K Number

Device Name

Cobra Catheter System

Manufacturer

Endovascular Engineering

Date Cleared

2023-02-15

(50 days)

Product Code

QEW KRA

Regulation Number

870.5150

Intended Use

The Cobra Catheter System is indicated for: - The non-surgical removal of thrombi and emboli from venous vasculature. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from the venous vasculature.

Device Description

The Cobra Catheter System (Cobra System) is a minimally invasive aspiration catheter with an integrated handle that connects to a commercially available vacuum pump. The aspiration catheter has an expanding funnel at the distal end for clot capture and features radiopaque markers for visibility under fluoroscopic quidance. The funnel resides within the outer sleeve of the aspiration catheter until it is manually deployed in the tarqet vessel using the slider on the handle. The Cobra System can be initially introduced with a 16Fr introducer sheath. The Cobra System allows for navigating to, engagement, ingestion, and transportation of the target obstructive clot out of the peripheral veins to re-establish blood flow from the lower extremities. The Cobra System is comprised of four (4) components: Aspiration Catheter: The Aspiration Catheter includes a catheter shaft with a funnel at the distal end an integrated handle that allows for manual control of the device features. The handle features a port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter and for measurement of intravascular pressure using a standard pressure line setup, if needed. The Aspiration Catheter is compatible with standard accessories such as a 0.035" or 0.038" quidewire. Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter and connects to the proximal end of the handle. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter lumen during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter System during use. Rotating Hemostasis Valve (RHV): The RHV is an accessory that attaches to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy-Borst valve to enable compatibility with the Dilator as well as sealing on ancillary devices, such as guidewires or diagnostic catheters. Dilator: An optional accessory to the Cobra System. The Dilator is compatible with 0.035" or 0.038″ guidewires and can be used to facilitate navigation.

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

K212632

Reference Devices

K211798

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI/ML algorithms or data processing for decision-making or analysis.

Therapeutic

Yes

The device is designed for the non-surgical removal of thrombi and emboli from venous vasculature to re-establish blood flow, which is a direct treatment of a medical condition.

Diagnostic

The Cobra Catheter System is described as a minimally invasive aspiration catheter intended for the non-surgical removal of thrombi and emboli, and for injection/aspiration of fluids. Its function is to clear blockages and deliver/remove substances, not to provide diagnostic information about a patient's condition.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including a catheter, handle, agitator, RHV, and dilator. The performance studies also detail testing related to physical properties and interactions with the body, indicating it is a physical 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 Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
Cobra Catheter System Function: The Cobra Catheter System is a medical device used within the body (in vivo) to physically remove blood clots from veins. It also facilitates the injection or aspiration of fluids directly into or from the venous system.
Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens. Its purpose is mechanical intervention within the circulatory system.

Therefore, the Cobra Catheter System falls under the category of an in vivo medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cobra Catheter System is indicated for:

The non-surgical removal of thrombi and emboli from venous vasculature.
Injection, infusion, and/or aspiration of contrast media and other fluids into or from the venous vasculature.

Product codes (comma separated list FDA assigned to the subject device)

QEW, KRA

Device Description

The Cobra System is comprised of four (4) components:

Aspiration Catheter: The Aspiration Catheter includes a catheter shaft with a funnel at the distal end an integrated handle that allows for manual control of the device features. The handle features a port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter and for measurement of intravascular pressure using a standard pressure line setup, if needed. The Aspiration Catheter is compatible with standard accessories such as a 0.035" or 0.038" quidewire.

Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter and connects to the proximal end of the handle. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter lumen during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter System during use.

Rotating Hemostasis Valve (RHV): The RHV is an accessory that attaches to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy-Borst valve to enable compatibility with the Dilator as well as sealing on ancillary devices, such as guidewires or diagnostic catheters.

Dilator: An optional accessory to the Cobra System. The Dilator is compatible with 0.035" or 0.038″ guidewires and can be used to facilitate navigation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Venous vasculature (peripheral vasculature, including deep vein thrombosis (DVT)).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

Bench studies: Performed in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testing included: Visual and Dimensional Inspection, Sheath Compatibility, Deployment/Retraction Force, Vacuum Compatibility, Pressure Connection, Trackability, Simulated Use, Accessibility, Durability, Suction Valve Force, Heat Generation, Guidewire Compatibility, Corrosion Resistance, Tensile Testing, Torque Testing, Pouch Seal Inspection, Pouch, Peel, Seal Strength, Particulate Matter.

Sterilization validation: Demonstrated a sterility assurance level of 10-6.

Biocompatibility testing: Conducted per ISO-10993-1, Biological Evaluation of Medical Devices. Concluded no chemical, toxicological, or safety risks, and the device is considered biocompatible for its intended use as an externally communicating device with limited

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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.

