CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
Device Facts
| Record ID | K241221 |
|---|---|
| Device Name | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set |
| Applicant | Cerenovus, Inc. |
| Product Code | NRY · Cardiovascular |
| Decision Date | Oct 16, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter of a compatible aspiration pump and to allow the user to control the fluid flow.
Device Story
Variable stiffness, single-lumen intermediate catheters; used for thrombus removal from neurovasculature via continuous aspiration. Input: vacuum pressure from external pump (-68 to -95 kPa). Operation: catheter navigated over steerable guidewire/microcatheter into neurovasculature; aspiration applied via Cerenovus Aspiration Tubing Set with integrated flow control switch. Output: thrombus removal. Used in clinical settings by physicians. Benefits: revascularization of occluded vessels in acute ischemic stroke patients. Features: stainless-steel braid, PTFE inner liner, hydrophilic coating, radiopaque marker band. Accessories: Tuohy Borst Rotating Hemostasis Valve, slit introducers.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including visual inspection, dimensional verification, leakage testing, kink resistance, tip stiffness, tensile strength, particulate count, coating integrity, burst pressure, torque strength, trackability, and in vitro usability studies for thrombus retrieval patency and accessory compatibility.
Technological Characteristics
Variable stiffness single-lumen catheter; stainless-steel braid reinforcement; PTFE inner liner; Pebax/urethane/nylon outer jacket; hydrophilic coating; radiopaque platinum/iridium marker band. Dimensions: 0.042"/0.057" ID. Sterilization: 100% Ethylene Oxide (ISO 11135). Connectivity: manual connection to external vacuum pump via tubing set. Single-use.
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, vertebral arteries) within 8 hours of symptom onset. Candidates include patients ineligible for or who failed thrombolytic drug 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
- Zenith Flex Aspiration System (046 Zenith Flex Catheter) (K190338)
Reference Devices
- CEREGLIDE 71 Intermediate Catheter (K221934)
Related Devices
- K221934 — CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set · Cerenovus, Inc. · Mar 9, 2023
- K233988 — Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set · Cerenovus, Inc. · Jan 17, 2024
- K193380 — CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set · Codman & Shurtleff, Inc. · Jul 20, 2020
- K234083 — Next Generation Aspiration Catheter; Balt Aspiration Tubing Set · Balt USA, LLC · Jul 2, 2024
- K251015 — APRO 45 Catheter and Alembic Aspiration Tubing · Alembic, LLC · Apr 30, 2025
Submission Summary (Full Text)
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October 16, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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. Cara Feely Regulatory Affairs Manager 6303 Waterford District Drive, Suites 215 & 315 Miami, Florida 33126
### Re: K241221
Trade/Device Name: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: September 2, 2024 Received: September 13, 2024
Dear Cara Feely:
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.
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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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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
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### Indications for Use
510(k) Number (if known) K241221
Device Name CEREGLIDE 42 Intermediate Catheter CEREGLIDE 57 Intermediate Catheter Cerenovus Aspiration Tubing Set
#### Indications for Use (Describe)
The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42 Intermediate Catheter of a compatible aspiration pump and to allow the user to control the fluid flow.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary – K241221
### I. Submitter
Cerenovus, Inc. 6303 Waterford District Drive, Suites 215 & 315 Miami, FL 33126 United States
Contact Person: Cara Feely (Regulatory Affairs Manager) Tel: 00353863335253 Email: Cfeely@its.jnj.com
II. Date Prepared
October 14, 2024
### III. Device Information
| Table 1. Device Information | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name | CEREGLIDE™ 42 Intermediate Catheter<br>CEREGLIDE™ 57 Intermediate Catheter<br>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 |
### IV. Predicate Device
The primary predicate device is listed below in Table 2.
Information
| Table 2. Primary Predicate Device | | | |
|-----------------------------------|----------------|-------------------------------------------------------------|-----------------|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K190338 | August 2, 2019 | Zenith Flex Aspiration System<br>(046 Zenith Flex Catheter) | InNeuroCo, Inc. |
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| V. Device Description | Both the CEREGLIDE <sup>TM</sup> 42 Intermediate Catheter and CEREGLIDE <sup>TM</sup> 57 Intermediate Catheter are variable stiffness, single lumen catheters 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 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 CEREGLIDE <sup>TM</sup> 42 Intermediate Catheter and the CEREGLIDE <sup>TM</sup> 57 Intermediate Catheter are designed for use in the removal of thrombus from the neurovasculature using continuous aspiration from an external vacuum source. The CEREGLIDE <sup>TM</sup> 42 Intermediate Catheter and CEREGLIDE <sup>TM</sup> 57 Intermediate Catheter are intended to be used with a compatible aspiration pump as a vacuum source that provides a minimum vacuum pressure of -68 kPa [-20 inHg] and a maximum vacuum pressure of -95 kPa [-28 inHg], and minimum 17 L/min flow rate, with a collection canister of at least 1000 mL volume. |
