(107 days)
The Cleaner™ Plus 18F Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.
The Cleaner Plus™ 18F Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement.
The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes an aspiration control and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the external vacuum reservoir with pump known as the Aspiration Canister.
The system is inserted percutaneously into the vessel using an introduction catheter, the system Aspiration Catheter and Dilator may be placed over-the-wire to the site of thrombus. The device macerates intra-lumen and wall adherent thrombus with a maceration wire. The macerated thrombus is removed from the vessel using an aspiration system. The aspiration of the clot can be performed simultaneous or independently.
Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.
The provided text describes information about the Cleaner™ Plus 18F Thrombectomy System, a medical device, and the basis for its FDA clearance through a 510(k) premarket notification (K233909). The information primarily focuses on establishing substantial equivalence to a predicate device (K211798), rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, many of the requested items related to AI/ML device study design (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this document, as it concerns a mechanical thrombectomy system, not an AI/ML-driven device.
However, I can provide the available information regarding the device's performance assessment and the basis for its clearance.
Acceptance Criteria and Device Performance (Non-AI/ML Medical Device)
The document does not present a table of numerical "acceptance criteria" in the same way one might find for an AI/ML model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device are qualitative, based on established industry standards, guidance, and the successful outcome of various performance and safety tests demonstrating substantial equivalence to a predicate device.
The "reported device performance" refers to the successful completion and meeting of predefined parameters for each test, indicating the device performs as intended and is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a mechanical device, not an AI/ML system, the "acceptance criteria" are the successful completion of various tests and the demonstration of substantial equivalence. The "reported device performance" refers to the outcomes of these tests.
| Test Category / Characteristic | Acceptance Criteria (Qualitative) | Reported Device Performance (Outcome) |
|---|---|---|
| Substantial Equivalence | Demonstrates comparable indications for use, mechanism of action, materials, technological characteristics, principle of operation, design features, and sterilization process to the predicate device, introducing no additional clinical risk. | Established based on in vitro performance testing, similarities in indications for use, materials, technological characteristics, principle of operation, design features, and sterilization process with the predicate device. Confirmed by in-vitro and in-vivo tests. Conclusion: Cleaner Plus 18F Thrombectomy System is substantially equivalent to the predicate device and introduces no additional clinical risk. |
| In-Vitro Performance Testing | Meet acceptance criteria based on requirements outlined in guidance and industry standards for each specific test. | Cleaner Plus 18F Thrombectomy System Performance: Visual, Dimensional, Simulated Use, Leak Testing.Handpiece Performance: Aspiration and Maceration Performance, Tensile and Torque, Kink Testing, Catheter Torque.Canister Performance: Simulated Use Maceration and Aspiration Performance.Maceration Wire Performance: Bond Strength, Resistance to Corrosion, Shape Retention, Flexing and Fracture, Kink Radius, Fatigue, Endurance, Torque, Tensile, Dimensional, Visual.Handpiece and Catheter Performance: Peel-Away Introducer Removal Force, Maceration Wire RPM, Wire to Coupler Tensile, Peel-Away Introducer Functionality, Tip Collapse.Other Tests: Particulates, Canister Performance (Visual, Functional, Tensile - joint strength), Luer Compliance, Pump Performance, IEC Compliance, Software Testing, Shipping Qualification. All tests met acceptance criteria. |
| Biocompatibility | Compliant with ISO 10993-1:2020 for an external communicating, circulating blood device with limited duration (<24hrs). | A Biological Risk Assessment was performed. Biocompatibility testing was appropriately leveraged from the predicate device (K211798) and a comparator device (K232679), performed following approved protocols under GLP and in compliance with FDA GLP, 21 CFR Part 58. |
| Animal Studies (In-vivo Safety & Performance) | Demonstrate substantially equivalent safety and performance outcomes, with no new questions of safety or effectiveness. Show no histological signs of thromboembolism, ruptures, hemorrhage, perforation, or dissection in treated vessels. | First animal study: Assessed safety and performance on vascular endothelium (vessel patency, clot burden, pulmonary embolism). No histological signs of thromboembolism, ruptures, hemorrhage, perforation, or dissection noted. All endpoints met.Second animal study: Assessed safety and performance of the aspiration aspect (vessel injury, patency, gross thrombogenicity). No histological signs of thromboembolism, ruptures, hemorrhage, perforation, or dissection noted. All endpoints met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated numerically as a "test set" in the context of an AI/ML model for classification or prediction. The "test set" here refers to the actual physical devices (or components) used for the various in-vitro and in-vivo performance and safety tests. The specific number of devices/samples tested for each individual performance test (e.g., tensile strength, kink testing) is not provided in this summary.
