Who is the manufacturer of CERENOVUS Large Bore Catheter?

Codman & Shurtleff, Inc. filed the 510(k) submission for CERENOVUS Large Bore Catheter (K191237).

What is the FDA product code for CERENOVUS Large Bore Catheter?

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

What is the regulatory pathway for CERENOVUS Large Bore Catheter?

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

Who can help prepare an FDA 510(k) submission like CERENOVUS Large Bore 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.

CERENOVUS Large Bore Catheter

Q: What are the predicate devices for CERENOVUS Large Bore Catheter?

AXS Catalyst Distal Access Catheter (K183463).

K191237 · Codman & Shurtleff, Inc. · DQY · Nov 8, 2019 · Cardiovascular

Device Facts

Record ID	K191237
Device Name	CERENOVUS Large Bore Catheter
Applicant	Codman & Shurtleff, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Nov 8, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

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.

Device Story

Variable stiffness, single-lumen catheter; designed for neurovascular navigation over steerable guidewire or microcatheter. Shaft construction: stainless steel variable-pitch braid, PTFE inner liner, polymer exterior (Pebax, Urethane, Nylon). Features: stiff proximal shaft, flexible distal shaft, radiopaque platinum/iridium marker band, hydrophilic coating for lubricity. Accessories: hemostasis valve with side port, peel-away introducer sheaths. Used in clinical settings by physicians; navigated under fluoroscopic visualization. Facilitates delivery of interventional devices or retrieval tools to target neurovascular sites. Benefits: enables access to tortuous neurovascular anatomy for therapeutic procedures.

Clinical Evidence

Bench testing only. No clinical or animal studies were required. Bench testing included visual inspection, dimensional verification, hub luer taper fit, air leak, liquid leakage, delamination, kink resistance, tip stiffness, coating lubricity/durability, tensile strength, introducer separation force, particle count, burst pressure, and in-vitro usability in a neurovascular model.

Technological Characteristics

Variable stiffness single-lumen catheter; stainless steel variable-pitch braid; PTFE inner liner; Pebax/Urethane/Nylon outer jacket; platinum/iridium (90/10) marker band; hydrophilic coating. Dimensions: 125-135 cm length, 0.071" ID. Sterilization: 100% Ethylene Oxide (SAL 10^-6). Biocompatibility per ISO 10993-1.

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

AXS Catalyst Distal Access Catheter (K183463)

