(251 days)
The CEREGLIDE™ 71 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE™ 71 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
The CEREGLIDE™ 71 Intermediate 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 radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief. 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.
The CEREGLIDE™ 71 Intermediate Catheter is a medical device for facilitating neurovascular interventions. The document provided outlines the non-clinical performance data to demonstrate its substantial equivalence to a legally marketed predicate device, the CERENOVUS Large Bore Catheter (K191237).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CEREGLIDE™ 71 Intermediate Catheter are implicitly defined by a series of bench tests and biocompatibility tests, with the reported performance consistently being "PASS" or "Samples met the established acceptance criteria," sometimes exceeding comparator devices.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Design Verification | 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 | |
| Catheter OD | Catheter outer diameters meet requirements. | PASS: Samples met the established acceptance criteria | |
| Catheter Working Length | Working length of the catheter as defined in ISO 10555-1 Section 3.6. | PASS: Samples met the established acceptance criteria | |
| Catheter Tip Length | Catheter tip length meets requirements. | PASS: Samples met the established acceptance criteria | |
| System Air Leakage | No air leak into the hub subassembly. | PASS: Samples met the established acceptance criteria | |
| System Liquid Leakage | Catheter joint strength meets the freedom from leakage (liquid during pressurization) requirements of ISO 10555-1:2013, section 4.7. | PASS: Samples met the established acceptance criteria | |
| Delamination of PTFE Liner | PTFE 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 the tip column stiffness requirement. | PASS: Samples met the established acceptance criteria | |
| Tip Linear Stiffness | Tip flexibility of the Catheter is acceptable, relative to other devices of similar design. | PASS: Samples met the established acceptance criteria | |
| Coating Lubricity and Durability | Lubriciousness and durability of the Catheter's hydrophilic coating are verified. | PASS: Samples met the established acceptance criteria | |
| Coating Length | Catheter hydrophilic coating length meets the design requirements. | PASS: Samples met the established acceptance criteria | |
| Peak Tensile Strength | Catheter joint strength meets the requirements of Section 4.5 of ISO 10555-1. | PASS: Samples met the established acceptance criteria | |
| Introducer ID | Introducer internal diameters meet the requirements. | PASS: Samples met the established acceptance criteria | |
| Particulate Count | Coating integrity of the Catheter's outer surface meets the requirements for content of Particle Matter in alignment with USP<788> counting methods and compared to the reference predicate device. | PASS: Samples met the established acceptance criteria | |
| Burst Pressure | Catheter can withstand the maximum hydrostatic pressure. | PASS: Samples met the established acceptance criteria | |
| Introducer Working Length | Working length of the introducer is confirmed. | PASS: Samples met the established acceptance criteria | |
| Introducer Separation Force | Force required to separate the introducer is confirmed. | PASS: Samples met the established acceptance criteria | |
| Torque Test | Number of revolutions to failure of the Catheter in simulated anatomy meets or exceeds established criteria. | PASS: Samples exceeded comparator devices in revolutions to failure | |
| Design Validation | In Vitro Usability Studies | Usability parameters such as trackability, tip stability, durability, and (ancillary) device compatibility with tracking of the Catheter to target sites and delivery of a stent-retriever in the neurovascular model are acceptable. | PASS: Samples met the established acceptance criteria |
| Biocompatibility | Chemical Characterization | Determination of extractable species from the test article in purified water, isopropyl alcohol, and hexane is acceptable. | PASS |
| Cytotoxicity | Lack of potential cytotoxic effects using monolayers of L-929 mouse fibroblast cells when evaluated with 1X MEM extract. | PASS | |
| Sensitization – Guinea Pig Maximization | No allergenic potential or sensitizing capacity. | PASS | |
| Irritation - Rabbit Intracutaneous Reactivity | No chemicals that may leach or be extracted capable of causing local irritation in the dermal tissues of rabbits. | PASS | |
| Acute Systemic Toxicity in Mice | No potential toxic effects as a result of a single-dose systemic injection in mice. | PASS | |
| Pyrogenicity – Materials Mediated Rabbit Pyrogen | No febrile response in rabbits caused by a saline extract of the test article. | PASS | |
| ASTM Hemolysis Study: Direct and Extraction Methods | Acceptable hemolytic potential of the test articles and test article extract according to ASTM method (F756-17). | PASS | |
