(251 days)
The CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
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 euro 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 which can be used to attach accessories for flushing and aspiration. 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, insertion of catheters, and connection to an external aspiration system. 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 can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
The provided text describes the regulatory clearance of a medical device (CEREGLIDE™ 71 Intermediate Catheter and Cerenovus Aspiration Tubing Set) and outlines the non-clinical performance data used to demonstrate its substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven device or study parameters related to AI/ML performance evaluation. Therefore, I cannot extract the requested information based on the input.
However, I can provide a summary of the non-clinical performance data presented in the document, which are described as meeting acceptance criteria, albeit not for an AI/ML device.
Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML)
| Test | Acceptance Criteria Summary | 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 |
| 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 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, relative to other devices of similar design, is acceptable. | 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 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 requirements. | PASS: Samples met the established acceptance criteria |
| Particulate Count | Coating integrity of the Catheter's outer surface meets 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 a specified 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 acceptable. | PASS: Samples met the established acceptance criteria |
| Torque Test | Number of revolutions to failure of the Catheter in simulated anatomy. | PASS: Samples exceeded comparator devices in revolutions to failure |
| In Vitro Usability Studies | Thrombus retrieval patency/durability, (ancillary) device compatibility, and accessory durability demonstrated. Simulated use evaluation of user requirements related to trackability and tip stability during thrombus removal. | PASS: Samples met the established acceptance criteria |
| Biocompatibility (Chemical Characterization) | Determination of extractable species from the test article was performed in purified water, isopropyl alcohol, and hexane. | PASS |
| Biocompatibility (Cytotoxicity) | Evaluation of potential cytotoxic effects using monolayers of L-929 mouse fibroblast cells with 1X MEM extract. | PASS |
| Biocompatibility (Sensitization) | Evaluation of the allergenic potential or sensitizing capacity in guinea pigs. | PASS |
| Biocompatibility (Irritation) | Determination of local irritation in the dermal tissues of rabbits. | PASS |
| Biocompatibility (Acute Systemic Toxicity) | Screening of test article extracts for potential toxic effects from a single-dose systemic injection in mice. | PASS |
| Biocompatibility (Pyrogenicity) | Determination if a saline extract causes a febrile response in rabbits. | PASS |
| Biocompatibility (ASTM Hemolysis Study) | Evaluation of the hemolytic potential of the test articles. | PASS |
| Biocompatibility (SC5b-9 Complement Activation Assay) | Measure of complement activation in Normal Human Serum (NHS). | PASS |
| Biocompatibility (ASTM Heparinized Platelet and Leukocyte Count) | Determination if medical materials exposed to human whole blood would adversely affect platelet and leukocyte ratios. | PASS |
| Biocompatibility (ASTM Partial Thromboplastin Time (PTT)) | Screening for detection of coagulation abnormalities in the intrinsic coagulation pathway. | PASS |
| Biocompatibility (In Vivo Thromboresistance) | Evaluation of the thrombogenic potential of a blood contacting medical device in comparison to a predicate device. | PASS |
Since the provided document is a 510(k) clearance letter for a physical medical device (catheter and aspiration tubing set) and does not describe any AI/ML components or studies, I cannot answer the questions related to AI/ML specific evaluations:
- Sample size used for the test set and the data provenance: Not applicable, as there's no machine learning test set described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests would be the established engineering and biocompatibility standards and specific design requirements.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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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 blue 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: K221934
Trade/Device Name: CEREGLIDE 71 Intermediate Catheter: Cerenovus Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY 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-reporting-
combination-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) K221934
Device Name
CEREGLIDE™ 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
Indications for Use (Describe)
CEREGLIDE™ 71 Intermediate Catheter
The CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Cerenovus Aspiration Tubing Set
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K221934
I. Submitter Cerenovus, Inc. 6303 Blue Lagoon Drive Suites 215 & 315 Miami, FL 33126 USA Contact Person: Ariell Joiner
Tel: (908) 249-0182 Email: ajoiner@jts.jnj.com
II. Date Prepared
March 8, 2023
III. Device Information
| Table 1. Device Information | |
|---|---|
| Device Proprietary Name | CEREGLIDE™ 71 Intermediate Catheter; CerenovusAspiration Tubing Set |
| Common or Usual name | Catheter, Thrombus Retriever |
| Classification Name | 21 CFR 870.1250 - Catheter, Percutaneous |
| Regulatory Classification | II |
| FDA Product Code | NRY |
IV. Predicate Device Information
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 |
| K193380 | July 20, 2020 | CERENOVUS Large BoreCatheter; CERENOVUSAspiration Tubing Set | Medos InternationalSARL* |
| Table 3. Reference Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K173200 | June 11, 2018 | SOFIA Plus AspirationCatheter | MicroVention, Inc. |
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| V. Device Description | The CEREGLIDETM 71 Intermediate Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the euro 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 which can be used to attach accessories for flushing and aspiration. 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, insertion of catheters, and connection to an external aspiration system. 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 CEREGLIDET™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set. | |
| VI. Indications for Use | The CEREGLIDET™ 71 Intermediate Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter to the canister of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDET™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow. |
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VII. Predicate Comparison
A comparison of the similarities and differences of product features between the CEREGLIDE™ 71 Intermediate Catheter, Cerenovus Aspiration Tubing Set and the predicate device is presented in Table 4.
