(70 days)
Product code NRY:
The CEREGLIDE 71 Catheter System, 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 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 to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Product code QJP:
The CEREGLIDE 71 Catheter System is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 71 Catheter System is also indicated for use as a conduit for retrieval devices.
The CEREGLIDE™ 71 Catheter System consists of the CEREGLIDE™ 71 Intermediate Catheter and associated accessories including the INNERGLIDE™ 7 Delivery Aid, Rotating Hemostasis Valve, and Slit Introducers.
The CEREGLIDE™ 71 Intermediate Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE inner lumen liner to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets.
These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.
The CEREGLIDE™ 71 Catheter System is packaged with an INNERGLIDE™ 7 Delivery Aid, a Rotating Hemostasis Valve (RHV) with a side port and two Slit Introducer accessories. The INNERGLIDE™ 7 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 71 Catheter System to facilitate delivery of the CEREGLIDE™ 71 Intermediate Catheter to select blood vessels in the neurovasculature. The RHV with side port is used for flushing and insertion of catheters. The Slit Introducers are designed to introduce the CEREGLIDE™ 71 Intermediate Catheter into the base catheter and protect the distal tip of the CEREGLIDE™ 71 Intermediate Catheter during insertion into the hemostasis valve of the base catheter.
Product code NRY: The CEREGLIDE™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
This document is a 510(k) clearance letter for a medical device (CEREGLIDE 71 Catheter System), and does not contain the information requested about acceptance criteria and a study proving a device meets these criteria for an AI/software medical device.
The 510(k) summary explicitly states:
- "No animal studies were required as appropriate verification and validation of the subject device design were achieved based on the similarities of the proposed device and the predicate devices, and from results of bench testing."
- "Clinical studies were not required as appropriate verification and validation of the subject device design were achieved based on the similarities of the proposed device and the predicate devices, and from results of bench testing."
The document details the device's technical specifications, indications for use, and a comparison to predicate devices, along with non-clinical (bench) performance testing. These bench tests are primarily focused on the physical characteristics and performance of the catheter system, such as dimensions, material properties, durability, and a simple in vitro usability study.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not present in the provided document. The device in question is a physical medical catheter system, not an AI/software medical device that would typically involve such studies for regulatory submission.
FDA 510(k) Clearance Letter - CEREGLIDE 71 Catheter System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 22, 2025
Cerenovus, Inc.
Cara Feely
Manager Regulatory Affairs
6303 Waterford District Drive, Suites 215 & 315
Miami, Florida 33126
Re: K251828
Trade/Device Name: CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: NRY, QJP
Dated: June 13, 2025
Received: July 25, 2025
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.
Page 2
K251828 - Cara Feely Page 2
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 (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-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 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K251828 - Cara Feely Page 3
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251828
Device Name: CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
Indications for Use (Describe)
Product Code NRY:
The CEREGLIDE 71 Catheter System, 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 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 to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Product Code QJP:
The CEREGLIDE 71 Catheter System is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 71 Catheter System is also indicated for use as a conduit for retrieval devices.
Type of Use (Select one or both, as applicable)
☒ 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."
Page 5
510(k) Summary K251828
I. Submitter
Cerenovus, Inc.
6303 Waterford District Drive
Suites 215 & 315
Miami, FL 33126 USA
Contact Person: Cara Feely
Tel: +353 86 3335253
Email: cfeely@its.jnj.com
II. Date Prepared
25th July 2025
III. Device Information
Table 1. Device Information
| Device Proprietary Name | CEREGLIDE™ 71 Catheter System; Cerenovus Aspiration Tubing Set |
|---|---|
| Common or Usual name | Catheter, Thrombus Retriever (product code NRY)Catheter, Percutaneous, Neurovasculature (product code QJP) |
| Classification Name | 21 CFR 870.1250 – Percutaneous Catheter |
| Regulatory Classification | II |
| FDA Product Codes | NRY, QJP |
IV. Predicate Device Information
The predicate devices and reference device are listed below in Table 2 and Table 3.
Table 2. Predicate Devices
| 510(k) Number | Date Cleared | Name | Manufacturer |
|---|---|---|---|
| K221934 | March 9, 2023 | CEREGLIDE™ 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. |
| K221930 | March 9, 2023 | CEREGLIDE™ 71 Intermediate Catheter | Cerenovus, Inc. |
Table 3. Reference Device
| 510(k) Number | Date Cleared | Name | Manufacturer |
|---|---|---|---|
| K233982 | May 09, 2024 | CEREGLIDE™ 92 Catheter System | Cerenovus, Inc. |
V. Device Description
The CEREGLIDE™ 71 Catheter System consists of the CEREGLIDE™ 71 Intermediate Catheter and associated accessories including the INNERGLIDE™ 7 Delivery Aid, Rotating Hemostasis Valve, and Slit Introducers.
