Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical aspiration and fluid infusion, with no mention of AI/ML components or data processing for decision-making or analysis.

Therapeutic

Yes.
The device is indicated for the removal of thrombi and emboli from peripheral venous vasculature, which are clinical conditions related to patient health, and it also allows for the infusion of physician-specified fluids, including thrombolytics, to treat these conditions. These functions directly involve the treatment of disease or injury, classifying it as a therapeutic device.

Diagnostic

No

The device is indicated for the removal of thrombi and emboli and for the infusion of fluids, which are therapeutic actions, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components like an Aspiration Catheter, Handpiece, and external vacuum reservoir with pump (Aspiration Canister), indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The Cleaner™ Pro Thrombectomy System is a medical device used within the patient's body (in vivo) to physically remove blood clots (thrombi and emboli) from peripheral veins and to infuse fluids. It is a therapeutic device, not a diagnostic one.
Intended Use: The intended use clearly states the removal of thrombi and emboli and the infusion of fluids, which are interventional procedures performed directly on the patient.
Device Description: The description details the physical components and how they are used to aspirate clots from within the vessel.
Anatomical Site: The device is used in the "peripheral venous vasculature," which is inside the patient's body.

The device's function and intended use are entirely focused on treating a condition within the patient's body, not on analyzing samples taken from the body for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes

QEW, KRA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vessels of the peripheral venous vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

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

An animal study was performed to assess substantially equivalent safety and performance outcomes of the Cleaner Pro Thrombectomy System when used in the target vasculature by evaluating for vessel injury, patency and gross thrombogenicity. There were no histological signs of thromboembolism noted in the treated vessels, there were no ruptures, hemorrhage, perforation, or dissection noted histologically in the treated veins. All the end points of this study were met.

Key Metrics

Not Found

Predicate Device(s)

K222358

Reference Device(s)

K223176

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

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).

1

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

2

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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3

510(k) Summary - K232679

Date Prepared:	January 19, 2024
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™ Pro Thrombectomy System
Cleaner™ Pro Aspiration Catheter with Handpiece
Cleaner™ Pro Aspiration Canister
Device Common Name:	Mechanical Thrombectomy Device
Device Classification:	Embolectomy Catheter
Continuous Flush Catheter
Product code, QEW/KRA
21 CFR 870.5150
Class II
Review Panel: Cardiovascular Devices
Predicate Device:	Predicate Device: K222358 Indigo® Aspiration System - Lighting® Flash
Reference 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. |

4

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 Thrombectomy
System, Cleaner™ Pro
Aspiration Catheter with
Handpiece, Cleaner™ Pro
Aspiration 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 Classification
Name	Embolectomy Catheter
Continuous Flush Catheter	Embolectomy Catheter	Embolectomy Catheter
Continuous Flush Catheter
Regulation	21 §CFR 870.5150	21 §CFR 870.5150	21 §CFR 870.5150
Product Code	QEW
KRA	QEW	QEW
KRA
Clinical Comparison
Indication for Use	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.	INDIGO Aspiration Catheters
and Separators: As part of the
INDIGO Aspiration System, the
INDIGO Aspiration Catheters
and Separators are indicated
for the removal of fresh, soft
emboli and thrombi from
vessels of the peripheral
arterial and venous systems,
and for the treatment of
pulmonary embolism.
INDIGO Aspiration Tubing: As
part of the INDIGO Aspiration
System, the INDIGO Sterile
Aspiration Tubing is indicated
to connect the INDIGO
Aspiration Catheters to the
Penumbra Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration
Pump is indicated as a vacuum
source for the Penumbra
Aspiration Systems.	Indicated for mechanical de-
clotting, aspiration, and
controlled and selective
infusion of physician specified
fluids, including thrombolytics,
in the peripheral venous
vasculature.
Principle of
Operation	The device is advanced over a
guidewire to the target site. The
access point may be the
common femoral vein, internal
jugular vein, or popliteal vein in
select patients. The target site
may be the peripheral venous
vasculature.
Once in the target site, the
device is activated by the user,
to remove fresh, soft thrombi
and emboli. The user may
maintain guidewire access
throughout the procedure.
Additionally, the device may be	The INDIGO Aspiration
Catheter targets aspiration
from the pump directly to the
thrombus. The INDIGO
Aspiration Catheter is
introduced through a guide
catheter or vascular sheath
into the peripheral vasculature
and guided over a guidewire to
the site of the primary
occlusion. The INDIGO
Aspiration Catheter is used
with the Penumbra Aspiration
Pump to aspirate thrombus
from an occluded vessel. As
needed, an INDIGO Separator
may be deployed from the
INDIGO Aspiration Catheter to	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
	Subject Device	Predicate Device	Reference Device
	Cleaner ™ Pro Thrombectomy
System, Cleaner™ Pro
Aspiration Catheter with
Handpiece, Cleaner™ Pro
Aspiration Canister	Indigo® Aspiration System –
Lighting® Flash	Cleaner Plus™
Thrombectomy System
	specified fluids, including
thrombolytics and/or contrast
media. Once thrombus
resolution is achieved, the
device is removed from the
patient and discarded.	assist with thrombus removal.
The INDIGO Separator is
advanced and retracted
through the INDIGO Aspiration
Catheter at the proximal
margin of the primary occlusion
to facilitate clearing of the
thrombus from the INDIGO
Aspiration Catheter tip.	physician-specified fluids,
including thrombolytics, during
the procedure. The infused
solution penetrates the clot
increasing the effectiveness of
the treatment
Contraindication	Not intended for use in the
coronaries and
neurovasculature	There are no known
contraindications	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.
Single Use	Yes	SAME	SAME
Supplied Sterile	Yes	SAME	SAME
Device Description	The Cleaner Pro Thrombectomy
System consists of:
• An Aspiration
Catheter/Dilator with
Handpiece and Flushing
Adapter
• An external vacuum
reservoir with pump known
as the Aspiration Canister	The INDIGO® Aspiration
System is comprised of the
several devices:
• INDIGO Aspiration Catheter
• Penumbra Aspiration Pump
• INDIGO Aspiration Pump
Canister
• INDIGO Aspiration Tubing
• INDIGO Separator	The Cleaner Plus System
consists of:
• Cleaner Plus Aspiration
Catheter with Dilator.
• Cleaner Plus Handpiece
with integrated Maceration
Wire.
• Cleaner Plus Aspiration
Canister.
• The system also includes a
peel-away introducer.
Technical and Biological Comparison
Aspiration Catheter
Diameter	18F OD	16F sheath compatibility	12.7F
Aspiration Catheter
Length	115cm	80cm, 100cm, & 115cm	65 & 135cm
Aspiration Catheter
Materials	Biocompatible, commonly
utilized for interventional devices	Biocompatible, commonly
utilized for interventional
devices	Biocompatible, commonly
utilized for interventional
devices
Reservoir size	400cc	1000cc	SAME
Maximum vacuum	28 inHg	29 in Hg	SAME
IEC 60601-1-2
IEC 60601-1
Compliance	Yes	SAME	SAME
	Subject Device	Predicate Device	Reference Device
	Cleaner™ Pro Thrombectomy
System, Cleaner™ Pro
Aspiration Catheter with
Handpiece, Cleaner™ Pro
Aspiration Canister	Indigo® Aspiration System -
Lighting® Flash	Cleaner Plus™
Thrombectomy System
Performance Testing
(In-Vitro)	• 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	• Lightning Flash Aspiration
Tubing
• Dimensional/Visual
Inspection
• Performance/Simulated Use
Testing
• Tensile Testing
• Indigo Aspiration System
Compatibility
• Valve Sense Testing