| SC5b-9 Complement Activation Assay | Test article is not capable of generating the activation fragment, SC5b-9, which contributes to inflammatory immune response in humans, as measured in Normal Human Serum (NHS). | PASS | |
| ASTM Heparinized Platelet and Leukocyte Count | Medical materials exposed to human whole blood do not adversely affect the platelet and leukocyte ratios in whole blood. | PASS | |
| ASTM Partial Thromboplastin Time (PTT) | No coagulation abnormalities in the intrinsic coagulation pathway that would indicate an adverse effect. | PASS | |
| In Vivo Thromboresistance | Acceptable thrombogenic potential of a blood contacting medical device in comparison to a predicate device. | PASS | |
| Shelf-Life | Stability Testing | Device maintains its performance and safety for 1 year when subjected to standard transportation conditioning and aging. | PASS: Results of testing on the subject device all met established acceptance criteria. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states: "All testing was conducted using sampling methods as required by internal procedure." Specific sample sizes for each test are not explicitly provided.
The data provenance is non-clinical bench testing and in-vitro testing. There is no mention of human clinical data or patient data. Therefore, there is no country of origin or retrospective/prospective distinction for patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device's evaluation relies on objective engineering and material science tests (bench and in-vitro, and biocompatibility tests), not expert interpretation of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" established by experts in this context.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. As the studies described are bench and biocompatibility tests, human adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a device clearance based on substantial equivalence using non-clinical performance data, not an AI or diagnostic imaging device requiring human reader interaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This pertains to an intermediate catheter, which is a physical medical device, not a software algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the non-clinical tests is established by pre-defined engineering specifications, material properties, and regulatory standards (e.g., ISO standards, ASTM methods, USP guidance). The device's performance is compared against these objective criteria. For the biocompatibility tests, the "ground truth" is typically the absence of adverse biological reactions as defined by the specific test (e.g., no cytotoxicity, no sensitization, no irritation).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established**
Not applicable. As there is no training set, there is no ground truth establishment for it.
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March 9, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cerenovus, Inc. Ariell Joiner, Ph.D. Manager, Regulatory Affairs 6303 Blue Lagoon Drive, Suite 315 Miami. Florida 33126
Re: K221930
Trade/Device Name: CEREGLIDE 71 Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: February 2, 2023 Received: February 3, 2023
Dear Ariell Joiner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221930
Device Name
CEREGLIDE™ 71 Intermediate Catheter
Indications for Use (Describe)
The CEREGLIDE™ 71 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE™ 71 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K221930
| I. Submitter | Cerenovus, Inc.6303 Blue Lagoon DriveSuites 215 & 315Miami, FL 33126 USA |
|---|---|
| Contact Person: Ariell JoinerTel: (908) 249-0182Email: aioiner@its.ini.com |
II. Date Prepared
March 8, 2023
III. Device Information
| Table 1. Device Information | |
|---|---|
| Device Proprietary Name | CEREGLIDE™ 71 Intermediate Catheter |
| Common or Usual name | Catheter, Percutaneous, Neurovasculature |
| Classification Name | 21 CFR 870.1250 – Catheter, Percutaneous |
| Regulatory Classification | II |
| FDA Product Code | QJP |
IV. Predicate Device Information
V. Device
The primary predicate device is listed below in Table 2 and the reference device is listed in Table 3.
| Table 2. Primary Predicate Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K191237 | November 8.2019 | CERENOVUS LargeBore Catheter | Medos InternationalSARL* |
| *510(k) was previously held by Codman & Shurtleff, Inc. The 510(k) was transferred to | |||
| Medos International SARL, which is the current holder of the 510(k). |
| Table 3. Reference Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K150366 | March 27, 2015 | SOFIA PLUS/DistalAccess Catheter | MicroVention, Inc. |
The CEREGLIDE™ 71 Intermediate Catheter is a variable stiffness, single lumen Description catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the end of the catheter hub. An ID band is placed at the distal end of the hub over a strain relief.
