CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set

K193380 · Codman & Shurtleff, Inc. · NRY · Jul 20, 2020 · Cardiovascular

Device Facts

• Record ID: K193380
• Device Name: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
• Applicant: Codman & Shurtleff, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Jul 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA are candidates for treatment. The CERENOVUS® Aspiration Tubing Set is intended to connect the CERENOVUS Large Bore Catheter to the canister of the NOUVAG Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

Device Story

Variable stiffness, single-lumen catheter designed for neurovascular access; introduced over steerable guidewire/microcatheter. Input: vacuum pressure from external pump (e.g., NOUVAG Vacuson 60) via aspiration tubing set. Operation: catheter tracks to target site under fluoroscopic guidance; aspiration applied to remove thrombus/clot. Output: restored blood flow in occluded intracranial vessels. Used in clinical/interventional settings by physicians. Healthcare provider uses fluoroscopy for navigation and monitors aspiration flow via tubing switch. Benefits: mechanical revascularization for acute ischemic stroke patients.

Clinical Evidence

No clinical studies performed. Evidence based on bench testing (visual, dimensional, mechanical integrity, flow rate, aspiration performance, coating durability) and GLP-compliant porcine animal model studies comparing subject device to predicate.

Technological Characteristics

Variable stiffness single-lumen catheter; stainless steel braid reinforcement; PTFE inner liner; Pebax/Urethane/Nylon outer jacket; hydrophilic coating (30 cm). Distal radiopaque marker (90% Platinum/10% Iridium). Dimensions: 125-135 cm length, 0.071" ID. Sterilization: 100% Ethylene Oxide (SAL 10^-6). Connectivity: Luer fitting for aspiration pump connection.

Indications for Use

Indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, and vertebral arteries) within 8 hours of symptom onset. Candidates include patients ineligible for or who failed IV t-PA.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Penumbra System ACE 68 Reperfusion Catheter (K161064)

Reference Devices

• CERENOVUS Large Bore Catheter (K191237)

Submission Summary (Full Text)

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July 20, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Codman & Shurtleff, Inc. Kirsten Franco, MS, RAC Associate Director of Regulatory Affairs 325 Paramount Drive Raynham, MA 02767

## Re: K193380

Trade/Device Name: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 21, 2020 Received: April 22, 2020

# Dear Kirsten Franco:

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K193380

Device Name

CERENOVUS Large Bore Catheter; CERENOVUS® Aspiration Tubing Set

#### Indications for Use (Describe)

The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing Set and NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA are candidates for treatment.

The CERENOVUS® Aspiration Tubing Set is intended to connect the CERENOVUS Large Bore Catheter to the canister of the NOUVAG Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

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

| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary K193380

Pursuant to the requirements of 21 CFR Section 807.92(c), this 510(k) summary is provided as part of this Premarket Notification containing sufficient details to understand the basis for a determination of substantial equivalence.

| Submitter | Codman & Shurtleff, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kirsten Franco<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | July 15, 2020 |
| Device Trade<br>or Proprietary<br>Name | CERENOVUS Large Bore Catheter<br>CERENOVUS® Aspiration Tubing Set |
| Device<br>Classification | Regulatory Classification: II<br>Common or Usual Name: Catheter, Thrombus Retriever<br>Classification Name: Percutaneous Catheter<br>Regulation Number: 21 CFR 870.1250<br>Product Code: NRY<br>Classification Panel: Neurology |

| Predicate Device | Primary Predicate Device |
|------------------|--------------------------|
|------------------|--------------------------|

| | 510(k)<br>Number | Date Cleared | Device Name | Manufacturer |
|--|------------------|---------------|------------------------------------------------|----------------|
| | K161064 | June 12, 2016 | Penumbra System ACE 68<br>Reperfusion Catheter | Penumbra, Inc. |

| | Reference Predicate Device |
|--|----------------------------|
|--|----------------------------|

| | 510(k)<br>Number | Date Cleared | Device Name | Manufacturer |
|--|------------------|--------------|----------------------------------|-----------------------------|
| | K191237 | Nov 8, 2019 | CERENOVUS Large Bore<br>Catheter | Medos International<br>SARL |

