(181 days)
Not Found
No
The device description focuses on mechanical and aspiration mechanisms, with no mention of AI or ML technologies. The performance studies are related to material properties and mechanical function, not algorithmic performance.
Yes
The device is indicated for "mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature," which are therapeutic actions.
No
The device is indicated for mechanical de-clotting, aspiration, and infusion of fluids to treat a condition, not to diagnose it.
No
The device description clearly outlines multiple hardware components including a catheter, handpiece with motor, maceration wire, and aspiration canister. It describes mechanical actions powered by a motor and aspiration via a pump, indicating a physical device, not software only.
Based on the provided information, the Cleaner Plus™ Thrombectomy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Cleaner Plus™ Thrombectomy System is a mechanical device used within the patient's peripheral venous vasculature to remove blood clots. It directly interacts with the patient's anatomy and performs a therapeutic action (thrombectomy, aspiration, infusion).
The device description and intended use clearly indicate a therapeutic and interventional purpose, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing In accordance with the Design Failure Modes and Effects Analysis, supplemental verification testing was identified to support the substantial equivalence of the modified 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
● Particulates
Biocompatibility:
● 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, the device meets the established product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Argon Medical Devices, Inc.
Page 1 of 1
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 Road
Athens, Texas 75751 USA
Facility Registration number: 1625425 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ana Jimenez-Hughes
Senior Regulatory Affairs Specialist
Phone: 903-676-4276
Fax: 903-677-9396
Email: ana.hughes@argonmedical.com |
| Device Trade
Name: | Cleaner Plus™ Thrombectomy System |
| Device Common
Name: | Mechanical Thrombectomy Device |
| Device
Classification: | Embolectomy Catheter
Product code, QEW/KRA
21 CFR 870.5150
Class II
Review Panel: Cardiovascular Devices |
| Predicate
Device(s): | Primary: K211798 Cleaner Plus™ Thrombectomy System |
| Description of
the Device: | 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. |
| Indication for
Use: | The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting,
aspiration, and controlled and selective infusion of physician-specified fluids,
including thrombolytics, in the peripheral venous vasculature. |
| Device
Modification: | The device modification included in this submission is limited to the addition of a
new helical component designed to assist the aspirate's movement through the
Cleaner Plus™ Handpiece. |
| Substantial
Equivalence: | There is no change of intended use or fundamental scientific technology between
the proposed modified and predicate device. The proposed modified device has
the same indication for use as the predicate, K211798.
Non-Clinical Testing
In accordance with the Design Failure Modes and Effects Analysis, supplemental
verification testing was identified to support the substantial equivalence of the
modified 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
● Particulates
Biocompatibility:
● 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, the
device meets the established product specifications. |
| Conclusion: | The proposed device modifications to the Cleaner Plus™ Thrombectomy System do
not change its intended use or principles of operation. Based on the Indication for
Use, design, and performance testing, the Cleaner Plus™ Thrombectomy System
meets the requirements for its intended use and is substantially equivalent to the
predicate device. |
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