Who is the manufacturer of Qlicksmart BladeFlask UNIVERSAL?

Qlicksmart Pty , Ltd. filed the 510(k) submission for Qlicksmart BladeFlask UNIVERSAL (K213274).

What is the FDA product code for Qlicksmart BladeFlask UNIVERSAL?

MMK. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Qlicksmart BladeFlask UNIVERSAL?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for Qlicksmart BladeFlask UNIVERSAL?

Qlicksmart BladeFLASK (K983367).

Who can help prepare an FDA 510(k) submission like Qlicksmart BladeFlask UNIVERSAL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Qlicksmart BladeFlask UNIVERSAL

K213274 · Qlicksmart Pty , Ltd. · MMK · Jun 22, 2022 · General Hospital

Device Facts

Record ID	K213274
Device Name	Qlicksmart BladeFlask UNIVERSAL
Applicant	Qlicksmart Pty , Ltd.
Product Code	MMK · General Hospital
Decision Date	Jun 22, 2022
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.5570
Device Class	Class 2

Indications for Use

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.

Device Story

Single-use sharps container with integrated scalpel blade removal mechanism; used in clinical settings to remove blades from handles via single-handed action; immediately contains blades to prevent injury. Device features mechanical counting and automatic shut-off system triggered after ~100 blades; prevents overfilling. Constructed of hard plastic (ABS) and hardened steel. Operated by clinicians; mounted via bracket or tape. Benefits include reduced risk of sharps injury by eliminating manual blade handling. Disposed as hazardous waste when full; not intended for reprocessing.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ISO 23907-1 (container stability, handle strength, penetration resistance, drop/leakage testing) and UN transport standards. Functional testing confirmed blade removal, counting accuracy (100±5 blades), and automatic shut-off mechanism performance.

Technological Characteristics

Hard plastic (ABS) sharps container; hardened steel blade removal mechanism. Dimensions: 13.5cm x 9.1cm x 12.3cm. Mechanical counting and automatic shut-off system. Single-use; non-sterile. Mounted via hardware bracket or adhesive. Complies with ISO 23907-1 and AS 4031-1992.

Indications for Use

Indicated for safe removal and containment of scalpel blades from compatible handles (Swann Morton, Lawton, Martin, Aesculap, Sayco, Smic, Nopa, AB Stainless, Lance, Pro-Med, Paragon, Rocket, Conqueror, Feather, LRI, Generic, L-dent, Medesy, Jakobi, CS, Helmut Zepf) in clinical settings. Contraindicated for Beaver-type and disposable handles.

Regulatory Classification

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.

Predicate Devices

Qlicksmart BladeFLASK (K983367)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213274 Device Name Qlicksmart BladeFlask PLUS #### Indications for Use (Describe) 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 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. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 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. #### V. INDICATIONS FOR USE 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 {5}------------------------------------------------ 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® [Original Trade Name used in the premarket 510(k) notification] Qlicksmart BladeFLASK (Current Trade Name) | N/A | | Product Code | MMK | MMK | Identical | | 510(k) Number | K213274 | K983367 | N/A | | Regulation Number | 21 CFR 880.5570 | 21 CFR 880.5570 | Identical | | Characteristics | Subject Device | Predicate Device | Comparison | | Intended use | The Qlicksmart BladeFlask PLUS is a sharps container with a scalpel blade removal function. 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® is a sharps container with a scalpel blade removal function. The QLICKSMART® is a single-use sharps container with a scalpel blade removal function that is used under non-sterile conditions. The QLICKSMART® removes scalpel blades from scalpel handles in a single-handed action and then immediately contains the used scalpel blade inside the QLICKSMART®. 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. | Identical | | Indications for use | 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 | The QLICKSMART® is a single-use sharps container with a scalpel blade removal function intended to permit the safe removal of scalpel blades commonly 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 Qlicksmart® 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 device removes scalpel blades from size No. 3, 4, 5, 6, 7, 8 & 9 scalpel handles whereas the predicate device removes scalpel blades from size No. 3, 4, 7 & 9 scalpel handles. The subject device removes scalpel blades up to a maximum blade size #60B whereas the predicate device removes scalpel blades up to a maximum blade size #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 4 Scalpel 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 and Dimensions | 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. | | Technological Characteristics | 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 | | Performance Specifications | 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 Tests The performance tests were conducted in accordance with the AS 4031-1992 "Non- reusable containers for the collection of sharp medical items used in health care areas". These tests included: • Impact resistance, integrity of closure and leakage as per Appendix B of AS 4031:1992 • Handle integrity as per Appendix A of AS 4031:1992 • Toppling resistance as per Appendix D of AS 4031:1992 • Resistance to penetration as per Appendix C of AS 4031:1992 Additional performance tests were conducted in accordance with the Recognized Standard ISO 23907-1 First edition 2019- 01, "Sharps injury protection - Requirements and test methods - Sharps containers". These tests included • Container Stability • Strength of Handle • Resistance to Penetration • Resistance to Damage and Leakage after Dropping • Resistance to Spillage by Toppling | The performance tests were conducted in accordance with the AS 4031-1992 "Non- reusable containers for the collection of sharp medical items used in health care areas". These tests included: • Impact resistance, integrity of closure and leakage as per Appendix B of AS 4031:1992 • Handle integrity as per Appendix A of AS 4031:1992 • Toppling resistance as per Appendix D of AS 4031:1992 • Resistance to penetration as per Appendix C of AS 4031:1992 | 23907-1 did not raise new issues of safety or efficacy. | | Mechanical and Functional Tests | The mechanical and functional tests were conducted in accordance with the ETRS Scalpel Blade Removal Testing Protocols that were specifically designed in collaboration | The mechanical and functional tests were conducted in accordance with the ETRS Scalpel Blade Removal Testing Protocols that were specifically designed in collaboration | The subject device passed all testing as the predicate device did. | | Characteristics | Subject Device | Predicate Device | Comparison | | | with Qlicksmart for this type of devices. The battery of testing included the following tests: • Blade removal function • Counting mechanism activation • Automatic shut-off mechanism activation • It can be installed into the bracket with reasonable force • Uses force to strip a scalpel blade from a scalpel handle that is less that the force required to uninstall the device from the bracket • Incorrect insertion of the scalpel handle | with Qlicksmart for this type of devices. The battery of testing included the following tests: • Blade removal function • Counting mechanism activation • Automatic shut-off mechanism activation • It can be installed into the bracket with reasonable force • Uses force to strip a scalpel blade from a scalpel handle that is less that the force required to uninstall the device from the bracket • Incorrect insertion of the scalpel handle | | | Transportation Tests | Tests for the subject device were conducted in accordance with the United Nations Recommendations on the Transport of Dangerous Goods 21st Edition 6.1.5.3 and 6.1.5.6. Falcon Test Engineers found that Qlicksmart BladeFlask PLUS successfully passed all these tests The battery of testing included the following tests: • Drop Test • Stacking Test | Tests for the subject device were conducted in accordance with the United Nations Recommendations on the Transport of Dangerous Goods 21st Edition 6.1.5.3 and 6.1.5.6. Falcon Test Engineers found that Qlicksmart BladeFlask PLUS successfully passed all these tests The battery of testing included the following tests: • Drop Test • Stacking Test | The subject device passed all testing as the predicate device did. | | TEST METHOD or STANDARD | TEST PURPOSE | ACCEPTANCE CRITERIA | 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…

Qlicksmart BladeFlask UNIVERSAL

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Qlicksmart BladeFlask UNIVERSAL

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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