(107 days)
No
The description focuses on mechanical and aspiration mechanisms for thrombectomy and does not mention any AI/ML components or functions.
Yes
The device is indicated for mechanical de-clotting and aspiration in the peripheral venous vasculature, which are therapeutic actions aimed at treating a medical condition (thrombosis).
No
Explanation: The device is described as a thrombectomy system for mechanical de-clotting and aspiration, which are therapeutic interventions, not diagnostic functions.
No
The device description explicitly details multiple hardware components, including a catheter, handpiece, maceration wire, and aspiration canister. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids... in the peripheral venous vasculature." This describes a therapeutic intervention performed within the patient's body (in vivo).
- Device Description: The description details a system for physically removing thrombus from blood vessels using mechanical action and aspiration. This is a procedural device, not a device used to examine specimens outside the body (in vitro).
- Anatomical Site: The specified anatomical site is the "peripheral venous vasculature," which is within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to treat a condition, not to diagnose one.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is entirely focused on a therapeutic procedure within the patient.
N/A
Intended Use / Indications for Use
The Cleaner™ Plus 18F Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.
Product codes
QEW, KRA
Device Description
The Cleaner Plus™ 18F Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement.
The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes an aspiration control and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the external vacuum reservoir with pump known as the Aspiration Canister.
The system is inserted percutaneously into the vessel using an introduction catheter, the system Aspiration Catheter and Dilator may be placed over-the-wire to the site of thrombus. The device macerates intra-lumen and wall adherent thrombus with a maceration wire. The macerated thrombus is removed from the vessel using an aspiration system. The aspiration of the clot can be performed simultaneous or independently.
Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-Clinical Data (Bench-top Testing):
A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.
The following tests were performed under the specified testing parameters to support the Cleaner Plus 18F Thrombectomy System substantial equivalence:
- Cleaner Plus 18F Thrombectomy System Performance ●
- · Visual
- Dimensional
- . Simulated Use
- Leak Testing .
- · Handpiece Performance
- · Aspiration and Maceration Performance
- · Tensile and Torque
- · Kink Testing
- · Catheter Torque
- Canister Performance .
- Simulated Use Maceration and Aspiration Performance
- Maceration Wire Performance
- · Bond Strength
- · Resistance to Corrosion
- . Shape Retention
- · Flexing and Fracture
- = Kink Radius
- · Fatique
- Endurance
- . Torque
- · Tensile
- · Dimensional
- · Visual
- Handpiece and Catheter Performance
- · Peel-Away Introducer Removal Force
- · Maceration Wire RPM
- · Wire to Coupler Tensile
- · Peel-Away Introducer Functionality
- · Tip Collapse
- Particulates ●
- Canister Performance ●
- · Visual
- · Functional
- · Tensile (joint strength)
- Luer Compliance ●
- Pump Performance ●
- IEC Compliance ●
- Software Testing ●
- Shipping Qualification ●
Non-Clinical - Animal Study:
Two separate animal studies were performed to assess substantially equivalent safety and performance outcomes of the Cleaner™ Plus Thrombectomy System.
First animal study was performed to assess substantially equivalent safety and performance outcomes of the Cleaner Thrombectomy System on vascular endothelium by evaluating for vessel patency, clot burden, and clinically significant pulmonary embolism after thrombectomy in the peripheral vasculature. There were no histological signs of thromboembolism noted in the treated vessels, there were no ruptures, hemorrhage, perforation, or dissection noted histologically in the treated veins. All the end points of this study were met and there are no new questions of safety or effectiveness.
Second animal study was performed to assess substantially equivalent safety and performance of the aspiration aspect of the Cleaner Thrombectomy System by evaluating for vessel injury, patency and gross thrombogenicity. There were no histological signs of thromboembolism noted in the treated vessels, there were no ruptures, hemorrhage, perforation, or dissection noted histologically in the treated veins. All the end points of this study were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2024
Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751
Re: K233909
Trade/Device Name: Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 13, 2024 Received: February 13, 2024
Dear Ana Jimenez-Hughes:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Digitally signed by Gregory W. Gregory W. O'connell -S Date: 2024.03.28 09:16:25 O'connell -S -04'00'
Gregorv O'Connell Assistant Director DHT2C: Division of Coronary
2
and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233909
Device Name
Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister
Indications for Use (Describe)
The Cleaner™ Plus 18F Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.
