Who is the manufacturer of CEREGLIDE 71 Intermediate Catheter?

Cerenovus, Inc. filed the 510(k) submission for CEREGLIDE 71 Intermediate Catheter (K221930).

What is the FDA product code for CEREGLIDE 71 Intermediate Catheter?

QJP. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CEREGLIDE 71 Intermediate Catheter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CEREGLIDE 71 Intermediate Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CEREGLIDE 71 Intermediate Catheter

K221930 · Cerenovus, Inc. · QJP · Mar 9, 2023 · Cardiovascular

Device Facts

Record ID	K221930
Device Name	CEREGLIDE 71 Intermediate Catheter
Applicant	Cerenovus, Inc.
Product Code	QJP · Cardiovascular
Decision Date	Mar 9, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended 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.

Device Story

Variable stiffness, single-lumen catheter; designed for neurovascular navigation over steerable guidewire or microcatheter. Construction: stainless steel variable-pitch braid; PTFE inner liner; polymer outer jacket (Pebax/Urethane). Features: radiopaque distal marker band; hydrophilic coating for lubricity; luer fitting hub. Used in clinical settings by physicians; facilitates delivery of interventional devices or retrieval tools to target sites. Navigation monitored via fluoroscopy. Benefits: provides stable conduit for neurovascular procedures; reduces friction during vessel navigation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (design verification, ISO 10555-1 compliance, torque, burst pressure, lubricity) and biocompatibility testing (ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility).

Technological Characteristics

Variable stiffness single-lumen catheter. Materials: Pt/Ir marker band, stainless steel braid, PTFE liner, Polyamide hub, Pebax/Urethane jacket. Dimensions: 115-137cm length, 0.071" ID. Hydrophilic coating. Sterilization: Ethylene Oxide (ISO 11135). Standards: ISO 10555-1 (catheter performance), ISO 10993 (biocompatibility), USP <788> (particulates).

Indications for Use

Indicated for facilitating insertion and guidance of interventional devices into neurovascular blood vessels and as a conduit for retrieval devices in patients requiring neurovascular intervention.

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 (K191237)

Reference Devices

SOFIA PLUS/Distal Access Catheter (K150366)

