(140 days)
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.
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.
The provided text is a 510(k) Summary for the Cleaner™ Pro Thrombectomy System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria based on clinical outcomes or standalone AI algorithm performance.
Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not present in this type of regulatory submission. This document describes the bench-top and animal performance testing to support the claim of substantial equivalence for a medical device, which is different from studies demonstrating efficacy of an AI algorithm or performance directly tied to a specific set of clinical acceptance criteria.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria with quantitative performance metrics for a clinical outcome study. Instead, it lists performance testing conducted to demonstrate substantial equivalence to the predicate devices. The acceptance criteria for these tests are generally that the device performs comparably to the predicate or meets established engineering/design specifications for safety and functionality.
| Test Category | Specific Tests Performed (examples) | Acceptance Criteria (Implied) | Reported Performance (Implied) |
|---|---|---|---|
| In-Vitro (Bench-top) Performance Testing | Catheter - Dimensional, Visual, Radiopacity, Hemostasis Valve Leak, System Leak, Burst, Kink Radius, Tensile Break, Torsional Break, Aspiration Tip Collapse. Dilator - Dimensional, Leak, Burst, Functional, Visual, Tensile Break, Radiopacity. Aspiration Canister - Visual, Functional, Tubing Tensile Break, Weld Strength. Handpiece - Functional, Simulate Use. System - Functional, Vacuum Decay, Noise Level, Integrity, Visual, Simulated Use. Shipping Qualification, IEC-60601 Compliance, Software Validation. | The device must meet predefined engineering specifications and perform comparably to predicate devices for these physical and functional characteristics, ensuring safety and intended function. | "The below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." (General statement that tests were successful) |
| Biocompatibility Testing | 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 and Leucocyte Counts, Partial Thromboplastin Time (PTT), ASTM Hemolysis Assay (Direct and Extract Methods). | Compliance with ISO 10993 standards for the specified biological endpoints, ensuring the device is biocompatible for its intended use. | "Biocompatibility is established for the Cleaner Pro Thrombectomy System according to ISO 10993-1:2020 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." (Overall claim of meeting biocompatibility requirements) |
| Animal Study | Evaluation for vessel injury, patency, and gross thrombogenicity in the target vasculature. | Demonstrating substantially equivalent safety and performance, specifically no vessel injury (ruptures, hemorrhage, perforation, dissection) or histological signs of thromboembolism. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Animal Study): The document states "An animal study was performed..." but does not specify the sample size (number of animals or procedures).
- Data Provenance: The animal study data provenance is "animal study," implying a prospective, controlled study within a laboratory setting. No country of origin for the animals or study location is explicitly stated, but it would typically be conducted under US regulations (GLP).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not describe the use of human experts to establish ground truth for a test set in the context of an AI algorithm or image analysis. The animal study's "ground truth" would be established by veterinary pathologists or other trained personnel performing histological analysis and gross observation, but the number and specific qualifications are not mentioned.
4. Adjudication Method for the Test Set
Not applicable, as the document doesn't describe ground truth establishment by multiple human readers for a test set in the context of an AI/image analysis setting. The animal study results would likely be adjudicated if multiple observers interpreted the findings, but no such method is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted or described. This type of study is typically done to assess the impact of an AI system on human reader performance, which is not the focus of this 510(k) submission for a mechanical thrombectomy device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a mechanical thrombectomy system, not an AI algorithm. Its performance is inherent in its physical and mechanical operation.
7. The Type of Ground Truth Used
For the animal study, the ground truth was based on post-procedural histological analysis of treated vessels and gross observation for signs of injury or thrombosis. For bench-top testing, the ground truth is against engineering specifications and physical measurements.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set.
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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).
