(251 days)
No
The device description and performance studies focus on the mechanical and material properties of the catheter and tubing set, with no mention of AI or ML algorithms for image processing, diagnosis, or treatment planning.
Yes.
The device is used for revascularization in patients with acute ischemic stroke, which is a medical treatment aimed at restoring blood flow to an organ or tissue.
No
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. It is a treatment device, not a diagnostic one.
No
The device description clearly details a physical catheter and associated hardware components (tubing set, accessories like RHV and slit introducers). The performance studies also focus on physical characteristics and bench testing of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) for a therapeutic procedure (revascularization of acute ischemic stroke). IVDs are used to examine specimens from the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a catheter designed to be introduced into the neuro vasculature, which is an in-vivo application.
- Lack of In Vitro Testing: The performance studies described focus on bench testing, in vitro usability studies (simulating use, not analyzing patient samples), and biocompatibility testing. There is no mention of testing involving patient samples or analysis of biological markers.
- Anatomical Site: The specified anatomical site is within the intracranial vessels, confirming an in-vivo application.
Therefore, the CEREGLIDE™ 71 Intermediate Catheter and its associated components are medical devices used for an interventional procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. All testing was conducted using sampling methods as required by internal procedure. Key results from tests like Visual Inspection, Catheter ID, Catheter OD, Catheter Working Length, Catheter Tip Length, System Air Leakage, System Liquid Leakage, Delamination of PTFE Liner, Kink (Distal & Proximal), Tip Movement, Tip Linear Stiffness, Coating Lubricity and Durability, Coating Length, Peak Tensile Strength, Introducer ID, Particulate Count, Burst Pressure, Introducer Working Length, Introducer Separation Force, and Torque Test all met the established acceptance criteria. For the Torque Test, samples exceeded comparator devices in revolutions to failure.
Design Validation: In Vitro Usability Studies were conducted to demonstrate thrombus retrieval patency/durability, ancillary device compatibility, and accessory durability. Studies also included simulated use evaluation of user requirements related to: trackability and tip stability during thrombus removal. All samples met the established acceptance criteria.
Sterilization: The device is sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 10-6 in accordance with ISO 11135. It meets EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating.
Shelf-Life: The device has a shelf life of one year based on the successful completion of stability testing. Results of testing on the subject device all met established acceptance criteria.
Biocompatibility Testing: A biological safety evaluation was conducted in accordance with FDA guidance ISO 10993-1. Tests performed include Chemical Characterization, Cytotoxicity, Sensitization - Guinea Pig Maximization, Irritation - Rabbit Intracutaneous Reactivity, Acute Systemic Toxicity in Mice, Pyrogenicity - Materials Mediated Rabbit Pyrogen, ASTM Hemolysis Study: Direct and Extraction Methods, SC5b-9 Complement Activation Assay, ASTM Heparinized Platelet and Leukocyte Count, ASTM Partial Thromboplastin Time (PTT), and In Vivo Thromboresistance. All tests resulted in PASS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary 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; Cerenovus |
| Aspiration 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 Bore | |
| Catheter; CERENOVUS | |||
| Aspiration Tubing Set | Medos International | ||
| SARL* |
| Table 3. Reference Device | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| K173200 | June 11, 2018 | SOFIA Plus Aspiration | |
| Catheter | MicroVention, Inc. |
4
| 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. |
5
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; Cerenovus | ||
| Aspiration Tubing Set | Predicate Device: | |
| CERENOVUS Large | ||
| Bore 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 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 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 CEREGLIDE™ 71 | ||
| Intermediate Catheter to the canister of a compatible aspiration pump and to allow the | ||
| user to control the fluid flow. | The CERENOVUS Large Bore | |
| Catheter, with the CERENOVUS | ||
| Aspiration Tubing Set and | ||
| NOUVAG Vacuson 60 aspiration | ||
| pump (or equivalent 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 sympton | ||
| 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. | ||
| 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; Cerenovus | ||
| Aspiration Tubing Set | Predicate Device: | |
| CERENOVUS Large | ||
| Bore 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 Assurance | ||
| Level (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Tyvek® Pouch, Carton | Same |
| Shelf Life | 1 year | 1 year |
| Required Additional | ||
| Accessories | Cerenovus Aspiration Tubing Set (K193380) | |
| Compatible aspiration pump | Same | |
| Aspiration Pump Requirements: | ||
| Minimum Aspiration | ||
| Pressure | -20 inHg (-68 kPa) | Same |
| Maximum Aspiration | ||
| Pressure | -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 Control | ||
| Mechanism | Flow Control Switch | Same |
6
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 | ||
| Visual | ||
| Inspection | Confirm that the Catheter meets the visual requirement | |
| described in ISO 10555-1 Section 4.4. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter ID | Verify that the Catheter internal diameters meet the | |
| requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter OD | Verify that the Catheter outer diameters meet the requirements. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter | ||
| Working | ||
| Length | Confirm the working length of the catheter as defined in ISO | |
