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 Description

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.

AI/ML Overview

The provided text describes the evaluation of a medical device, the Cleaner Plus™ Thrombectomy System, for substantial equivalence to predicate devices, as part of an FDA 510(k) submission. This document is a regulatory submission, and as such, it focuses on non-clinical data (bench-top and animal studies) rather than clinical study data involving human patients or complex AI performance metrics.

Therefore, many of the requested points related to AI performance, human reader studies (MRMC), data provenance, expert consensus on ground truth, and training data for AI models are not applicable to this type of medical device submission.

Here's an analysis of the acceptance criteria and study information provided, focusing on what is relevant in this context:

1. Table of Acceptance Criteria and Reported Device Performance

The document details non-clinical performance tests that were conducted and states that the device "were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list quantified acceptance criteria for each test or detailed performance results in a table format. Instead, it lists the types of tests performed.

Test Category	Specific Tests Performed	Device Performance (as stated)
Bench-top Testing	- Wire - Atraumatic Tip Pull, Corrosion Resistance, Fatigue, Dynamic Retention, Flexing and Fracture, Kink, Tensile Break, Dimensional	Met acceptance criteria to demonstrate substantial equivalence for all tests in this category. Specific quantitative results or acceptance thresholds are not provided in this summary.
	- Catheter - Dimensional, Aspiration Tip Collapse, Kink, Hemostasis Valve Leak, Torsional Break, System Leak, Tensile Break, Coating Performance and Integrity
	- Shipping Qualification, Luer Functional, Luer Dimensional, Software Validation, IEC 60601 Compliance, Canister & Dead Volume Study, Pump Functionality - Relief Valve, Pump Tubing Pull, Pump Performance, Pump Button Press Endurance, Simulated Use, Handpiece Motor & Battery Performance, Pump Battery Performance, Handpiece Dimensional, Handpiece Functionality, Handpiece – Peel-away Introducer, System - Vacuum Decay, Radiopacity, Functional, Performance, and Software Testing, Float Valve Study
Biocompatibility	- Cytotoxicity (ISO 10993-5)	All studies were performed following approved protocol under GLP and in compliance with FDA GLP, 21 CFR Part 58. The device is established as biocompatible for its intended use (external communicating, circulating blood, limited duration <24hrs).
	- Sensitization (ISO 10993-10)
	- Irritation or Intracutaneous Reactivity (ISO 10993-10)
	- Acute Systemic Toxicity (ISO 10993-11)
	- Material Mediated Pyrogen (ISO 10993-11)
	- Hemocompatibility (ISO10993-4) including: In-vitro Blood Assay, Complement Activation (SC5b-9), Heparinized Platelet and Leucocyte Counts, Partial Thromboplastin Time (PTT), ASTM Hemolysis Assay (Direct and Extract Methods)
Non-Clinical Animal Study	Assessment of vessel patency, clot burden, and clinically significant pulmonary embolism after thrombectomy in the peripheral vasculature.	No histological signs of thromboembolism, ruptures, hemorrhage, perforation, or dissection noted in treated veins. All endpoints met, and no new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify exact sample sizes for each bench-top test (e.g., number of wires tested for fatigue). For the animal study, the sample size is not explicitly stated, but it is implied to be sufficient for regulatory assessment.
Data Provenance: The studies are described as "non-clinical" (bench-top and animal studies) performed to support the 510(k) submission. The location or specific country of origin for these non-clinical tests is not detailed, but they are conducted under "Good Laboratory Practices (GLP) in compliance to FDA GLP, 21 CFR Part 58," indicating they are intended for a US regulatory submission. They are inherently "prospective" in that they are designed and executed for device evaluation rather than analyzing existing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This is not applicable. This submission concerns a physical medical device, not an AI/imaging diagnostic device requiring human expert ground truth for interpretation of images or other data. The "ground truth" for these tests are objective measurements of device performance, material properties, and biological responses in laboratory and animal models.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) where there may be disagreement among readers on findings. For physical device testing, the "ground truth" is established by the test procedures themselves and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists). This submission is for a mechanical thrombectomy system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. There is no AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device evaluation is established through:

Bench-top test results: Objective measurements of physical properties, mechanical performance, and system functionality (e.g., wire tensile strength, catheter kink resistance, pump vacuum performance).
Biocompatibility test results: Laboratory analyses demonstrating the device's biological safety according to established ISO standards.
Animal study observations: Histological findings, gross observations related to vessel integrity, and assessments of thromboembolism. These are based on established pathological and physiological evaluations in an animal model.

