(184 days)
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 CERENOVUS Large Bore Catheter is a variable stiffness, single lumen 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 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.
Here's the information about the acceptance criteria and the study proving the device meets them, based on the provided text:
Note: The provided document is a 510(k) summary for a medical device (CERENOVUS Large Bore Catheter). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy in the same way a new drug or high-risk device might. Therefore, the "study" described is primarily a series of bench tests and biocompatibility assessments, not clinical trials comparing device performance with and without AI, or studies involving human experts for ground truth establishment. Many of the specific points requested (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study effect size, standalone performance, training set details) are generally not applicable or not reported in this type of document for a Class II percutaneous catheter.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Catheter meets visual requirements described in ISO 10555-1 Section 4.4 | PASS: Samples met the established acceptance criteria |
| Catheter ID | Catheter internal diameters meet requirements | PASS: Samples met the established acceptance criteria |
| Introducer ID | Introducer internal diameters meet requirements | PASS: Samples met the established acceptance criteria |
| Catheter OD | Catheter outer diameters meet requirements | PASS: Samples met the established acceptance criteria |
| Introducer OD | Introducer outer diameters meet requirements | PASS: Samples met the established acceptance criteria |
| Catheter Working Length | Catheter working length confirms to ISO10555-1 Section 3.6 | PASS: Samples met the established acceptance criteria |
| Introducer Working Length | Introducer working length confirms to requirements | PASS: Samples met the established acceptance criteria |
| Distal Tip Length | Distal tip length of catheter meets requirements | PASS: Samples met the established acceptance criteria |
| Hub Luer Taper | Catheter hub luer taper fits standard luer fittings using a taper device | PASS: Samples met the established acceptance criteria |
| Air Leak testing | No air leak into the hub subassembly | PASS: Samples met the established acceptance criteria |
| System Liquid Leakage | Catheter joint strength meets 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 | PTFE has appropriately adhered to the inner lumen of the catheter with braid reinforcement | PASS: Samples met the established acceptance criteria |
| Kink (Distal & Proximal) | Catheter remains stable and does not kink during use | PASS: Samples met the established acceptance criteria |
| Tip Movement | Catheter meets tip column stiffness requirement | PASS: Samples met the established acceptance criteria |
| Tip Linear Stiffness | Demonstrates tip flexibility relative to other devices of similar design | PASS: Samples met the established acceptance criteria |
| Coating Lubricity & Durability | Lubriciousness and durability of the catheter hydrophilic coating | PASS: Samples met the established acceptance criteria |
| Coating Length | Catheter hydrophilic coating length meets design requirements | PASS: Samples met the established acceptance criteria |
| Catheter Tensile Strength | Catheter joint strength meets requirements of Section 4.5 of ISO 10555-1 | PASS: Samples met the established acceptance criteria |
| Introducer Separation Force | Force required to separate the peel-away introducer accessory | PASS: Samples met the established acceptance criteria |
| Particle Count | Coating integrity of the catheter's outer surface meets requirements for content of particulates | PASS: Samples met the established acceptance criteria |
| Burst Pressure (static) | Maximum hydrostatic pressure a catheter can withstand | 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. | PASS: Samples met the established acceptance criteria |
| Packaging Visual Inspection | 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 | Sterile package integrity by detecting and locating defects in package seals and pinholes in the packaging materials | PASS: Samples met the established acceptance criteria |
| Biocompatibility (Catheter) | ||
| Cytotoxicity (MEM Elution) | Test article extract shows no evidence of causing cell lysis or toxicity (grade < 2) | PASS: Grade = 0, considered non-cytotoxic |
| Sensitization (Maximization Study) | Test article extracts show no evidence of causing delayed dermal contact sensitization (all erythema scores =0) | PASS: Not considered a sensitizer |
