(228 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter and aspiration system, with no mention of AI or ML.
Yes
The device is indicated for use in the revascularization of patients with acute ischemic stroke, which directly treats a disease condition.
No.
The device is designed for therapeutic purposes, specifically for the revascularization of patients with acute ischemic stroke by removing occlusions. It does not perform diagnostic functions.
No
The device description clearly outlines physical components like a catheter shaft, braid, liner, coating, marker band, luer fitting, and accessories, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This is a therapeutic procedure performed in vivo (within the body) to restore blood flow.
- Device Description: The description details a catheter designed to be introduced into the neurovasculature for aspiration. This is a medical device used for intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used directly within the body to treat a condition.
N/A
Intended Use / Indications for Use
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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA 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.
Product codes
NRY
Device Description
The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub 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 hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.
The CERENOVUS Large Bore Catheter can be connected to the NOUVAG Vacuson 60 aspiration pump (or equivalent 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
Prescription Use
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 CERENOVUS Large Bore Catheter to demonstrate that it is substantially equivalent to the legally marketed Predicate device. The following performance data has been provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures. The bench testing included the following tests:
Visual Inspection, Catheter ID, Introducer ID, Catheter OD, Introducer OD, Catheter Working Length, Introducer Working Length, Distal Tip Length, Hub Luer Taper, Air Leak testing, System Liquid Leakage, Delamination of PTFE Liner, Kink (Distal & Proximal), Tip Movement, Tip Linear Stiffness, Coating Lubricity & Durability, Coating Length, Catheter Tensile Strength, Introducer Separation Force, Particle Count, Burst Pressure (static), Static Flow Rate, Aspiration Flow Rate, In-vitro Usability Studies.
Results: All tests passed, meaning samples met the established acceptance criteria.
The CERENOVUS Aspiration Tubing Set also met all design and performance requirements through the following bench testing:
Dimensional/Visual Inspection, Tensile Strength, Connection to Vacuum Pump, Connection to Catheter, Resist ovalization / Lumen Patency, Resist Leak, Component Connections, Flow Switch Function.
Results: All tests passed, meaning samples met the established acceptance criteria.
Performance Testing - Animal
Non-clinical animal testing was conducted to evaluate the safety, efficacy, and usability of the CERENOVUS Large Bore Catheter in comparison to the Penumbra ACE 68 Reperfusion Catheter at acute and chronic time points in a porcine model, both in the presence and absence of simulated clot. Non-clinical animal testing was conducted in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.
Performance Testing - Clinical
No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Sterilization
The CERENOVUS Large Bore Catheter, as packaged with included accessories, and the CERENOVUS Aspiration Tubing are sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 106 in accordance with ISO 11135-1. The CERENOVUS Large Bore Catheter and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CERENOVUS Large Bore Catheter and all accessories are for single use only.
Shelf-Life Testing
The CERENOVUS Large Bore Catheter will have a shelf life of one year based on the successful completion of stability testing. Shelf life testing was performed using standard test methods and acceptance criteria. Prior to aging, all samples were exposed to standard transportation conditioning. Results of testing on the subject device all met established acceptance criteria. The CERENOVUS Aspiration Tubing will have a shelf life of three (3) years based on the successful completion of stability testing conducted by the manufacturer.
Biocompatibility Testing
The CERENOVUS Large Bore Catheter was assessed for biocompatibility in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process." and FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Issued June 16, 2016), as previously presented in K191237. The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The following Biocompatibility Testing was completed as part of this evaluation: Cytotoxicity (MEM Elution), Sensitization (Maximization Study), Irritation (Intracutaneous Reactivity).
Results: All tests passed. The test article is considered non-cytotoxic, not a sensitizer, and a negligible irritant.