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| V. DeviceDescription,continued | The catheter is packaged with a Tuohy Borst rotating hemostasis valve (RHV) with aside port and two slit introducers as accessories. The RHV with side port is used forflushing and insertion of catheters. The slit introducers are designed to introduce thecatheter into the base catheter and protect the distal tip of the catheter during insertioninto the RHV of the base catheter. |
|---|---|
| VI. Indicationsfor Use | The CEREGLIDE™ 71 Intermediate Catheter is indicated for use in facilitating theinsertion and guidance of appropriately sized interventional devices into a selectedblood vessel in the neurovascular system. The CEREGLIDE™ 71 IntermediateCatheter is also indicated for use as a conduit for retrieval devices. |
| VII. PredicateComparison | A comparison of the similarities and differences of product features between theCEREGLIDE™ 71 Intermediate Catheter and the predicate device is presented inTable 4. |
| Table 4. Subject and Predicate Device Comparison Summary | ||
|---|---|---|
| Description | Subject Device:CEREGLIDETM 71 Intermediate Catheter | Predicate Device:CERENOVUS Large Bore Catheter(K191237) |
| Product Code | QJP | DQY |
| Regulatory Name | Catheter, Percutaneous | Same |
| Classification | Class II - 21 CFR 870.1250 | Same |
| Basic Design | Variable stiffness single lumen catheter | Same |
| Indications ForUse | The CEREGLIDETM 71 Intermediate Catheter is indicatedfor use in facilitating the insertion and guidance ofappropriately sized interventional devices into a selectedblood vessel in the neurovascular system. TheCEREGLIDETM 71 Intermediate Catheter is alsoindicated for use as a conduit for retrieval devices. | The CERENOVUS Large Bore Catheter is indicated for use infacilitating the insertion and guidance of appropriatelysized interventional devices into a selected blood vessel in theneurovascular system. The CERENOVUS Large BoreCatheter is also indicated for use as a conduit for retrievaldevices. |
| Dimensions: | ||
| Length | 115 - 137cm | 125 - 135cm |
| Inner Diameter(ID) | 0.071" | Same |
| Distal OuterDiameter (OD) | 0.082"(0.0825" max) | 0.081" |
| Proximal OD | 0.0837" max | 0.0825" |
| Catheter Coating | Hydrophilic | Same |
| Coating Length | 55 cm | 30 cm |
| Materials: | ||
| Marker Band | Metal Platinum (90%) / Iridium (10%) | Same |
| Braid | Stainless Steel | Same |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Same |
| Strain Relief | Same | Same |
| Outer Jacket | Pebax and Urethane | Pebax, Urethane, Nylon |
| Accessories Included: | ||
| Hemostasis Valve | Included: Tuohy Borst Hemostasis Valve with Side PortExtension Tubing | Same |
| IntroducerSheath | Introducer (2) | Peel-Away Sheath Introducer (2) |
| SterilizationMethod | Ethylene Oxide | Same |
| SterilityAssurance Level(SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch,Carton | Same |
| Shelf Life | 1 year | 1 year |
Continued on next page
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VIII. Non-Clinical Performance Data
Performance Testing - Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the CEREGLIDE™ 71 Intermediate Catheter to demonstrate that it is substantially equivalent to the legally marketed predicate device. The following performance data are being provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by internal procedure. The bench testing included the following tests:
| Table 5. Performance Testing Summary | ||
|---|---|---|
| Test | Test Summary | Result |
| Design Verification | ||
| VisualInspection | Confirm that the Catheter meets the visual requirementdescribed in ISO 10555-1 Section 4.4. | PASS:Samples met the establishedacceptance criteria |
| Catheter ID | Verify that the Catheter internal diameters meet therequirements. | PASS:Samples met the establishedacceptance criteria |
| Catheter OD | Verify that the Catheter outer diameters meet the requirements. | PASS:Samples met the establishedacceptance criteria |