| Irritation (Intracutaneous Reactivity) | Difference between test and control mean scores is 0.0 for saline and sesame oil | PASS: Considered a non-irritant |
| Acute Systemic Toxicity | No mortality or evidence of systemic toxicity from extracts | PASS: Does not indicate signs of toxicity |
| Pyrogenicity (Material Mediated) | No single animal shows temperature rise of ≥ 0.5 °C; total rise within USP limits | PASS: Judged as nonpyrogenic |
| In Vitro Hemolysis | Hemolytic index for direct contact and extract is 0.0% | PASS: Non-hemolytic |
| Complement Activation | Not considered a potential activator of the complement system | PASS: Not considered a potential activator of the complement system |
| In Vivo Thromboresistance Study - Jugular Vein | Thrombus formation is slight (Grade ≤ 2) for both test and control articles | PASS: Both test and control articles considered thromboresistant |
| ISO 10993-18 Chemical Characterization | Extractable compounds do not present a toxicological risk to patients | PASS: Extractable compounds do not present a toxicological risk |
| Biocompatibility (Introducer) | ||
| Cytotoxicity (MEM Elution) | Test article extract shows no evidence of causing cell lysis or toxicity (grade < 2) | PASS: Grade = 0, considered non-cytotoxic |
| Sensitization (Maximization Study) | Test article extracts show no evidence of causing delayed dermal contact sensitization (all erythema scores =0) | PASS: Not considered a sensitizer |
| Irritation (Intracutaneous Reactivity) | Difference between test and control mean scores is 0.0 for saline and sesame oil | PASS: Considered a non-irritant |
| Acute Systemic Toxicity | No mortality or evidence of systemic toxicity from extracts | PASS: Does not indicate signs of toxicity |
| Pyrogenicity (Material Mediated) | No single animal shows temperature rise of ≥ 0.5°C; total rise within USP limits | PASS: Judged as nonpyrogenic |
| In Vitro Hemolysis | Hemolytic index for direct contact and extract is 0.0% | PASS: Non-hemolytic |
| Complement Activation | Not considered a potential activator of the complement system | PASS: Not considered to be a potential activator of the complement system |
| Chemical Characterization | No peaks of significant interest, nor any residues in the extract found above quantitation limits | PASS: No presence of extractables |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document repeatedly states "Samples met the established acceptance criteria" for bench tests. While the exact number of samples for each test is not explicitly given, it mentions, "All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures." For biocompatibility, some tests specify the number of animals (e.g., mice for systemic toxicity, rabbits for pyrogenicity, 3 for "In Vivo Thromboresistance Study - Jugular Vein").
- Data Provenance: The studies are bench testing (in-vitro physical and mechanical tests) and biocompatibility testing (in-vitro and some in-vivo animal tests).
- Country of Origin: Not specified, but likely performed by or for Codman & Shurtleff, Inc. (Raynham, MA, USA).
- Retrospective or Prospective: These were prospective tests conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. The device is a physical medical instrument (catheter), not an AI or diagnostic device that relies on expert interpretation for ground truth. "Ground truth" in this context is established by objective measurements based on engineering specifications and international standards (e.g., ISO, USP).
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is not a study requiring human adjudication for diagnostic ground truth. The acceptance is based on objective measurements and compliance with specified standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance was not performed and is not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Objective Measurements and Compliance with International Standards:
- Bench Testing: Engineering specifications (e.g., dimensions, strength, flow rates), and compliance with international standards such as ISO 10555-1 and related test methods.
- Sterilization: ISO 11135-1 and requirements for Ethylene Oxide residuals per EN ISO 10993-7 for SAL of 10⁻⁶.
- Biocompatibility: ISO 10993-1, specific parts of ISO 10993 for various tests (e.g., cytotoxicity, sensitization, irritation), and USP limits for pyrogenicity.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in this context refers to the development and manufacturing process based on established engineering principles.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no training set in the AI sense. The design and manufacturing processes are validated against established engineering and quality control standards.