The CERENOVUS Aspiration Tubing Set is also biocompatible for its intended use. Biological evaluation of the aspiration tubing was conducted pursuant to the recommendations in FDA guidance document titled: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". As the aspiration tubing does not have any patient contact, it was evaluated for intact skin contact as a worstcase scenario. All test results passed, indicating that the aspiration tubing is biocompatible for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
July 20, 2020
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.
Codman & Shurtleff, Inc. Kirsten Franco, MS, RAC Associate Director of Regulatory Affairs 325 Paramount Drive Raynham, MA 02767
Re: K193380
Trade/Device Name: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 21, 2020 Received: April 22, 2020
Dear Kirsten Franco:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director (Acting) 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) K193380
Device Name
CERENOVUS Large Bore Catheter; CERENOVUS® Aspiration Tubing Set
Indications for Use (Describe)
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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA 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.
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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3
510(k) Summary K193380
Pursuant to the requirements of 21 CFR Section 807.92(c), this 510(k) summary is provided as part of this Premarket Notification containing sufficient details to understand the basis for a determination of substantial equivalence.
| Submitter | Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kirsten Franco
Phone: (484) 868-7991
Email: kfranco5@its.jnj.com |
| Date Prepared | July 15, 2020 |
| Device Trade
or Proprietary
Name | CERENOVUS Large Bore Catheter
CERENOVUS® Aspiration Tubing Set |
| Device
Classification | Regulatory Classification: II
Common or Usual Name: Catheter, Thrombus Retriever
Classification Name: Percutaneous Catheter
Regulation Number: 21 CFR 870.1250
Product Code: NRY
Classification Panel: Neurology |
| Predicate Device | Primary Predicate Device |
|---|---|
| ------------------ | -------------------------- |
| | 510(k)
Number | Date Cleared | Device Name | Manufacturer |
|--|------------------|---------------|------------------------------------------------|----------------|
| | K161064 | June 12, 2016 | Penumbra System ACE 68
Reperfusion Catheter | Penumbra, Inc. |
| Reference Predicate Device | |
|---|---|
| -- | ---------------------------- |
| | 510(k)
Number | Date Cleared | Device Name | Manufacturer |
|--|------------------|--------------|----------------------------------|-----------------------------|
| | K191237 | Nov 8, 2019 | CERENOVUS Large Bore
Catheter | Medos International
SARL |
4
| Device
Description | The CERENOVUS Large Bore Catheter is a variable stiffness, single lumen catheter
designed to be introduced over a steerable guide wire or microcatheter into the neuro
vasculature. The catheter shaft is composed of a stainless steel variable pitch braid
with a PTFE inner liner to facilitate movement of guide wires and other devices. The
exterior of the catheter shaft is covered with polymer materials, which encapsulate
the stainless steel braid construction. The catheter has a stiff proximal shaft which
transitions into the flexible distal shaft to facilitate the advancement of the catheter in
the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate
fluoroscopic visualization and has a hydrophilic coating to provide lubricity for
navigation of vessels. The proximal end of the catheter has a luer fitting located on
the end of the catheter hub 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 hemostasis valve with a side port and two peel-away
introducers as accessories. The hemostasis valve with side port is used for flushing,
insertion of catheters, and connection to an external aspiration system. The peel
away introducer sheaths are designed to protect the distal tip of the catheter during
insertion into the hemostasis valve.
The CERENOVUS Large Bore Catheter can be connected to the NOUVAG Vacuson
60 aspiration pump (or equivalent aspiration pump) using the CERENOVUS®
Aspiration Tubing Set. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | 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 symptom onset. Patients who are ineligible for intravenous tissue plasminogen
activator (IV t-PA) or who failed IV t-PA 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. |
| Predicate
Comparison | A comparison of the similarities and differences of product features between the
CERENOVUS Large Bore Catheter and the primary predicate device is presented in |
Table 1.