The CEREGLIDE™ 71 Intermediate Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE inner lumen liner to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets.
Continued on next page
Page 6
510(k) Summary, continued
V. Device Description (continued)
These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.
The CEREGLIDE™ 71 Catheter System is packaged with an INNERGLIDE™ 7 Delivery Aid, a Rotating Hemostasis Valve (RHV) with a side port and two Slit Introducer accessories. The INNERGLIDE™ 7 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 71 Catheter System to facilitate delivery of the CEREGLIDE™ 71 Intermediate Catheter to select blood vessels in the neurovasculature. The RHV with side port is used for flushing and insertion of catheters. The Slit Introducers are designed to introduce the CEREGLIDE™ 71 Intermediate Catheter into the base catheter and protect the distal tip of the CEREGLIDE™ 71 Intermediate Catheter during insertion into the hemostasis valve of the base catheter.
Product code NRY: The CEREGLIDE™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
VI. Indications for Use
Product code NRY:
The CEREGLIDE™ 71 Catheter System, 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 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 to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Product code QJP:
The CEREGLIDE™ 71 Catheter System is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE™ 71 Catheter System is also indicated for use as a conduit for retrieval devices.
VII. Predicate Comparison
A comparison of indications for use and technological characteristics between the CEREGLIDE™ 71 Catheter System and the predicate devices is presented in Table 4 and Table 5.
Continued on next page
Page 7
510(k) Summary, continued
VII. Predicate Comparison (continued)
Table 4. Predicate and Subject Device Comparison (NRY)
| Description | Predicate Device: CEREGLIDE™ 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set K221934 | Subject Device: CEREGLIDE™ 71 Catheter System; Cerenovus Aspiration Tubing Set K251828 |
|---|---|---|
| Indications for 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 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 CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. | The CEREGLIDE™ 71 Catheter System, 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 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 to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. |
| 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 |
| Catheter Dimensions: | ||
| Length | 115-137cm | Same |
| ID | 0.071" | Same |
| Distal OD | 0.082" (0.0825" max) | Same |
| Proximal OD | 0.0837" max | Same |
| Catheter Coating | Hydrophilic | Same |
| Coating Length | 55cm | Same |
| Catheter Materials: | ||
| Marker Band | Metal Platinum (90%)/ Iridium (10%) | Same |
| Braid | Stainless Steel | Same |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Same |
| Strain Relief/ ID Band | Same | |
| Outer Jacket | Pebax and Urethane | Same |
Continued on next page
Page 8
510(k) Summary, continued
Table 4. Predicate and Subject Device Comparison (NRY)
| Description | Predicate Device: CEREGLIDE™ 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set K221934 | Subject Device: CEREGLIDE™ 71 Catheter System; Cerenovus Aspiration Tubing Set K251828 |
|---|---|---|
| Accessories Included: | ||
| Hemostasis Valve | Tuohy Borst Valve with Side Port Extension Tubing | Same |
| Introducer Sheath | Introducer (2) | Same |
| INNERGLIDE™ 7 Delivery Aid Dimensions: | ||
| Length | None | 165cm |
| ID | 0.030" | |
| Distal OD | 0.042" | |
| Proximal OD | 0.059" | |
| Catheter Coating | Hydrophilic | |
| Coating Length | 30cm | |
| Materials: | ||
| Marker Band | None | Tungsten |
| Liner | PTFE Liner | |
| Hub | Makrolon | |
| Strain Relief | Pebax | |
| Outer Jacket | Pebax, Vestamid | |
| Sterilization Method | Ethylene Oxide | Same |
| Sterility Assurance Level (SAL) | 10⁻⁶ | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Same |
| Shelf Life | 1 year | 3 years |
Continued on next page
Page 9
510(k) Summary, continued
Table 5. Predicate and Subject Device Comparison (QJP)
| Description | Predicate Device: CEREGLIDE™ 71 Intermediate Catheter K221930 | Subject Device: CEREGLIDE™ 71 Catheter System K251828 |
|---|---|---|
| Indications for Use | The CEREGLIDE™ 71 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE™ 71 Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | The CEREGLIDE™ 71 Catheter System is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE™ 71 Catheter System is also indicated for use as a conduit for retrieval devices. |
