K Number

Device Name

Cleaner Plus Thrombectomy System

Manufacturer

Argon Medical Devices, Inc.

Date Cleared

2022-02-24

(259 days)

Product Code

QEW KRA

Regulation Number

870.5150

Intended 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 Description

The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement. The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister. The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Like the current Cleaner15/CleanerXT devices, mechanical thrombectomy will be achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K141617

Reference Devices

K142870

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical and aspiration mechanisms, and there is no mention of AI or ML in the provided text.

Therapeutic

Yes
The device is indicated for mechanical de-clotting and aspiration in the peripheral venous vasculature to treat thrombotic conditions, which directly addresses a disease state.

Diagnostic

The device is indicated for mechanical de-clotting and aspiration, and the description clearly states it is a therapeutic device for thrombectomy. There is no mention of it being used to diagnose conditions or gather diagnostic information.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including a catheter, handpiece with integrated maceration wire and motor, and an aspiration canister. It is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Cleaner Plus™ Thrombectomy System is not an In Vitro Diagnostic (IVD) device.

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 body (in the peripheral venous vasculature) to remove blood clots.
The intended use and device description clearly state its function is mechanical de-clotting, aspiration, and fluid infusion directly within the patient's veins. It does not analyze biological samples.
There is no mention of analyzing or testing any biological specimens.

Therefore, the Cleaner Plus™ Thrombectomy System is a therapeutic medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister.

The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Like the current Cleaner15/CleanerXT devices, mechanical thrombectomy will be achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

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

Physician

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)

Performance Testing (In-Vitro):

Wire - Atraumatic Tip Pull
Wire - Corrosion Resistance
Wire - Fatigue
Wire - Dynamic Retention
Wire - Flexing and Fracture
Wire - Kink
Wire - Tensile Break
Wire - Dimensional
Catheter - Dimensional
Catheter - Aspiration 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
Software Validation
System - Vacuum Decay
Float Valve Study

Biocompatibility Testing:

Cytotoxicity (ISO 10993-5)
Sensitization (ISO 10993-10)
Irritation or Intracutaneous Reactivity (ISO 10993-10)
Acute Systemic Toxicity (ISO 10993-11)
Material Mediated Pyrogen (ISO 10993-11)
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 and performance outcomes of the Cleaner Plus™ 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.

Key results: The Cleaner Plus™ Thrombectomy System was shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence, and introduces no additional clinical risk based on its comparable indication for use and mechanism of action.

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.

K141617

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.

K142870

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

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 24, 2022

Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751

Re: K211798

Trade/Device Name: Cleaner Plus™ Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: January 21, 2022 Received: January 24, 2022

Dear Ana Jimenez-Hughes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K211798