| Description | Subject Device:
CERENOVUS Large Bore Catheter | Primary Predicate Device:
ACE 68 Reperfusion Catheter
(K161064) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Description | Subject Device:
CERENOVUS Large Bore Catheter | Primary Predicate Device:
ACE 68 Reperfusion Catheter
(K161064) |
| Indications For Use | 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
symptom onset. Patients who are ineligible for
intravenous tissue plasminogen activator (IV t-PA) or
who failed IV t-PA 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 Penumbra System is intended 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. |
| Dimensions: | | |
| Length | 125 - 135 cm | 115 – 132 cm |
| ID | 0.071" | 0.068" |
| Distal OD | 0.081" | 0.084" |
| Proximal OD | 0.0825" | 0.084" |
| Catheter Coating | Hydrophilic | Hydrophilic |
| Coating Length | 30 cm | Same |
| Materials: | | |
| Marker Band | Metal Platinum (90%) / Iridium (10%) | Same |
| Braid | Stainless Steel | Stainless Steel, Nitinol |
| Liner | PTFE Liner | Same |
| Hub | Polyamide | Polyamide |
| Strain Relief | Polyamide | Polyamide, Stainless Steel |
| Outer Jacket | Pebax, Urethane, Nylon | Same |
| Tip Configuration | Non-shapeable tip | Steam shapeable by user |
| Accessories Included: | | |
| Hemostasis valve | Hemostasis Valve with Side Port Extension
Tubing | Rotating Hemostasis Valve |
| Introducer
Sheath | Peel-Away Sheath Introducer (2) | Peelable Sheath |
| Shaping | N/A | Shaping Mandrel 0.038" SST |
| Sterilization
Method | Ethylene Oxide | Same |
| Sterility Assurance
Level (SAL) | 10-6 | Same |
| Packaging | Polyethylene Hoop and Mounting Card, Pouch,
Carton | Same |
| Shelf Life | 1 year | 8 months |
| Required
Additional
Accessories | CERENOVUS Aspiration Tubing
NOUVAG Vacuson 60 Pump | Penumbra Hi-Flow Tubing
Penumbra Pump MAX |
| Aspiration Pump Requirements | | |
| Minimum
Aspiration Pressure | -20 inHg (-68 kPa) | Same |
| Maximum
Aspiration Pressure | -29 inHg (-98 kPa) | Same |
| Flowrate (Air) | 0 to 60LPM | 0 to 23 LPM |
| Aspiration Tubing Requirements | | |
| Tubing ID | 0.110 in minimum | Same |
| Tubing Length | 112 in | Same |
| Flow Control
Mechanism | Flow Control Switch | Same |
Table 1. Subject and Predicate Device Comparison Summary
5
6
Non-Clinical Testing Summary
Performance Testing - Bench
Appropriate testing was identified based on design, risk analyses and the intended use of the CERENOVUS Large Bore Catheter to demonstrate that it is substantially equivalent to the legally marketed Predicate device. The following performance data has been provided in support of the substantial equivalence determination. All testing was conducted using sampling methods as required by Codman & Shurtleff, Inc. Design Control procedures. The bench testing included the following tests:
| Test | Test Summary | Result |
|---|---|---|
| Visual Inspection | Confirm that the CERENOVUS Large Bore 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 | ||
| Introducer ID | Verify that the introducer 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 | ||
| Introducer OD | Verify that the introducer outer diameters meet the requirements | PASS: |
| Samples met the established acceptance criteria | ||
| Catheter Working Length | Confirm the working length of a catheter as defined in ISO10555-1 Section 3.6. | PASS: |
| Samples met the established acceptance criteria | ||
| Introducer Working Length | Confirm the working length of the introducer | PASS: |
| Samples met the established acceptance criteria | ||
| Distal Tip Length | Verify the distal tip length of the catheter | PASS: |
| Samples met the established acceptance criteria | ||
| Hub Luer Taper | Verify that the catheter hub luer taper fit standard luer fittings using a taper device | PASS: |
| Samples met the established acceptance criteria | ||
| Air Leak testing | Verify that there is no air leak into the hub subassembly | PASS: |
| Samples met the established acceptance criteria | ||
| 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 CERENOVUS Large Bore Catheter meets the requirement for the catheter to remain stable and not kink during use | PASS: |
| Samples met the established acceptance criteria | ||
| Tip Movement | Confirm that the CERENOVUS Large Bore Catheter meets the tip column stiffness requirement | PASS: |
| Samples met the established acceptance criteria | ||
| Tip Linear Stiffness | Test the tip flexibility of the CERENOVUS Large Bore catheter, relative to other devices of similar design | PASS: |
