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 < 90N).
Qlicksmart In-house Testing	Test of Scalpel Removal Functional Performance	The force required to insert or retrieve the scalpel handle into or from the container must be less than the force in Newtons to remove the container from the bracket.	Force required to insert the scalpel handle is 22.50 Newtons and to remove the scalpel handle is 23.75 Newtons (These values are less than 75.30N, which is the force to remove the container from the bracket).
Qlicksmart In-house Testing	Test of Scalpel Insertion Functional Performance	The device is not jammed, and the device is not become non-functional should the scalpel handle be inserted incorrectly.	PASS
The United Nations Recommendations on the Transport of Dangerous Goods 21st Edition 6.1.5.3	Test of Product Functional Performance (Drop Test)	No rupture is permitted in packaging which would be permit the spillage of loose explosive substances or articles from the outer packaging.	PASS
The United Nations Recommendations on the Transport of Dangerous Goods 21st Edition 6.1.5.3	Test of Product Functional Performance (Stacking Test)	No test sample may leak. No test sample may show any deterioration which could adversely affect transport safety or any distortion liable to reduce its strength or cause instability in stacks of packages.	PASS

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: The document does not explicitly state the specific sample number for each test (e.g., how many units were subjected to the drop test or how many blades were removed for the blade removal performance test). It mentions that the volume is sufficient to hold "100 of the largest scalpel blades tested," indicating a capacity, but not a test sample size.
Data Provenance: The tests were conducted by Falcon Test Engineers, which is "a NATA (National Association of Testing Authorities) approved laboratory." This suggests the testing was likely done in Australia, where Qlicksmart Pty Ltd is based (Brisbane, Queensland, Australia). The data appears to be prospective as it's performance testing for a new device to support a 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of device (a sharps container/blade remover) relies on mechanical and functional performance testing, not expert interpretation of medical images or patient outcomes. Therefore, the concept of "experts establishing ground truth for a test set" as it applies to, for example, a diagnostic AI device, is not applicable here. The ground truth is defined by the physical/mechanical specifications and performance standards (e.g., ISO 23907-1, AS 4031-1992, and in-house protocols). The "experts" would be the engineers and technicians at Falcon Test Engineers who conducted the tests according to these established standards. Their qualifications are implied by the NATA accreditation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests are objective, quantifiable mechanical and functional evaluations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical instrument, not an AI or diagnostic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable, as this is not an algorithm or AI device. The "standalone" performance here refers to the device's functional integrity as a physical product meeting its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's performance is based on:

Established mechanical and safety standards:
- AS 4031-1992 "Non-reusable containers for the collection of sharp medical items used in health care areas" (for impact resistance, integrity of closure and leakage, handle integrity, toppling resistance, resistance to penetration).
- ISO 23907-1:2019 "Sharps injury protection – Requirements and test methods – Sharps containers" (for container stability, strength of handle, resistance to penetration, resistance to damage and leakage after dropping, resistance to spillage by toppling).
- United Nations Recommendations on the Transport of Dangerous Goods 21st Edition 6.1.5.3 and 6.1.5.6 (for drop and stacking tests).
In-house derived functional specifications: For aspects like blade removal performance with specific handle types, counting mechanism accuracy, automatic shut-off activation, and bracket/scalpel insertion/removal forces. These were "specifically designed in collaboration with Qlicksmart for this type of devices," suggesting engineering specifications.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

June 22, 2022

Qlicksmart Pty Ltd. Carlos Castellanos Quality Assurance Manager Level 1, 148 Boundary Street, West End Brisbane. Oueensland 4101 Australia

Re: K213274

Trade/Device Name: Qlicksmart BladeFlask UNIVERSAL Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: September 30, 2021 Received: September 30, 2021

Dear Carlos Castellanos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213274

Device Name Qlicksmart BladeFlask PLUS

Indications for Use (Describe)

□ 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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for QlickSmart. The logo features a stylized letter Q in blue, with a red swoosh across the top. Below the Q, the word "QLICKSMART" is written in blue, with a registered trademark symbol next to it. Underneath "QLICKSMART", the tagline "... and be safe" is written in a smaller font.