| CatheterWorkingLength | Confirm the working length of the catheter as defined in ISO10555-1 Section 3.6. | PASS:Samples met the establishedacceptance criteria |
| Catheter TipLength | Verify the catheter tip length of the Catheter. | PASS:Samples met the establishedacceptance criteria |
| System AirLeakage | Verify that there is no air leak into the hub subassembly. | PASS:Samples met the establishedacceptance criteria |
| System LiquidLeakage | Verify that the catheter joint strength meets the freedom fromleakage (liquid during pressurization) requirements of ISO10555-1:2013, section 4.7. | PASS:Samples met the establishedacceptance criteria |
| Delamination ofPTFE Liner | Verify that the PTFE has appropriately adhered to the innerlumen of the Catheter with braid reinforcement. | PASS:Samples met the establishedacceptance criteria |
| Kink (Distal &Proximal) | Confirm that the Catheter meets the requirement for thecatheter to remain stable and not kink during use. | PASS:Samples met the establishedacceptance criteria |
| Tip Movement | Confirm that the Catheter meets the tip column stiffnessrequirement. | PASS:Samples met the establishedacceptance criteria |
| Tip LinearStiffness | Test the tip flexibility of the Catheter, relative to other devicesof similar design. | PASS:Samples met the establishedacceptance criteria |
| CoatingLubricity andDurability | Verify the lubriciousness and durability of the Catheter'shydrophilic coating. | PASS:Samples met the establishedacceptance criteria |
| Coating Length | Verify that the Catheter hydrophilic coating length meets thedesign requirements. | PASS:Samples met the establishedacceptance criteria |
| Peak TensileStrength | Verify that the Catheter joint strength meets the requirements ofSection 4.5 of ISO 10555-1. | PASS:Samples met the establishedacceptance criteria |
| Introducer ID | Verify that the introducer internal diameters meet therequirements. | PASS:Samples met the establishedacceptance criteria |
| ParticulateCount | Verify that the coating integrity of the Catheter's outer surfacemeets the requirements for content of Particle Matter inalignment with USP<788> counting methods and compared tothe reference predicate device. | PASS:Samples met the establishedacceptance criteria |
| Table 5. Performance Testing Summary, continued | ||
| Test | Test Summary | Result |
| Design Verification, continued | ||
| Burst Pressure | Confirm the maximum hydrostatic pressure the Cathetercan withstand using a Crescent Hydraulic Burst-leakTester. | PASS:Samples met the establishedacceptance criteria |
| Introducer WorkingLength | Confirm the working length of the introducer. | PASS:Samples met the establishedacceptance criteria |
| IntroducerSeparation Force | Confirm the force required to separate the introducer. | PASS:Samples met the establishedacceptance criteria |
| Torque Test | To determine the number of revolutions to failure of theCatheter in simulated anatomy. | PASS:Samples exceeded comparatordevices in revolutions to failure |
| Design Validation | ||
| In Vitro UsabilityStudies | The in-vitro studies were conducted to evaluate usabilityparameters such as trackability, tip stability, durability, and(ancillary) device compatibility with tracking of theCatheter to target sites and delivery of a stent-retriever inthe neurovascular model. | PASS:Samples met the establishedacceptance criteria |
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VIII. Non-Clinical Performance Data, continued
Performance Testing - Animal
No animal studies were required as appropriate verification and validation of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing.
Performance Testing - Clinical
Clinical studies were not required as appropriate verification and validation of the device design were achieved based on the similarities of the proposed device and the predicate device, and from results of bench testing.