| Samples met the established acceptance criteria | ||
| Coating Lubricity & Durability | Verify the lubriciousness and durability of the catheter hydrophilic coating | PASS: |
| Samples met the established acceptance criteria | ||
| Coating Length | Verify that the catheter hydrophilic coating | |
| length meets the design requirements | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Catheter Tensile | ||
| Strength | Verify that the catheter joint strength meets the | |
| requirements of Section 4.5 of ISO 10555-1 | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Introducer | ||
| Separation Force | Confirm the force required to separate the peel- | |
| away introducer accessory | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Particle Count | Verify that the coating integrity of the catheter's | |
| outer surface meets the requirements for content | ||
| of Particle Matter in alignment with USP. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Burst Pressure | ||
| (static) | Confirm the maximum hydrostatic pressure a | |
| catheter can withstand using a Crescent | ||
| Hydraulic Burst-leak Tester | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Static Flow Rate | Determine the flow rate through a catheter | PASS: |
| Samples met the established | ||
| acceptance criteria | ||
| Aspiration Flow | ||
| Rate | Determine the aspiration flow rate through a | |
| catheter when the catheter is connected to a | ||
| constant vacuum source. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| In-vitro Usability | ||
| Studies | Evaluate catheter trackability, tip stability and | |
| visibility under fluoroscopy, aspiration | ||
| integrity, ability to aspirate emboli/clot to | ||
| restore flow and the durability, Subject and | ||
| Predicate devices were tracked to the target site | ||
| with the provided accessories to perform | ||
| simulated neurothrombectomy procedure in the | ||
| neurovascular model that replicates the | ||
| tortuosity, diameter and location of the arteries | ||
| in the neurovasculature. | PASS: | |
| Samples met the | ||
| established acceptance | ||
| criteria |
7
Codman also confirmed that the CERENOVUS Aspiration Tubing Set meets all design and performance requirements through the following bench testing:
| Test | Test Summary | Result |
|---|---|---|
| Dimensional/ | ||
| Visual Inspection | Confirm that the Cerenovus Aspiration Tubing | |
| meets all dimensional and visual inspection | ||
| specifications. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Tensile Strength | Confirm that the Cerenovus Aspiration Tubing | |
| meets the existing tensile strength | ||
| specifications. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Connection to | ||
| Vacuum Pump | Suction Connector of Aspiration Tubing | |
| Assembly securely attaches to Pump Canister | ||
| lid via press fit. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Connection to | ||
| Catheter | Rotating Luer of Aspiration Tubing Assembly | |
| securely connects to the female luer of the | ||
| catheter hemostasis valve. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Resist ovalization / | ||
| Lumen Patency | Aspiration Tubing Assembly maintains | |
| functionality and maintains an open lumen, with | ||
| no signs of ovalization, at vacuum pressure per | ||
| product specification. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Resist Leak | Aspiration Tubing Assembly maintains | |
| functionality with no leaks at vacuum pressure | ||
| per product specification. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Component | ||
| Connections | Aspiration Tubing Assembly maintains | |
| functionality with no detachments of any | ||
| bonded components during use. | PASS: | |
| Samples met the established | ||
| acceptance criteria | ||
| Flow Switch | ||
| Function | Flow Control Switch arrests fluid flow in the | |
| OFF position and restores fluid flow in the ON | ||
| position. | PASS: | |
| Samples met the established | ||
| acceptance criteria |
8
Performance Testing - Animal
Non-clinical animal testing was conducted to evaluate the safety, efficacy, and usability of the CERENOVUS Large Bore Catheter in comparison to the Penumbra ACE 68 Reperfusion Catheter at acute and chronic time points in a porcine model, both in the presence and absence of simulated clot. Non-clinical animal testing was conducted in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.