K213274 page 1 of 9 www.qlicksmart.com +61 7 3844 1182 T +61 7 3844 1183 F

K213274 510(k) SUMMARY

I. SUBMITTER

Qlicksmart Pty Ltd Level 1, 148 Boundary Street West End. OLD. 4101. Australia Phone: +61 7 3844 1182 Contact Person: Michael Sinnott Date Prepared: 17 June 2022

II. SUBJECT DEVICE

Trade Name of Device: Qlicksmart BladeFlask PLUS Common or Usual Name: Sharps Container with a scalpel blade removing function Classification Name: Hypodermic single lumen needle (21 CFR 880.5570) Regulatory Class: II Product Code: MMK

III. PREDICATE DEVICE

Predicate Device 510(k) application number: K983367 Original Name of the legally marketed predicate device was OLICKSMART®, Current trading name of the legally marketed predicate device: Qlicksmart BladeFLASK

IV. DEVICE DESCRIPTION

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

V. INDICATIONS FOR USE

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Image /page/5/Picture/0 description: The image shows the logo for QlickSmart. The logo features the word "QLICKSMART" in a bold, blue font. Above the text is a stylized graphic of a red swoosh over a blue arc. Below the text is the tagline "... and be safe" in a smaller, less bold font.

K213274 page 2 of 9 www.qlicksmart.com +61 7 3844 1182 T +61 7 3844 1183 F

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
Savco 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 Olicksmart BladeFlask PLUS include:

Beaver type handles ●
Disposable handles ●

TECHNOLOGICAL CHARACTERISTICS COMPARISON OF WITH THE VI. PREDICATE DEVICE

A sharps container with a scalpel blade removal function that is used under non-sterile conditions is the technological principle for both the subject and predicate devices. It is based on the use of a mechanism for removing scalpel blades from scalpel handles in a single-handed action and then immediately contains the used scalpel blade inside the device.