8. The Sample Size for the Training Set

This is not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable. As there is no AI/ML component, there's no training set or associated ground truth for it.

In summary: The provided document is a 510(k) summary for a physical medical device. The "acceptance criteria" discussed relate to the successful completion of a battery of non-clinical (bench-top and animal) tests, demonstrating the device's safety and performance characteristics are substantially equivalent to marketed predicate devices. The study design and reporting reflect the requirements for physical device clearance, rather than those for AI/ML-driven diagnostic tools.

Summary

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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.

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

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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

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Indications for Use

510(k) Number (if known) K211798

Device Name

Cleaner Plus™ Thrombectomy System

Indications for Use (Describe)

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)

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510(k) Summary

Date Prepared:	February 23, 2022
Company:	Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number: 1625425
Contact:	Ana Jimenez-HughesSr. Regulatory Affairs SpecialistPhone: 903-676-4276Fax: 903-677-9396Email: ana.hughes@argonmedical.com
Device Trade Name:	Cleaner Plus ™ Thrombectomy System
Device CommonName:	Mechanical Thrombectomy Device
Device Classification:	Embolectomy CatheterProduct code, QEW/KRA21 CFR 870.5150Class IIReview Panel: Cardiovascular Devices
Predicate Device(s):	Primary: K141617 Rotational Thrombectomy System,Cleaner15/CleanerXTReference: K142870 Indigo Aspiration System
Description of theDevice:	The Cleaner Plus™ Thrombectomy System is a single use device usedto provide thrombectomy in the peripheral venous vasculature. Thedevice 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 anintegrated Maceration Wire, and a Peel-Away Introducer and (3) theAspiration Canister.The Aspiration Catheter with Dilator may be placed over-the-wire tonavigate 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 theAspiration Catheter to the therapeutic site and connected to thehandpiece. To complete the system, the provided AspirationCanister is connected to the handpiece to provide aspiration. TheHandpiece provides controls to turn on/off maceration and/or theapplication of suction. Like the current Cleaner15/CleanerXTdevices, mechanical thrombectomy will be achieved by rotating aflexible stainless-steel maceration wire powered by a motor insidethe handpiece. The aspiration source is provided to aspiratemacerated clot from the distal portion of the device through thehandpiece and captures the macerated clot in the AspirationCanister reservoir. The Aspiration Canister includes a switch toinitiate the pump, and LEDs that indicate the level of the vacuum.
Indication for Use:	The Cleaner Plus™ Thrombectomy System is indicated formechanical de-clotting, aspiration, and controlled and selectiveinfusion of physician-specified fluids, including thrombolytics, in theperipheral venous vasculature.
TechnologicalCharacteristics:	A comparison of the technological characteristics of the subjectdevice and the predicate devices shows the CleanerPlus™ Thrombectomy System to be substantially equivalent to thecurrent marketed predicate devices.Equivalence is established on performance testing in vitro and invivo, and similarities in indications for use, materials, technologicalcharacteristics, principle of operation, design features andsterilization process.

