CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter

{0}------------------------------------------------ October 16, 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Cerenovus, Inc. Cara Feely Regulatory Affairs Manager 6303 Waterford District Drive, Suites 215 & 315 Miami, Florida 33126 Re: K241244 Trade/Device Name: CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K241244 Device Name CEREGLIDE 42 Intermediate Catheter CEREGLIDE 57 Intermediate Catheter #### Indications for Use (Describe) The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter are 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 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {4}------------------------------------------------ ### 510(k) Summary - K241244 ### 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 | | 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 The primary predicate device is listed below in Table 2. | | Table 2. Primary Predicate Device | | | |---------------|-----------------------------------|---------------------------------------|--------------------------| | 510(k) Number | Date Cleared | Name | Manufacturer | | K202752 | August 27, 2021 | AXS Vecta 46<br>Intermediate Catheter | Stryker<br>Neurovascular | V. Device Description Both the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter (hereafter referred to as the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters) 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 stainlesssteel 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 catheter hub which can be used to attach accessories for flushing. 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 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. Continued on the next page {5}------------------------------------------------ | VI. Indications<br>for Use | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter are<br>indicated for use in facilitating the insertion and guidance of appropriately sized interventional<br>devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 57<br>Intermediate Catheter is also indicated for use as a conduit for retrieval devices. | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | VII. Predicate<br>Comparison | A comparison of the similarities and differences of product features between the<br>CEREGLIDE™ 42 Intermediate Catheter, the CEREGLIDE™ 57 Intermediate Catheter, and<br>the predicate device are presented in Table 3. | | Table 3. Predicate and Subject Device Comparison | | | | |--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | Predicate Device:<br>AXS Vecta 46 Intermediate<br>Catheter (K202752) | Subject Device:<br>CEREGLIDE™ 42<br>Intermediate Catheter | Subject Device:<br>CEREGLIDE™ 57<br>Intermediate Catheter | | Indications For<br>Use | The AXS Vecta Intermediate<br>Catheter is indicated for use in<br>facilitating the insertion and<br>guidance of appropriately sized<br>interventional devices into a selected<br>blood vessel in the neurovascular<br>system. The AXS Vecta<br>Intermediate Catheter is also<br>indicated for use as a conduit for<br>retrieval devices. | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57<br>Intermediate Catheter are indicated for use in facilitating the insertion<br>and guidance of appropriately sized interventional devices into a<br>selected blood vessel in the neurovascular system. The CEREGLIDE<br>57 Intermediate Catheter is also indicated for use as a conduit for<br>retrieval devices. | The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57<br>Intermediate Catheter are indicated for use in facilitating the insertion<br>and guidance of appropriately sized interventional devices into a<br>selected blood vessel in the neurovascular system. The CEREGLIDE<br>57 Intermediate Catheter is also indicated for use as a conduit for<br>retrieval devices. | | Product Code | QJP | Same as predicate | Same as predicate | | Regulatory<br>Name | Catheter, Percutaneous | Same as predicate | | | Classification | Class II - 21 CFR 870.1250 | Same as predicate | | | Basic Design | Variable stiffness single lumen<br>catheter | Same as predicate | | | Length | 125 cm<br>146 cm<br>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 | | | Liner | PTFE Liner | Same as predicate | | | Hub | Polycarbonate | Same as predicate | | | Strain Relief | Polyolefin | Same as predicate | | | Outer Jacket | Polyether Block Amide (Pebax),<br>Urethane, Nylon | Pebax, Urethane | | | Hemostasis Valve | Included | Same as predicate | Same as predicate | | Introducer<br>Sheath | Peel-Away Introducer | Slit Introducer (2) | Slit Introducer (2) | Continued on the next page {6}------------------------------------------------ | Table 3. Predicate and Subject Device Comparison | | | | |--------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------| | Description | Predicate Device:<br>AXS Vecta 46 Intermediate<br>Catheter (K202752) | Subject Device:<br>CEREGLIDE™ 42<br>Intermediate Catheter | Subject Device:<br>CEREGLIDE™ 57<br>Intermediate Catheter | | Sterilization<br>Method | Ethylene Oxide | Same as predicate | Same as predicate | | Sterility Assurance<br>Level (SAL) | Not Specified | 10-6 | 10-6 | | Packaging | Tyvek/Nylon Pouch, polyethylene<br>support tube, packaging card,<br>SBS 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 | ### 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: | Test | Test Summary<br>Design Verification | Result | |--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | 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 | Verify that the CEREGLIDETM 42 and CEREGLIDETM 57<br>Intermediate Catheters' internal diameters meet the<br>requirements. | PASS:<br>Samples met the established<br>acceptance criteria | | Catheter OD | Verify that the CEREGLIDETM 42 and CEREGLIDETM 57<br>Intermediate Catheters' outer diameters meet the requirements. | PASS:<br>Samples met the established<br>acceptance criteria | | Catheter<br>Working<br>Length | Confirm the working lengths