Type of Use (Select one or both, as applicable)
| ☑ Residential | ☐ Commercial |
|---|---|
| --------------- | -------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, less bold font, also in blue. The overall design is clean and professional, suggesting a company focused on medical technology.
| Date Prepared: | March 26, 2024 |
|---|---|
| Company: | Argon Medical Devices, Inc. |
| 1445 Flat Creek Road | |
| Athens, Texas 75751 USA | |
| Facility Registration number: 1625425 | |
| Contact: | Ana Jimenez-Hughes |
| Sr. Regulatory Affairs Specialist | |
| Phone: 903-676-4276 | |
| Fax: 903-677-9396 | |
| Email: ana.hughes@argonmedical.com | |
| Device Trade Name: | Cleaner™ Plus 18F Thrombectomy System - |
| Cleaner™ Plus 18F Aspiration Catheter, | |
| Cleaner™ Plus 18F Handpiece with Maceration Wire, | |
| Cleaner™ Plus 18F Aspiration Canister | |
| Device Common Name: | Mechanical Thrombectomy Device |
| Device Classification | |
| Name: | Embolectomy Catheter |
| Catheter, Continuous Flush | |
| Class II | |
| Product code QEW/KRA | |
| 21 CFR 870.5150 | |
| Review Panel: Cardiovascular Devices | |
| Predicate Device(s): | Primary: K211798 Cleaner Plus™ Thrombectomy System |
| Description of the | |
| Device: | The Cleaner Plus™ 18F Thrombectomy System is a single use device used to |
| provide thrombectomy in the peripheral venous vasculature. The device | |
| provides additional features, such as aspiration and over-the-wire device | |
| placement. |
The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2)
the Handpiece that includes an aspiration control and an integrated
Maceration Wire, and a Peel-Away Introducer and (3) the external vacuum
reservoir with pump known as the Aspiration Canister.
The system is inserted percutaneously into the vessel using an introduction
catheter, the system Aspiration Catheter and Dilator may be placed over-the-
wire to the site of thrombus. The device macerates intra-lumen and wall
adherent thrombus with a maceration wire. The macerated thrombus is
removed from the vessel using an aspiration system. The aspiration of the
clot can be performed simultaneous or independently.
Additionally, the device may be used for infusion of thrombolytics and/or
contrast media. Once thrombus resolution is achieved, the device is
removed from the patient and discarded. |
| Technological
Characteristics: | A comparison of the technological characteristics of the subject device and
the predicate devices shows the Cleaner Plus 18F Thrombectomy System to
be substantially equivalent to the current marketed predicate device. |
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Image /page/5/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" is the text "MEDICAL DEVICES" in a smaller, lighter blue font. The logo is simple and professional, conveying a sense of trust and reliability.
510(k) Summary – K233909
Equivalence is established on in vitro performance testing, and similarities in indications for use, materials, technological characteristics, principle of operation, design features and sterilization process.
| Subject Device | Predicate Device | |
|---|---|---|
| Cleaner™ Plus 18F Thrombectomy | ||
| System | Cleaner Plus™ Thrombectomy System | |
| Manufacturer | Argon Medical Devices, Inc. | Argon Medical Devices, Inc |
| FDA Clearance | TBD | K211798 |
| Class | II | II |
| Device Classification Name | Peripheral Mechanical Thrombectomy with | |
| Aspiration; | ||
| Catheter, Continuous Flush | Peripheral Mechanical Thrombectomy with | |
| Aspiration; | ||
| Catheter, Continuous Flush | ||
| Regulation Description | Embolectomy Catheter; | |
| Catheter, Continuous Flush | Embolectomy Catheter; | |
| Catheter, Continuous Flush | ||
| Regulation | 21 CFR 870.5150 | 21 CFR 870.5150 |
| Product Code | QEW/KRA | QEW/KRA |
| Intended Use | Thrombus removal | Thrombus removal |
| Principle of Operation | Inserted percutaneously into the vessel using | |
| an introduction catheter, the system | ||
| Aspiration Catheter and Dilator may be | ||
| placed over-the-wire to the site of thrombus. | ||
| The device macerates intra-lumen and wall | ||
| adherent thrombus with a maceration wire. | ||
| The macerated thrombus is removed from | ||
| the vessel using an aspiration system. The | ||