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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
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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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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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 DriveRaynham, MA 02767 |
|---|---|
| Contact | Kirsten FrancoPhone: (484) 868-7991Email: kfranco5@its.jnj.com |
| Date Prepared | June 19, 2019 |
| Device Tradeor ProprietaryName | CERENOVUS Large Bore Catheter |
| DeviceClassification | Regulatory Classification: IICommon or Usual Name: Catheter, PercutaneousClassification Name: Percutaneous CatheterRegulation Number: 21 CFR 870.1250Product Code: DQYClassification Panel: Cardiovascular |
| PredicateDevice | 510(k)Number | Date Cleared | Device Name | Manufacturer |
|---|---|---|---|---|
| K183463 | March 13, 2019 | AXS Catalyst Distal AccessCatheter | Stryker Neurovascular |
Continued on next page
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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 infacilitating the insertion and guidance of appropriately sizedinterventional devices into a selected blood vessel in theneurovascular system. The CERENOVUS Large BoreCatheter is also indicated for use as a conduit for retrievaldevices. | The AXS Catalyst Distal Access Catheter isindicated for use in facilitating the insertion andguidance of appropriately sized interventionaldevices into a selected blood vessel in theperipheral and neurovascular systems. The AXSCatalyst Distal Access Catheter is also indicatedfor 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
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| 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 BorstValve with Sideport |
| IntroducerSheath | Peel-Away Sheath Introducer (2) | Same |
| SterilizationMethod | Ethylene Oxide | Same |
| Sterility AssuranceLevel (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 criteriaPASS: | ||
| 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 LiquidLeakage | freedom from leakage (liquid during | PASS: |
| pressurization) requirements of ISO 10555- | Samples met the established | |
| 1:2013. section 4.7 | acceptance criteria | |
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| Test | Test Summary | Result |
|---|---|---|
| Delamination ofPTFE Liner | Verify that the PTFE has appropriately adheredto the inner lumen of the catheter with braidreinforcement | PASS:Samples met the establishedacceptance criteria |
| Kink (Distal &Proximal) | Confirm that the CERENOVUS Large BoreCatheter meets the requirement for the catheterto remain stable and not kink during use | PASS:Samples met the establishedacceptance criteria |
| Tip Movement | Confirm that the CERENOVUS Large BoreCatheter meets the tip column stiffnessrequirement | PASS:Samples met the establishedacceptance criteria |
| Tip LinearStiffness | Test the tip flexibility of the CERENOVUSLarge Bore Catheter, relative to other devices ofsimilar design | PASS:Samples met the establishedacceptance criteria |
| Coating Lubricity& Durability | Verify the lubriciousness and durability of thecatheter hydrophilic coating | PASS:Samples met the establishedacceptance criteria |
| Coating Length | Verify that the catheter hydrophilic coatinglength meets the design requirements | PASS:Samples met the establishedacceptance criteria |
| Catheter TensileStrength | Verify that the catheter joint strength meets therequirements of Section 4.5 of ISO 10555-1 | PASS:Samples met the establishedacceptance criteria |
| IntroducerSeparation Force | Confirm the force required to separate the peel-away introducer accessory | PASS:Samples met the establishedacceptance criteria |
| Particle Count | Verify that the coating integrity of the catheter'souter surface meets the requirements for contentof particulates. | PASS:Samples met the establishedacceptance criteria |
| Burst Pressure(static) | Confirm the maximum hydrostatic pressure acatheter can withstand using a CrescentHydraulic Burst-leak Tester | PASS:Samples met the establishedacceptance criteria |
| In-vitro UsabilityStudies | Evaluate catheter usability parameters such astrackability, tip stability and visibility underfluoroscopy, durability, etc. Subject andPredicate devices were tracked to the target siteto deliver a stent-retriever in the neurovascularmodel that replicates the tortuosity, diameterand location of the arteries in theneurovasculature. | PASS:Samples met theestablished acceptancecriteria |
| Packaging VisualInspection | Confirm that the proposed packaging system hasno visible defects that would result in exposureof the primary package or IFU | PASS:Samples met the establishedacceptance criteria |
| Packaging DyeLeak | Evaluate sterile package integrity by detectingand locating defects in package seals andpinholes in the packaging materials | PASS:Samples met the establishedacceptance 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.