| Table 4. Subject and Predicate Device Comparison Summary | ||
|---|---|---|
| Description | Subject Device:CEREGLIDE™ 71 Intermediate Catheter; CerenovusAspiration Tubing Set | Predicate Device:CERENOVUS LargeBore Catheter (K193380) |
| Product Code | NRY | 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 CEREGLIDE™ 71 Intermediate Catheter, with the Cerenovus Aspiration TubingSet and a compatible aspiration pump, is indicated for use in the revascularization ofpatients with acute ischemic stroke secondary to intracranial large vessel occlusivedisease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar,and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligiblefor intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus LargeBore Catheter to the canister of the Nouvag Vacuson 60 Aspiration Pump (orequivalent vacuum pump) and to allow the user to control the fluid flow. TheCerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71Intermediate Catheter to the canister of a compatible aspiration pump and to allow theuser to control the fluid flow. | The CERENOVUS Large BoreCatheter, with the CERENOVUSAspiration Tubing Set andNOUVAG Vacuson 60 aspirationpump (or equivalent aspirationpump), is indicated for use in therevascularization of patients withacute ischemic stroke secondary tointracranial large vessel occlusivedisease (within the internal carotid,middle cerebral - M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptononset. Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA) or who fail IV t-PA therapy are candidates fortreatment.The CERENOVUS AspirationTubing Set is intended to connectthe CERENOVUS Large BoreCatheter to the canister of theNOUVAG Vacuson 60 AspirationPump (or equivalent vacuum pump)and to allow the user to control thefluid flow. |
| Dimensions: | ||
| Length | 115 - 137cm | 125 - 135cm |
| Inner Diameter (ID) | 0.071" | Same |
| Distal Outer | 0.082" | 0.081 " |
| Diameter (OD) | (0.0825" max) | |
| Proximal OD | 0.0837" max | 0.0825" |
| Catheter Coating | Hydrophilic | Same |
| Coating Length | 55 cm | 30 cm |
| Tip Configuration | Non-shapeable tip | Same |
| Materials: | ||
| Marker Band | Metal Platinum (90%) / Iridium (10%) | Same |
| Braid | Stainless Steel | Same |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Same |
| Strain Relief | Same | |
| Outer Jacket | Pebax and Urethane | Pebax, Urethane, Nylon |
| Table 4. Subject and Predicate Device Comparison Summary, continued | ||
| Description | Subject Device:CEREGLIDE™ 71 Intermediate Catheter; CerenovusAspiration Tubing Set | Predicate Device:CERENOVUS LargeBore Catheter (K193380) |
| Accessories Included:Hemostasis Valve | Included: Tuohy Borst Hemostasis Valve with Side Port Extension Tubing | Same |
| Introducer Sheath | Introducer (2) | Peel-Away Sheath Introducer (2) |
| Sterilization Method | Ethylene Oxide | Same |
| Sterility AssuranceLevel (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Same |
| Shelf Life | 1 year | 1 year |
| Required AdditionalAccessories | Cerenovus Aspiration Tubing Set (K193380)Compatible aspiration pump | Same |
| Aspiration Pump Requirements:Minimum AspirationPressure | -20 inHg (-68 kPa) | Same |
| Maximum AspirationPressure | -28 inHg (-95 kPa) | -29 inHg (-98kPa) |
| Flowrate (Air) | 0 to 60LPM | Same |
| Aspiration Tubing Requirements:Tubing ID | 0.110 in minimum | Same |
| Tubing Length | 112 in | Same |
| Flow ControlMechanism | Flow Control Switch | Same |
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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 |
| Table 5. Performance Testing Summary, continued | ||
| Test | Test Summary | Result |
| Design Verification | ||
| 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 |
| Burst Pressure | Confirm the maximum hydrostatic pressure the Catheter canwithstand using a Crescent Hydraulic Burst-leak Tester. | PASS:Samples met the establishedacceptance criteria |
| IntroducerWorkingLength | Confirm the working length of the introducer. | PASS:Samples met the establishedacceptance criteria |
| IntroducerSeparationForce | 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 VitroUsabilityStudies | The in-vitro studies were conducted to demonstrate thrombusretrieval patency/durability, (ancillary) device compatibility,and accessory durability. Studies also included simulated useevaluation of user requirements related to: trackability and tipstability during thrombus removal. | PASS:Samples met the establishedacceptance criteria |
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VIII. Non- Clinical Performance Data, continued
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VIII. Non-Performance Testing - Animal Clinical No animal studies were required as appropriate verification and validation of the Performance device design were achieved based on the similarities of the proposed device and the Data, continued 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.
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 (K193380). 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 IntermediateCatheter 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 |
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| VIII. Non-Clinical | Table 6. Biocompatibility Test Summary for CEREGLIDE™ 71 IntermediateCatheter and Introducer, continued | |||
|---|---|---|---|---|
| Performance | Test | Test Summary | Results | |
| Data, continued | 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 |
Based upon the intended use, design, materials, function, and side-by-side in-vitro and IX. Conclusion in-vivo testing, it is concluded that the subject device, CEREGLIDE™ 71 Intermediate Catheter, Cerenovus Aspiration Tubing Set is substantially equivalent to the predicate device, CERENOVUS Large Bore Catheter, CERENOVUS Aspiration Tubing Set (K193380). 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).