| 10555-1 Section 3.6. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter Tip | ||
| Length | Verify the catheter tip length of the Catheter. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| System Air | ||
| Leakage | Verify that there is no air leak into the hub subassembly. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Table 5. Performance Testing Summary, continued | ||
| Test | Test Summary | Result |
| Design Verification | ||
| System Liquid | ||
| Leakage | Verify that the 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 | Verify that the PTFE has appropriately adhered to the inner | |
| lumen of the Catheter with braid reinforcement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Kink (Distal & | ||
| Proximal) | Confirm that the Catheter meets the requirement for the | |
| catheter to remain stable and not kink during use. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Tip Movement | Confirm that the Catheter meets the tip column stiffness | |
| requirement. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Tip Linear | ||
| Stiffness | Test the tip flexibility of the Catheter, relative to other devices | |
| of similar design. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Coating | ||
| Lubricity and | ||
| Durability | Verify the lubriciousness and durability of the Catheter's | |
| hydrophilic coating. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Coating Length | Verify that the Catheter hydrophilic coating length meets the | |
| design requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Peak Tensile | ||
| Strength | Verify that the Catheter joint strength meets the requirements of | |
| Section 4.5 of ISO 10555-1. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Introducer ID | Verify that the introducer internal diameters meet the | |
| requirements. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Particulate | ||
| Count | Verify that the coating integrity of the Catheter's outer surface | |
| meets the requirements for content of Particle Matter in | ||
| alignment with USP counting methods and compared to | ||
| the reference predicate device. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Burst Pressure | Confirm the maximum hydrostatic pressure the Catheter can | |
| withstand using a Crescent Hydraulic Burst-leak Tester. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Introducer | ||
| Working | ||
| Length | Confirm the working length of the introducer. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Introducer | ||
| Separation | ||
| Force | Confirm the force required to separate the introducer. | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Torque Test | To determine the number of revolutions to failure of the | |
| Catheter in simulated anatomy. | PASS: | |
| Samples exceeded comparator | ||
| devices in revolutions to failure | ||
| Design Validation | ||
| In Vitro | ||
| Usability | ||
| Studies | The in-vitro studies were conducted to demonstrate thrombus | |
| retrieval patency/durability, (ancillary) device compatibility, | ||
| and accessory durability. Studies also included simulated use | ||
| evaluation of user requirements related to: trackability and tip | ||
| stability during thrombus removal. | PASS: | |
| Samples met the established | ||
| acceptance criteria |
7
VIII. Non- Clinical Performance Data, continued
8
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 Intermediate
| Catheter and Introducer | ||
|---|---|---|
| Test | Test Summary | Results |
| Chemical | ||
| Characterization | Determination of extractable species from the test article was | |
| performed in purified water, isopropyl alcohol, and hexane. | PASS | |
| Cytotoxicity | Cytotoxicity Study Using the ISO Elution Method (compliant | |
| with ISO 10993-5:2009/(R)2014 and ISO 10993-12:2012). | ||
| 1X MEM extract (6 cm²/ mL at 37°C for 72 hours) was evaluated | ||
| for potential cytotoxic effects using monolayers of L-929 mouse | ||
| fibroblast cells. | PASS |
9
| VIII. Non-
Clinical | Table 6. Biocompatibility Test Summary for CEREGLIDE™ 71 Intermediate
Catheter and Introducer, continued | | | |
|------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--|
| Performance | Test | Test Summary | Results | |
| Data, continued | Sensitization -
Guinea Pig
Maximization | Evaluation of the allergenic potential or sensitizing capacity of a
test article by screening of contact allergens in guinea pigs and
extrapolating the results to humans. | PASS | |
| | Irritation - Rabbit
Intracutaneous
Reactivity | Determination of any chemicals that may leach or be extracted
from the test article capable of causing local irritation in the
dermal tissues of rabbits. | PASS | |
| | Acute Systemic
Toxicity in Mice | Screening of test article extracts for potential toxic effects as a
result of a single-dose systemic injection in mice. | PASS | |
| | Pyrogenicity -
Materials Mediated
Rabbit Pyrogen | Determination if a saline extract of the test article causes a
febrile response in rabbits. | PASS | |
| | ASTM Hemolysis
Study: Direct and
Extraction Methods | Evaluation of the hemolytic potential of the test articles and test
article extract according to ASTM method (F756-17). | PASS | |
| | SC5b-9
Complement
Activation Assay | Measure of complement activation in Normal Human Serum
(NHS) indicates whether a test article is capable of generating the
activation fragment, SC5b-9, which in turn contributes to the
inflammatory immune response in humans. | PASS | |
| | ASTM Heparinized
Platelet and
Leukocyte Count | Determination if medical materials exposed to human whole
blood would adversely affect the platelet and leukocyte ratios in
whole blood. | PASS | |
| | ASTM Partial
Thromboplastin
Time (PTT) | Screening for detection of coagulation abnormalities in the
intrinsic coagulation pathway. The PTT indirectly measures the
formation of thrombin by its action on fibrinogen, forming the
fibrin clot through a method compliant with ISO 10993-4. | PASS | |
| | In Vivo
Thromboresistance | Evaluate the thrombogenic potential of a blood contacting
medical 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.