- Data Provenance:
- In-vitro Performance Testing: Conducted by the manufacturer (Argon Medical Devices, Inc.)
- Biocompatibility Testing: Leveraging data from predicate device (K211798) and a comparator device (K232679). These studies were performed under Good Laboratory Practices (GLP) in compliance with FDA GLP, 21 CFR Part 58.
- Animal Studies: Conducted as part of the submission to demonstrate safety and performance. (Specific country/institution not mentioned, implied to be part of the submission package leveraged by the manufacturer).
- Retrospective or Prospective: All tests described are prospective, conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable for this type of device. The "ground truth" for a mechanical device like this is established through engineering and scientific measurement, and observable biological/physical outcomes, rather than expert interpretation of images or clinical data. Device performance is measured against established physical and safety parameters.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in scenarios where human interpretation of complex data (like medical images) is being used to establish ground truth or evaluate diagnostic performance. For a mechanical device, performance is evaluated against objective, measurable criteria and laboratory test results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is relevant for AI/ML devices where reader performance (e.g., radiologists, pathologists) is being evaluated with and without AI assistance. This document describes a mechanical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to AI/ML algorithm performance.
7. The Type of Ground Truth Used
- Objective Engineering & Biological Measurements: The ground truth for this device is based on:
- Physical/Dimensional conformity: Verified dimensions and visual appearance.
- Functional performance: Successful operation during simulated use, aspiration and maceration efficiency, tensile strength, torque, kink resistance, etc.
- Biocompatibility: Established through ISO standards and GLP-compliant testing results (e.g., absence of cytotoxicity, sensitization, irritation).
- Biological safety and effectiveness (animal studies): Observable clinical and histological outcomes in vivo (e.g., vessel patency, absence of thromboembolism, rupture, hemorrhage).
- Compliance with industry standards: Meeting parameters set forth in standards like IEC 60601.
8. The Sample Size for the Training Set
- Not applicable. This document describes a mechanical device, not an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML training set, this question is not relevant.
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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.
March 28, 2024
Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751
Re: K233909
Trade/Device Name: Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 13, 2024 Received: February 13, 2024
Dear Ana Jimenez-Hughes:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Gregory W. Gregory W. O'connell -S Date: 2024.03.28 09:16:25 O'connell -S -04'00'
Gregorv O'Connell Assistant Director DHT2C: Division of Coronary
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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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Indications for Use
510(k) Number (if known) K233909
Device Name
Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister
Indications for Use (Describe)
The Cleaner™ Plus 18F Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.
Type of Use (Select one or both, as applicable)
| ☑ Residential | ☐ Commercial |
|---|---|
| --------------- | -------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, less bold font, also in blue. The overall design is clean and professional, suggesting a company focused on medical technology.
| Date Prepared: | March 26, 2024 |
|---|---|
| Company: | Argon Medical Devices, Inc.1445 Flat Creek 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 18F Thrombectomy System -Cleaner™ Plus 18F Aspiration Catheter,Cleaner™ Plus 18F Handpiece with Maceration Wire,Cleaner™ Plus 18F Aspiration Canister |
| Device Common Name: | Mechanical Thrombectomy Device |
| Device ClassificationName: | Embolectomy CatheterCatheter, Continuous FlushClass IIProduct code QEW/KRA21 CFR 870.5150Review Panel: Cardiovascular Devices |
| Predicate Device(s): | Primary: K211798 Cleaner Plus™ Thrombectomy System |
| Description of theDevice: | The Cleaner Plus™ 18F Thrombectomy System is a single use device used toprovide thrombectomy in the peripheral venous vasculature. The deviceprovides additional features, such as aspiration and over-the-wire deviceplacement.The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2)the Handpiece that includes an aspiration control and an integratedMaceration Wire, and a Peel-Away Introducer and (3) the external vacuumreservoir with pump known as the Aspiration Canister.The system is inserted percutaneously into the vessel using an introductioncatheter, the system Aspiration Catheter and Dilator may be placed over-the-wire to the site of thrombus. The device macerates intra-lumen and walladherent thrombus with a maceration wire. The macerated thrombus isremoved from the vessel using an aspiration system. The aspiration of theclot can be performed simultaneous or independently.Additionally, the device may be used for infusion of thrombolytics and/orcontrast media. Once thrombus resolution is achieved, the device isremoved from the patient and discarded. |
| TechnologicalCharacteristics: | A comparison of the technological characteristics of the subject device andthe predicate devices shows the Cleaner Plus 18F Thrombectomy System tobe substantially equivalent to the current marketed predicate device. |
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Image /page/5/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" is the text "MEDICAL DEVICES" in a smaller, lighter blue font. The logo is simple and professional, conveying a sense of trust and reliability.