Related Devices

K221930 — CEREGLIDE 71 Intermediate Catheter · Cerenovus, Inc. · Mar 9, 2023
K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter · Cerenovus, Inc. · Oct 16, 2024
K230726 — CEREGLIDE 92 Intermediate Catheter · Cerenovus, Inc. · Nov 29, 2023
K202752 — AXS Vecta 46 Intermediate Catheter · Stryker Neurovascular · Aug 27, 2021
K190833 — AXS Vecta Aspiration Catheter · Stryker Neurovascular · Dec 15, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 acronym followed by the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue, while the Department of Health & Human Services logo is in black. November 8, 2019 Codman & Shurtleff, Inc. Kirsten Franco, MS, RAC Regulatory Affairs Manager 325 Paramount Drive Raynham, Massachusetts 02767 Re: K191237 Device Name: CERENOVUS Large Bore Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 7, 2019 Received: October 9, 2019 ## Dear Kirsten Franco: 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 medical devices and radiation-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, Xiaolin Zheng, Ph.D. Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K191237 Device Name CERENOVUS Large Bore Catheter #### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ 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." {3}------------------------------------------------ # 510(k) Summary - K191237 Pursuant to the requirements of 21 CFR Section 807.92(c), this 510(k) summary is provided as part of this Premarket Notification containing sufficient details to understand the basis for a determination of substantial equivalence. | Submitter | Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767 | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Kirsten Franco Phone: (484) 868-7991 Email: kfranco5@its.jnj.com | | Date Prepared | June 19, 2019 | | Device Trade or Proprietary Name | CERENOVUS Large Bore Catheter | | Device Classification | Regulatory Classification: II Common or Usual Name: Catheter, Percutaneous Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Product Code: DQY Classification Panel: Cardiovascular | | Predicate Device | 510(k) Number | Date Cleared | Device Name | Manufacturer | |---------------------|------------------|----------------|----------------------------------------|-----------------------| | | K183463 | March 13, 2019 | AXS Catalyst Distal Access Catheter | Stryker Neurovascular | Continued on next page {4}------------------------------------------------ Device The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter Description 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 radiopague marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing and insertion of catheters. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve. Indications for The CERENOVUS Large Bore Catheter is indicated for use in facilitating the insertion Use 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. Predicate A comparison of the similarities and differences of product features between the Comparison CERENOVUS Large Bore Catheter and the predicate device is presented in Table 1. | Description | Subject Device: CERENOVUS Large Bore Catheter (K191237) | Predicate Device: AXS Catalyst Distal Access Catheter (K183463) | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DQY | Same | | 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 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. | The AXS Catalyst Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The AXS Catalyst Distal Access Catheter is also indicated for use as a conduit for retrieval devices. | | Dimensions: | | | | Length | 125 - 135 cm | 115 - 132 cm | | ID | 0.071" | 0.068" | | Distal OD | 0.081" | 0.082" | | Proximal OD | 0.0825" | 0.0825" | | Catheter Coating | Hydrophilic | Hydrophilic | | Coating Length | 30 cm | Same | | Materials: | | | | Marker Band | Metal Platinum (90%) / Iridium (10%) | Same | | Braid | Stainless Steel | Nitinol wire and polymer fiber | | Liner | PTFE Liner | Same | | Hub | Polyamide | Nylon | | Strain Relief | | Thermoplastic rubber (Polyolefin) | Table 1. Subject and Predicate Device Comparison Summary {5}------------------------------------------------ | Description | Subject Device: CERENOVUS Large Bore Catheter (K191237) | Predicate Device: AXS Catalyst Distal Access Catheter (K183463) | |------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------| | Outer Jacket | Pebax, Urethane, Nylon | Pebax with Nylon, Tecoflex | | Accessories Included: | | | | Hemostasis valve | Hemostasis Valve with Side Port Extension Tubing | Rotating Hemostasis Valve; Tuohy Borst Valve with Sideport | | Introducer Sheath | Peel-Away Sheath Introducer (2) | Same | | Sterilization Method | Ethylene Oxide | Same | | Sterility Assurance Level (SAL) | 10-6 | Same | | Packaging | Polyethylene Hoop and Mounting Card, Pouch, Carton | Same | | Shelf Life | 1 year | Same | Non-Clinical Testing Summary ## Performance Testing - Bench Appropriate testing was identified based on design, risk analyses and the intended use of the CERENOVUS Large Bore Catheter to 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 Codman & Shurtleff, Inc. Design Control procedures. The bench testing included the following tests: | Test | Test Summary | Result | |--------------------------|---------------------------------------------------|------------------------------| | | Confirm that the CERENOVUS Large Bore | PASS: | | Visual Inspection | Catheter meets the visual requirement described | Samples met the established | | | in ISO 10555-1 Section 4.4 | acceptance criteria | | | Verify that the catheter internal diameters meet | PASS: | | Catheter ID | the requirements | Samples met the established | | | | acceptance criteria | | | Verify that the introducer internal diameters | PASS: | | Introducer ID | meet the requirements | Samples met the established | | | | acceptance criteria | | | Verify