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

K223176 · Argon Medical Devices, Inc. · KRA · Apr 10, 2023 · Cardiovascular

Device Facts

• Record ID: K223176
• Device Name: 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
• Applicant: Argon Medical Devices, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Apr 10, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Cleaner Plus™ Thrombectomy System is a single-use mechanical thrombectomy device for peripheral venous vasculature. System components: aspiration catheter with dilator, handpiece with integrated maceration wire, peel-away introducer, and aspiration canister. Physician navigates catheter over-the-wire to therapeutic site; removes dilator/guidewire; advances maceration wire through catheter. Handpiece motor rotates flexible stainless-steel maceration wire to break up clot; integrated pump provides suction to aspirate macerated clot through handpiece into canister. Handpiece includes controls for maceration and suction; canister includes vacuum level indicator LEDs. Device enables mechanical de-clotting and selective infusion of fluids/thrombolytics. Modification adds helical component to handpiece to assist aspirate movement. Benefits include efficient clot removal and controlled fluid delivery.

Clinical Evidence

No clinical data was required for this determination. Substantial equivalence was established through non-clinical bench testing and biocompatibility evaluation.

Technological Characteristics

Single-use mechanical thrombectomy system. Components: stainless-steel maceration wire, aspiration catheter, handpiece with motor, aspiration canister. Features: over-the-wire placement, aspiration, and fluid infusion. Modification: helical component in handpiece. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility).

Indications for Use

Indicated for mechanical de-clotting, aspiration, and controlled/selective infusion of physician-specified fluids (including thrombolytics) in the peripheral venous vasculature.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Cleaner Plus™ Thrombectomy System (K211798)

Submission Summary (Full Text)

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April 10, 2023

Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751

Re: K223176

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: October 10, 2022 Received: October 11, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2023.04.10 12:42:19 -04'00'

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K223176

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)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Argon Medical Devices, Inc.

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Special 510(k): Device Modification Cleaner Plus Thrombectomy System Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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# 510(k) Summary — K223176

Date Prepared: April 5, 2023

| Company: | Argon Medical Devices, Inc.<br>1445 Flat Creek Road<br>Athens, Texas 75751 USA<br>Facility Registration number: 1625425 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ana Jimenez-Hughes<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Trade<br>Name: | Cleaner Plus™ Thrombectomy System |
| Device Common<br>Name: | Mechanical Thrombectomy Device |
| Device<br>Classification: | Embolectomy Catheter<br>Product code, QEW/KRA<br>21 CFR 870.5150<br>Class II<br>Review Panel: Cardiovascular Devices |
| Predicate<br>Device(s): | Primary: K211798 Cleaner Plus™ Thrombectomy System |
| Description of<br>the Device: | The Cleaner Plus™ Thrombectomy System is a single use device used to provide<br>thrombectomy in the peripheral venous vasculature. The device provides additional<br>features, such as aspiration and over-the wire device placement.<br><br>The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the<br>Handpiece that includes system controls, and an integrated Maceration Wire, and a<br>Peel-Away Introducer and (3) the Aspiration Canister.<br><br>The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the<br>device to the therapeutic site. The dilator and guidewire are removed, and the<br>Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis<br>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<br>the handpiece to provide aspiration. The Handpiece provides controls to turn on/off<br>maceration and/or the application of suction. Mechanical thrombectomy is achieved<br>by rotating a flexible stainless-steel maceration wire powered by a motor inside the<br>handpiece. The aspiration source is provided to aspirate macerated clot from the distal<br>portion of the device through the handpiece and captures the macerated clot in the<br>Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the<br>pump, and LEDs that indicate the level of the vacuum. |
| Indication for<br>Use: | The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting,<br>aspiration, and controlled and selective infusion of physician-specified fluids,<br>including thrombolytics, in the peripheral venous vasculature. |
| Device<br>Modification: | The device modification included in this submission is limited to the addition of a<br>new helical component designed to assist the aspirate's movement through the<br>Cleaner Plus™ Handpiece. |
| Substantial<br>Equivalence: | There is no change of intended use or fundamental scientific technology between<br>the proposed modified and predicate device. The proposed modified device has<br>the same indication for use as the predicate, K211798.<br>Non-Clinical Testing<br>In accordance with the Design Failure Modes and Effects Analysis, supplemental<br>verification testing was identified to support the substantial equivalence of the<br>modified Cleaner Plus™ Thrombectomy System. The tests included:<br>● Corrosion Resistance<br>● Tensile Break<br>● Simulated Use:<br>○ Handpiece performance with Helical component<br>○ Aspiration Performance<br>● Torque Strength (Helical Component to Wire)<br>● Wire Fatigue<br>● Particulates<br>Biocompatibility:<br>● Cytotoxicity - MEM Elution<br>● Sensitization – Guinea Pig Maximization<br>● Irritation - Intracutaneous Reactivity<br>● Systemic Toxicity - Material Mediated Pyrogen<br>● Systemic Toxicity - Acute Systemic Toxicity<br>● Hemocompatibility – Hemolysis Indirect<br> |
| | Animal testing was not required for the determination of substantial equivalence. |
| | Clinical testing was not required for the determination of substantial equivalence. |
| | Test results demonstrate that all acceptance criteria were met; therefore, the<br>device meets the established product specifications. |
| Conclusion: | The proposed device modifications to the Cleaner Plus™ Thrombectomy System do<br>not change its intended use or principles of operation. Based on the Indication for<br>Use, design, and performance testing, the Cleaner Plus™ Thrombectomy System<br>meets the requirements for its intended use and is substantially equivalent to the<br>predicate device. |

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