510(k) Summary – K233909
Equivalence is established on in vitro performance testing, and similarities in indications for use, materials, technological characteristics, principle of operation, design features and sterilization process.
| Subject Device | Predicate Device | |
|---|---|---|
| Cleaner™ Plus 18F ThrombectomySystem | Cleaner Plus™ Thrombectomy System | |
| Manufacturer | Argon Medical Devices, Inc. | Argon Medical Devices, Inc |
| FDA Clearance | TBD | K211798 |
| Class | II | II |
| Device Classification Name | Peripheral Mechanical Thrombectomy withAspiration;Catheter, Continuous Flush | Peripheral Mechanical Thrombectomy withAspiration;Catheter, Continuous Flush |
| Regulation Description | Embolectomy Catheter;Catheter, Continuous Flush | Embolectomy Catheter;Catheter, Continuous Flush |
| Regulation | 21 CFR 870.5150 | 21 CFR 870.5150 |
| Product Code | QEW/KRA | QEW/KRA |
| Intended Use | Thrombus removal | Thrombus removal |
| Principle of Operation | Inserted percutaneously into the vessel usingan introduction catheter, the systemAspiration Catheter and Dilator may beplaced over-the-wire to the site of thrombus.The device macerates intra-lumen and walladherent thrombus with a maceration wire.The macerated thrombus is removed fromthe vessel using an aspiration system. Theaspiration of the clot can be performedsimultaneous or independently. The devicefluids, including thrombolytics, during theprocedure. The infused solution penetratesthe clot increasing the effectiveness of thetreatment | SAME |
| Mechanism of Action | Mechanical maceration and aspiration ofthrombus | SAME |
| Indication for Use | Indicated for mechanical de-clotting,aspiration, and controlled and selectiveinfusion of physician-specified fluids,including thrombolytics, in the peripheralvenous vasculature | SAME |
| Contraindication | The Cleaner Plus 18F ThrombectomySystem is contraindicated in the following:• For infusion of blood or blood products.• In native vessels smaller than 6mm indiameter | The Cleaner Plus™ Thrombectomy Systemis contraindicated in the following:• When, in the medical judgment of thephysician, such a procedure maycompromise the patient's condition.• For infusion of blood or blood products.• In native vessels smaller than 6mm indiameter. |
| Single Use | Yes | SAME |
| Supplied Sterile | Yes | SAME |
| Subject Device | Predicate Device | |
| Cleaner™ Plus 18F Thrombectomy System | Cleaner Plus™ Thrombectomy System | |
| Device Description | The Cleaner Plus™ 18F Thrombectomy System consists of:• Cleaner Plus™ Aspiration Catheter with Dilator.• Cleaner Plus™ Handpiece that includes system controls, and an integrated Maceration Wire.• Cleaner Plus™ Aspiration Canister.The system also includes a peel-away introducer. | SAME |
| Technical and Biological Comparison | ||
| Dispersion Wire (rpm) | 4000rpm | 4000rpm |
| Aspiration Catheter Diameter | 18F | 12F |
| Aspiration Catheter Length | 115cm | 65cm & 135cm |
| Maceration Wire (amplitude) | 15mm (uncovered) | 15mm (uncovered) |
| Maceration Wire Diameter | 0.035" | 0.035" |
| Maceration Wire Material | Stainless Steel, Pebax/BaSO4 and Virgin PTFE | Stainless Steel, Pebax/BaSO4 and Virgin PTFE |
| Reservoir size | 400cc | 400cc |
| Maximum vacuum | 28 inHg | 28 inHg |
| IEC 60601 Compliance | Yes | SAME |
