Who is the manufacturer of Cleaner Plus Thrombectomy System?

Argon Medical Devices, Inc. filed the 510(k) submission for Cleaner Plus Thrombectomy System (K211798).

What is the FDA product code for Cleaner Plus Thrombectomy System?

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

What is the regulatory pathway for Cleaner Plus Thrombectomy System?

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

What are the predicate devices for Cleaner Plus Thrombectomy System?

Rotational Thrombectomy System, Cleaner15/CleanerXT (K141617).

Who can help prepare an FDA 510(k) submission like Cleaner Plus Thrombectomy System?

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.

Cleaner Plus Thrombectomy System

K211798 · Argon Medical Devices, Inc. · QEW · Feb 24, 2022 · Cardiovascular

Device Facts

Record ID	K211798
Device Name	Cleaner Plus Thrombectomy System
Applicant	Argon Medical Devices, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Feb 24, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Cleaner Plus™ 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. Components: aspiration catheter with dilator, handpiece with integrated maceration wire, and aspiration canister. Physician inserts catheter percutaneously over-the-wire to thrombus site; dilator/guidewire removed; maceration wire advanced through hemostasis valve. Handpiece motor rotates flexible stainless-steel maceration wire to break up intra-lumen and wall-adherent thrombus. Aspiration canister provides vacuum to remove macerated clot through handpiece. System allows simultaneous or independent infusion of fluids/thrombolytics to enhance treatment. Handpiece controls maceration and suction; canister includes vacuum level LEDs. Used in clinical settings by physicians. Output is removal of thrombus, improving vessel patency.

Clinical Evidence

No human clinical data. Evidence based on extensive in vitro bench testing (mechanical, functional, software, biocompatibility per ISO 10993) and an in vivo animal study. Animal study evaluated vascular endothelium, vessel patency, clot burden, and pulmonary embolism; results showed no histological signs of thromboembolism, rupture, hemorrhage, perforation, or dissection.

Technological Characteristics

System includes stainless steel maceration wire (0.035" diameter), Pebax/BaSO4 and Virgin PTFE materials. Motor-driven rotation at 4000 rpm. Aspiration catheter (10F/12F, 65cm/135cm). Battery-powered handpiece. Connectivity: standalone. Sterilization: EtO (SAL 10^-6). Software: embedded firmware for motor/pump control.

Indications for Use

Indicated for mechanical de-clotting, aspiration, and controlled/selective infusion of physician-specified fluids (including thrombolytics) in peripheral venous vasculature. Contraindicated if procedure compromises patient condition, for infusion of blood/blood products, or 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

Rotational Thrombectomy System, Cleaner15/CleanerXT (K141617)

Reference Devices

Indigo Aspiration System (K142870)

