Search Results

The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function intended to permit the safe removal of scalpel blades from most currently available scalpel handles and contain the blade immediately upon removal to eliminate the need for further handling prior to be disposed as medical waste while allowing the user to monitor its use to see when it is becoming full and will need changing. Scalpel handles compatible with the Qlicksmart BladeFlask PLUS include:

Swann Morton sizes 3. 4. 5. 6. 7. 8. and 9
Lawton size 4
Martin sizes 3, 4, and 7
Aesculap sizes 3. 4. 6. and 7
Sayco sizes 3, 4, and 5
Smic sizes 3 and 4
Nopa sizes 3 and 4
AB Stainless size 4
Lance sizes 3 and 4
Pro-Med sizes 3 and 4
Paragon sizes 3 and 4
Rocket size 5
Conqueror size 3
Feather sizes 3. 4. and 7
LRI sizes 3 and 4
Generic handle size 4
L-dent
Medesy size 5
Jakobi size 4
CS size 5
Helmut Zepf

Scalpel handles known to be incompatible with the Qlicksmart BladeFlask PLUS include:

Beaver type handles
Disposable handles

Device Description

The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function that is used under non-sterile conditions. The Qlicksmart BladeFlask PLUS removes scalpel blades from scalpel handles in a single-handed action and then immediately contains the used scalpel blade inside the Qlicksmart BladeFlask PLUS. The handle is intended to be used to dispose the entire container as hazardous waste when full (100 removed blades and shut-off system is activated) and the device is not intended to be reprocessed.

The Qlicksmart BladeFlask PLUS combines a hard plastic sharps container with an internal blade remover mechanism made of hard plastic and hardened steel parts.

It is approximately (13.5 cm) tall by (9.1 cm) wide by (12.3 cm) deep. It weighs less than 250gm per unit when empty. It is red in color. It is labelled as shown on the samples provided with this application.

AI/ML Overview

This document is a 510(k) Summary for the Qlicksmart BladeFlask PLUS, a medical device intended for safe scalpel blade removal and containment. The summary outlines the device's characteristics, intended use, and most importantly, the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided information, structured to answer your questions regarding acceptance criteria and study proving device performance:

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

The document provides a detailed table within the "TECHNOLOGICAL CHARACTERISTICS COMPARISON OF WITH THE VI. PREDICATE DEVICE" section under "Performance Specifications." This table, along with the "Mechanical and Functional Tests" and "Transportation Tests" sections, outlines the acceptance criteria and corresponding results.

TEST METHOD or STANDARD	TEST PURPOSE	ACCEPTANCE CRITERIA	REPORTED DEVICE PERFORMANCE (RESULTS)
ISO 23907-1	Test Container Stability	The container shall not topple over when tested.	PASS
ISO 23907-1	Test Strength of Handle	The handle shall not break or detach during testing.	PASS
ISO 23907-1	Test Resistance to Penetration	The force needed to penetrate test specimens shall be minimum of 16N and an average of 18N or greater.	PASS
ISO 23907-1	Test Resistance to Damage and Leakage after Dropping	No evidence of leakage and no breach of the sharp's containment area.	PASS
ISO 23907-1	Test Resistance to Spillage by Toppling	No evidence that the performance or function of the container has been compromised, closure remains intact.	PASS
Qlicksmart In-house Testing	Test Blade Removal Performance	If one scalpel blade is not removed from a particular combination, that particular handle and blade combination will be not approved for being used with the BladeFlask PLUS and declared as incompatible.	The results show that all the different combinations of known handles and blades were removed in a safe and effective manner using only one hand. Except for Beaver and disposable handles (which were explicitly listed as incompatible).
Qlicksmart In-house Testing	Test Counting Accuracy	The counter should read to an accuracy of 100±5 scalpel blades to be inserted before the full sign appears.	PASS
Qlicksmart In-house Testing	Test Performance of Automatic shut-off mechanism activation	The counter should activate with an accuracy of 100± 5 scalpel blades to be inserted before the automatic shut-off mechanism is activated.	PASS
Qlicksmart In-house Testing	Test of Bracket Functional Performance	The force required to install or remove the container from the bracket must be more than the force in Newtons to insert or retrieve the scalpel handles into the container and less than 90 Newtons which will be a safety amount of force for the user to install or remove the container.	Force required to install and remove the container 75.30 Newtons (This value is within the acceptance range as it's > force to insert/retrieve scalpel handles [22.50N/23.75N] and

Ask a Question

Ask a specific question about this device

Page 1 of 1