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The EVICEL™ Application Device is intended for the simultaneous topical application of the two biological components of EVICEL® Fibrin Sealant via dripping (no air pressure) or via spraying (CO2 pressure only, utilizing the pressure regulator unit) onto the surface.

The EVICEL Application device is a sterile single used to apply the two biological components of the EVICEL® Fibrin Sealant (Human). Accessory tips are also provided separately to help provide the user different options for various clinical uses. The pressure regulator (Class I, Exempt) may also be provided as an accessory to help reduce the pressure of the gas obtained from a CO2 source to within the recommended range for use.

This document does not contain any information regarding acceptance criteria or a study that proves a device meets specific acceptance criteria.

The provided text is a 510(k) premarket notification summary for the "EVICEL™ Application Device." Its primary purpose is to demonstrate substantial equivalence to a predicate device, not to present data from a performance study against acceptance criteria.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Data: The document explicitly states, "Since there are no changes to the device design, principles of operation and fundamental scientific technology, we conclude that the proposed device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act." This indicates that a new performance study to establish acceptance criteria for the new device was not performed because it is identical to an existing, cleared device.
• Focus on Substantial Equivalence: The entire document revolves around demonstrating that the new device is "exactly the same as the current EVICEL Application device," with only changes to the Indications for Use and a contraindication. This regulatory pathway (510(k)) often relies on demonstrating similarity to a legally marketed predicate device rather than conducting a full de novo efficacy or performance study.

Therefore, I cannot populate any of the requested sections (1-9) as the necessary information is not present within the provided text.

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The EVICELTM Application Device is intended for the simultaneous topical application of the two biological components of EVICEL™ fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO2 pressure utilizing the pressure regulator unit) onto the surface.

Not Found

This document is an FDA 510(k) clearance letter for the EVICEL™ Application Device, classifying it as a Class II piston syringe. It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information based on this document. The document primarily focuses on regulatory clearance and substantial equivalence to a predicate device.

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The EVICEL TM Application Device is intended for the simultaneous topical application of the two biological components of EVICEL TM fibrin sealant via dripping (no air Pressure) or via spraying (with air or CO 2 pressure utilizing the pressure regulator unit) onto the surface.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details. The letter confirms that the device, EVICEL™ Application Device, has been found substantially equivalent to a legally marketed predicate device based on its intended use.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided document.

Ask a specific question about this device