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	Subject Device	Primary Predicate	Reference Predicate
	Cleaner Plus™ ThrombectomySystem	Rotational Thrombectomy SystemCleaner15/CleanerXT	Penumbra EmbolectomyAspiration 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 ClassificationName	Embolectomy CatheterCatheter, Continuous Flush	Embolectomy CatheterCatheter, 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™ ThrombectomySystem	Rotational Thrombectomy SystemCleaner15/CleanerXT	Penumbra EmbolectomyAspiration System (INDIGO®Aspiration System)
Principle of Operation	Inserted percutaneously into thevessel using an introductioncatheter, the system AspirationCatheter and Dilator may beplaced over-the-wire to the site ofthrombus.The device macerates intra-lumenand wall adherent thrombus with amaceration wire. The maceratedthrombus is removed from thevessel using an aspiration system.The aspiration of the clot can beperformed simultaneous orindependently. The device allowsfor infusion of physician-specifiedfluids, including thrombolytics,during the procedure. The infusedsolution penetrates the clotincreasing the effectiveness of thetreatment	Inserted percutaneous int the vesselusing an introducer sheath. Thedevice macerates intra-lumen andwall adherent thrombus. Thesinusoidal wire creates a fluid vortexthat effectively maceratesthrombus. Contrast media andphysician specified solutions,including thrombolytics, may beinfused through the catheter lumento a side hole at the distal end. Thedispersion wire uses mechanicalrotation to allow the infusedsolution to penetrate the clotincreasing the effectiveness of thetreatment. Any residual clot can beaspirated through an introducersheath prior to restoration of flow.	The INDIGO Aspiration Systemfundamental mechanism of actionis aspiration. Aspiration draws theembolus or thrombus into theAspiration Catheter to remove theembolus or thrombus from thebody. All the Separators functionto break up the clot inside of thecathter to make it more amenableto removal from the body viaaspiration.
Mechanism of Action	Mechanical maceration andaspiration of thrombus	Mechanical maceration of thrombus	Mechanical aspiration of thrombus
Indication for Use	Indicated for mechanical de-clotting, aspiration, and controlledand selective infusion of physician-specified fluids, includingthrombolytics, in the peripheralvenous vasculature.	Indicated for (1) mechanical de-clotting of native vessel dialysisfistulae and synthetic dialysis accessgrafts and (2) mechanical declottingand controlled and selective infusionof physician-specified fluids,including thrombolytics, in theperipheral vasculature.	The Penumbra EmbolectomyAspiration System (Indigo™Aspiration System) is intended forremoval of fresh, soft emboli andthrombi from vessels of theperipheral arterial and venoussystems.
Contraindication	The Cleaner Plus™ ThrombectomySystem is contraindicated in thefollowing:• When, in the medical judgmentof the physician, such aprocedure may compromisethe patient's condition.• For infusion of blood or bloodproducts.• In native vessels smaller than6mm in diameter.	For the peripheral vasculature is notto be used:• When in the medical judgment ofthe physician, such a proceduremay compromise the patient'scondition.• For peripheral vasculaturedilation purposes.• For the infusion of blood or bloodproducts.• In native vessels smaller than 6mm (Cleaner15 only)• In patients without a vascularfilter such as an inferior venacava.	• Not for use in the coronaries orthe neurovasculature.
Single Use	Yes	SAME	SAME
Supplied Sterile	Yes	SAME	SAME
Device Description	The Cleaner Plus™ System consistsof:• Cleaner Plus™ AspirationCatheter with Dilator.• Cleaner Plus™ Handpiece thatincludes system controls, and anintegrated Maceration Wire.• Cleaner Plus™ AspirationCanister.• The system also includes a peel-away introducer.	Rotational Thrombectomy SystemCleaner15/CleanerXT consists of ahandpiece unit. Attached to the unitis a sinusoidal shaped tip wire (S-wire). A sliding lever on top of theunit advances and retracts thecatheter (6F or 7F). The device has a3-way side port and a distal sidehole on catheter for the infusion offluids and contrast media	The Penumbra EmbolectomyAspiration System (INDIGO®Aspiration System) is comprised ofseveral devices:• INDIGO Aspiration Catheter• Penumbra Aspiration Pump• INDIGO Pump/Canister Tubing• INDIGO Aspiration Tubing• INDIGO Separator™