| aspiration of the clot can be performed | ||
| simultaneous or independently. The devicefluids, including thrombolytics, during the | ||
| procedure. The infused solution penetrates | ||
| the clot increasing the effectiveness of the | ||
| treatment | SAME | |
| Mechanism of Action | Mechanical maceration and aspiration of | |
| thrombus | SAME | |
| Indication for Use | Indicated for mechanical de-clotting, | |
| aspiration, and controlled and selective | ||
| infusion of physician-specified fluids, | ||
| including thrombolytics, in the peripheral | ||
| venous vasculature | SAME | |
| Contraindication | The Cleaner Plus 18F Thrombectomy | |
| System is contraindicated in the following: | ||
| • For infusion of blood or blood products. | ||
| • In native vessels smaller than 6mm in | ||
| diameter | The Cleaner Plus™ Thrombectomy System | |
| is contraindicated in the following: | ||
| • When, in the medical judgment of the | ||
| physician, such a procedure may | ||
| compromise the patient's condition. | ||
| • For infusion of blood or blood products. | ||
| • In native vessels smaller than 6mm in | ||
| diameter. | ||
| Single Use | Yes | SAME |
| Supplied Sterile | Yes | SAME |
| Subject Device | Predicate Device | |
| Cleaner™ Plus 18F Thrombectomy System | Cleaner Plus™ Thrombectomy System | |
| Device Description | The Cleaner Plus™ 18F Thrombectomy System consists of: | |
| • Cleaner Plus™ Aspiration Catheter with Dilator. | ||
| • Cleaner Plus™ Handpiece that includes system controls, and an integrated Maceration Wire. | ||
| • Cleaner Plus™ Aspiration Canister. | ||
| The system also includes a peel-away introducer. | SAME | |
| Technical and Biological Comparison | ||
| Dispersion Wire (rpm) | 4000rpm | 4000rpm |
| Aspiration Catheter Diameter | 18F | 12F |
| Aspiration Catheter Length | 115cm | 65cm & 135cm |
| Maceration Wire (amplitude) | 15mm (uncovered) | 15mm (uncovered) |
| Maceration Wire Diameter | 0.035" | 0.035" |
| Maceration Wire Material | Stainless Steel, Pebax/BaSO4 and Virgin PTFE | Stainless Steel, Pebax/BaSO4 and Virgin PTFE |
| Reservoir size | 400cc | 400cc |
| Maximum vacuum | 28 inHg | 28 inHg |
| IEC 60601 Compliance | Yes | SAME |
| Performance Testing (In-Vitro) | • Cleaner Plus 18F Thrombectomy System Performance | |
| • Visual | ||
| • Dimensional | ||
| • Simulated Use | ||
| • Leak Testing | ||
| • Handpiece Performance | ||
| • Aspiration and Maceration Performance | ||
| • Tensile and Torque | ||
| • Kink Testing | ||
| • Catheter Torque | ||
| • Canister Performance | ||
| • Simulated Use Maceration and Aspiration Performance | ||
| • Maceration Wire Performance | ||
| • Bond Strength | ||
| • Resistance to Corrosion | ||
| • Shape Retention | ||
| • Flexing and Fracture | ||
| • Kink Radius | ||
| • Fatigue | ||
| • Endurance | ||
| • Torque | ||
| • Tensile | ||
| • Dimensional | ||
| • Visual | ||
| • Handpiece and Catheter Performance | ||
| • Peel-Away Introducer Removal Force | ||
| • Maceration Wire RPM | ||
| • Wire to Coupler Tensile | ||
| • Peel-Away Introducer Functionality | ||
| • Tip Collapse | ||
| • Particulates | ||
| • Canister Performance | ||
| • Visual | ||
| • Functional | • Wire - Atraumatic Tip Pull | |
| • Wire - Corrosion Resistance | ||
| • Wire - Fatigue | ||
| • Wire - Dynamic Retention | ||
| • Wire - Flexing and Fracture | ||
| • Wire – Kink | ||
| • Wire - Tensile Break | ||
| • Wire - Dimensional | ||
| • Catheter - Dimensional | ||
| • Catheter - Aspiration Tip Collapse | ||
| • Catheter - Kink | ||
| • Catheter - Hemostasis Valve Leak | ||
| • Catheter - Torsional Break | ||
| • Catheter - System Leak | ||
| • Catheter - Tensile Break | ||
| • Shipping Qualification | ||
| • Luer Functional | ||
| • Catheter - Coating Performance and Integrity | ||
| • IEC 60601 Compliance | ||
| • Canister & Dead Volume Study | ||
| • Pump Functionality - Relief Valve | ||
| • Pump Tubing - Pull | ||
| • Pump Performance | ||
| • Pump - Button Press Endurance | ||
| • Simulated Use | ||
| • Handpiece Dimensional | ||
| • Handpiece Motor & Battery Performance | ||
| • Pump Battery Performance | ||
| • Handpiece - Functionality | ||
| • Handpiece - Peel-away Introducer | ||
| • Luer Dimensional | ||
| • Radiopacity | ||