| Performance Testing (In-Vitro) | • Cleaner Plus 18F Thrombectomy System Performance• Visual• Dimensional• Simulated Use• Leak Testing• Handpiece Performance• Aspiration and Maceration Performance• Tensile and Torque• Kink Testing• Catheter Torque• Canister Performance• Simulated Use Maceration and Aspiration Performance• Maceration Wire Performance• Bond Strength• Resistance to Corrosion• Shape Retention• Flexing and Fracture• Kink Radius• Fatigue• Endurance• Torque• Tensile• Dimensional• Visual• Handpiece and Catheter Performance• Peel-Away Introducer Removal Force• Maceration Wire RPM• Wire to Coupler Tensile• Peel-Away Introducer Functionality• Tip Collapse• Particulates• Canister Performance• Visual• Functional | • Wire - Atraumatic Tip Pull• Wire - Corrosion Resistance• Wire - Fatigue• Wire - Dynamic Retention• Wire - Flexing and Fracture• Wire – Kink• Wire - Tensile Break• Wire - Dimensional• Catheter - Dimensional• Catheter - Aspiration Tip Collapse• Catheter - Kink• Catheter - Hemostasis Valve Leak• Catheter - Torsional Break• Catheter - System Leak• Catheter - Tensile Break• Shipping Qualification• Luer Functional• Catheter - Coating Performance and Integrity• IEC 60601 Compliance• Canister & Dead Volume Study• Pump Functionality - Relief Valve• Pump Tubing - Pull• Pump Performance• Pump - Button Press Endurance• Simulated Use• Handpiece Dimensional• Handpiece Motor & Battery Performance• Pump Battery Performance• Handpiece - Functionality• Handpiece - Peel-away Introducer• Luer Dimensional• Radiopacity• Functional, Performance, and Software Testing• Float Valve Study• Wire - Torque Strength |
| Subject Device | Predicate Device | |
| Cleaner™ Plus 18F ThrombectomySystem | Cleaner Plus™ Thrombectomy System | |
| • Luer Compliance• Pump Performance• IEC Compliance• Software Testing• Shipping Qualification | ||
| Non-Clinical, Animal Study | Yes | Yes |
| Biological Comparison | Biocompatibility testing was leveraged frompredicate device and a comparator device. | • Cytotoxicity (ISO 10993-5)• Sensitization (ISO 10993-10)• Irritation or Intracutaneous Reactivity(ISO 10993-10)• Material Mediated Pyrogen (ISO 10993-11)• Acute Systemic Toxicity (ISO 10993-11• Hemocompatibility (ISO10993-4)○ In-vitro Blood Assay○ Complement Activation, SC5b-9○ Heparinized Platelet andLeucocyte Counts○ Partial Thromboplastin Time (PTT)○ ASTM Hemolysis Assay, Directand Extract Methods (ISO) |
| Packaging Configuration | 1) Aspiration Catheter and Dilator aresealed in a Tyvek pouch. Pouch placedin a shelf carton.2) Handpiece with Maceration Wire isplaced in a base tray with lid and thensealed in a Tyvek pouch. Pouch placedin a shelf carton.3) Aspiration Canister is placed in a basetray with lid and then sealed in a Tyvekpouch. Pouch placed in a shelf carton.4) All the individual system components areplaced in a single labeled shipper box.Packaging materials are commonly used formedical devices. | 1) Aspiration Catheter and Dilator are sealedin a Tyvek pouch. Pouch placed in a shelfcarton.2) Handpiece with Maceration Wire isplaced in a base tray with lid and thensealed in a Tyvek pouch. Pouch placed ina shelf carton.3) Aspiration Canister is placed in a basetray with lid and then sealed in a Tyvekpouch. Pouch placed in a shelf carton.4) All the individual system components areplaced in a single labeled shipper box.Packaging materials are commonly used formedical devices. |
| Sterilization | Minimum SAL 10-6, EtO | SAME |
| Shelf-Life | 6 months | SAME |
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Image /page/6/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, lighter blue font. The logo is simple and modern, with a focus on the company name.
