CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set

K221934 · Cerenovus, Inc. · NRY · Mar 9, 2023 · Cardiovascular

Device Facts

• Record ID: K221934
• Device Name: CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
• Applicant: Cerenovus, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Mar 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible 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 fail IV t-PA therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

Device Story

Variable stiffness, single-lumen catheter; designed for navigation through neurovasculature over steerable guidewire/microcatheter. Input: manual navigation by physician; aspiration vacuum source. Operation: catheter advanced to occlusion site; aspiration applied via compatible pump to remove thrombus. Output: revascularization of occluded vessel. Used in clinical/interventional settings by physicians. Benefits: restoration of blood flow in acute ischemic stroke patients. Features: stainless steel braid, PTFE liner, hydrophilic coating, radiopaque marker band. Accessories: Tuohy Borst hemostasis valve, slit introducers, aspiration tubing set.

Clinical Evidence

Bench testing only. No clinical data. Verification included visual inspection, dimensional analysis, leakage testing, kink resistance, tip stiffness, coating lubricity/durability, tensile strength, particulate count, burst pressure, and torque testing. In vitro usability studies confirmed thrombus retrieval patency, durability, and trackability. Biocompatibility testing (ISO 10993-1) included cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, and thromboresistance.

Technological Characteristics

Variable stiffness single-lumen catheter. Materials: stainless steel braid, PTFE inner liner, Pebax/Urethane outer jacket, Platinum/Iridium marker band. Hydrophilic coating. Dimensions: 115-137cm length, 0.071" ID. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: Luer fitting for aspiration pump connection. No software/electronics.

Indications for Use

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

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

• CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (K193380)

Reference Devices

• SOFIA Plus Aspiration Catheter (K173200)

Submission Summary (Full Text)

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March 9, 2023

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.

Cerenovus, Inc. Ariell Joiner, Ph.D. Manager, Regulatory Affairs 6303 Blue Lagoon Drive, Suite 315 Miami. Florida 33126

Re: K221934

Trade/Device Name: CEREGLIDE 71 Intermediate Catheter: Cerenovus Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: February 2, 2023 Received: February 3, 2023

Dear Ariell Joiner:

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-reporting-

combination-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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director 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) K221934

#### Device Name

CEREGLIDE™ 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set

#### Indications for Use (Describe)

CEREGLIDE™ 71 Intermediate Catheter

The CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible 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 fail IV t-PA therapy are candidates for treatment.

### Cerenovus Aspiration Tubing Set

The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

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

| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary K221934

# I. Submitter Cerenovus, Inc. 6303 Blue Lagoon Drive Suites 215 & 315 Miami, FL 33126 USA Contact Person: Ariell Joiner

Tel: [phone] Email: [e-mail]

II. Date Prepared

March 8, 2023

### III. Device Information

| Table 1. Device Information | |
|-----------------------------|-------------------------------------------------------------------------|
| Device Proprietary Name | CEREGLIDE™ 71 Intermediate Catheter; Cerenovus<br>Aspiration Tubing Set |
| Common or Usual name | Catheter, Thrombus Retriever |
| Classification Name | 21 CFR 870.1250 - Catheter, Percutaneous |
| Regulatory Classification | II |
| FDA Product Code | NRY |

## IV. Predicate Device Information

The primary predicate device is listed below in Table 2 and the reference device is listed in Table 3.

| Table 2. Primary Predicate Device | | | |
|-----------------------------------|---------------|----------------------------------------------------------------------|------------------------------|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K193380 | July 20, 2020 | CERENOVUS Large Bore<br>Catheter; CERENOVUS<br>Aspiration Tubing Set | Medos International<br>SARL* |

| Table 3. Reference Device | | | |
|---------------------------|---------------|-----------------------------------|--------------------|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K173200 | June 11, 2018 | SOFIA Plus Aspiration<br>Catheter | MicroVention, Inc. |

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| V. Device Description | The CEREGLIDETM 71 Intermediate Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the euro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The catheter is packaged with a Tuohy Borst rotating hemostasis valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter. The CEREGLIDET™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set. |
| VI. Indications for Use | The CEREGLIDET™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible 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 fail IV t-PA therapy 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. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDET™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. |

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## VII. Predicate Comparison

A comparison of the similarities and differences of product features between the CEREGLIDE™ 71 Intermediate Catheter, Cerenovus Aspiration Tubing Set and the predicate device is presented in Table 4.

| Table 4. Subject and Predicate Device Comparison Summary | | |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Subject Device:<br>CEREGLIDE™ 71 Intermediate Catheter; Cerenovus<br>Aspiration Tubing Set | Predicate Device:<br>CERENOVUS Large<br>Bore Catheter (K193380) |
| 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 |
| Indications For Use | The CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing<br>Set and a compatible aspiration pump, is indicated for use in the revascularization of<br>patients with acute ischemic stroke secondary to intracranial large vessel occlusive<br>disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar,<br>and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible<br>for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large<br>Bore Catheter to the canister of the Nouvag Vacuson 60 Aspiration Pump (or<br>equivalent vacuum pump) and to allow the user to control the fluid flow. The<br>Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71<br>Intermediate Catheter to the canister of a compatible aspiration pump and to allow the<br>user to control the fluid flow. | The CERENOVUS Large Bore<br>Catheter, with the CERENOVUS<br>Aspiration Tubing Set and<br>NOUVAG Vacuson 60 aspiration<br>pump (or equivalent aspiration<br>pump), is indicated for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary to<br>intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral - M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of sympton<br>onset. Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-<br>PA therapy are candidates for<br>treatment.<br>The CERENOVUS Aspiration<br>Tubing Set is intended to connect<br>the CERENOVUS Large Bore<br>Catheter to the canister of the<br>NOUVAG Vacuson 60 Aspiration<br>Pump (or equivalent vacuum pump)<br>and to allow the user to control the<br>fluid flow. |
| Dimensions: | | |
| Length | 115 - 137cm | 125 - 135cm |
| Inner Diameter (ID) | 0.071" | Same |
| Distal Outer | 0.082" | 0.081 " |
| Diameter (OD) | (0.0825" max) | |
| Proximal OD | 0.0837" max | 0.0825" |
| Catheter Coating | Hydrophilic | Same |
| Coating Length | 55 cm | 30 cm |
| Tip Configuration | Non-shapeable tip | Same |
| Materials: | | |
| Marker Band | Metal Platinum (90%) / Iridium (10%) | Same |
| Braid | Stainless Steel | Same |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Same |
| Strain Relief | | Same |
| Outer Jacket | Pebax and Urethane | Pebax, Urethane, Nylon |
| Table 4. Subject and Predicate Device Comparison Summary, continued | | |
| Description | Subject Device:<br>CEREGLIDE™ 71 Intermediate Catheter; Cerenovus<br>Aspiration Tubing Set | Predicate Device:<br>CERENOVUS Large<br>Bore Catheter (K193380) |
| Accessories Included:<br>Hemostasis Valve | Included: Tuohy Borst Hemostasis Valve with Side Port Extension Tubing | Same |
| Introducer Sheath | Introducer (2) | Peel-Away Sheath Introducer (2) |
| Sterilization Method | Ethylene Oxide | Same |
| Sterility Assurance<br>Level (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Same |
| Shelf Life | 1 year | 1 year |
| Required Additional<br>Accessories | Cerenovus Aspiration Tubing Set (K193380)<br>Compatible aspiration pump | Same |
| Aspiration Pump Requirements:<br>Minimum Aspiration<br>Pressure | -20 inHg (-68 kPa) | Same |
| Maximum Aspiration<br>Pressure | -28 inHg (-95 kPa)…