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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 celllysis or toxicity (grade = 0). The test article extract met therequirements of the test since the grade was less than a grade2 (mild reactivity). | The test article is considerednon-cytotoxic.PASS |
| Sensitization(MaximizationStudy) | The test article exacts showed no evidence of causingdelayed dermal contact sensitization (all erythema scores=0). | The test article was notconsidered a sensitizer.PASS |
| Irritation(IntracutaneousReactivity) | The test article met the requirements of the test since thedifference between each test article extract overall meanscore and corresponding control overall mean score was 0.0for both the saline and the sesame oil test article extracts. | The test article is considereda non-irritant.PASS |
| Acute SystemicToxicity | There was no mortality or evidence of systemic toxicity fromthe extracts injected into the mice. Each test article extractmet the requirements of the study. | The test article does notindicate signs of toxicity.PASS |
| Pyrogenicity(MaterialMediated) | No single animal showed a temperature rise of 0.5 °C ormore above its baseline temperature. The total rise of therabbits' temperature during 3 hours was 0.4 °C. The totalrise of rabbit temperatures during the 3 hour observationperiod was within the acceptable USP limits. | The test article was judgedas nonpyrogenic.PASS |
| In VitroHemolysis | The hemolytic index for the test article in direct contact withblood was 0.0%, and the hemolytic index for the test articleextract was 0.0%. | The test article is non-hemolytic.PASS |
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| Summary of Catheter Biocompatibility Testing (Continued) | ||
|---|---|---|
| Test | Summary of Results | Conclusion |
| ComplementActivation | The concentration of SC5b-9 in the Test Group 1 was8,712.8 ± 427.3 ng/mL (mean ± S.D.) which was higher andstatistically different (p=0.0059) than the activated NHScontrol, and was higher however not statistically different(p=0.2048) than the negative control. | The test article was notconsidered to be a potentialactivator of the complementsystem.PASS |
| The concentration of SC5b-9 in the Test Group 2 was higherand statistically different than the activated NHS control, andwas not higher nor statistically different than the negativecontrol. | ||
| The concentration of SC5b-9 in the Test Group 3 was higherhowever not statistically different than the activated NHScontrol, and was not higher nor statistically different than thenegative control. | ||
| In VivoThromboresistance Study -Jugular Vein | Slight thrombus formation was noted with both the test andcontrol articles (Grade ≤ 2). Therefore, both test and controlarticles were considered thromboresistant. | Both test and control articleswere consideredthromboresistant.PASS |
| ISO 10993-18ChemicalCharacterization(ExaggeratedExtraction) | FTIR: No bands of interestGC/MS: No semi-volatile compounds greater than thequantitation limitICP/MS: trace amounts of Mg, Zn, and Sb detectedUPLC/MS: No compounds greater than the quantitation limitGC/MS HS: No volatile compounds greater than thequantitation limit | Extractable compounds donot present a toxicologicalrisk to patients |
| FTIR: Most closely matches Pebax 4033 SN 00tGC/MS: 3 peaks identifiedUPLC/MS: Irganox 1010 standard analysis | Extractable compounds donot present a toxicologicalrisk to patients | |
| FTIR: Most closely matches Nylon compound 600GC/MS: No semi-volatile compounds greater than thequantitation limitUPLC/MS: Irganox 1010 | Extractable compounds donot present a toxicologicalrisk to patients |
| Summary of Introducer Biocompatibility Testing | ||
|---|---|---|
| Test | Summary of Results | Results |
| Cytotoxicity (MEMElution) | 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 considerednon-cytotoxic.PASS |
| Sensitization(MaximizationStudy) | 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 notconsidered a sensitizer.PASS |
| Irritation(IntracutaneousReactivity) | 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 considereda non-irritant.PASS |
| Acute SystemicToxicity | 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 notindicate signs of toxicity.PASS |
| Pyrogenicity(MaterialMediated) | 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 judgedas nonpyrogenic.PASS |
| In VitroHemolysis | 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 |
| ComplementActivation | 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 |
| ChemicalCharacteriza-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.
§ 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).