| | The CEREGLIDE <sup>TM</sup> 42 Intermediate Catheter and the CEREGLIDE <sup>TM</sup> 57 Intermediate Catheter are intended to be connected to the vacuum source using the Cerenovus Aspiration Tubing Set which is an externally manufactured tubing set with an internal diameter (ID) of 0.110" and overall length of 112", containing an integrated flow control switch. |
| VI. Indications for Use | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE <sup>TM</sup> 71, 57 or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. |
| VII. Predicate Comparison | A comparison of the similarities and differences of product features between the CEREGLIDE <sup>TM</sup> 42 Intermediate Catheter, the CEREGLIDE <sup>TM</sup> 57 Intermediate Catheter, and the predicate device are presented in Table 3. |
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| Table 3. Predicate and Subject Device Comparison | | | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Description | Predicate Device:<br>Zenith Flex Aspiration<br>System (046 Zenith Flex<br>Catheter) (K190338) | Subject Device:<br>CEREGLIDE™ 42<br>Intermediate Catheter;<br>Cerenovus Aspiration<br>Tubing Set | Subject Device:<br>CEREGLIDE™ 57<br>Intermediate Catheter;<br>Cerenovus Aspiration<br>Tubing Set |
| Indications For<br>Use | The Zenith Flex Aspiration System,<br>including the 046 Zenith Flex Catheter,<br>Aspiration Tubing Set, and VC-701<br>Cliq Aspirator Pump, is indicated in the<br>revascularization of patients with acute<br>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 symptom<br>onset. Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who failed IV t-<br>PA therapy are candidates for<br>treatment. | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE<br>57 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set<br>and a compatible aspiration pump, are indicated for use in the<br>revascularization of patients with acute ischemic stroke secondary<br>to intracranial large vessel occlusive disease (within the internal<br>carotid, middle cerebral - M1 and M2 segments, basilar, and<br>vertebral arteries) within 8 hours of symptom onset. Patients who<br>are ineligible for thrombolytic drug therapy or who failed<br>thrombolytic drug therapy are candidates for treatment.<br>The Cerenovus Aspiration Tubing Set is intended to connect the<br>Cerenovus Large Bore Catheter or the CEREGLIDE™ 71, 57 or 42<br>Intermediate Catheter to the canister of a compatible aspiration<br>pump and to allow the user to control the fluid flow. | |
| Product Code | NRY | Same as predicate | Same as predicate |
| Regulatory<br>Name | Percutaneous Catheter | Same as predicate | Same as predicate |
| Classification | Class II - 21 CFR 870.1250 | Same as predicate | Same as predicate |
| Basic Design | Variable stiffness single lumen<br>catheter | Same as predicate | Same as predicate |
| Length | 153 cm<br>160 cm | 115 cm<br>125 cm<br>132 cm<br>144 cm<br>152 cm<br>160 cm | 115 cm<br>125 cm<br>132 cm<br>137 cm |
| Inner Diameter<br>(ID) | 0.046" | 0.042" | 0.057" |
| Distal Outer<br>Diameter (OD) | 0.056" | 0.053"<br>(1.35 mm) | 0.068"<br>(1.73 mm) |
| Proximal OD | 0.058" | 0.0535"<br>(1.36 mm) | 0.0685"<br>(1.74 mm) |
| Catheter Coating | Hydrophilic | Hydrophilic | Hydrophilic |
| Coating Length | Not Specified | 55 cm | 55 cm |
| Tip<br>Configuration | Not Specified | Non-shapeable tip | Non-shapeable tip |
| Marker Band | Platinum/ Iridium | Same as predicate | Same as predicate |
| Braid | Stainless Steel/Nitinol | Stainless Steel | Stainless Steel |
| Liner | PTFE Liner | Same as predicate | Same as predicate |
| Hub | Polycarbonate | Same as predicate | Same as predicate |
| Strain Relief | Polyolefin | Same as predicate | Same as predicate |
| Outer Jacket | Polyether Block Amide (Pebax),<br>Urethane, Nylon | Same as predicate | Pebax, Urethane |
| Hemostasis Valve | Included | Same as predicate | Same as predicate |
| Introducer<br>Sheath | Peel-Away Introducer | Slit Introducer (2) | Slit Introducer (2) |
| Sterilization<br>Method | Ethylene Oxide | Same as predicate | Same as predicate |
| Sterility<br>Assurance Level<br>(SAL) | Not Specified | $10^{-6}$ | $10^{-6}$ |
| Packaging | Tyvek/Nylon Pouch, polyethylene<br>support tube, packaging card, SBS<br>carton | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton |
| Shelf Life | Not Specified | 3 years | 3 years |
| Table 3. Predicate and Subject Device Comparison | | | |
| Description | Predicate Device:<br>Zenith Flex<br>Aspiration System (046<br>Zenith Flex Catheter)<br>(K190338) | Subject Device:<br>CEREGLIDE™ 42<br>Intermediate Catheter;<br>Cerenovus Aspiration Tubing<br>Set | Subject Device:<br>CEREGLIDE™ 57<br>Intermediate Catheter;<br>Cerenovus Aspiration<br>Tubing Set |
| Required<br>Additional<br>Accessories | Vacuum Pump,<br>Aspiration Tubing | Cerenovus Aspiration Tubing Set<br>Compatible Aspiration Pump | |
| Minimum<br>Aspiration<br>Pressure | -22 inHg | -20 inHg (-68 kPa) | |
| Maximum<br>Aspiration<br>Pressure | -28 inHg | -28 inHg (-95 kPa) | |
| Flowrate (Air) | Not Specified | 0 to 60LPM | |
| Tubing ID | Not Specified | 0.110 in minimum | |
| Tubing Length | Not Specified | 112 in | |
| Flow Control<br>Mechanism | Not Specified | Flow Control Switch | |
Continued on the next page
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### VIII. Non-Clinical Performance Data
### Performance Testing - Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter to demonstrate that they are substantially equivalent to the legally marketed predicate device. The following performance data are being provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by internal procedure. The bench testing included the following tests:
| Table 4. Performance Testing Summary | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Test | Test Summary | Result |
| Design Verification | | |
| Visual<br>Inspection | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57<br>Intermediate Catheters meet the visual requirement described in<br>ISO 10555-1 Section 4.4. | PASS:<br>Samples met the established<br>acceptance criteria |
| Catheter ID…