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. February 24, 2022 Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751 Re: K211798 Trade/Device Name: Cleaner Plus™ Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: January 21, 2022 Received: January 24, 2022 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 (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 {1}------------------------------------------------ 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 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 (OS) 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 Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K211798 Device Name Cleaner Plus™ Thrombectomy System Indications for Use (Describe) The Cleaner Plus™ 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) [X] 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." {3}------------------------------------------------ # 510(k) Summary | Date Prepared: | February 23, 2022 | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 ™ Thrombectomy System | | Device Common Name: | Mechanical Thrombectomy Device | | Device Classification: | Embolectomy Catheter Product code, QEW/KRA 21 CFR 870.5150 Class II Review Panel: Cardiovascular Devices | | Predicate Device(s): | Primary: K141617 Rotational Thrombectomy System, Cleaner15/CleanerXT Reference: K142870 Indigo Aspiration System | | Description of the Device: | The Cleaner Plus™ 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 system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister. The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and | | | guidewire are removed, and the Maceration Wire, using the Peel- Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Like the current Cleaner15/CleanerXT devices, mechanical thrombectomy will be achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum. | | Indication for Use: | The Cleaner Plus™ 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. | | Technological Characteristics: | A comparison of the technological characteristics of the subject device and the predicate devices shows the Cleaner Plus™ Thrombectomy System to be substantially equivalent to the current marketed predicate devices. Equivalence is established on performance testing in vitro and in vivo, and similarities in indications for use, materials, technological characteristics, principle of operation, design features and sterilization process. | {4}------------------------------------------------ | | Subject Device | Primary Predicate | Reference Predicate | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Cleaner Plus™ Thrombectomy System | Rotational Thrombectomy System Cleaner15/CleanerXT | Penumbra Embolectomy Aspiration System (INDIGO® Aspiration System) | | Manufacturer | Argon Medical Devices, Inc | Argon Medical Devices, Inc. | Penumbra Inc. | | FDA Clearance | TBD | K141617 | K142870 | | Class | II | SAME | SAME | | Device Classification Name | Embolectomy Catheter Catheter, Continuous Flush | Embolectomy Catheter Catheter, Continuous Flush | Embolectomy Catheter | | Regulation | 870.5150 | 870.1210 | 870.5150 | | Product Code | QEW/KRA | QEW/KRA | QEW | | Clinical Comparison | | | | | Intended Use | Thrombus removal | Thrombus removal | Thrombus removal | | | Subject Device | Primary Predicate | Reference Predicate | | | Cleaner Plus™ Thrombectomy System | Rotational Thrombectomy System Cleaner15/CleanerXT | Penumbra Embolectomy Aspiration System (INDIGO® Aspiration System) | | 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 device allows for infusion of physician-specified fluids, including thrombolytics, during the procedure. The infused solution penetrates the clot increasing the effectiveness of the treatment | Inserted percutaneous int the vessel using an introducer sheath. The device macerates intra-lumen and wall adherent thrombus. The sinusoidal wire creates a fluid vortex that effectively macerates thrombus. Contrast media and physician specified solutions, including thrombolytics, may be infused through the catheter lumen to a side hole at the distal end. The dispersion wire uses mechanical rotation to allow the infused solution to penetrate the clot increasing the effectiveness of the treatment. Any residual clot can be aspirated through an introducer sheath prior to restoration of flow. | The INDIGO Aspiration System fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All the Separators function to break up the clot inside of the cathter to make it more amenable to removal from the body via aspiration. | | Mechanism of Action | Mechanical maceration and aspiration of thrombus | Mechanical maceration of thrombus | Mechanical aspiration of thrombus | | 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. | Indicated for (1) mechanical de- clotting of native vessel dialysis fistulae and synthetic dialysis access grafts and (2) mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature. | The Penumbra Embolectomy Aspiration System (Indigo™ Aspiration System) is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. | | Contraindication | 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. | For the peripheral vasculature is not to be used: • When in the medical judgment of the physician, such a procedure may compromise the patient's condition. • For peripheral vasculature dilation purposes. • For the infusion of blood or blood products. • In native vessels smaller than 6 mm (Cleaner15 only) • In patients without a vascular filter such as an inferior vena cava. | • Not for use in the coronaries or the neurovasculature. | | Single Use | Yes | SAME | SAME | | Supplied Sterile | Yes | SAME | SAME | | Device Description | The Cleaner Plus™ 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. | Rotational Thrombectomy System Cleaner15/CleanerXT consists of a handpiece unit. Attached to the unit is a sinusoidal shaped tip wire (S- wire). A sliding lever on top of the unit advances and retracts the catheter (6F or 7F). The device has a 3-way side port and a distal side hole on catheter for the infusion of fluids and contrast media | The Penumbra Embolectomy Aspiration System (INDIGO® Aspiration System) is comprised of several devices: • INDIGO Aspiration Catheter • Penumbra Aspiration Pump • INDIGO Pump/Canister Tubing • INDIGO Aspiration Tubing • INDIGO Separator™ | | | Subject Device | Primary Predicate | Reference Predicate | | | Cleaner Plus™ Thrombectomy System | Rotational Thrombectomy System Cleaner15/CleanerXT | Penumbra Embolectomy Aspiration System (INDIGO® Aspiration System) | | Technical and Biological Comparison | | | | | Dispersion Wire (rpm) | 4000rpm | 4000rpm | N/A | | Aspiration Catheter Diameter | 10F & 12F | 6F & 7F | 6F, 8F & 12F | | Aspiration Catheter Length | 65cm & 135cm | 65cm & 135cm | 85-150cm | | Maceration Wire (amplitude) | 15mm (uncovered) | 9mm & 15mm (uncovered) | N/A | | Maceration Wire Diameter | 0.035" | 0.035" & 0.044" | N/A | | Maceration Wire Material | Stainless Steel; Pebax/BaSO4 and Virgin PTFE | Stainless Steel; Pebax/BaSO4, Virgin PTFE | N/A | | Reservoir size | 400cc…

Cleaner Plus Thrombectomy System

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)

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Device Story

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Technological Characteristics

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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