Device Name

Cleaner Plus™ Thrombectomy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared:	February 23, 2022
Company:	Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens, Texas 75751 USA
Facility Registration number: 1625425
Contact:	Ana Jimenez-Hughes
Sr. 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: K141617 Rotational Thrombectomy System,
Cleaner15/CleanerXT
Reference: K142870 Indigo Aspiration 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. Like the current Cleaner15/CleanerXT
devices, mechanical thrombectomy will be achieved by rotating a
flexible stainless-steel maceration wire powered by a motor inside
the handpiece. The aspiration source is provided to aspirate
macerated clot from the distal portion of the device through the
handpiece and captures the macerated clot in the Aspiration
Canister reservoir. The Aspiration Canister includes a switch to
initiate the pump, and LEDs that indicate the level of the vacuum. |
| 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. |
| Technological
Characteristics: | A comparison of the technological characteristics of the subject
device and the predicate devices shows the Cleaner
Plus™ 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	Primary Predicate	Reference Predicate
	Cleaner Plus™ Thrombectomy
System	Rotational Thrombectomy System
Cleaner15/CleanerXT	Penumbra Embolectomy
Aspiration System (INDIGO®
Aspiration System)
Manufacturer	Argon Medical Devices, Inc	Argon Medical Devices, Inc.	Penumbra Inc.
FDA Clearance	TBD	K141617	K142870
Class	II	SAME	SAME
Device Classification
Name	Embolectomy Catheter
Catheter, Continuous Flush	Embolectomy Catheter
Catheter, Continuous Flush	Embolectomy Catheter
Regulation	870.5150	870.1210	870.5150
Product Code	QEW/KRA	QEW/KRA	QEW
Clinical Comparison
Intended Use	Thrombus removal	Thrombus removal	Thrombus removal
	Subject Device	Primary Predicate	Reference Predicate
	Cleaner Plus™ Thrombectomy
System	Rotational Thrombectomy System
Cleaner15/CleanerXT	Penumbra Embolectomy
Aspiration System (INDIGO®
Aspiration System)
Principle of Operation	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. The device allows
for infusion of physician-specified
fluids, including thrombolytics,
during the procedure. The infused
solution penetrates the clot
increasing the effectiveness of the
treatment	Inserted percutaneous int the vessel
using an introducer sheath. The
device macerates intra-lumen and
wall adherent thrombus. The
sinusoidal wire creates a fluid vortex
that effectively macerates
thrombus. Contrast media and
physician specified solutions,
including thrombolytics, may be
infused through the catheter lumen
to a side hole at the distal end. The
dispersion wire uses mechanical
rotation to allow the infused
solution to penetrate the clot
increasing the effectiveness of the
treatment. Any residual clot can be
aspirated through an introducer
sheath prior to restoration of flow.	The INDIGO Aspiration System
fundamental mechanism of action
is aspiration. Aspiration draws the
embolus or thrombus into the
Aspiration Catheter to remove the
embolus or thrombus from the
body. All the Separators function
to break up the clot inside of the
cathter to make it more amenable
to removal from the body via
aspiration.
Mechanism of Action	Mechanical maceration and
aspiration of thrombus	Mechanical maceration of thrombus	Mechanical aspiration of thrombus
Indication for Use	Indicated for mechanical de-
clotting, aspiration, and controlled
and selective infusion of physician-
specified fluids, including
thrombolytics, in the peripheral
venous vasculature.	Indicated for (1) mechanical de-
clotting of native vessel dialysis
fistulae and synthetic dialysis access
grafts and (2) mechanical declotting
and controlled and selective infusion
of physician-specified fluids,
including thrombolytics, in the
peripheral vasculature.	The Penumbra Embolectomy
Aspiration System (Indigo™
Aspiration System) is intended for
removal of fresh, soft emboli and
thrombi from vessels of the
peripheral arterial and venous
systems.
Contraindication	The Cleaner Plus™ Thrombectomy
System is contraindicated in the
following:
• When, in the medical judgment
of the physician, such a
procedure may compromise
the patient's condition.
• For infusion of blood or blood
products.
• In native vessels smaller than
6mm in diameter.	For the peripheral vasculature is not
to be used:
• When in the medical judgment of
the physician, such a procedure
may compromise the patient's
condition.
• For peripheral vasculature
dilation purposes.
• For the infusion of blood or blood
products.
• In native vessels smaller than 6
mm (Cleaner15 only)
• In patients without a vascular
filter such as an inferior vena
cava.	• Not for use in the coronaries or
the neurovasculature.
Single Use	Yes	SAME	SAME
Supplied Sterile	Yes	SAME	SAME
Device Description	The Cleaner Plus™ 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.	Rotational Thrombectomy System
Cleaner15/CleanerXT consists of a
handpiece unit. Attached to the unit
is a sinusoidal shaped tip wire (S-
wire). A sliding lever on top of the
unit advances and retracts the
catheter (6F or 7F). The device has a
3-way side port and a distal side
hole on catheter for the infusion of
fluids and contrast media	The Penumbra Embolectomy
Aspiration System (INDIGO®
Aspiration System) is comprised of
several devices:
• INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Pump/Canister Tubing
• INDIGO Aspiration Tubing
• INDIGO Separator™
	Subject Device	Primary Predicate	Reference Predicate
	Cleaner Plus™ Thrombectomy
System	Rotational Thrombectomy System
Cleaner15/CleanerXT	Penumbra Embolectomy
Aspiration System (INDIGO®
Aspiration System)
Technical and Biological Comparison
Dispersion Wire (rpm)	4000rpm	4000rpm	N/A
Aspiration Catheter
Diameter	10F & 12F	6F & 7F	6F, 8F & 12F
Aspiration Catheter
Length	65cm & 135cm	65cm & 135cm	85-150cm
Maceration Wire
(amplitude)	15mm (uncovered)	9mm & 15mm (uncovered)	N/A
Maceration Wire
Diameter	0.035"	0.035" & 0.044"	N/A
Maceration Wire
Material	Stainless Steel; Pebax/BaSO4 and
Virgin PTFE	Stainless Steel; Pebax/BaSO4, Virgin
PTFE	N/A
Reservoir size	400cc	N/A	1000cc
Maximum vacuum	28 inHg	N/A	29 inHg
IEC 60601 Compliance	Yes	SAME	SAME
Performance Testing
(In-Vitro)	• Wire - Atraumatic Tip Pull
• Wire - Corrosion Resistance
• Wire - Fatigue
• Wire - Dynamic Retention
• Wire - Flexing and Fracture
• Wire - Kink
• Wire - Tensile Break
• Wire - Dimensional
• Catheter - Dimensional
• Catheter - Aspiration 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	• Wire Break Test
• Wire Fatigue Test
• Gelatin Test
• Graft Abrasion
• Kink/Resiliency
• Shape Retention
• Wire Tensile Test
• Torsion Test
• Valve Compression
• Vessel Energy	• Visual & Dimensional
• Tensile Strength
• Bond Strength
• Hub Aspiration test
• Burst Test
• Particulate Test
• Coating Integrity Test
• Flexibility Test
• Kink Resistance Test
• Ovalization Resistance Test
• Friction Test
• Flow Rate Test
• Elongation Test
• Corrosion Test
• Torsion Test
• Simulated Use Test
• Leak Test
• Clot Removal Test
• Vacuum Collapse Test
• Trackability Test
	Subject Device	Primary Predicate	Reference Predicate
	Cleaner Plus™ Thrombectomy
System	Rotational Thrombectomy System
Cleaner15/CleanerXT	Penumbra Embolectomy
Aspiration System (INDIGO®
Aspiration System)
Non-Clinical, Animal
Study	Yes	Yes	Yes
Biological Comparison	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)	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-

