(k) submission is to implement labeling updates as part of mitigations for a recent Class I Recall and that no new safety or effectiveness issues were raised during the device testing. The document highlights that the subject device has the same intended use, indications for use, and technological characteristics as its predicate device (also OBSIDIO™ Conformable Embolic, K213385 cleared July 1, 2022).

Therefore, this document does not contain information about acceptance criteria and a study proving the device meets those criteria for the current submission, as the submission is for labeling updates and asserts substantial equivalence based on the technological identity with the predicate and prior testing. The "summary of non-clinical performance testing" refers to "use characterization analysis" to support label updates, not a new clinical or performance study to establish new acceptance criteria or device performance.

Consequently, I cannot provide the requested information. The document explicitly states:

• "No new safety or effectiveness issues were raised during the device testing."
• "This 510(k) was submitted to implement labeling updates as part of mitigations for a recent Class I Recall."
• "The subject and predicate OBSIDIO™ Conformable Embolic have the same technical characteristics."
• "Predicate and subject device intended use / indications for use are the same."

These statements confirm that no new study was conducted to establish new performance criteria or to re-evaluate the device against existing criteria in the context of this 510(k) application. The substantial equivalence is based on the device's prior clearance (K213385).

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