Characteristics	Subject Device	Predicate Device	Comparison
Trade Name	Qlicksmart BladeFlask PLUS(Proposed Trade Name)	QLICKSMART® [OriginalTrade Name used in thepremarket 510(k) notification]Qlicksmart BladeFLASK(Current Trade Name)	N/A
Product Code	MMK	MMK	Identical
510(k) Number	K213274	K983367	N/A
RegulationNumber	21 CFR 880.5570	21 CFR 880.5570	Identical
Characteristics	Subject Device	Predicate Device	Comparison
Intended use	The Qlicksmart BladeFlaskPLUS is a sharps container witha scalpel blade removalfunction.The Qlicksmart BladeFlaskPLUS is a single-use sharpscontainer with a scalpel bladeremoval function that is usedunder non-sterile conditions.The Qlicksmart BladeFlaskPLUS removes scalpel bladesfrom scalpel handles in a single-handed action and thenimmediately contains the usedscalpel blade inside theQlicksmart BladeFlask PLUS.The handle is intended to beused to dispose the entirecontainer as hazardous wastewhen full (100 removed bladesand shut-off system is activated)and the device is not intended tobe reprocessed.	The QLICKSMART® is asharps container with a scalpelblade removal function.The QLICKSMART® is asingle-use sharps container witha scalpel blade removal functionthat is used under non-sterileconditions.The QLICKSMART® removesscalpel blades from scalpelhandles in a single-handedaction and then immediatelycontains the used scalpel bladeinside the QLICKSMART®.The handle is intended to beused to dispose the entirecontainer as hazardous wastewhen full (100 removed bladesand shut-off system is activated)and the device is not intended tobe reprocessed.	Identical
Indications foruse	The Qlicksmart BladeFlaskPLUS is a single-use sharpscontainer with a scalpel bladeremoval function intended topermit the safe removal ofscalpel blades from mostcurrently available scalpelhandles and contain the bladeimmediately upon removal toeliminate the need for furtherhandling prior to be disposed asmedical waste while allowingthe user to monitor its use to seewhen it is becoming full andwill need changing. Scalpelhandles compatible with theQlicksmart BladeFlask PLUSinclude:• 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	The QLICKSMART® is asingle-use sharps container witha scalpel blade removal functionintended to permit the saferemoval of scalpel bladescommonly available scalpelhandles and contain the bladeimmediately upon removal toeliminate the need for furtherhandling prior to be disposed asmedical waste while allowingthe user to monitor its use to seewhen it is becoming full andwill need changing. Scalpelhandles compatible withQlicksmart® include:• Swann Morton sizes 3, 4, 7,and 9• Lawton sizes 3 and 4• Martin sizes 3, 4, and 7• Aesculap sizes 3, 3L, 4, 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	Similar.The subject deviceremoves scalpelblades from sizeNo. 3, 4, 5, 6, 7, 8& 9 scalpel handleswhereas thepredicate deviceremoves scalpelblades from sizeNo. 3, 4, 7 & 9scalpelhandles.The subject deviceremoves scalpelblades up to amaximum bladesize #60B whereasthepredicate deviceremoves scalpelblades up to amaximum bladesize #36.
Characteristics	Subject Device	Predicate Device	Comparison
	• 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	• Paragon sizes 3 and 4• Rocket size 5• Conqueror size 3• Feather size 7• LRI size 4• Generic handle size 4• Jakobi size 4Scalpel handles known to be incompatible with the Qlicksmart® include:- Barron Handle- Beaver type handles- Disposable handles
	Scalpel handles known to be incompatible with the Qlicksmart BladeFlask PLUS include:• Beaver type handles• Disposable handles
Conditions of Use	Non-Sterile, Single use, Non-reusable when full with appx 100 blades. Disposal as Hazardous Waste	Non-Sterile, Single use, Non-reusable when full with appx 100 blades. Disposal as Hazardous Waste	Identical
Anatomical Site	Not applicable	Not applicable	Identical
Where used	General hospitals and other clinical settings. It can be fixed in the correct position by a hardware bracket or sticky tape.	General hospitals and other clinical settings. It can be fixed in the correct position by a hardware bracket or sticky tape.	Identical
Materials of Construction	The flask is a hard plastic (ABS), opaque and red in color, fully enclosed single-use sharps container.The minimum thickness of the flask is 1.5mm, no value below this is permitted.The two parts of the container have been designed and mechanically sealed to	The flask is a hard plastic (ABS), opaque and red in color, fully enclosed single-use sharps container.The minimum thickness of the flask is 1.5mm, no value below this is permitted.The two halves are contiguously ultrasonically welded together.	Similar. The subject device is mechanical sealed to ensure the container is leak proof whereas the predicate device is ultrasonically welded two keep the two halves together.
Characteristics	Subject Device	Predicate Device	Comparison
Weights andDimensions	Approximately (13.5cm) tall by (9.1 cm) wide by (12.3) cm) deep. The volume is sufficient to hold 100 of the largest scalpel blades tested. Weights less than 250gm per unit when empty	Approximately (15 cm) tall by (10 cm) wide by (13 cm) deep. The volume is 14.2ml, sufficient to hold 100 of the largest scalpel blades tested. Weights less than 250gm per unit when empty	Similar.The subject device is slightly smaller than the predicate device.However, the volume is sufficient to hold 100 of the largest scalpel blades tested.
TechnologicalCharacteristics	A scalpel blade removal mechanism that:Contains a mechanism, that strips scalpel blades from scalpel handles; that is, made up of plastic and hardened steel It incorporates a mechanical counting mechanism and automatic mechanical shut off system that closes the unit once the unit has removed around 100 blades and thus prevents overfilling The mechanism is designed to be operated using one hand. Removes scalpel blades from size No. 3, 4, 5, 6, 7, 8, & 9 scalpel handles Removes scalpel blades up to a maximum blade size #60B. Is not to be used for Beaver handles, or Disposable handles.	A scalpel blade removal mechanism that:Contains a mechanism, that strips scalpel blades from scalpel handles; that is, made up of plastic and hardened steel It incorporates a mechanical counting mechanism and automatic mechanical shut off system that closes the unit once the unit has removed around 100 blades and thus prevents overfilling The mechanism is designed to be operated using one hand. Removes scalpel blades from size No. 3, 4, 7, & 9 scalpel handles Removes scalpel blades up to a maximum blade size #36. Is not to be used for Baron handles, Beaver handles, or Disposable handles.	Similar.The subject device removes blades from additional handle types and additional types of blades.Differences in operational range addressed by the performance testing.No new issues of safety raised.
Shelf Life	Not applicable	Not applicable	Identical