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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
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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)
| Residential Use (Per 24 CFR 982.1 Subpart D) | Owner-Financed Properties (Per 24 CFR 982.1 Subpart G) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------- |
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 - K232679
| Date Prepared: | January 19, 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™ Pro Thrombectomy SystemCleaner™ Pro Aspiration Catheter with HandpieceCleaner™ Pro Aspiration Canister |
| Device Common Name: | Mechanical Thrombectomy Device |
| Device Classification: | Embolectomy CatheterContinuous Flush CatheterProduct code, QEW/KRA21 CFR 870.5150Class IIReview Panel: Cardiovascular Devices |
| Predicate Device: | Predicate Device: K222358 Indigo® Aspiration System - Lighting® FlashReference 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. |
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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 ThrombectomySystem, Cleaner™ ProAspiration Catheter withHandpiece, Cleaner™ ProAspiration 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 ClassificationName | Embolectomy CatheterContinuous Flush Catheter | Embolectomy Catheter | Embolectomy CatheterContinuous Flush Catheter |
| Regulation | 21 §CFR 870.5150 | 21 §CFR 870.5150 | 21 §CFR 870.5150 |
| Product Code | QEWKRA | QEW | QEWKRA |
| Clinical Comparison | |||
| Indication for Use | Indicated for the removal offresh, soft thrombi and embolifrom the vessels of theperipheral venous vasculature,and for the infusion of physician-specified fluids, includingthrombolytics.The Cleaner Pro ThrombectomySystem is not intended for use inthe pulmonary vasculature fortreating of pulmonary embolism. | INDIGO Aspiration Cathetersand Separators: As part of theINDIGO Aspiration System, theINDIGO Aspiration Cathetersand Separators are indicatedfor the removal of fresh, softemboli and thrombi fromvessels of the peripheralarterial and venous systems,and for the treatment ofpulmonary embolism.INDIGO Aspiration Tubing: Aspart of the INDIGO AspirationSystem, the INDIGO SterileAspiration Tubing is indicatedto connect the INDIGOAspiration Catheters to thePenumbra Aspiration Pump.Penumbra Aspiration Pump:The Penumbra AspirationPump is indicated as a vacuumsource for the PenumbraAspiration Systems. | Indicated for mechanical de-clotting, aspiration, andcontrolled and selectiveinfusion of physician specifiedfluids, including thrombolytics,in the peripheral venousvasculature. |
| Principle ofOperation | The device is advanced over aguidewire to the target site. Theaccess point may be thecommon femoral vein, internaljugular vein, or popliteal vein inselect patients. The target sitemay be the peripheral venousvasculature.Once in the target site, thedevice is activated by the user,to remove fresh, soft thrombiand emboli. The user maymaintain guidewire accessthroughout the procedure.Additionally, the device may be | The INDIGO AspirationCatheter targets aspirationfrom the pump directly to thethrombus. The INDIGOAspiration Catheter isintroduced through a guidecatheter or vascular sheathinto the peripheral vasculatureand guided over a guidewire tothe site of the primaryocclusion. The INDIGOAspiration Catheter is usedwith the Penumbra AspirationPump to aspirate thrombusfrom an occluded vessel. Asneeded, an INDIGO Separatormay be deployed from theINDIGO Aspiration Catheter to | Inserted percutaneously intothe vessel using anintroduction catheter, thesystem Aspiration Catheterand Dilator may be placedover-the-wire to the site ofthrombus.The device macerates intra-lumen and wall adherentthrombus with a macerationwire. The maceratedthrombus is removed from thevessel using an aspirationsystem. The aspiration of theclot can be performedsimultaneous orindependently. The deviceallows for infusion of |
| Subject Device | Predicate Device | Reference Device | |
| Cleaner ™ Pro ThrombectomySystem, Cleaner™ ProAspiration Catheter withHandpiece, Cleaner™ ProAspiration Canister | Indigo® Aspiration System –Lighting® Flash | Cleaner Plus™Thrombectomy System | |