| • Functional, Performance, and Software Testing | ||
| • Float Valve Study | ||
| • Wire - Torque Strength | ||
| Subject Device | Predicate Device | |
| Cleaner™ Plus 18F Thrombectomy | ||
| System | Cleaner Plus™ Thrombectomy System | |
| • Luer Compliance | ||
| • Pump Performance | ||
| • IEC Compliance | ||
| • Software Testing | ||
| • Shipping Qualification | ||
| Non-Clinical, Animal Study | Yes | Yes |
| Biological Comparison | Biocompatibility testing was leveraged from | |
| predicate device and a comparator device. | • Cytotoxicity (ISO 10993-5) | |
| • Sensitization (ISO 10993-10) | ||
| • Irritation or Intracutaneous Reactivity | ||
| (ISO 10993-10) | ||
| • Material Mediated Pyrogen (ISO 10993- |
• Acute Systemic Toxicity (ISO 10993-11
• Hemocompatibility (ISO10993-4)
○ In-vitro Blood Assay
○ Complement Activation, SC5b-9
○ Heparinized Platelet and
Leucocyte Counts
○ Partial Thromboplastin Time (PTT)
○ ASTM Hemolysis Assay, Direct
and Extract Methods (ISO) |
| Packaging Configuration | 1) Aspiration Catheter and Dilator are
sealed in a Tyvek pouch. Pouch placed
in a shelf carton.
2) Handpiece with Maceration Wire is
placed in a base tray with lid and then
sealed in a Tyvek pouch. Pouch placed
in a shelf carton.
3) Aspiration Canister is placed in a base
tray with lid and then sealed in a Tyvek
pouch. Pouch placed in a shelf carton.
4) All the individual system components are
placed in a single labeled shipper box.
Packaging materials are commonly used for
medical devices. | 1) Aspiration Catheter and Dilator are sealed
in a Tyvek pouch. Pouch placed in a shelf
carton.
2) Handpiece with Maceration Wire is
placed in a base tray with lid and then
sealed in a Tyvek pouch. Pouch placed in
a shelf carton.
3) Aspiration Canister is placed in a base
tray with lid and then sealed in a Tyvek
pouch. Pouch placed in a shelf carton.
4) All the individual system components are
placed in a single labeled shipper box.
Packaging materials are commonly used for
medical devices. |
| Sterilization | Minimum SAL 10-6, EtO | SAME |
| Shelf-Life | 6 months | SAME |
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Image /page/6/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, lighter blue font. The logo is simple and modern, with a focus on the company name.
7
Image /page/7/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo consists of a blue triangle above the word "ARGON" in blue, bold letters. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, less bold font. The overall design is clean and professional, reflecting the company's focus on medical technology.
Non-Clinical Data (Bench-top Testing):
No performance standards have been established under section 514, performance standards, of the Food, Drug and Cosmetic Act for these devices.
A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.
The following tests were performed under the specified testing parameters to support the Cleaner Plus 18F Thrombectomy System substantial equivalence:
- Cleaner Plus 18F Thrombectomy System Performance ●
- · Visual
- Dimensional
- · Visual
8
Image /page/8/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, lighter font. The overall design is clean and professional.
510(k) Summary - K233909
- . Simulated Use
- Leak Testing .
- · Handpiece Performance
- · Aspiration and Maceration Performance
- · Tensile and Torque
- · Kink Testing
- · Catheter Torque
- Canister Performance .
- Simulated Use Maceration and Aspiration Performance
- Maceration Wire Performance
- · Bond Strength
- · Resistance to Corrosion
- . Shape Retention
- · Flexing and Fracture
- = Kink Radius
- · Fatique
- Endurance
- . Torque
- · Tensile
- · Dimensional
- · Visual
- Handpiece and Catheter Performance
- · Peel-Away Introducer Removal Force
- · Maceration Wire RPM
- · Wire to Coupler Tensile
- · Peel-Away Introducer Functionality
- · Tip Collapse
- Particulates ●
- Canister Performance ●
- · Visual
- · Functional
- · Tensile (joint strength)
- Luer Compliance ●
- Pump Performance ●
- IEC Compliance ●
- Software Testing ●
- Shipping Qualification ●
Non-Clinical Data Biocompatibility is established for the Cleaner Plus 18F Thrombectomy Biocompatibility System according to ISO 10993-1:2020 as an external communicating, circulating blood with limited duration