Sterilization
The CEREGLIDE™ 71 Intermediate Catheter, as packaged with included accessories, is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 106 in accordance with ISO 11135. The CEREGLIDE™ 71 Intermediate Catheter and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CEREGLIDE™ 71 Intermediate Catheter and all accessories are for single use only.
Shelf-Life
The CEREGLIDE™ 71 Intermediate Catheter will have a shelf life of one year based on the successful completion of stability testing. Shelf life testing was performed using standard test methods and acceptance criteria. Prior to aging, all samples were exposed to standard transportation conditioning. Results of testing on the subject device all met established acceptance criteria.
Continued on next page
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VIII. Non-Clinical Performance Data, continued
Biocompatibility Testing
A biological safety evaluation was conducted on the CEREGLIDE™ 71 Intermediate Catheter in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", (Issued June 16, 2016) based on the changes to the predicate device, CERENOVUS Large Bore Catheter (K191237). Biocompatibility testing was conducted in accordance with International Standard ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing Within a Risk Management Process (2018).
The following testing was performed:
| Table 6. Biocompatibility Test Summary for CEREGLIDE™ 71 Intermediate | ||
|---|---|---|
| Catheter and Introducer | ||
| Test | Test Summary | Results |
| ChemicalCharacterization | Determination of extractable species from the test article wasperformed in purified water, isopropyl alcohol, and hexane. | PASS |
| Cytotoxicity | Cytotoxicity Study Using the ISO Elution Method (compliantwith ISO 10993-5:2009/(R)2014 and ISO 10993-12:2012).1X MEM extract (6 cm²/ mL at 37°C for 72 hours) was evaluatedfor potential cytotoxic effects using monolayers of L-929 mousefibroblast cells. | PASS |
| Sensitization –Guinea PigMaximization | Evaluation of the allergenic potential or sensitizing capacity of atest article by screening of contact allergens in guinea pigs andextrapolating the results to humans. | PASS |
| Irritation - RabbitIntracutaneousReactivity | Determination of any chemicals that may leach or be extractedfrom the test article capable of causing local irritation in thedermal tissues of rabbits. | PASS |
| Acute SystemicToxicity in Mice | Screening of test article extracts for potential toxic effects as aresult of a single-dose systemic injection in mice. | PASS |
| Pyrogenicity –Materials MediatedRabbit Pyrogen | Determination if a saline extract of the test article causes afebrile response in rabbits. | PASS |
| ASTM HemolysisStudy: Direct andExtraction Methods | Evaluation of the hemolytic potential of the test articles and testarticle extract according to ASTM method (F756-17). | PASS |
| SC5b-9ComplementActivation Assay | Measure of complement activation in Normal Human Serum(NHS) indicates whether a test article is capable of generating theactivation fragment, SC5b-9, which in turn contributes to theinflammatory immune response in humans. | PASS |
| ASTM HeparinizedPlatelet andLeukocyte Count | Determination if medical materials exposed to human wholeblood would adversely affect the platelet and leukocyte ratios inwhole blood. | PASS |
| ASTM PartialThromboplastinTime (PTT) | Screening for detection of coagulation abnormalities in theintrinsic coagulation pathway. The PTT indirectly measures theformation of thrombin by its action on fibrinogen, forming thefibrin clot through a method compliant with ISO 10993-4. | PASS |
| In VivoThromboresistance | Evaluate the thrombogenic potential of a blood contactingmedical device in comparison to a predicate device. | PASS |
Continued on next page
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IX. Conclusion
Based upon the intended use, design, materials, function, and side-by-side in-vitro and in-vivo testing, it is concluded that the subject device, CEREGLIDE™ 71 Intermediate Catheter is substantially equivalent to the predicate device, CERENOVUS Large Bore Catheter (K191237). The differences in materials and design do not raise new questions regarding the safety and effectiveness of the device. The device, as designed, manufactured, packaged and sterilized, is substantially equivalent to the primary predicate and reference devices currently marketed under the Federal Food, Drug and Cosmetic Act.
§ 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).