February 15, 2023

Endovascular Engineering Debra Cogan VP Regulatory & Clinical 3925 Bohannon Drive, Suite 300 Menlo Park, California 94025

Re: K223891

Trade/Device Name: Cobra Catheter System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: December 22, 2022 Received: December 27, 2022

Dear Debra Cogan:

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 (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,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S ○'connell -S Date: 2023.02.15
15:38:50 -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

Enclosure

Indications for Use

510(k) Number (if known) K223891

Device Name Cobra Catheter System

Indications for Use (Describe)

The Cobra Catheter System is indicated for:

· The non-surgical removal of thrombi and emboli from venous vasculature.
· Injection, infusion, and/or aspiration of contrast media and other fluids into or from the 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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."

Image /page/3/Picture/0 description: The image shows the logo for Endovascular Engineering. The logo consists of a green circle with a stylized "e" inside, followed by the words "endovascular" in green and "engineering" in dark green. The logo is clean and modern, and the colors are vibrant.

TRADITIONAL 510(k) SUMMARY - K223891 Endovascular Engineering Cobra Catheter System

I. SUBMITTER

Name: Address:
Contact: Telephone:

Email:

Endovascular Engineering 3925 Bohannon Drive, Suite 300 Menlo Park, CA 94025, USA

Debra Cogan, VP Regulatory & Clinical 408-515-0820 dcogan@endovascularengineering.com

Date Prepared:

DEVICE II.

Name of Device: Common or Usual Name: Classification Name: Regulatory Class: Requlation Number: Product Code:

PREDICATE DEVICE III.

Primary Predicate Device:

Cobra Catheter System Embolectomy Catheter Catheter, Embolectomy II 21 CFR 870.5150 QEW, KRA

February 13, 2023

Inari Medical ClotTriever Thrombectomy System (K212632)

Reference Predicate Device:

Argon Medical Devices Cleaner Plus Thrombectomy System (K211798)

DEVICE DESCRIPTION IV.

The Cobra System is comprised of four (4) components:

Aspiration Catheter: The Aspiration Catheter includes a catheter shaft with a ● funnel at the distal end an integrated handle that allows for manual control of the device features. The handle features a port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter and for measurement of intravascular pressure using a standard pressure line setup, if needed. The Aspiration Catheter is compatible with standard accessories such as a 0.035" or 0.038" quidewire.

. Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter and connects to the proximal end of the handle. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter lumen during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter System during use.

. Rotating Hemostasis Valve (RHV): The RHV is an accessory that attaches to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy-Borst valve to enable compatibility with the Dilator as well as sealing on ancillary devices, such as guidewires or diagnostic catheters.

Dilator: An optional accessory to the Cobra System. The Dilator is compatible with . 0.035" or 0.038″ guidewires and can be used to facilitate navigation.

INDICATIONS FOR USE V.

The Cobra Catheter System is indicated for:

the non-surgical removal of emboli and thrombi from venous vasculature
· injection, infusion, and/or aspiration of contrast media and other fluids into or from venous vasculature.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES '

The technical features of the Cobra Catheter System and the primary and reference predicate devices are the same or similar for both the design components and the mechanism of action. All 3 devices are single-use, disposable, catheter-based technologies that are provided sterile and are sterilized by the same method (EtO). Like both predicate devices, the Cobra Catheter System is delivered over a dilator with a quidewire to the target clot. The working length of all 3 devices are clinically relevant for treating peripheral thrombosis. The subject device and the primary predicate both feature a self-expanding element for capturing clot. The subject device and reference predicate both feature an agitator for macerating clot and applying suction using a powered vacuum pump.

Characteristic	Subject Device	Primary Predicate	Reference Predicate
Device Name	Cobra Catheter System	ClotTriever Thrombectomy System	Cleaner Plus Thrombectomy System
Manufacturer	Endovascular Engineering, Inc.	Inari Medical, Inc.	Argon Medical Devices, Inc.
510(k) Number	K223891	K212632	K211798
Classification	II	II	II
Classification Name	Embolectomy Catheter	Embolectomy Catheter	Embolectomy Catheter
Regulation Number	870.5150	870.5150	870.5150
Product Code	QEW. KRA	QEW	QEW, KRA