that the catheter outer diameters meet the | PASS: | | Catheter OD | requirements | Samples met the established | | | | acceptance criteria | | | Verify that the introducer outer diameters meet | PASS: | | Introducer OD | the requirements | Samples met the established | | | | acceptance criteria | | Catheter Working | Confirm the working length of a catheter as | PASS: | | Length | defined in ISO10555-1 Section 3.6. | Samples met the established | | | | acceptance criteria PASS: | | Introducer | Confirm the working length of the introducer | Samples met the established | | Working Length | | acceptance criteria | | | Verify the distal tip length of the catheter | PASS: | | Distal Tip Length | | Samples met the established | | | | acceptance criteria | | | Verify that the catheter hub luer taper fit | PASS: | | Hub Luer Taper | standard luer fittings using a taper device | Samples met the established | | | | acceptance criteria | | Air Leak testing | Verify that there is no air leak into the hub | PASS: | | | subassembly | Samples met the established | | | | acceptance criteria | | | Verify that the catheter joint strength meets the | | | System Liquid Leakage | freedom from leakage (liquid during | PASS: | | | pressurization) requirements of ISO 10555- | Samples met the established | | | 1:2013. section 4.7 | acceptance criteria | | | | | {6}------------------------------------------------ | Test | Test Summary | Result | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | 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 CERENOVUS Large Bore 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 CERENOVUS Large Bore Catheter meets the tip column stiffness requirement | PASS: Samples met the established acceptance criteria | | Tip Linear Stiffness | Test the tip flexibility of the CERENOVUS Large Bore Catheter, relative to other devices of similar design | PASS: Samples met the established acceptance criteria | | Coating Lubricity & Durability | Verify the lubriciousness and durability of the catheter 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 | | Catheter 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 Separation Force | Confirm the force required to separate the peel- away introducer accessory | PASS: Samples met the established acceptance criteria | | Particle Count | Verify that the coating integrity of the catheter's outer surface meets the requirements for content of particulates. | PASS: Samples met the established acceptance criteria | | Burst Pressure (static) | Confirm the maximum hydrostatic pressure a catheter can withstand using a Crescent Hydraulic Burst-leak Tester | PASS: Samples met the established acceptance criteria | | In-vitro Usability Studies | Evaluate catheter usability parameters such as trackability, tip stability and visibility under fluoroscopy, durability, etc. Subject and Predicate devices were tracked to the target site to deliver a stent-retriever in the neurovascular model that replicates the tortuosity, diameter and location of the arteries in the neurovasculature. | PASS: Samples met the established acceptance criteria | | Packaging Visual Inspection | Confirm that the proposed packaging system has no visible defects that would result in exposure of the primary package or IFU | PASS: Samples met the established acceptance criteria | | Packaging Dye Leak | Evaluate sterile package integrity by detecting and locating defects in package seals and pinholes in the packaging materials | PASS: Samples met the established acceptance criteria | ## Performance Testing - Animal No animal testing was required as appropriate verification and validation of the subject device were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing. ## Performance Testing - Clinical No clinical studies were required as appropriate verification and validation of the subject device were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing. {7}------------------------------------------------ ## Sterilization The CERENOVUS Large Bore Catheter, 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 11135-1. The CERENOVUS Large Bore Catheter and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CERENOVUS Large Bore Catheter and all accessories are for single use only. ## Shelf-Life Testing The CERENOVUS Large Bore 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. ## Biocompatibility Testing The CERENOVUS Large Bore Catheter was assessed for biocompatibility in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process." and FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Issued June 16, 2016). The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The following Biocompatibility Testing was completed as part of this evaluation: | Summary of Catheter Biocompatibility Testing | | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------| | Test | Summary of Results | Conclusion | | Cytotoxicity (MEM Elution) | The test article extract showed no evidence of causing cell lysis or toxicity (grade = 0). The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity). | The test article is considered non-cytotoxic. PASS | | Sensitization (Maximization Study) | The test article exacts showed no evidence of causing delayed dermal contact sensitization (all erythema scores =0). | The test article was not considered a sensitizer. PASS | | Irritation (Intracutaneous Reactivity) | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control overall mean score was 0.0 for both the saline and the sesame oil test article extracts. | The test article is considered a non-irritant. PASS | | Acute Systemic Toxicity | There was no mortality or evidence of systemic toxicity from the extracts injected into the mice. Each test article extract met the requirements of the study. | The test article does not indicate signs of toxicity. PASS | | Pyrogenicity (Material Mediated) | No single animal showed a