PerformanceSpecifications	It underwent the following tests conducted by Falcon Test Engineers, a NATA (National Association of Testing Authorities) approved laboratory:	It underwent the following tests conducted by ETRS, a NATA (National Association of Testing Authorities) approved laboratory: Performance Tests	Additional performance testing for subject device based upon the recognize standard ISO
Characteristics	Subject Device	Predicate Device	Comparison
	Performance TestsThe performance tests wereconducted in accordance withthe AS 4031-1992 "Non-reusable containers for thecollection of sharp medicalitems used in health careareas".These tests included:• Impact resistance,integrity of closure andleakage as per AppendixB of AS 4031:1992• Handle integrity as perAppendix A of AS4031:1992• Toppling resistance as perAppendix D of AS4031:1992• Resistance to penetration asper Appendix C of AS4031:1992Additional performance testswere conducted inaccordance with theRecognized Standard ISO23907-1 First edition 2019-01, "Sharps injury protection- Requirements and testmethods - Sharps containers".These tests included• Container Stability• Strength of Handle• Resistance to Penetration• Resistance to Damageand Leakage afterDropping• Resistance to Spillage byToppling	The performance tests wereconducted in accordance withthe AS 4031-1992 "Non-reusable containers for thecollection of sharp medicalitems used in health careareas".These tests included:• Impact resistance,integrity of closure andleakage as per AppendixB of AS 4031:1992• Handle integrity as perAppendix A of AS4031:1992• Toppling resistance as perAppendix D of AS4031:1992• Resistance to penetrationas per Appendix C of AS4031:1992	23907-1 did notraise new issuesof safety orefficacy.
Mechanicaland FunctionalTests	The mechanical andfunctional tests wereconducted in accordance withthe ETRS Scalpel BladeRemoval Testing Protocolsthat were specificallydesigned in collaboration	The mechanical andfunctional tests wereconducted in accordance withthe ETRS Scalpel BladeRemoval Testing Protocolsthat were specificallydesigned in collaboration	The subjectdevice passed alltesting as thepredicate devicedid.
Characteristics	Subject Device	Predicate Device	Comparison
	with Qlicksmart for this typeof devices. The battery oftesting included the followingtests:• Blade removal function• Counting mechanismactivation• Automatic shut-offmechanism activation• It can be installed into thebracket with reasonableforce• Uses force to strip ascalpel blade from ascalpel handle that is lessthat the force required touninstall the device fromthe bracket• Incorrect insertion of thescalpel handle	with Qlicksmart for this typeof devices. The battery oftesting included the followingtests:• Blade removal function• Counting mechanismactivation• Automatic shut-offmechanism activation• It can be installed into thebracket with reasonableforce• Uses force to strip ascalpel blade from ascalpel handle that is lessthat the force required touninstall the device fromthe bracket• Incorrect insertion of thescalpel handle
TransportationTests	Tests for the subject devicewere conducted inaccordance with the UnitedNations Recommendationson the Transport ofDangerous Goods 21stEdition 6.1.5.3 and 6.1.5.6.Falcon Test Engineers foundthat Qlicksmart BladeFlaskPLUS successfully passed allthese testsThe battery of testingincluded the following tests:• Drop Test• Stacking Test	Tests for the subject devicewere conducted inaccordance with the UnitedNations Recommendationson the Transport ofDangerous Goods 21stEdition 6.1.5.3 and 6.1.5.6.Falcon Test Engineers foundthat Qlicksmart BladeFlaskPLUS successfully passed allthese testsThe battery of testingincluded the following tests:• Drop Test• Stacking Test	The subjectdevice passed alltesting as thepredicate devicedid.
TEST METHOD orSTANDARD	TESTPURPOSE	ACCEPTANCE CRITERIA	RESULTS
ISO 23907-1	Test ContainerStability	The container shall not topple overwhen tested	PASS
ISO 23907-1	Test Strength ofHandle	The handle shall not break or detachduring testing	PASS
ISO 23907-1	Test Resistanceto Penetration	The force needed to penetrate testspecimens shall be minimum of 16Nand an average of 18N or greater	PASS
ISO 23907-1	Test Resistanceto Damage andLeakage afterDropping	No evidence of leakage and no breachof the sharp's containment area	PASS
ISO 23907-1	Test Resistanceto Spillage byDropping	No evidence that the performanceor function of the container has beencompromised, closure remains intact	PASS
Blade RemovalQlicksmart In -houseTesting	Test BladeRemovalPerformance	If one scalpel blade is not removedfrom a particular combination, thatparticular handle and bladecombination will be not approved forbeing used with the BladeFlask PLUSand declared as incompatible	The results showsthat all the differentcombinationsofknown handles andblades wereremoved in a safeandeffectivemanner using onlyone hand. Except forBeaveranddisposable handles.
Counting mechanismactivationQlicksmart In -houseTesting	Test CountingAccuracy	The counter should read to anaccuracy of 100±5 scalpel bladesto be inserted before the full signappears	PASS
Automatic shut-offmechanism activationQlicksmart In -houseTesting	TestPerformance ofAutomatic shut-offmechanismactivation	The counter should activate withan accuracy of 100± 5 scalpelblades to be inserted before theautomatic shut-off mechanism isactivated	PASS
Bracket SuitabilityTestQlicksmart In -houseTesting	Test of BracketFunctionalPerformance	The force required to install orremove the container from thebracket must be more than theforce in Newtons to insert orretrieve the scalpel handles into thecontainer and less than 90Newtons which will be a safetyamount of force for the user toinstall or remove the container	Force required toinstall and removethe container75.30 Newtons
TEST METHOD orSTANDARD	TESTPURPOSE	ACCEPTANCE CRITERIA	RESULTS
Scalpel Removal TestQlicksmart In -houseTesting	Test of ScalpelRemovalFunctionalPerformance	The force required to insert orretrieve the scalpel handle into orfrom the container must be lessthan the force in Newtons toremove the container from thebracket	Force required toinsert the scalpelhandle is 22.50Newtons and toremove the scalpelhandle is 23.75Newtons
Scalpel Insertion TestQlicksmart In -houseTesting	Test of ScalpelInsertionFunctionalPerformance	The device is not jammed, and thedevice is not become non-functional should the scalpelhandle be inserted incorrectly	PASS
Drop TestThe United NationsRecommendations onthe Transport ofDangerous Goods 21stEdition 6.1.5.3	Test of ProductFunctionalPerformance	No rupture is permitted inpackaging which would be permitthe spillage of loose explosivesubstances or articles from theouter packaging	PASS
Stacking TestThe United NationsRecommendations onthe Transport ofDangerous Goods 21stEdition 6.1.5.3	Test of ProductFunctionalPerformance	No test sample may leak. No testsample may show anydeterioration which couldadversely affect transport safety orany distortion liable to reduce itsstrength or cause instability instacks of packages	PASS