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Image /page/7/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo consists of a blue triangle above the word "ARGON" in blue, bold letters. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, less bold font. The overall design is clean and professional, reflecting the company's focus on medical technology.
Non-Clinical Data (Bench-top Testing):
No performance standards have been established under section 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.
The following tests were performed under the specified testing parameters to support the Cleaner Plus 18F Thrombectomy System substantial equivalence:
- Cleaner Plus 18F Thrombectomy System Performance ●
- · Visual
- Dimensional
- · Visual
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Image /page/8/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, lighter font. The overall design is clean and professional.
510(k) Summary - K233909
- . Simulated Use
- Leak Testing .
- · Handpiece Performance
- · Aspiration and Maceration Performance
- · Tensile and Torque
- · Kink Testing
- · Catheter Torque
- Canister Performance .
- Simulated Use Maceration and Aspiration Performance
- Maceration Wire Performance
- · Bond Strength
- · Resistance to Corrosion
- . Shape Retention
- · Flexing and Fracture
- = Kink Radius
- · Fatique
- Endurance
- . Torque
- · Tensile
- · Dimensional
- · Visual
- Handpiece and Catheter Performance
- · Peel-Away Introducer Removal Force
- · Maceration Wire RPM
- · Wire to Coupler Tensile
- · Peel-Away Introducer Functionality
- · Tip Collapse
- Particulates ●
- Canister Performance ●
- · Visual
- · Functional
- · Tensile (joint strength)
- Luer Compliance ●
- Pump Performance ●
- IEC Compliance ●
- Software Testing ●
- Shipping Qualification ●
Non-Clinical Data Biocompatibility is established for the Cleaner Plus 18F Thrombectomy Biocompatibility System according to ISO 10993-1:2020 as an external communicating, circulating blood with limited duration <24hrs. A Biological Risk Assessment was performed for the Cleaner Plus 18F Thrombectomy System, based on which biocompatibility testing was appropriately leveraged from the predicate device (K211798) and a comparator device, the Cleaner Pro Thrombectomy System (K232679). Leveraged biocompatibility studies were performed following the approved protocol under Good Laboratory Practices (GLP) in compliance to FDA GLP, 21 CFR Part 58 were leveraged from the predicate device.
Non-Clinical -Two separate animal studies were performed to assess substantially Animal Study equivalent safety and performance outcomes of the Cleaner™ Plus Thrombectomy System.
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Image /page/9/Picture/0 description: The image shows the logo for Argon Medical Devices. The logo features a blue triangle above the word "ARGON" in a bold, blue font. Below "ARGON" are the words "MEDICAL DEVICES" in a smaller, lighter font. The overall design is clean and professional, reflecting the company's focus on medical technology.
First animal study was performed to assess substantially equivalent safety
and performance outcomes of the Cleaner Thrombectomy System on
vascular endothelium by evaluating for vessel patency, clot burden, and
clinically significant pulmonary embolism after thrombectomy in the peripheral
vasculature.
There were no histological signs of thromboembolism noted in the treated
vessels, there were no ruptures, hemorrhage, perforation, or dissection noted
histologically in the treated veins. All the end points of this study were met
and there are no new questions of safety or effectiveness.
Second animal study was performed to assess substantially equivalent safety
and performance of the aspiration aspect of the Cleaner Thrombectomy
System by evaluating for vessel injury, patency and gross thrombogenicity.
There were no histological signs of thromboembolism noted in the treated
vessels, there were no ruptures, hemorrhage, perforation, or dissection noted
histologically in the treated veins. All the end points of this study were met.
| Substantial Equivalence: | Based on the Indication for Use, design, in vivo animal safety and in vitro performance testing, the Cleaner Plus 18F Thrombectomy System meets the requirements for its intended use and is substantially equivalent to the predicate device. |
|---|---|
| Conclusion: | The Cleaner Plus 18F Thrombectomy System introduces no additional clinical risk, based on its comparable indications for use and mechanism of action. Based on performance testing in-vitro and in-vivo, indications for use, materials, technological characteristics, principle of operation, design features and sterilization process; the Cleaner Plus 18F Thrombectomy System is substantially equivalent to the predicate device. |
§ 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).