(134 days)
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.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).