Cobra Catheter System
Device Facts
| Record ID | K223891 |
|---|---|
| Device Name | Cobra Catheter System |
| Applicant | Endovascular Engineering |
| Product Code | QEW · Cardiovascular |
| Decision Date | Feb 15, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Minimally invasive aspiration catheter system for venous thrombus removal; utilizes expanding distal funnel for clot capture; features integrated handle with slider for manual funnel deployment; includes agitator for mechanical clot disruption within catheter lumen; connects to external vacuum pump for aspiration; compatible with 0.035"/0.038" guidewires; used in peripheral vasculature; operated by physicians under fluoroscopic guidance; provides mechanical maceration and suction to re-establish blood flow; benefits patients by enabling minimally invasive removal of obstructive clots.
Clinical Evidence
Bench testing only; no human clinical data. Bench studies included visual/dimensional inspection, sheath compatibility, deployment/retraction force, vacuum compatibility, trackability, simulated use, durability, heat generation, and biocompatibility (ISO 10993-1). Electrical safety/EMC testing per IEC 60601-1/2. Animal study conducted per 21 CFR Part 58 showed performance and pathologic responses similar to control device.
Technological Characteristics
Single-use, sterile (EtO), catheter-based system. Components: aspiration catheter with distal expanding funnel, agitator, rotating hemostasis valve (Tuohy-Borst), and dilator. Compatible with 16Fr introducer sheath. Materials biocompatible per ISO 10993-1. Mechanical sensing/actuation via manual handle controls and external vacuum pump. Complies with IEC 60601-1 and IEC 60601-2.
Indications for Use
Indicated for non-surgical removal of emboli and thrombi from venous vasculature and for injection, infusion, or aspiration of fluids/contrast media in the venous vasculature. No specific age or gender restrictions provided.
Regulatory Classification
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.
Predicate Devices
- ClotTriever Thrombectomy System (K212632)
Reference Devices
- Cleaner Plus Thrombectomy System (K211798)
Submission Summary (Full Text)
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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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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# 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) | |
|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 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 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.
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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 |
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| 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 | | | | |
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| Characteristic | Subject Device | Primary Predicate | Reference Predicate |
|----------------|----------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | • Handpiece Motor & Battery<br>Performance<br>• Pump Battery Performance<br>• Handpiece - Functionality<br>• Handpiece – Peel-away<br>Introducer<br>• Luer Dimensional<br>• Radiopacity<br>• Functional, Performance,<br>and Software Testing<br>• 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 < 24-hour contact with circulating blood exposure.
## Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted on the Cobra Catheter System and complies with IEC 60601-1 and IEC 60601-2.
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### Animal Testing
The Cobra Catheter System was subjected to an animal study was conducted per the US Food and Drug Administration, 21 CFR, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies. The Cobra Catheter System and control device showed similar results of performance evaluations, post-treatment and interim angiographies, animal health conditions, and pathologic responses.
### VIII. CONCLUSIONS
The Cobra Catheter System and its predicate devices have the same intended use and similar technological characteristics. The differences do not raise different questions of safety or effectiveness. Performance testing further demonstrates that the device is substantially equivalent to the predicate devices for its intended use.