| Product Code | QJP | Same |
| Regulatory Name | Catheter, Percutaneous | Same |
| Classification | Class II – 21 CFR 870.1250 | Same |
| Basic Design | Variable stiffness single lumen catheter | Same |
| Catheter Dimensions: | ||
| Length | 115-137cm | Same |
| ID | 0.071" | Same |
| Distal OD | 0.082" (0.0825" max) | Same |
| Proximal OD | 0.0837" max | Same |
| Catheter Coating | Hydrophilic | Same |
| Coating Length | 55cm | Same |
| Catheter Materials: | ||
| Marker Band | Metal Platinum (90%)/ Iridium (10%) | Same |
| Braid | Stainless Steel | Same |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Same |
| Strain Relief/ ID Band | Same | |
| Outer Jacket | Pebax and Urethane | Same |
| Accessories Included: | ||
| Hemostasis Valve | Tuohy Borst Valve with Side Port Extension Tubing | Same |
| Introducer Sheath | Introducer (2) | Same |
| INNERGLIDE™ 7 Delivery Aid Dimensions: | ||
| Length | None | 165cm |
| ID | 0.030" | |
| Distal OD | 0.042" | |
| Proximal OD | 0.059" | |
| Catheter Coating | Hydrophilic | |
| Coating Length | 30cm |
Continued on next page
Page 10
510(k) Summary, continued
Table 5. Predicate and Subject Device Comparison (QJP)
| Description | Predicate Device: CEREGLIDE™ 71 Intermediate Catheter K221930 | Subject Device: CEREGLIDE™ 71 Catheter System K251828 |
|---|---|---|
| INNERGLIDE™ 7 Delivery Aid Materials: | ||
| Marker Band | None | Tungsten |
| Liner | PTFE Liner | |
| Hub | Makrolon | |
| Strain Relief | Pebax | |
| Outer Jacket | Pebax, Vestamid | |
| Sterilization Method | Ethylene Oxide | Same |
| Sterility Assurance Level (SAL) | 10⁻⁶ | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Same |
| Shelf Life | 1 year | 3 years |
Continued on next page
Page 11
510(k) Summary, continued
VIII. Non-Clinical Performance Testing
Performance Testing – Bench
There are no changes to the CEREGLIDE 71 Intermediate Catheter (K221934, K221930) included with the CEREGLIDE 71 Catheter System or the Cerenovus Aspiration Tubing Set (K221934). Appropriate testing was identified based on design, risk analyses and the intended use of the INNERGLIDE 7 Delivery Aid to demonstrate that the CEREGLIDE 71 Catheter System is 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 design control procedures.
Table 6. Performance Testing Summary
| Test | Test Summary | Result |
|---|---|---|
| Design Verification | ||
| Visual Inspection | Confirm that the INNERGLIDE 7 Delivery Aid meets the visual requirement described in ISO 10555-1 Section 4.4. | PASS: Samples met the established acceptance criteria |
| Catheter ID | Verify that the INNERGLIDE 7 Delivery Aid internal diameters meet the design requirements. | PASS: Samples met the established acceptance criteria |
| Catheter OD | Verify that the INNERGLIDE 7 Delivery Aid outer diameters meet the design requirements. | PASS: Samples met the established acceptance criteria |
| Catheter Working Length | Confirm the working length of the INNERGLIDE 7 Delivery Aid as defined in ISO 10555-1 Section 3.6. | PASS: Samples met the established acceptance criteria |
| Catheter Tip Length | Verify that the tip length & navigation length of the INNERGLIDE 7 Delivery Aid meet the design requirements. | PASS: Samples met the established acceptance criteria |
| Hub Luer | Verify that the hub luer taper on the INNERGLIDE 7 Delivery Aid meets dimensional, interconnectability, and performance requirements defined in ISO 80369-7. | PASS: Samples met the established acceptance criteria |
| System Air Leak Resistance | Verify that the INNERGLIDE 7 Delivery Aid has no air leak under aspiration as defined in ISO 10555-1, section 4.11. | PASS: Samples met the established acceptance criteria |
| Inner Lumen Integrity (Pressure) | Verify that the INNERGLIDE 7 Delivery Aid joint strength meets the freedom from leakage (liquid during pressurization) requirements of ISO 10555-1:2013, section 4.7. | PASS: Samples met the established acceptance criteria |
| Hub Pull Testing | Verify that the INNERGLIDE 7 Delivery Aid and CEREGLIDE 71 Intermediate Catheter hub to joint strength meets acceptance criteria. | PASS: Samples met the established acceptance criteria |
| Shaft Tensile Strength | Verify that the INNERGLIDE 7 Delivery Aid and CEREGLIDE 71 Intermediate Catheter joint strength meets the acceptance criteria. | PASS: Samples met the established acceptance criteria |
| Particulate Count | Verify the particulate size and counts of the CEREGLIDE 71 Catheter System under simulated use conditions with comparison to the predicate devices. | PASS: Samples met the established acceptance criteria |
