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The E-Brik™ Visualization Assistant is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

The E-Brik™ Visualization Assistant is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile and is intended for single use only in a healthcare facility/ hospital.

The E-Brik™ is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by an LED which is illuminated below both ports. The E-Brik™ has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 10mm in diameter. Both ports can be used prior to the surgical case to warm the scope(s) before the insertion into a body cavity. The E-Brik™ can act as a scope stand as it is designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. A sterile surfactant solution is added to the ports prior to use, which is warmed when the device is active. The ports allow for the user to apply the warmed surfactant prior to and during the case.

The E-Brik™ is powered by alkaline batteries and has a single-use surgical life of a minimum of 4 hours.

Here's a summary of the acceptance criteria and study information for the E-Brik Visualization Assistant, based on the provided FDA 510(k) summary:

Device Name: E-Brik Visualization Assistant
Intended Use: To be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for functional aspects. However, it states that "All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence."

The following performance characteristics were tested and "passed," implying they met their respective acceptance criteria:

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