(181 days)
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.
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. Mechanical thrombectomy is 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.
The provided text describes a 510(k) submission for a device modification to the Cleaner Plus™ Thrombectomy System. This is a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm-only) performance," and "ground truth for the test and training set," are not applicable.
The submission focuses on demonstrating the substantial equivalence of a modified device to a predicate device through non-clinical performance testing.
Here's the relevant information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Test results demonstrate that all acceptance criteria were met." However, the specific acceptance criteria values are not detailed in the provided text. The types of tests performed indicate the areas for which acceptance criteria would have been established.
| Acceptance Criteria Category (implied from tests) | Reported Device Performance |
|---|---|
| Corrosion Resistance | Met acceptance criteria |
| Tensile Break | Met acceptance criteria |
| Simulated Use (Handpiece performance with Helical component) | Met acceptance criteria |
| Simulated Use (Aspiration Performance) | Met acceptance criteria |
| Torque Strength (Helical Component to Wire) | Met acceptance criteria |
| Wire Fatigue | Met acceptance criteria |
| Particulates | Met acceptance criteria |
| Biocompatibility (Cytotoxicity - MEM Elution) | Met acceptance criteria |
| Biocompatibility (Sensitization – Guinea Pig Maximization) | Met acceptance criteria |
| Biocompatibility (Irritation - Intracutaneous Reactivity) | Met acceptance criteria |
| Biocompatibility (Systemic Toxicity - Material Mediated Pyrogen) | Met acceptance criteria |
| Biocompatibility (Systemic Toxicity - Acute Systemic Toxicity) | Met acceptance criteria |
| Biocompatibility (Hemocompatibility – Hemolysis Indirect) | Met acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the individual tests. The tests were non-clinical (laboratory/bench testing), so data provenance from countries or whether it was retrospective/prospective is not applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a medical device performance study, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical studies or studies involving expert interpretation, not for bench testing of device components.
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
Not applicable. This is a medical device, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The documentation did not specify a "ground truth" in the context of clinical or diagnostic outcomes. For performance testing of a physical device, the "ground truth" would be established physical measurements and material properties relevant to the device's function and safety (e.g., tensile strength, torque, aspiration volume, biocompatibility assays).
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set with established ground truth.
Summary of Study Type:
The study described is a non-clinical verification testing of a medical device modification to support substantial equivalence to a predicate device. The tests included various engineering performance tests (e.g., corrosion, tensile, torque, fatigue, simulated use) and biocompatibility assessments. Clinical and animal testing were not required for this determination of substantial equivalence.
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April 10, 2023
Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751
Re: K223176
Trade/Device Name: Cleaner Plus™ Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: October 10, 2022 Received: October 11, 2022
Dear Ana Jimenez-Hughes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2023.04.10 12:42:19 -04'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K223176
Device Name
Cleaner Plus™ Thrombectomy System
Indications for Use (Describe)
The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Argon Medical Devices, Inc.
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Special 510(k): Device Modification Cleaner Plus Thrombectomy System Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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510(k) Summary — K223176
Date Prepared: April 5, 2023
| Company: | Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number: 1625425 |
|---|---|
| Contact: | Ana Jimenez-HughesSenior Regulatory Affairs SpecialistPhone: 903-676-4276Fax: 903-677-9396Email: ana.hughes@argonmedical.com |
| Device TradeName: | Cleaner Plus™ Thrombectomy System |
| Device CommonName: | Mechanical Thrombectomy Device |
| DeviceClassification: | Embolectomy CatheterProduct code, QEW/KRA21 CFR 870.5150Class IIReview Panel: Cardiovascular Devices |
| PredicateDevice(s): | Primary: K211798 Cleaner Plus™ Thrombectomy System |
| Description ofthe Device: | The Cleaner Plus™ Thrombectomy System is a single use device used to providethrombectomy in the peripheral venous vasculature. The device provides additionalfeatures, such as aspiration and over-the wire device placement.The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) theHandpiece that includes system controls, and an integrated Maceration Wire, and aPeel-Away Introducer and (3) the Aspiration Canister.The Aspiration Catheter with Dilator may be placed over-the-wire to navigate thedevice to the therapeutic site. The dilator and guidewire are removed, and theMaceration Wire, using the Peel-Away introducer is advanced through the hemostasisvalve of the Aspiration Catheter to the therapeutic site and connected to the |
| handpiece. To complete the system, the provided Aspiration Canister is connected tothe handpiece to provide aspiration. The Handpiece provides controls to turn on/offmaceration and/or the application of suction. Mechanical thrombectomy is achievedby rotating a flexible stainless-steel maceration wire powered by a motor inside thehandpiece. The aspiration source is provided to aspirate macerated clot from the distalportion of the device through the handpiece and captures the macerated clot in theAspiration Canister reservoir. The Aspiration Canister includes a switch to initiate thepump, and LEDs that indicate the level of the vacuum. | |
| Indication forUse: | 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. |
| DeviceModification: | The device modification included in this submission is limited to the addition of anew helical component designed to assist the aspirate's movement through theCleaner Plus™ Handpiece. |
| SubstantialEquivalence: | There is no change of intended use or fundamental scientific technology betweenthe proposed modified and predicate device. The proposed modified device hasthe same indication for use as the predicate, K211798.Non-Clinical TestingIn accordance with the Design Failure Modes and Effects Analysis, supplementalverification testing was identified to support the substantial equivalence of themodified Cleaner Plus™ Thrombectomy System. The tests included:● Corrosion Resistance● Tensile Break● Simulated Use:○ Handpiece performance with Helical component○ Aspiration Performance● Torque Strength (Helical Component to Wire)● Wire Fatigue● ParticulatesBiocompatibility:● Cytotoxicity - MEM Elution● Sensitization – Guinea Pig Maximization● Irritation - Intracutaneous Reactivity● Systemic Toxicity - Material Mediated Pyrogen● Systemic Toxicity - Acute Systemic Toxicity● Hemocompatibility – Hemolysis Indirect |
| Animal testing was not required for the determination of substantial equivalence. | |
| Clinical testing was not required for the determination of substantial equivalence. | |
| Test results demonstrate that all acceptance criteria were met; therefore, thedevice meets the established product specifications. | |
| Conclusion: | The proposed device modifications to the Cleaner Plus™ Thrombectomy System donot change its intended use or principles of operation. Based on the Indication forUse, design, and performance testing, the Cleaner Plus™ Thrombectomy Systemmeets the requirements for its intended use and is substantially equivalent to thepredicate device. |
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§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).