Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister

Q: Who is the manufacturer of Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister?

Argon Medical Devices, Inc. filed the 510(k) submission for Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister (K233909).

Q: What is the FDA product code for Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister?

QEW. It is classified under 21 CFR 870.5150 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister?

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

Q: What are the predicate devices for Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister?

Cleaner Plus™ Thrombectomy System (K211798).

Q: Who can help prepare an FDA 510(k) submission like Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister?

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.

K233909 · Argon Medical Devices, Inc. · QEW · Mar 28, 2024 · Cardiovascular

Device Facts

Record ID	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
Applicant	Argon Medical Devices, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Mar 28, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Single-use mechanical thrombectomy system for peripheral venous vasculature; consists of aspiration catheter/dilator, handpiece with integrated maceration wire, and external vacuum aspiration canister. Percutaneous insertion over-the-wire to thrombus site; maceration wire (0.035" diameter, 4000 rpm) breaks down intra-lumen and wall-adherent thrombus; macerated material removed via aspiration system (up to 28 inHg vacuum). Aspiration and maceration performed simultaneously or independently; system also allows infusion of thrombolytics or contrast media. Used by physicians in clinical settings; device removed and discarded post-procedure. Benefits include effective thrombus resolution and vessel patency restoration.

Clinical Evidence

No human clinical data. Evidence based on bench-top performance testing and two animal studies. Animal studies evaluated vessel patency, clot burden, vessel injury, and thromboembolism in peripheral vasculature; results showed no histological signs of thromboembolism, rupture, hemorrhage, perforation, or dissection. Bench testing confirmed performance across mechanical, functional, and software parameters.

Technological Characteristics

System components: Aspiration catheter (18F), handpiece with maceration wire, aspiration canister. Maceration wire: 0.035" diameter, 4000 rpm, 15mm amplitude. Materials: Stainless steel, Pebax/BaSO4, Virgin PTFE. Energy: Mechanical (maceration), Vacuum (aspiration). Sterilization: EtO (SAL 10^-6). Connectivity: Standalone. Compliance: IEC 60601.

Indications for Use

Indicated for mechanical de-clotting, aspiration, and controlled/selective infusion of physician-specified fluids (including thrombolytics) in peripheral venous vasculature. Contraindicated for infusion of blood/blood products and use in native vessels <6mm diameter.

Regulatory Classification

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.

Predicate Devices

Cleaner Plus™ Thrombectomy System (K211798)

Reference Devices

Cleaner Pro Thrombectomy System (K232679)

Submission Summary (Full Text)

{0}------------------------------------------------ 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 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. | {5}------------------------------------------------ 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 Soft…

Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister

Device Facts

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Predicate Devices

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Submission Summary (Full Text)

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Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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