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The ViVi® Hood is used with the ViVi® Helmet and/or ViVi® Helmet HPL as the ViVi® Surgical Helmet System to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The ViVi® Helmet and ViVi® Helmet HPL has a battery powered fan, which provides a continuous flow of air in the the ViVi® Hood.

The ViVi® Hood is a stand-alone head covers that may be worn with a separate surgical gown. The ViVi® Hood, must be worn over a ViVi® Helmet or ViVi® Helmet HPL.

Device Description

The ViVi" Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The ViVi" Surgical Helmet System is composed of sterile ViVi" Hood, which is used with the unsterile ViVi" Helmet or the unsterile ViVi" Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. The components include a top-covering sterile surgical hood (ViVi" Hood), an air-exchanging surgical helmet (ViVi" Helmet), and an air-exchanging surgical helmet with LED light (ViVi" Helmet HPL). The surgical hood is sterilized with Ethylene Oxide (EO). The surgical hood is worn over the helmets. The unsterile accessories include a rechargeable Lithium lon battery pack, a battery holster, a 1-bay battery charger, a 4-bay battery charger, and a non-sterile set of three foam pads (ViVi® Muffle).

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA regarding the ViVi® Surgical Helmet System. It details the device's characteristics, indications for use, and a summary of non-clinical testing. It is crucial to understand that this document describes a medical device, specifically surgical apparel, and not an AI/ML powered device or a diagnostic/imaging device. Therefore, many of the typical acceptance criteria and study methodologies applicable to AI/ML or diagnostic devices (e.g., ground truth establishment, expert adjudication, MRMC studies, standalone performance of an algorithm) are not relevant to this product.

The "study" described herein refers to non-clinical laboratory testing to ensure the safety and performance of the surgical helmet system, rather than typical clinical studies for diagnostic accuracy or treatment efficacy.

Here's an attempt to answer your questions based on the provided text, highlighting the differences where your questions pertain to AI/ML or diagnostic devices:

1. A table of acceptance criteria and the reported device performance

The document provides two tables outlining acceptance criteria and test results for the Helmet and Hood components.

Table 1: ViVi® Surgical Helmet System - Acceptance Criteria and Performance (Non-Clinical Testing)

Characteristic (Component)	Requirement (Acceptance Criteria)	Reported Performance (Test Result)
HELMET TESTING
Weight	≤ 500g (helmet)	PASS
Air Quality	≤ 3°C temperature increase	PASS
	≤ 0% RH increase	PASS
	Below 5000 ppm CO2 concentration (at ≤ 800 ppm ambient concentration)	PASS
	No fogging of face shield	PASS
System Size	Significant lower crown line profile than predecessor product	PASS
Noise	Noise level ≤ predecessor product	PASS
Operational runtime	Battery runtime ≥4 hours (without LED light)	PASS
Gesture Control	Average score for 'ease of use': ≥ "4-good" (Score table: 5 'very good' - 1 'not sufficient')	PASS
	No score for 'ease of use' below "2-sufficient"	PASS
HOOD TESTING
Tear Resistance	>10 N	PASS
Tensile Strength	>30 N	PASS
Fire protection Flammability of Clothing Textiles	Fulfil requirements for Class 1	PASS
Laser resistance	No ignition	PASS
Ethylene Oxide residuals	EO:

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