| specified fluids, includingthrombolytics and/or contrastmedia. Once thrombusresolution is achieved, thedevice is removed from thepatient and discarded. | assist with thrombus removal.The INDIGO Separator isadvanced and retractedthrough the INDIGO AspirationCatheter at the proximalmargin of the primary occlusionto facilitate clearing of thethrombus from the INDIGOAspiration Catheter tip. | physician-specified fluids,including thrombolytics, duringthe procedure. The infusedsolution penetrates the clotincreasing the effectiveness ofthe treatment | |
| Contraindication | Not intended for use in thecoronaries andneurovasculature | There are no knowncontraindications | The Cleaner Plus™Thrombectomy System iscontraindicated in thefollowing:When, in the medicaljudgment of the physician,such a procedure maycompromise the patient'scondition.For infusion of blood or bloodproducts.In native vessels smaller than6mm in diameter. |
| Single Use | Yes | SAME | SAME |
| Supplied Sterile | Yes | SAME | SAME |
| Device Description | The Cleaner Pro ThrombectomySystem consists of:• An AspirationCatheter/Dilator withHandpiece and FlushingAdapter• An external vacuumreservoir with pump knownas the Aspiration Canister | The INDIGO® AspirationSystem is comprised of theseveral devices:• INDIGO Aspiration Catheter• Penumbra Aspiration Pump• INDIGO Aspiration PumpCanister• INDIGO Aspiration Tubing• INDIGO Separator | The Cleaner Plus Systemconsists of:• Cleaner Plus AspirationCatheter with Dilator.• Cleaner Plus Handpiecewith integrated MacerationWire.• Cleaner Plus AspirationCanister.• The system also includes apeel-away introducer. |
| Technical and Biological Comparison | |||
| Aspiration CatheterDiameter | 18F OD | 16F sheath compatibility | 12.7F |
| Aspiration CatheterLength | 115cm | 80cm, 100cm, & 115cm | 65 & 135cm |
| Aspiration CatheterMaterials | Biocompatible, commonlyutilized for interventional devices | Biocompatible, commonlyutilized for interventionaldevices | Biocompatible, commonlyutilized for interventionaldevices |
| Reservoir size | 400cc | 1000cc | SAME |
| Maximum vacuum | 28 inHg | 29 in Hg | SAME |
| IEC 60601-1-2IEC 60601-1Compliance | Yes | SAME | SAME |
| Subject Device | Predicate Device | Reference Device | |
| Cleaner™ Pro ThrombectomySystem, Cleaner™ ProAspiration Catheter withHandpiece, Cleaner™ ProAspiration Canister | Indigo® Aspiration System -Lighting® Flash | Cleaner Plus™Thrombectomy System | |
| Performance Testing(In-Vitro) | • Catheter - Dimensional• Catheter - Visual• Catheter - Radiopacity• Catheter - Hemostasis ValveLeak• Catheter - System Leak Test• Catheter - Burst Test• Catheter - Kink Radius• Catheter - Tensile Break• Catheter - Torsional Break• Catheter - Aspiration TipCollapse• Dilator - Dimensional• Dilator - Leak Test• Dilator Burst Test• Dilator - Functional• Dilator - Visual• Dilator - Tensile Break• Dilator - Radiopacity• Aspiration Canister - Visual• Aspiration Canister -Functional• Aspiration Canister Tubing -Tensile Break• Aspiration Canister - WeldStrength• Handpiece – Functional• Handpiece – Simulate Use• System - Functional• System Vacuum Decay• System - Noise Level• System Integrity• System - Visual• System - Simulated Use• Shipping Qualification• IEC-60601 Compliance• Software Validation | • Lightning Flash AspirationTubing• Dimensional/VisualInspection• Performance/Simulated UseTesting• Tensile Testing• Indigo Aspiration SystemCompatibility• Valve Sense Testing• Flash Aspiration Catheterand Select Catheter• Dimensional/VisualInspection• Friction Testing• Performance/Simulated Useand Torsion Testing• Vacuum Test• Coating Integrity Testing• Particulate Testing• Hub Air Aspiration• Catheter Pressure• Hub / Shaft Tensile Strength• Catheter Shaft Tensile orElongation to Failure• Corrosion | • Wire - Atraumatic Tip Pull• Wire - CorrosionResistance• Wire - Fatigue• Wire - Dynamic Retention• Wire - Flexing and Fracture• Wire – Kink• Wire - Tensile Break• Wire - Dimensional• Catheter - Dimensional• Catheter - Aspiration TipCollapse• Catheter - Kink• Catheter - HemostasisValve Leak• Catheter - Torsional Break• Catheter - System Leak• Catheter - Tensile Break• Shipping Qualification• Luer Functional• Catheter - Coating• Performance and Integrity• IEC 60601 Compliance• Canister & Dead VolumeStudy• 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 Software Testing• Float Valve Study |
| Non-Clinical, AnimalStudy | Yes | Previously performed animaltesting | Yes |
| Subject Device | Predicate Device | Reference Device | |