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Image /page/6/Picture/0 description: The image shows the logo for QlickSmart. The logo features a stylized letter "Q" in blue, with a red swoosh cutting across the top of the "Q". Below the "Q" is the text "QLICKSMART" in a bold, sans-serif font, followed by the trademark symbol. Underneath "QLICKSMART" is the tagline "... and be safe" in a smaller, less prominent font.

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Image /page/7/Picture/0 description: The image is a logo for QlickSmart. The logo features a stylized letter "Q" in blue, with a red swoosh across the top. Below the "Q" is the word "QLICKSMART" in blue, with the trademark symbol. Underneath the company name is the tagline "... and be safe" in a smaller font.

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Image /page/8/Picture/0 description: The image is a logo for QlickSmart. The logo features a stylized letter "Q" in blue, with a red swoosh cutting across the top of the "Q". Below the "Q", the word "QLICKSMART" is written in blue, with a registered trademark symbol next to it. Underneath the word, the tagline "... and be safe" is written in a smaller font.

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Image /page/9/Picture/1 description: The image shows the logo for QlickSmart. The logo features a stylized letter 'Q' in blue, with a red swoosh above it. Below the 'Q', the word "QLICKSMART" is written in blue, and below that, the tagline "... and be safe" is written in a smaller font.

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Image /page/10/Picture/1 description: The image is a logo for QlickSmart. The logo features a stylized blue letter "Q" with a red swoosh across the top. Below the "Q" is the text "QLICKSMART" in blue, followed by the tagline "... and be safe" in a smaller font size.

VII. SUMMARY OF NON-CLINICAL TESTING

PERFORMANCE DATA

Performance testing was provided to demonstrate that the Qlicksmart BladeFlask PLUS met the acceptance criteria or specifications found in the standards and guidance provided below.

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Image /page/11/Picture/0 description: The image shows the logo for QlickSmart. The logo features a stylized letter 'Q' in blue, with a red swoosh above it. Below the 'Q' is the text "QLICKSMART" in a bold, blue font, and below that is the tagline "... and be safe" in a smaller, purple font.

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PERFORMANCE TESTING

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Image /page/12/Picture/0 description: The image shows the logo for Qlicksmart. The logo features a blue oval with a red swoosh across the top left portion of the oval. Below the oval is the word "QLICKSMART" in blue, with the trademark symbol. Below that is the tagline "... and be safe" in a smaller font.

The test results demonstrate the subject device complies with the applicable requirements.

CLINICAL TEST

Not applicable.

VIII. CONCLUSIONS

The non-clinical data demonstrate that the subject device, Qlicksmart BladeFlask PLUS, is as safe, as effective, and performs as well as or better than the predicate device, Qlicksmart BladeFLASK with Premarket Submission Number, K983367.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).