(265 days)
Not Found
No
The device description and performance testing focus on mechanical functions and physical properties, with no mention of AI or ML.
No.
The device is a sharps container designed for the safe removal and containment of scalpel blades, not for treating or diagnosing diseases.
No
The Qlicksmart BladeFlask PLUS is a sharps container designed for the safe removal and containment of scalpel blades, not for diagnosing medical conditions.
No
The device description clearly states it is a physical sharps container made of hard plastic and hardened steel parts, with mechanical functions for blade removal and counting. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to safely remove and contain scalpel blades. This is a physical process related to handling medical waste, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a sharps container with a blade removal mechanism. This aligns with a device for handling medical waste, not for performing diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health.
- Performance Studies: The performance studies focus on the physical integrity, safety, and functionality of the device in removing and containing scalpel blades. They do not involve any evaluation of diagnostic accuracy or performance with biological samples.
In summary, the Qlicksmart BladeFlask PLUS is a device for the safe handling and disposal of medical waste (scalpel blades), not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / 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
- 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
Product codes
MMK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not applicable
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General hospitals and other clinical settings. It can be fixed in the correct position by a hardware bracket or sticky tape.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. All tests passed.
The mechanical and functional tests were conducted in accordance with the ETRS Scalpel Blade Removal Testing Protocols. The battery of testing included: 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. The subject device passed all testing as the predicate device did. The results for blade removal performance indicated that all different combinations of known handles and blades were removed safely and effectively using one hand, except for Beaver and disposable handles. The counter read with an accuracy of 100±5 scalpel blades. The automatic shut-off mechanism activated with an accuracy of 100±5 scalpel blades. Force required to install and remove the container was 75.30 Newtons. Force required to insert the scalpel handle was 22.50 Newtons and to remove it was 23.75 Newtons.
Tests for transportation 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. These included Drop Test and Stacking Test. The subject device successfully passed all these tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Blade removal performance: All combinations of known handles and blades were removed safely and effectively using one hand, except for Beaver and disposable handles.
Counting Accuracy: The counter should read to an accuracy of 100±5 scalpel blades to be inserted before the full sign appears. (PASS)
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)
Bracket Suitability Test: Force required to install and remove the container 75.30 Newtons.
Scalpel Removal Test: Force required to insert the scalpel handle is 22.50 Newtons and to remove the scalpel handle is 23.75 Newtons.
Scalpel Insertion Test: PASS (Device is not jammed, and not non-functional if scalpel handle inserted incorrectly).
Drop Test: PASS (No rupture permitted).
Stacking Test: PASS (No test sample may leak or show deterioration affecting transport safety or distortion liable to reduce strength/cause instability).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
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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 | 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
Dropping | No evidence that the performance
or function of the container has been
compromised, closure remains intact | PASS |
| Blade Removal
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 shows
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. |
| Counting mechanism
activation
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 |
| Automatic shut-off
mechanism activation
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 |
| Bracket Suitability
Test
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 |
| TEST METHOD or
STANDARD | TEST
PURPOSE | ACCEPTANCE CRITERIA | RESULTS |
| Scalpel Removal Test
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 |
| Scalpel Insertion Test
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 |
| Drop Test
The United Nations
Recommendations on
the Transport of
Dangerous Goods 21st
Edition 6.1.5.3 | Test of Product
Functional
Performance | No rupture is permitted in
packaging which would be permit
the spillage of loose explosive
substances or articles from the
outer packaging | PASS |
| Stacking Test
The United Nations
Recommendations on
the Transport of
Dangerous Goods 21st
Edition 6.1.5.3 | Test of Product
Functional
Performance | 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 |
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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.
K213274 page 4 of 9 www.qlicksmart.com +61 7 3844 1182 T +61 7 3844 1183 F
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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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K213274 page 6 of 9 www.qlicksmart.com +61 7 3844 1182 T +61 7 3844 1183 F
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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K213274 page 7 of 9 www.qlicksmart.com +61 7 3844 1182 T +61 7 3844 1183 F
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.
K213274 page 8 of 9 www.qlicksmart.com +61 7 3844 1182 T +61 7 3844 1183 F
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.