Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
Device Facts
| Record ID | K233988 |
|---|---|
| Device Name | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set |
| Applicant | Cerenovus, Inc. |
| Product Code | NRY · Cardiovascular |
| Decision Date | Jan 17, 2024 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Cerenovus Large Bore 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 or 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; stainless steel braid with PTFE liner; polymer-encapsulated shaft; hydrophilic coating; radiopaque marker band. Used in neurovasculature for aspiration of thrombi in acute ischemic stroke. Operated by physicians in clinical settings (e.g., neuro-interventional suites). Input: manual navigation over guidewire/microcatheter; vacuum pressure from external aspiration pump. Output: mechanical aspiration of thrombus. Benefits: revascularization of occluded intracranial vessels. Connects to aspiration pump via Aspiration Tubing Set; user controls fluid flow via tubing switch.
Clinical Evidence
Bench testing only. Performance testing included static flow rate and aspiration flow rate verification. All samples met established acceptance criteria. No clinical or animal studies were required.
Technological Characteristics
Variable stiffness single-lumen catheter; stainless steel braid; PTFE inner liner; polymer outer jacket; platinum/iridium (90/10) marker band; hydrophilic coating. Dimensions: 125-135 cm length, 0.071 inch ID, 0.081 inch distal OD. Sterilization: Ethylene Oxide. Connectivity: mechanical connection to external aspiration pump.
Indications for Use
Indicated for revascularization in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, 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
- CEREGLIDE™ 71 Intermediate Catheter
Submission Summary (Full Text)
{0}------------------------------------------------
January 17, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cerenovus, Inc. Ryan Rivera Senior Regulatory Affairs Project Lead 6303 Waterford District Drive, Suites 215 & 315 Miami. Florida 33216
## Re: K233988
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: December 15, 2023 Received: December 18, 2023
## Dear Ryan Rivera:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
{1}------------------------------------------------
2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K233988
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 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 or 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) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
# 510(k) Summary K233988
| Submitter | Cerenovus, Inc.<br>6303 Waterford District Drive<br>Suites 215 & 315<br>Miami, FL 33126 USA | | | | | | | | | | | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|-------------------------|----------------------------------------------------------------|----------------------|------------------------------|---------------------|------------------------------------------|---------------------------|----|------------------|-----|
| Contact | Ryan Rivera<br>Tel: (714) 876-5048<br>Email: rriver82@its.jnj.com | | | | | | | | | | | | |
| Date Prepared | January 12, 2024 | | | | | | | | | | | | |
| Device Trade<br>or Proprietary<br>Name | Cerenovus Large Bore Catheter<br>Cerenovus Aspiration Tubing Set | | | | | | | | | | | | |
| Device<br>Information | <table><tr><th colspan="2">Table 1. Device Information</th></tr><tr><td>Device Proprietary Name</td><td>Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set</td></tr><tr><td>Common or Usual name</td><td>Catheter, Thrombus Retriever</td></tr><tr><td>Classification Name</td><td>21 CFR 870.1250 - Catheter, Percutaneous</td></tr><tr><td>Regulatory Classification</td><td>II</td></tr><tr><td>FDA Product Code</td><td>NRY</td></tr></table> | Table 1. Device Information | | Device Proprietary Name | Cerenovus Large Bore Catheter; Cerenovus 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 |
| Table 1. Device Information | | | | | | | | | | | | | |
| Device Proprietary Name | Cerenovus Large Bore Catheter; Cerenovus 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 | | | | | | | | | | | | |
| Predicate | | | | | | | | | | | | | |
## Device
| 510(k)<br>Number | Date Cleared | Device Name | Manufacturer |
|------------------|--------------|----------------------------------------------------------------------|------------------|