C3a Complement Assay Complement Activation,
SC5b-9 ASTM Partial
Thromboplastin Time
(PTT) ASTM Hemolysis Genotoxicity, carcinogenicity
and reproductive toxicity (ISO
10993-3). | Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation or Intracutaneous
Reactivity (ISO 10993-10) Acute Systemic Toxicity (ISO
10993-11 Hemocompatibility
(ISO10993-4) Complement Activation Hemolysis Coagulation - PT Coagulation - PTT In vivo thrombogenicity Material Mediated Pyrogen
(ISO 10993-11) Genotoxicity Mouse Lymphoma
Mutagenesis Assay -
ISO Ames test Micronucleus Assay |
| Packaging
Configuration | 1) Aspiration Catheter and Dilator
are sealed in a Tyvek pouch.
Pouch placed in a shelf carton.
Handpiece with Maceration
Wire is placed in a base tray
with lid and then sealed in a
Tyvek pouch. Pouch placed in a
shelf carton.
Aspiration Canister is placed in
a base tray with lid and then
sealed in a Tyvek pouch. Pouch
placed in a shelf carton.
All the individual system
components are placed in a
single labeled shipper box.
Packaging materials are commonly
used for medical devices. | Handpiece is placed in a base tray
with lid and then sealed in a Tyvek
pouch. Pouch is placed in a shelf
carton.
Packaging materials are commonly
used for medical devices. | Individually packed components.
Packaging materials are commonly
used for interventional devices |
| Sterilization | Minimum SAL 10-6, EtO | Minimum SAL 10-6, EtO | Minimum SAL 10-6, EtO |
| Shelf-Life | 6 months | 36 months | 36 months |

Non-Clinical Data No performance standards have been established under section (Bench-top Testing): 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.

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

Wire - Atraumatic Tip Pull
Wire - Corrosion Resistance
Wire - Fatigue
. Wire - Dynamic Retention
Wire Flexing and Fracture ●
Wire - Kink
Wire - Tensile Break
Wire Dimensional ●
. Catheter - Dimensional
Catheter Aspiration Tip ● Collapse
. Catheter - Kink
Catheter - Hemostasis Valve Leak
Catheter - Torsional Break
Catheter - System Leak
Catheter - Tensile Break
Shipping Qualification ●
Luer Functional ●
Luer Dimensional
Catheter - Coating and Performance and Integrity
Software Validation
IEC 60601 Compliance
Canister & Dead Volume ● Study
Pump Functionality - Relief Valve
Pump Tubing Pull ●
Pump Performance
Pump Button Press ● Endurance
Simulated Use
Handpiece Motor & Battery Performance
Pump Battery Performance
Handpiece Dimensional
Handpiece Functionality ●
Handpiece – Peel-away Introducer
System - Vacuum Decay
Radiopacity ●
Functional, Performance, and Software Testing
. Float Valve Study

Non-Clinical Data Biocompatibility

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