Related Devices

K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter · Cerenovus, Inc. · Oct 16, 2024
K191237 — CERENOVUS Large Bore Catheter · Codman & Shurtleff, Inc. · Nov 8, 2019
K230726 — CEREGLIDE 92 Intermediate Catheter · Cerenovus, Inc. · Nov 29, 2023
K202752 — AXS Vecta 46 Intermediate Catheter · Stryker Neurovascular · Aug 27, 2021
K182512 — Route 92 Medical Delivery Catheter · Route 92 Medical, Inc. · Dec 10, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ March 9, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Cerenovus, Inc. Ariell Joiner, Ph.D. Manager, Regulatory Affairs 6303 Blue Lagoon Drive, Suite 315 Miami. Florida 33126 Re: K221930 Trade/Device Name: CEREGLIDE 71 Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: February 2, 2023 Received: February 3, 2023 Dear Ariell Joiner: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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) K221930 ### Device Name CEREGLIDE™ 71 Intermediate Catheter #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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 K221930 | I. Submitter | Cerenovus, Inc. 6303 Blue Lagoon Drive Suites 215 & 315 Miami, FL 33126 USA | |--------------|--------------------------------------------------------------------------------------| | | Contact Person: Ariell Joiner Tel: (908) 249-0182 Email: aioiner@its.ini.com | II. Date Prepared March 8, 2023 #### III. Device Information | Table 1. Device Information | | |-----------------------------|------------------------------------------| | Device Proprietary Name | CEREGLIDE™ 71 Intermediate Catheter | | Common or Usual name | Catheter, Percutaneous, Neurovasculature | | Classification Name | 21 CFR 870.1250 – Catheter, Percutaneous | | Regulatory Classification | II | | FDA Product Code | QJP | ### IV. Predicate Device Information V. Device The primary predicate device is listed below in Table 2 and the reference device is listed in Table 3. | Table 2. Primary Predicate Device | | | | |---------------------------------------------------------------------------------------|---------------------|----------------------------------|------------------------------| | 510(k) Number | Date Cleared | Name | Manufacturer | | K191237 | November 8. 2019 | CERENOVUS Large Bore Catheter | Medos International SARL* | | *510(k) was previously held by Codman & Shurtleff, Inc. The 510(k) was transferred to | | | | | Medos International SARL, which is the current holder of the 510(k). | | | | | Table 3. Reference Device | | | | |---------------------------|----------------|--------------------------------------|--------------------| | 510(k) Number | Date Cleared | Name | Manufacturer | | K150366 | March 27, 2015 | SOFIA PLUS/Distal Access Catheter | MicroVention, Inc. | The CEREGLIDE™ 71 Intermediate Catheter is a variable stiffness, single lumen Description 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 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. An ID band is placed at the distal end of the hub over a strain relief. {4}------------------------------------------------ | V. Device Description, continued | 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 and insertion of catheters. 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. | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | VI. 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. | | VII. Predicate Comparison | A comparison of the similarities and differences of product features between the CEREGLIDE™ 71 Intermediate Catheter and the predicate device is presented in Table 4. | | Table 4. Subject and Predicate Device Comparison Summary | | | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | Subject Device: CEREGLIDETM 71 Intermediate Catheter | Predicate Device: CERENOVUS Large Bore Catheter (K191237) | | Product Code | QJP | DQY | | Regulatory Name | Catheter, Percutaneous | Same | | Classification | Class II - 21 CFR 870.1250 | Same | | Basic Design | Variable stiffness single lumen catheter | Same | | Indications For Use | The CEREGLIDETM 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 CEREGLIDETM 71 Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | The CERENOVUS Large Bore 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 CERENOVUS Large Bore Catheter is also indicated for use as a conduit for retrieval devices. | | Dimensions: | | | | Length | 115 - 137cm | 125 - 135cm | | Inner Diameter (ID) | 0.071" | Same | | Distal Outer Diameter (OD) | 0.082" (0.0825" max) | 0.081" | | Proximal OD | 0.0837" max | 0.0825" | | Catheter Coating | Hydrophilic | Same | | Coating Length | 55 cm | 30 cm | | Materials: | | | | Marker Band | Metal Platinum (90%) / Iridium (10%) | Same | | Braid | Stainless Steel | Same | | Liner | PTFE Liner | Same | | Hub | Polyamide | Same | | Strain Relief | Same | Same | | Outer Jacket | Pebax and Urethane | Pebax, Urethane, Nylon | | Accessories Included: | | | | Hemostasis Valve | Included: Tuohy Borst Hemostasis Valve with Side Port Extension Tubing | Same | | Introducer Sheath | Introducer (2) | Peel-Away Sheath Introducer (2) | | Sterilization Method | Ethylene Oxide | Same | | Sterility Assurance Level (SAL) | 10-6 | Same | | Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Same | | Shelf Life | 1 year | 1 year | Continued on next page {5}------------------------------------------------ ### VIII. Non-Clinical Performance Data ### Performance Testing - Bench Appropriate testing was identified based on design, risk analyses and the intended use of the CEREGLIDE™ 71 Intermediate Catheter to demonstrate that it 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 procedure. The bench testing included the following tests: | Table 5. Performance Testing Summary | | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | Test | Test Summary | Result | | Design Verification | | | | Visual Inspection | Confirm that the Catheter meets the visual requirement described in ISO 10555-1 Section 4.4. | PASS: Samples met the established acceptance criteria | | Catheter ID | Verify that the Catheter internal diameters meet the requirements. | PASS: Samples met the established acceptance criteria | | Catheter OD | Verify that the Catheter outer diameters meet the requirements. | PASS: Samples met the established acceptance criteria | | Catheter Working Length | Confirm the working length of the catheter as defined in ISO 10555-1 Section 3.6. | PASS: Samples met the established acceptance criteria | | Catheter Tip Length | Verify the catheter tip length of the Catheter. | PASS: Samples met the established acceptance criteria | | System Air Leakage | Verify that there is no air leak into the hub subassembly. | PASS: Samples met the established acceptance criteria | | System Liquid Leakage | Verify that the catheter 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 | | Delamination of PTFE Liner | Verify that the PTFE has appropriately adhered to the inner lumen of the Catheter with braid reinforcement. | PASS: Samples met the established acceptance criteria | | Kink (Distal & Proximal) | Confirm that the Catheter meets the requirement for the catheter to remain stable and not kink during use. | PASS: Samples met the established acceptance criteria | | Tip Movement | Confirm that the Catheter meets the tip column stiffness requirement. | PASS: Samples met the established acceptance criteria | | Tip Linear Stiffness | Test the tip flexibility of the Catheter, relative to other devices of similar design. | PASS: Samples met the established acceptance criteria | | Coating Lubricity and Durability | Verify the lubriciousness and durability of the Catheter's hydrophilic coating. | PASS: Samples met the established acceptance criteria | | Coating Length | Verify that the Catheter hydrophilic coating length meets the design requirements. | PASS: Samples met the established acceptance criteria | | Peak Tensile Strength | Verify that the Catheter joint strength meets the requirements of Section 4.5 of ISO 10555-1. | PASS: Samples met the established acceptance criteria | | Introducer ID | Verify that the introducer internal diameters meet the requirements. | PASS: Samples met the established acceptance criteria | | Particulate Count | Verify that the coating integrity of the Catheter's outer surface meets the requirements for content of Particle Matter in alignment with USP<788> counting methods and compared to the reference predicate device. | PASS: Samples met the established acceptance criteria | | Table 5. Performance Testing Summary, continued | | | | Test | Test Summary | Result | | Design Verification, continued | | | | Burst Pressure | Confirm the maximum hydrostatic pressure the Catheter can withstand using a Crescent Hydraulic Burst-leak Tester. | PASS: Samples met the established acceptance criteria | | Introducer Working Length | Confirm the working length of the introducer. | PASS: Samples met the established acceptance criteria | | Introducer Separation Force | Confirm the force required to separate the introducer. | PASS: Samples met the established acceptance criteria | | Torque Test | To determine the number of revolutions to failure of the Catheter in simulated anatomy. | PASS: Samples exceeded comparator devices in revolutions to failure | | Design Validation | | | | In Vitro Usability Studies | The in-vitro studies were conducted to evaluate usability parameters such as trackability, tip stability, durability, and (ancillary) device compatibility with tracking of the Catheter to target sites and delivery of a stent-retriever in the neurovascular model. | PASS: Samples met the established acceptance criteria | {6}------------------------------------------------ ### VIII. Non-Clinical Performance Data, continued ### Performance Testing - Animal No animal studies were required as appropriate verification and validation of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing. ### Performance Testing - Clinical Clinical studies were not required as appropriate verification and validation of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing. ### Sterilization The CEREGLIDE™ 71 Intermediate Catheter, as packaged with included accessories, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 106 in accordance with ISO 11135. The CEREGLIDE™ 71 Intermediate Catheter and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CEREGLIDE™ 71 Intermediate Catheter and all accessories are for single use only. ### Shelf-Life The CEREGLIDE™ 71 Intermediate Catheter will have a shelf life of one year 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. Continued on next page {7}------------------------------------------------ ### VIII. Non-Clinical Performance Data, continued #### Biocompatibility Testing A biological safety evaluation was conducted on the CEREGLIDE™ 71 Intermediate Catheter in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", (Issued June 16, 2016) based on the changes to the predicate device, CERENOVUS Large Bore Catheter (K191237). Biocompatibility testing was conducted in accordance with International Standard ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing Within a Risk Management Process (2018). The following testing was performed: | Table 6. Biocompatibility Test Summary for CEREGLIDE™ 71 Intermediate | | | |-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Catheter and Introducer | | | | Test | Test Summary | Results | | Chemical Characterization | Determination of extractable species from the test article was performed in purified water, isopropyl alcohol, and hexane. | PASS | | Cytotoxicity | Cytotoxicity Study Using the ISO Elution Method (compliant with ISO 10993-5:2009/(R)2014 and ISO 10993-12:2012). 1X MEM extract (6 cm²/ mL at 37°C for 72 hours) was evaluated for potential cytotoxic effects using monolayers of L-929 mouse fibroblast cells. | PASS | | Sensitization – Guinea Pig Maximization | Evaluation of the allergenic potential or sensitizing capacity of a test article by screening of contact allergens in guinea pigs and extrapolating the results to humans. | PASS | | Irritation - Rabbit Intracutaneous Reactivity | Determination of any chemicals that may leach or be extracted from the test article capable of causing local irritation in the dermal tissues of rabbits. | PASS | | Acute Systemic Toxicity in Mice | Screening of test article extracts for potential toxic effects as a result of a single-dose systemic injection in mice. | PASS | | Pyrogenicity – Materials Mediated Rabbit Pyrogen | Determination if a saline extract of the test article causes a febrile response in rabbits. | PASS | | ASTM Hemolysis Study: Direct and Extraction Methods | Evaluation of the hemolytic potential of the test articles and test article extract according to ASTM method (F756-17). | PASS | | SC5b-9 Complement Activation Assay | Measure of complement activation in Normal Human Serum (NHS) indicates whether a test article is capable of generating the activation fragment, SC5b-9, which in turn contributes to the inflammatory immune response in humans. | PASS | | ASTM Heparinized Platelet and Leukocyte Count | Determination if medical materials exposed to human whole blood would adversely affect the platelet and leukocyte ratios in whole blood. | PASS | | ASTM Partial Thromboplastin Time (PTT) | Screening for detection of coagulation abnormalities in the intrinsic coagulation pathway. The PTT indirectly measures the formation of thrombin by its action on fibrinogen, forming the fibrin clot through a method compliant with ISO 10993-4. | PASS | | In Vivo Thromboresistance | Evaluate the thrombogenic potential of a blood contacting medical device in comparison to a predicate device. | PASS | Continued on next page {8}------------------------------------------------ #### IX. Conclusion Based upon the intended use, design, materials, function, and side-by-side in-vitro and in-vivo testing, it is concluded that the subject device, CEREGLIDE™ 71 Intermediate Catheter is substantially equivalent to the predicate device, CERENOVUS Large Bore Catheter (K191237). The differences in materials and design do not raise new questions regarding the safety and effectiveness of the device. The device, as designed, manufactured, packaged and sterilized, is substantially equivalent to the primary predicate and reference devices currently marketed under the Federal Food, Drug and Cosmetic Act.