	Subject Device	Primary Predicate	Reference Predicate
	Cleaner Plus™ ThrombectomySystem	Rotational Thrombectomy SystemCleaner15/CleanerXT	Penumbra EmbolectomyAspiration System (INDIGO®Aspiration System)
Technical and Biological Comparison
Dispersion Wire (rpm)	4000rpm	4000rpm	N/A
Aspiration CatheterDiameter	10F & 12F	6F & 7F	6F, 8F & 12F
Aspiration CatheterLength	65cm & 135cm	65cm & 135cm	85-150cm
Maceration Wire(amplitude)	15mm (uncovered)	9mm & 15mm (uncovered)	N/A
Maceration WireDiameter	0.035"	0.035" & 0.044"	N/A
Maceration WireMaterial	Stainless Steel; Pebax/BaSO4 andVirgin PTFE	Stainless Steel; Pebax/BaSO4, VirginPTFE	N/A
Reservoir size	400cc	N/A	1000cc
Maximum vacuum	28 inHg	N/A	29 inHg
IEC 60601 Compliance	Yes	SAME	SAME
Performance Testing(In-Vitro)	• 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 TipCollapse• Catheter - Kink• Catheter - Hemostasis ValveLeak• Catheter - Torsional Break• Catheter - System Leak• Catheter - Tensile Break• Shipping Qualification• Luer Functional• Catheter - Coating Performanceand Integrity• IEC 60601 Compliance• Canister & Dead Volume Study• Pump Functionality - ReliefValve• Pump Tubing - Pull• Pump Performance• Pump - Button Press Endurance• Simulated Use• Handpiece Dimensional• Handpiece Motor & BatteryPerformance• Pump Battery Performance• Handpiece - Functionality• Handpiece - Peel-awayIntroducer• Luer Dimensional• Radiopacity• Functional, Performance, and	• Wire Break Test• Wire Fatigue Test• Gelatin Test• Graft Abrasion• Kink/Resiliency• Shape Retention• Wire Tensile Test• Torsion Test• Valve Compression• Vessel Energy	• Visual & Dimensional• Tensile Strength• Bond Strength• Hub Aspiration test• Burst Test• Particulate Test• Coating Integrity Test• Flexibility Test• Kink Resistance Test• Ovalization Resistance Test• Friction Test• Flow Rate Test• Elongation Test• Corrosion Test• Torsion Test• Simulated Use Test• Leak Test• Clot Removal Test• Vacuum Collapse Test• Trackability Test
	Subject Device	Primary Predicate	Reference Predicate
	Cleaner Plus™ ThrombectomySystem	Rotational Thrombectomy SystemCleaner15/CleanerXT	Penumbra EmbolectomyAspiration System (INDIGO®Aspiration System)
Non-Clinical, AnimalStudy	Yes	Yes	Yes
Biological Comparison	Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation or IntracutaneousReactivity (ISO 10993-10) Material Mediated Pyrogen(ISO 10993-11) Acute Systemic Toxicity (ISO10993-11 Hemocompatibility(ISO10993-4) In-vitro Blood Assay Complement Activation,SC5b-9 Heparinized Platelet andLeucocyte Counts Partial ThromboplastinTime (PTT) ASTM Hemolysis Assay,Direct and ExtractMethods (ISO)	Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation or IntracutaneousReactivity (ISO 10993-10) Material Mediated Pyrogen(ISO 10993-11) Acute Systemic Toxicity (ISO10993-11 Hemocompatibility (ISO10993-4) C3a Complement Assay Complement Activation,SC5b-9 ASTM PartialThromboplastin Time(PTT) ASTM Hemolysis Genotoxicity, carcinogenicityand reproductive toxicity (ISO10993-3).	Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation or IntracutaneousReactivity (ISO 10993-10) Acute Systemic Toxicity (ISO10993-11 Hemocompatibility(ISO10993-4) Complement Activation Hemolysis Coagulation - PT Coagulation - PTT In vivo thrombogenicity Material Mediated Pyrogen(ISO 10993-11) Genotoxicity Mouse LymphomaMutagenesis Assay -ISO Ames test Micronucleus Assay
PackagingConfiguration	1) Aspiration Catheter and Dilatorare sealed in a Tyvek pouch.Pouch placed in a shelf carton.2) Handpiece with MacerationWire is placed in a base traywith lid and then sealed in aTyvek pouch. Pouch placed in ashelf carton.3) Aspiration Canister is placed ina base tray with lid and thensealed in a Tyvek pouch. Pouchplaced in a shelf carton.4) All the individual systemcomponents are placed in asingle labeled shipper box.Packaging materials are commonlyused for medical devices.	Handpiece is placed in a base traywith lid and then sealed in a Tyvekpouch. Pouch is placed in a shelfcarton.Packaging materials are commonlyused for medical devices.	Individually packed components.Packaging materials are commonlyused for interventional devices
Sterilization	Minimum SAL 10-6, EtO	Minimum SAL 10-6, EtO	Minimum SAL 10-6, EtO
Shelf-Life	6 months	36 months	36 months