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| Device<br>Description | The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter<br>designed to be introduced over a steerable guide wire or microcatheter into the neuro<br>vasculature. The catheter shaft is composed of a stainless steel variable pitch braid<br>with a PTFE inner liner to facilitate movement of guide wires and other devices. The<br>exterior of the catheter shaft is covered with polymer materials, which encapsulate<br>the stainless steel braid construction. The catheter has a stiff proximal shaft which<br>transitions into the flexible distal shaft to facilitate the advancement of the catheter in<br>the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate<br>fluoroscopic visualization and has a hydrophilic coating to provide lubricity for<br>navigation of vessels. The proximal end of the catheter has a luer fitting located on<br>the end of the catheter hub which can be used to attach accessories for flushing and<br>aspiration. An ID band is placed at the distal end of the hub over a strain relief. The<br>catheter is packaged with a hemostasis valve with a side port and two peel-away<br>introducers as accessories. The hemostasis valve with side port is used for flushing,<br>insertion of catheters, and connection to an external aspiration system. The peel<br>away introducer sheaths are designed to protect the distal tip of the catheter during<br>insertion into the hemostasis valve.<br>The CERENOVUS Large Bore Catheter can be connected to the NOUVAG Vacuson<br>60 aspiration pump (or equivalent aspiration pump) using the CERENOVUS®<br>Aspiration Tubing Set. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The CERENOVUS Large Bore Catheter, with the CERENOVUS® Aspiration Tubing<br>Set and NOUVAG Vacuson 60 aspiration pump (or equivalent aspiration pump), is<br>indicated for use in the revascularization of patients with acute ischemic stroke<br>secondary to intracranial large vessel occlusive disease (within the internal carotid,<br>middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours<br>of symptom onset. Patients who are ineligible for intravenous tissue plasminogen<br>activator (IV t-PA) or who failed IV t-PA are candidates for treatment.<br>The CERENOVUS® Aspiration Tubing Set is intended to connect the CERENOVUS<br>Large Bore Catheter to the canister of the NOUVAG Vacuson 60 Aspiration Pump<br>(or equivalent vacuum pump) and to allow the user to control the fluid flow. |
| Predicate<br>Comparison | A comparison of the similarities and differences of product features between the<br>CERENOVUS Large Bore Catheter and the primary predicate device is presented in |

# Table 1.

| Description | Subject Device:<br>CERENOVUS Large Bore Catheter | Primary Predicate Device:<br>ACE 68 Reperfusion Catheter<br>(K161064) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | NRY | Same |
| Regulatory Name | Catheter, Percutaneous | Same |
| Classification | Class II - 21 CFR 870.1250 | Same |
| Basic Design | Variable stiffness single lumen catheter | Same |
| Description | Subject Device:<br>CERENOVUS Large Bore Catheter | Primary Predicate Device:<br>ACE 68 Reperfusion Catheter<br>(K161064) |
| Indications For Use | The CERENOVUS Large Bore Catheter, with the<br>CERENOVUS® Aspiration Tubing Set and NOUVAG<br>Vacuson 60 aspiration pump (or equivalent aspiration<br>pump), is indicated for use in the revascularization of<br>patients with acute ischemic stroke secondary to<br>intracranial large vessel occlusive disease (within the<br>internal carotid, middle cerebral - M1 and M2 segments,<br>basilar, and vertebral arteries) within 8 hours of<br>symptom onset. Patients who are ineligible for<br>intravenous tissue plasminogen activator (IV t-PA) or<br>who failed IV t-PA are candidates for treatment.<br><br>The CERENOVUS® Aspiration Tubing Set is intended<br>to connect the CERENOVUS Large Bore Catheter to the<br>canister of the NOUVAG Vacuson 60 Aspiration Pump<br>(or equivalent vacuum pump) and to allow the user to<br>control the fluid flow. | The Penumbra System is intended for use in<br>the revascularization of patients with acute<br>ischemic stroke secondary to intracranial<br>large vessel occlusive disease (within the<br>internal carotid, middle cerebral – M1 and<br>M2 segments, basilar, and vertebral<br>arteries) within 8 hours of symptom onset. |
| Dimensions: | | |
| Length | 125 - 135 cm | 115 – 132 cm |
| ID | 0.071" | 0.068" |
| Distal OD | 0.081" | 0.084" |
| Proximal OD | 0.0825" | 0.084" |
| Catheter Coating | Hydrophilic | Hydrophilic |
| Coating Length | 30 cm | Same |
| Materials: | | |
| Marker Band | Metal Platinum (90%) / Iridium (10%) | Same |
| Braid | Stainless Steel | Stainless Steel, Nitinol |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Polyamide |
| Strain Relief | Polyamide | Polyamide, Stainless Steel |
| Outer Jacket | Pebax, Urethane, Nylon | Same |
| Tip Configuration | Non-shapeable tip | Steam shapeable by user |
| Accessories Included: | | |
| Hemostasis valve | Hemostasis Valve with Side Port Extension<br>Tubing | Rotating Hemostasis Valve |
| Introducer<br>Sheath | Peel-Away Sheath Introducer (2) | Peelable Sheath |
| Shaping | N/A | Shaping Mandrel 0.038" SST |
| Sterilization<br>Method | Ethylene Oxide | Same |
| Sterility Assurance<br>Level (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Pouch,<br>Carton | Same |
| Shelf Life | 1 year | 8 months |
| Required<br>Additional<br>Accessories | CERENOVUS Aspiration Tubing<br>NOUVAG Vacuson 60 Pump | Penumbra Hi-Flow Tubing<br>Penumbra Pump MAX |
| Aspiration Pump Requirements | | |
| Minimum<br>Aspiration Pressure | -20 inHg (-68 kPa) | Same |
| Maximum<br>Aspiration Pressure | -29 inHg (-98 kPa) | Same |
| Flowrate (Air) | 0 to 60LPM | 0 to 23 LPM |
| Aspiration Tubing Requirements | | |
| Tubing ID | 0.110 in minimum | Same |
| Tubing Length | 112 in | Same |
| Flow Control<br>Mechanism | Flow Control Switch | Same |

