(50 days)
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.
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.
The provided text describes the Cobra Catheter System and its associated studies for FDA 510(k) clearance. However, it does not contain specific acceptance criteria or quantitative performance metrics for the device. The information focuses on bench testing, sterilization, biocompatibility, electrical safety, and an animal study, all of which confirm the device performs as intended and is safe, but without numerical targets or results for specific clinical or performance endpoints.
Therefore, many of the requested sections regarding acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted directly from this document.
Here's an analysis of what can be extracted:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document in a quantitative format. The document states that "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." However, it does not elaborate on what these "performance standards" are or the numerical results of the device's performance against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Animal Study: An animal study was conducted. The sample size is not explicitly stated, nor is the country of origin. It is prospective by nature of being an "animal study."
- For other bench tests (e.g., Visual and Dimensional Inspection, Sheath Compatibility, Durability, etc.), sample sizes are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided as the document does not detail clinical or human-read imaging studies that would require expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided as there is no mention of a human-read test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was mentioned. The device described is a physical medical device (catheter system), not an AI/software device intended for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance was mentioned. The device described is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the animal study, "post-treatment and interim angiographies, animal health conditions, and pathologic responses" were used to evaluate performance, suggesting outcomes data and potentially expert assessment of angio/pathology results. For bench tests, physical measurements and adherence to engineering specifications served as the "ground truth."
8. The sample size for the training set:
This information is not applicable/provided as the document describes a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/provided for the same reason as above.
Summary of available information:
The FDA 510(k) summary for the Cobra Catheter System (K223891) describes a physical medical device used for thrombus and emboli removal from venous vasculature. The clearance is based on substantial equivalence to predicate devices and extensive non-clinical testing.
The document does not contain specific acceptance criteria with numerical targets and reported device performance in the way one might expect for a diagnostic or algorithmic device. Instead, it lists comprehensive bench tests confirming the device's functional integrity and safety characteristics.
Table of Acceptance Criteria and Reported Device Performance (based on provided text):
| Test Category | Acceptance Criteria/Requirement | Reported Device Performance |
|---|---|---|
| Functional/Mechanical Performance | Performs as intended; Conforms to design inputs; Meets performance standards for peripheral vascular embolectomy devices for: 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. | "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." (Specific numerical results are not provided). |
| Sterilization | Achieves a sterility assurance level (SAL) of 10^-6. | "Sterilization validation was conducted on the Cobra Catheter System and demonstrated a sterility assurance level of 10^-6." |
| Biocompatibility | Compliant with ISO 10993-1 for biological evaluation of medical devices; No chemical, toxicological, or safety risks for intended use (externally communicating device, limited < 24-hour contact with circulating blood exposure). | "Biocompatibility testing was conducted per the requirements of ISO-10993-1... The tests concluded that there is no chemical, toxicological, or safety risks... and the device is considered biocompatible for its intended use..." |
| Electrical Safety & EMC | Compliant with IEC 60601-1 and IEC 60601-2. | "Electrical safety and EMC testing was conducted on the Cobra Catheter System and complies with IEC 60601-1 and IEC 60601-2." |
| Animal Study | Similar performance evaluations, post-treatment and interim angiographies, animal health conditions, and pathologic responses compared to a control device. | "The Cobra Catheter System and control device showed similar results of performance evaluations, post-treatment and interim angiographies, animal health conditions, and pathologic responses." The study adhered to "21 CFR, Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies." (Specific quantitative equivalence metrics are not provided). |
In summary, the provided document focuses on confirming the safety and functional performance of a physical medical device through a variety of non-clinical tests, rather than detailing clinical performance metrics commonly associated with AI/software medical devices.
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 & BatteryPerformance• Pump Battery Performance• Handpiece - Functionality• Handpiece – Peel-awayIntroducer• 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 < 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.
§ 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).