Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister

Q: Who is the manufacturer of Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister?

Argon Medical Devices, Inc. filed the 510(k) submission for Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister (K232679).

Q: What is the FDA product code for Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro 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 Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister?

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

Q: What are the predicate devices for Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister?

Indigo® Aspiration System - Lighting® Flash (K222358).

Q: Who can help prepare an FDA 510(k) submission like Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro 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.

K232679 · Argon Medical Devices, Inc. · QEW · Jan 19, 2024 · Cardiovascular

Device Facts

Record ID	K232679
Device Name	Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister
Applicant	Argon Medical Devices, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Jan 19, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Cleaner™ Pro Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The Cleaner™ Pro Thrombectomy System is not intended for use in the pulmonary vasculature for treating of pulmonary embolism.

Device Story

Single-use mechanical thrombectomy system for peripheral venous vasculature. Components: aspiration catheter with dilator, handpiece with flushing adapter, and external vacuum reservoir (aspiration canister). User advances catheter over-the-wire to target site; removes dilator; connects canister to handpiece. Device activated to aspirate soft thrombi/emboli into canister; also allows infusion of thrombolytics or contrast media. Used in clinical settings by physicians. Output is physical removal of clot and delivery of fluids. Benefits include thrombus resolution in peripheral veins.

Clinical Evidence

No human clinical data provided. Evidence consists of extensive in vitro bench testing (dimensional, mechanical integrity, vacuum performance, software validation) and an in vivo animal study evaluating vessel injury, patency, and gross thrombogenicity. Animal study showed no histological signs of thromboembolism, rupture, hemorrhage, perforation, or dissection.

Technological Characteristics

System includes aspiration catheter (18F OD, 115cm), handpiece, and 400cc vacuum canister. Materials are biocompatible interventional grade. Operates via external vacuum source (max 28 inHg). Sterilized via EtO (SAL 10^-6). Complies with IEC 60601-1 and IEC 60601-1-2. Software validation performed.

Indications for Use

Indicated for removal of fresh, soft thrombi and emboli from peripheral venous vasculature and infusion of physician-specified fluids (e.g., thrombolytics). Contraindicated for pulmonary vasculature/pulmonary embolism treatment.

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

Indigo® Aspiration System - Lighting® Flash (K222358)

Reference Devices

Cleaner Plus™ Thrombectomy System (K223176)

Related Devices

K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister · Argon Medical Devices, Inc. · Feb 5, 2026
K211798 — Cleaner Plus Thrombectomy System · Argon Medical Devices, Inc. · Feb 24, 2022
K233909 — 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. · Mar 28, 2024
K142870 — Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] · Penumbra, Inc. · May 26, 2015
K223176 — Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister · Argon Medical Devices, Inc. · Apr 10, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 19, 2024 Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751 ## Re: K232679 Trade/Device Name: Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece: Cleaner™ Pro Aspiration Canister Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: August 30, 2023 Received: September 1, 2023 ### 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. 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). {1}------------------------------------------------ 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 O'connell -S Date: 2024.01.19 13:52:30 -05'00 Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232679 Device Name Cleaner™ Pro Thrombectomy System CleanerTM Pro Aspiration Catheter with Handpiece Cleaner™ Pro Aspiration Canister #### Indications for Use (Describe) The Cleaner™ Pro Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The Cleaner™ Pro Thrombectomy System is not intended for use in the pulmonary vasculature for treating of pulmonary embolism. Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> Residential Use (Per 24 CFR 982.1 Subpart D) </div> | <div> <input type="checkbox"/> Owner-Financed Properties (Per 24 CFR 982.1 Subpart G) </div> | |----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| 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 - K232679 | Date Prepared: | January 19, 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™ Pro Thrombectomy System Cleaner™ Pro Aspiration Catheter with Handpiece Cleaner™ Pro Aspiration Canister | | Device Common Name: | Mechanical Thrombectomy Device | | Device Classification: | Embolectomy Catheter Continuous Flush Catheter Product code, QEW/KRA 21 CFR 870.5150 Class II Review Panel: Cardiovascular Devices | | Predicate Device: | Predicate Device: K222358 Indigo® Aspiration System - Lighting® Flash Reference Device: K223176 Cleaner Plus™ Thrombectomy System | | Description of the Device: | The Cleaner Pro Thrombectomy System is a single use device in the removal of fresh, soft emboli and thrombi and for the infusion of physician-selected fluids through the side-port of the aspiration catheter. The disposable system consists of: (1) the Aspiration Catheter with Dilator, (2) the Handpiece with Flushing Adapter, and (3) the external vacuum reservoir with pump known as the Aspiration Canister. The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the target site. Once in the target site, to complete the system, the Aspiration Canister is connected to the handpiece. The dilator is removed, and the device is activated by the user to aspirate soft emboli and thrombi. The clot is aspirated from the distal portion of the device through the handpiece and then collected in the aspiration canister reservoir. 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. | | Indication for Use: | The Cleaner™ Pro Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The Cleaner™ Pro Thrombectomy System is not intended for use in the pulmonary vasculature for treating of pulmonary embolism. | {4}------------------------------------------------ #### Technological Characteristics: A comparison of the technological characteristics of the subject device and the predicate devices shows the Cleaner Pro 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. | | Subject Device | Predicate Device | Reference Device | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Cleaner™ Pro Thrombectomy System, Cleaner™ Pro Aspiration Catheter with Handpiece, Cleaner™ Pro Aspiration Canister | Indigo® Aspiration System – Lighting® Flash | Cleaner Plus™ Thrombectomy System | | Manufacturer | Argon Medical Devices, Inc | Penumbra, Inc. | Argon Medical Devices | | FDA Clearance | K232679 | K222358 | K223176 | | Class | II | SAME | SAME | | Device Classification Name | Embolectomy Catheter Continuous Flush Catheter | Embolectomy Catheter | Embolectomy Catheter Continuous Flush Catheter | | Regulation | 21 §CFR 870.5150 | 21 §CFR 870.5150 | 21 §CFR 870.5150 | | Product Code | QEW KRA | QEW | QEW KRA | | Clinical Comparison | | | | | Indication for Use | Indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician- specified fluids, including thrombolytics. The Cleaner Pro Thrombectomy System is not intended for use in the pulmonary vasculature for treating of pulmonary embolism. | INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. | Indicated for mechanical de- clotting, aspiration, and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral venous vasculature. | | Principle of Operation | The device is advanced over a guidewire to the target site. The access point may be the common femoral vein, internal jugular vein, or popliteal vein in select patients. The target site may be the peripheral venous vasculature. Once in the target site, the device is activated by the user, to remove fresh, soft thrombi and emboli. The user may maintain guidewire access throughout the procedure. Additionally, the device may be | The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to | 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 | | | Subject Device | Predicate Device | Reference Device | | | Cleaner ™ Pro Thrombectomy System, Cleaner™ Pro Aspiration Catheter with Handpiece, Cleaner™ Pro Aspiration Canister | Indigo® Aspiration System – Lighting® Flash | Cleaner Plus™ Thrombectomy System | | | specified fluids, including thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded. | assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. | physician-specified fluids, including thrombolytics, during the procedure. The infused solution penetrates the clot increasing the effectiveness of the treatment | | Contraindication | Not intended for use in the coronaries and neurovasculature | There are no known contraindications | 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 | SAME | | Supplied Sterile | Yes…