temperature rise of 0.5 °C or more above its baseline temperature. The total rise of the rabbits' temperature during 3 hours was 0.4 °C. The total rise of rabbit temperatures during the 3 hour observation period was within the acceptable USP limits. | The test article was judged as nonpyrogenic. PASS | | In Vitro Hemolysis | The hemolytic index for the test article in direct contact with blood was 0.0%, and the hemolytic index for the test article extract was 0.0%. | The test article is non- hemolytic. PASS | {8}------------------------------------------------ | Summary of Catheter Biocompatibility Testing (Continued) | | | |-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Test | Summary of Results | Conclusion | | Complement Activation | The concentration of SC5b-9 in the Test Group 1 was 8,712.8 ± 427.3 ng/mL (mean ± S.D.) which was higher and statistically different (p=0.0059) than the activated NHS control, and was higher however not statistically different (p=0.2048) than the negative control. | The test article was not considered to be a potential activator of the complement system. PASS | | | The concentration of SC5b-9 in the Test Group 2 was higher and statistically different than the activated NHS control, and was not higher nor statistically different than the negative control. | | | | The concentration of SC5b-9 in the Test Group 3 was higher however not statistically different than the activated NHS control, and was not higher nor statistically different than the negative control. | | | In Vivo Thromboresistan ce Study - Jugular Vein | Slight thrombus formation was noted with both the test and control articles (Grade ≤ 2). Therefore, both test and control articles were considered thromboresistant. | Both test and control articles were considered thromboresistant. PASS | | ISO 10993-18 Chemical Characterization (Exaggerated Extraction) | FTIR: No bands of interest GC/MS: No semi-volatile compounds greater than the quantitation limit ICP/MS: trace amounts of Mg, Zn, and Sb detected UPLC/MS: No compounds greater than the quantitation limit GC/MS HS: No volatile compounds greater than the quantitation limit | Extractable compounds do not present a toxicological risk to patients | | | FTIR: Most closely matches Pebax 4033 SN 00t GC/MS: 3 peaks identified UPLC/MS: Irganox 1010 standard analysis | Extractable compounds do not present a toxicological risk to patients | | | FTIR: Most closely matches Nylon compound 600 GC/MS: No semi-volatile compounds greater than the quantitation limit UPLC/MS: Irganox 1010 | Extractable compounds do not present a toxicological risk to patients | | Summary of Introducer Biocompatibility Testing | | | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | Test | Summary of Results | Results | | Cytotoxicity (MEM Elution) | The test article extract showed no evidence of causing cell lysis or toxicity (grade = 0). The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity). | The test article is considered non-cytotoxic. PASS | | Sensitization (Maximization Study) | The test article exacts showed no evidence of causing delayed dermal contact sensitization (all erythema scores =0). The test article was not considered a sensitizer. | The test article is not considered a sensitizer. PASS | | Irritation (Intracutaneous Reactivity) | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control overall mean score was 0.0 for both the saline and the sesame oil test article extracts. | The test article is considered a non-irritant. PASS | | Acute Systemic Toxicity | There was no mortality or evidence of systemic toxicity from the extracts injected into the mice. Each test article extract met the requirements of the study. | The test article does not indicate signs of toxicity. PASS | | Pyrogenicity (Material Mediated) | No single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the rabbits' temperature during 3 hours was 0.0°C. The total rise of rabbit temperatures during the 3 hour observation period was within the acceptable USP limits. The test article was judged as nonpyrogenic. | The test article was judged as nonpyrogenic. PASS | | In Vitro Hemolysis | The hemolytic index for the test article in direct contact with blood was 0.0%, and the hemolytic index for the test article extract was 0.0%. Both the test article in direct contact with blood and the test article extract were non-hemolytic. | The test article is non- hemolytic. PASS | {9}------------------------------------------------ | Summary of Introducer Biocompatibility Testing (Continued) | | | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Test | Summary of Results | Results | | Complement Activation | The concentration of SC5b-9 in the test article sample was higher and statistically different than the activated NHS control, and was higher however not statistically different than the negative control. The test article was not considered to be a potential activator of the complement system. | The test article was not considered to be a potential activator of the complement system. PASS | | Chemical Characteriza- tion | No peaks of significant interest, nor any residues in the extract found above the quantitation limits. | No presence of extractables | ## Conclusion Based upon the intended use, design, materials, function, and side-by-side in-vitro testing, it is concluded that the subject device, CERENOVUS Large Bore Catheter is substantially equivalent to the predicate device, AXS Catalyst Distal Access Catheter (K183463, cleared 13 March 2019). The differences in verbiage in the Indications for Use statement, materials, and design, do not raise any questions regarding the safety and effectiveness of the device. The device, as designed, manufactured, packaged and sterilized, is substantially equivalent to the primary and referenced predicate device(s) currently marketed under the Federal Food, Drug and Cosmetic Act.