Table 1. Subject and Predicate Device Comparison Summary

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## Non-Clinical Testing Summary

#### Performance Testing - Bench

Appropriate testing was identified based on design, risk analyses and the intended use of the CERENOVUS Large Bore Catheter to demonstrate that it is substantially equivalent to the legally marketed Predicate device. The following performance data has been provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures. The bench testing included the following tests:

| Test | Test Summary | Result |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Visual Inspection | Confirm that the CERENOVUS Large Bore Catheter meets the visual requirement described in ISO 10555-1 Section 4.4 | PASS:<br>Samples met the established acceptance criteria |
| Catheter ID | Verify that the catheter internal diameters meet the requirements | PASS:<br>Samples met the established acceptance criteria |
| Introducer ID | Verify that the introducer internal diameters meet the requirements | PASS:<br>Samples met the established acceptance criteria |
| Catheter OD | Verify that the catheter outer diameters meet the requirements | PASS:<br>Samples met the established acceptance criteria |
| Introducer OD | Verify that the introducer outer diameters meet the requirements | PASS:<br>Samples met the established acceptance criteria |
| Catheter Working Length | Confirm the working length of a catheter as defined in ISO10555-1 Section 3.6. | PASS:<br>Samples met the established acceptance criteria |
| Introducer Working Length | Confirm the working length of the introducer | PASS:<br>Samples met the established acceptance criteria |
| Distal Tip Length | Verify the distal tip length of the catheter | PASS:<br>Samples met the established acceptance criteria |
| Hub Luer Taper | Verify that the catheter hub luer taper fit standard luer fittings using a taper device | PASS:<br>Samples met the established acceptance criteria |
| Air Leak testing | Verify that there is no air leak into the hub subassembly | PASS:<br>Samples met the established acceptance criteria |
| System Liquid Leakage | Verify that the catheter joint strength meets the freedom from leakage (liquid during pressurization) requirements of ISO 10555-1:2013, section 4.7 | PASS:<br>Samples met the established acceptance criteria |
| Delamination of PTFE Liner | Verify that the PTFE has appropriately adhered to the inner lumen of the catheter with braid reinforcement | PASS:<br>Samples met the established acceptance criteria |
| Kink (Distal & Proximal) | Confirm that the CERENOVUS Large Bore Catheter meets the requirement for the catheter to remain stable and not kink during use | PASS:<br>Samples met the established acceptance criteria |
| Tip Movement | Confirm that the CERENOVUS Large Bore Catheter meets the tip column stiffness requirement | PASS:<br>Samples met the established acceptance criteria |
| Tip Linear Stiffness | Test the tip flexibility of the CERENOVUS Large Bore catheter, relative to other devices of similar design | PASS:<br>Samples met the established acceptance criteria |
| Coating Lubricity & Durability | Verify the lubriciousness and durability of the catheter hydrophilic coating | PASS:<br>Samples met the established acceptance criteria |
| Coating Length | Verify that the catheter hydrophilic coating<br>length meets the design requirements | PASS:<br>Samples met the established<br>acceptance criteria |
| Catheter Tensile<br>Strength | Verify that the catheter joint strength meets the<br>requirements of Section 4.5 of ISO 10555-1 | PASS:<br>Samples met the established<br>acceptance criteria |
| Introducer<br>Separation Force | Confirm the force required to separate the peel-<br>away introducer accessory | PASS:<br>Samples met the established<br>acceptance criteria |
| Particle Count | Verify that the coating integrity of the catheter's<br>outer surface meets the requirements for content<br>of Particle Matter in alignment with USP<788>. | PASS:<br>Samples met the established<br>acceptance criteria |
| Burst Pressure<br>(static) | Confirm the maximum hydrostatic pressure a<br>catheter can withstand using a Crescent<br>Hydraulic Burst-leak Tester | PASS:<br>Samples met the established<br>acceptance criteria |
| Static Flow Rate | Determine the flow rate through a catheter | PASS:<br>Samples met the established<br>acceptance criteria |
| Aspiration Flow<br>Rate | Determine the aspiration flow rate through a<br>catheter when the catheter is connected to a<br>constant vacuum source. | PASS:<br>Samples met the established<br>acceptance criteria |
| In-vitro Usability<br>Studies | Evaluate catheter trackability, tip stability and<br>visibility under fluoroscopy, aspiration<br>integrity, ability to aspirate emboli/clot to<br>restore flow and the durability, Subject and<br>Predicate devices were tracked to the target site<br>with the provided accessories to perform<br>simulated neurothrombectomy procedure in the<br>neurovascular model that replicates the<br>tortuosity, diameter and location of the arteries<br>in the neurovasculature. | PASS:<br>Samples met the<br>established acceptance<br>criteria |

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