| Coating Durability/Friction | Verify the friction force and durability of the hydrophilic coating on the INNERGLIDE 7 Delivery Aid meets the design requirements. | PASS: Samples met the established acceptance criteria |
| Coating Length | Verify that the INNERGLIDE 7 Delivery Aid hydrophilic coating length meets the design requirements. | PASS: Samples met the established acceptance criteria |
| Coating Thickness | Verify that the INNERGLIDE 7 Delivery Aid hydrophilic coating thickness meets the design requirements. | PASS: Samples met the established acceptance criteria |
| Coating Integrity | Verify that the coating on the INNERGLIDE 7 Delivery Aid is free of uncoated individual voids when evaluated with Congo Red Dye Coverage Test. | PASS: Samples met the established acceptance criteria |
Continued on next page
Page 12
510(k) Summary, continued
Table 6. Performance Testing Summary (continued)
| Test | Test Summary | Result |
|---|---|---|
| Design Verification (continued) | ||
| Kink Resistance | Confirm that the INNERGLIDE 7 Delivery Aid meets the requirement to remain stable and not kink during use. | PASS: Samples met the established acceptance criteria |
| Tip Flexibility | Test the tip flexibility of the INNERGLIDE 7 Delivery Aid, relative to cleared devices of similar design. | PASS: Samples met the established acceptance criteria |
| Torque Performance | Confirm that the INNERGLIDE 7 Delivery Aid meets the torque strength requirement. | PASS: Samples met the established acceptance criteria |
| Tracking (Delivery and Withdrawal Force) | Confirm that the INNERGLIDE 7 Delivery Aid trackability meets the design requirements. | PASS: Samples met the established acceptance criteria |
| Burst Pressure | Verify the CEREGLIDE 71 Intermediate Catheter continues to meet minimum static burst pressure requirements. | PASS: Samples met the established acceptance criteria |
| Design Validation | ||
| In Vitro Usability Studies | The in vitro studies were conducted in a neurovascular model to evaluate compatibility, trackability, and durability of the INNERGLIDE 7 Delivery Aid and use for delivery of the CEREGLIDE 71 Intermediate Catheter. | PASS: Samples met the established acceptance criteria |
Performance Testing – Animal
No animal studies were required as appropriate verification and validation of the subject device design were achieved based on the similarities of the proposed device and the predicate devices, and from results of bench testing.
Performance Testing – Clinical
Clinical studies were not required as appropriate verification and validation of the subject device design were achieved based on the similarities of the proposed device and the predicate devices, and from results of bench testing.
Sterilization
The CEREGLIDE™ 71 Catheter System, as packaged with included accessories, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 10⁻⁶ in accordance with ISO 11135. The CEREGLIDE™ 71 Catheter System and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system – externally communicating. The CEREGLIDE™ 71 Catheter System and all accessories are for single use only.
Shelf-Life
The CEREGLIDE™ 71 Catheter System will have a shelf life of 3 years based on the successful completion of stability testing. Shelf-life testing was performed using standard test methods and acceptance criteria. Prior to aging, all samples were exposed to standard transportation conditioning. Results of testing on the subject device all met established acceptance criteria.
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510(k) Summary, continued
Biocompatibility Testing
No biocompatibility testing was conducted for the INNERGLIDE™ 7 Delivery Aid. The biocompatibility of the INNERGLIDE™ 7 Delivery Aid is supported by the biocompatibility testing of the INNERGLIDE™ 9 Delivery Aid, that has the same materials and manufacturing, cleared under K233982.
IX. Conclusion
Based upon the intended use, design, materials, function, and performance testing, it is concluded that the subject device, CEREGLIDE™ 71 Catheter System and Cerenovus Aspiration Tubing Set, is substantially equivalent to the predicate devices, the CEREGLIDE™ 71 Intermediate Catheter and Cerenovus Aspiration Tubing Set (K221934) and the CEREGLIDE™ 71 Intermediate Catheter (K221930). The addition of the INNERGLIDE™ 7 Delivery Aid did not raise any new questions regarding the safety and effectiveness of the CEREGLIDE 71 Catheter System. The CEREGLIDE 71 Catheter System, as designed, manufactured, packaged, and sterilized, is substantially equivalent to the predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.
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§ 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).