| K193380 | Jul 20, 2020 | CERENOVUS Large Bore<br>Catheter; CERENOVUS<br>Aspiration Tubing Set | Cerenovus, Inc*. |
{4}------------------------------------------------
| 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 with<br>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 the<br>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 the<br>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 away<br>introducer sheaths are designed to protect the distal tip of the catheter during insertion<br>into the hemostasis valve.<br>The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pump<br>using the Cerenovus Aspiration Tubing Set. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Cerenovus Large Bore Catheter, with the Cerenovus Aspiration Tubing Set and a<br>compatible aspiration pump, is indicated for use in the revascularization of patients<br>with acute ischemic stroke secondary to intracranial large vessel occlusive disease<br>(within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and<br>vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for<br>intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are<br>candidates for treatment.<br>The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore<br>Catheter or the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible<br>aspiration 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 predicate device is presented in Table 3. |
| Table 3. Subject and Predicate Device Comparison Summary | | |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device (K193380): | Subject Device (K233988): |
| Description | CERENOVUS Large Bore Catheter;<br>CERENOVUS Aspiration Tubing Set | Cerenovus Large Bore Catheter;<br>Cerenovus Aspiration Tubing Set |
| 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 |
| Table 3. Subject and Predicate Device Comparison Summary | | |
| Description | Predicate Device:<br>CERENOVUS Large Bore Catheter<br>(K193380) | Subject Device (K233988):<br>Cerenovus Large Bore Catheter;<br>Cerenovus Aspiration Tubing Set |
| Indications For Use | The CERENOVUS Large Bore Catheter, with the<br>CERENOVUS® Aspiration Tubing Set and<br>NOUVAG Vacuson 60 aspiration pump (or equivalent<br>aspiration pump), is indicated for use in the<br>revascularization of patients with acute ischemic<br>stroke secondary to intracranial large vessel occlusive<br>disease (within the internal carotid, middle cerebral -<br>M1 and M2 segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset. Patients who are<br>ineligible for intravenous tissue plasminogen activator<br>(IV t-PA) or who failed IV t-PA are candidates for<br>treatment.<br><br>The CERENOVUS® Aspiration Tubing Set is<br>intended to connect the CERENOVUS Large Bore<br>Catheter to the canister of the NOUVAG Vacuson 60<br>Aspiration Pump (or equivalent vacuum pump) and to<br>allow the user to control the fluid flow. | The Cerenovus Large Bore Catheter, with the<br>Cerenovus Aspiration Tubing Set and a<br>compatible aspiration pump, is indicated for use<br>in the revascularization of patients with acute<br>ischemic stroke secondary to intracranial large<br>vessel occlusive disease (within the internal<br>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-<br>PA) or who fail IV t-PA therapy are candidates<br>for treatment.<br><br>The Cerenovus Aspiration Tubing Set is intended<br>to connect the Cerenovus Large Bore Catheter or<br>the CEREGLIDE™ 71 Intermediate Catheter to<br>the canister of a compatible aspiration<br>pump and to allow the user to control the fluid flow. |
| Length | 125 - 135 cm | Same |
| ID | 0.071 inch | Same |
| Distal OD | 0.081 inch | Same |
| Proximal OD | 0.0825 inch | Same |
| Catheter Coating | Hydrophilic | Same |
| Coating Length | 30 cm | Same |
| Marker Band | Metal Platinum (90%) / Iridium (10%) | Same |
| Braid | Stainless Steel | Same |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Same |
| Strain Relief | Pebax, Urethane, Nylon | Same |
| Outer Jacket | | Same |
| Tip Configuration | Non-shapeable tip | Same |
| Hemostasis Valve | Hemostasis Valve with Side Port Extension Tubing | Same |
| Introducer Sheath | Peel-Away Sheath Introducer (2) | Same |
| 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 | Same |
| Required<br>Additional<br>Accessories | CERENOVUS Aspiration Tubing Set<br>NOUVAG Vacuson 60 Pump | Cerenovus Aspiration Tubing Set<br>Compatible Aspiration Pump |
| Aspiration Pump Requirements: | |…