of the catheters as defined in ISO<br>10555-1 Section 3.6. | PASS:<br>Samples met the established<br>acceptance criteria | | Catheter Tip<br>Length | Verify the catheter tip length of the CEREGLIDETM 42 and<br>CEREGLIDETM 57 Intermediate Catheters. | PASS:<br>Samples met the established<br>acceptance criteria | | System Air<br>Leakage | Verify that there is no air leak into the hub subassembly. | PASS:<br>Samples met the established<br>acceptance criteria | | System Liquid<br>Leakage | Verify that the catheter joint strength meets the freedom from<br>leakage (liquid during pressurization) requirements of ISO<br>10555-1:2013, section 4.7. | PASS:<br>Samples met the established<br>acceptance criteria | | Delamination of<br>PTFE Liner | Verify that the PTFE has appropriately adhered to the inner<br>lumen of the catheter with braid reinforcement. | PASS:<br>Samples met the established<br>acceptance criteria | | Kink | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57<br>Intermediate Catheters meet the requirement for the catheter to<br>remain stable and not kink during use. | PASS:<br>Samples met the established<br>acceptance criteria | | Tip Movement | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57<br>Intermediate Catheters meet the tip column stiffness<br>requirement. | PASS:<br>Samples met the established<br>acceptance criteria | | Distal Tip<br>Stiffness | Test the tip flexibility of the CEREGLIDETM 42 and<br>CEREGLIDETM 57 Intermediate Catheters, relative to other<br>devices of similar design. | PASS:<br>Samples met the established<br>acceptance criteria | | Peak Tensile<br>Strength | Verify that the CEREGLIDETM 42 Intermediate Catheter joint<br>strength meets the acceptance criteria of Section 4.5 of ISO<br>10555-1. | PASS:<br>Samples met the established<br>acceptance criteria | | Particulate<br>Count and<br>Coating<br>Integrity | Verify the particulate size and counts of the CEREGLIDETM 42<br>Intermediate Catheter under simulated use conditions with<br>comparison to the predicate device. Coating integrity was<br>visually inspected and verified to be free of coating defects<br>after simulated use. | PASS:<br>Samples met the established<br>acceptance criteria | {7}------------------------------------------------ VIII. Non-Clinical Performance Data, continued | Table 4. Performance Testing Summary | | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Test | Test Summary | Result | | Design Verification | | | | Burst Pressure | Verify that the CEREGLIDETM 42 and 57 Intermediate<br>Catheters meet minimum static burst pressure specifications. | PASS:<br>Samples met the established<br>acceptance criteria | | Torque Strength | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57<br>Intermediate Catheters meet the torque strength requirement. | PASS:<br>Samples met the established<br>acceptance criteria | | Trackability | Confirm that the CEREGLIDETM 42 and CEREGLIDETM 57<br>Intermediate Catheters meet the trackability requirement. | PASS: Samples met the<br>established acceptance criteria | | Design Validation | | | | In Vitro<br>Usability<br>Studies | The <i>in-vitro</i> studies were conducted to evaluate usability<br>parameters such as trackability, tip stability, durability, and<br>(ancillary) device compatibility with tracking of the<br>CEREGLIDETM 42 and CEREGLIDETM 57 Intermediate<br>Catheters to target sites and delivery of a stent-retriever in the<br>neurovascular model. | PASS:<br>Samples met the established<br>acceptance criteria | ### Performance Testing - Animal No animal studies were required as appropriate verification 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 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™ 42 and CEREGLIDE™ 57 Intermediate Catheters are packaged with included accessories and sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 106 in accordance with ISO 11135. The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters and all accessories are for single use only. ### Shelf-Life The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters will have a shelf life of three years. Shelf-life testing was adopted from CEREGLIDE™ 71 Intermediate Catheter (K221930) that shares the same materials, design features, and manufacturing processes as the subject devices. Prior to aging, all samples were exposed to standard transportation conditioning. Results of shelf-life performance testing all met established acceptance criteria. ### Biocompatibility Testing A biological safety evaluation was conducted for the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters in accordance with the FDA biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" (issued September 2023). Additionally, biocompatibility testing conducted on the CEREGLIDE™ 71 Intermediate Catheter (K221930), per ISO 10993-1 and applicable regulatory requirements, adequately evaluates the biocompatibility profile of the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters for endpoints recommended by the FDA biocompatibility guidance for an externally communicating device with limited (≤24 hours) duration of contact with circulating blood. The CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters have met the requirements of biocompatibility assessments, for their intended use. Continued on the next page {8}------------------------------------------------ IX. Conclusion Based upon the intended use, design, materials, function, and side-by-side in-vitro testing, it is concluded that the subject devices, the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters, are substantially equivalent to the predicate device, AXS Vecta 46 Intermediate Catheter (K202752). The differences in materials and design do not raise new questions regarding the safety and effectiveness of the devices. The subject devices, as designed, manufactured, packaged, and sterilized, are substantially equivalent to the primary predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. End of document