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Non-Clinical Data No performance standards have been established under section (Bench-top Testing): 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.

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The following tests were performed under the specified testing parameters to support the Cleaner Plus™ Thrombectomy System substantial equivalence:

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 ●
Luer Dimensional
Catheter - Coating and Performance and Integrity
Software Validation
IEC 60601 Compliance
Canister & Dead Volume ● Study
Pump Functionality - Relief Valve
Pump Tubing Pull ●
Pump Performance
Pump Button Press ● Endurance
Simulated Use
Handpiece Motor & Battery Performance
Pump Battery Performance
Handpiece Dimensional
Handpiece Functionality ●
Handpiece – Peel-away Introducer
System - Vacuum Decay
Radiopacity ●
Functional, Performance, and Software Testing
. Float Valve Study

Non-Clinical Data Biocompatibility

Biocompatibility is established for the Cleaner Plus™ Thrombectomy System according to ISO 10993-1:2018 as an external communicating, circulating blood with limited duration <24hrs.

All studies were performed following the approved protocol under Good Laboratory Practices (GLP) in compliance to FDA GLP, 21 CFR Part 58.

Biocompatibility Testing included:

Cytotoxicity (ISO 10993-5) .
Sensitization (ISO 10993-10) .
. Irritation or Intracutaneous Reactivity (ISO 10993-10)
· Acute Systemic Toxicity (ISO 10993-11)
Material Mediated Pyrogen (ISO 10993-11)
Acute Systemic Toxicity (ISO 10993-11 .
Hemocompatibility (ISO10993-4) .
- o In-vitro Blood Assay

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	Complement Activation, SC5b-9 Heparinized Platelet and Leucocyte Counts Partial Thromboplastin Time (PTT) ASTM Hemolysis Assay, Direct and Extract Methods (ISO)
Non-Clinical -Animal Study	An animal study was performed to assess substantially equivalentsafety and performance outcomes of the Cleaner Plus™ ThrombectomySystem on vascular endothelium by evaluating for vessel patency, clotburden, and clinically significant pulmonary embolism afterthrombectomy in the peripheral vasculature.There were no histological signs of thromboembolism noted in thetreated vessels, there were no ruptures, hemorrhage, perforation, ordissection noted histologically in the treated veins. All the end pointsof this study were met and there are no new questions of safety oreffectiveness.
SubstantialEquivalence:	Based on the Indication for Use, design, and non-clinical bench andanimal testing, the Cleaner Plus™ Thrombectomy System meets therequirements for its intended use and is substantially equivalent tothe predicate devices.
Conclusion:	The Cleaner Plus™ Rotational Thrombectomy System introduces noadditional clinical risk, based on its comparable indication for use andmechanism of action. Based on performance testing in vitro and invivo, and similarities in indications for use, materials, technologicalcharacteristics, principle of operation, design features and sterilizationprocess; the Cleaner Plus™ Thrombectomy System is substantiallyequivalent to the predicate devices.

Regulation Number and Section

§ 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).