K Number
K233988
Device Name
Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
Manufacturer
Date Cleared
2024-01-17

(30 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 Description
The Cerenovus Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro 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 for navigation of vessels. 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 hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve. The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
More Information

Not Found

No
The device description focuses on the mechanical and material properties of the catheter and tubing set, with no mention of AI or ML. The performance studies are bench tests evaluating flow rates, not algorithmic performance.

Yes
The device is indicated for use in the revascularization of patients with acute ischemic stroke, which directly treats a disease condition.

No

This device is a catheter and tubing set used for revascularization in acute ischemic stroke, which is a therapeutic intervention, not a diagnostic one. Its purpose is to remove occlusions, not to detect or analyze medical conditions.

No

The device description clearly details physical components like a catheter shaft, stainless steel braid, PTFE inner liner, polymer materials, radiopaque marker band, hydrophilic coating, luer fitting, and accessories like a hemostasis valve and peel-away introducers. This indicates it is a hardware device, not software-only.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a device used for revascularization in patients with acute ischemic stroke. This is a therapeutic intervention performed directly on the patient's vascular system.
  • Device Description: The description details a catheter designed for insertion into the neurovasculature to facilitate the removal of blockages. This is a physical device used for a medical procedure.
  • Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are primarily used for testing samples outside the body to diagnose or monitor diseases.

The device is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

NRY

Device Description

The Cerenovus Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro 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 for navigation of vessels. 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 hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.
The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Testing - Bench:

  • Test: Static Flow Rate; Test Summary: Determine the flow rate through the catheter.; Result: PASS: Samples met the established acceptance criteria.
  • Test: Aspiration Flow Rate; Test Summary: Determine the aspiration flow rate through the catheter when the catheter is connected to a constant vacuum source.; Result: PASS: Samples met the established acceptance criteria.

Animal Testing: N/A - No animal studies were deemed necessary as appropriate verification and validation of the modifications were achieved based on the results of the previously completed bench testing, considering the similarities of the subject and predicate devices.

Shelf-Life Testing: N/A – Changes do not impact the shelf-life of the product.

Biocompatibility Testing: N/A - Changes do not impact biocompatibility.

Sterilization: N/A - Changes do not impact sterilization.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K193380

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).

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)

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3

510(k) Summary K233988

| Submitter | Cerenovus, Inc.
6303 Waterford District Drive
Suites 215 & 315
Miami, FL 33126 USA | | | | | | | | | | | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|-------------------------|----------------------------------------------------------------|----------------------|------------------------------|---------------------|------------------------------------------|---------------------------|----|------------------|-----|
| Contact | Ryan Rivera
Tel: (714) 876-5048
Email: rriver82@its.jnj.com | | | | | | | | | | | | |
| Date Prepared | January 12, 2024 | | | | | | | | | | | | |
| Device Trade
or Proprietary
Name | Cerenovus Large Bore Catheter
Cerenovus Aspiration Tubing Set | | | | | | | | | | | | |
| Device
Information | Table 1. Device InformationDevice Proprietary NameCerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCommon or Usual nameCatheter, Thrombus RetrieverClassification Name21 CFR 870.1250 - Catheter, PercutaneousRegulatory ClassificationIIFDA Product CodeNRY | 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)

NumberDate ClearedDevice NameManufacturer
K193380Jul 20, 2020CERENOVUS Large Bore
Catheter; CERENOVUS
Aspiration Tubing SetCerenovus, Inc*.

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| Device
Description | The Cerenovus Large Bore Catheter is a variable stiffness, single lumen catheter
designed to be introduced over a steerable guide wire or microcatheter into the neuro
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 for
navigation of vessels. 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 hemostasis valve with a side port and two peel-away
introducers as accessories. The hemostasis valve with side port is used for flushing,
insertion of catheters, and connection to an external aspiration system. The peel away
introducer sheaths are designed to protect the distal tip of the catheter during insertion
into the hemostasis valve.
The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pump
using the Cerenovus Aspiration Tubing Set. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Predicate
Comparison | A comparison of the similarities and differences of product features between the
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):
DescriptionCERENOVUS Large Bore Catheter;
CERENOVUS Aspiration Tubing SetCerenovus Large Bore Catheter;
Cerenovus Aspiration Tubing Set
Product CodeNRYSame
Regulatory NameCatheter, PercutaneousSame
ClassificationClass II - 21 CFR 870.1250Same
Basic DesignVariable stiffness single lumen catheterSame
Table 3. Subject and Predicate Device Comparison Summary
DescriptionPredicate Device:
CERENOVUS Large Bore Catheter
(K193380)Subject Device (K233988):
Cerenovus Large Bore Catheter;
Cerenovus Aspiration Tubing Set
Indications For UseThe 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. | 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. |
| 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
Method | Ethylene Oxide | Same |
| Sterility Assurance
Level (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Pouch,
Carton | Same |
| Shelf Life | 1 year | Same |
| Required
Additional
Accessories | CERENOVUS Aspiration Tubing Set
NOUVAG Vacuson 60 Pump | Cerenovus Aspiration Tubing Set
Compatible Aspiration Pump |
| Aspiration Pump Requirements: | | |
| Minimum
Aspiration Pressure | -20 inHg (-68 kPa) | Same |
| Maximum
Aspiration Pressure | -29 inHg (-98 kPa) | Same |
| Flowrate (Air) | 0 to 60 LPM | Same |
| Aspiration Tubing Requirements: | | |
| Tubing ID | 0.110 in minimum | Same |
| Tubing Length | 112 in | Same |
| Flow Control | Flow Control Switch | Same |
| Mechanism | | |

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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 support the proposed change and demonstrate that the subject device is substantially equivalent to the legally marketed predicate device. This testing was previously completed and submitted in K193380.

Table 4. Performance Testing Summary
TestTest SummaryResult
Static Flow RateDetermine the flow rate through the
catheter.PASS:
Samples met the established
acceptance criteria
Aspiration Flow
RateDetermine the aspiration flow rate
through the catheter when the catheter is
connected to a constant vacuum source.PASS:
Samples met the established
acceptance criteria

Animal Testing

N/A - No animal studies were deemed necessary as appropriate verification and validation of the modifications were achieved based on the results of the previously completed bench testing, considering the similarities of the subject and predicate devices.

Shelf-Life Testing

N/A – Changes do not impact the shelf-life of the product.

Biocompatibility Testing

N/A - Changes do not impact biocompatibility.

Sterilization

N/A - Changes do not impact sterilization.

Conclusion Based upon the intended use, design, materials, and function, it is concluded that the subject device, Cerenovus Large Bore Catheter is substantially equivalent to the predicate device, CERENOVUS Large Bore Catheter (K193380). The differences in wording of the Indications for Use statement do not raise any new questions regarding the safety and effectiveness of the device. The subject device, as designed, manufactured, packaged and sterilized, is substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act.