| Cleaner™ Pro ThrombectomySystem, Cleaner™ ProAspiration Catheter withHandpiece, Cleaner™ ProAspiration Canister | Indigo® Aspiration System -Lighting® Flash | Cleaner Plus™Thrombectomy System | |
| BiologicalComparison | 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(ISO 10993-11 Hemocompatibility(ISO10993-4) C3a Complement Assay Complement Activation,SC5b-9 ASTM PartialThromboplastin Time(PTT) ASTM HemolysisGenotoxicity, carcinogenicityand reproductive toxicity(ISO 10993-3). | Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation or IntracutaneousReactivity (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 Plateletand Leucocyte Counts Partial ThromboplastinTime (PTT) ASTM HemolysisAssay, Direct andExtract Methods (ISO) |
| PackagingConfiguration | 1) Aspiration Catheter/Dilatorwith Handpiece andFlushing Adapter on abacker card sealed in aTyvek pouch. Pouch placedin a shelf carton.2) Aspiration Canister is placedin a base tray with lid andthen sealed in a Tyvekpouch. Pouch placed in ashelf carton.3) All the individual systemcomponents are placed in asingle labeled shipper box.Packaging materials arecommonly used for medicaldevices. | Individually packedcomponents.Packaging materials arecommonly used forinterventional devices | 1) Aspiration Catheter andDilator are sealed in aTyvek pouch. Pouch placedin a shelf carton.2) Handpiece with MacerationWire is placed in a basetray with lid and thensealed in a Tyvek pouch.Pouch placed in a shelfcarton.3) Aspiration Canister isplaced in a base tray withlid and then sealed in aTyvek pouch. Pouch placedin a shelf carton.4) All the individual systemcomponents are placed in asingle labeled shipper box.Packaging materials arecommonly used for medicaldevices. |
| Sterilization | SAL 10-6, EtO | SAME | SAME |
| Shelf-Life | 6 monthsTarget 36 months | 36 months | SAME |
| Non-Clinical DataBiocompatibility | Catheter – Dimensional Catheter – Visual Catheter – Radiopacity Catheter – Hemostasis Valve Leak Catheter – System Leak Test Catheter – Burst Test Catheter – Kink Radius Catheter – Tensile Break Catheter – Torsional Break Catheter – Aspiration Tip Collapse Dilator – Dimensional Dilator – Leak Test Dilator Burst Test Dilator – Functional Dilator – Visual Dilator – Tensile Break Dilator – Radiopacity | Aspiration Canister – Visual Aspiration Canister – Functional Aspiration Canister Tubing – Tensile Break Aspiration Canister – Weld Strength Handpiece – Functional Handpiece – Simulate Use System – Functional System Vacuum Decay System – Noise Level System Integrity System – Visual System – Simulated Use Shipping Qualification IEC-60601 Compliance Software Validation | |
| Biocompatibility is established for the Cleaner Pro Thrombectomy Systemaccording to ISO 10993-1:2020 as an external communicating, circulatingblood with limited duration <24hrs.All studies were performed following the approved protocol under GoodLaboratory 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) 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 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 equivalent safety andperformance outcomes of the Cleaner Pro Thrombectomy System when usedin the target vasculature by evaluating for vessel injury, patency and grossthrombogenicity.There were no histological signs of thromboembolism noted in the treatedvessels, there were no ruptures, hemorrhage, perforation, or dissection notedhistologically in the treated veins. All the end points of this study were met. | ||
| SubstantialEquivalence: | Based on the Indication for Use, design, and safety and performance testing,the Cleaner Pro Thrombectomy System meets the requirements for itsintended use and is substantially equivalent to the predicate devices. |
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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 Pro Thrombectomy System substantial equivalence:
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| Conclusion: | The Cleaner Pro Rotational Thrombectomy System introduces no additionalclinical risk, based on its comparable indication for use and mechanism ofaction. Based on performance testing in vitro and in vivo, and similarities inindications for use, materials, technological characteristics, principle ofoperation, design features and sterilization process; the Cleaner ProThrombectomy System is substantially equivalent to the predicate devices. |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
§ 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).