• Flash Aspiration Catheter
and Select Catheter
• Dimensional/Visual
Inspection
• Friction Testing
• Performance/Simulated Use
and Torsion Testing
• Vacuum Test
• Coating Integrity Testing
• Particulate Testing
• Hub Air Aspiration
• Catheter Pressure
• Hub / Shaft Tensile Strength
• Catheter Shaft Tensile or
Elongation to Failure
• Corrosion | • Wire - Atraumatic Tip Pull
• Wire - Corrosion
Resistance
• Wire - Fatigue
• Wire - Dynamic Retention
• Wire - Flexing and Fracture
• Wire – Kink
• Wire - Tensile Break
• Wire - Dimensional
• Catheter - Dimensional
• Catheter - Aspiration Tip
Collapse
• Catheter - Kink
• Catheter - Hemostasis
Valve Leak
• Catheter - Torsional Break
• Catheter - System Leak
• Catheter - Tensile Break
• Shipping Qualification
• Luer Functional
• Catheter - Coating
• Performance and Integrity
• IEC 60601 Compliance
• Canister & Dead Volume
Study
• Pump Functionality - Relief
Valve
• Pump Tubing - Pull
• Pump Performance
• Pump - Button Press
• Endurance
• Simulated Use
• Handpiece Dimensional
• Handpiece Motor & Battery
Performance
• Pump Battery Performance
• Handpiece - Functionality
• Handpiece - Peel-away
Introducer
• Luer Dimensional
• Radiopacity
• Functional, Performance,
and Software Testing
• Float Valve Study |
| Non-Clinical, Animal
Study | Yes | Previously performed animal
testing | Yes |
| | Subject Device | Predicate Device | Reference Device |
| | Cleaner™ Pro Thrombectomy
System, Cleaner™ Pro
Aspiration Catheter with
Handpiece, Cleaner™ Pro
Aspiration Canister | Indigo® Aspiration System -
Lighting® Flash | Cleaner Plus™
Thrombectomy System |
| 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
(ISO10993-4) 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) 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) |
| Packaging
Configuration | 1) Aspiration Catheter/Dilator
with Handpiece and
Flushing Adapter on a
backer card sealed in a
Tyvek pouch. Pouch placed
in a shelf carton.
2) Aspiration Canister is placed
in a base tray with lid and
then sealed in a Tyvek
pouch. Pouch placed in a
shelf carton.
3) All the individual system
components are placed in a
single labeled shipper box.
Packaging materials are
commonly used for medical
devices. | Individually packed
components.
Packaging materials are
commonly used for
interventional devices | 1) Aspiration Catheter and
Dilator are sealed in a
Tyvek pouch. Pouch placed
in a shelf carton.
2) 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.
3) Aspiration Canister is
placed in a base tray with
lid and then sealed in a
Tyvek pouch. Pouch placed
in a shelf carton.
4) All the individual system
components are placed in a
single labeled shipper box.
Packaging materials are
commonly used for medical
devices. |
| Sterilization | SAL 10-6, EtO | SAME | SAME |
| Shelf-Life | 6 months
Target 36 months | 36 months | SAME |
| Non-Clinical Data
Biocompatibility | 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 System
according to ISO 10993-1:2020 as an external communicating, circulating
blood with limited duration