Performance Testing - Clinical
No clinical studies were required as appropriate verification and validation of the catheter and packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Sterilization
The CERENOVUS Large Bore Catheter, as packaged with included accessories, and the CERENOVUS Aspiration Tubing are sterilized using a validated 100% Ethylene Oxide sterilization process to ensure sterility assurance level (SAL) of 106 in accordance with ISO 11135-1. The CERENOVUS Large Bore Catheter and all accessories meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The CERENOVUS Large Bore Catheter and all accessories are for single use only.
Shelf-Life Testing
The CERENOVUS Large Bore Catheter will have a shelf life of one year based on the successful completion of stability testing. Shelf life testing was performed using standard test methods and acceptance criteria. Prior to aging, all samples were exposed to standard transportation conditioning. Results of testing on the subject device all met established acceptance criteria. The CERENOVUS Aspiration Tubing will have a shelf life of three (3) years based on the successful completion of stability testing conducted by the manufacturer.
Biocompatibility Testing
The CERENOVUS Large Bore Catheter was assessed for biocompatibility in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process." and FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Issued June 16, 2016), as previously presented in K191237. The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The following Biocompatibility Testing was completed as part of this evaluation:
Biocompatibility testing previously presented in K191237 is representative of the subject CERENOVUS Large Bore Catheter because the subject device is comprised of the same materials and manufacturing processes.
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Codman also confirmed that the CERENOVUS Aspiration Tubing Set is biocompatible for its intended use. Biological evaluation of the aspiration tubing was conducted pursuant to the recommendations in FDA guidance document titled: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". As the aspiration tubing does not have any patient contact, it was evaluated for intact skin contact as a worstcase scenario. All test results passed, indicating that the aspiration tubing is biocompatible for the intended use.
| Summary of Catheter Biocompatibility Testing | ||
|---|---|---|
| Test | Summary of Results | Conclusion |
| Cytotoxicity | ||
| (MEM Elution) | The test article extract showed no evidence of causing cell | |
| lysis or toxicity (grade = 0). The test article extract met the | ||
| requirements of the test since the grade was less than a grade | ||
| 2 (mild reactivity). | The test article is considered | |
| non-cytotoxic. | ||
| PASS | ||
| Sensitization | ||
| (Maximization | ||
| Study) | The test article extracts showed no evidence of causing | |
| delayed dermal contact sensitization (all erythema scores | ||
| =0). | The test article was not | |
| considered a sensitizer. | ||
| PASS | ||
| Irritation | ||
| (Intracutaneous | ||
| Reactivity) | The test article met the requirements of the test since the | |
| difference between each test article extract overall mean | ||
| score and corresponding control overall mean score was 0.0 | ||
| for both the saline and the sesame oil test article extracts. | The test article is considered | |
| a negligible irritant. | ||
| PASS |
Conclusion
Based upon the intended use, design, materials, function, side-by-side in-vitro testing and animal testing, it is concluded that the subject device, CERENOVUS Large Bore Catheter is substantially equivalent to the primary predicate device, ACE 68 Catheter (K161064, cleared 12 June 2016). The differences in verbiage in the Indications for Use statement, materials, design, and packaging, do not raise any questions regarding the safety and effectiveness of the device. The device, as designed, manufactured, packaged and sterilized, is substantially equivalent to the primary and referenced predicate device(s) currently marketed under the Federal Food, Drug and Cosmetic Act.