Characteristic	Subject Device	Primary Predicate	Reference Predicate
Intended Use	Thrombus removal	Thrombus removal	Thrombus removal
Indications for Use	The Cobra Catheter System is	The ClotTriever	Indicated for mechanical de-
	indicated for:	Thrombectomy System is	clotting, aspiration, and
	• The non-surgical removal	indicated for:	controlled and selective
	of emboli and thrombi	• The non-surgical removal	infusion of physician-
	from venous vasculature.	of thrombi and emboli	specified fluids, including
	• Injection, infusion, and/or	from blood vessels.	thrombolytics, in the
	aspiration of contrast	• Injection, infusion, and/or	peripheral venous
	media and other fluids	aspiration of contrast	vasculature.
	into or from venous	media and other fluids
	vasculature.	into or from blood
		vessels.
		The ClotTriever
		Thrombectomy System is
		intended for use in the
		peripheral vasculature
		including deep vein
		thrombosis (DVT).
Target Anatomy	Peripheral vasculature	Peripheral vasculature	Peripheral vasculature
Guidewire access	OTW	OTW	OTW
Sheath inner	16F	16F, 19F	10 & 12F
diameter
Catheter working	95cm	80cm	65cm & 135 cm
length
IEC 60601	Yes	N/A	Yes
Compliance
Mechanism of action	Mechanical maceration and	Cores, captures and removes	Mechanical maceration and
	aspiration of thrombus using	thrombus with supplemental	aspiration of thrombus using
	a vacuum pump for suction.	manual suction using a large	a vacuum pump for suction.
		bore syringe.
Single Use	Yes	Yes	Yes
Sterile	Yes	Yes	Yes
Sterilization Method	Eto	EtO	EtO
Performance Tests	• Visual and Dimensional	• Visual and Dimensional	• Wire - Atraumatic Tip Pull
	Inspection	Inspection	• Wire - Corrosion Resistance
	• Sheath Compatibility	• ClotTriever Sheath	• Wire - Fatigue
	• Deployment/Retraction	Compatibility	• Wire – Dynamic Retention
	Force	• Deployment/Retraction	• Wire - Flexing and Fracture
	• Vacuum Compatibility	Force	• Wire – Kink
	• Pressure Connection	• Kink Radius	• Wire – Tensile Break
	• Trackability	• Fluid Leakage, Sheath	• Wire – Dimensional
	• Simulated Use	• Vacuum Leakage, Sheath	• Catheter - Dimensional
	• Accessibility	• Simulated Use, Track &	• Catheter - Aspiration Tip
	• Durability	Rotation	Collapse • Catheter – Kink
	• Suction Valve Force	• Simulated Use, Track &	• Catheter - Hemostasis
	• Heat Generation	Tensile	Valve Leak
	• Guidewire Compatibility		• Catheter – Torsional Break
	• Corrosion Resistance		• Catheter – System Leak
	• Tensile Testing		• Catheter – Tensile Break
	• Torque Testing		• Shipping Qualification
	• Pouch Seal Inspection		• Luer Functional
	• Pouch, Peel, Seal Strength		• Catheter - Coating
	• Particulate Matter		Performance and Integrity
	• Biocompatibility Validation		• IEC 60601 Compliance
	• Sterilization Validation		• Canister & Dead Volume
	• IEC 60601 Compliance		Study
			• Pump Functionality - Relief
			Valve
			• Pump Tubing - Pull
				• Pump Performance	• Pump Performance
			• Pump – Button Press
			Endurance
			• Simulated Use
			• Handpiece Dimensional

Characteristic	Subject Device	Primary Predicate	Reference Predicate
			• Handpiece Motor & Battery
Performance
• Pump Battery Performance
• Handpiece - Functionality
• Handpiece – Peel-away
Introducer
• Luer Dimensional
• Radiopacity
• Functional, Performance,
and Software Testing
• Float Valve Study

VII. PERFORMANCE DATA

Bench studies indicate that the Cobra Catheter System performs as intended. Testing was performed in conformance with design inputs, including performance standards for peripheral vascular embolectomy devices. Testing included:

Visual and Dimensional Inspection
· Sheath Compatibility
Deployment/Retraction Force
Vacuum Compatibility
· Pressure Connection
Trackability
Simulated Use
· Accessibility
Durability
· Suction Valve Force
· Heat Generation
· Guidewire Compatibility
Corrosion Resistance
· Tensile Testing
· Torque Testing
Pouch Seal Inspection
Pouch, Peel, Seal Strength
Particulate Matter

Sterilization Validation

Sterilization validation was conducted on the Cobra Catheter System and demonstrated a sterility assurance level of 10-6.

Biocompatibility Testing

Biocompatibility testing was conducted per the requirements of ISO-10993-1, Biological Evaluation of Medical Devices.

The tests concluded that there is no chemical, toxicological, or safety risks from the Cobra Catheter System components, manufacturing procedures and sterilization process and the device is considered biocompatible for its intended use as ISO 10993-1 category: externally communicating device, limited